San Francisco, Calif., September 16, 2014 – The Institute for Clinical and Economic Review (ICER) has released the final California Technology Assessment Forum (CTAF) report “Controversies in Migraine Management” and three complementary Action Guides, which reflect deliberations at the July 11, 2014 CTAF public meeting in Los Angeles, CA. At the meeting, the CTAF Panel, an independent committee of medical evidence experts, reviewed and voted on the evidence surrounding the comparative clinical effectiveness and comparative value of four distinct migraine treatment approaches.
Several key findings emerged from the panel’s votes and review of the evidence. The panel found that:
- There is insufficient evidence to determine whether two devices, SpringTMS for the treatment of acute migraine with aura and Cefaly for the prevention of episodic migraine, are as effective as other currently available options;
- BOTOX® injections are superior to no therapy for the prevention of chronic migraine, but the evidence is inadequate to determine its comparative effectiveness to lower-cost, commonly-prescribed oral agents for chronic migraine prevention; and
- Opioids are inferior to other treatment options for relief of migraine pain in the emergency department (ED).
“Migraine diagnosis and treatment are challenging because the causes of migraine are not well understood and there are many treatment options,” said Steven D. Pearson, MD, MSc, President of ICER. “The Action Guides provide patients, clinicians, and policymakers with a clear pathway to improve outcomes for migraine sufferers. Specifically, the Action Guides address ways to reduce the use of opioids in the emergency department and ensure that patients afflicted with this debilitating condition receive the most appropriate and effective therapies.”
Migraines, which are three times more common in women than men, affect 12% of the US population, with peak prevalence occurring at the age of 40. They are typically unilateral, can cause pain for between four and 72 hours, and are often accompanied by other symptoms including aura, nausea, and light and sound sensitivity. Currently, migraines are classified as either episodic (occurring less than 15 days per month), or chronic (headaches occurring on 15 or more days per month for three months with migraine features on at least eight days).
The CTAF Panel includes practicing clinicians, methodologists, and leaders in patient engagement, all of whom meet strict conflict of interest guidelines. A non-voting policy roundtable that included headache specialists and neurologists, emergency physicians, a patient advocate, and representatives from two insurers provided the panel with expert opinions and context to inform the voting process and the subsequent policy discussion.
CTAF voted that the evidence on the two devices was inadequate to judge comparative clinical effectiveness, noting that further study of the two devices is needed. BOTOX, which is approved by the FDA for the prevention of chronic migraine, has been studied extensively in comparison to placebo injections, but the CTAF Panel said that further study is needed to understand its effectiveness compared to other commonly prescribed agents. The panel voted that opioids are inferior to other agents in treating migraine in the ED, as opioids come with associated risks of dependence and conversion of episodic migraine to chronic migraine. The CTAF report noted that reducing the opioid prescribing rate in the ED from 53% to 25% across California could save $126 million, with greater reductions in opioid prescribing rates resulting in further savings.
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 and organizations interpret and apply the best available evidence on these four migraine therapies to policy and practice.
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.