What are new drugs to prevent migraine worth? The question is driving a forthcoming report from cost-effectiveness giant the Institute for Clinical and Economic Review (ICER) – and already eliciting an outpouring of feedback from the migraine patient community.
The new drugs are known as CGRP inhibitors because they target the calcitonin gene-related peptide, which is involved in the experience of migraine pain. The Food and Drug Administration has received three applications for CGRP inhibitors and expects to make approval decisions by mid-to-late 2018.
But timing hasn’t deterred ICER from moving forward with a cost-effectiveness analysis of the therapies. The organization offered an open input period in November, inviting patient advocates to share their experiences with migraine – and their hopes for the forthcoming analysis.
The Headache and Migraine Policy Forum submitted a letter describing migraine’s “substantial systemic impact” on patients. “Even if not fatal, migraine robs many patients of a meaningful quality of life,” the letter notes. “For migraine patients, therefore, the immense value of a life-changing medication can be difficult to quantify.” The letter was signed by 24 patient organizations, including the Coalition for Headache and Migraine Patients, the American Migraine Foundation, and the Alliance for Headache Disorders Advocacy.
The Institute for Patient Access also weighed in. “As IfPA has noted to ICER previously,” the letter notes,” treatments for some disease states simply do not lend themselves to economic number crunching.” The letter conveys the need for ICER to factor in comorbidities commonly faced by migraine patients, as well as migraine’s impact on productivity. “Accounting for any potential improvement in patients’ quality of life is imperative,” the letter explains.
Just four days after the open input period closed, ICER issued the plan for its analysis – known as its scoping document. The document acknowledges several themes of patients’ letters, such as:
- Migraines prevent patients from having normal lives
- Relief from existing preventive treatments is often temporary
- Patients struggle to access effective care or treatment
- Patients seek treatments that improve their quality of life.
It is unclear, however, whether ICER plans to incorporate these into its analytical approach in a meaningful way. Moreover, as IfPA noted in a follow-up letter about the scoping document, ICER’s plan excludes several key components. One missing element is the impact of effective migraine treatments on America’s opioid abuse epidemic and related costs. At present, lack of targeted treatments leaves nine percent of migraine patients taking prescription opioids for migraine pain. Migraine-specific therapies could potentially decrease the need for opioids in this patient population.
The Institute for Patient Access also reiterated concerns about the timing of ICER’s analysis, noting, “When conducting the analysis, it is likely that ICER will have access only to the clinical trial data, and (at best) initial post-marketing data.” IfPA’s letter explains that robust post-marketing data often provides details about drugs’ side effects and impact that would be critical to accurately assessing value.
ICER will issue a revised scoping document in January, followed by a draft evidence report on CGRP inhibitors in April 2018.