Amgen and Novartis inaugurated a much-anticipated new class of migraine drugs Wednesday with FDA approval for Aimovig, an injectable med laden with blockbuster hopes. But Aimovig has several more hurdles to clear before it can reach those lofty goals.
The partners need to win over payers that have already warned how costly this new type of medication—which targets the calcitonin gene-related peptide pathway—could be to the healthcare system, and they've started by setting the price at $6,900 per year, lower than the $8,000 to $10,000 payers had warned against.
With a rival drug from Eli Lilly only months behind, Amgen and Novartis have a limited amount of time to make the most of their first-mover advantage. Already, an Express Scripts representative said the company will have a prior authorization program in place to manage access to Aimovig.
The approval is arguably more important for Amgen, which is bracing for new biosimilar competition for some key products, including Neulasta. But Novartis has its own financial challenges, including generic competition for its big-selling leukemia drug Gleevec, and with a political scandal raging, it can use this dose of good news.
With Wednesday's nod, the race is on. Amgen had the chance to set initial pricing in the class, VP of Development Rob Lenz said ahead of the approval, and now it can work to capture what he called "pent-up demand" for better migraine meds. "There's a lot of buzz in the field," he said of patient and doctor excitement for the drug. "This is the first preventative therapy ever designed specifically for migraine."
As Lenz pointed out, older migraine drugs were repurposed from other uses. That lack of purpose-built treatments is one reason why the CGRP class is so crowded, with other entrants expected from Teva and Allergan as well as Lilly. But Teva's drug, which might have been approved next month, will be delayed by manufacturing problems, that company said in February, giving Amgen and Novartis a little more runway for their launch than previously expected. Allergan's ubrogepant, expected to be the first oral CGRP drug, is farther behind, with a potential FDA filing next year.
Patients will appreciate a tolerability profile that's "similar to a sugar pill" and efficacy that can be seen within days, Lenz said. The once-monthly self-injection allows patients "built-in compliance" because they don't have to remember to take a pill every day, he said. Lilly's injection is also monthly, while Teva's has been tested with monthly and quarterly schedules.
Payers could be a tougher crowd, but Amgen may be able to apply some lessons it learned while launching Repatha, a PCSK9 cholesterol drug with blockbuster ambitions. It quickly ran into payer resistance, though, and uptake still isn't as strong as expected.
In an effort to win favorable coverage, Amgen—and its rivals, Regeneron and Sanofi—ran large outcomes trials hoping to show the drugs could deliver cardiovascular benefits. But even with data showing the drugs could reduce CV risks, the PCSK9 drugmakers have discounted their meds by 40% or more to gain coverage. The dynamics have led to sales far below initial projections.
With that in mind, analysts have raised questions about uptake for the new migraine drugs. In a note this week, Wells Fargo analyst David Maris said it remains to be seen whether CGRP meds "will be the next PCSK9-like category–a major advance that must be priced low in order to get access."
Aimovig's approval closely follows a Praluent discount deal Maris sees as a potential harbinger of trouble for the new migraine drugs. For an exclusive spot on the PBM's formulary—and access to millions of patients it covers—Regeneron and Sanofi offered up big price cuts. The deal "does not bode well for the anti-CGRP drug class," Maris wrote this week. At the time of the deal, Bernstein analyst Ronny Gal called it a "capitulation," because of its tacit admission that the class will never become a major commercial success.
"When classes go exclusive, payers win," Gal said in a video discussing the deal.
Payers have been eyeing CGRP drugs already. In a recent Reuters interview, Express Scripts chief medical officer Steve Miller suggested Amgen avoid the usual approach of setting a high list price and offering large rebates and discounts. The company could trying narrowing the "gross-to-net" gap instead, he suggested.
In a statement Thursday, an Express Scripts spokesperson said Amgen is "being responsible" with its Aimovig pricing. While citing "serious unmet need" for migraine sufferers, she said not all patients will need Aimovig. Express Scripts believes the drug is appropriate for patients who have failed on a previous preventative therapy.
With that considered, the company will "have a prior authorization program in place to help payers get the most value for the money they spend," she added.
Amgen and Novartis are co-marketing Aimovig under a partnership first struck in 2015 and expanded last April. Under the latest agreement, the companies will co-commercialize the drug in the U.S. Amgen will book U.S. sales and pay Novartis royalties on them, while Novartis will book ex-U.S. sales and pay Amgen royalties for revenues elsewhere. Amgen has exclusive rights in Japan, and Novartis has exclusive rights in Canada.
Thursday's approval comes ahead of some serious competition for other Amgen meds. This week, Pfizer won approval for its biosimilar of anemia blockbuster Epogen, with plans to launch this year. Amgen could also face new competition this year on Neulasta and on calcium Sensipar.
Together, those drugs generate billions of sales, and Amgen knows Aimovig will be a key factor for growth as those drugs fall off the patent cliff. Analysts predict Aimovig can generate $1.2 billion in sales by 2022.