Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Migraine headache. 
Treatment: Ajovy 225 mg (milligram) /1.5 ml (milliliter) injection. 

The insurer denied coverage for Ajovy 225 mg (milligram) /1.5 ml (milliliter) injection.  The denial is overturned. 
 
The patient has been diagnosed with migraines. The patient has tried and failed Cambia, Tylenol, Aleve, aspirin, Fiorinal and Ubrelvy as preventative agents. The patient has tried Botox injections, trigger point injections, topiramate, propranolol, Aimovig injections and Emgality injections for prophylaxis. The patient's current migraine therapy includes Botox injections, Ajovy injections, Amitriptyline and Ubrelvy. The patient has been well managed with Ajovy since a few years ago. The request is for Ajovy 225 mg (milligrams) /1.5 ml (milliliter) injection, which is under review. 

The patient was seen for follow up. The provider noted that the patient reported decrease in her headache frequency. The provider noted that the patient had no benefit from Emgality. The provider noted that the plan was to change to Ajovy. 

The provider noted that the patient reported increase in headache frequency, that the patient was using Aimovig for four months, and that the plan was to stop Aimovig and start Emgality. 

The provider noted that the patient reported decrease in headache frequency and intensity on Botox, and that the patient was given a dose of Aimovig. 

The patient had already tried and failed the formulary alternative, Aimovig. 

The formulary drug, Aimovig has been ineffective based on the patient's clinical history. 

The patient has tried and failed Aimovig, Emgality, Topamax, and Inderal. 

The requested drug would be more effective than the formulary alternative drug, Aimovig. 

The patient has tried and failed Aimovig, and has responded well to and been managed well on Ajovy since a few years ago.  

"AJOVY is a calcitonin gene-related peptide antagonist indicated for the
preventive treatment of migraine in adults. (1)" (Ajovy Package Insert). 

"Fremanezumab (free" ma nez' ue mab) is a recombinant, humanized monoclonal antibody to the calcitonin gene related peptide (CGRP), a neuropeptide which plays an important role in migraine headaches. CGRP is a found throughout the central and peripheral nervous systems and has potent vasodilator and pain-signaling activities. Circulating levels of CGRP are elevated in patients with migraines, and the efficacy of migraine therapies (serotonin receptor agonists, ergot alkaloids) is associated with lowering of CGRP levels. Fremanezumab is a CGRP antagonist which blocks the binding of the neuropeptide to its receptor and the subsequent downstream activation of the intracellular signaling pathways. Fremanezumab was approved for use in the United States in 2018 as a means of prevention of migraine headaches and was one of three CGRP antagonists approved in 2018 for this indication (the others being erenumab and galcanezumab). Fremanezumab in available in solution in single use prefilled syringes of 225 mg under the brand name Ajovy. The recommended dose is 225 mg subcutaneously once monthly or 675 mg every 3 months. Fremanezumab is not effective as therapy of acute migraine, and it lowers the frequency but typically does not abolish all episodes of chronic migraine headaches. Side effects of fremanezumab are uncommon but can include injection site reactions and hypersensitivity reactions" (LiverTox, 2019). 

The formulary drugs are expected to cause adverse effects. 

The formulary drugs were tried, and the patient did have an adverse reaction or contraindication. 

The formulary drug is expected to be ineffective. 

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

The carrier's denial of a request for a Formulary Exception for Ajovy 225 mg (milligrams) /1.5 ml (milliliter) injection is reversed.