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false, "secondary": false }, { "week": 4, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 8, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 12, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 16, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 20, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 24, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 28, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 32, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 36, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 40, "units": 1, "mg": 300, "weightBased": false, "secondary": false } ], "ages": [ "12 and over", "Under 18" ] } ] } }, "atopic-dermatitis/upadacitinib": { "key": "atopic-dermatitis/upadacitinib", "name": "Upadacitinib", "slug": "upadacitinib", "condition": "atopic-dermatitis", "condition_label": "Atopic dermatitis", "atc_code": "L04AF", "atc_label": "Oral agents", "brands": [ "Rinvoq" ], "target": "JAK1", "note": "", "indications": [ "Chronic severe atopic dermatitis" ], "severities": [ "severe" ], "authority_tags": [ "Authority" ], "age_groups": [ "18 and over", "12 and over", "Under 18" ], "phase_groups": [ "INITIAL", "CONTINUING", "DOSE_CHANGE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "12828E", "brands": [ "Rinvoq" ], "form": "15 mg tablet", "manner_of_administration": "Oral", "max_quantity": "28", "max_packs": "1", "pack_size": "28", "repeats": "4", "setting": "", "total_units": 140, "max_weeks": "", "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "12 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "Initial", "regimen": "15 mg once daily. Initial script covers about 20 weeks (140 tablets)." } ] }, { "pbs_code": "12836N", "brands": [ "Rinvoq" ], "form": "30 mg tablet", "manner_of_administration": "Oral", "max_quantity": "28", "max_packs": "1", "pack_size": "28", "repeats": "4", "setting": "", "total_units": 140, "max_weeks": "", "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "12 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] } ], "regimen": "Adults: start 15 mg once daily (15 mg initial item); in adults under 65 years the dose may be increased to 30 mg once daily from week 4 if clinically warranted, prescribed under the 30 mg dose-change item, with the remaining 15 mg repeats cancelled, then continued at the lowest effective dose. Adolescents (12-17 years, ≥40 kg): 15 mg once daily. The 30 mg initial item is PBS-listed (the PBS criteria do not specify a strength) but the PI recommends a 15 mg start, so it is only relevant to a patient commencing PBS supply already established on 30 mg.", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "12831H", "brands": [ "Rinvoq" ], "form": "15 mg tablet", "manner_of_administration": "Oral", "max_quantity": "28", "max_packs": "1", "pack_size": "28", "repeats": "5", "setting": "", "total_units": 168, "max_weeks": "", "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "12 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "15 mg tablet", "regimen": "15 mg once daily from week 20, or 30 mg once daily if the dose was increased (lowest effective dose for maintenance). Continuing script covers about 24 weeks (168 tablets)." }, { "variant": "Continuing", "regimen": "15 mg once daily from week 20. Continuing script covers about 24 weeks (168 tablets)." } ] }, { "pbs_code": "12829F", "brands": [ "Rinvoq" ], "form": "30 mg tablet", "manner_of_administration": "Oral", "max_quantity": "28", "max_packs": "1", "pack_size": "28", "repeats": "5", "setting": "", "total_units": 168, "max_weeks": "", "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "12 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "30 mg tablet (if the dose was increased)", "regimen": "15 mg once daily from week 20, or 30 mg once daily if the dose was increased (lowest effective dose for maintenance). Continuing script covers about 24 weeks (168 tablets)." } ] } ], "regimen": "Continue at the lowest effective maintenance dose from week 20: 15 mg once daily (15 mg continuing item), or 30 mg once daily if the dose was increased (30 mg continuing item).", "regimen_source": "" }, { "phases": [ "DOSE_CHANGE" ], "label": "Dose change", "items": [ { "pbs_code": "12835M", "brands": [ "Rinvoq" ], "form": "15 mg tablet", "manner_of_administration": "Oral", "max_quantity": "28", "max_packs": "1", "pack_size": "28", "repeats": "3", "setting": "", "total_units": 112, "max_weeks": "", "treatment_phases": [ "Dose change" ], "is_balance": false, "age_groups": [ "12 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] }, { "pbs_code": "12827D", "brands": [ "Rinvoq" ], "form": "30 mg tablet", "manner_of_administration": "Oral", "max_quantity": "28", "max_packs": "1", "pack_size": "28", "repeats": "3", "setting": "", "total_units": 112, "max_weeks": "", "treatment_phases": [ "Dose change" ], "is_balance": false, "age_groups": [ "12 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] } ], "regimen": "Dose increase or decrease. Maximum 4 packs (16 weeks). Only permitted once an initial or continuing treatment phase has commenced, and not on more than 2 consecutive occasions within the same prescription period.", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "AbbVie", "name": "Andre Harridge", "phone": "0438 284 729", "email": "andre.harridge@abbvie.com", "note": "rinvoq.com.au (access code: ASPIRE)", "note_href": "https://www.rinvoq.com.au" } ], "compassionate": [ { "text": "Not available" } ] }, "timeline": { "max_week": 44, "tracks": [ { "label": "18 years and over: 15 mg", "segments": [ { "kind": "continuous", "start": 0, "end": 24, "daily_units": "1", "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 0, "weightBased": false, "variant": "Initial", "formulation": "Initial", "escalation": "In adults under 65 years, the dose may be increased to 30 mg once daily from 4 weeks after initiation if clinically warranted. A dose change after the initial script must be prescribed under the 30 mg dose change item code:", "escalation_items": [ { "code": "12827D", "streamlined": [], "setting": "" } ], "deescalation": "The lowest effective dose for maintenance should be considered. A reduction back to 15 mg once daily must be prescribed under the 15 mg dose change item code:", "deescalation_items": [ { "code": "12835M", "streamlined": [], "setting": "" } ], "openEnd": false, "regimen": "15 mg once daily. Initial script covers about 20 weeks (140 tablets).", "items": [ { "code": "12828E", "streamlined": [], "setting": "" } ] }, { "kind": "continuous", "start": 20, "end": 44, "daily_units": "1", "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 20, "coverWeeks": 0, "weightBased": false, "variant": "", "formulation": "15 mg tablet", "escalation": "In adults under 65 years, the dose may be increased to 30 mg once daily if clinically warranted. A dose change during continuing treatment must be prescribed under the 30 mg dose change item code:", "escalation_items": [ { "code": "12827D", "streamlined": [], "setting": "" } ], "deescalation": "The lowest effective dose for maintenance should be considered. A reduction back to 15 mg once daily must be prescribed under the 15 mg dose change item code:", "deescalation_items": [ { "code": "12835M", "streamlined": [], "setting": "" } ], "openEnd": false, "regimen": "15 mg once daily from week 20, or 30 mg once daily if the dose was increased (lowest effective dose for maintenance). Continuing script covers about 24 weeks (168 tablets).", "items": [ { "code": "12831H", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "15 mg tablet", "items": [ { "code": "12831H", "streamlined": [], "setting": "" } ] }, { "label": "30 mg tablet (if the dose was increased)", "items": [ { "code": "12829F", "streamlined": [], "setting": "" } ] } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 20 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 20, "end": 44 } ], "doses": [], "ages": [ "12 and over", "18 and over" ] }, { "label": "12 to 17 years (≥40 kg): 15 mg", "segments": [ { "kind": "continuous", "start": 0, "end": 24, "daily_units": "1", "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 0, "weightBased": false, "variant": "Initial", "formulation": "Initial", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "15 mg once daily. Initial script covers about 20 weeks (140 tablets).", "items": [ { "code": "12828E", "streamlined": [], "setting": "" } ] }, { "kind": "continuous", "start": 20, "end": 44, "daily_units": "1", "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 20, "coverWeeks": 0, "weightBased": false, "variant": "Continuing", "formulation": "Continuing", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "15 mg once daily from week 20. Continuing script covers about 24 weeks (168 tablets).", "items": [ { "code": "12831H", "streamlined": [], "setting": "" } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 20 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 20, "end": 44 } ], "doses": [], "ages": [ "12 and over", "Under 18" ] } ] } }, "chronic-spontaneous-urticaria/omalizumab": { "key": "chronic-spontaneous-urticaria/omalizumab", "name": "Omalizumab", "slug": "omalizumab", "condition": "chronic-spontaneous-urticaria", "condition_label": "Chronic spontaneous urticaria", "atc_code": "D11AH", "atc_label": "Anti-IgE", "brands": [ "Xolair", "Omlyclo" ], "target": "IgE", "note": "", "indications": [ "Severe chronic spontaneous urticaria" ], "severities": [ "Severe" ], "authority_tags": [ "Authority", "Streamlined" ], "age_groups": [ "18 and over", "Under 18", "All ages" ], "phase_groups": [ "INITIAL", "CONTINUING" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "14903J", "brands": [ "Xolair" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "2", "setting": "Private hospital", "total_units": 6, "max_weeks": 12, "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "150 mg pen (2 per dose)", "regimen": "300 mg every 4 weeks (weeks 0, 4 and 8)." }, { "variant": "150 mg pen", "regimen": "150 mg every 4 weeks (weeks 0, 4 and 8) (reduced dose)." } ] }, { "pbs_code": "14945N", "brands": [ "Xolair" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "2", "setting": "Public hospital", "total_units": 6, "max_weeks": 12, "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "150 mg pen (2 per dose)", "regimen": "300 mg every 4 weeks (weeks 0, 4 and 8)." }, { "variant": "150 mg pen", "regimen": "150 mg every 4 weeks (weeks 0, 4 and 8) (reduced dose)." } ] }, { "pbs_code": "11175E", "brands": [ "Omlyclo" ], "form": "150 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "2", "setting": "Private hospital", "total_units": 6, "max_weeks": 12, "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "150 mg syringe (2 per dose)", "regimen": "300 mg every 4 weeks (weeks 0, 4 and 8)." }, { "variant": "150 mg syringe", "regimen": "150 mg every 4 weeks (weeks 0, 4 and 8) (reduced dose)." } ] }, { "pbs_code": "11176F", "brands": [ "Omlyclo" ], "form": "150 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "2", "setting": "Public hospital", "total_units": 6, "max_weeks": 12, "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "150 mg syringe (2 per dose)", "regimen": "300 mg every 4 weeks (weeks 0, 4 and 8)." }, { "variant": "150 mg syringe", "regimen": "150 mg every 4 weeks (weeks 0, 4 and 8) (reduced dose)." } ] }, { "pbs_code": "14940H", "brands": [ "Xolair" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "Private hospital", "total_units": 3, "max_weeks": 12, "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "300 mg pen", "regimen": "300 mg every 4 weeks (weeks 0, 4 and 8)." } ] }, { "pbs_code": "14895Y", "brands": [ "Xolair" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "Public hospital", "total_units": 3, "max_weeks": 12, "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "300 mg pen", "regimen": "300 mg every 4 weeks (weeks 0, 4 and 8)." } ] } ], "regimen": "300 mg every 4 weeks, given as 1 × 300 mg pen, 2 × 150 mg pens or 2 × 150 mg syringes. Some patients are controlled on 150 mg every 4 weeks. Adults and adolescents from 12 years (all presentations; the pens are not for use under 12 years). Initial treatment: 3 doses over 12 weeks.", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "14938F", "brands": [ "Xolair" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "Private hospital", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "150 mg pen (2 per dose)", "regimen": "300 mg every 4 weeks, from week 12." }, { "variant": "150 mg pen", "regimen": "150 mg every 4 weeks (reduced dose), from week 12." } ] }, { "pbs_code": "14937E", "brands": [ "Xolair" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "Public hospital", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "150 mg pen (2 per dose)", "regimen": "300 mg every 4 weeks, from week 12." }, { "variant": "150 mg pen", "regimen": "150 mg every 4 weeks (reduced dose), from week 12." } ] }, { "pbs_code": "11163M", "brands": [ "Omlyclo" ], "form": "150 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "Private hospital", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] }, { "pbs_code": "14911T", "brands": [ "Omlyclo" ], "form": "150 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "Private hospital", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "16960", "label": "" } ], "dosing": [ { "variant": "150 mg syringe (2 per dose)", "regimen": "300 mg every 4 weeks, from week 12." }, { "variant": "150 mg syringe", "regimen": "150 mg every 4 weeks (reduced dose), from week 12." } ] }, { "pbs_code": "11168T", "brands": [ "Omlyclo" ], "form": "150 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "Public hospital", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] }, { "pbs_code": "14946P", "brands": [ "Omlyclo" ], "form": "150 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "Public hospital", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "16905", "label": "" } ], "dosing": [ { "variant": "150 mg syringe (2 per dose)", "regimen": "300 mg every 4 weeks, from week 12." }, { "variant": "150 mg syringe", "regimen": "150 mg every 4 weeks (reduced dose), from week 12." } ] }, { "pbs_code": "14930T", "brands": [ "Xolair" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "5", "setting": "Private hospital", "total_units": 6, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "300 mg pen", "regimen": "300 mg every 4 weeks, from week 12." } ] }, { "pbs_code": "14913X", "brands": [ "Xolair" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "5", "setting": "Public hospital", "total_units": 6, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "300 mg pen", "regimen": "300 mg every 4 weeks, from week 12." } ] } ], "regimen": "300 mg (or 150 mg) subcutaneously every 4 weeks, from week 12.", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "Novartis", "name": "Hesham Mahmoud", "email": "Hesham.mahmoud@novartis.com" } ], "compassionate": [ { "text": "access.program-aunz@novartis.com", "href": "mailto:access.program-aunz@novartis.com" } ] }, "timeline": { "max_week": 36, "tracks": [ { "label": "Adults and adolescents ≥12 years · 300 mg every 4 weeks", "segments": [ { "kind": "doses", "start": 0, "end": 8, "doses": [ { "week": 0, "units": 1, "mg": 300 }, { "week": 4, "units": 1, "mg": 300 }, { "week": 8, "units": 1, "mg": 300 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 12, "weightBased": false, "variant": "", "formulation": "300 mg pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "300 mg every 4 weeks (weeks 0, 4 and 8).", "items": [ { "code": "14940H", "streamlined": [], "setting": "Private hospital" }, { "code": "14895Y", "streamlined": [], "setting": "Public hospital" } ], "formulations": [ { "label": "300 mg pen", "items": [ { "code": "14940H", "streamlined": [], "setting": "Private hospital" }, { "code": "14895Y", "streamlined": [], "setting": "Public hospital" } ] }, { "label": "150 mg pen (2 per dose)", "items": [ { "code": "14903J", "streamlined": [], "setting": "Private hospital" }, { "code": "14945N", "streamlined": [], "setting": "Public hospital" } ] }, { "label": "150 mg syringe (2 per dose)", "items": [ { "code": "11175E", "streamlined": [], "setting": "Private hospital" }, { "code": "11176F", "streamlined": [], "setting": "Public hospital" } ] } ] }, { "kind": "doses", "start": 12, "end": 32, "doses": [ { "week": 12, "units": 1, "mg": 300 }, { "week": 16, "units": 1, "mg": 300 }, { "week": 20, "units": 1, "mg": 300 }, { "week": 24, "units": 1, "mg": 300 }, { "week": 28, "units": 1, "mg": 300 }, { "week": 32, "units": 1, "mg": 300 } ], "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 12, "coverWeeks": 24, "weightBased": false, "variant": "", "formulation": "300 mg pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "300 mg every 4 weeks, from week 12.", "items": [ { "code": "14930T", "streamlined": [], "setting": "Private hospital" }, { "code": "14913X", "streamlined": [], "setting": "Public hospital" } ], "formulations": [ { "label": "300 mg pen", "items": [ { "code": "14930T", "streamlined": [], "setting": "Private hospital" }, { "code": "14913X", "streamlined": [], "setting": "Public hospital" } ] }, { "label": "150 mg pen (2 per dose)", "items": [ { "code": "14938F", "streamlined": [], "setting": "Private hospital" }, { "code": "14937E", "streamlined": [], "setting": "Public hospital" } ] }, { "label": "150 mg syringe (2 per dose)", "items": [ { "code": "14911T", "streamlined": [ { "code": "16960", "label": "" } ], "setting": "Private hospital" }, { "code": "14946P", "streamlined": [ { "code": "16905", "label": "" } ], "setting": "Public hospital" } ] } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 12 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 12, "end": 36 } ], "doses": [ { "week": 0, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 4, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 8, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 12, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 16, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 20, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 24, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 28, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 32, "units": 1, "mg": 300, "weightBased": false, "secondary": false } ], "ages": [ "All ages", "18 and over", "Under 18" ] }, { "label": "Adults and adolescents ≥12 years · 150 mg every 4 weeks", "segments": [ { "kind": "doses", "start": 0, "end": 8, "doses": [ { "week": 0, "units": 1, "mg": 150 }, { "week": 4, "units": 1, "mg": 150 }, { "week": 8, "units": 1, "mg": 150 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 12, "weightBased": false, "variant": "", "formulation": "150 mg pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "150 mg every 4 weeks (weeks 0, 4 and 8) (reduced dose).", "items": [ { "code": "14903J", "streamlined": [], "setting": "Private hospital" }, { "code": "14945N", "streamlined": [], "setting": "Public hospital" } ], "formulations": [ { "label": "150 mg pen", "items": [ { "code": "14903J", "streamlined": [], "setting": "Private hospital" }, { "code": "14945N", "streamlined": [], "setting": "Public hospital" } ] }, { "label": "150 mg syringe", "items": [ { "code": "11175E", "streamlined": [], "setting": "Private hospital" }, { "code": "11176F", "streamlined": [], "setting": "Public hospital" } ] } ] }, { "kind": "doses", "start": 12, "end": 32, "doses": [ { "week": 12, "units": 1, "mg": 150 }, { "week": 16, "units": 1, "mg": 150 }, { "week": 20, "units": 1, "mg": 150 }, { "week": 24, "units": 1, "mg": 150 }, { "week": 28, "units": 1, "mg": 150 }, { "week": 32, "units": 1, "mg": 150 } ], "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 12, "coverWeeks": 24, "weightBased": false, "variant": "", "formulation": "150 mg pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "150 mg every 4 weeks (reduced dose), from week 12.", "items": [ { "code": "14938F", "streamlined": [], "setting": "Private hospital" }, { "code": "14937E", "streamlined": [], "setting": "Public hospital" } ], "formulations": [ { "label": "150 mg pen", "items": [ { "code": "14938F", "streamlined": [], "setting": "Private hospital" }, { "code": "14937E", "streamlined": [], "setting": "Public hospital" } ] }, { "label": "150 mg syringe", "items": [ { "code": "14911T", "streamlined": [ { "code": "16960", "label": "" } ], "setting": "Private hospital" }, { "code": "14946P", "streamlined": [ { "code": "16905", "label": "" } ], "setting": "Public hospital" } ] } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 12 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 12, "end": 36 } ], "doses": [ { "week": 0, "units": 1, "mg": 150, "weightBased": false, "secondary": false }, { "week": 4, "units": 1, "mg": 150, "weightBased": false, "secondary": false }, { "week": 8, "units": 1, "mg": 150, "weightBased": false, "secondary": false }, { "week": 12, "units": 1, "mg": 150, "weightBased": false, "secondary": false }, { "week": 16, "units": 1, "mg": 150, "weightBased": false, "secondary": false }, { "week": 20, "units": 1, "mg": 150, "weightBased": false, "secondary": false }, { "week": 24, "units": 1, "mg": 150, "weightBased": false, "secondary": false }, { "week": 28, "units": 1, "mg": 150, "weightBased": false, "secondary": false }, { "week": 32, "units": 1, "mg": 150, "weightBased": false, "secondary": false } ], "ages": [ "All ages", "18 and over", "Under 18" ] } ] } }, "hidradenitis-suppurativa/adalimumab": { "key": "hidradenitis-suppurativa/adalimumab", "name": "Adalimumab", "slug": "adalimumab", "condition": "hidradenitis-suppurativa", "condition_label": "Hidradenitis suppurativa", "atc_code": "L04AB", "atc_label": "TNF-α inhibitors", "brands": [ "Humira", "Abrilada", "Amgevita", "Hadlima", "Hyrimoz", "Yuflyma" ], "target": "TNF-α", "note": "Prescribing a biosimilar brand is encouraged for treatment-naive patients.", "indications": [ "Moderate to severe hidradenitis suppurativa" ], "severities": [ "Moderate to severe" ], "authority_tags": [ "Authority", "Streamlined" ], "age_groups": [ "18 and over", "Under 18", "All ages" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "12454L", "brands": [ "Humira", "Hadlima", "Hyrimoz", "Yuflyma" ], "form": "40 mg in 0.4 mL pen", "manner_of_administration": "Injection", "max_quantity": "6", "max_packs": "3", "pack_size": "2", "repeats": "0", "setting": "", "total_units": 6, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "40 mg in 0.4 mL pen", "regimen": "160 mg at week 0 (as 4 × 40 mg), then 80 mg at week 2 (as 2 × 40 mg). This initial script supplies the first 4 weeks." }, { "variant": "40 mg in 0.4 mL pen", "regimen": "160 mg at week 0 (as 4 × 40 mg or 2 × 80 mg), then 80 mg at week 2 (as 2 × 40 mg or 1 × 80 mg). This initial script supplies the first 4 weeks." }, { "variant": "40 mg in 0.4 mL pen", "regimen": "80 mg at week 0 (as 2 × 40 mg), then 40 mg every 2 weeks from week 1. This initial script supplies the first 4 weeks." } ] }, { "pbs_code": "12383R", "brands": [ "Humira", "Hadlima", "Hyrimoz", "Yuflyma" ], "form": "40 mg in 0.4 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "2", "pack_size": "2", "repeats": "2", "setting": "", "total_units": 12, "max_weeks": 16, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "40 mg in 0.4 mL pen", "regimen": "40 mg every week from week 4 to week 15; balance-of-supply script completing the 16-week initial course." }, { "variant": "40 mg in 0.4 mL pen (2 per dose)", "regimen": "80 mg every 2 weeks from week 4 to week 14; balance-of-supply script completing the 16-week initial course." }, { "variant": "40 mg in 0.4 mL pen", "regimen": "40 mg every 2 weeks to week 15; balance-of-supply script completing the 16-week initial course." } ] }, { "pbs_code": "12356H", "brands": [ "Abrilada", "Amgevita", "Hadlima", "Hyrimoz" ], "form": "40 mg in 0.8 mL pen", "manner_of_administration": "Injection", "max_quantity": "6", "max_packs": "3", "pack_size": "2", "repeats": "0", "setting": "", "total_units": 6, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "40 mg in 0.8 mL pen", "regimen": "160 mg at week 0 (as 4 × 40 mg), then 80 mg at week 2 (as 2 × 40 mg). This initial script supplies the first 4 weeks." }, { "variant": "40 mg in 0.8 mL pen", "regimen": "160 mg at week 0 (as 4 × 40 mg or 2 × 80 mg), then 80 mg at week 2 (as 2 × 40 mg or 1 × 80 mg). This initial script supplies the first 4 weeks." }, { "variant": "40 mg in 0.8 mL pen", "regimen": "80 mg at week 0 (as 2 × 40 mg), then 40 mg every 2 weeks from week 1. This initial script supplies the first 4 weeks." } ] }, { "pbs_code": "12385W", "brands": [ "Abrilada", "Amgevita", "Hadlima", "Hyrimoz" ], "form": "40 mg in 0.8 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "2", "pack_size": "2", "repeats": "2", "setting": "", "total_units": 12, "max_weeks": 16, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "40 mg in 0.8 mL pen", "regimen": "40 mg every week from week 4 to week 15; balance-of-supply script completing the 16-week initial course." }, { "variant": "40 mg in 0.8 mL pen (2 per dose)", "regimen": "80 mg every 2 weeks from week 4 to week 14; balance-of-supply script completing the 16-week initial course." }, { "variant": "40 mg in 0.8 mL pen", "regimen": "40 mg every 2 weeks