The Institute for Patient Access has issued a response to the Institute for Clinical and Economic Review (ICER) following its report assessing the clinical effectiveness and economic value of calcitonin gene-related peptide (CGRP) inhibitors for the treatment of chronic or episodic migraines.
In April, the Institute for Clinical and Economic Review (ICER) issued a report stating that although calcitonin gene-related peptide (CGRP) inhibitors are projected to have a positive impact on the health of patients with chronic or episodic migraine who have failed on previous treatment, it is likely that the inhibitors will exceed commonly cited willingness-to-pay thresholds. Following the review, the Institute for Patient Access has issued a response to ICER.
The response begins, “Migraine is one of the most prevalent neurological disorders worldwide, associated with substantial health, sociological, and economic consequences. Yet, ICER’s draft evidence report, dated April 11, 2018, inaccurately assesses the benefits that migraine patients can receive from CGRP inhibitors.” The institute then outlined 5 components:
1. Data limitations restrict the ability to evaluate the cost-effectiveness of CGRP inhibitors
According to the Institute, the CGRP inhibitors were either in phase 2 or phase 3 clinical trials and none had gained FDA approval at the time of the ICER report, resulting in limited clinical and safety data. Due to the novelty of these inhibitors, there are no available data on the long-term benefits or adherence rates of the inhibitors. The Institute also pointed out that the CGRPs do not have publicly available prices; therefore, ICER used an “analyst-estimated” price that may not reflect actual market prices once available.
2. Potential impact on mortality
Tying together mortality risks associated with migraine and early indications that CGRP inhibitors may control migraine better, the Institute recommends that the report instead incorporate an estimate of benefit in terms of reduced mortality risk from better controlling migraine.
3. Impact of CGRP inhibitors on depression comorbidity
As studies have indicated that up to 80% of people with chronic migraine exhibit signs of depression, which is linked to reduced quality of life, the Institute states that CGRP inhibitors may also help with these symptoms and should be taken into consideration.
4. CGRP inhibitors have the potential to reduce the costs associated with the opioid crisis
Due to the lack of effective treatment options, patients with migraine are sometimes prescribed opioids, which not only claim the lives of thousands but also come with a large economic cost. The Institute argues that CGRP inhibitors would decrease the need for opioid prescriptions and opioid dependence for this patient population.
5. Redacting data on mean reduction in migraine days
According to the Institute, ICER reports redacting data on the mean reduction in migraine days—which the Institute maintains is a fundamental benefit that the inhibitors provide patients with migraine—because they were submitted as academic-in-confidence data. They state that releasing these data helps readers better understand the benefits of the inhibitors and ensures other academics and analysts have the necessary information on them.
The Institute for Patient Access is not the first to issue a response to ICER. Shortly after the review, Amgen and Novartis responded with 5 recommendations, including that ICER employ a patient-centered approach, assess erenumab only in treatment-experienced patients as opposed to treatment-naïve patients, and incorporate responder rates. The response also emphasized that there has been no real innovation in 2 decades, and patients are in need of new treatment options.