For 30 years, the Society for Women’s Health Research (SWHR) has been dedicated to “promoting research on biological sex differences and improving women’s health through science, policy and education.” As an education and advocacy nonprofit organization, SWHR hasn’t been shy about pointing out the need to better understand how diseases, their treatments and caregiver burdens impact women and their health.
It’s also why SWHR is calling on groups like the Institute for Clinical and Economic Review (ICER) to ensure their value frameworks and assessments “reflect factors relevant to women and the ongoing improvement of their health.” SWHR has developed a set of principles outlining these factors and expects ICER and others to use them when evaluating the value of any treatment, but more especially for conditions that disproportionately affect women.
On January 23 in Chicago, ICER will hold a public meeting to discuss treatments for acute migraine, a debilitating condition that is three times more common in women than men and is the second leading cause of global disability burden. SWHR’s Sarah Wells Kocsis, MBA, vice president of public policy, will participate in the meeting to share SWHR’s concerns and perspectives on ICER’s assessment process and evidence report findings.
The National Pharmaceutical Council caught up with Ms. Wells Kocsis to learn more about SWHR’s approach to value assessment and what they hope ICER will focus on during the January 23 meeting.
NPC: First, tell us more about SWHR and why it’s important to be involved in value assessment discussions.
SWHR: Our mission is to eliminate imbalances in health care for women. Women comprise more than half of the U.S. population, and their diverse needs as patients, caregivers, and health care decision-makers must be captured in health care value assessments. Women won’t benefit from new health care tools and therapies unless they can access them, so SWHR urges the unique burdens that many diseases have on women to be accounted for in determining the value of these innovations. The current landscape of value frameworks doesn’t examine burden of illness factors, such as quality of life, that are important to women, and SWHR is committed to addressing those gaps.
NPC: What was your previous experience with ICER like, and how did that inform your current efforts regarding their review of acute migraine treatments?
SWHR: We first engaged with ICER on its 2018 reviews of new preventive treatments for migraine and a new therapy for endometriosis. SWHR was quite concerned about the approach ICER took in evaluating the endometriosis treatment because it only reviewed one drug, and the bulk of the report focused on ICER acknowledging the limitations of its own analysis. Given this, our comments, along with others, called out the flawed, premature nature of this review. Our main recommendation was to stop the review and wait, which ICER did not do.
ICER’s report on the migraine preventive treatments was a bit different because it reviewed three drugs in a new class of therapies called calcitonin gene-related peptide (CGRP) inhibitors. There was an exceptionally high level of stakeholder engagement on that review, which was very beneficial in infusing the patient voice into the process and educating ICER about what migraine patients value most. SWHR encouraged ICER to incorporate into its analysis the extended impact and burden that migraine has on individuals, families, the workplace, and the economy, because an undervaluation of this burden may deprive patients access to needed treatments.
I am honored to be representing the patient advocacy perspective at ICER’s second review on migraine — this one evaluating three new therapies for the acute treatment of migraine. Unfortunately, the migraine patient community has a number of concerns about this review, too. The main one is that ICER’s quantitative model uses the wrong comparators and neglects to value the full potential benefits of these new therapies. For example, ICER’s primary comparison of these new therapies with generic drugs like triptans runs counter to established clinical guidelines for migraine treatment. The immense indirect costs and societal burden of migraine disease are not sufficiently captured in ICER’s analytic framework.
NPC: Do you believe ICER will include changes in the acute migraine report based on what they hear from participants at January meeting?
SWHR: I intend to raise a number of concerns based on my review of the draft and updated evidence reports, and I sincerely hope that ICER’s voting panel will take those into consideration.
For example, migraine interferes with education, career, and social activities for more than 90% of people affected by the disease. These associated indirect costs are uniquely significant for migraine and should be reflected in ICER’s analysis in order to capture the full potential of these new treatments.
NPC: Based on your experiences, what advice would you give to other organizations that want to get involved with ICER on value assessments?
SWHR: Engage early and often. Share any and all relevant data to fill evidence gaps, and don’t hesitate to share the same information multiple times during the review process. In addition to pointing out your concerns, offer solutions to address them. Describe the patient experience, including barriers to treatment, so it’s clear what patients encounter in the real world and what outcomes are most important to them.
NPC: What do you think ICER needs to do differently?
SWHR: Listen more. Instead of staunchly defending its process and methods, ICER needs to be more open to constructive feedback for improvements. Multidisciplinary stakeholders invest significant time and resources to provide thoughtful feedback to ICER, but they often feel their comments are not heard or taken seriously.
On January 31, ICER will unveil an update to its value assessment framework, which underpins its evidence reports on new drugs and other health care interventions. The current iteration of ICER’s framework has guided its assessments from 2017 to 2019 and has garnered a lot of attention for not comprehensively measuring value. If ICER’s updated framework is largely unchanged from the previous one, the outcomes of future reviews will be more of the same, which hurts patients who need access to a full range of treatment options.
NPC: More recently, SWHR developed value principles “to help ensure value frameworks and assessments reflect factors relevant to women and the ongoing improvement of their health.” What are those factors, and how can groups like ICER incorporate them into their frameworks?
SWHR: Our goal is ensure that women have access to innovative new therapies and interventions, so our value assessment principles recommend that frameworks account for diversity in patients (including sex and gender) and evaluate factors that matter to women, such as ability to work and function.
In order to account for what matters most to patients, caregivers, and society, value frameworks should use a range of high-quality evidence, including real-world evidence and data from caregivers (the majority of whom are women).
Value assessments should also acknowledge the full spectrum of treatment options for a given medical condition, not focus exclusively on one type of medical intervention, as well as consider the long-term effects of a treatment because focusing only on short-term outcomes may overlook important clinical benefits.
Finally, it’s critical that value assessment frameworks are not used to prevent patients and their physicians from making evidence-based decisions tailored to the needs of individual patients.
NPC: Thanks for speaking with us.
For more on SWHR, check out the organization’s website and principles for value assessment. You can learn more about ICER and migraine assessments from NPC’s previous interview with Lindsay Videnieks, director of the Headache and Migraine Policy Forum (HMPF).