---
title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Cost-effectiveness evidence"
description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Cost-effectiveness evidence. Topics: Summary: published economic evaluations and HTA status; Cost-effectiveness thresholds for a functional cure regimen in the United States and China; Cost-saving price thresholds for a potential cure in the United States, China, and Australia; Early health technology assessment of bepirovirsen in China; 7 further topics. 11 evidence topics quoted from 11 sources."
canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics/cost-effectiveness"
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: Cost-effectiveness evidence
## 4.1 Modeling Overview
### Summary: published 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 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.
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); [GSK FY2023 results slides (2024)](https://www.gsk.com/media/afnjlfik/fy-2023-results-slides.pdf); [Fierce Pharma (2026)](https://www.fiercepharma.com/pharma/gsk-brings-promise-functional-cure-hepatitis-b-finish-line-fda-nod-hibsago)
### Cost-effectiveness thresholds for a functional cure regimen in the United States and China
> “We simulated disease progression comparing achieving FC defined as HBsAg loss and unquantifiable HBV DNA 24 weeks off treatment with a novel therapeutic regimen to long-term NUC treatment.”
> “The base case was a 50-year-old man with hepatitis B e antigen (HBeAg)-negative non-cirrhotic CHB and NUC-suppressed HBV DNA ≥1year.”
> “Compared to long-term NUC, a 30% effective FC regimen would yield 17.18 and 16.14 quality-adjusted life years (QALYs), and 0.30 and 0.57 QALYs gained per patient in the U.S. and China, respectively.”
> “With an HCC annual incidence rate of 0.1% after FC, a FC regimen could be cost-effective at a one-time treatment cost under the threshold of USD46,642 in the U.S., and USD13,008 in China.”
> “The cost-effectiveness threshold increases with higher FC rates, younger patients, and increasing medical costs, but may be lower in women.”
Source: [Wong et al. (2026c)](https://pubmed.ncbi.nlm.nih.gov/42803761/)
### Cost-saving price thresholds for a potential cure in the United States, China, and Australia
> “We simulated patients' hepatitis B progression, under three scenarios: current long-term suppressive antiviral therapy, functional cure defined as sustained undetectable HBsAg and HBV DNA, and partial cure defined as sustained undetectable HBV DNA only after a finite, 48-week treatment.”
> “In financial terms, for CHB patients with and without cirrhosis, this would be cost-saving at a one-time treatment cost under US$11 944 and US$6694, respectively, in the USA, US$1744 and US$1001 in China, and US$12 063 and US$10 983 in Australia.”
> “The threshold price for cure is largely determined by the current antiviral drug costs, since it will replace a daily antiviral pill that is inexpensive and effective, although not curative.”
Source: [Toy et al. (2022b)](https://pubmed.ncbi.nlm.nih.gov/34328697/)
### Early health technology assessment of bepirovirsen in China
> “A lifetime Markov model simulated bepirovirsen 300 mg/week for 24 weeks plus background NAs against comparator-specific standard-of-care options.”
> “Bepirovirsen yielded 0.41-0.82 incremental QALYs across standard-of-care comparators. Compared with entecavir (ETV), the base case generated 0.82 additional QALYs, incurred an incremental total cost of $10,833.72 per patient at the value-based price, and avoided 906 hepatocellular carcinoma (HCC) cases per 10,000 patients.”
> “Under the $13,500/QALY threshold, the value-based price per dose ranged from $92.92 to $367.44 across comparators.”
> “The societal-perspective scenario increased the value-based price per dose to $426.41.”
> “Phase III B-Well evidence became available after this model was parameterized and is discussed as contextual evidence rather than incorporated into the base case”
> “Clinical efficacy parameters were derived from phase II evidence with stringent inclusion criteria, and the model does not include explicit relapse, viral rebound, or retreatment states.”
Source: [Yao et al. (2026)](https://doi.org/10.1186/s13561-026-00827-8)
### Cost-effectiveness of treating all HBsAg-positive individuals in the United States at three annual drug prices
> “At an annual treatment cost of $2000, treating all HBV infections would be highly cost-effective, and at $750 would be cost saving and would achieve a positive return on investment before 2050.”
> “Such interventions can also be cost-effective compared to the status quo strategy, and cost saving at a treatment price threshold of $750 annually, above the current lowest annual treatment cost of $362.”
Source: [Razavi-Shearer et al. (2023b)](https://doi.org/10.1111/jvh.13843)
### NICE technology appraisal of bepirovirsen (ID6608)
| Field | Project page |
| --- | --- |
| Title | “Bepirovirsen with nucleoside or nucleotide analogues for treating chronic hepatitis B [ID6608]” |
| Suggested remit | “To appraise the clinical and cost effectiveness of bepirovirsen within its marketing authorisation for treating chronic hepatitis B.” |
| Status | “In progress” |
| Process | “STA” |
| Decision publication date | “16 June 2025” |
| Committee meeting | “12 January 2027” |
| Expected publication | “10 March 2027” |
| External assessment group | “Southampton Health Technology Assessment Centre (SHTAC), University of Southampton” |
Source: [NICE ID6608](https://www.nice.org.uk/guidance/indevelopment/gid-ta11803)
### CDA-AMC reimbursement review of bepirovirsen
| Field | Project page |
| --- | --- |
| Project status | “Active” |
| Project number | “SR0948-000” |
| Call for patient and clinician input closed | “September 28, 2026” |
| NOC status at filing | “Pre NOC” |
| Submission complexity | “Complex Review” |
| Manufacturer requested reimbursement criteria | “Bepirovirsen injection is indicated as a finite treatment to achieve functional cure of chronic hepatitis B virus (HBV) infection in patients without cirrhosis who are already on nucleos(t)ide analogue therapy and have hepatitis B surface antigen (HBsAg) levels ≤3,000 IU/mL.” |
Source: [CDA-AMC bepirovirsen reimbursement review (2026)](https://www.cda-amc.ca/bepirovirsen)
### ICER review of bepirovirsen or chronic hepatitis B
No evidence found.
### Estimated cost in the UK horizon-scanning briefing
> “The estimated cost of bepirovirsen is not yet known.”
Source: [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)
### Company peak sales projection
> “bepirovirsen - hepatitis B virus >£2bn in peak year sales”
> “Non-risk adjusted peak year sales potential”
Source: [GSK FY2023 results slides (2024)](https://www.gsk.com/media/afnjlfik/fy-2023-results-slides.pdf)
> “The company is modelling peak sales of bepirovirsen at around £2 billion a year.”
Source: [Pharmaphorum (2026)](https://pharmaphorum.com/news/gsk-hails-unprecedented-cure-rates-hep-b-drug)
### Analyst peak sales forecast and list price status after U.S. approval
> “the analysts said they continue to expect the drug to reach potential peak sales of 2.2 billion pounds sterling (around $2.95 billion).”
> “Hibsago should be made available to U.S. patients before the end of the year, a GSK spokesperson told Fierce, adding that the drug’s list price will become public once pricing and reimbursement discussions have wrapped with payers.”
Source: [Fierce Pharma (2026)](https://www.fiercepharma.com/pharma/gsk-brings-promise-functional-cure-hepatitis-b-finish-line-fda-nod-hibsago)
### Manufacturer peak market forecast submitted for the Japan price listing
> “新薬収載希望者による市場規模予測”
> “予測年度 予測本剤投与患者数 予測販売金額 (ピーク時) ４年度 ５．６千人 ３９８億円”
Source: [MHLW Chuikyo new drug price listing (2026)](https://www.mhlw.go.jp/content/10808000/001756860.pdf)
## Related pages
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- [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)
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