to week 15; balance-of-supply script completing the 16-week initial course." } ] }, { "pbs_code": "12450G", "brands": [ "Humira", "Hyrimoz", "Yuflyma" ], "form": "80 mg in 0.8 mL pen", "manner_of_administration": "Injection", "max_quantity": "3", "max_packs": "3", "pack_size": "1", "repeats": "0", "setting": "", "total_units": 3, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "80 mg in 0.8 mL pen", "regimen": "160 mg at week 0 (as 4 × 40 mg or 2 × 80 mg), then 80 mg at week 2 (as 2 × 40 mg or 1 × 80 mg). This initial script supplies the first 4 weeks." } ] }, { "pbs_code": "12449F", "brands": [ "Humira", "Hyrimoz", "Yuflyma" ], "form": "80 mg in 0.8 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 6, "max_weeks": 16, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "80 mg in 0.8 mL pen", "regimen": "80 mg every 2 weeks from week 4 to week 14; balance-of-supply script completing the 16-week initial course." } ] }, { "pbs_code": "12524E", "brands": [ "Humira", "Yuflyma" ], "form": "80 mg in 0.8 mL syringe", "manner_of_administration": "Injection", "max_quantity": "3", "max_packs": "3", "pack_size": "1", "repeats": "0", "setting": "", "total_units": 3, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "80 mg in 0.8 mL syringe", "regimen": "160 mg at week 0 (as 4 × 40 mg or 2 × 80 mg), then 80 mg at week 2 (as 2 × 40 mg or 1 × 80 mg). This initial script supplies the first 4 weeks." } ] }, { "pbs_code": "12395J", "brands": [ "Humira", "Yuflyma" ], "form": "80 mg in 0.8 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 6, "max_weeks": 16, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "80 mg in 0.8 mL syringe", "regimen": "80 mg every 2 weeks from week 4 to week 14; balance-of-supply script completing the 16-week initial course." } ] } ], "regimen": "18 and over: 160 mg at week 0 (as 4 × 40 mg or 2 × 80 mg), then 80 mg at week 2, then from week 4 either 40 mg every week or 80 mg every 2 weeks. The initial script supplies the first 4 weeks and the balance-of-supply script supplies weeks 4-15, completing the 16-week initial course. 12-17 years (≥30 kg): 80 mg at week 0 (as 2 × 40 mg), then 40 mg every 2 weeks from week 1; if response is inadequate the dose may be increased to 40 mg every week or 80 mg every 2 weeks.", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "12414J", "brands": [ "Humira", "Hadlima", "Hyrimoz", "Yuflyma" ], "form": "40 mg in 0.4 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "2", "pack_size": "2", "repeats": "5", "setting": "", "total_units": 24, "max_weeks": "", "treatment_phases": [ "First continuing", "Subsequent continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "40 mg in 0.4 mL pen", "regimen": "40 mg every week, from week 16." }, { "variant": "40 mg in 0.4 mL pen", "regimen": "40 mg every week, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." }, { "variant": "40 mg in 0.4 mL pen (2 per dose)", "regimen": "80 mg every 2 weeks, from week 16." }, { "variant": "40 mg in 0.4 mL pen (2 per dose)", "regimen": "80 mg every 2 weeks, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." }, { "variant": "40 mg in 0.4 mL pen", "regimen": "40 mg every 2 weeks, from week 17." }, { "variant": "40 mg in 0.4 mL pen", "regimen": "40 mg every 2 weeks, from week 41. Authority Required code, or the streamlined code for eligible biosimilar brands." } ] }, { "pbs_code": "13221W", "brands": [ "Hadlima", "Hyrimoz", "Yuflyma" ], "form": "40 mg in 0.4 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "2", "pack_size": "2", "repeats": "5", "setting": "", "total_units": 24, "max_weeks": "", "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "11528", "label": "" } ], "dosing": [ { "variant": "40 mg in 0.4 mL pen", "regimen": "40 mg every week, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." }, { "variant": "40 mg in 0.4 mL pen (2 per dose)", "regimen": "80 mg every 2 weeks, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." }, { "variant": "40 mg in 0.4 mL pen", "regimen": "40 mg every 2 weeks, from week 41. Authority Required code, or the streamlined code for eligible biosimilar brands." } ] }, { "pbs_code": "12369B", "brands": [ "Abrilada", "Amgevita", "Hadlima", "Hyrimoz" ], "form": "40 mg in 0.8 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "2", "pack_size": "2", "repeats": "5", "setting": "", "total_units": 24, "max_weeks": "", "treatment_phases": [ "First continuing", "Subsequent continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "40 mg in 0.8 mL pen", "regimen": "40 mg every week, from week 16." }, { "variant": "40 mg in 0.8 mL pen", "regimen": "40 mg every week, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." }, { "variant": "40 mg in 0.8 mL pen (2 per dose)", "regimen": "80 mg every 2 weeks, from week 16." }, { "variant": "40 mg in 0.8 mL pen (2 per dose)", "regimen": "80 mg every 2 weeks, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." }, { "variant": "40 mg in 0.8 mL pen", "regimen": "40 mg every 2 weeks, from week 17." }, { "variant": "40 mg in 0.8 mL pen", "regimen": "40 mg every 2 weeks, from week 41. Authority Required code, or the streamlined code for eligible biosimilar brands." } ] }, { "pbs_code": "12330Y", "brands": [ "Abrilada", "Amgevita", "Hadlima", "Hyrimoz" ], "form": "40 mg in 0.8 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "2", "pack_size": "2", "repeats": "5", "setting": "", "total_units": 24, "max_weeks": "", "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "11528", "label": "" } ], "dosing": [ { "variant": "40 mg in 0.8 mL pen", "regimen": "40 mg every week, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." }, { "variant": "40 mg in 0.8 mL pen (2 per dose)", "regimen": "80 mg every 2 weeks, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." }, { "variant": "40 mg in 0.8 mL pen", "regimen": "40 mg every 2 weeks, from week 41. Authority Required code, or the streamlined code for eligible biosimilar brands." } ] }, { "pbs_code": "12448E", "brands": [ "Humira", "Hyrimoz", "Yuflyma" ], "form": "80 mg in 0.8 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": "", "treatment_phases": [ "First continuing", "Subsequent continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "80 mg in 0.8 mL pen", "regimen": "80 mg every 2 weeks, from week 16." }, { "variant": "80 mg in 0.8 mL pen", "regimen": "80 mg every 2 weeks, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." } ] }, { "pbs_code": "14587R", "brands": [ "Hyrimoz", "Yuflyma" ], "form": "80 mg in 0.8 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": "", "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "11528", "label": "" } ], "dosing": [ { "variant": "80 mg in 0.8 mL pen", "regimen": "80 mg every 2 weeks, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." } ] }, { "pbs_code": "12408C", "brands": [ "Humira", "Yuflyma" ], "form": "80 mg in 0.8 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": "", "treatment_phases": [ "First continuing", "Subsequent continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "80 mg in 0.8 mL syringe", "regimen": "80 mg every 2 weeks, from week 16." }, { "variant": "80 mg in 0.8 mL syringe", "regimen": "80 mg every 2 weeks, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." } ] }, { "pbs_code": "14622N", "brands": [ "Yuflyma" ], "form": "80 mg in 0.8 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": "", "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "11528", "label": "" } ], "dosing": [ { "variant": "80 mg in 0.8 mL syringe", "regimen": "80 mg every 2 weeks, from week 40. Authority Required code, or the streamlined code for eligible biosimilar brands." } ] } ], "regimen": "18 and over: 40 mg every week or 80 mg every 2 weeks, from week 16 (24 weeks per continuing course; subsequent continuing from week 40). 12-17 years: 40 mg every 2 weeks, or 40 mg every week / 80 mg every 2 weeks if the dose was increased. Subsequent continuing courses of a biosimilar brand may use the streamlined code (11528).", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "AbbVie", "name": "Andre Harridge", "phone": "0438 284 729", "email": "andre.harridge@abbvie.com" } ], "compassionate": [ { "text": "compassionate.abbvie.com.au", "href": "https://compassionate.abbvie.com.au" } ] }, "timeline": { "max_week": 65, "tracks": [ { "label": "18 and over: 40 mg every week", "segments": [ { "kind": "doses", "start": 0, "end": 2, "doses": [ { "week": 0, "units": 4, "mg": 160 }, { "week": 2, "units": 2, "mg": 80 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 16, "weightBased": false, "variant": "", "formulation": "40 mg in 0.4 mL pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "160 mg at week 0 (as 4 × 40 mg), then 80 mg at week 2 (as 2 × 40 mg). 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false }, { "week": 25, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 27, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 29, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 31, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 33, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 35, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 37, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 39, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 41, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 43, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 45, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 47, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 49, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 51, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 53, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 55, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 57, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 59, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 61, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 63, "units": 1, "mg": 40, "weightBased": false, "secondary": false } ], "ages": [ "All ages", "Under 18" ] } ] } }, "hidradenitis-suppurativa/bimekizumab": { "key": "hidradenitis-suppurativa/bimekizumab", "name": "bimekizumab", "slug": "bimekizumab", "condition": "hidradenitis-suppurativa", "condition_label": "Hidradenitis suppurativa", "atc_code": "L04AC", "atc_label": "IL-17 inhibitors", "brands": [ "Bimzelx" ], "target": "IL-17A & IL-17F", "note": "", "indications": [ "Moderate to severe hidradenitis suppurativa" ], "severities": [ "Moderate to severe" ], "authority_tags": [ "Authority" ], "age_groups": [ "All ages" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "15116N", "brands": [ "Bimzelx" ], "form": "160 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "2", "pack_size": "2", "repeats": "3", "setting": "", "total_units": 16, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "160 mg pen (2 per dose)", "regimen": "320 mg (2 × 160 mg) every 4 weeks (monthly) through the initial period to week 16" } ] }, { "pbs_code": "15110G", "brands": [ "Bimzelx" ], "form": "160 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "2", "pack_size": "2", "repeats": "3", "setting": "", "total_units": 16, "max_weeks": 16, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] }, { "pbs_code": "15131J", "brands": [ "Bimzelx" ], "form": "320 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 8, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "320 mg pen", "regimen": "320 mg every 4 weeks (monthly) through the initial period to week 16" } ] }, { "pbs_code": "15119R", "brands": [ "Bimzelx" ], "form": "320 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 8, "max_weeks": 16, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] } ], "regimen": "320 mg every 4 weeks (monthly) to week 16. If more rapid disease control is desired, 320 mg may be given every 2 weeks (fortnightly) until week 16, then return to every 4 weeks; add the balance-of-supply script for the extra doses (320 mg pen 15119R; 160 mg pen 15110G).", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "15133L", "brands": [ "Bimzelx" ], "form": "160 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "160 mg pen (2 per dose)", "regimen": "320 mg (2 × 160 mg) every 4 weeks" } ] }, { "pbs_code": "15112J", "brands": [ "Bimzelx" ], "form": "320 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 6, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "320 mg pen", "regimen": "320 mg every 4 weeks, from week 16" } ] } ], "regimen": "320 mg every 4 weeks, from week 16", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "UCB", "name": "Genevieve Wuoti", "email": "Genevieve.wuoti@ucb.com" } ], "compassionate": [ { "text": "Tracey.M.Edwards@ucb.com", "href": "mailto:Tracey.M.Edwards@ucb.com" } ] }, "timeline": { "max_week": 40, "tracks": [ { "label": "320 mg: every 4 weeks (monthly)", "segments": [ { "kind": "doses", "start": 0, "end": 12, "doses": [ { "week": 0, "units": 1, "mg": 320 }, { "week": 4, "units": 1, "mg": 320 }, { "week": 8, "units": 1, "mg": 320 }, { "week": 12, "units": 1, "mg": 320 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 16, "weightBased": false, "variant": "", "formulation": "320 mg pen", "escalation": "If more rapid disease control is desired, 320 mg may be given every 2 weeks (fortnightly) until week 16, then return to every 4 weeks. Add the balance-of-supply script for the extra doses (320 mg pen, or 2 × 160 mg pen per dose):", "escalation_items": [ { "code": "15119R", "streamlined": [], "setting": "" }, { "code": "15110G", "streamlined": [], "setting": "" } ], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "320 mg every 4 weeks (monthly) through the initial period to week 16", "items": [ { "code": "15131J", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "320 mg pen", "items": [ { "code": "15131J", "streamlined": [], "setting": "" } ] }, { "label": "160 mg pen (2 per dose)", "items": [ { "code": "15116N", "streamlined": [], "setting": "" } ] } ] }, { "kind": "doses", "start": 16, "end": 36, "doses": [ { "week": 16, "units": 1, "mg": 320 }, { "week": 20, "units": 1, "mg": 320 }, { "week": 24, "units": 1, "mg": 320 }, { "week": 28, "units": 1, "mg": 320 }, { "week": 32, "units": 1, "mg": 320 }, { "week": 36, "units": 1, "mg": 320 } ], "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 16, "coverWeeks": 24, "weightBased": false, "variant": "", "formulation": "320 mg pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "320 mg every 4 weeks, from week 16", "items": [ { "code": "15112J", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "320 mg pen", "items": [ { "code": "15112J", "streamlined": [], "setting": "" } ] }, { "label": "160 mg pen (2 per dose)", "items": [ { "code": "15133L", "streamlined": [], "setting": "" } ] } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 16 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 16, "end": 40 } ], "doses": [ { "week": 0, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 4, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 8, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 12, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 16, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 20, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 24, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 28, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 32, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 36, "units": 1, "mg": 320, "weightBased": false, "secondary": false } ], "ages": [ "All ages" ] } ] } }, "hidradenitis-suppurativa/secukinumab": { "key": "hidradenitis-suppurativa/secukinumab", "name": "Secukinumab", "slug": "secukinumab", "condition": "hidradenitis-suppurativa", "condition_label": "Hidradenitis suppurativa", "atc_code": "L04AC", "atc_label": "IL-17 inhibitors", "brands": [ "Cosentyx" ], "target": "IL-17A", "note": "", "indications": [ "Moderate to severe hidradenitis suppurativa" ], "severities": [ "Moderate to severe" ], "authority_tags": [ "Authority" ], "age_groups": [ "All ages" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "14154Y", "brands": [ "Cosentyx" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "8", "max_packs": "4", "pack_size": "2", "repeats": "0", "setting": "", "total_units": 8, "max_weeks": 20, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "Loading", "regimen": "300 mg (2 × 150 mg) weekly at weeks 0, 1, 2 and 3." } ] }, { "pbs_code": "14161H", "brands": [ "Cosentyx" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "3", "setting": "", "total_units": 8, "max_weeks": 20, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg (2 × 150 mg) every 4 weeks from week 4." } ] }, { "pbs_code": "14164L", "brands": [ "Cosentyx" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "3", "setting": "", "total_units": 8, "max_weeks": 20, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] }, { "pbs_code": "15004Q", "brands": [ "Cosentyx" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "4", "pack_size": "1", "repeats": "0", "setting": "", "total_units": 4, "max_weeks": 20, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "Loading", "regimen": "300 mg weekly at weeks 0, 1, 2 and 3." } ] }, { "pbs_code": "15030C", "brands": [ "Cosentyx" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 4, "max_weeks": 20, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg every 4 weeks from week 4." } ] }, { "pbs_code": "14983N", "brands": [ "Cosentyx" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 4, "max_weeks": 20, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] } ], "regimen": "300 mg weekly at weeks 0-3, then 300 mg every 4 weeks (monthly) or, if response is inadequate, every 2 weeks (fortnightly) from week 4. Initial treatment covers 16 weeks.", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "14146M", "brands": [ "Cosentyx" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": "", "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg (2 × 150 mg) every 4 weeks from week 20, or every 2 weeks (fortnightly) if the dose was escalated." } ] }, { "pbs_code": "14970X", "brands": [ "Cosentyx" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 6, "max_weeks": "", "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "All ages" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg every 4 weeks from week 20, or every 2 weeks (fortnightly) if the dose was escalated." } ] } ], "regimen": "300 mg every 4 weeks (monthly) from week 20, or every 2 weeks (fortnightly) if response is inadequate.", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "Novartis", "name": "Jo Taylor", "phone": "0423 890 017", "email": "Joanne-1.taylor@novartis.com" } ], "compassionate": [ { "text": "access.program-aunz@novartis.com", "href": "mailto:access.program-aunz@novartis.com" } ] }, "timeline": { "max_week": 44, "tracks": [ { "label": "300 mg pen", "segments": [ { "kind": "doses", "start": 0, "end": 3, "doses": [ { "week": 0, "units": 1, "mg": 300 }, { "week": 1, "units": 1, "mg": 300 }, { "week": 2, "units": 1, "mg": 300 }, { "week": 3, "units": 1, "mg": 300 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 20, "weightBased": false, "variant": "Loading", "formulation": "Loading", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "300 mg weekly at weeks 0, 1, 2 and 3.", "items": [ { "code": "15004Q", "streamlined": [], "setting": "" } ] }, { "kind": "doses", "start": 4, "end": 16, "doses": [ { "week": 4, "units": 1, "mg": 300 }, { "week": 8, "units": 1, "mg": 300 }, { "week": 12, "units": 1, "mg": 300 }, { "week": 16, "units": 1, "mg": 300 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 4, "coverWeeks": 20, "weightBased": false, "variant": "", "formulation": "300 mg in 2 mL pen", "escalation": "If response is inadequate, 300 mg may be given every 2 weeks (fortnightly) from week 4; the extra doses are supplied by the balance-of-supply code:", "escalation_items": [ { "code": "14983N", "streamlined": [], "setting": "" } ], "deescalation": "", "deescalation_items": [], "openEnd": true, "regimen": "300 mg every 4 weeks from week 4.", "items": [ { "code": "15030C", "streamlined": [], "setting": "" } ] }, { "kind": "doses", "start": 20, "end": 40, "doses": [ { "week": 20, "units": 1, "mg": 300 }, { "week": 24, "units": 1, "mg": 300 }, { "week": 28, "units": 1, "mg": 300 }, { "week": 32, "units": 1, "mg": 300 }, { "week": 36, "units": 1, "mg": 300 }, { "week": 40, "units": 1, "mg": 300 } ], "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 20, "coverWeeks": 0, "weightBased": false, "variant": "", "formulation": "300 mg in 2 mL pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": true, "regimen": "300 mg every 4 weeks from week 20, or every 2 weeks (fortnightly) if the dose was escalated.", "items": [ { "code": "14970X", "streamlined": [], "setting": "" } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 4 }, { "band": "INITIAL", "phase": "INITIAL", "start": 4, "end": 20 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 20, "end": 44 } ], "doses": [ { "week": 0, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 1, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 2, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 3, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 4, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 8, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 12, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 16, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 20, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 24, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 28, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 32, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 36, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 40, "units": 1, "mg": 300, "weightBased": false, "secondary": false } ], "ages": [ "All ages" ] }, { "label": "150 mg pen", "segments": [ { "kind": "doses", "start": 0, "end": 3, "doses": [ { "week": 0, "units": 2, "mg": 300 }, { "week": 1, "units": 2, "mg": 300 }, { "week": 2, "units": 2, "mg": 300 }, { "week": 3, "units": 2, "mg": 300 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 20, "weightBased": false, "variant": "Loading", "formulation": "Loading", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "300 mg (2 × 150 mg) weekly at weeks 0, 1, 2 and 3.", "items": [ { "code": "14154Y", "streamlined": [], "setting": "" } ] }, { "kind": "doses", "start": 4, "end": 16, "doses": [ { "week": 4, "units": 2, "mg": 300 }, { "week": 8, "units": 2, "mg": 300 }, { "week": 12, "units": 2, "mg": 300 }, { "week": 16, "units": 2, "mg": 300 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 4, "coverWeeks": 20, "weightBased": false, "variant": "", "formulation": "150 mg in 1 mL pen", "escalation": "If response is inadequate, 300 mg may be given every 2 weeks (fortnightly) from week 4; the extra doses are supplied by the balance-of-supply code:", "escalation_items": [ { "code": "14164L", "streamlined": [], "setting": "" } ], "deescalation": "", "deescalation_items": [], "openEnd": true, "regimen": "300 mg (2 × 150 mg) every 4 weeks from week 4.", "items": [ { "code": "14161H", "streamlined": [], "setting": "" } ] }, { "kind": "doses", "start": 20, "end": 40, "doses": [ { "week": 20, "units": 2, "mg": 300 }, { "week": 24, "units": 2, "mg": 300 }, { "week": 28, "units": 2, "mg": 300 }, { "week": 32, "units": 2, "mg": 300 }, { "week": 36, "units": 2, "mg": 300 }, { "week": 40, "units": 2, "mg": 300 } ], "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 20, "coverWeeks": 0, "weightBased": false, "variant": "", "formulation": "150 mg in 1 mL pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": true, "regimen": "300 mg (2 × 150 mg) every 4 weeks from week 20, or every 2 weeks (fortnightly) if the dose was escalated.", "items": [ { "code": "14146M", "streamlined": [], "setting": "" } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 4 }, { "band": "INITIAL", "phase": "INITIAL", "start": 4, "end": 20 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 20, "end": 44 } ], "doses": [ { "week": 0, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 1, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 2, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 3, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 4, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 8, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 12, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 16, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 20, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 24, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 28, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 32, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 36, "units": 2, "mg": 300, "weightBased": false, "secondary": false }, { "week": 40, "units": 2, "mg": 300, "weightBased": false, "secondary": false } ], "ages": [ "All ages" ] } ] } }, "psoriasis/adalimumab": { "key": "psoriasis/adalimumab", "name": "Adalimumab", "slug": "adalimumab", "condition": "psoriasis", "condition_label": "Psoriasis", "atc_code": "L04AB", "atc_label": "TNF-α inhibitors", "brands": [ "Humira", "Abrilada", "Amgevita", "Hadlima", "Hyrimoz", "Yuflyma" ], "target": "TNF-α", "note": "Prescribing a biosimilar brand is encouraged for treatment-naive patients.", "indications": [ "Severe