San Francisco, Calif., May 20, 2014 – The California Technology Assessment Forum (CTAF), a core program of the Institute for Clinical and Economic Review (ICER), has released a final evidence report and three Action Guides (one each for patients, clinicians, and payers/ policymakers) on new treatments for hepatitis C. The final report and Action Guides are based on a March 2014 CTAF public meeting where the evidence on effectiveness and value of different drug treatment options was reviewed and recommendations made to guide practice and policy. The key findings of the review and the votes of the CTAF Panel were that the evidence was adequate to demonstrate that the new drugs are clinically superior to existing therapies, yet they represent a “low value” to the health care system due to the high potential cost of treating such a large number of patients with very expensive medication. The CTAF Panel is an independent committee of medical evidence experts from across California, including practicing clinicians, methodologists, and leaders in patient engagement, all of whom meet strict conflict of interest guidelines.
”The CTAF process of conducting a systematic review of the evidence, analyzing the economic impact of different treatment options, and convening independent thinkers to deliberate on the findings, is the bedrock of producing actionable, trustworthy information for health care stakeholders,” stated Steven D. Pearson, MD, MSc, President of ICER. “CTAF’s judgment of the low comparative value of these new drugs compared to existing treatments highlights the importance of ongoing discussions concerning the high costs of medical treatments and the trade-offs inherent in our health care system. Provider groups, state Medicaid agencies, pharmacy benefit managers, and patients alike are all joining the conversation to create a more efficient and effective health care system; we hope this report and these Action Guides help stakeholders make the best use of available resources based on the current state of the evidence.”
The final report, “The Comparative Clinical Effectiveness and Value of Simeprevir and Sofosbuvir in the Treatment of Chronic Hepatitis C Infection,” compares these two drugs to the previous standard of care. The report includes a clinical evidence review as well as supplemental information on regional and national payer coverage policies, practice guidelines, and cost models for California.
Chronic hepatitis C is a common infection that is a major cause of chronic liver disease, liver failure, and liver cancer. Some 3-5 million individuals in the US are believed to be infected with the hepatitis C virus, and only about half are aware of their infection. In 2013, the FDA approved two new drugs to treat chronic hepatitis C that were easier for patients to take and had fewer side effects; several other drugs with similar profiles are currently in late-stage clinical trials. However, information on treatment-related side effects and how the drugs work in some patient populations is still emerging. The costs for initial treatment regimens including the two drugs range from approximately $88,000 to $175,000 per patient, depending on the drugs selected and the duration of initial treatment.
At its March 2014 public meeting, the CTAF Panel voted that the two new drugs are likely superior in terms of clinical effectiveness for most patients and offer clinical benefits beyond current treatments. However, a majority of the CTAF Panel rated the new treatments as “low value” compared with older drugs due to the magnitude of the potential impact on health care budgets of treating large numbers of patients with these high-priced drug regimens.
The clinical advantages of the newer treatment regimens would come with a substantial impact on health care budgets if large numbers of patients are treated. If only patients with advanced liver fibrosis are started on the new treatment regimens, drug expenditures are estimated to increase by $7 billion in the first year for the population of California, one-third of the estimated $22 billion needed to treat all infected patients. At 20 years, cost offsets due to avoided liver transplants and other savings from higher cure rates are estimated to produce a net savings to the statewide health care system of about $1 billion if only patients with advanced liver fibrosis are treated. No such net savings are seen at 20 years if all patients are treated.
Because the financial impact of using these new drugs to treat all eligible patients with hepatitis C is untenable, the CTAF Panel and several clinical experts in hepatology serving on a policy roundtable at the meeting stated that it is reasonable to consider prioritizing treatment with the new drugs for patients who need urgent treatment and are expected to benefit the most from immediate treatment. The policy roundtable included clinical experts in liver disease, a patient advocate, payer representatives, and a representative from a manufacturer of one of the new drugs who were selected for their expertise on the specific meeting topic and did not vote at the meeting.
The Action Guides for patients, clinicians, and payers/policymakers are companion materials to the full report. The Action Guides provide a practical list of evidence-based action steps and resources tailored to help individuals or organizations interpret and apply the best available evidence regarding new treatments for hepatitis C to policy and practice. The final report and Action Guides are available for download on the CTAF website.
The California Technology Assessment Forum (CTAF) – a core program of the Institute for Clinical and Economic Review (ICER) – produces 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.
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