Dr David RindDavid Rind, MD
The Institute for Clinical and Economic Review (ICER) has released its Final Evidence Report and accompanying Report-at-a-Glance on the clinical effectiveness and economic value of a trio of recently approved acute migraine treatments—lasmiditan (Reyvow; Eli Lilly), rimegepant (Nurtec ODT; Biohaven), and ubrogepant (Ubrelvy; Allergan)—deciding that the available evidence suggests with moderate certainty that all 3 offer a small or substantial net health benefit, and with a high certainty of at least a small net health benefit.1-2

Clinical trial data suggest that the therapies all decrease symptoms of migraine attacks and improve function compared with placebo for those who are unable to take triptans, and ICER noted that for those who can, its indirect comparisons imply that triptans are similar or more effective than these newly approved agents.

“For patients who are unable to take triptans or who don’t get adequate benefit from those more affordable options, these new migraine therapies appear to relieve migraine symptoms in 10% to 20% more patients than who respond to placebo,” David Rind, MD, chief medical officer, ICER, said in a statement.3

He added that following the prior iteration of this report, ICER worked with Allergan to identify any high-quality evidence of a possible benefit offered by ubrogepant that extended beyond the 2-hour time frame assessed in its clinical development for FDA approval. “This additional benefit, which likely also applies to rimegepant, supports a near doubling of ICER’s health-benefit price benchmark for these 2 treatments, and is also a key example of how ICER works closely with stakeholders to ensure we have the best evidence-based approach to capturing the full value of a product,” he said.
 
READ MORE: NDA for Qtrypta Accepted for Acute Migraine

ICER noted that without evidence showing superiority to other, less expensive options, clear and effective prior authorization criteria based on clinical evidence, specialty society guidelines, and input from clinical experts and patient groups would be reasonable to develop to ensure practical use of these new therapies.

The report states that manufacturers and researchers should undertake comparative, long-term trials to assess outcomes over the course of migraine attacks and suggested that real-world comparative studies of these treatments would be helpful.

Although the report suggests that lasmiditan most likely has similar efficacy to the 2 Gepant agents, it also has significantly higher rates of dizziness and discontinuation. Additionally, excess sleepiness and tingling sensations were also reported in clinical trials of the Eli Lilly product.

Economically, the ICER report suggests that the long-term cost-effectiveness of lasmiditan was in excess of the accepted thresholds per quality-adjusted life-year (QALY), which ranges from $50,000 to $150,000, for patients who find triptans ineffective. The Cost per QALY gained for lasmiditan was $177,500 compared to placebo, while both ubrogepant’s and rimegepant’s Cost per QALY was below the threshold at $40,000 and $39,800, respectively. For those who respond to treatment with triptans, ICER suggested that both sumatriptan and eletriptan are both less expensive and more effective than the newer agents.

Fair prices based on patient and health care value for the therapies, determined by their annual price to achieve a $100,000 to $150,000 QALY threshold, were deemed as $2770 to $3150 for lasmiditan, $4160 to $4640 for rimegepant, and $4150 to $4630 for ubrogepant. In comparison, the list prices of lasmiditan, rimegepant, and ubrogepant are $4610, $4896, and $4896, respectively. Using an $819 million budget impact threshold, 12% of eligible patients for lasmiditan and 16% of eligible patients for both rimegepant and ubrogepant could be treated in a given year before crossing that threshold.

Worth noting is that the report did conduct its analysis under the assumption that rimegepant’s price would be the same as ubrogepant’s.

Biohaven’s oral calcitonin gene-related peptide (CGRP) antagonist rimegepant was approved in a 75-mg dose for adults with migraine in late February 2020. Allergan’s ubrogepant received the regulatory go-ahead 2 months prior, in late December 2019, for migraine with or without aura in adults—marking it as the first-in-class oral CGRP antagonist for its indication. Lasmiditan, a selective serotonin 5-HT1F agonist, was granted FDA approval in October 2019, for migraine with or without aura in adults.4-6

To read the  Final Evidence Report in full, click here.
REFERENCES
1. ICER. Acute Migraine: Final Evidence Report and Meeting Summary. ICER website. Published February 25, 2020. Accessed March 10, 2020. icer-review.org/wp-content/uploads/2019/06/ICER_Acute-Migraine_Final-Evidence-Report_updated_030320.pdf
2. ICER. Acute Migraine: Report-at-a-Glance. ICER website. Published February 25, 2020. Accessed March 10, 2020. icer-review.org/wp-content/uploads/2019/06/Acute-Migraine-RAAG-022420.pdf
3. ICER Issues Final Report and Policy Recommendations on Acute Treatments for Migraine [press release]. Boston, MA: ICER; Published February 25, 2020. Accessed March 10, 2020. /icer-review.org/announcements/acute_migraine_final_report
4. Biohaven's NURTEC™ ODT (rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults [press release]. New Haven, CT: Biohaven; Published February 27, 2020. Accessed March 11, 2020. prnewswire.com/news-releases/biohavens-nurtec-odt-rimegepant-receives-fda-approval-for-the-acute-treatment-of-migraine-in-adults-301013021.html.
5. FDA approves new treatment for adults with migraine [press release]. Silver Springs, MD: FDA; Published December 23, 2019. Accessed March 11, 2020. fda.gov/news-events/press-announcements/fda-approves-new-treatment-adults-migraine
6. FDA approves new treatment for patients with migraine [press release]. Silver Spring, MD: FDA; Published October 11, 2019. Accessed March 11, 2020. prnewswire.com/news-releases/fda-approves-new-treatment-for-patients-with-migraine-300937273.html.