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Recently, the FDA approved a groundbreaking medication aimed at preventing migraines. This innovative treatment is delivered through an auto-injector, requiring a single monthly self-administered dose, priced at $575 per injection. Surprisingly, this cost is lower than what investors had anticipated, highlighting the ongoing issue of high drug prices in the U.S. Meanwhile, discussions on r/migraine suggest that the price is comparable to other migraine medications currently in use.
Aimovig, the newly approved drug, is an antibody-based treatment, similar to the antibodies our immune system produces to combat viruses and other foreign invaders. These lab-engineered antibodies are designed to bind to specific receptors in the body that typically interact with a protein known as CGRP. While the exact role of CGRP and its increase during migraines remains unclear, Amgen, the manufacturer of Aimovig, provides a summary on its website: 'There may be a link between CGRP, CGRP receptors, and migraine.'
Several uncertainties remain. According to the patient information provided for Aimovig, the safety of the drug during pregnancy or breastfeeding has not been established. Elizabeth Loder, a neurologist at Harvard, highlighted in a tweet that the FDA's approval of Aimovig was contingent on the company conducting studies to determine if the drug increases the risk of liver toxicity, heart attacks, and stroke in users.
For those suffering from severe migraines, the benefits of Aimovig may outweigh the risks. Amgen anticipates that most insurance plans will cover the drug for patients experiencing at least four migraines per month. Additionally, the company is offering a copay discount program, with plans to reduce patient copays to $5, to incentivize usage while ensuring insurance companies cover the majority of the cost. The Aimovig website also promotes a two-month free trial for new patients.
While Aimovig isn't a miracle cure, its website highlights that individuals with chronic migraines experienced six to seven fewer migraine days each month. However, participants in the same study who received a placebo (an injection without the active drug) also reported a reduction in migraine days. The FDA announcement provided comparative data against the placebo group, which is the standard approach. Across three studies, participants saw an average reduction of one to two and a half fewer migraine days per month, depending on the severity of their condition.
These figures represent averages, masking a crucial detail: 40% of trial participants experienced a significant reduction in migraine days—50% or more. If you fall into this category, that's excellent news! Similarly, if you're among the 24% who saw the same improvement in the placebo group, that's also a win. However, for some to achieve such dramatic results, others must have seen little to no benefit. This means that some individuals paying $575 monthly for this treatment might not experience any improvement. Currently, there's no way to predict which group you'll belong to before trying the drug.
