CGRP migraine drugs need prior approval for use, recommends ICER

A new generation of migraine drugs headed by Amgen and Novartis’ Aimovig have a role in patients with no other treatment options, but a lack of long-term safety data means they should be used with caution, says a US cost-effectiveness watchdog.

The Institute for Clinical and Economic Review (ICER) is recommending that insurers introduce “evidence-based prior authorisation criteria” to make sure that Aimovig (erenumab) and other CGRP inhibitors such as Teva’s fremanezumab and Eli Lilly’s galcanezumab are used prudently.

ICER thinks that the authorisation procedure should however be a fairly simple affair, coming down to a clinician statement that patients have tried two or three other preventive therapies. At least one pharmacy benefits manager – Express Scripts – has already introduced a prior authorisation programme for Aimovig.

The recommendations for the introduction of payer barriers come as Novartis and Amgen are reportedly seeing strong demand for Aimovig, which was launched in May and may have just a few months to make its mark before Teva and Lilly’s drugs are approved in the US.

Last month, ICER said that Amgen and Novartis’ decision to price the injectable drug at $6,900 per year – reducing to around $5,000 a year after discounts and rebates – meant that it offered value for money, but only if other migraine prevention options such as Allergan’s Botox and anti-epilepsy drugs such as topiramate had been exhausted.

Since then the watchdog has held a public meeting to gauge the affordability of the new CGRP class, and the latest report takes into account those deliberations.

At that meeting, panel members drawn from patient advocates, physicians, public and private payers, and drug manufacturers voted that evidence was adequate to demonstrate a net health benefit of the CGRP inhibitors for individuals with chronic migraine and no other available treatment options, but also concluded that for episodic migraine the benefits of Aimovig were “promising but inconclusive”.

While acknowledging that even infrequent migraines can have a dramatic impact on individuals’ day-to-day life, ICER said that “clinicians should be aware of the uncertainties in long-term efficacy and potential harms” of these new drugs, noting that the FDA has requested additional research into liver toxicity and risks for heart attack and stroke after exposure to erenumab, and into potential adverse effects when it is used during pregnancy.

The organisation is extending its overall conclusions to the two other CGRP drugs on the grounds that they will likely priced at around the same level as Aimovig. Fremanezumab and galcanezumab remain under FDA review but should have decisions before year-end, will also be priced around the same level as Aimovig.

“Following the example set by the launch of the first CGRP inhibitor, manufacturers should continue to exercise restraint and ensure net prices align reasonably with the added benefits for patients,” it says.