Amplifying the Migraine Community Voice in ICER Value Assessment Process

In an interview with NPC, Lindsay Videnieks, director of the Headache and Migraine Policy Forum (HMPF), discusses the kind of effort it takes to become involved in the ICER value assessment process, what her organization learned along the way and how ICER’s patient engagement process could be improved.

During the past year, there’s been a clear shift in how patient organizations are engaging with the Institute for Clinical and Economic Review (ICER) and its value assessments of new, and often first-of-their-kind, medicines. These organizations have recognized the need to become involved earlier in the assessment process so that they have ample time to provide patient and stakeholder perspectives on important issues, such as what it’s like to live with a particular condition and how quality of life and work productivity are affected, and to shape the questions that ICER will address.

Recently, the Headache and Migraine Policy Forum (HMPF) played a vital role in connecting organizations so that all voices — from large organizations to individual patients — provided input to the ICER value assessment process for novel treatments for chronic migraines. Migraine is the eighth highest specific cause of years lived with disability in the U.S. New treatments, known as calcitonin gene-related peptide (CGRP) inhibitors, could greatly reduce the number of migraines suffered each month. For patients diagnosed with chronic migraines — defined as having 15 or more episodes each month — these treatments are especially significant. This importance did not go unnoticed — more than 200 comments were submitted during ICER’s assessment process. A major concern voiced by many in reviewing ICER’s evaluation on migraine concerned the burden of illness, particularly as those burdens often fall outside ICER’s focus area of health care system-level impacts.

In an interview with NPC, Lindsay Videnieks, director of the Headache and Migraine Policy Forum (HMPF), discusses the kind of effort it takes to become involved in the ICER value assessment process, what her organization learned along the way and how ICER’s patient engagement process could be improved.

NPC: First, tell us about HMPF and how your organization first became involved with the ICER assessment process on migraine medicines.

LV: Sure. The Headache and Migraine Policy Forum is a coalition of stakeholder members who care deeply about patient access to innovative therapies and treatments. We’re physicians, patients, caregivers, clinical experts, scientists and thought leaders who recognize the importance of speaking out on access issues. ICER matters to our community because their value assessments are considered by insurance companies in determining coverage policies for new therapies. We knew that engaging earlier in the process would provide an opportunity to help ICER better understand the scope of this disease and its burden on patients, caregivers, employers and society as a whole.

Migraine is called an “invisible disease” because it’s often dismissed as “just a headache” — so most people don’t realize the devastating impact. Chances are you know someone who has migraine or cares for someone with migraine.

NPC: Physicians advocate for patients during their daily medical practice navigating referrals, addressing prior authorizations and even motivating their patients.  Value assessments seem far removed from day-to-day practice, so why get involved?

LV: I would also add nurse practitioners to that list.  The clinicians on the front lines of patient care are seeing firsthand the time that appeals and denials are taking away from the practice of medicine. They know that in order to reassert the primacy of the clinician-patient relationship and deliver the care they know their patients deserve, they have to get involved and speak out. Clinicians I’ve talked to say that they didn’t go to medical school or undergo additional training and education to spend all of their time on paperwork. They know that changing that will take action on a policy or payer level — and that means starting with ICER.  

NPC: HMPF also played a vital role in connecting organizations and encouraging broader engagement on the value assessment of migraines. Why was it so important for these groups to become involved?

LV:  The migraine community is a close-knit one; that’s powerful. I am not a migraine patient myself, but I am honored to help convey their stories. The one thing that I have said to groups is that this is a true campaign — but it’s for your lives. When you understand the impact and burden of this disease — missing children’s birthdays or having to leave a job you loved because you couldn't be reasonably accommodated, having to leave school early because you couldn’t perform the coursework, or sometimes even suicide because of the anxiety and depression that we know are co-morbidities to migraine — that’s heartbreaking. This disease, to quote Jaime Sanders, the Migraine Diva, is a thief. It takes.

NPC: How were you able to mobilize other organizations so quickly, and ensure they were engaging early enough in the assessment process?