chronic plaque psoriasis" ], "severities": [ "Severe" ], "authority_tags": [ "Authority", "Streamlined" ], "age_groups": [ "18 and over", "Under 18" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "12342N", "brands": [ "Humira", "Hadlima", "Hyrimoz", "Yuflyma" ], "form": "40 mg in 0.4 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "4", "setting": "", "total_units": 10, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "80 mg at week 0 (as 2 × 40 mg or 1 × 80 mg), then 40 mg every 2 weeks from week 1 to week 15." } ] }, { "pbs_code": "12421R", "brands": [ "Humira", "Hadlima", "Hyrimoz", "Yuflyma" ], "form": "40 mg in 0.4 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "4", "setting": "", "total_units": 10, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "80 mg at week 0 (as 2 × 40 mg or 1 × 80 mg), then 40 mg every 2 weeks from week 1 to week 15." } ] }, { "pbs_code": "9426D", "brands": [ "Abrilada", "Amgevita", "Hadlima", "Hyrimoz" ], "form": "40 mg in 0.8 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "4", "setting": "", "total_units": 10, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "80 mg at week 0 (as 2 × 40 mg or 1 × 80 mg), then 40 mg every 2 weeks from week 1 to week 15." } ] }, { "pbs_code": "9425C", "brands": [ "Amgevita", "Hadlima", "Hyrimoz" ], "form": "40 mg in 0.8 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "4", "setting": "", "total_units": 10, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "80 mg at week 0 (as 2 × 40 mg or 1 × 80 mg), then 40 mg every 2 weeks from week 1 to week 15." } ] }, { "pbs_code": "12447D", "brands": [ "Humira", "Hyrimoz", "Yuflyma" ], "form": "80 mg in 0.8 mL pen", "manner_of_administration": "Injection", 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40, "weightBased": false, "secondary": false }, { "week": 35, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 37, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 39, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 41, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 43, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 45, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 47, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 49, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 51, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 53, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 55, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 57, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 59, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 61, "units": 1, "mg": 40, "weightBased": false, "secondary": false }, { "week": 63, "units": 1, "mg": 40, "weightBased": false, "secondary": false } ], "ages": [ "Under 18" ] } ] } }, "psoriasis/apremilast": { "key": "psoriasis/apremilast", "name": "Apremilast", "slug": "apremilast", "condition": "psoriasis", "condition_label": "Psoriasis", "atc_code": "L04AA", "atc_label": "Oral agents", "brands": [ "Otezla" ], "target": "PDE4", "note": "", "indications": [ "Severe chronic plaque psoriasis" ], "severities": [ "Severe" ], "authority_tags": [ "Streamlined" ], "age_groups": [ "18 and over" ], "phase_groups": [ "INITIAL", "CONTINUING" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "12218C", "brands": [ "Otezla" ], "form": "Titration pack: 4 tablets 10 mg, 4 tablets 20 mg and 19 tablets 30 mg", "manner_of_administration": "Oral", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "0", "setting": "", "total_units": 1, "max_weeks": "", "treatment_phases": [], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "17396", "label": "" } ], "dosing": [ { "variant": "", "regimen": "Titration pack: the dose steps up over the first 2 weeks:\nDay 1: 10 mg in the morning\nDay 2: 10 mg twice daily\nDay 3: 10 mg morning + 20 mg evening\nDay 4: 20 mg twice daily\nDay 5: 20 mg morning + 30 mg evening\nDay 6 onward: 30 mg twice daily" } ] } ], "regimen": "Titration pack for the first 2 weeks (10 mg stepping up to 30 mg twice daily), then 30 mg twice daily; prescribe the 30 mg tablets (56, 5 repeats) together with the titration pack.", "regimen_source": "" }, { "phases": [ "INITIAL", "CONTINUING" ], "label": "Initial + Continuing", "items": [ { "pbs_code": "12223H", "brands": [ "Otezla" ], "form": "30 mg tablet", "manner_of_administration": "Oral", "max_quantity": "56", "max_packs": "1", "pack_size": "56", "repeats": "5", "setting": "", "total_units": 336, "max_weeks": "", "treatment_phases": [], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "17396", "label": "" } ], "dosing": [ { "variant": "", "regimen": "30 mg twice daily from week 2 (after the titration pack)." } ] } ], "regimen": "30 mg twice daily (from week 2, after the titration pack). The same streamlined code covers initial and continuing supply.", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "Amgen", "name": "David Weir", "phone": "0448 064 138", "phone2": "02 9870 1446", "email": "dweir@amgen.com" } ], "compassionate": [ { "text": "Titration pack available" }, { "text": "amgenmedicationrequests.com.au", "href": "https://amgenmedicationrequests.com.au" } ] }, "timeline": { "max_week": 26, "tracks": [ { "label": "Oral", "segments": [ { "kind": "doses", "start": 0, "end": 0, "doses": [ { "week": 0, "units": 1, "mg": 30 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 0, "weightBased": false, "variant": "", "formulation": "Titration pack: 4 tablets 10 mg, 4 tablets 20 mg and 19 tablets 30 mg", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "Titration pack: the dose steps up over the first 2 weeks:\nDay 1: 10 mg in the morning\nDay 2: 10 mg twice daily\nDay 3: 10 mg morning + 20 mg evening\nDay 4: 20 mg twice daily\nDay 5: 20 mg morning + 30 mg evening\nDay 6 onward: 30 mg twice daily", "items": [ { "code": "12218C", "streamlined": [ { "code": "17396", "label": "" } ], "setting": "" } ] }, { "kind": "continuous", "start": 2, "end": 26, "daily_units": "2", "phase": "INITIAL+CONTINUING", "band": "CONTINUING", "phaseStart": 2, "coverWeeks": 0, "weightBased": false, "variant": "", "formulation": "30 mg tablet", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "30 mg twice daily from week 2 (after the titration pack).", "items": [ { "code": "12223H", "streamlined": [ { "code": "17396", "label": "" } ], "setting": "" } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 2 }, { "band": "CONTINUING", "phase": "INITIAL+CONTINUING", "start": 2, "end": 26 } ], "doses": [ { "week": 0, "units": 1, "mg": 30, "weightBased": false, "secondary": false } ], "ages": [ "18 and over" ] } ] } }, "psoriasis/bimekizumab": { "key": "psoriasis/bimekizumab", "name": "bimekizumab", "slug": "bimekizumab", "condition": "psoriasis", "condition_label": "Psoriasis", "atc_code": "L04AC", "atc_label": "IL-17 inhibitors", "brands": [ "Bimzelx" ], "target": "IL-17A & IL-17F", "note": "", "indications": [ "Severe chronic plaque psoriasis" ], "severities": [ "Severe" ], "authority_tags": [ "Authority" ], "age_groups": [ "18 and over" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "13644D", "brands": [ "Bimzelx" ], "form": "160 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "4", "setting": "", "total_units": 10, "max_weeks": 24, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "320 mg (2 × 160 mg) every 4 weeks to week 16" } ] }, { "pbs_code": "15256Y", "brands": [ "Bimzelx" ], "form": "320 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "4", "setting": "", "total_units": 5, "max_weeks": 24, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "320 mg every 4 weeks to week 16" } ] } ], "regimen": "320 mg every 4 weeks to week 16", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "13652M", "brands": [ "Bimzelx" ], "form": "160 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "2", "setting": "", "total_units": 6, "max_weeks": 24, "treatment_phases": [ "Continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "320 mg (2 × 160 mg) every 8 weeks (from week 24)" } ] }, { "pbs_code": "15262G", "brands": [ "Bimzelx" ], "form": "320 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 24, "treatment_phases": [ "Continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "320 mg every 8 weeks, from week 24" } ] } ], "regimen": "320 mg every 8 weeks, from week 24. For patients weighing 120 kg or more, 320 mg every 4 weeks after week 16 may be considered.", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "UCB", "name": "Kate Ziebell", "phone": "0409 239 077", "email": "kate.ziebell@ucb.com" } ], "compassionate": [ { "text": "Tracey.M.Edwards@ucb.com", "href": "mailto:Tracey.M.Edwards@ucb.com" } ] }, "timeline": { "max_week": 48, "tracks": [ { "label": "320 mg: every 4 weeks, then every 8 weeks", "segments": [ { "kind": "doses", "start": 0, "end": 16, "doses": [ { "week": 0, "units": 1, "mg": 320 }, { "week": 4, "units": 1, "mg": 320 }, { "week": 8, "units": 1, "mg": 320 }, { "week": 12, "units": 1, "mg": 320 }, { "week": 16, "units": 1, "mg": 320 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 24, "weightBased": false, "variant": "", "formulation": "320 mg in 2 mL pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "320 mg every 4 weeks to week 16", "items": [ { "code": "15256Y", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "320 mg in 2 mL pen", "items": [ { "code": "15256Y", "streamlined": [], "setting": "" } ] }, { "label": "160 mg in 1 mL pen", "items": [ { "code": "13644D", "streamlined": [], "setting": "" } ] } ] }, { "kind": "doses", "start": 24, "end": 40, "doses": [ { "week": 24, "units": 1, "mg": 320 }, { "week": 32, "units": 1, "mg": 320 }, { "week": 40, "units": 1, "mg": 320 } ], "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 24, "coverWeeks": 24, "weightBased": false, "variant": "", "formulation": "320 mg in 2 mL pen", "escalation": "For patients weighing 120 kg or more, 320 mg every 4 weeks after week 16 may be considered.", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "320 mg every 8 weeks, from week 24", "items": [ { "code": "15262G", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "320 mg in 2 mL pen", "items": [ { "code": "15262G", "streamlined": [], "setting": "" } ] }, { "label": "160 mg in 1 mL pen", "items": [ { "code": "13652M", "streamlined": [], "setting": "" } ] } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 24 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 24, "end": 48 } ], "doses": [ { "week": 0, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 4, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 8, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 12, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 16, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 24, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 32, "units": 1, "mg": 320, "weightBased": false, "secondary": false }, { "week": 40, "units": 1, "mg": 320, "weightBased": false, "secondary": false } ], "ages": [ "18 and over" ] } ] } }, "psoriasis/deucravacitinib": { "key": "psoriasis/deucravacitinib", "name": "deucravacitinib", "slug": "deucravacitinib", "condition": "psoriasis", "condition_label": "Psoriasis", "atc_code": "L04AF", "atc_label": "Oral agents", "brands": [ "Sotyktu" ], "target": "TYK2", "note": "", "indications": [ "Severe chronic plaque psoriasis" ], "severities": [ "Severe" ], "authority_tags": [ "Streamlined" ], "age_groups": [ "18 and over" ], "phase_groups": [ "INITIAL", "CONTINUING" ], "groups": [ { "phases": [ "INITIAL", "CONTINUING" ], "label": "Initial + Continuing", "items": [ { "pbs_code": "13649J", "brands": [ "Sotyktu" ], "form": "6 mg tablet", "manner_of_administration": "Oral", "max_quantity": "28", "max_packs": "1", "pack_size": "28", "repeats": "5", "setting": "", "total_units": 168, "max_weeks": "", "treatment_phases": [], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "17319", "label": "" } ] } ], "regimen": "6 mg once daily. The same streamlined code covers initial and continuing supply.", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "BMS", "name": "Sally De Jonge", "phone": "0437 646 796", "email": "sally.dejonge@bms.com" } ], "compassionate": [ { "text": "bmsmedicineaccess@bms.com", "href": "mailto:bmsmedicineaccess@bms.com" } ] }, "timeline": { "max_week": 24, "tracks": [ { "label": "Oral", "segments": [ { "kind": "continuous", "start": 0, "end": 24, "daily_units": "1", "phase": "INITIAL+CONTINUING", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 0, "weightBased": false, "variant": "Initial and continuing", "formulation": "Initial and continuing", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "6 mg once daily. The same streamlined code covers initial and