Latest FDA Approved Preventative Treatment for Migraine, Qulipta, Enters Intensely Competitive Market


September 28e, the Food and Drug Administration (FDA) has approved a once-daily oral drug, Qulipta (atogepant), for the preventive treatment of episodic migraine in adults. It is the second oral anti-calcitonin gene-linked peptide (CGRP) drug approved by the FDA for the prevention of migraine. The first was Nurtec ODT (rimegepant), which was approved as a treatment for acute migraine in 2020, and in May this year gained approval as a preventative treatment in adult patients with less than 15 ailments. head days a month.

Following an all-round blitz and advertising campaign, Nurtec ODT is currently competing with Ubrelvy (ubrogepant) for market share in the acute oral treatment space. In 2019, Ubrelvy became the first oral anti-CGRP drug approved by the FDA for acute migraine.

A battle is looming between Nurtec ODT and Qulipta in the field of prophylaxis. And, in the future, Nurtec ODT may have a leading market advantage over Qulipta as an oral prophylactic treatment for migraine.

Initially, it was believed that given the convenience of an oral tablet, Nurtec ODT could erode the market share of injectable CGRP antagonists. But, it appears that expanding the market, rather than moving the market (taking away market share from competitors) is what is happening. This makes sense considering the fact that of the roughly 38 million Americans with migraines, only about half take prescription drugs. Indeed, the migraine category is a relatively untapped market, with an expected compound annual growth rate of nearly 10% over the next five to 10 years, and global sales expected to reach around $ 13 billion by the time. 2027.

Migraine is characterized by severe headaches that can last for hours to several days. Before a migraine, up to 33% of sufferers will have visual, sensory, motor or verbal disturbances that signal the onset of a seizure. During an episode, a person may experience sensitivity to light, as well as gastrointestinal, cognitive, and vestibular symptoms. Following a migraine attack, a person may feel dizzy and tired. Migraine accounts for more than 800,000 emergency room visits in the United States each year.

In addition to health and cost issues, migraine has significant societal burdens; loss of productivity and absenteeism, in particular.

The most common treatments for acute migraine include the triptan class of drugs (selective serotonin 5-hydroxytryptamine receptor agonist). However, at least a third of patients do not respond well to triptans, and for many responders, they lose their effectiveness over time.

To address this unmet need, 8 migraine treatments have been approved by the FDA since 2018. This includes four monoclonal antibodies targeting CGRP – Aimovig (erenumab), Emgality (galcanezumab), Ajovy (fremanezumab) and Vyepti (eptinezumab) . All four were started as preventative migraine treatments. The first three are self-administered subcutaneous injections once a month. Vyepti is a medicine given once every three months by a healthcare professional. In addition, there are now three oral antagonists of CGRP (two of which have preventive properties) and Reyvow (lasmiditan), an oral medicine used for the acute treatment of migraine. Reyvow belongs to a class of medicines called ditans.

However, new, more expensive treatment options come with reimbursement challenges. The costs of newer migraine treatments are considerably higher than those of generic triptans and most other migraine therapies (including antihypertensives, antiepileptics, and antidepressants) except Botox.

The Institute for Clinical and Economic Review (ICER) performed an analysis of CGRP inhibitors and found that, overall, migraine patients had a greater reduction in the number of headache days per month compared to the use of other preventive drugs.

For some patients for whom triptans are not effective, not tolerated, or contraindicated, Nurtec ODT and Ubrelvy as agents for the treatment of acute migraine are considered by the ICER to be relatively cost effective.

Payers are a key arbiter determining patient access to new treatment options. To limit what they may consider excessive financial exposure, payers will classify migraine patients into categories, including headache types and frequency, as well as non-responders versus traditional drug responders and less. expensive, like triptans.

Payers will then examine the data on the comparative effectiveness of acute and preventive treatments for different subpopulations. For CGRP monoclonal antibody antagonists, there is growing evidence for their efficacy, as reported in the ICER study and elsewhere. Multiple analyzes of the “number needed to treat” show that one in five or six patients taking Aimovig will benefit from this medicine. At present, there is less data on oral prophylactic agents, such as Nurtec ODT. According to one study, the number to be treated appears to be around four or five, so slightly better than Aimovig.

Clinical data along with discounts, or net prices outside of wholesale acquisition cost (WAC), help shape the use of payer formulary management tools, such as patient cost sharing, authorization prior, quantity limits, indication restrictions to avoid the use of labels and step modifications. For example, one of UnitedHealthcare’s staged change policies – fail-first – requires a member to use a series of low-cost options before receiving coverage for any of the CGRP antagonists; whether injectable or oral. WAC prices for anti-CGRP monoclonal antibody treatments are higher than those for oral CGRP antagonist therapeutic agents. With the exception of Botox, the prices of triptans and other older drugs are much lower than those of injectable or oral anti-CGRP drugs.

This may explain why it took some time for CGRP inhibitors from monoclonal antibodies to gain traction. Gradually they did, as the income data shows. As convenient once-daily tablet options, Nurtec ODT and Qulipta are poised to further expand the market for migraine prophylaxis drugs.


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