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Competition, Preferences Within a New Class of Drugs
A few months ago, I wrote an article about my initial impressions of the landscape of calcitonin gene-related peptide (CGRP) receptor antagonists for the treatment of migraines just after the launch of the first drug approved in this class, Aimovig (erenumab, Amgen). I concluded that I was pleasantly surprised by the initial pricing of the medication and that I felt there was a positive stage set for this class. In the few short months since then, we have had our second and third CGRP drugs—Ajovy (fremanezumab, Teva Pharmaceuticals) and Emgality (galcanezumab, Eli Lilly). Competition within a new class of drugs often leads to a balance between plan coverage and coverage requirements benefiting patients, payers, and manufacturers; so, I wanted to provide an overview of the class landscape today.
As many of us expected, following the release of Aimovig, Ajovy, and Emgality to the market, a parity pricing with an average wholesale price (AWP) of about $690 per month. Each offer a coupon savings card for commercially insured patients with slight differences in terms and minimum copay, but I do not think the differences will make much of an impact in patient preference of a product. With no large differences between list prices and coupon copays, preferencing in this class will likely come down to potential rebate offers, clinical considerations, and brand recognition among prescribers.
As the first drug released in a new class of medications, I believe Aimovig may have the early advantage in brand recognition. It will be interesting to see if this changes as the other manufacturers begin marketing their products to providers and potentially directly to consumers. Aimovig is a once-monthly injection of 70 mg with a note that some patients may see benefit from a dose of 140 mg (2 injections of 70 mg) once a month. We have seen other biologic products suffer from increased scrutiny when increased doses are an option, but Amgen will likely avoid that as they offer the same price on both doses. In pivotal studies, Amgen used the number of monthly migraine days as the primary endpoint with an ability to decrease the number of migraine days by about 1 to 2 more than placebo.
Ajovy is approved with two dosing options—225 mg once monthly or 675 mg (3 injections of 225 mg) every 3 months subcutaneously. While the quarterly dosing option may be appealing for some patients, the duration of effect may not be quite as robust as when the medication is dosed monthly when looking at the data from the pivotal clinical trials. Teva also used a primary endpoint looking at the number of migraine days per month and showed a similar decrease compared with placebo ranging from about 1 to 2 days per month.
Emgality stands alone as the only FDA-approved CGRP medication with a loading dose. It is approved with a loading dose of 240 mg (2 injections of 120 mg) followed by a monthly dose of 120 mg subcutaneously. The loading dose may put Emgality at a small financial disadvantage as it does double the cost for the first month. In pivotal clinical trials, Emgality’s ability to reduce the number of migraine days per month compared with placebo was similar to its competitors hovering around 2 days per month.
When looking at the safety profile of these medications, none of them showed any reason for concerns of major adverse reactions. As may be expected with injectable biologics, the most common adverse reaction seen was injection site reactions. While the reported percentage of participants varied from drug to drug (Aimovig 6%, Ajovy 45%, Emgality 18%), the number of participants discontinuing from any of the studies as a result of adverse reactions was low.
I have not seen much in the way of official information regarding rebate strategies of the manufacturers in this class. With my ear to the ground, I believe the current preference within this class among the manufacturers is to offer modest access rebates for parity formulary status with the competition. With the relatively affordable list price, I believe payers will accept this strategy until the market for these medications matures.
As I look at this new class of medications, I am glad to see new options for migraine sufferers who have tried everything previously available and in need of another option. I personally do not see any clinical or financial reason for preferencing between currently available products and expect to see parity formulary placement as the norm for now. As real-world evidence emerges and other competitors come to market (including potential oral options), it will be interesting to watch this class and if any preferencing naturally emerges.
