San Francisco, Calif., February 27, 2015 – The Institute for Clinical and Economic Review (ICER) has released the final California Technology Assessment Forum (CTAF) report “Newest Treatments for Hepatitis C, Genotype 1” and three complementary Action Guides, which reflect deliberations from the December 18, 2014 CTAF public meeting in Oakland, CA. At the meeting, the CTAF Panel, an independent committee of medical evidence experts, reviewed the evidence on the comparative clinical effectiveness and value of several new treatments for hepatitis C.
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.
“These drugs have crystallized the tension in the US health care system between paying for medical innovation and ensuring affordable access to treatment,” said Steven D. Pearson, MD, President of ICER. “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.”
ICER’s evidence review examined two additional DAA combinations: simeprevir (Olysio®, Janssen) and sofosbuvir (Sovaldi®, Gilead Sciences, Inc.); and paritaprevir, ritonavir, ombitasvir and dasabuvir with ribavirin (Viekira Pak™, AbbVie Inc., referred to as 3D in the report). The CTAF panel voted that there was insufficient evidence to distinguish clinical effectiveness among the three treatments. In clinical trials, each combination-DAA treatment produced a sustained virologic response (SVR), a measure often associated with a cure, 12 weeks after therapy 95-100% of the time.
ICER’s budgetary impact analysis of the LDV/SOF combination demonstrated substantial short-term costs – $3 billion if all California Medi-Cal and Department of Corrections patients with hepatitis C genotype 1 were to be treated with LDV/SOF, and all patients with genotypes 2 and 3 were to be treated with the combination of sofosbuvir and ribavirin (LDV/SOF is not FDA-approved for genotypes 2 and 3).
The large projected budget impact associated with the drugs has led many payers to ask doctors to prioritize treatment for patients with more advanced liver disease. There is great demand for the new treatments, however, and members of two policy roundtables at the meeting discussed the clinician and patient desires that all people with hepatitis C infections who seek treatment and would benefit from it have access.
“We are certainly hearing from many groups that it is unconscionable to not treat everybody, and I agree,” said Matt Salo, Executive Director of the National Association of Medicaid Directors, and a participant on the pricing and payment roundtable. “But to arrive at that goal, policymakers need to work together to create innovative policy solutions aimed at making these drugs more affordable and accessible to the patients that need them.”
Action Guides for patients, clinicians, and payers/policymakers are companion materials to the full report. The Action Guides provide a practical list of action steps and resources tailored to help individuals and organizations interpret and apply the results from the ICER report and the CTAF meeting on the newest treatments for hepatitis C, genotype 1.
The California Technology Assessment Forum (CTAF) – a core program of the Institute for Clinical and Economic Review (ICER) – reviews objective evidence reports and holds public meetings to develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about CTAF, please visit www.ctaf.org.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit health care research organization dedicated to improving the interpretation and application of evidence in the health care system. ICER directs two core programs: CTAF, and the New England Comparative Effectiveness Public Advisory Council (CEPAC). For more information about ICER, please visit ICER’s website, www.icer-review.org.