Amgen and Novartis inaugurated a new long-awaited class of migraine drugs on Wednesday with FDA approval for Aimovig, an injectable drug full of hope. But Aimovig has several more obstacles to overcome before he can reach those noble goals.
The partners need to win over the payers who have already warned about the cost of this new type of med, which is directed to the peptide pathway related to the calcitonin gene, could be to the health system, and they started fixing the price at $ 6,900 per year, less than the payers of $ 8,000 to $ 10,000 had warned.
With a rival drug from Eli Lilly just a few months ago, Amgen and Novartis have a limited amount of time to make the most of their first-player advantage. Already an Express Scripts representative said that the company will have a pre-authorization program to manage access to Aimovig.
The approval is possibly more important for Amgen, which is preparing for a new biosimilar competition for some key products, including the drug for anemia Neupogen. But Novartis has its own financial challenges, including generic competition for its Gleevec leukemia drug, and with a political scandal in full swing, you can use this dose of good news.
With the assent on Wednesday, the race is under way. Amgen had the opportunity to set the initial prices in the class, said Vice President of Development, Rob Lenz, before approval, and now can work to capture what he called "pent-up demand" for better anti-migraine drugs. "There are a lot of rumors in the field," he said about the patient's emotion and the doctor's for the drug. "This is the first preventive therapy designed specifically for migraine."
As Lenz pointed out, the oldest migraine drugs were reused for other uses. The lack of specially designed treatments is one of the reasons why the cGRP class is so crowded, and other Teva and Allergan participants, as well as Lilly, are expected. But Teva's drug, which could have been approved next month, will be delayed due to manufacturing problems, the company said in February, giving Amgen and Novartis a bit more clue to their release than expected. Allergan's, which is expected to be the first oral CGRP drug, is far behind, with a possible submission from the FDA next year.
RELATED: The 15 best expiration dates of 2018 drug patents – Neulasta – Epogen – Sensipar  Patients will appreciate a tolerability profile that is "similar to a sugar pill" and the effectiveness that can be see in a matter of days, said Lenz. Self-injection once a month allows patients to "meet established standards" because they do not 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 calendars.
Payers may be more demanding, but Amgen could apply some lessons he learned by launching Repatha, a PCSK9 drug with high ambitions. However, it quickly encounters the resistance of the payers, and the acceptance is not yet as strong as expected.
In an effort to gain favorable coverage, Amgen and his rivals, Regeneron and Sanofi, conducted large trial results in hopes of showing the drugs could deliver cardiovascular benefits. But even with data showing that drugs could reduce CV risks, PCSK9 manufacturers have discounted their medications by 40% or more to get coverage. The dynamic has led to sales well below the initial projections.
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With this in mind, analysts have raised doubts about the acceptance of new migraine drugs. In a note this week, Wells Fargo analyst David Maris said it remains to be seen if CGRP drugs "will be the next category similar to PCSK9, an important advance that must be priced low to access."
The approval of Aimovig closely follows a Praluent discount agreement that Maris sees as a possible harbinger of problems for new drugs for migraine. To obtain an exclusive place on the PBM form, and access to millions of patients it covers, Regeneron and Sanofi offered big price cuts. The agreement "does not bode well for the class of anti-CGRP drugs," Maris wrote this week. At the time of the agreement, Bernstein analyst Ronny Gal called it a "capitulation," because it is a tacit admission that the class will never become a huge commercial success.
"When classes are exclusive, taxpayers win," Gal said in a statement. video discussing the deal.
Taxpayers have already been analyzing CGRP medications. In a recent interview with Reuters, Express Scripts medical chief Steve Miller suggested that Amgen avoid the usual approach of setting a high price on the list and offering large discounts and rebates. Instead, the company could try to reduce the "gross to net" gap, he suggested.
In a statement on Thursday, a spokesperson for Express Scripts said Amgen is "responsible" with its Aimovig price. In citing "serious unmet needs" for people with migraine, he said that not all patients will need Aimovig. Express Scripts believes that the medication is appropriate for patients who have failed prior preventive therapy.
With that in mind, the company "will have a pre-authorization program to help payers get the most value for the money they spend." she added.
Amgen and Novartis are co-marketing Aimovig under an association first established in 2015 and extended last April. Under the latest agreement, the companies will jointly market the drug in the United States. Amgen will reserve US sales UU And it will pay them the Novartis royalties, while Novartis will make the reservation of US exports. UU sell and pay Amgen royalties for income elsewhere. Amgen has exclusive rights in Japan, and Novartis has exclusive rights in Canada.
RELATED: Amgen faces a blow when the competition is mounted for Repatha and Sensipar
Thursday's approval of some serious competition for other Amgen drugs approaches. This week, Pfizer won approval for its biosimilar Epogen, the success of anemia, with plans for its launch this year. Amgen could also face a new competition this year in Neulasta and Sensipar for calcium.
Together, those drugs generate billions of sales, and Amgen knows that Aimovig will be a key factor for growth as those drugs fall off the obvious cliff. Analysts predict that Aimovig can generate $ 1.2 billion in sales by 2022.