continuing supply.", "items": [ { "code": "13649J", "streamlined": [ { "code": "17319", "label": "" } ], "setting": "" } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL+CONTINUING", "start": 0, "end": 24 } ], "doses": [], "ages": [ "18 and over" ] } ] } }, "psoriasis/etanercept": { "key": "psoriasis/etanercept", "name": "Etanercept", "slug": "etanercept", "condition": "psoriasis", "condition_label": "Psoriasis", "atc_code": "L04AB", "atc_label": "TNF-α inhibitors", "brands": [ "Enbrel", "Brenzys", "Erelzi", "Nepexto" ], "target": "TNF-α", "note": "", "indications": [ "Severe chronic plaque psoriasis" ], "severities": [ "Severe" ], "authority_tags": [ "Authority", "Streamlined" ], "age_groups": [ "18 and over", "Under 18" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "9037P", "brands": [ "Enbrel" ], "form": "Pack containing 4 vials powder for injection 25 mg and 4 syringes solvent 1 mL", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 8, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "Powder for injection (25 mg vials)", "regimen": "50 mg once weekly (or 25 mg twice weekly), to week 16." } ] }, { "pbs_code": "9461Y", "brands": [ "Enbrel", "Brenzys", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 pens", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 4, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "50 mg pen", "regimen": "50 mg once weekly, to week 16." } ] }, { "pbs_code": "9091L", "brands": [ "Enbrel", "Brenzys", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 syringes", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 4, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "50 mg syringe", "regimen": "50 mg once weekly, to week 16." } ] }, { "pbs_code": "1954W", "brands": [ "Enbrel" ], "form": "Pack containing 4 vials powder for injection 25 mg and 4 syringes solvent 1 mL", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 8, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2, 3 or 4", "Balance of supply" ], "is_balance": true, "age_groups": [ "Under 18" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "0.8 mg/kg once weekly (maximum 50 mg per dose), using the 25 mg powder vials, to week 16." }, { "variant": "Powder for injection (25 mg vials)", "regimen": "50 mg once weekly (2 × 25 mg vials), to week 16." } ] }, { "pbs_code": "1964J", "brands": [ "Enbrel", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 pens", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 4, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2, 3 or 4", "Balance of supply" ], "is_balance": true, "age_groups": [ "Under 18" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "50 mg pen", "regimen": "50 mg once weekly, to week 16." } ] }, { "pbs_code": "1963H", "brands": [ "Enbrel", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 syringes", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "3", "setting": "", "total_units": 4, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2, 3 or 4", "Balance of supply" ], "is_balance": true, "age_groups": [ "Under 18" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "50 mg syringe", "regimen": "50 mg once weekly, to week 16." } ] } ], "regimen": "Adults: 50 mg once weekly (or 25 mg twice weekly); alternatively 50 mg twice weekly to week 12, then 50 mg weekly, to week 16. Children ≥62.5 kg: 50 mg once weekly; <62.5 kg: 0.8 mg/kg once weekly (max 50 mg per dose).", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "9429G", "brands": [ "Enbrel" ], "form": "Pack containing 4 vials powder for injection 25 mg and 4 syringes solvent 1 mL", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "First continuing", "Subsequent continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "Powder for injection (25 mg vials)", "regimen": "50 mg once weekly, from week 16." } ] }, { "pbs_code": "9462B", "brands": [ "Enbrel", "Brenzys", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 pens", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 6, "max_weeks": 24, "treatment_phases": [ "First continuing", "Subsequent continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "50 mg pen", "regimen": "50 mg once weekly, from week 16." } ] }, { "pbs_code": "11221N", "brands": [ "Brenzys", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 pens", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 6, "max_weeks": 24, "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "16719", "label": "Whole body" }, { "code": "16776", "label": "Face, hand, foot" } ], "dosing": [ { "variant": "50 mg pen", "regimen": "50 mg once weekly, from week 16." } ] }, { "pbs_code": "9431J", "brands": [ "Enbrel", "Brenzys", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 syringes", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 6, "max_weeks": 24, "treatment_phases": [ "First continuing", "Subsequent continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "50 mg syringe", "regimen": "50 mg once weekly, from week 16." } ] }, { "pbs_code": "11225T", "brands": [ "Brenzys", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 syringes", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 6, "max_weeks": 24, "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "16719", "label": "Whole body" }, { "code": "16776", "label": "Face, hand, foot" } ], "dosing": [ { "variant": "50 mg syringe", "regimen": "50 mg once weekly, from week 16." } ] }, { "pbs_code": "13693Q", "brands": [ "Enbrel" ], "form": "Pack containing 4 vials powder for injection 25 mg and 4 syringes solvent 1 mL", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "1", "setting": "", "total_units": 4, "max_weeks": 8, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "Under 18" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "14549", "label": "Whole body" }, { "code": "14598", "label": "Face, hand, foot" } ], "dosing": [ { "variant": "", "regimen": "0.8 mg/kg once weekly (maximum 50 mg per dose), from week 16 to week 24 (maximum duration)." }, { "variant": "Powder for injection (25 mg vials)", "regimen": "50 mg once weekly (2 × 25 mg vials), from week 16 to week 24 (maximum duration)." } ] }, { "pbs_code": "13697X", "brands": [ "Enbrel", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 pens", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "1", "setting": "", "total_units": 2, "max_weeks": 8, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "Under 18" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "14549", "label": "Whole body" }, { "code": "14598", "label": "Face, hand, foot" } ], "dosing": [ { "variant": "50 mg pen", "regimen": "50 mg once weekly, to week 24 (maximum duration)." } ] }, { "pbs_code": "13733T", "brands": [ "Enbrel", "Erelzi", "Nepexto" ], "form": "50 mg in 1 mL, 4 syringes", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "1", "setting": "", "total_units": 2, "max_weeks": 8, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "Under 18" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "14549", "label": "Whole body" }, { "code": "14598", "label": "Face, hand, foot" } ], "dosing": [ { "variant": "50 mg syringe", "regimen": "50 mg once weekly, to week 24 (maximum duration)." } ] } ], "regimen": "Adults: 50 mg once weekly, from week 16. Children: continue the initial dose. Paediatric supply runs to week 24 (maximum duration of therapy).", "regimen_source": "" } ], "timeline": { "max_week": 40, "tracks": [ { "label": "18 and over: 50 mg once weekly", "segments": [ { "kind": "continuous", "start": 0, "end": 16, "daily_units": "", "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 16, "weightBased": true, "variant": "", "formulation": "Powder for injection (25 mg vials)", "escalation": "Higher responses may be achieved from initial treatment for up to 12 weeks with 50 mg given twice weekly, after which the dose should be reduced to the standard 50 mg per week.", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "50 mg once weekly (or 25 mg twice weekly), to week 16.", "items": [ { "code": "9037P", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "Powder for injection (25 mg vials)", "items": [ { "code": "9037P", "streamlined": [], "setting": "" } ] }, { "label": "50 mg pen", "items": [ { "code": "9461Y", "streamlined": [], "setting": "" } ] }, { "label": "50 mg syringe", "items": [ { "code": "9091L", "streamlined": [], "setting": "" } ] } ] }, { "kind": "continuous", "start": 16, "end": 40, "daily_units": "", "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 16, "coverWeeks": 24, "weightBased": true, "variant": "", "formulation": "Powder for injection (25 mg vials)", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "50 mg once weekly, from week 16.", "items": [ { "code": "9429G", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "Powder for injection (25 mg vials)", "items": [ { "code": "9429G", "streamlined": [], "setting": "" } ] }, { "label": "50 mg pen", "items": [ { "code": "9462B", "streamlined": [], "setting": "" }, { "code": "11221N", "streamlined": [ { "code": "16719", "label": "Whole body" }, { "code": "16776", "label": "Face, hand, foot" } ], "setting": "" } ] }, { "label": "50 mg syringe", "items": [ { "code": "9431J", "streamlined": [], "setting": "" }, { "code": "11225T", "streamlined": [ { "code": "16719", "label": "Whole body" }, { "code": "16776", "label": "Face, hand, foot" } ], "setting": "" } ] } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 16 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 16, "end": 40 } ], "doses": [], "ages": [ "18 and over" ] }, { "label": "Under 18, <62.5 kg: powder for injection", "segments": [ { "kind": "continuous", "start": 0, "end": 16, "daily_units": "", "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 16, "weightBased": true, "variant": "", "formulation": "Pack containing 4 vials powder for injection 25 mg and 4 syringes solvent 1 mL", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "0.8 mg/kg once weekly (maximum 50 mg per dose), using the 25 mg powder vials, to week 16.", "items": [ { "code": "1954W", "streamlined": [], "setting": "" } ] }, { "kind": "continuous", "start": 16, "end": 24, "daily_units": "", "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 16, "coverWeeks": 8, "weightBased": true, "variant": "", "formulation": "Pack containing 4 vials powder for injection 25 mg and 4 syringes solvent 1 mL", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "0.8 mg/kg once weekly (maximum 50 mg per dose), from week 16 to week 24 (maximum duration).", "items": [ { "code": "13693Q", "streamlined": [ { "code": "14549", "label": "Whole body" }, { "code": "14598", "label": "Face, hand, foot" } ], "setting": "" } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 16 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 16, "end": 24 } ], "doses": [], "ages": [ "Under 18" ] }, { "label": "Under 18, ≥62.5 kg: 50 mg once weekly", "segments": [ { "kind": "continuous", "start": 0, "end": 16, "daily_units": "", "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 16, "weightBased": true, "variant": "", "formulation": "Powder for injection (25 mg vials)", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "50 mg once weekly (2 × 25 mg vials), to week 16.", "items": [ { "code": "1954W", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "Powder for injection (25 mg vials)", "items": [ { "code": "1954W", "streamlined": [], "setting": "" } ] }, { "label": "50 mg pen", "items": [ { "code": "1964J", "streamlined": [], "setting": "" } ] }, { "label": "50 mg syringe", "items": [ { "code": "1963H", "streamlined": [], "setting": "" } ] } ] }, { "kind": "continuous", "start": 16, "end": 24, "daily_units": "", "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 16, "coverWeeks": 8, "weightBased": true, "variant": "", "formulation": "Powder for injection (25 mg vials)", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "50 mg once weekly (2 × 25 mg vials), from week 16 to week 24 (maximum duration).", "items": [ { "code": "13693Q", "streamlined": [ { "code": "14549", "label": "Whole body" }, { "code": "14598", "label": "Face, hand, foot" } ], "setting": "" } ], "formulations": [ { "label": "Powder for injection (25 mg vials)", "items": [ { "code": "13693Q", "streamlined": [ { "code": "14549", "label": "Whole body" }, { "code": "14598", "label": "Face, hand, foot" } ], "setting": "" } ] }, { "label": "50 mg pen", "items": [ { "code": "13697X", "streamlined": [ { "code": "14549", "label": "Whole body" }, { "code": "14598", "label": "Face, hand, foot" } ], "setting": "" } ] }, { "label": "50 mg syringe", "items": [ { "code": "13733T", "streamlined": [ { "code": "14549", "label": "Whole