--- title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Budget impact" description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Budget impact. Topics: Summary: U.S. price status and Japan price; Summary: economic evaluations and HTA status; Summary: eligible population, dosing quantities, and cost inputs. 3 evidence topics quoted from 19 sources." canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary/budget-impact" published: "2026-10-21T22:39:04-04:00" modified: "2026-10-22T19:07:03-04:00" --- # Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Budget impact ## 1.1.3 Budget Impact of Bepirovirsen ### Summary: U.S. price status and Japan price - No U.S. wholesale acquisition cost or average sales price had been published at the time of U.S. approval. A GSK spokesperson stated that the drug’s “list price will become public once pricing and reimbursement discussions have wrapped with payers”. No U.S. budget impact model of bepirovirsen has been published. - Ionis is eligible for “tiered royalties of 10-12% on net sales of bepirovirsen”. - Japan, the first country of approval (24 August 2026), scheduled National Health Insurance listing for 14 October 2026 at 183,015 yen per 150 mg (1 mL) prefilled syringe. - The Japan price was set by the cost accounting method because no listed product had the same indication, pharmacological action, or chemical structure, so no comparator product was identified. The cost components per syringe are 130,733 yen total product cost, 24,164 yen operating profit (15.6% of the price excluding distribution costs), 11,480 yen distribution cost (6.9% of the price excluding consumption tax), and 16,638 yen consumption tax. - A usefulness premium (I) of 50% and a SENKU premium of 10% were assessed with a premium coefficient of 0, so the price is 183,015 yen before and after premiums. The product qualifies for the innovative new drug price maintenance system and is designated for Japan's cost-effectiveness evaluation (category H1). - For inpatient DPC payment, the standard drug cost is 366,030 yen per 300 mg administration, with concomitant drug costs in addition; fee-for-service payment until the next medical fee revision was proposed. - The company's forecast submitted for the Japan listing is 5.6 thousand treated patients and 39.8 billion yen in sales at peak, in year 4. Source: [Fierce Pharma (2026)](https://www.fiercepharma.com/pharma/gsk-brings-promise-functional-cure-hepatitis-b-finish-line-fda-nod-hibsago); [Ionis press release, Hibsago US approval (2026)](https://ir.ionis.com/news-releases/news-release-details/ionis-partner-gsk-announces-hibsago-bepirovirsen-approved-us); [MHLW Chuikyo new drug price listing (2026)](https://www.mhlw.go.jp/content/10808000/001756860.pdf); [MHLW Chuikyo DPC high-cost new drugs (2026)](https://www.mhlw.go.jp/content/10808000/001756861.pdf) ### Summary: economic evaluations and HTA status - 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 in a 50-year-old man with HBeAg-negative, noncirrhotic, NUC-suppressed infection estimated that a 30% effective regimen would yield 0.30 QALYs gained per patient in the U.S. and 0.57 in China. With an annual HCC incidence of 0.1% after functional cure, the regimen could be cost-effective at a one-time treatment cost under USD 46,642 in the U.S. and USD 13,008 in China. - An earlier threshold analysis of a finite 48-week cure regimen estimated that a cure would be cost-saving in the USA at a one-time treatment cost under US$11,944 for patients with cirrhosis and US$6,694 for patients 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 across standard-of-care comparators and a value-based price per dose of $92.92 to $367.44 at a $13,500 per QALY threshold ($426.41 per dose from the societal perspective). Its efficacy parameters came from phase 2 evidence, and B-Well phase 3 results were not incorporated into the base case. - NICE appraisal ID6608 (single technology appraisal) is in progress, with a committee meeting on 12 January 2027 and expected publication on 10 March 2027. The CDA-AMC reimbursement review (SR0948-000) is active as a complex review filed before a notice of compliance. No ICER review was identified. The 2025 UK horizon-scanning briefing states that the estimated cost “is not yet known”. Source: [Wong et al. (2026c)](https://pubmed.ncbi.nlm.nih.gov/42803761/); [Toy et al. (2022b)](https://pubmed.ncbi.nlm.nih.gov/34328697/); [Yao et al. (2026)](https://doi.org/10.1186/s13561-026-00827-8); [NICE ID6608](https://www.nice.org.uk/guidance/indevelopment/gid-ta11803); [CDA-AMC