Amgen and the Institute for Clinical and Economic Review have often clashed over drug prices, most recently after the cost watchdog said a new class of migraine meds would be a pricey burden on U.S. healthcare. But now that ICER has Amgen's official launch price for first-in-class Aimovig—a price several thousand dollars below expectations—it has endorsed the med's cost-effectiveness.
But there's a caveat: That backing is only for Aimovig in patients who've exhausted other options.
After learning Aimovig's official list price of $6,900 per year, ICER reworked its calculations and found Aimovig's cost-effectiveness is "substantially more favorable than in the draft report." The group concluded, however, that even with the lower price Aimovig is cost-effective only after patients try "existing preventive treatments, which are far less expensive." The report also includes a cost-effectiveness endorsement for Aimovig's future rival, Teva Pharmaceutical Industries' fremanezumab, after patients fail other options.
In a previous review, ICER estimated a $8,500 annual list price for Amgen and Teva's CGRP (calcitonin gene-related peptide) meds, yielding cost-effectiveness results that weren't so favorable. The organization said data on Eli Lilly's galcanezumab are too limited for a cost-effectiveness determination.
For its latest assessment, ICER assumed a 27% discount to payers, for a net price of $5,000 per year for both meds. The conclusion? Both drugs are cost-effective long-term. But in the short term, payers have decisions to make. The group is convening June 14 to address "how to manage short-term affordability if these agents are widely prescribed." Analysts have previously predicted Aimovig can generate $1.2 billion in sales by 2022.
Amgen and marketing partner Novartis said they agree with ICER's analysis that Aimovig "delivers value to patients and the health care system, and is a cost-effective therapy." Still, the company said it is concerned ICER didn't include "indirect costs including the important impact on work-related productivity in their base-case analysis." Because of that, the drug's cost-effectiveness may be "under-estimated," Amgen says.
"Patients have been waiting a long time for an option developed specifically for migraine prevention, and decisions as to who should try Aimovig should be left to the discretion of the physician based on patient need," a spokesperson told FiercePharma.
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Aimovig's recent approval marks the debut of the migraine meds that target the CGRP pathway. Rivals from Teva and Eli Lilly are also up for FDA green lights. The FDA is expected to act on Lilly's drug in the second half of the year, and Teva says it expects a decision by year's end, too, after a manufacturing problem pushed back its June decision date.
Ahead of the Aimovig approval, Amgen VP of development Rob Lenz told FiercePharma the first-mover advantage allowed Amgen to set the initial price in the class and tap a "pent-up demand" for better migraine meds.
ICER reviews have generated serious pushback from pharma companies on several occasions, including from Amgen. Pharma companies have argued that ICER reviews are flawed and that payers could use the watchdog's work to put up barriers to patient access.
RELATED: Amgen's Aimovig won its first-in-class migraine nod. Will payers step up to the $6,900 price?
Tensions flared between Amgen and ICER after the cost watchdog said new osteoporosis drugs from Radius Health, Eli Lilly and Amgen are overpriced. Amgen said it disagrees "with ICER’s approach, methodology and assumptions." In the past, ICER has said Amgen's PCSK9 cholesterol drug Repatha is too expensive, along with the biotech's multiple myeloma drug Kyprolis.
Editor's note: This story was updated with a statement from Amgen.