Cost-Effectiveness and Budget Impact of Hepatitis C Virus Treatment With Sofosbuvir and Ledipasvir in the United States

Abstract

Background The recently approved drugs, sofosbuvir and ledipasvir, for chronic hepatitis C virus (HCV) treatment are more efficacious and safer but are substantially more expensive than the old standard-of-care (oSOC). It remains unclear whether and in which patients their improved efficacy justifies their increased cost. Objective To evaluate the cost-effectiveness and budget impact of sofosbuvir- and ledipasvir-based therapies. Design Simulation model of the natural history of HCV. Data Sources Published literature. Target population Treatment-naive and treatment-experienced HCV population defined on the basis of HCV genotype, age and fibrosis distribution in the United States. Time Horizon Lifetime. Perspective Third-party payer. Interventions Simulation of sofosbuvir/ledipasvir-based therapies compared with the oSOC that consisted of interferon-based therapies. Outcomes Measures Quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and 5-year spending on antiviral drugs. Results of Base-Case Analysis Sofosbuvir-based therapies added 0.56 QALY relative to the oSOC, at an incremental cost of $55 400 per additional QALY. The ICERs ranged from $9700 to $284 300 per QALY depending on the patient’s status with respect to prior treatment, HCV genotype, and the presence of cirrhosis. At $100 000 willingness-to-pay per QALY, sofosbuivr-based therapies were cost-effective in 83% of treatment-naive and 81% of treatment-experienced patients. Compared with the oSOC, new drugs would cost an additional $65 billion in the next 5 years to treat eligible HCV-infected people in the United States, whereas the resulting cost offsets would be $16 billion. Results of Sensitivity Analysis Results were sensitive to the drug price, drug efficacy and quality-of-life after a successful treatment. Limitation Data on real world effectiveness of new antivirals is lacking. Conclusions HCV treatment is cost-effective in the majority of patients, but additional resource and value-based patient prioritization are needed to manage HCV patients.

A Methodological Review of US Budget-Impact Models for New Drugs

“…Table 3 presents the seven key elements of the design of a budget-impact analysis when it is presented alongside a cost-effectiveness model. An overall finding for the ten studies that presented the results of both a cost-effectiveness analysis and a budget-impact model in the same article is that the information provided for the budget-impact model design, assumptions, inputs, and results was sparse and not sufficient to completely characterize the model [57][58][59][60][61][62][63][64][65][66]. More detailed information was provided for the cost-effectiveness analysis, some of which was relevant for the budget-impact analysis.…”

A hepatitis C-vírus-fertőzés és kezelésének költségvonzata

“…Az Amerikai Egyesült Államokban elfogadott 100 000 USD/QALY költséghatárt fi gyelembe véve a betegek több mint 80%-ánál minősül költséghatékonynak ez a kezelés -függetlenül a kezelési előzményektől. Ugyanakkor a sofosbuvir-ledipasvir kezelés a jelenlegi kezelési intenzitás mellett öt év alatt az eddigi ráfordításnál 16 milliárd USD-vel több, összesen 65 milliárd USD költ-séggel járna [28]. Előnyösnek találták e sofosbuvir/ledipasvir kezelést más közleményekben is, beleértve a HCV-G1-fertőzött betegeket [29].…”

New, Expensive Treatments for Chronic Hepatitis C: Insuring Good Outcomes?

“…These highly effective treatment regimens improve sustained virologic response rates to well over 90 % among chronically HCV-infected patients, though their price can exceed $50,000 per patient. Despite findings that such treatments offer good value [1][2][3], their high price challenges the affordability of their delivery to all eligible patients. It is estimated that there are more than 3 million free-living people in the USA with chronic HCV infections as well as nearly 1 million incarcerated or institutionalized people with such infections [1,4].…”

“…Combined with the higher perpatient costs, the total potential expenditures to treat all eligible individuals are now estimated in the hundreds of billions of dollars [1,2]. Who is likely to pay?…”

“…A substantial fraction of the potential burden falls on public payers such as Medicaid, prison healthcare systems, the VA Healthcare System, and increasingly on Medicare as the birth cohorts with the highest HCV prevalence reach the age of Medicare eligibility. Likewise, private commercial insurers shoulder a substantial share [2].…”