bepirovirsen reimbursement review (2026)](https://www.cda-amc.ca/bepirovirsen); [NIHR Innovation Observatory (2025)](https://io.nihr.ac.uk/wp-content/uploads/2025/04/30147-Bepirovirsen-for-Chronic-Hepatitis-B-V1.0-APR2025-NON-CONF.pdf) ### Summary: eligible population, dosing quantities, and cost inputs - U.S. population estimates: 660,000 persons (0.2% of persons aged 6 years and older) with HBV infection in the National Health and Nutrition Examination Survey (NHANES), of whom 49.8% were aware of their infection; 1.8 million HBV-positive individuals (0.55%) in a 2020 model; and a range of 580,000 to 2.4 million persons cited in the 2023 CDC screening recommendations. - Diagnosed and treated: the 2020 model estimated approximately 334,800 diagnosed infections (18%) and 90,500 of 534,100 eligible individuals (just under 17%) on treatment. A U.S. projection model (2020 to 2050) used 300,000 diagnosed individuals and 143,500 individuals on antiviral treatment. - The label population is adults without cirrhosis who “have been on NrtI therapy for at least 6 months and have suppressed HBV deoxyribonucleic acid (DNA)” and have baseline HBsAg of 3,000 IU/mL or less by quantitative testing. GSK states that HBsAg of 1000 IU/mL or less represents “approximately 45% of diagnosed CHB cases globally”. No source reports the share of U.S. adults on NrtI therapy with HBsAg of 3,000 IU/mL or less. - Dosing: 300 mg, given as two 150 mg prefilled syringes, twice a week in weeks 1 and 2 and once a week in weeks 3 to 24, for a maximum of 24 weeks. Syringes are supplied in cartons of 2 (NDC 0173-0941-39). Early cessation may be considered in patients without HBsAg below 1 IU/mL by week 12, and NrtI therapy continues for at least 24 weeks after the last dose. - Required testing: quantitative HBsAg before initiation; ALT and total bilirubin weekly through week 12 and every other week from weeks 12 through 24; platelet count weekly through week 24; and eGFR every other week through week 24. - Published U.S. cost inputs: an annual generic antiviral drug cost of $502 (60% generic tenofovir disoproxil fumarate and 40% generic entecavir; lowest price $325 per year for generic tenofovir disoproxil fumarate); an annual HBV medication cost of $5382 (range $362 to $12,310) from drug sales data in the projection model; and Medicare reimbursement of $59 per HBV DNA test and $10.33 per HBsAg test. Source: [Bixler et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC10069827/); [Razavi-Shearer et al. (2023a)](https://pmc.ncbi.nlm.nih.gov/articles/PMC10239007/); [Conners et al. (2023)](https://pmc.ncbi.nlm.nih.gov/articles/PMC9997714/); [Razavi-Shearer et al. (2023b)](https://doi.org/10.1111/jvh.13843); [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF); [FDA Hibsago approval announcement (2026)](https://www.fda.gov/news-events/press-announcements/fda-approves-first-its-kind-chronic-hepatitis-b-treatment); [GSK press release, Hibsago US approval (2026)](https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-hepatitis-b-chb/); [Hutton et al. (2022)](https://pmc.ncbi.nlm.nih.gov/articles/PMC9188991/); [Toy et al. (2025)](https://pmc.ncbi.nlm.nih.gov/articles/PMC12598672/) ## Related pages - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Terms and abbreviations](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/terms-and-abbreviations.md) - [Hibsago (bepirovirsen): Chronic hepatitis B virus infection in adults without cirrhosis](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/executive-summary.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Product information and disease description](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/product-information-and-disease-description.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Clinical evidence](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/clinical-evidence.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Economic information and modeling report](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: References](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/references.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: new drug review](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/monograph/review.md) - [Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: cost-effectiveness analyses and utility weights](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses) · [Markdown](https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/cost-effectiveness-analyses.md)