Interventions of interest:

  • Simeprevir (Olysio®, Janssen Products, LP) + sofosbuvir (Sovaldi®, Gilead Sciences, Inc.)
  • Ledipasvir/sofosbuvir (Harvoni®, Gilead Sciences, Inc.)
  • Daclatasvir (Daklinza™, Bristol-Myers Squibb Company) + sofosbuvir (Sovaldi®, Gilead Sciences, Inc.)
  • Paritaprevir/ritonavir/ombitasvir + dasabuvir with ribavirin (Viekira Pak™, AbbVie, Inc.)
  • Simeprevir (Olysio®, Janssen Products, LP)+ pegylated interferon and ribavirin
  • Sofosbuvir (Sovaldi®, Gilead Sciences, Inc.) + ribavirin
  • Sofosbuvir (Sovaldi®, Gilead Sciences, Inc.) + pegylated interferon and ribavirin

Chronic hepatitis C is a common infection that is a major cause of chronic liver disease, liver failure, and hepatocellular carcinoma (HCC), and it is the leading indication for liver transplantation in the Western world. Prior to 2011, the combination of pegylated interferon and ribavirin was the gold standard of therapy for the treatment of chronic hepatitis C. Since 2014, several therapies have been approved to treat hepatitis C offering patients new options for treating the chronic illness.

The panel found that the combination of ledipasvir and sofosbuvir (Harvoni®, Gilead Sciences Inc.), an all-oral combination of direct-acting antiviral (DAA) drugs, was clinically superior to therapy with a single-DAA and cost-effective when compared to treatment with interferon and ribavirin, but represents a low value to health systems due to the immediate budget impact imposed by its high cost. List prices of eight- and 12-weeks of the combination, referred to as LDV/SOF in the report, are $63,000 and $94,500, respectively.

Date of review: December 2014

For questions, contact info@icer.org.

Final Documents

Below you will find the final documents from the assessments review process:

Public Comments Download
Response to Public CommentsDownload
Final Evidence Report and Meeting SummaryDownload

ICER’s President Steve Pearson, MD, MSc stated:

“These drugs have crystallized the tension in the US health care system between paying for medical innovation and ensuring affordable access to treatment. With insights gained from the CTAF evidence review and policy development process, our Action Guides present multiple approaches to care delivery, pricing, and payment that will help ensure the highest value for patients and for the health care system.”