---
title: "Hibsago (bepirovirsen) in Chronic hepatitis B virus infection in adults without cirrhosis: Economic information and modeling report"
description: "Formulary evidence on Hibsago (bepirovirsen, GSK3228836) in Chronic hepatitis B virus infection in adults without cirrhosis: Economic information and modeling report. Covers Cost-effectiveness evidence and Budget impact model. 12 evidence topics quoted from 13 sources."
canonical: "https://www.evicenter.com/drugs/hibsago--chronic-hepatitis-b-virus-infection-in-adults-without-cirrhosis/economics"
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: Economic information and modeling report
## 4 Economic Information and Modeling Report
### 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)
### 4.2 Budget Impact Model
#### 4.2.1 Approach and Framework
No evidence found.
#### 4.2.2 Perspective and Time Frame
No evidence found.
#### 4.2.3 Epidemiology and Eligible Population Inputs
No evidence found.
#### 4.2.4 Cost Assumptions
No evidence found.
#### 4.2.5 Model Outcomes
No evidence found.
#### 4.2.6 Results
##### 4.2.6.1 Base Case
No evidence found.
##### 4.2.6.2 Scenario Analyses
No evidence found.
#### 4.2.7 Budget impact model discussion
##### Summary: absence of a published budget impact model
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.
Source: [Fierce Pharma (2026)](https://www.fiercepharma.com/pharma/gsk-brings-promise-functional-cure-hepatitis-b-finish-line-fda-nod-hibsago); [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); [Hibsago prescribing information (2026)](https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Hibsago/pdf/HIBSAGO-PI-MG-IFU.PDF); [Razavi-Shearer et al. (2023b)](https://doi.org/10.1111/jvh.13843); [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/)
## 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: 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)