EXOME

all the information, none of the junk | biotech • healthcare • life sciences

Drug Price Watchdog ICER Deems Amgen Migraine Drug “Cost-Effective”

Xconomy National — 

As Amgen approached an FDA decision last month for its migraine-prevention treatment, concern mounted that the drug would come at premium. In setting a price thousands of dollars less than expected, Amgen has won over one of the pharmaceutical industry’s fiercest drug price critics.

The non-profit Institute for Clinical and Economic Review (ICER) assessed the effectiveness and value of the Amgen (NASDAQ: AMGN) drug erenumab (Aimovig) and other new migraine drugs, and concluded in an updated report that erenumab offers value to patients in the price range of $3,700 to $5,300 per year. After the FDA approved erenumab last month, Amgen and partner Novartis (NYSE: NVS) set a $6,900 annual price for the drug. But the cost to most patients will likely be less. The rebates and discounts that companies typically offer are expected to put the migraine drug’s annual cost at approximately $5,000— within ICER’s value range, the group said.

Before the FDA approved erenumab, analysts estimated the drug —part of the first new class of migraine medicines in a generation—could cost as much as $10,000 a year. ICER used an $8,500 price in making the calculations in its draft report in April.

Even though the Amgen drug carries a lower than expected price, ICER still maintains the treatment is not cost-effective if it’s used for patients who have not first tried older, less expensive migraine-prevention treatments. Other medicines that have won additional approvals for migraine prevention include the anti-seizure drug topiramate (Topamax), as well as beta blockers, a class of drugs used to treat high blood pressure.

The Amgen drug, given as a once-monthly injection, is part of a new drug class called calcitonin gene-related peptide (CGRP) inhibitors. These drugs block the CGRP protein, which is thought to play a role in the transmission of pain. Other companies have developed CGRP drugs to head off migraine pain before it starts. Eli Lilly (NYSE: LLY) and Teva Pharmaceutical (NYSE: TEVA) await FDA decisions for their respective drugs. Alder BioPharmaceuticals (NASDAQ: ALDR) has said it expects to file for FDA approval early next year.

ICER’s review of clinical studies of the Amgen drug and others in the class found that these drugs, on average, reduced the frequency of migraines by one to three days per month. The FDA’s approval of Amgen’s drug covers episodic migraine, ranging from five to 14 headaches per month, as well as chronic migraine, defined as 15 or more headaches per month.

In a research note, Evercore ISI analyst Umer Raffat wrote that Amgen’s drug was priced to make it accessible to patients, though terms of that access are still being negotiated with insurance companies. Amgen told Raffat it expects insurers will require patients to have failed one, perhaps two previous preventative migraine therapies. Those patients will likely also need to have tried to treat their migraines with triptans, a group of drugs that won FDA approval in the 1990s to treat migraines at the onset of pain.

Those requirements aren’t big hurdles, Raffat said. An estimated 3.5 million patients have already tried a migraine preventative therapy and approximately 80 percent stop that therapy within a year, according to Amgen’s calculations.

But erenumab’s lower price may still cause insurance companies to take a financial hit, at least in the near term, because migraine is so common, ICER said. The group calculated that if the Amgen drug is prescribed to more than 16 percent of eligible patients, insurers will feel the sting in their budgets.

ICER said the clinical data for the CGRP drugs was not enough to show whether the Amgen drug or fremanezumab, which was developed by Teva, would help patients more than older migraine-prevention treatments. The group also said that there was not enough information to evaluate Lilly’s drug, galcanezumab.

Photo by Amgen