Watching the needle move

By Lindsay Videnieks, JD, and Katie M. Golden, PP (professional patient)

For three decades, those living with migraine disease demanded and waited for new treatment options tailored to their disease, instead of being prescribed off-label medications developed for other diseases. That was until 2018, which proved to be a pivotal year in migraine and headache treatment with the release of calcitonin gene-related peptide (CGRP) monoclonal antibodies for the prevention of migraine. In 2019, new classes of acute (or rescue) medications taken at the onset of an attack provided more hope to solving the secrets of the migraine brain. However, FDA approval of these innovative medications doesn’t mean immediate access for patients, even if prescribed by their doctor. This was a moment that inspired strong action within the community.

The migraine community stands up to ICER
Migraine advocates have jumped feet first into the battle for access to these new therapies. The first battle was to engage with the Institute for Clinical and Economic Review (ICER), an organization that evaluates the cost-effectiveness of newly FDA-approved medications. Many insurance companies use ICER’s assessment when determining whether health plans will provide access to treatment—and at what cost. In calculating their bottom line, insurance companies and pharmacy benefit managers often ignore the full potential of new therapies and the positive effect it will have on an individual’s life.

Building the army
Coalition groups like Headache and Migraine Policy Forum (HMPF) and CHAMP (Coalition For Headache And Migraine Patients) rallied stakeholders to provide public comment, testimony, scientific data, and real-world evidence to make the strongest case that every migraine journey is different, and that each person deserves patient-centered care tailored to their disease.

Migraine patients, providers, and caregivers answered the call. In 2018, migraine patients provided a record number of patient responses—nearly 400 over two rounds!—during ICER’s review of CGRP inhibitors. The day before the ICER public meeting, migraine patients held their own forum to tell their stories and balance the hearing.

It paid off. While 92 percent of ICER’s assessments result in a negative response, ICER’s final report found CGRP inhibitors to be cost-effective. But in 2019, the community was faced with yet another ICER review; this time for acute migraine medications, taken at the onset of an attack. Two new classes of medications were approaching FDA approval: gepants and ditans. The battle had to begin anew. Again, migraine patients and health care professionals submitted their personal stories.

Incremental reports published by ICER during their nine-month review of the new acute therapies were unfavorable as to the cost-effectiveness of these two new classes. However, for only the second time in ICER history, the final report had a different conclusion than the draft evidence report. Due to new evidence and compelling testimony provided by patients and clinicians at the public meeting, ICER’s final report reversed previous conclusions and found the gepants to be cost-effective. This was another major win for patients. Unfortunately, ditans were still ruled to be non-cost-effective, thus creating new challenges for patients in their quest to find safe, effective, and affordable medications.

Same tactics, new challenges
Although ICER validated the need for and value of CGRP inhibitors for prevention, and gepants for rescue, insurance companies continue to put up roadblocks for patients. These are a few of the unfair tactics payers have used that restrict patient access:

  • Require patients to obtain a prescription from a certified headache specialist, even if there are none in the state.
  • Prohibit the use of certain therapies in combination even though migraine patients have safely and effectively used multiple treatments together for years.
  • Decline to add these new migraine medications to their preferred drug lists, making the cost to patients burdensome.
  • Switch patients to another therapy that is cheaper for them, but may not work as well for the patient.

Successes in access challenges
Migraine advocates are continuing the fight to help patients access the course of care their clinicians deem appropriate. Recently, HMPF members sent a letter to the Iowa state legislature asking them to pass a bill to prohibit forcing stable patients off of medications that are successfully managing their conditions. We also challenged CVS Health, a national pharmacy benefit manager, to provide coverage for combination therapy. They agreed to adjust their coverage policy related to combined use of CGRP inhibitors and onabotulinumtoxinA.

By sending a strong message to policymakers, plans, and insurance commissioners that restrictive practices will cause unnecessary pain, expensive ER visits, and lost productivity, our community continues the movement for expanded access to all treatment options.

Here’s how you can get involved
Our greatest strength is patient and clinician voices. If you’ve experienced access challenges, let your voice be heard. Groups like HMPF, CHAMP, and the U.S. Pain Foundation stand ready to bring your stories to decision-makers. As a consumer, you are entitled to file a complaint with your state insurance commissioner. Patients—and their providers—have an opportunity to get help in appealing their insurance company’s denial. While fighting for yourself, you are adding to the number of migraine warriors who are challenging the status quo, demanding access, and moving the needle to create a new world in which those with migraine are respected, valued, and treated effectively. •

Call to action: Learn how to appeal to your state insurance commissioner.

Visit HMPF Insurance complaint guide:

Katie M. Golden is the Migraine Advocacy Liaison for the U.S. Pain Foundation, contributing editor of the INvisible Project, and director of Patient Relations for CHAMP (Coalition For Headache And Migraine Patients). Writing and advocating have given back the power that chronic migraine had stolen from her.


Lindsay Videnieks, JD, is executive director of the Headache and Migraine Policy Forum (HMPF), a diverse stakeholder coalition that brings together policy-minded partners that care about patient access. HMPF helped convene the migraine community to prepare comprehensive input during the ICER review of acute therapies. She has more than a decade of experience advising nonprofit institutions on strategies to support public policy goals and to secure funding through the federal appropriations process. She previously worked in the office of Congressman John E. Baldacci (D-ME) as well as on his re-election to the U.S. House of Representatives. A graduate of the University of Maine at Orono, Lindsay received her law degree from the