Migraine is a common condition affecting approximately 20% of women and 6% to 10% of men in the United States; as a result, a new class of treatments to prevent migraine has been of great interest to clinicians, patients, and families. However, with just 1 of these new drugs approved by the FDA, there remains uncertainty regarding the effectiveness of the treatment compared with existing preventive therapies.
Erenumab (sold as Aimovig by Amgen and Novartis) is the first calcitonin gene-related peptide (CGRP) inhibitor to be approved by the FDA
for the prevention of migraine. The Institute for Clinical and Economic Review (ICER) assessed
the comparative effectiveness and value of erenumab with 2 other CGRP inhibitors for the prevention of migraine attacks that are still under FDA review. The FDA is expected to make a decision on fremanezumab from Teva in September 2018 and on galcanezumab from Eli Lilly in the third quarter of 2018.
The ICER report assessed comparative clinical effectiveness and economic impacts for patients with chronic or episodic migraine and was informed by a systematic review of the existing evidence and an economic evaluation.
The outcomes of interest for the review included:
- Frequency, intensity, and duration of migraine events
- Other symptoms: nausea, vomiting, dizziness, and sensitivity to light, sound, smell, or touch
- Cognitive functioning/impairment
- Health-related quality of life
- Number of emergency department and primary care visits
- Harms/adverse events
The list price of erenumab is $6900, and ICER applied an industry-wide average discount rate of 27% for an estimated annual net price of $5000. Using that estimated price, ICER found that the price of the CGRP therapies aligns with the value to patients who failed other preventive treatments. In patients who had not already tried existing preventive therapies, the drugs were not considered cost effective.
Previously, ICER had used a placeholder price of $8500 per year for erenumab in its Draft Evidence Report
, but the price has been updated following the announcement of the drug’s list price.
At the current estimated net price, ICER estimated that 16% of the eligible migraine population could be treated with erenumab, and 22% could be treated with fremanezumab without crossing the ICER annual budget impact threshold. There is still limited data available for galcanezumab.
"CGRP inhibitors appear to offer modest improvements in outcomes for patients with chronic migraine and frequent episodic migraine,” David Rind, MD, MSc, ICER's chief medical officer, said in a statement. “For individuals for whom prior preventive therapies have not been effective or tolerated, the price of erenumab after expected discounts seems to align with those added benefits for patients.”
However, there are concerns remaining regarding unanticipated harms of the medication. So far, the medication has only been tested in short trials assessing outcomes by 12 or 24 weeks. There are some concerns about the long-term effects of continuous blocking of the CGRP or its receptor, but as these are the first inventions in the class, long-term effects remain unknown. In addition, since migraine is fairly common, there may be concerns about affordability and access, Rind said.
“While the therapies are cost-effective in the long-term, CGRP inhibitors could potentially have a significant impact on short-term health budgets,” he said.