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.

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.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“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.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“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.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“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.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“The cost-effectiveness threshold increases with higher FC rates, younger patients, and increasing medical costs, but may be lower in women.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

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.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“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.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“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.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

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.” (opens the source at this quote in a new tab)
“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.” (opens the source at this quote in a new tab)
“Under the $13,500/QALY threshold, the value-based price per dose ranged from $92.92 to $367.44 across comparators.” (opens the source at this quote in a new tab)
“The societal-perspective scenario increased the value-based price per dose to $426.41.” (opens the source at this quote in a new tab)
“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” (opens the source at this quote in a new tab)
“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.” (opens the source at this quote in a new tab)

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.” (opens the source at this quote in a new tab)
“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.” (opens the source at this quote in a new tab)

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”

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.”

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.” (opens the source at this quote in a new tab)

Company peak sales projection

“bepirovirsen - hepatitis B virus >£2bn in peak year sales” (opens the source at this quote in a new tab)
“Non-risk adjusted peak year sales potential” (opens the source at this quote in a new tab)

“The company is modelling peak sales of bepirovirsen at around £2 billion a year.” (opens the source at this quote in a new tab)

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).” (opens the source at this quote in a new tab)
“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.” (opens the source at this quote in a new tab)

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” (opens the source at this quote in a new tab)
“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” (opens the source at this quote in a new tab)