erenumab’s ability to reduce patients’ average monthly migraine days by at least 50 percent, or lessen the need for other migraine drugs. Some of the key numbers:
—43.3 percent of patients on a low dose of erenumab had at least a 50 percent reduction in migraine days, compared to 50 percent of those in the high dose group and 26.6 percent of those on placebo.
—The low-dose group used acute migraine drugs 1.1 fewer days, on average, over the final three months of the study compared to a 1.6-day reduction for the high dose group and a 0.2-day decrease for placebo patients.
—8 patients on placebo dropped out of the study because of side effects, versus 7 on a low erenumab dose and 7 on the high dose.
Similarly, the NEJM paper on fremanezumab provided new details. Among them:
—38 percent of patients on a quarterly dose of fremanezumab had at least a 50 percent reduction in migraine days, compared to 41 percent of those in the monthly dose group and 18 percent of those on placebo.
—8 patients on placebo dropped out of the study because of side effects, versus 5 on the quarterly fremanezumab dose and 7 on the monthly dose.
Migraines affect some 38 million people in the U.S. alone, according to the Migraine Research Foundation. About 90 percent of them have the episodic variety, while another 5 to 8 percent have chronic migraines. A migraine attack can be debilitating, bringing with it sensitivity to light and sound, and visual disorientation called an aura. Though the aura typically lasts an hour, migraines can last from several hours to several days.
The condition also takes an economic toll. The foundation pegs the U.S. productivity lost to migraines at more than $13 billion a year.
Migraines are currently treated with a generic class of drugs called triptans. They ease pain and are taken at the earliest signs of a migraine attack. But triptans only temporarily help after symptoms start and can lead to rebound headaches.
Erenumab and fremanezumab belong to a new class of drugs that aim to prevent migraines from starting. The drugs, block calcitonin gene-related peptide (CGRP), a protein thought to play a role in pain transmission. So far in clinical testing, CGRP blockers have reduced the number of attacks. That can be very important for people who spend days completely debilitated by migraines, says Louise Klebanoff, a neurologist at Weill Cornell Medicine and NewYork-Presbyterian. She isn’t involved with Amgen or Teva.
Still, she cautions, “It’s not a cure-all. We always have to be careful when there’s a new medication on the market that we don’t overestimate what it can do.”
Indeed, there are important unresolved questions about erenumab and fremanezumab. It’s still unclear how the drugs will impact people over the long term, who will benefit and who won’t, and whether safety problems will emerge over time. Goadsby wonders how long a patient who responds, for instance, might need to be treated, whether doses can be changed over time, or whether new ways might emerge to predict who will respond to treatment. These questions are particularly important because both drugs are meant to be taken for life.
In an editorial published along with the erenumab and fremanezumab papers, Andrew Hershey, the director of neurology at Cincinnati Children’s Hospital, cautioned that the existence of four similar-type drugs heading towards the market will make it hard for determine which one is best, and which patients will likely respond to each one.”Furthermore, many patients will probably still have a response to standard multidisciplinary treatment that is less costly in patient and provider time and dollars,” he wrote.
All these uncertainties will likely spur tension between pharmaceutical companies and insurers. Erenumab, fremanezumab, and two other CGRP blockers from Eli Lilly (NYSE: [[ticker:LLY]]) and Alder Biopharmaceuticals ((NASDAQ: [[ticker:ALDR]]), could all be approved within the next few years.
They could be expensive, too. Klebanoff and Goadsby are expecting a fight over access. Klebanoff plans first to prescribe it to people who don’t respond to other therapies before expanding its use if she sees positive results, but fears that won’t be easy.
“My guess I there are going to have to be a bunch of hoops we have to jump through” to get patients on treatment, she says, “and jumping through hoops is a pain in the ass.”
Klebanoff says insurers already limit the number of triptans patients can get covered per month. She wouldn’t be surprised if insurers require a certain amount of migraine days, or require patients to fail a few other therapies, before covering erenumab. “I’ll have patients calling me crying saying they ran through their four [pills] that they were allowed this month,” she says.
Goadsby expects payers to push back, and rightly so, “to ask questions about who” should get treated, says Goadsby. Like Klebanoff, he points first to people with disabling migraines who fail other therapies.
Amgen spokesperson Kristen Davis said it is too early to discuss specific pricing strategy for erenumab.
Amgen is well familiar with pricing battles. It is still trying to overcome insurance company barriers to its cholesterol-lowering drug, evolocumab (Repatha), with a list price of $14,000 a year. The company began offering insurers refunds earlier this year for patients who take evolocumab but still suffer heart attacks and strokes.
As with its cholesterol drug, Amgen plans to keep following erenumab patients over a longer span and gather data to convince insurers of erenumab’s value. It doesn’t have the luxury of too much time, however. Competition could be on the way. Eli Lilly has said it plans to file for FDA approval of galcanezumab by the end of the year. And Alder has said it expects to file for approval in the second half of 2018.
—Frank Vinluan contributed to this report.
