Survey Finds Patients Wary of Trying CGRP Migraine Drugs

By Pat Anson, PNN Editor

Khloe Kardashian and Serena Williams have their work cut out for them. Despite their endorsement of a new type of migraine medication, many patients remain wary of the drugs and few have tried them, according to a large new survey.

The annual survey of nearly 4,700 migraine patients by Health Union found that about one in four (26%) are currently using a preventive CGRP medication, down from 29% in last year’s survey. And only 11 percent of patients said they were using a CGRP to treat migraine pain.

CGRP stands for calcitonin gene-related peptides, a protein that binds to nerve receptors in the brain and triggers migraine pain. Since 2018, the FDA has approved four injectable CGRP inhibitors (Aimovig, Ajovy, Emgality, Vyepti) to prevent migraine and two CGRP tablets for acute migraine (Ubrelvy, Nurtec). The latter two were recently endorsed by reality star Kardashian and tennis star Williams.   

Although Eli Lilly, Teva, Amgen, and other drug companies have aggressively marketed CGRP medications and even given the drugs away for free to get people to try them, sales growth has been slow. Only Aimovig and Emgality are used by at least 10 percent of migraine patients.

PERCENTAGE OF PATIENTS CURRENTLY USING CGRP INHIBITORS

SOURCE: HEALTH UNION 'MIGRAINE IN AMERICA 2020'

Most migraine patients continue to rely on older and cheaper medications such as triptans, anti-depressants, anti-convulsants, over-the-counter drugs, and Botox injections.

The Health Union survey helps explain why. While most patients are aware of CGRP inhibitors and nearly half (43%) had tried a preventive CGRP, most stopped taking them after trying just one brand. That’s not uncommon for migraine sufferers, who often have try multiple treatments before finding one that works.   

“Everybody’s experience with treatment is different. And the fact that there are multiple brands available is actually a really good thing. Because some of them just happen to work better for some people than others,” says Brian Green, Health Union’s vice-president of community business solutions.

CGRP’s do work for some patients. The Health Union survey found that 58% of patients currently using a preventive CGRP reported having less head pain. And nearly half said they didn’t react as strongly to migraine triggers such as loud noises and bright light.  

Those who had heard of preventive CGRP medications but had not tried them cited a number of reasons:

• 44% Doctor has not recommended it

• 27% Concerned about side effects

• 21% Concerned about long-term safety

• 19% Can’t afford them

• 14% Insurance won’t cover

CGRP medications are not cheap. Eight doses of Nurtec, the acute CGRP endorsed by Kardashian, can cost over $1,000 without insurance.

Nearly half the patients surveyed said they were still using triptans or over-the-counter pain medication for migraine relief. Antidepressants and Topamax were the most commonly used medications for migraine prevention. 

Migraine affects more than 37 million people in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can cause nausea, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraines than men.

New Migraine Prevention Drugs Making Inroads

By Pat Anson, PNN Editor

Over half the patients taking a new class of medication designed to prevent migraines say the benefits of treatment outweigh the drugs’ side effects, according to a new survey.

The drugs prevent migraines by blocking a protein — calcitonin gene-related peptides (CGRP) -- from binding to nerve receptors in the brain. Since 2018, the FDA has approved three injectable CGRP inhibitors for migraine prevention and recently approved the first oral tablet for migraine treatment.

Although the drugs are still relatively new, a recent survey of over 4,700 migraine patients by Health Union found that about a third (29%) are currently using a CGRP medication, while 12% had used one in the past.

Most said the drugs were effective at migraine prevention and worth the side effects, which include constipation, fatigue and weight gain. Only 9 percent said the drugs were not worth the side effects.

“CGRPs are in many ways a treatment revolution,” says Brian Green, vice-president of community development for Health Union. “There has not been a new class of medication specifically designed for treatment of migraine for decades. So this really is groundbreaking.” 

Green said patients with chronic severe migraine are more likely to be early adopters of CGRP therapy, as opposed to people who have episodic migraines and fewer attacks.   

Patients on CGRP therapy were more likely to say their migraine attacks increased over time and that they experience a wide array of symptoms, including head pain, brain fog, difficulty concentrating, fatigue, loss of words, memory loss and sensitivity to touch. 

“Their symptoms are so severe they want the first available new treatment,” Green told PNN. 

