Evaluating acute migraine therapies: ICER


The Institute for Clinical and Economic Review (ICER), a drug pricing watchdog in the U.S., has ruled that novel oral migraine therapies have similar effectiveness but are not superior to triptans (5-HT 1B/1D agonists).

The report examined clinical data for two calcitonin gene-related peptide (CGRP) receptor antagonists (ubrogepant, rimegepant) and a 5-HT-1F receptor agonist (lasmiditan). All three drugs have recently received FDA approval. None of the therapies is listed by Health Canada as being in review.

An ICER panel voted unanimously that all three oral migraine drugs provide a net health benefit compared to placebo. However, the data were insufficient to show superiority over triptans for acute migraine. All panellists voted that the two gepant compounds had similar efficacy, and most found that there was insufficient evidence to show superiority of the gepant drugs over lasmiditan. The panel noted that the new drugs have novel mechanisms of action that may be clinically useful in patients with an inadequate response to a triptan.

The group conducted a network meta-analysis of 31 acute migraine trials to compare relative effectiveness. They concluded that a smaller proportion of patients achieved freedom from pain or relief from pain at two hours post-dosing with lasmiditan, ubrogepant or rimegepant compared to a triptan. For patients with an inadequate response to a triptan or a non-prescription drug, there was a moderate certainty of a health benefit (ranging from small to substantial) with one of the newer oral drugs. A final report card gave ubrogepant, rimegepant and lasmiditan a C-minus grade (comparable or inferior) versus a triptan.

The report also examined two subgroup analyses of patients receiving migraine prophylaxis; use of monoclonal CGRP antagonists was not permitted in the trials. The studies found that lasmiditan and rimegepant were superior to placebo but there was no additional benefit in patients receiving concomitant migraine prophylaxis (Loo et al. J Headache Pain 2019;20:84. Dodick et al. AHS 2019; abstract P239LB).

For its cost analyses, ICER estimated that the oral CGRP drugs would be priced at 20% above the current price of branded sumatriptan (actual pricing was not available). As such, none of the new drugs would be considered as cost-effective in patients who could not take a triptan. For patients eligible for a triptan, both sumatriptan and eletriptan would be more effective and less expensive. Subsequent discussions set a price-benefit benchmark of up to $3200/year for lasmiditan and $4600/year for ubrogepant – about 10-30% lower than current list prices.

Click here for a free download of the ICER report: https://icer-review.org/wp-content/uploads/2019/06/ICER_Acute-Migraine_Evidence_Report_011020_updated_011320.pdf.

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