Addressing the Restricted Use of DAA therapies

Posted on July 6, 2015

Results of a new US cost effectiveness study indicate that effective direct acting antiviral (DAA) therapies should be not be restricted to only those HCV-infected patients with advanced fibrosis. Authors note that as a society, we have an opportunity to eliminate hepatitis C by taking appropriate and timely steps, and we should be willing to pay for the current HCV therapies by providing additional resources and giving hepatitis C the attention it deserves.

The use of new DAAs, coupled with updates in HCV screening guidelines, could make HCV a rare disease in the US in the next 20 years. But the high price of DAAs is perceived as a barrier, and Medicaid in at least 30 US states has restricted these treatments to patients with advanced fibrosis. However, several recent studies have shown that DAAs provide a good value for money. Furthermore, the price of DAAs has come down since their first availability.

The results of a new cost effectiveness study recently published in the journal Clinical Gastroenterology and Hepatology highlight the value of HCV treatment with oral DAAs (Chhatwal J, et al. Clin Gastroenterol Hepatol. 2015 Jun 16. [Epub ahead of print]).

Value of HCV treatment

  • When compared to the previous standard of care, “new” HCV treatment has historically cost an additional $50,000 to $100,000 for one additional quality-adjusted life year (QALY) gained. Analyses show that the DAA therapies are no exception to this rule.
    • The QALY is a measure of disease burden, including both the quality and the quantity of life lived. It is used in assessing the value for money of a medical intervention.

HCV Treatment is Now Cost-Saving

  • Authors used their previously published cost simulation model to evaluate the cost effectiveness of DAAs compared with treatment with telaprevir/boceprevir or peginterferon-based therapies
    • Treatment with sofosbuvir-ledipasvir regimens was found to be cost-saving in all patients, ie, these regimens increased QALYs and saved healthcare costs.
      • This effect was most prominent in patients with genotype 1 infection
      • Treatment was not cost-saving, although it was cost-effective, in patients with other genotypes

Decreased Cost per SVR

  • Authors note that although the cost of antiviral treatment increased with the availability of new therapies, the cost-per-SVR has decreased
    • While the cost of treating HCV genotype 1 with peginterferon-ribavirin, first-generation protease inhibitors, and sofosbuvir-ledipasvir (at wholesale acquisition cost) increased from $43,000 to $103,000 per patient, the corresponding costs-per-SVR decreased from $213,000 to $108,000.
    • With recent rebates on drug prices, sofosbuvir-based treatment in 2015 on an average costs 54% of the wholesale acquisition cost. After applying this recent discount (46%), the cost of treatment decreased to $56,000, which is less expensive than boceprevir- and telaprevir-based therapies, and the cost-per-SVR fell to $58,000.

Health Economics of HCV versus HIV Treatment

  • The discounted lifetime cost of treating one person with HIV in the US is $315,000 in 2014 US dollars. However, the corresponding cost of curing HCV with oral DAAs is $58,000–which is only 18% of the total HIV treatment cost. Authors note that while HIV antiretroviral treatment is cost-effective in the US, HCV treatment is cost-saving.
  • The total federal budget requested for HIV and AIDS in 2015 is $24.2 billion, of which $17.5 billion is allocated to HIV treatment and care. Using a simulation model, the authors of this new study predicted that the maximum 5-year budget needed to treat all patients (by private as well as government payers) who are candidates for HCV treatment is $37 billion, ie, $7.4 billion per year.
  • Of note, unlike HIV, HCV treatment offers a cure; therefore annual spending on HCV treatment would reduce sharply in subsequent years.

Study authors conclude the following: “The cost of HCV treatment with the available oral DAAs has decreased substantially since their first availability in 2014. Furthermore, we anticipate more discounts with increased competition from other manufacturers in the near future. The overall budget needed to treat HCV is not huge and is reasonable when comparable to that of HIV. Therefore, HCV treatment should be not be restricted to only those in advanced fibrosis stages. We have an opportunity to eliminate hepatitis C by taking appropriate and timely steps. We as a society should be willing to pay for the current HCV therapies by providing additional resources and giving attention to hepatitis C that it deserves.”

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