Amgen, Novartis ready to roll as FDA green lights blockbuster campaign for migraine drug — priced at $6,900
Amgen and Novartis have brought home the big Aimovig (erenumab) approval they’ve been hunting, scoring first-mover advantage for a blockbuster contender that will now look to start changing the standard of care for debilitating migraines.
Significantly, the heavyweight partners — who will share the US marketing rights — are launching this CGRP pioneer with a list price of $6,900 a year. That number comes in well below the $8,000 to $10,000 spread that Express Scripts had already warned would be unacceptable to them. It’s also well under the $8,500 figure the Institute for Clinical and Economic Review pencilled in for their review, which they considered too costly for all but the most seriously afflicted.
That message clearly got through to the manufacturers. Amgen in particular has had to work out some deals on its PCSK9 drug to get that past steep payer hurdles.
They’ll be selling their drug at $575 list for once monthly 70 or 140 mg single-use injectors. And something to keep in mind: Disease advocates say that migraines aren’t uncommon, costing the economy tens of billions of dollars a year for the devastating attacks.
Steve Miller, chief medical officer of Express Scripts, had raised a warning flag on this drug, trying to steer the companies away from a high wholesale price, which would be used to set out-of-pocket costs for consumers and a high-water mark for payers to discount against.
“If your expectation is that you are not going to actually get that high list price, then don’t do that to patients who have high co-pays,” Miller told Reuters. “Let’s be more balanced. Let’s get back to where gross-to-net is not so different.”
Express Scripts gave the drug price a quick thumbs up this morning, but that doesn’t mean that they’ll make the drug readily available to everyone who asks for it. A spokesperson tells me:
“We believe they are pricing the drug responsibly at the lower end of the value-based price range. We believe there is a serious unmet need for patients with migraine. However, not all patients will need this therapy. We see it for people with migraine who have failed preventive therapy. We will ensure appropriate patients have access to this medicine and will put a prior authorization program in place to help payers get the most value for the money they spend.”
In a sign of the times, Amgen and Novartis marketing teams are wasting no time setting up an aggressive campaign to focus more attention on migraine as they roll out a major marketing effort. And they’ve got a patient support group — Aimovig Ally — ready to roll.
Time is a crucial factor here. Eli Lilly is lined up as the second entry to the CGRP space in a matter of months, with familiar data on its ability to significantly cut the number of migraines chronic sufferers have to endure. Then there’s Teva, which has to endure a damaging delay for its therapy. And little Alder is waiting in the wings as Allergan presses ahead with an oral drug they’d like to use to leapfrog everyone.
Today, though, belongs to Amgen and Novartis, which executed well on a huge Phase III effort.
“In addition to bringing a new therapeutic option to patients in the U.S., Amgen also has a commitment to reshape the public’s perception of this stigmatized disease,” said Anthony Hooper, executive vice president of global commercial operations at Amgen. “We have pledged a mission to help change misconceptions, stereotyping and even judgment that people with migraine face on a daily basis. Through educational programs and initiatives, we hope to promote more meaningful connectivity and dialogue among patients, physicians, employers and payers.”