Appeal type: Step Therapy
Decision: Overturned

Diagnosis: Migraines. 
Treatment: Emgality 120mg/mL (milligrams per milliliter) SC (subcutaneous) SOAJ (solution prefilled autoinjector). 
The insurer denied coverage for Emgality 120 mg/ml SC SOAJ. 
The denial is overturned. 
 
This case involves a patient with a history of migraine headache, cardiac arrhythmia, Long Haul COVID (coronavirus disease) syndrome, bipolar disorder, neuroendocrine carcinoma, irritable bowel syndrome (IBS) and rheumatoid arthritis who is being recommended for the use of Emgality.  

The patient appealed the denial stating that propranolol, metoprolol, Talal, nadolol, and atenolol are all beta-blockers. She has failed propranolol, which she was placed on to treat cardiac arrhythmias caused by long-haul COVID syndrome.  She ultimately was taken off the propranolol by her cardiologist due to her blood pressure "bottoming out". She is currently on Bystolic for rate and rhythm control given that she is considered baseline hypotensive. She is stable on her medication at this time and adding another beta-blocker could result in a cardiac medical emergency. The remaining medications listed in the step therapy criteria are divalproex, amitriptyline, and venlafaxine. The patient claimed to have a documented history of bipolar disorder, which has been stable for over a few years. Taking any of the preferred medications could result in having a psychiatric medical emergency and could result in hospitalization. The patient went on to state that she has an extensive medical history, including neuroendocrine carcinoma, gluten sensitivity, irritable bowel syndrome, partial bowel obstruction due to intussusception, Raynaud's and rheumatoid arthritis. Her rheumatoid arthritis treatment is oral methotrexate and folic acid. Due to these medications, in addition to her other additional medications, adding another oral medication would be contraindicated due to inaccuracy of the ability for absorption. She had been on Emgality in the past with great success, but due to circumstances which caused a lapse in medical coverage and a change in insurance, she was unfortunately unable to afford the medication and came off Emgality. This is a request for reconsideration regarding the use of Emgality. 

According to the patient's history, the insurer's approved medications are likely to cause an adverse reaction to the patient. 

The insurer's required medications (Propranolol, Metoprolol, Timolol, Nadolol, Atenolol, Divalproex Delayed-Release or Extended-Release tablet, Amitriptyline, Venlafaxine or Venlafaxine Extended-Release) are expected to be ineffective based on the patient's known clinical history, conditions, and prescription drug regimen. 

The records state that the patient has tried propranolol to treat cardiac arrhythmias caused by long-haul COVID syndrome. She was ultimately taken off the propranolol by her cardiologist due to her blood pressure bottoming out. 

The patient is stable on her current prescription drug selected by her healthcare professional for her medical condition. 

It can be said that the insurers required prescription drugs (Propranolol, Metoprolol, Timolol, Nadolol, Atenolol, Divalproex Delayed-Release or Extended-Release tablet, Amitriptyline, Venlafaxine or Venlafaxine Extended-Release) are not in the patient's best interest because it would likely worsen a comorbid condition. 

The Food and Drug Administration states that Emgality is indicated in adults for the preventative treatment of migraines and treatment of episodic cluster headache. The documentation provided for the review stated the patient previously used Emgality with success, and due to various circumstances, she was unable to afford the medication and subsequently discontinued the drug. The patient provided information explaining the reason why she is unable to take the other preferred drugs on the formulary. 

In taking this information into consideration, it was determined that the use of Emgality would be reasonable. As such, the denial is reversed as the medical necessity of Emgality is substantiated.