San Francisco, Calif., August 18, 2014 – The California Technology Assessment Forum (CTAF), a core program of the Institute for Clinical and Economic Review (ICER), will hold a public meeting on December 18, 2014 in Oakland, CA to assess the comparative effectiveness and value of multiple new, all-oral direct-acting antiviral agent (DAA) regimens for the treatment of hepatitis C. The review will cover treatments under review by the FDA, including those developed by Gilead Sciences, Inc., AbbVie Inc., and Bristol-Myers Squibb Co. CTAF examined the first two DAAs approved for treating hepatitis C (sofosbuvir and simeprevir) at its March 2014 meeting, and the December 2014 meeting will further help clinicians, patients, and policymakers understand the evolving evidence base on how best to treat hepatitis C. A policy roundtable discussion will focus on the issue of drug pricing and payment models for expensive drugs, of which the hepatitis C drugs are one example.
The DAAs pending FDA approval feature simplified and shorter dosing regimens, along with fewer side effects and negative interactions with other drugs. It is expected that, for most patients in the US, the newest DAAs to treat hepatitis C will be prescribed without the addition of pegylated interferon, an older drug that is injected weekly, can cause serious side effects, and has led to many patients discontinuing treatment.
Between three and five million Americans suffer from chronic hepatitis C, with approximately 17,000 new infections occurring every year. The disease often progresses slowly, and in many cases, does not cause liver damage serious enough to require medication, two factors that complicate the decision of whether or not to initiate treatment. An estimated 50 percent of Americans infected are undiagnosed, and historically, less than 15 percent of those suffering from the disease have received treatment.
Date: Thursday, December 18, 2014
Time: 10:00 AM – 4:00 PM PT
Location: Oakland, CA
In-person tickets to the meeting are currently sold-out. Members of the public wishing to join the waitlist for in-person tickets to the meeting should register by December 10, 2014 by clicking here. Alternatively, members of the public can register to participate by webinar by clicking here.The draft evidence report that will form the basis of the CTAF meeting will be posted to the CTAF website on or about Thursday, November 13, 2014. The CTAF website also includes instructions for those wishing to submit written comments prior to the meeting, for which the deadline is 5:00 PM PT Thursday, December 4, 2014. Members of the public wishing to deliver an oral comment during the public meeting must send an email by 5:00 PM PT Thursday, December 11, 2014. Availability of time slots for public comments is limited. Any updates to the timeline will be posted on the CTAF website.
A recording of the December 18, 2014 meeting will be made available on the CTAF website following the meeting for members of the public unable to attend in person.
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.