Migraine disease exists on a spectrum, presenting patients with different frequencies of attacks, whose duration and effect vary from person to person. Treating migraine disease is, therefore, an exercise in mixing and matching, trial and error. A medley of therapies, both on-label and off-label, exist for migraine disease and headache disorders. Patients work with their health care providers to find the right combination – at the right doses, in the right order – to address the disease.
But new health plan barriers make this individualized treatment approach less feasible.
Ironically, combination therapy, as it’s called, has been a mainstay of headache treatment for decades. Patients may use a preventive mediation to ward off attacks and then a pain medication when an attack occurs. Or perhaps they use a pain medication along with an anti-nausea drug to handle the ancillary symptoms of a migraine attack. Combination therapy is also common for other disease states, including cancer and cardiovascular disease.
With the advent of new treatment options, new combinations have proven useful for people with migraine disease. In particular, some patients and their health care providers have found success combining two innovative injectable medicines – botulinum neurotoxins and CGRP inhibitors. But the relief may be short lived.
Insurers have begun limiting coverage for this combination. As conversation at the inaugural meeting of AfPA’s Headache and Migraine Working Group recently revealed, some national insurers demand that providers justify in detail why their patients need the two treatments. Working group members, which include neurologists, nurse practitioners, headache specialists and other clinicians, explained that, even with the requested information, health plans frequently deny coverage.
In other cases, insurers use clinical trials data to justify coverage denials. Insurers may argue that, because the clinical trial for a CGRP inhibitor didn’t include patients who were currently taking the second medicine, the combination cannot be approved for real-world use. The approach misapplies clinical trials criteria while ignoring the reality that some people with migraine need combination therapy.
In the most egregious example described by the clinicians at AfPA’s meeting, some large, national health plans routinely reject botulinum neurotoxin prescriptions if a patient’s files show that he or she has received a free sample of a CGRP inhibitor. Even when medical records suggests the two are more effective when taken concurrently, decreasing the number of headache days. Even when the insurer is not bearing the cost of the CGRP inhibitor provided as a free sample. Here again, some insurers argue that the combination is “experimental” because patients included in the clinical trials were not actively taking both medications.
In the world of migraine disease, variability is the true constant. The disease is experienced differently by each patient. Treatment must likewise be individualized. But without the ability to find and access the best combination of therapies, people living with migraine will find themselves unable to treat their disease – even as new, life-changing treatment options continue to become available.