Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Migraine

Treatment Aimovig

The insurer denied coverage for Aimovig

The denial is overturned

This is the case of a female patient who has been diagnosed with chronic migraine headaches. She had Botox injections which helped but not completely. She began Aimovig and has found that combination therapy has allowed her to have not only a reduction in severity but also frequency of migraine headaches. The combination therapy has allowed the patient to have a better quality of life. She has tried and failed therapies including Topamax, Depakote, Zonisamide, Propranolol, Gabapentin, Cymbalta, Imitrex, Zomig, Fioricet, and trigger point injections. The prescribing provider is recommending approval of combination of Botox and Aimovig. 

Calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) and Botox are effective as preventatives in many studies. While they both work in different ways, they seem to have a similar impact of inhibiting the nociceptive pathways involved in headaches. While CGRP mAbs are thought to inhibit the sensation of pain by antagonizing a major inflammation marker such as CGRP, Botox does it by inhibiting the release of acetylcholine in neuromuscular junctions. Recent studies that tested the efficacy of CGRP mAbs and had a large sample size proved that these drugs were potent preventatives for chronic migraines. Botox was shown to be effective in multiple studies over the past decade. Regarding side effects, both CGRP mAbs and Botox have mild short-time adverse effects; however, one long-term side effect seen in patients who took CGRP mAbs was constipation. The injections for CGRP mAbs are also much more painful compared to the injections of Botox. There is growing body of evidence showing that for some patients who do not achieve adequate control of headache with either CGRP mAbs or Botox alone, may have better efficacy with the 2 therapies combined given that they each target a different nociceptive pathway. 

According to Cohen et al, after being treated with OnabotulinumtoxinA, patients experienced an average decrease of 10.96 monthly headache days, a 43.3% (percent) reduction from baseline [95% confidence interval (CI), 9.2-12.6]. However, they determined that these patients were continuing to experience, on average, 14.34 headache days each month. Patients who were also treated with a CGRP monoclonal antibody medication had an additional decrease of 5.64 headache days each month, or an additional reduction of 22.3% from baseline compared with those taking OnabotulinumtoxinA alone (95% CI, 4.5-6.7). These patients experienced 8.69 headache days each month, Cohen and colleagues found, and experienced a decrease of 16.6 headache days each month, or a 65.6% reduction from baseline (95% CI, 14.3-18.8).

Therefore, based on the above as well as lack of any evidence that the combination of these two therapies causes any significant harm, the risk/benefit analysis suggests that this therapy should be approved in this patient, especially given that she has clinically done well with this therapy regiment. 

The health care plan did not act reasonably and with sound medical judgment and in the best interest of this patient.

The insurer's denial of coverage for Aimovig to treat chronic migraines is overturned. Medical necessity is substantiated.