body" }, { "code": "14598", "label": "Face, hand, foot" } ], "setting": "" } ] } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 16 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 16, "end": 24 } ], "doses": [], "ages": [ "Under 18" ] } ] } }, "psoriasis/guselkumab": { "key": "psoriasis/guselkumab", "name": "Guselkumab", "slug": "guselkumab", "condition": "psoriasis", "condition_label": "Psoriasis", "atc_code": "L04AC", "atc_label": "IL-23 inhibitors", "brands": [ "Tremfya" ], "target": "IL-23 (p19)", "note": "", "indications": [ "Severe chronic plaque psoriasis" ], "severities": [ "Severe" ], "authority_tags": [ "Authority" ], "age_groups": [ "18 and over" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL", "CONTINUING" ], "label": "Initial + Continuing", "items": [ { "pbs_code": "11614G", "brands": [ "Tremfya" ], "form": "100 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 24, "treatment_phases": [ "Initial 1, 2 or 3", "Continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "Initial", "regimen": "100 mg at weeks 0, 4 and 12" }, { "variant": "Continuing", "regimen": "100 mg every 8 weeks, from week 20" } ] } ], "regimen": "100 mg at weeks 0, 4 and 12, then every 8 weeks from week 20", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "Janssen", "name": "Layla Carrol", "phone": "0476 776 206", "email": "LCarrol7@its.jnj.com" } ], "compassionate": [ { "text": "janssenpro.com.au", "href": "https://www.janssenpro.com.au" }, { "text": "1800 226 334", "href": "tel:1800226334" }, { "text": "product.access@janau.jnj.com", "href": "mailto:product.access@janau.jnj.com" } ] }, "timeline": { "max_week": 44, "tracks": [ { "label": "100 mg syringe", "segments": [ { "kind": "doses", "start": 0, "end": 12, "doses": [ { "week": 0, "units": 1, "mg": 100 }, { "week": 4, "units": 1, "mg": 100 }, { "week": 12, "units": 1, "mg": 100 } ], "phase": "INITIAL+CONTINUING", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 24, "weightBased": false, "variant": "Initial", "formulation": "Initial", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "100 mg at weeks 0, 4 and 12", "items": [ { "code": "11614G", "streamlined": [], "setting": "" } ] }, { "kind": "doses", "start": 20, "end": 36, "doses": [ { "week": 20, "units": 1, "mg": 100 }, { "week": 28, "units": 1, "mg": 100 }, { "week": 36, "units": 1, "mg": 100 } ], "phase": "INITIAL+CONTINUING", "band": "CONTINUING", "phaseStart": 20, "coverWeeks": 24, "weightBased": false, "variant": "Continuing", "formulation": "Continuing", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "100 mg every 8 weeks, from week 20", "items": [ { "code": "11614G", "streamlined": [], "setting": "" } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL+CONTINUING", "start": 0, "end": 20 }, { "band": "CONTINUING", "phase": "INITIAL+CONTINUING", "start": 20, "end": 44 } ], "doses": [ { "week": 0, "units": 1, "mg": 100, "weightBased": false, "secondary": false }, { "week": 4, "units": 1, "mg": 100, "weightBased": false, "secondary": false }, { "week": 12, "units": 1, "mg": 100, "weightBased": false, "secondary": false }, { "week": 20, "units": 1, "mg": 100, "weightBased": false, "secondary": false }, { "week": 28, "units": 1, "mg": 100, "weightBased": false, "secondary": false }, { "week": 36, "units": 1, "mg": 100, "weightBased": false, "secondary": false } ], "ages": [ "18 and over" ] } ] } }, "psoriasis/infliximab": { "key": "psoriasis/infliximab", "name": "Infliximab", "slug": "infliximab", "condition": "psoriasis", "condition_label": "Psoriasis", "atc_code": "L04AB", "atc_label": "TNF-α inhibitors", "brands": [ "Remicade", "Inflectra", "Ixifi", "Remsima", "Remsima SC", "Renflexis" ], "target": "TNF-α", "note": "", "indications": [ "Severe chronic plaque psoriasis" ], "severities": [ "Severe" ], "authority_tags": [ "Authority", "Streamlined" ], "age_groups": [ "18 and over" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "13062L", "brands": [ "Remsima SC" ], "form": "120 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 6, "max_weeks": "", "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "Subcutaneous 120 mg", "regimen": "120 mg subcutaneously every 2 weeks, starting 4 weeks after the second IV infusion (week 6)." } ] }, { "pbs_code": "13067R", "brands": [ "Remsima SC" ], "form": "120 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 6, "max_weeks": "", "treatment_phases": [ "Initial" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "Subcutaneous 120 mg", "regimen": "120 mg subcutaneously every 2 weeks, starting 4 weeks after the second IV infusion (week 6)." } ] } ], "regimen": "Subcutaneous (Remsima SC): after IV induction (5 mg/kg at weeks 0 and 2), 120 mg every 2 weeks starting 4 weeks after the second infusion (week 6); continuing injections commence at week 18.", "regimen_source": "" }, { "phases": [ "INITIAL", "CONTINUING" ], "label": "Initial + Continuing", "items": [ { "pbs_code": "9617E", "brands": [ "Remicade", "Inflectra", "Ixifi", "Remsima", "Renflexis" ], "form": "100 mg powder, IV infusion", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "0", "setting": "Private hospital", "total_units": 1, "max_weeks": 24, "treatment_phases": [ "Initial 1, 2 or 3", "First continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "IV induction", "regimen": "5 mg/kg IV at weeks 0 and 2 (weight-based), before switching to subcutaneous dosing." }, { "variant": "", "regimen": "5 mg/kg at weeks 0, 2, 6 and 14: 4 infusions (weight-based; the number of 100 mg vials varies). The initial authority covers 22 weeks." }, { "variant": "", "regimen": "5 mg/kg every 8 weeks: 3 infusions (weeks 22, 30 and 38) per 24-week continuing course." } ] }, { "pbs_code": "5758C", "brands": [ "Remicade", "Inflectra", "Ixifi", "Remsima", "Renflexis" ], "form": "100 mg powder, IV infusion", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "0", "setting": "Public hospital", "total_units": 1, "max_weeks": 24, "treatment_phases": [ "Initial 1, 2 or 3", "First continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "IV induction", "regimen": "5 mg/kg IV at weeks 0 and 2 (weight-based), before switching to subcutaneous dosing." }, { "variant": "", "regimen": "5 mg/kg at weeks 0, 2, 6 and 14: 4 infusions (weight-based; the number of 100 mg vials varies). The initial authority covers 22 weeks." }, { "variant": "", "regimen": "5 mg/kg every 8 weeks: 3 infusions (weeks 22, 30 and 38) per 24-week continuing course." } ] } ], "regimen": "Intravenous: 5 mg/kg at weeks 0, 2 and 6, then every 8 weeks (weight-based; the number of 100 mg vials varies with body weight). The initial authority covers 4 infusions over 22 weeks; each continuing course covers 3 infusions over 24 weeks.", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "11595G", "brands": [ "Inflectra", "Ixifi", "Remsima", "Renflexis" ], "form": "100 mg powder, IV infusion", "manner_of_administration": "Injection", "max_quantity": "5", "max_packs": "5", "pack_size": "1", "repeats": "2", "setting": "Private hospital", "total_units": 15, "max_weeks": 24, "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "9616", "label": "Whole body" }, { "code": "9471", "label": "Face, hand, foot" } ], "dosing": [ { "variant": "", "regimen": "5 mg/kg every 8 weeks: 3 infusions (weeks 46, 54 and 62) per 24-week continuing course. Authority Required codes, or the streamlined codes for eligible biosimilar brands." } ] }, { "pbs_code": "11605T", "brands": [ "Inflectra", "Ixifi", "Remsima", "Renflexis" ], "form": "100 mg powder, IV infusion", "manner_of_administration": "Injection", "max_quantity": "5", "max_packs": "5", "pack_size": "1", "repeats": "2", "setting": "Public hospital", "total_units": 15, "max_weeks": 24, "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "9001", "label": "Whole body" }, { "code": "8843", "label": "Face, hand, foot" } ], "dosing": [ { "variant": "", "regimen": "5 mg/kg every 8 weeks: 3 infusions (weeks 46, 54 and 62) per 24-week continuing course. Authority Required codes, or the streamlined codes for eligible biosimilar brands." } ] }, { "pbs_code": "11590B", "brands": [ "Remicade", "Inflectra", "Ixifi", "Remsima", "Renflexis" ], "form": "100 mg powder, IV infusion", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "0", "setting": "Private hospital", "total_units": 1, "max_weeks": 24, "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "5 mg/kg every 8 weeks: 3 infusions (weeks 46, 54 and 62) per 24-week continuing course. Authority Required codes, or the streamlined codes for eligible biosimilar brands." } ] }, { "pbs_code": "11606W", "brands": [ "Remicade", "Inflectra", "Ixifi", "Remsima", "Renflexis" ], "form": "100 mg powder, IV infusion", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "0", "setting": "Public hospital", "total_units": 1, "max_weeks": 24, "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "5 mg/kg every 8 weeks: 3 infusions (weeks 46, 54 and 62) per 24-week continuing course. Authority Required codes, or the streamlined codes for eligible biosimilar brands." } ] }, { "pbs_code": "13076F", "brands": [ "Remsima SC" ], "form": "120 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "17553", "label": "Whole body / Face, hand, foot" } ], "dosing": [ { "variant": "", "regimen": "120 mg every 2 weeks, from week 18." } ] }, { "pbs_code": "13050W", "brands": [ "Remsima SC" ], "form": "120 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Streamlined" ], "streamlined_codes": [ { "code": "17553", "label": "Whole body / Face, hand, foot" } ], "dosing": [ { "variant": "", "regimen": "120 mg every 2 weeks, from week 18." } ] } ], "regimen": "Intravenous: 5 mg/kg every 8 weeks, from week 22. Subcutaneous: 120 mg every 2 weeks, from week 18.", "regimen_source": "" }, { "phases": [ "BALANCE" ], "label": "Balance of supply", "items": [ { "pbs_code": "13070X", "brands": [ "Remsima SC" ], "form": "120 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "0", "setting": "", "total_units": 2, "max_weeks": "", "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] }, { "pbs_code": "13058G", "brands": [ "Remsima SC" ], "form": "120 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "2", "pack_size": "1", "repeats": "0", "setting": "", "total_units": 2, "max_weeks": "", "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] } ] } ], "contacts": { "reps": [ { "company": "Janssen", "name": "Layla Carrol", "phone": "0476 776 206", "email": "LCarrol7@its.jnj.com" }, { "company": "MSD", "name": "Kris McGrath", "phone": "0411 519 126", "email": "kristine.mcgrath@merck.com" } ], "compassionate": [ { "text": "janssenpro.com.au", "href": "https://www.janssenpro.com.au" }, { "text": "1800 226 334", "href": "tel:1800226334" }, { "text": "product.access@janau.jnj.com", "href": "mailto:product.access@janau.jnj.com" }, { "text": "NB: if the patient starts on a biosimilar, subsequent compassionate access is not permitted for Remicade®." }, { "text": "Renflexis®: seek approval from Dr Chris Morris." } ] }, "timeline": { "max_week": 70, "tracks": [ { "label": "120 mg pen", "segments": [ { "kind": "doses", "start": 0, "end": 2, "doses": [ { "week": 0, "units": 1, "mg": null }, { "week": 2, "units": 1, "mg": null } ], "phase": "INITIAL+CONTINUING", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 24, "weightBased": true, "variant": "IV induction", 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[ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg (2 × 150 mg) weekly at weeks 0, 1, 2 and 3" } ] }, { "pbs_code": "10494H", "brands": [ "Cosentyx" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "2", "setting": "", "total_units": 6, "max_weeks": 16, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg (2 × 150 mg) at weeks 4, 8 and 12" } ] }, { "pbs_code": "15028Y", "brands": [ "Cosentyx" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "4", "max_packs": "4", "pack_size": "1", "repeats": "0", "setting": "", "total_units": 4, "max_weeks": 16, "treatment_phases": [ "Initial 1, 2 or 3" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg weekly at weeks 0, 1, 2 and 3" } ] }, { "pbs_code": "14971Y", "brands": [ "Cosentyx" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 16, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg at weeks 4, 8 and 12" } ] } ], "regimen": "300 mg at weeks 0, 1, 2, 3, 4, 8 and 12 - 7 doses over 12 weeks", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "10425Q", "brands": [ "Cosentyx" ], "form": "150 mg in 1 mL pen", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "5", "setting": "", "total_units": 12, "max_weeks": 24, "treatment_phases": [ "Continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg (2 × 150 