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Harvoni cost-effective for most patients with HCV

Harvoni is cost-effective for most patients with hepatitis C virus infection, but additional resources and value-based patient prioritization are needed, according to newly published data in Annals of Internal Medicine.

“We have millions of people who need treatment for hepatitis C and payers obviously don’t have the budget to cover this tremendous expense,” Jagpreet Chhatwal, PhD, assistant professor in the division of cancer prevention and population sciences, The University of Texas MD Anderson Cancer Center, said in a press release. “As a result, physicians have to prioritize the new drugs to the sickest of patients, and several payers have added restrictions that only those with the most advanced disease receive treatment.”

Jagpreet Chhatwal

Chhatwal and colleagues developed a model, Markov-based Analyses of Treatments for Chronic Hepatitis C (MATCH), from a third-party payer perspective. The model used a base-case population of 120 patients with HCV in two developed scenarios: treatment using the old standard of care, defined as pegylated interferon and ribavirin, with or without Victrelis (boceprevir, Merck) and Incivek (telaprevir, Vertex Pharmaceuticals); and treatment with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences). The researchers used efficacy data published from previous studies (ie, ION, FUSION) and used efficacy data from either the same studies or other previously published studies using protease inhibitors and peginterferon and ribavirin, according to the research.

The weekly cost of sofosbuvir was $7,000 and ledipasvir was $875 compared with $587 for peginterferon, $309 for ribavirin, $1,100 for boceprevir and $4,100 for telaprevir. An average discount of 11% was applied to all drug costs, as well as lifetime horizon and discounted future costs and quality-adjusted life-years (QALYs) at 3% per year, according to the research.

Overall, the average per-person QALYs for the old standard of care was 10.07 compared with treatment with sofosbuvir and ledipasvir at 10.63. Treating 10,000 patients with HCV with sofosbuvir and ledipasvir could prevent 600 cases of decompensated cirrhosis, 310 cases of hepatocellular carcinoma, 60 liver transplantations and 550 liver-related deaths vs. the old standard of care.

The average per-patient cost was higher for sofosbuvir and ledipasvir compared with the old standard of care ($66,000-$154,000 vs. $15,000-$71,600), according to HCV genotype and previous treatment history. The incremental cost-effectiveness ratio (ICER) for sofosbuvir and ledipasvir was $55,400 per additional QALY gained compared with the old standard of care, according to the research. ICERs ranged from $9,700 to $284,300 per QALY based on a patient’s previous treatment history, presence of cirrhosis and HCV genotype.

“While most developed countries factor in treatment cost before approving a drug, US law prohibits considering such costs,” Chhatwal said in the release. “Therefore, patients almost always end up paying more for the drugs that were developed in the US. Considering the law also prohibits Medicare from negotiating drug pricing, the new treatment cost could strain the budget of Centers for Medicare and Medicaid Services.”

Sofosbuvir and ledipasvir therapy was cost-effective in 82% of treatment-naive patients and 60% of treatment-experienced patients at a willingness-to-pay (WTP) threshold of $50,000. At a threshold of $100,000, the WTP was 83% for treatment-naive and 81% for treatment-experienced patients.

Researchers estimated that approximately 1.6 million people will be eligible for HCV treatment during the next 5 years. To cover all treatment-eligible patients during the next 5 years, $136 billion is needed to cover all drugs costs. Sofosbuvir and ledipasvir therapy would cost $65 billion more than the old standard of care, with costs offsetting $16 billion from the new drugs.

“Economics need to play an important part of improving the health care system,” Chhatwal said in the release. “Hepatitis C presents an unusual case where we have cost-effective therapeutic options that our health care system cannot afford. While lower drug prices will help, that’s not sufficient. Both the government and private insurers will need additional resources to effectively manage this epidemic.”

Further analyses showed that costs for sofosbuvir and ledipasvir decreased over time. ICERs at 10 years were $148,500 vs. $66,800 at 30 years.

“The use of sofosbuvir [and] ledipasvir would substantially reduce the clinical burden of HCV disease,” the researchers wrote. “At its current price, this therapy is cost-effective in selected patient groups when a WTP of $50,000 per additional QALY is used.” – by Melinda Stevens

Disclosure: The study was supported by an award from the National Center for Advancing Translational Sciences of the National Institutes of Health. Authors’ disclosures can be viewed online at www.acponline.org.

Editor's Note: This item was updated on March 17, 2015 with additional quotes from the researchers.