№ lp_1_2_53237
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Excerpt from an Australian pharmaceutical reimbursement assessment summarising regulatory background, clinical evidence, economic evaluation, and prior committee decisions regarding apremilast for PBS listing in 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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
APREMILAST, Pack containing 4 tablets of 10 mg, 4 tablets of 20 mg and 19 tablets of 30; Tablet 30 mg, Otezla®, Celgene Pty Ltd
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
APREMILAST, Pack containing 4 tablets of 10 mg, 4 tablets of 20 mg and 19 tablets of 30; Tablet 30 mg, Otezla®, Celgene Pty Ltd
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
Historic Wilmington Foundation Plaque Application & Instructions
Year: 2022
Region / City: Wilmington
Topic: Historic Preservation
Document Type: Application Instructions
Organization / Institution: Historic Wilmington Foundation
Author: Historic Wilmington Foundation
Target Audience: Property Owners
Effective Period: Ongoing
Approval Date: April 2022
Amendment Date: N/A
Price SPD Square Plaque Diffusers
Note: Year
Flare-up of mild plaque psoriasis
Year: 2024
Region / City: Australia
Topic: Psoriasis Treatment
Document Type: Patient Handout
Organization: Victorian Government, Department of Health
Author: Not specified
Target Audience: Patients with mild plaque psoriasis
Period of validity: Not specified
Approval Date: March 2024
Amendment Date: Not specified
Cost Information: Free consultation; medicine costs vary based on Medicare and PBS status
Eligibility: Adults aged 18 or older with mild plaque psoriasis
Additional Support: Websites provided for more information
Complaint Process: Information on complaints available at www.health.vic.gov.au/feedback-and-complaints
Safety Net Information: Medications not included in PBS Safety Net
Consultation Details: Private consultation with a pharmacist
Prescription Information: Medicines under PBS or full price for non-listed items
International Students: Eligible based on specific countries
Consent Process: Provided during consultation
Health Advice: Self-care and lifestyle tips included
Expected Outcome: Symptoms should improve within 2-4 weeks
What to do if symptoms worsen: Visit a doctor if no improvement or worsening of condition
Contact: [email protected]
bDMARDs for severe chronic plaque psoriasis: analysis of utilisation
Year: 2014
Region / city: Australia
Topic: Pharmaceutical benefits scheme, biological disease-modifying anti-rheumatic drugs (bDMARDs), chronic plaque psoriasis
Document Type: Research report
Organization / institution: Drug utilisation sub-committee (DUSC)
Author: Not specified
Target Audience: Healthcare professionals, policymakers
Period of validity: Not specified
Approval date: Not specified
Date of changes: Not specified
HISTORIC TEXAS CEMETERY MARKERS: Medallion/Name & Date Plaque Application
Year: 2023
Region / City: Texas
Theme: Historic Preservation
Document Type: Application Form
Organization: Texas Historical Commission
Author: Texas Historical Commission
Target Audience: Cemetery Administrators, Historical Markers Sponsors
Approval Date: 2023-01-01
Modification Date: 2023-01-01
Period of Validity: Until marker approval
Date of Submission: 2023-01-01
Marker Title: Historic Texas Cemetery Marker
Marker Type: HTC Medallion, Name & Date Plaque
Shipping Address: Required business street address
Approval Process: Completed HTC designation required
Payment Information: Non-refundable application fee of $100, with a 45-day payment deadline
Marker Fees: Subject to change due to material costs
Description: Application form for requesting a Historic Texas Cemetery marker with Medallion and Name & Date Plaque, requiring prior HTC designation approval and payment process.
Supplemental Material: Guselkumab for the treatment of moderate-to-severe plaque psoriasis in pediatric patients: results of the phase 3, randomized, placebo-controlled PROTOSTAR study
Year: 2026
Region / city: Not specified
Topic: Guselkumab treatment for pediatric plaque psoriasis
Document type: Research study
Institution: Not specified
Author: Vimal H. Prajapati, Marieke M.B. Seyger, Dagmar Wilsmann-Theis, Erzsebet Szakos, Andrzej Kaszuba, Bart van Hartingsveldt, Meg Jett, Gigi Jiang, Shu Li, Vikash Sinha, Herta Crauwels, Cynthia M.C. DeKlotz, Amy S. Paller
Target audience: Healthcare professionals, dermatologists
Study period: Not specified
Date of approval: Not specified
Date of revisions: Not specified
Description: Phase 3, randomized, placebo-controlled study of Guselkumab for pediatric patients with moderate-to-severe plaque psoriasis.
Topics: Apremilast Otezla Plaque