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


The use of therapies based on sofosbuvir and ledipasvir would substantially reduce the clinical burden of HCV. At their current price, these therapies are profitable in selected patient groups using a threshold of $50,000 wtp per additional qaly. however, at $100,000 wtp, these therapies are cost-effective in most patients. Newer therapies offer better value for money in patients who have HCV genotype 1, are in advanced stages of the disease, or are younger. Although reported ices are within the range of therapies for other medical conditions in the United States (61-63), the resources needed to treat large numbers of eligible HCV patients could be immense and unsustainable. Compared to osoc, downstream cost offsets due to the use of sofosbuvir/ledipasvir-based therapies would be only 24% of the additional $65 billion spent on these new drugs. therefore, our analysis does not support the claim that new drugs at current prices will lead to an overall reduction in the cost of HCV disease.

To our knowledge, this is the first study to fully evaluate the cost-effectiveness of sofosbuvir/ledipasvir-based regimens. Previous cost-effectiveness studies of oral HCV therapies did not evaluate current recommendations or draw conclusions based on drug prices that were significantly lower than listed drug prices (64-67). another report evaluated the value of sofosbuvir/simeprevir but did not use models to simulate subsequent events (68). Rather, we present a comprehensive and updated review of the value of HCV treatment by including four major genotypes, interferon tolerance, and prior treatment history. In addition, we carry out a budget impact analysis, which is especially important given the high price of new antivirals.

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The large number of HCV-infected people in need of treatment could place an enormous burden on health spending, reaching an average of $27 billion per year, which represents 10% of US prescription drug spending. uu. in 2012 (69). a large part of the cost of treatment will fall on the shoulders of the government. The Affordable Care Act is expected to increase the number of HCV patients on Medicaid (70). In addition, with the widespread implementation of HCV screening in birth cohorts, many new diagnoses are expected in people covered by Medicare. Although manufacturers generally provide discounts to most buyers, current law prohibits Medicare from negotiating drug prices (71). Therefore, treating all HCV patients with sofosbuvir/ledipasvir at current prices would drastically affect the financial resources of Medicare and Medicaid.

The profitability of HCV treatment depends on society’s willingness to pay for health improvements. Unlike most other developed countries, the United States has not adopted any official threshold for determining whether or not a new intervention is cost-effective (72). the commonly used threshold of $50,000 is questionable and the most appropriate threshold might be between $100,000 and $200,000 (73, 74). however, even though hcv treatment is cost-effective, our analysis shows that it is unaffordable at current prices. this raises the question whether the threshold should depend on the available budget and the prevalence of the disease; that is, lower thresholds for the treatment of diseases such as HCV and higher for the treatment of a rare disease.

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The cost-effectiveness of HCV treatment also depends on the type of insurance. for private payers, where the median length of patient enrollment is less than 10 years, sofosbuvir/ledipasvir-based therapies may not be cost-effective. therefore, a lower drug price may provide better value to private payers. while for medicaid/medicare and the veterans administration, where the length of enrollment is longer, these therapies can be cost-effective. therefore, providing additional resources to these public HCV treatment programs could provide good value for money.

Our results were highly sensitive to quality of life after achieving svr. therefore, more research is needed in patients who achieved svr with newer therapies. results were also sensitive to sofosbuvir/ledipasvir discounts; therefore, giving larger discounts will improve the value of the treatment. In addition, the results were sensitive to the following baseline patient demographics: HCV genotype, presence of cirrhosis, treatment history, and age.

Our study has several limitations. First, several clinical trials included in our analysis were not randomized and did not directly compare the efficacy of new drugs; therefore, our study only used the best available evidence on the efficacy of treatment, which could have high uncertainty due to the low number of patients. we used efficacy data from phase II clinical trials when data were not available from phase III trials or meta-analyses, but performed sensitivity analyses. the use of data from international clinical trials for the US population could have resulted in an overestimation of the benefits of new therapies. our analysis assumed that the quality of life after achieving svr is equivalent to that of a normal person. this could have overestimated the benefits of the new therapies. we also did not model the future possibility of retreatment with next-generation antivirals due to the lack of these data at the time of our study. Finally, we do not consider changes in insurance group as a result of the Affordable Care Act, which may affect the budget impact of HCV treatment.

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