Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Chronic migraines
Treatment: Qulipta
The insurer denied coverage for Qulipta.
The denial is overturned.

The patient has a diagnosis of chronic migraines. The request is for Qulipta, which is under review.  The patient was seen by their provider for obstructive sleep apnea. The patient was then seen by another provider for chronic migraine. In multiple visits, the provider noted that the patient continued to have 5-7 or 6-10 days of intense headaches per month and the patient continued to have mild headaches on a daily basis.  The patient was on the combination of Ajovy and Botox.  The patient's medication list included amitriptyline, Depakote, escitalopram, and lisinopril. The provider noted that the plan was to try Qulipta instead of Ajovy. The provider noted that the patient was given samples of Qulipta to try. 

The formulary drug(s) would likely cause the patient an adverse effect.  The patient is already on blood pressure medication (lisinopril), antidepressant (amitriptyline and escitalopram), and a seizure medication (Depkaote). Another antidepressant can put the patient at the risk of serotonin syndrome. Another blood pressure medication would put the patient at risk of hypotension. Combining seizure medications can affect mood and cognitive function.

It is not appropriate to try another medication from the formulary list as explained. The provider wanted to switch from Ajovy to Qulipta, which is appropriate and medically necessary.      

"Both the Eight Joint National Commission (JNC8) and American Heart Association/American College of Cardiology (AHA/ACC) guidelines recommend avoiding the combination of the two renin-angiotensin system blockers, angiotensin-converting enzyme inhibitor (ACEI), and angiotensin-receptor blocker (ARB), based on studies such as ONTARGET that showed worse cardiovascular and renal outcomes with this combination. Using evidence from prior studies including a large meta-analysis of patients treated with multiple drug classes, the AHA/ACC guideline specifically recommends combining drugs with complementary activity to achieve greater blood pressure (BP)-lowering effect" (2). 

Serotonin syndrome (SS) is a drug induced, potentially fatal, clinical syndrome resulting from drugs that have serotonergic properties. Several antiepileptic drugs (AEDs) are known to have serotonergic properties and it can be hypothesized that such AEDs can cause SS (Serotonin syndrome). This study aims to review the literature on SS (Serotonin syndrome) in patients receiving AEDs (antiepileptic drugs). We performed a systematic review of Scopus and MEDLINE/PUBMED for case reports and case series of SS (Serotonin syndrome) where patients had received at least one AED (antiepileptic drugs) at the onset of symptoms. The cases published in the English literature were included. Initial search identified 1263 articles of which 63 (76 patients) were included in the final analysis. Most of the included cases (53 cases, 70% (percent)) have been published in the last 10 years. The mean age of the 76 patients was 40.6  17.8 years, and 51% (percent) of cases were females. These patients had been exposed to a total of 8 different types of AEDs (antiepileptic drugs). Valproic acid was the most common drug (29, 38% (percent), followed by lamotrigine (22, 29% (percent)), gabapentin (16, 21%(percent)), pregabalin (seven, 9% (percent)), topiramate (five, 7% (percent)) and carbamazepine (two, 3% (percent))" (3).

"Oral atogepant once daily was effective in reducing the number of migraine days and headache days over a period of 12 weeks" (1).

The formulary drugs are expected to cause adverse effects.
 
The formulary drugs were not all tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is expected to be ineffective.

The non formulary drug is expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Qulipta to treat migraine is reversed.