mg) every 4 weeks" } ] }, { "pbs_code": "14972B", "brands": [ "Cosentyx" ], "form": "300 mg in 2 mL pen", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "5", "setting": "", "total_units": 6, "max_weeks": 24, "treatment_phases": [ "Continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "300 mg every 4 weeks, from week 16" } ] } ], "regimen": "300 mg every 4 weeks, from week 16. Some patients weighing 90 kg or more may derive additional benefit from 300 mg every 2 weeks.", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "Novartis", "name": "Jo Taylor", "phone": "0423 890 017", "email": "Joanne-1.taylor@novartis.com" } ], "compassionate": [ { "text": "Email the ACCESS request form (or the resupply form for ongoing supply) to:" }, { "text": "access.program-aunz@novartis.com", "href": "mailto:access.program-aunz@novartis.com" } ] }, "timeline": { "max_week": 40, "tracks": [ { "label": "300 mg: weekly loading, then every 4 weeks", "segments": [ { "kind": "doses", "start": 0, "end": 3, "doses": [ { "week": 0, "units": 1, "mg": 300 }, { "week": 1, "units": 1, "mg": 300 }, { "week": 2, "units": 1, "mg": 300 }, { "week": 3, "units": 1, "mg": 300 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 16, "weightBased": false, "variant": "", "formulation": "300 mg in 2 mL pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "300 mg weekly at weeks 0, 1, 2 and 3", "items": [ { "code": "15028Y", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "300 mg in 2 mL pen", "items": [ { "code": "15028Y", "streamlined": [], "setting": "" } ] }, { "label": "150 mg in 1 mL pen", "items": [ { "code": "10910F", "streamlined": [], "setting": "" } ] } ] }, { "kind": "doses", "start": 4, "end": 12, "doses": [ { "week": 4, "units": 1, "mg": 300 }, { "week": 8, "units": 1, "mg": 300 }, { "week": 12, "units": 1, "mg": 300 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 4, "coverWeeks": 16, "weightBased": false, "variant": "", "formulation": "300 mg in 2 mL pen", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "300 mg at weeks 4, 8 and 12", "items": [ { "code": "14971Y", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "300 mg in 2 mL pen", "items": [ { "code": "14971Y", "streamlined": [], "setting": "" } ] }, { "label": "150 mg in 1 mL pen", "items": [ { "code": "10494H", "streamlined": [], "setting": "" } ] } ] }, { "kind": "doses", "start": 16, "end": 36, "doses": [ { "week": 16, "units": 1, "mg": 300 }, { "week": 20, "units": 1, "mg": 300 }, { "week": 24, "units": 1, "mg": 300 }, { "week": 28, "units": 1, "mg": 300 }, { "week": 32, "units": 1, "mg": 300 }, { "week": 36, "units": 1, "mg": 300 } ], "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 16, "coverWeeks": 24, "weightBased": false, "variant": "", "formulation": "300 mg in 2 mL pen", "escalation": "Some patients weighing 90 kg or more may derive additional benefit from 300 mg every 2 weeks.", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "300 mg every 4 weeks, from week 16", "items": [ { "code": "14972B", "streamlined": [], "setting": "" } ], "formulations": [ { "label": "300 mg in 2 mL pen", "items": [ { "code": "14972B", "streamlined": [], "setting": "" } ] }, { "label": "150 mg in 1 mL pen", "items": [ { "code": "10425Q", "streamlined": [], "setting": "" } ] } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 4 }, { "band": "INITIAL", "phase": "INITIAL", "start": 4, "end": 16 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 16, "end": 40 } ], "doses": [ { "week": 0, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 1, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 2, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 3, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 4, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 8, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 12, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 16, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 20, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 24, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 28, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 32, "units": 1, "mg": 300, "weightBased": false, "secondary": false }, { "week": 36, "units": 1, "mg": 300, "weightBased": false, "secondary": false } ], "ages": [ "18 and over" ] } ] } }, "psoriasis/tildrakizumab": { "key": "psoriasis/tildrakizumab", "name": "Tildrakizumab", "slug": "tildrakizumab", "condition": "psoriasis", "condition_label": "Psoriasis", "atc_code": "L04AC", "atc_label": "IL-23 inhibitors", "brands": [ "Ilumya" ], "target": "IL-23 (p19)", "note": "", "indications": [ "Severe chronic plaque psoriasis" ], "severities": [ "Severe" ], "authority_tags": [ "Authority" ], "age_groups": [ "18 and over" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "11616J", "brands": [ "Ilumya" ], "form": "100 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 28, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "100 mg at weeks 0, 4 and 16" } ] } ], "regimen": "100 mg at weeks 0, 4 and 16", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "11613F", "brands": [ "Ilumya" ], "form": "100 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "1", "setting": "", "total_units": 2, "max_weeks": 24, "treatment_phases": [ "Continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "100 mg every 12 weeks, from week 28" } ] }, { "pbs_code": "15449D", "brands": [ "Ilumya" ], "form": "100 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "1", "setting": "", "total_units": 4, "max_weeks": 24, "treatment_phases": [ "Continuing (face, hand or foot)" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] }, { "pbs_code": "15458N", "brands": [ "Ilumya" ], "form": "100 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "1", "setting": "", "total_units": 4, "max_weeks": 24, "treatment_phases": [ "Continuing (whole body)" ], "is_balance": false, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] }, { "pbs_code": "15448C", "brands": [ "Ilumya" ], "form": "100 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "2", "max_packs": "1", "pack_size": "2", "repeats": "1", "setting": "", "total_units": 4, "max_weeks": 24, "treatment_phases": [ "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [] } ], "regimen": "100 mg every 12 weeks, from week 28. If high disease burden, or above 90 kg with an unsatisfactory response: 200 mg (2 × 100 mg) may be considered, using the 200 mg item for the body area treated (15448C supplies the balance of that course).", "regimen_source": "" } ], "contacts": { "reps": [ { "company": "Sun Pharma", "name": "Sveta Kiem", "phone": "0448 072 155", "email": "Sveta.kiem@sunpharma.com" }, { "company": "Sun Pharma", "name": "Nicole Atkins", "phone": "0499 084 934", "email": "Nicole.Atkins@sunpharma.com" } ], "compassionate": [ { "text": "Nic.Kurstjens@sunpharma.com", "href": "mailto:Nic.Kurstjens@sunpharma.com" }, { "text": "0420 718 829", "href": "tel:0420718829" } ] }, "timeline": { "max_week": 52, "tracks": [ { "label": "100 mg syringe", "segments": [ { "kind": "doses", "start": 0, "end": 16, "doses": [ { "week": 0, "units": 1, "mg": 100 }, { "week": 4, "units": 1, "mg": 100 }, { "week": 16, "units": 1, "mg": 100 } ], "phase": "INITIAL", "band": "INITIAL", "phaseStart": 0, "coverWeeks": 28, "weightBased": false, "variant": "", "formulation": "100 mg in 1 mL syringe", "escalation": "", "escalation_items": [], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "100 mg at weeks 0, 4 and 16", "items": [ { "code": "11616J", "streamlined": [], "setting": "" } ] }, { "kind": "doses", "start": 28, "end": 40, "doses": [ { "week": 28, "units": 1, "mg": 100 }, { "week": 40, "units": 1, "mg": 100 } ], "phase": "CONTINUING", "band": "CONTINUING", "phaseStart": 28, "coverWeeks": 24, "weightBased": false, "variant": "", "formulation": "100 mg in 1 mL syringe", "escalation": "If high disease burden, or above 90 kg of body weight with an unsatisfactory response: 200 mg (2 × 100 mg) may be considered. Continuing supply is prescribed under the 200 mg item for the body area treated:", "escalation_items": [ { "code": "15458N", "streamlined": [], "setting": "", "label": "whole body" }, { "code": "15449D", "streamlined": [], "setting": "", "label": "face/hand/foot" } ], "deescalation": "", "deescalation_items": [], "openEnd": false, "regimen": "100 mg every 12 weeks, from week 28", "items": [ { "code": "11613F", "streamlined": [], "setting": "" } ] } ], "bands": [ { "band": "INITIAL", "phase": "INITIAL", "start": 0, "end": 28 }, { "band": "CONTINUING", "phase": "CONTINUING", "start": 28, "end": 52 } ], "doses": [ { "week": 0, "units": 1, "mg": 100, "weightBased": false, "secondary": false }, { "week": 4, "units": 1, "mg": 100, "weightBased": false, "secondary": false }, { "week": 16, "units": 1, "mg": 100, "weightBased": false, "secondary": false }, { "week": 28, "units": 1, "mg": 100, "weightBased": false, "secondary": false }, { "week": 40, "units": 1, "mg": 100, "weightBased": false, "secondary": false } ], "ages": [ "18 and over" ] } ] } }, "psoriasis/ustekinumab": { "key": "psoriasis/ustekinumab", "name": "Ustekinumab", "slug": "ustekinumab", "condition": "psoriasis", "condition_label": "Psoriasis", "atc_code": "L04AC", "atc_label": "IL-23 inhibitors", "brands": [ "Stelara", "Steqeyma", "Wezlana" ], "target": "IL-12 & IL-23 (p40)", "note": "", "indications": [ "Severe chronic plaque psoriasis" ], "severities": [ "Severe" ], "authority_tags": [ "Authority", "Streamlined" ], "age_groups": [ "18 and over", "Under 18" ], "phase_groups": [ "INITIAL", "CONTINUING", "BALANCE" ], "groups": [ { "phases": [ "INITIAL" ], "label": "Initial", "items": [ { "pbs_code": "14892T", "brands": [ "Steqeyma", "Wezlana" ], "form": "45 mg in 0.5 mL syringe", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 28, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "45 mg syringe", "regimen": "45 mg at weeks 0, 4 and 16" } ] }, { "pbs_code": "9304Q", "brands": [ "Stelara", "Wezlana" ], "form": "45 mg in 0.5 mL vial", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 28, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "45 mg vial", "regimen": "45 mg at weeks 0, 4 and 16" } ] }, { "pbs_code": "14935C", "brands": [ "Steqeyma", "Wezlana" ], "form": "90 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 28, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "18 and over (>100 kg): 90 mg syringe", "regimen": "90 mg at weeks 0, 4 and 16" } ] }, { "pbs_code": "14879D", "brands": [ "Steqeyma", "Wezlana" ], "form": "45 mg in 0.5 mL syringe", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 28, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "Under 18" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "45 mg syringe", "regimen": "45 mg at weeks 0, 4 and 16" } ] }, { "pbs_code": "12669T", "brands": [ "Stelara", "Wezlana" ], "form": "45 mg in 0.5 mL vial", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 28, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "Under 18" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "0.75 mg/kg at weeks 0, 4 and 16 (weight-based, drawn from the 45 mg vial)" }, { "variant": "45 mg vial", "regimen": "45 mg at weeks 0, 4 and 16" } ] }, { "pbs_code": "14897C", "brands": [ "Steqeyma", "Wezlana" ], "form": "90 mg in 1 mL syringe", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "2", "setting": "", "total_units": 3, "max_weeks": 28, "treatment_phases": [ "Initial 1, 2 or 3", "Balance of supply" ], "is_balance": true, "age_groups": [ "Under 18" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "", "regimen": "90 mg at weeks 0, 4 and 16" } ] } ], "regimen": "45 mg (90 mg if >100 kg) at weeks 0, 4 and 16", "regimen_source": "" }, { "phases": [ "CONTINUING" ], "label": "Continuing", "items": [ { "pbs_code": "14899E", "brands": [ "Steqeyma", "Wezlana" ], "form": "45 mg in 0.5 mL syringe", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "1", "setting": "", "total_units": 2, "max_weeks": 24, "treatment_phases": [ "First continuing", "Balance of supply" ], "is_balance": true, "age_groups": [ "18 and over" ], "authority_tags": [ "Authority" ], "streamlined_codes": [], "dosing": [ { "variant": "45 mg syringe", "regimen": "45 mg every 12 weeks, from week 28" } ] }, { "pbs_code": "14944M", "brands": [ "Steqeyma", "Wezlana" ], "form": "45 mg in 0.5 mL syringe", "manner_of_administration": "Injection", "max_quantity": "1", "max_packs": "1", "pack_size": "1", "repeats": "1", "setting": "", "total_units": 2, "max_weeks": 24, "treatment_phases": [ "Subsequent continuing" ], "is_balance": false, "age_groups": [ "18 and over" ], 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