Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Migraine
Treatment: Qulipta 60 mg (milligrams) or (oral) tabs
The insurer denied coverage for Qulipta 60 mg or tabs
The denial is upheld.

This case involves an adult patient with a history of migraines and obesity. In message notes, it was stated that the patient previously utilized Imitrex without benefit, Maxalt without benefit, Fioricet without benefit, Topamax which caused changes of taste of food and dizziness, and Ubrelvy which was not covered by insurance. There was a plan to initiate Eletriptan for abortive therapy.

The patient was having 10-12 migraines per month at that time. Topamax had been tapered off and replaced with amitriptyline for prevention. Ubrelvy continued for abortive therapy. The patient's migraines were down to 5-6 migraines per month. However, the patient had gained 7 pounds since starting amitriptyline. The patient was on 20 milligrams (mg) nightly. The provider recommended stopping amitriptyline and starting Qulipta for prophylaxis.

The patient had been on amitriptyline 20mg nightly and was not interested in increasing the dose as the medication was causing significant weight gain. Amitriptyline had been discontinued and the patient was started on Qulipta 60mg daily for prophylaxis. The patient continued with Ubrelvy for abortive therapy. The patient reported that they had been unable to receive Qulipta as their insurance preferred that the patient trial monthly injectable medication first. As a result of the denial, the patient's headaches had increased to daily. Outpatient medications included Tylenol, Amitriptyline, Atogepant, Vitamin D3, Flexeril, Flonase, Atarax, Claritin, Mobic, and Ubrogepant. The patient's review of systems was positive for fatigue, visual disturbance, nausea, and headaches. The exam findings of the patient noted that the patient was alert and oriented to person, place, and time. The patient's speech was normal. The patient had 5 out of 5 strength in the bilateral upper and lower extremities. The patient's sensation was normal in the upper and lower extremities. Prior magnetic resonance imaging of the brain had been unremarkable. The provider noted that Qulipta samples had worked very well for the patient. Prior medications included Amitriptyline and Topamax. There was a plan to initiate Emgality injections every 28 days for migraine prophylaxis as this was on the list of recommended/preferred medications. The patient was given samples of the medication.

The Food and Drug Administration states that Qulipta is recommended for episodic migraines in adults. The recommended dosage is 10mg, 30mg, or 60mg taken orally once daily with or without food. In this case, the patient was being treated for migraines. Prior treatments included Maxalt, Imitrex, Fioricet, Topamax, Ubrelvy, and Amitriptyline. Amitriptyline had caused weight gain and the provider recommended switching to Qulipta. The Food and Drug Administration recommends Qulipta for the patient's clinical presentation and prevention of episodic migraines. However, it is noted that Emgality, which is also a calcitonin-gene related peptide antagonist, was on the patient's formulary. The documentation did not offer a contraindication, trial and failure, or other rationale that indicated that the Qulipta would be safer or more effective for the patient than the formulary alternative. In addition, the most recent clinical note submitted for review indicated that the patient was going to trial Emgality, which was a formulary preferred medication. The patient was also given samples of medication at that time. The results of the newly prescribed medication should be evaluated for efficacy prior to consideration for another switch of medication. 

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. 

The medical necessity for Qulipta 60 mg or tabs is not substantiated.