№ files_lp_3_process_9_64522
File format: docx Character count: 9683 File size: 60 KB
Regulatory and health technology assessment submission outlining the request to list a new 28-tablet pack size of rabeprazole 20 mg (Pariet®) on the Australian PBS/RPBS, including pricing justification, utilisation projections, legislative considerations, and estimated budget impact for 2022–2027.
Year: 2020
Country: Australia
Medicine: Rabeprazole sodium 20 mg enteric coated tablets
Brand: Pariet®
Sponsor: Janssen-Cilag Pty Ltd
Regulatory register: Australian Register of Therapeutic Goods (ARTG)
ARTG registration date: 22 June 2020
Type of submission: General Schedule Authority Required (STREAMLINED) PBS/RPBS listing request
Committee: Pharmaceutical Benefits Advisory Committee (PBAC)
Legislation referenced: National Health Act 1953 (section 85D)
Existing listing comparison: Rabeprazole 20 mg 30-tablet pack
Requested maximum quantity: 28 tablets
Proposed repeats: Up to 5 repeats depending on item code
Approved ex-manufacturer price proposed: $2.83
Adjusted proportional AEMP: $2.64
Indications: Gastro-oesophageal reflux disease (GORD); prevention of relapse of GORD; symptomatic treatment of GORD; active duodenal ulcer; gastric ulcer
Target population: Adult patients requiring short-term treatment (4–8 weeks)
Financial impact period: 2022–2027
Estimated net financial impact: $0 to < $10 million over six years
Hearing: No sponsor hearing conducted
Consumer comments: None received
Price: 8 / 10 USD
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