Product information and disease description Place of product in therapy Disease description Burden of Chronic hepatitis B virus infection in adults without cirrhosis

Economic impact of diagnostic testing

7 evidence topics · 5 sources

Quantitative HBsAg testing required for patient selection

“Prior to initiation of HIBSAGO for treatment of chronic HBV infection, test all patients to quantify HBsAg levels in serum or plasma to identify patients with baseline HBsAg levels less than or equal to 3,000 IU/mL” (opens the prescribing information at this quote)
“In addition, test patients for HBV DNA, ALT, AST, bilirubin, platelet count, urine albumin-creatinine ratio (uACR), and estimated glomerular filtration rate (eGFR) prior to initiation of treatment and as directed while on treatment and following treatment completion” (opens the prescribing information at this quote)
“Information on FDA-authorized tests for the quantification of HBsAg levels is available at:” (opens the prescribing information at this quote)

Minimum on-treatment laboratory monitoring required by the prescribing information

“HIBSAGO therapy should be prescribed only when appropriate laboratory monitoring can be performed to manage the treatment regimen.” (opens the prescribing information at this quote)
“Weekly through Week 12 and every other week from Weeks 12 through 24” (opens the prescribing information at this quote)
“The minimum recommended on-treatment monitoring of ALT and total bilirubin in all patients.” (opens the prescribing information at this quote)
“The minimum recommended on-treatment monitoring of platelet counts in all patients.” (opens the prescribing information at this quote)
“Monitor eGFR every other week through Week 24” (opens the prescribing information at this quote)

Availability of quantitative HBsAg tests at approval

“Quantitative surface antigen testing will support the diagnosis and identification of patients suitable for treatment with bepirovirsen who have baseline HBsAg levels ≤3000 IU/ml. Several tests are available, including a recently authorised FDA test.” (opens the source at this quote in a new tab)

Medicare reimbursement for hepatitis B laboratory tests used in a U.S. hepatitis D testing cost-effectiveness model (2024 U.S. dollars)

Test or service	Unit cost and frequency over 48 weeks of treatment	Cost basis
HBV DNA test	“$59 × 4”View highlighted excerpt for this quote	“Medicare reimbursement”View highlighted excerpt for this quote
HBsAg test	“$10.33 × 4”View highlighted excerpt for this quote	“Medicare reimbursement”View highlighted excerpt for this quote
LFT and CBC with platelet count	“$86.74 × 4”View highlighted excerpt for this quote	“Medicare reimbursement”View highlighted excerpt for this quote
Comprehensive metabolic panel	“$10.56 × 4”View highlighted excerpt for this quote	“Medicare reimbursement”View highlighted excerpt for this quote
Clinic visits	“$74 × 8”View highlighted excerpt for this quote	“Medicare reimbursement”View highlighted excerpt for this quote

Medicare reimbursement for hepatitis B serology tests used in a U.S. testing cost-effectiveness model

“The costs of HBsAg ($10.33), anti-HBc ($10.74), anti-HBs ($12.05) tests, and a 3 HepB tests package ($28.27) were based on Medicare reimbursement.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

Cost-effectiveness of one-time universal HBsAg screening of U.S. adults

“At an estimated 0.24% prevalence of undiagnosed CHB, universal hepatitis B surface antigen (HBsAg) screening in adults aged 18-69 years is cost-saving compared with current practice if antiviral treatment drug costs remain below $894/year.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“Compared with current practice, universal screening would avert an additional 7.4 cases of compensated cirrhosis, 3.3 cases of decompensated cirrhosis, 5.5 cases of hepatocellular carcinoma, 1.9 liver transplants, and 10.3 hepatitis B virus-related deaths at a saving of $263 000/100 000 adults screened.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote
“Testing costs were based on Medicare reimbursement rates.” (opens the original PubMed page at this quote in a new tab)View highlighted excerpt for this quote

Cost-effectiveness of one-time HBV testing at vaccination in adults seeking care for sexually transmitted infection

“Compared with current recommendations, the addition of 1-time HBV testing is cost-saving and would prevent an additional 138 cases of cirrhosis, 47 cases of decompensated cirrhosis, 90 cases of hepatocellular carcinoma, 33 liver transplants, and 163 HBV-related deaths, and gain 2185 QALYs, per 100,000 adults screened.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote
“Screening with the 3-test panel would save $41.6 to $42.7 million per 100,000 adults tested compared with $41.5 to $42.5 million for the 2-test panel and $40.2 to $40.3 million for HBsAg alone.” (opens the original PMC page at this quote in a new tab)View highlighted excerpt for this quote

Reimbursement specific to quantitative HBsAg assays and to fibrosis assessment for excluding cirrhosis

No evidence found.