We appreciate the opportunity to provide our comments on ICER’s April 11th draft evidence
report, “Calcitonin Gene-Related Peptide (CGRP) Inhibitors as Preventive Treatments for
Patients with Episodic or Chronic Migraine: Effectiveness and Value.” At the outset, we want to
recognize the patient-oriented perspective that migraines are a very difficult area of pain
management to evaluate and treat. Therefore, evaluating treatment options with different
mechanisms of action – either individually, in combination, by analyzing individual trials, or
with meta-analyses – complicates this activity. An additional complication ICER undertook in
this draft report was including three biopharmaceuticals that have not been approved by the FDA
– which means there is essentially only efficacy data (i.e., from ideal clinical trial situations) and
scant information about the effectiveness of those treatments in real-world situations.
