Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Migraine headache.
Treatment:  Qulipta 10 mg (milligram) tablet.

The insurer denied coverage for Qulipta 10 mg (milligram) tablet.  The denial is upheld.

The patient is an adult with chronic migraines. The request is for Qulipta. 

Per appeal letter the patient has tried and failed topiramate, zonisamide, and propranolol. The patient has needle phobia. Qulipta is the most appropriate treatment option for this patient.

Formulary alternatives are Ajovy and Emgality.

The formulary drug(s) are not likely to cause the patient an adverse reaction.

The patient has a history of chronic migraines. The patient has tried and failed topiramate, zonisamide, and propranolol. In this case, there are effective, safe alternatives (Ajovy and Emgality) that have not been trialed. There are insufficient head-to-head trials showing superiority of Qulipta to Ajovy and Emgality. Current medical literature does not support the use of Qulipta over the available formulary alternatives. 

"Currently, Food and Drug Administration (FDA)-approved drugs acting on the Calcitonin gene-related peptide antibodies (CGRP), or its receptor, are those used in the treatment or prophylaxis of migraine. This group includes monoclonal antibodies (erenumab, eptinezumab, galcanezumab, fremanezumab) against the CGRP receptor and CGRP receptor antagonists (rimegepant and ubrogepant). In addition, Atogepant (Qulipta) and vazegepant are other receptor antagonists undergoing clinical trials and are yet to receive FDA approval." (Rashid, A., & Manghi, A. 2021).

"Migraine is highly prevalent and associated with a large socio-economic burden in the United States. Current preventive medications have variable efficacy, and their use is often limited by intolerable side effects. Calcitonin gene-related peptide (CGRP) has been identified as an integral part of migraine pathophysiology. There are currently seven CGRP antagonists under investigation, all of which are undergoing or have completed phase 3 clinical trials. Three of the investigated CGRP antagonists are approved for use within and outside of the United States. The trials have resulted in positive efficacy and safety data. The purpose of this review is to evaluate the seven CGRP antagonists and their future place in therapy." (Henson, et al., 2020).

Per Sprenger, et al., (2018), "Although the different compounds used for migraine prevention clearly act at different receptor sites or channels, it has been suggested that they may modulate common pathways or mechanisms implicated in migraine pathogenesis. For example, several migraine preventives such as propranolol, topiramate, valproate, amitriptyline [11], and flunarizine [12], but also CGRP antagonists [13] have been shown to suppress Cortical spreading depression (CSD). Other compounds have been suggested to reduce neuronal sensitization [14, 15]. Moreover, some of the available migraine preventives may reduce levels of circulating neuropeptides such as CGRP [16] and of "hyperalgesic" cytokines such as tumor necrosis factor , interleukin 1, and interleukin 6 [17], although it remains unclear whether such effects directly relate to the medication or indirectly relate to the reduction of attacks".      

Formulary drug(s) have not been ineffective based on the patient's clinical history.

The requested drug is not more effective than the formulary drug.  The formulary drugs are not expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is not expected to be ineffective.

The non- formulary drug is not expected to be more effective than the formulary alternatives.

The carrier's denial of a request for a Formulary Exception for Qulipta 10 mg (milligram) tablet for use in the treatment of chronic migraine w/o (without) aura, not intractable, w/o status migraine is upheld.