This article comes from Patrik Jonsson, senior vice president and president, Lilly Bio-Medicines.
We are in a golden era of treatment for migraine. Recent scientific advancements have yielded new medicines that give people living with migraine, and those treating them, a renewed hope that outcomes once considered long shots are now a reality.
Despite this recent wave of innovation, we are still approaching migraine, a severely disabling neurologic disease that affects more than 30 million U.S. adults, with a 20th century mindset.1, 2, 3, 4 For far too long, the standard of acute treatment for migraine has been pain relief, rather than freedom from pain of a migraine attack. Fortunately, in 2018, as a benefit to patients, the U.S. Food and Drug Administration (FDA) raised the clinical trial bar and issued new guidance that migraine clinical trial efficacy endpoints for acute treatments should demonstrate complete elimination of pain and elimination of the most bothersome associated symptoms, rather than just pain relief.5 In the same year, the American Headache Society (AHS) issued similar guidance, in which it notes rapid and consistent freedom from pain as a goal of acute treatment for migraine.6 We are pleased that the new acute treatments for migraine support this new standard.
However, migraine remains underdiagnosed and undertreated, despite being one of the most prevalent diseases in the world affecting more than one billion people.1, 7, 8 Migraine patients frequently face a long and frustrating wait for an accurate diagnosis and effective treatment – in fact, approximately half of all people living with migraine remain undiagnosed.7Among those diagnosed with migraine, 87% report that complete pain freedom provided by acute treatment is important or very important to them.8 Yet patients often report that treatments only help “keep the pain at bay” or “manage pain.”2 With this renewed hope, pain freedom from a migraine attack, instead of pain relief, can be everyone’s treatment goal.
This renaissance in migraine research and new treatment standards has led to significant investment and innovation in the scientific understanding and spectrum of migraine treatment.9 Migraine is more than just a headache – it affects personal and professional lives, so much so that total unadjusted cost associated with migraine is estimated to be $56 billion annually in the United States.10 One migraine per week means more than 50 days per year impacted. It’s critical we leverage this wave of innovation and attention to accelerate a shift that ensures people living with migraine are properly diagnosed, properly treated and most importantly, properly respected. Migraine patients should be able to live their lives without fear of a migraine attack by having appropriate medicines to both treat and decrease future attacks.
I am proud that Lilly is leading the charge in creating this new normal in migraine. We are in the midst of a new generation of preventive and acute treatments for migraine. With it comes a new optimism for those living with the disease. A migraine attack doesn’t have to mean the end of their day. Lilly has been at the forefront of innovative medicines spanning the headache disorder spectrum with two recent FDA-approved treatments for two distinct headache disorders. Beyond developing novel medicines, we are dedicated to empowering those affected by migraine and to enabling a renewed conversation about the disease. This commitment is critical to help people with migraine get the outcomes they seek with their migraine care.
We are committed to working with the entire migraine community, including patients, health care providers, health insurance agencies and advocacy organizations such as the American Headache Society, the American Migraine Foundation, the Migraine Research Foundation, the National Headache Foundation, Migraine Again, Miles for Migraine, The Association of Migraine Disorders and The Coalition For Headache and Migraine Patients (CHAMP), to raise the bar on migraine care.
Complete elimination of pain from a migraine attack or a migraine-free month should no longer be a hope, but the standard of care everyone strives for. Let’s raise the bar for both acute and preventive treatment for migraine. The time for a new normal is now.
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016. (2017). Lancet, 390 (10100), pp.1211-59.
Lipton RB, Bigal ME, Diamond M, et al; on behalf of the AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343-349.
Data on file. Indianapolis, IN:Lilly USA, LLC.
U.S. Census Bureau Quick Facts. https://www.census.gov/quickfacts/fact/table/US/PST045217. Updated July 1, 2018. Last accessed September 10, 2019.
FDA. Migraine: Developing Drugs for Acute Treatment Guidance for Industry. 2018. Retrieved from: https://www.fda.gov/media/89829/download
AHS. The American Headache Society Position Statement on Integrating New Migraine Treatments Into Clinical Practice. Headache.2019; 59(1): 1-18
Diamond S, Bigal M, Silberstein S, et al. Patterns of Diagnosis and Acute and Preventive Treatment for Migraine in the United States: Results from the American Migraine Prevalence and Prevention Study. Headache. 2007; 47:355-363.
Lipton RB, Stewart WF. Acute migraine therapy: do doctors understand what patients with migraine want from therapy? Headache. 1999;39[suppl 2]:S20-S26.
Tassorelli C, De Icco R. Getting closer to a cure for migraine. Nature Reviews Neurology. 2019. 15: 64-65.
Raval AD, Shah A. National trends in direct health care expenditures among US adults with migraine: 2004 to 2013. The Journal of Pain. 2017; 18(1):96-107.