According to The World Health Organization, migraine headaches are one of the 10 most disabling medical issues on the planet. In a given year, migraines cost the United States more than $20 billion, attributed to direct (medication, doctor visits) and indirect (loss of work and productivity) medical costs1.
A migraine headache is a common type of headache of varying intensity, that can cause throbbing or pulsing in a specified area of the head. Migraine headaches are commonly accompanied by other symptoms such as nausea, vomiting, and sensitivity to light and sound. Migraines can cause significant pain for hours or days, ranging from 4–72 hours, and affect about 12% of the U.S. population, more prevalently found in women than men2.
Over the next 24 months, the migraine medication landscape will be expanding into a new class of migraine medication: anti-CGRP (calcitonin gene-related peptide) peptides. CGRP is a substance (peptide) that has been shown to play a part in the painful phase of a migraine and may also be involved in the origin of the headache itself. Anti-CGRP peptides block the receptors for CGRP in various locations of the brain, therefore decreasing stimulation, preventing either the painful phase or migraine itself.
There are currently 3 medications included in the anti-CGRP pipeline that are in the final stages of FDA approval. So far, all have demonstrated similar safety and efficacy and are administered by either subcutaneous or intravenous methods.
Erenumab (Aimovig) is currently in development for the prevention of individuals experiencing greater than or equal to 4 migraines a month. Erenumab requires injection, which may not be the preferred route of administration by most patients.
Erenumab is slated for a decision regarding full FDA-approval by late May 2018.
Fremanezumab, like erenumab, represents a new class of medication in the prevention of migraine headaches. This drug may offer a beneficial option for treatment-resistant patients and is being studied for once quarterly administration.
Fremanezumab is in the development phase, with an FDA decision regarding the approval slated for the middle-end of 2018.
Galcanezumab is the third medication that is currently in the pending stage and slated for approval in late 2018.
The following medications are in Phase III clinical trials with an approval date to be determined:
ProAct will be watching this category of medications very closely as they have the potential to add significant costs to our clients’ prescription drug plan. When these medications do become available, ProAct’s plan will be to manage them through edits such as dose and/or quantity restrictions, prior authorization requirements, and documented failure(s) to other currently available options. This will help ensure the most cost-effective therapy is being used to treat the member’s condition.
-ProAct Clinical Team