LV: First of all, this is a true team effort — no one can do this alone. HMPF engaged nearly 20 stakeholder groups on a monthly call for close to a year to work together on ICER education, awareness and communication. And more than 20 groups signed on to multiple inputs to ICER — that sends a message.

Thanks to the great work by patient-focused stakeholder members like the Coalition For Headache and Migraine Patients (CHAMP) and bloggers like Katie Golden (GoldenGraine), ICER’s migraine assessment also received a record number of patient comments — 188 in the first public comment period and 210 in the second round. That’s astonishing. Think about what it means for a migraine patient, who may not even know day to day if they will able to function, to take time out of their day to engage via an ICER questionnaire. It shows the power of this community and just how much they want a range of innovative treatment options. I think a point that gets lost by ICER is that many chronic pain communities — especially the migraine community — are quite diverse. What quality of life means to one patient may not be the same for another. By using a cookie-cutter approach in its assessment, ICER diminishes the patient experience. We hoped that a resounding number of comments by patients would help them understand the diversity of this patient population and what this disease takes away.

NPC: Based on your experience, what would you tell other patient organizations about getting engaged with ICER?

LV: Start early. Don’t wait until the ICER public meeting to make your voice heard because the report is largely completed by that date. We started organizing prior to the Draft Scoping Document, which sets the table for the ICER process and lays out the issues that will be discussed.

Get to know ICER experts. Educate yourself by engaging with ICER experts that are access focused, like our stakeholder member, the Alliance for Patient Access (AfPA). They have a think tank arm called the Institute for Patient Access (IfPA) that has a lot of great resources about ICER and toolkits on how to approach the process.

Learn from your peers in other disease states. Through CHAMP, we spent time on webinars to learn from folks in non-migraine organizations that had gone through the ICER process before. It was helpful to know what worked and what didn’t work.

Don’t underestimate the power of social media to find patient advocates. I mentioned one blogger, Katie Golden, but we also engaged with the Migraine Diva Jaime Sanders, who is also a patient ambassador for the Global Healthy Living Foundation (GHLF). GHLF has a 50-state network that reaches migraine patients and lets them know how to become engaged. Golden Graine, The Migraine Diva and GHLF used the power of social media platforms like Twitter and Facebook to recruit patients to get involved in letter-writing and showing up at patient advocate forums near the ICER meeting.

Last but not least, the clinician voice is critical. One of our stakeholder members, Mary Franklin of the National Headache Foundation, has been one of the most active in engaging with ICER, speaking at the public meeting in Los Angeles this past June to represent headache physicians. The winning combination is the physician and patient narrative that brings the science/data and personal stories to life.

NPC: How could the ICER process be made better for patients and patient organizations? What should ICER do to make those improvements?

LV:  We’ve spoken with ICER about letting more patients speak at the public forum. The fact that a record number of patients weighed in on this assessment and only four individuals were allowed to speak for five minutes apiece over the course of the entire daylong public meeting is unacceptable.

On the flip side, keep an open dialogue with ICER. During the migraine assessment, they were very responsive to our questions and concerns about the process.

ICER uses the “QALY” (Quality-Adjusted Life Year) metric, which equates to one year of perfect health and is a generic measure of disease burden in determining value, which is a problem. The QALY is discriminatory to patients with chronic diseases like migraine. Keep sending that message to ICER.

ICER should open its quantitative model to include economic costs to society, such as presenteeism and absenteeism in the workplace. Human Resources professionals can quantify the costs to employers for chronic diseases; such costs should be considered in the model instead of used as contextual concerns in the final report.

Encourage ICER to include clinical experts on its voting panel who are within the specialty of the field of medicine the panel is assessing. Originally, ICER included only an OB-GYN physician on the voting panel (because 75 percent of migraine patients are women). We worked with them to make sure they understood the importance of including a neurologist who could better understand the disease.


Learn more about HMPF and read the patient guide for ICER engagement on their website, and view other patient organizations’ stories on NPC’s blog.