But the early adopters were also more impatient. Health Union’s survey found that patients who were not satisfied with a CGRP inhibitor wasted little time switching to a new brand. About 40% waited less than a month and 43% waited up to 3 months. Most of those who switched said the drugs did not work or stopped working after an initial period of efficacy. 

The three CGRP inhibitors currently on the market are Aimovig, Ajovy, and Emgality, which are taken by injection about once a month. The first oral CGRP for migraine treatment, Ubrelvy, was approved by the FDA last month and is expected to be available in the next few weeks.  

Most patients surveyed by Health Union said they would prefer taking a daily CGRP pill as opposed to a monthly injection.  

Constipation was the leading side effect reported by patients getting CGRP injections. Nearly a third said the drugs made them constipated, while others complained of reaction at the injection site (16%), fatigue (15%), weight gain (12%) and dry mouth (11%). 

About half the patients surveyed said they were still using a triptan or over-the-counter pain medication for migraine relief. Antidepressants and Topamax were the most commonly used medications for migraine prevention. 

Regardless of the drugs used, only 12% of patients said their migraines were well controlled under their current treatment plan.  

FDA Approves Third Injectable Migraine Drug

By Pat Anson, PNN Editor

Migraine sufferers will soon have another treatment option. Eli Lilly has announced that the U.S. Food and Drug Administration has approved Emgality (galcanezumab), a monthly self-injected drug for the prevention of migraine in adults.

Emgality is the third injectable migraine drug the FDA has approved this year. In May, the agency gave approval to Amgen’s Aimovig (erenumab), the first migraine drug that uses fully human monoclonal antibodies to target receptors in the brain where migraines are thought to originate.  Last week, the FDA approved Teva’s Ajovy, a migraine prevention drug that can be injected monthly or quarterly.

Lilly said the efficacy and safety of Emgality was demonstrated in three Phase 3 clinical trials in patients with episodic or chronic migraine.

Emgality reduced the number of monthly migraine headache days by an average of 4.7 days in patients with episodic migraine and by 4.8 days in patients with chronic migraine.  

Migraine affects a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can cause vomiting, blurriness or visual disturbances, as well as sensitivity to light and sound. Women are three times more likely to suffer from migraine than men.

“Despite the devastating impact of migraine, only about 10 percent of people living with the disease are currently taking a preventive treatment,” Christi Shaw, president of Lilly Bio-Medicines, said in a statement. “With this approval, we are thrilled to offer a preventive treatment option to adults living with this disease.”

Lilly said Emgality would be available “shortly” at a listed price of $575 for a single injection or $6,900 annually. That introductory price is identical to that of Aimovig and Ajovy, although various discounts or rebates could make the cost lower. Lilly said it would offer Emgality for up to 12 months free to patients with commercial insurance under its patient assistance program.   

“We know the impact high deductible and rising out-of-pocket costs have on families, and Lilly takes seriously our role in ensuring affordable access to Emgality for as many patients as possible,” said Shaw.

Earlier this month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use issued a positive opinion of Emgality for the prevention of migraine in adults who have at least four migraine days per month. That positive opinion was referred for final action to the European Commission, which grants drug approval in the European Union.

Migraine Costly to Workers and Employers

By Steve Weakley

Most employees who suffer from chronic migraine headaches miss nearly a full week of work (4.6 days) due to migraines each month, according to a large new online survey.

Amgen and Novartis surveyed over 11,000 migraine sufferers in 31 countries to demonstrate how painful and costly the condition can be for both workers and employers.  The My Migraine Voice survey included people who had four or more migraine days a month.

Eighty percent of the survey takers in the U.S. said their employers knew about their migraines, but only 21 percent said their bosses offered support and understanding. Nearly two-thirds (63%) said migraines impaired their work performance and many felt judged by co-workers as a result.

"From being afraid to speak up about their disease at work in fear of losing their jobs, to feeling judged by colleagues, the stigma around migraine in the workplace is an ongoing issue that the migraine community faces daily," said Mary Franklin, executive director of the National Headache Foundation, in a press release.

"The findings from the My Migraine Voice survey shed light on the true impact of migraine at work, and showcase the urgent need for employers and employees to change the dialogue around migraine."

According to one estimate, U.S. employers lose about $11 billion a year in missed work and lost productivity because of migraines.

Amgen and Novartis presented the survey findings at the 60th annual meeting of the American Headache Society in San Francisco, to help stir up interest in their new injectable migraine drug, Aimovig (erenumab). The FDA recently approved the monthly self-injected drug for the prevention of migraine in adults.

