Risk Of Developing Liver Cancer After HCV Treatment

Monday, March 16, 2015

Gilead's Harvoni cost-effective for most patients with HCV

Gilead's hepatitis C drugs largely cost-effective in U.S.: study
BY ANDREW M. SEAMAN
Tue Mar 17, 2015 2:34am IST

(Reuters Health) - New hepatitis C drugs that shorten treatment times are largely cost-effective despite their hefty U.S. price tags, according to two new analyses.

The widespread use of a combination of drugs that include Gilead Sciences Inc's Sovaldi, known generically as sofosbuvir, will nonetheless be a significant cost for the U.S. healthcare system, researchers wrote.

Sovaldi's initial $84,000 price drew widespread criticism last year, and insurers have since pressed Gilead and rival AbbVie Inc to offer steep discounts on the treatments.

One analysis published on Monday in the Annals of Internal Medicine found treatment involving Sovaldi cost-effective for people with the most common type of hepatitis C, known as genotype 1, compared with older treatments.

It was funded by CVS Health, one of the largest U.S. pharmacy benefits managers, and was based on Gilead's 2014 pricing, before it began to offer greater discounts.

The new drugs cost $12,825 for every healthy year of life patients gained over older treatments, the researchers said. That was below the usual cutoff of $50,000 per healthy year of life gained for cost-effectiveness.

Senior author Dr. Niteesh Choudhry cautioned that the analysis looks at benefits over the course of a person's life, while the cost of treatment is paid upfront.

"We look over the long term and it takes a long time for these dollars to be incorporated," said Choudhry, of Brigham and Women's Hospital in Boston.

A second analysis published in the same journal found that treating all eligible U.S. hepatitis C patients over the next five years, at 2014 prices, would cost an additional $65 billion more than older and less-effective treatments.

Based on reduced 2015 prices, the researchers said, the costs would total an additional $20 billion over the next five years.

Treating the patients with the new drugs would also prevent about $16 billion in healthcare spending in the future, the researchers said. The study was funded by the National Institutes of Health.

"These drugs are good value for the money," said lead author Jagpreet Chhatwal, from the University of Texas MD Anderson Cancer Center in Houston.

Gilead offers a combination drug known as Harvoni, which combines Sovaldi and the company's ledipasvir. AbbVie's Viekira Pak, which was approved in the United States in late 2014, was not evaluated in either of the analyses.
(Reporting by Andrew M. Seaman; Editing by Dan Grebler)

Harvoni cost-effective for most patients with HCV
March 16, 2015

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.

“In a cost-effectiveness analysis, combination therapy with sofosbuvir and ledipasvir reduced HCV-related complications and was cost-effective for most patients,” the researchers wrote. “However, its use would cost an additional $65 billion over the next 5 years while offsetting only $16 billion of the overall cost of HCV care.”

Researchers, including Jagpreet Chhatwal, PhD, assistant professor in the division of cancer prevention and population sciences, The University of Texas MD Anderson Cancer Center, 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 withoutVictrelis (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.

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.

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.

Source - Healio


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