Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic headache after surgery
Treatment: Epitinezumab (Vyepti)
The insurer denied coverage for: Epitinezumab (Vyepti)
The denial is: Overturned
This case involves an adult with a review for the coverage for Epitinezumab (Vyepti) for chronic headache after surgery (procedure code J3032) at Albany Medical Center.

The patient presented for an urgent appointment as the patient experienced the worst headache. The patient also reported that they had 25 migraine days per month. The patient is reported as alert and oriented, with no new focal neurological findings. Emgality 240 milligram (mg) loading dose was initiated.

The patient was seen for a follow-up, the patient reported having headaches nearly daily which is associated with photophobia, phonophobia, and nausea. 

The patient was seen for postural orthostatic tachycardia syndrome, the patient's cardiac issues are well controlled with Ivabradine. The patient gets symptomatic improvement within an hour of taking it. 

The patient had a follow-up and the patient reported that they're doing well in general. Emgality helped with their headache for several weeks. The patient stated that they wanted to stop Emgality and start with Vyepti. 

An appeal letter was submitted for the denial of Vyepti 100 milligram (mg)/milliliter (ml) intravenous (IV), 100 mg to be infused over 30 minutes every 3 months for migraine treatment. The patient is on Celexa for depression which is stable, and a trial of other antidepressants could have a negative effect on their health. The patient reported upwards of 25 migraine days per month. The patient was previously being treated with Emgality, but it is no longer effective. 

The patient reported that they had been experiencing a migraine headache on a daily basis except the first week following Emgality. The patient is stable from a neurological point, the patient also reported that they are photosensitive. 

The Food and Drug Administration indicates VYEPTI for the preventive treatment of migraine in adults. The recommended dosage is 100 milligram (mg) as an intravenous infusion over approximately 30 minutes every 3 months. Some patients may benefit from a dosage of 300 mg. VYEPTI is contraindicated in patients with serious hypersensitivity to Eptinezumab-jjmr or to any of the excipients.

According to Murphy and Hameed, Prophylactic pharmacologic treatment should be used. First-line therapy includes beta-blockers, anticonvulsants, and antidepressants. The most commonly used medications are Propranolol, Topiramate, and Amitriptyline. Botulinum toxin A is a Food and Drug Administration (FDA) approved treatment for chronic migraines and is considered second-line therapy. Monoclonal antibodies that target calcitonin gene-related peptide (CGRP) are the newest development in chronic migraine treatment. Erenumab, Fremanezumab, and Galcanezumab are approved for chronic migraines, which have failed to respond to other treatments.

The medical records received indicate the patient has failed Emgality and the patient is unable to try Botox. With regard to other First-line therapy that includes beta-blockers, anticonvulsants, and antidepressants the following needs to be considered: 1) Topiramate has Central Nervous System (CNS) side effects that could affect her depression/POTs. 2) the patient is already on Celexa - an antidepressant. 3) In addition, the patient has Postural Tachycardia Syndrome (POTS) and on Ivadrabine which slows the heart rate which makes the use of betablockers, calcium antagonists etc. inappropriate. 

As such, given the clinical circumstances, Vyepti (Epitinezumab) is considered medically necessary.

Based on above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Epitinezumab (Vyepti) for chronic headache after surgery (procedure code J3032) at on a date yet to be determined is substantiated.