Experts Say CGRP Drugs Are First-Line Therapies for Migraine Prevention

By Pat Anson, PNN Editor

Migraine medications that block calcitonin gene-related peptides (CGRPs) are “equal to or greater” than other migraine prevention drugs and should be considered first-line therapies, according to a new guideline from the American Headache Society (AHS).

It’s the first time the organization has endorsed CGRP inhibitors for migraine prevention, despite their high cost and limited availability due to insurance requirements. Many insurers have step-therapy policies that require patients to start with cheaper first-line treatments before trying other drugs.

"Moving CGRP-targeting therapies to the first line of treatment could have a transformational impact on the prevention of migraine attacks and their associated burdens," Andrew Charles, MD, AHS president and lead author of the guideline recently published in the journal Headache. 

CGRP inhibitors block a protein that binds to nerve receptors in the brain and trigger migraine pain. Since 2018, the FDA has approved over half a dozen CGRP medications for migraine prevention and/or treatment, the biggest innovation in migraine therapy in decades.   

Older drugs that have long been used for migraine prevention were originally developed for other conditions. They include amitriptyline, a tricyclic antidepressant; simvastatin, which is used to control cholesterol; topiramate (Topamax), an antiseizure medication; and beta-blockers commonly used to control blood pressure.  

The AHS says there is growing “real world” experience that CGRP inhibitors work better than the older, repurposed medications.

“The evidence for the efficacy, tolerability, and safety of CGRP-targeting migraine preventive therapies is substantial, and vastly exceeds that for any other preventive treatment approach,” the AHS said. “The data indicates that the efficacy and tolerability of CGRP-targeting therapies are equal to or greater than those of previous first-line therapies and that serious adverse events associated with CGRP-targeting therapies are rare.”

The biggest problem with CGRP inhibitors is their cost, which can reach tens of thousands of dollars a year. Eight doses of Nurtec, a tablet taken daily, cost over $1,000; while the listed price for Emgality is $706 for a self-injectable syringe used monthly. Prices will vary, depending on insurance and whether a patient qualifies for discounts or patient assistance programs.

By comparison, amitriptyline and simvastatin are bargains. A bottle of 30 simvastatin tablets will cost about $14, while amitriptyline costs about $13 for a supply of 28 tablets. A recent study suggests that amitriptyline and simvastatin work just as well as CGRP inhibitors in reducing the need for medications to treat migraine pain, an indication that they are effective at prevention.

Despite the disparity in cost, the AHS maintains the overall benefits of CGRP inhibitors may justify the price. There are substantial hidden costs to migraine attacks, which can result in lost productivity, income, education, and personal relationships.   

“We recognize that the CGRP-targeting preventive therapies are significantly more expensive on a yearly basis than most of the previously established therapies, and some argue that this expense is a primary consideration in clinical decision-making,” the AHS said. “On the other hand, we argue that it is critically important to consider not only the direct cost of the treatment but also the substantial costs to the individual and society if effective treatment is delayed.”

Migraine affects about 39 million people in the United States and 1.1 billion worldwide. In addition to headache pain, migraine can cause nausea, blurriness, and sensitivity to light or sound. Women are three times more likely to suffer from migraines than men.  

FDA Approves Wearable Device for Migraine Prevention

By Pat Anson, PNN Editor

A wearable neuromodulation device has been approved by the Food and Drug Administration as a preventative treatment for migraine. In a recent study, the Nerivio device significantly reduced the number of migraine days per month in patients with episodic and chronic migraine.

Nerivio is worn on the upper arm and controlled by a smartphone app. It uses mild electrical pulses to disrupt pain signals in the brain without the use of drugs. The device has previously received clearance from the FDA as an acute treatment for migraine in adults and children over age 12.

"Nerivio already has a well-established efficacy and safety profile in acute migraine treatment," said Andrew Blumenfeld, MD, Director of the Los Angeles Headache Center and co-author of the study published in the journal Headache. "Effective preventive treatment is key to managing migraine, but it is often underutilized.”

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The randomized, placebo-controlled trial involved 248 migraine sufferers who used either Nerivio or a placebo device for 45 minutes every other day. Those who used Nerivio experienced a mean reduction of 4 migraine days per month, compared to a reduction of 1.3 days in the placebo group. Participants also experienced statistically significant reductions in the number of days they required acute migraine medication.

“The trial data demonstrates Nerivio can now cover the full treatment spectrum and provide access to migraine prevention and relief, especially for the adolescent population, who have a strong preference for clinically effective, drug-free treatment solutions. With FDA clearance of the device, its availability and potential use for preventive and acute treatment is welcome news for both physicians and patients," Blumenfeld said in a statement.

Like most new migraine treatments, Nerivio can be expensive, with the wholesale price currently listed at $599 for a 12-treatment unit. Out of pocket costs will be less if the device is covered by insurance or if patients enroll in Nerivio’s Patient Savings Program. A prescription is required.

With Nerivio’s new dual-use indication, patients may use the device more often to proactively prevent migraines. To better support existing and new users, the number of treatments per unit is being expanded from 12 to 18 treatments.

The Nerivio app allows patients to customize their treatment, receive reminders for preventive treatment, track their migraine patterns, and share migraine data with their doctor. The app can also leads users through a Guided Intervention of Education and Relaxation, using techniques such as diaphragmatic breathing, muscle relaxation and guided imagery.

Nerivio is made by Theranica, a medical technology company based in Israel, which estimates the device has over 40,000 users in the United States. The company is investigating whether the device may help treat other chronic pain conditions besides migraine.