Aimovig uses human antibodies to target brain receptors that are thought to trigger migraines. Three clinical trials demonstrated that the drug reduced the number of migraine days for sufferers by an average of 2.5 days per month.

One obstacle in getting people to try Aimovig is its price. Amgen say the drug will cost about $6,900 a year, or $575 for each monthly dose. Amgen holds the sales rights for Aimovig in the United States, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.

Amgen is offering a migraine management program to several large U.S. employers. The program consists of an educational program as well as a research study to document the impact of migraine on worker absenteeism, presenteeism, healthcare utilization and costs. The wellness portion of the program includes webinars, email and website tips, and a  mobile app to track migraine symptoms.

FDA Approves Injectable Migraine Drug

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a monthly self-injected drug for the prevention of migraine in adults.

Aimovig (erenumab) is the first FDA-approved migraine treatment in a new class of drugs – known as fully human monoclonal antibodies -- that target receptors in the brain where migraines are thought to originate. It blocks the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks.

"The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine," said Sean Harper, MD, executive vice president of Research and Development for Amgen, which shares the licensing rights to Aimovig with Novartis.

The effectiveness of Aimovig for the prevention of migraine was evaluated in three clinical trials, which found that patients experienced one to 2.5 fewer migraine days per month compared to those who took a placebo. The most common side effects were irritation at the injection site and constipation. 

Like many specialized drugs used to treat chronic conditions, Aimovig comes with a hefty price tag. Amgen says the drug will cost about $6,900 a year, or $575 for each monthly dose.

Out-of-pocket costs will vary for patients depending on their insurance. Amgen has a co-pay program for Aimovig that could reduce the cost to as little as $5 per month for eligible patients.

The company says Aimovig will be available to patients within one week.

"Aimovig offers self-administration with proven efficacy across a spectrum of patients, including in those who have previously tried other preventive therapies without success," said Stewart  Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth Medical School. "Importantly, in clinical trials, Aimovig patients were able to start and stay on therapy – with a discontinuation rate of two percent due to adverse events – and experienced sustained migraine prevention."

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound. Women are three times more likely to suffer from migraine than men.

About one-third of migraine sufferers can predict the onset of a migraine because it is preceded by an aura – a sensory or visual disturbances that appear as flashing lights, zig-zag lines or a temporary loss of vision. People with migraine tend to have recurring attacks, triggered by stress, hormonal changes, bright or flashing lights, lack of food or sleep, and diet.

Amgen and Novartis expect Aimovig to be approved in the European Union in the next few months. Amgen holds the sales rights for Aimovig in the United States, Canada and Japan, while Novartis will sell the drug in Europe and the rest of the world.

New Hope for Hard-to-Treat Migraine Patients

Amgen and Novartis have announced promising results from a Phase III clinical trial of an injectable new migraine drug called Aimovig (erenumab).

In a study of 246 patients with episodic migraine, significantly more patients injected with Aimovig had at least a 50 percent reduction in the number of monthly migraine days compared to a placebo. The study was the first of its kind to include hard-to-treat patients who have tried and failed at least two other migraine medications due to lack of efficacy or intolerable side effects.

"We've purposely designed a clinical program for Aimovig that examined a broad spectrum of migraine patients, ranging from those who have never tried a preventive treatment to patients who have tried and failed such treatments," said Sean Harper, MD, executive vice president of Research and Development at Amgen.

"These data in patients with multiple treatment failures, who are not only considered difficult to treat but also have few options available, add to the consistent body of evidence for Aimovig.”

Aimovig belongs to a new class of medication – known as fully human monoclonal antibodies -- that target and block receptors in the brain where migraines are thought to originate. It is designed to be administered once a month with a self-injection device for migraine prevention.

"The results add to the consistent body of evidence for erenumab (Aimovig) across the full spectrum of migraine patients, from those trying preventive medication for the first time through to those who have failed multiple therapies and have been suffering for years,” said Danny Bar-Zohar, Global Head of Neuroscience Development for Novartis.

“We look forward to making erenumab, the first targeted preventive option specifically designed for migraine, available to patients as soon as possible."

Amgen and Novartis expect the Food and Drug Administration to make a decision on Aimovig in May. The two companies will share sales rights to Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize it in Europe and the rest of world.

Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

About half of people living with migraine are undiagnosed. Current medications to prevent migraines have been repurposed from other medical conditions, and are often associated with poor results.