Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Migraines
Treatment: J3032 injection, eptinezumab JJMR, 1 milligram (mg) units: 600 units
The insurer denied coverage for J3032 injection, eptinezumab JJMR, 1 milligram (mg) units: 600 units.
The denial is overturned.

This case involves a female with a history of migraine and associated head pain who was requesting Vyepti treatment that was previously received to treat her condition.  Records indicated the patient had tried other calcitonin gene related peptide blockers including Aimovig, Emgality, and Ajovy without success. Other treatment measures included an amitriptyline and nortriptyline for migraine and a 1-month use of duloxetine. She endorsed fatigue and weight gain with tricyclic's, which also had cognitive effects and also reported use of Nurtec. Records stated the patient last received an infusion of Vyepti with plans for an additional infusion. The patient received a notice of adverse determination regarding Vyepti stating that there was insufficient information to determine if the injection was medically necessary. Information that was not received from the treating provider in a timely manner prompting the denial included that there was no record of the patient using a combination therapy with Aimovig, Ajovy, Emgality, or preventative treatment of migraine with Nurtec ODT (orally disintegrating). There was no documentation that the patient had tried at least one subcutaneous calcitonin gene related peptide inhibitor approved for migraine prophylaxis (such as Aimovig, Ajovy, or Emgality). The patient responded stating that she had tried Aimovig, Emgality, and Ajovy, all without success. Preventatives included Topamax, amitriptyline, nortriptyline, verapamil, propranolol, Flexeril, protriptyline, zonisamide, Cymbalta, indomethacin, nadolol, gabapentin, Aimovig, Emgality, Ajovy, Vyepti, with abortive medications consisting of Relpax, sumatriptan, baclofen, ketorolac injectable, Thorazine suppositories, also gabapentin, Ubrelvy, and Nurtec. Other treatments consisted of Botox injections, greater occipital nerve blocks, frontal nerve blocks, cervical facet blocks, radiofrequency ablation, physical therapy, and Migrelief vitamins.  
The healthcare plan did not act reasonably and with some medical judgment and in the best interest of the patient.

The Food and Drug Administration states that a Vyepti injection is indicated for the preventative treatment of migraines in adults. Recommended dosage is 100 mg as an intravenous infusion over approximately 30 minutes every 3 months.  Some patients may benefit from a dosage of 300 mg. Records confirmed that the patient had tried and failed multiple treatment measures to include prophylactic medications, preventative medications, and other modalities. Given the extent of prior treatment measures without sufficient response to care, it was reasonable to allow the patient to continue using the Vyepti for treatment of her migraines.  As such, the prior determination is overturned.

The insurer's denial of coverage for J3032 injection, eptinezumab JJMR, 1 milligram (mg) units: 600 units is overturned. Medical Necessity is substantiated.