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This document presents a resubmission for the listing of apremilast for the treatment of moderate to severe plaque psoriasis on the PBS in Australia, including a cost comparison with cyclosporin and proposed restrictions for its use.
Year: 2017
Region / city: Australia
Topic: Treatment of moderate to severe plaque psoriasis
Document type: Resubmission for PBS listing
Authority: Therapeutic Goods Administration (TGA)
Author: Celgene Pty Ltd
Target audience: Healthcare professionals, dermatologists, general physicians
Period of validity: Ongoing
Approval date: 2017
Date of amendments: 2017
Price: 8 / 10 USD
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Apremilast (Otezla) PBS Listing Resubmission for Severe Plaque Psoriasis
Drug name: Apremilast
Brand name: Otezla
Dosage form: Tablet
Strength: 30 mg
Pack composition: 4 tablets of 10 mg, 4 tablets of 20 mg, 19 tablets of 30 mg
Sponsor: Amgen Australia Pty Ltd
Regulatory status: TGA registered
TGA registration date: 19 March 2015
Indication: Severe plaque psoriasis
Previous indication: Psoriatic arthritis and moderate to severe plaque psoriasis
Application type: Minor resubmission
Requested listing: PBS General Schedule, Authority Required (STREAMLINED)
Comparator: Cyclosporin
Clinical population: Patients with severe plaque psoriasis intolerant of or contraindicated to methotrexate
Primary outcome: PASI-75 at 16 weeks
Clinical claim: Non-inferior comparative efficacy and safety versus cyclosporin
Regulatory body: Pharmaceutical Benefits Advisory Committee
Submission history period: 2015–2018
Geographic scope: Australia
Source type: Public summary document excerpt
Apremilast (Otezla) PBS Listing Resubmission for Severe Plaque Psoriasis
Drug name: Apremilast
Brand name: Otezla
Dosage form: Tablet
Strength: 30 mg
Pack composition: 4 tablets of 10 mg, 4 tablets of 20 mg, 19 tablets of 30 mg
Sponsor: Amgen Australia Pty Ltd
Regulatory status: TGA registered
TGA registration date: 19 March 2015
Indication: Severe plaque psoriasis
Previous indication: Psoriatic arthritis and moderate to severe plaque psoriasis
Application type: Minor resubmission
Requested listing: PBS General Schedule, Authority Required (STREAMLINED)
Comparator: Cyclosporin
Clinical population: Patients with severe plaque psoriasis intolerant of or contraindicated to methotrexate
Primary outcome: PASI-75 at 16 weeks
Clinical claim: Non-inferior comparative efficacy and safety versus cyclosporin
Regulatory body: Pharmaceutical Benefits Advisory Committee
Submission history period: 2015–2018
Geographic scope: Australia
Source type: Public summary document excerpt
Topics: Apremilast Otezla Celgene