Economic information and modeling report

No cost-effectiveness analysis of bepirovirsen from a U.S. perspective has been published. A U.S. and China threshold analysis of a hypothetical functional cure regimen with 30% efficacy in a 50-year-old man with HBeAg-negative, noncirrhotic, NUC-suppressed infection estimated 0.30 QALYs gained per patient in the U.S. and cost-effectiveness “at a one-time treatment cost under the threshold of USD46,642 in the U.S.”; an earlier threshold analysis of a finite 48-week regimen estimated that a cure would be cost-saving in U.S. patients at a one-time treatment cost “under US$11 944” with cirrhosis and “US$6694” without cirrhosis. A lifetime Markov model of bepirovirsen 300 mg weekly for 24 weeks plus background nucleos(t)ide analogues estimated 0.41 to 0.82 incremental QALYs and a value-based price per dose of $92.92 to $367.44 at a $13,500 per QALY threshold. The NICE appraisal (ID6608) is in progress with an expected publication date of 10 March 2027, the CDA-AMC reimbursement review (SR0948-000) is active, no ICER review was identified, GSK has projected “>£2bn in peak year sales” on a non-risk-adjusted basis, and analysts project potential peak sales of 2.2 billion pounds sterling.

No budget impact model of bepirovirsen has been published, and no U.S. list price is public: GSK states that the “list price will become public once pricing and reimbursement discussions have wrapped with payers”, and the UK horizon-scanning briefing states that the cost “is not yet known”. A plan building its own model would need the eligible population defined by the label (adults without cirrhosis who “have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA)” and have HBsAg levels “less than or equal to 3,000 IU/mL”), measured locally with quantitative HBsAg testing. Published U.S. inputs are an estimated 300,000 individuals diagnosed with chronic hepatitis B and 143,500 individuals on antiviral treatment, without restriction to the label population, and GSK states that HBsAg ≤1000 IU/mL represents “approximately 45% of diagnosed CHB cases globally”; no source reports the share of U.S. adults on NrtI therapy with HBsAg ≤3,000 IU/mL. The plan would also need the price, the treatment duration (the label states that “The maximum recommended duration of HIBSAGO treatment is 24 weeks”, given as 300 mg twice weekly in weeks 1 and 2 and once weekly in weeks 3 to 24, each dose as two 150 mg prefilled syringes supplied in cartons of 2), the cost of required laboratory monitoring, and continued NrtI therapy costs.