Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Migraine Headaches

Treatment: Qulipta 60 milligram (mg) Tablet

The insurer denied coverage for Qulipta 60 milligram (mg) Tablet

The denial is overturned.
 

This case involves an adult female with a request for Formulary Exception for Qulipta 60 milligram (mg) tablet for chronic migraine prevention. 

It was noted that the patient has a documented phobia of needles meaning that Aimovig, Ajovy, and Emgality are not the best options as she will not be able to self-inject or allow her family to give her injections. She was on Topamax without relief. She was on Ubrelvy. She currently takes Lexapro and Klonopin for her anxiety and depression. There are interactions between Klonopin, Depakote, and Lamictal. According to the doctor, there is a risk of serotonin syndrome with venlafaxine and amitriptyline to Lexapro. The patient is currently taking Propranolol for her tachycardia, and it is unsafe to consider taking timolol for migraines. The doctor added that it would be beneficial to the patient to continue Qulipta since it has worked well for her for so long. 

Food and Drug Administration states that QULIPTA is a calcitonin gene-related peptide receptor antagonist indicated for the preventive treatment of episodic migraine in adults. The recommended dosage is 10 mg, 30 mg, or 60 mg taken orally once daily with or without food.

In this case, the patient was prescribed Qulipta 60 mg tablet for the prevention of chronic migraine. The request was not authorized due to no record of patient's serious side effect or drug failure with all formulary medications within drug class such as: Aimovig, Ajovy, Emgality, Propranolol, Timolol, Topiramate, Valproic acid, Amitriptyline, Venlafaxine, and Lamotrigine. 

In a cited article titled "Antiepileptic drugs and serotonin syndrome (SS)- A systematic review of case series and case reports", "Several antiepileptic drugs (AEDs) including valproic acid (VPA), lamotrigine (LTG), phenytoin (PHT), carbamazepine (CBZ), oxcarbazepine (OXCBZ), and zonisamide have serotonergic properties [4]. There is growing evidence that serotonin is involved in the pathogenesis of seizures. In general, serotonin prevents seizures, and a decrease in serotonin has opposite effects [5]. Selective serotonin reuptake inhibitors (SSRIs) and certain antidepressants are reported to reduce seizure frequency. A few AEDs increase extracellular serotonin, and it is believed that elevated serotonin helps in control seizures [4]. Therefore, AEDs with serotonergic properties can potentially cause SS."

The medical records provided for review do support the service being requested. The patient has maintained positive response to the medication Qulipta for a long period, according to the medical records. The patient is unable to try the following Formulary Drugs: Aimovig, Ajovy, and Emgality due to phobia of needles; Topamax without relief, risk of serotonin syndrome with venlafaxine and amitriptyline to Lexapro; and unsafe to consider timolol for migraines. Although it is reasonable to suggest Formulary Drugs to be used as the first line of treatment for the prevention of migraines, the risk of serious side effect or drug failure is present to this patient. In addition, needle fear is a common barrier to initiating or adhering to medical treatments. Without such treatment, this patient will most likely suffer from episodic migraine attacks, a reduced quality of life, an increased burden of illness, and decreased functioning and activities of daily living. Thus, continuation of the treatment is the most appropriate and safest option for the patient.

1) The formulary drugs are expected to cause adverse effects.

2) The formulary drugs were tried or would cause an adverse effect.

3) The formulary drugs are expected to be ineffective.

4) 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 60 mg Tablet  is overturned.