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Amgen Migraine Decision Looms, Maybe the Next Drug Price Fight, Too

Xconomy National — 

For some migraine sufferers, bright lights or loud sounds are enough to touch off an attack. For others, stress sparks the onset of pain. Bright lights, loud sounds, stress: Migraine triggers vary from one patient to another. But a common element is the abundance of a pain-inducing protein in the blood.

During a migraine attack, nerves release this protein, called calcitonin gene-related peptide (CGRP). A number of companies are developing drugs to block CGRP and stop migraine pain before it starts. The most advanced of these experimental migraine prevention drugs, from Amgen (NASDAQ: AMGN), is expected to receive an FDA decision Thursday. An approval will likely trigger the latest debate over pharmaceutical costs.

The last new class of migraine drugs entered the market nearly three decades ago. Estimates place the number of Americans who suffer from migraines at 28 million. Depending on coverage decisions that insurance companies make, many could be eligible for the CGRP blockers. But migraine is a chronic condition, and a drug to prevent migraine attacks would need to be taken on a regular basis—at considerable expense—for an extended period, perhaps even for life. Those factors have patients, physicians, and insurers paying close attention to emerging data.

“I imagine that these are going to be expensive,” says Gary Jay, a neurologist at the University of North Carolina at Chapel Hill. “I can’t imagine that an insurance company would say ‘no.’ But I also can’t imagine how much money a patient is going to have to pay.”

On Amgen’s heels are CGRP blockers from Eli Lilly (NYSE: LLY), Teva Pharmaceutical (NYSE: TEVA), and Alder BioPharmaceuticals (NYSE: ALDR), whose CEO unexpectedly stepped down two months ago as the company was working to bring its migraine drug to the finish line.

Some in the field believe competition could tamp down high prices. Jay was involved in clinical trials for sumatriptan, the first among the triptan class of drugs that were approved a generation ago. Jay recalls that sumatriptan carried a high price tag when it launched in 1991. Subsequent triptan approvals brought prices down, he says.

An influential drug-price watchdog notes that competition doesn’t always work that way in the drug industry. David Rind, chief medical officer of the Institute for Clinical and Economic Review, says physicians who treat hemophilia tell him that every time a new drug formulation becomes available, the prices go up. He also points to the 2015 launch of two cholesterol-lowering PCSK9 inhibitors, which were meant to be an improvement over widely prescribed statin drugs. The presence of a market competitor did not bring prices down. Instead, both drugs carried the same $14,000 price tag—which many insurers balked at paying.

“I don’t know what will happen with this,” Rind says of the new migraine drugs.

Some estimates that ICER has reviewed place the annual cost of a CGRP drug at $10,000 a year, Rind says. ICER has run a preliminary analysis, which found these drugs help patients reduce migraine attacks but, assuming an $8,500 annual price tag, would only be cost effective for patients who have more frequent migraines and have also exhausted other treatment options.

Healthcare expenses and lost productivity due to migraines cost an estimated $36 billion annually in the U.S., according to the Migraine Research Foundation, which is backed by Amgen, Lilly, and other drug companies. Rind acknowledges that migraine does have an impact on employers, but he says ICER’s analysis of the CGRP drugs focused on their value to patients. ICER plans to release a final version of its report, along with firmer pricing details, by the end of May.

Rind says Amgen and its peers aren’t saying yet how much they plan to charge for them. He has also spoken with insurance companies, who “are pretty nervous about these drugs,” Rind says. “Migraine is a common condition and if a drug comes on the market at many thousands of dollars per year, that will have significant budget impacts.”

EXPENSIVE PROTEINS

The expected higher price of the new injectable migraine drugs has another parallel to the new anti-cholesterol drugs. Both are proteins—monoclonal antibodies—aiming to replace or supplement pills, which are far cheaper to produce.

German firm Boehringer Ingelheim was the first to develop a … Next Page »

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