Even though Amgen and Novartis rolled out their hot new migraine drug, Aimovig, at a lower-than-expected price of $6,900, the companies expected pushback from payers, and they prepared for that by handing out a lot of the product for free. But are they having trouble switching those patients to full-paying customers, courtesy of their insurers, and how will that affect the ultimate market potential of the drug?

That was the prevailing concern during Amgen’s second-quarter earnings call on Thursday evening, and judging from the tenor of the questions analysts asked, the company hasn’t quite eased investors’ fears.

"Right now, the majority of our business is in free drug, but we are rapidly converting that business to paid prescriptions," said Anthony Hooper, Amgen’s executive vice president of global commercial operations. Hooper, whose retirement was announced along with earnings, didn’t offer many details about how that transition is progressing.

Fact is, Amgen needs to get payers on board with Aimovig—and fast. Even though the biotech giant and partner Novartis boasted first-mover advantage in the new class of migraine drugs known as CGRP inhibitors, they won’t own the market for long. Eli Lilly, Teva and Allergan are in late-stage development of their CGRP drugs, with Lilly and Teva expecting FDA decisions in September.

Reports of payer pushback on Aimovig emerged just before Amgen’s earnings call. Several Blue Cross plans told Reuters they’re only approving coverage of the drug when the prescriptions come with the blessing of a specialist who is certified by the United Council for Neurologic Subspecialties, and only a tiny percentage of neurologists are in that group. Other payers require preauthorization, proof that patients have tried older, less expensive therapies, or other information that can be a hassle for physicians to provide. 

Hooper reminded analysts during the earnings call that Amgen set up a patient hub to provide two months' worth of Aimovig for free while it completed negotiations with insurers. The company also has a "bridging program," he said, to provide even more drug if patients can’t get their insurance companies on board before the end of the two-month period. Amgen has succeeded in attaining coverage for almost 30% of covered patients so far, he said.

Hooper reported that Amgen "received a large bolus of requests from the Headache Centers of Excellence reflecting the pent-up demand for this innovative new therapy." But when pressed by analysts to define the size of the bolus so they could predict the revenue impact, Hooper declined to elaborate.

"We're trying to make sure that we understand how unique each of those patients are, coming in, and that they are appropriate patients. I would say that, as you watch the evolution of the prescriptions coming out of that, you'll start getting a feel of the size of the bolus," he said.

One analyst asked Hooper to look beyond the bolus and to predict how important primary care physicians will be in driving the growth of Aimovig. Hooper admitted there are only 20 headache specialty centers in the U.S. and "another couple of thousand neurologists" who could also be prescribers. "But I do believe that the role of primary care physicians down the road becomes important. They do see patients and their ability to refer patients who are appropriate for a drug like Aimovig would be critical for the long-term value of this drug," he said.

Aimovig fears overshadowed what was otherwise a solid quarter for Amgen. The company’s revenues of $6.06 billion beat estimates by 3% and its earnings per share of $3.83 came in 33 cents higher than expected, driven by better-than-expected performance of older products like Prolia for osteoporosis and Sensipar to treat hyperparathyroidism.

Still, the pressure on the company to move beyond its older hit products and forge into more lucrative markets was evident, not just in the Aimovig discussion during the earnings call but also in the C-suite shakeup. Hooper is being replaced by Murdo Gordon, chief commercial officer of Bristol-Myers Squibb. And Amgen’s R&D chief, Sean Harper, M.D., is also retiring. He’ll be replaced by David M. Reese, M.D., Amgen’s senior vice president of translational sciences and oncology, the company said.

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