Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Amyotrophic lateral sclerosis
Treatment: Radicava ORS 105 milligram (mg)/5 milliliter (mL) injection
The insurer denied coverage for Radicava ORS 105 mg/5 mL injection.
The denial is overturned.

This case involves a patient diagnosed with amyotrophic lateral sclerosis (ALS) who was being recommended for the use of Radicava ORS 105 mg/5mL injection. When the patient was seen she had known positive SOD1 (superoxide dismutase 1 gene) mutation with symptoms consisting of lower extremity weakness. She had since experienced progressive lower extremity weakness with the development of dysarthria and then dysphagia in the past 8-9 months. She had been in a Biogen Tofersen [SOD1 ASO (antisense oligonucleotide)] trial and was on the open label portion of the trial, receiving an infusion monthly for most 4 years. At the time of her visit, she had strong upper extremities with no issues but had weakness bilaterally in the lower extremities.  She was receiving help with activities of daily living and was using a motorized scooter to get around. The patient has dysarthria but was largely understandable. For dysphagia, the patient was using atropine drops as needed for sialorrhea, particularly at night. She was documented as coughing on thin liquids and had difficulty clearing secretions. Her weight was stable, and she denied shortness of breath, orthopnea, or other breathing issues. She had a hard time coping with new bulbar symptoms, and started to stay positive. There were no changes in her cognition and for treatment of ALS, she was taking Nuedexta, riluzole, and wanted to take Radicava, but had not been approved by insurance. She also signed paperwork to get Relyvrio started. On physical examination, the patient appeared well and was in no apparent distress. She sat comfortably on the exam table and was found to have dysarthria-intelligible with infrequent need for repetition. She had weakness around the mouth bilaterally and was unable to purse her lips. The physician noted that the atropine drops were not helping with secretions and the plan was for the patient to continue the Tofersen trial. They will continue to pursue oral Radicava and Relyvrio. The physician noted that Radicava ORS is in the appeal process and may get declined because of the length of time the patient has had ALS despite Food and Drug Administration (FDA) approving oral Radicava for all ALS (not only for people with ALS early in disease). The physician also noted that Relyvrio has been approved and the product is going out to pharmacies but is not available to patients yet. This review pertains to the Radicava ORS.

Radicava ORS 105 mg/5mL injection is considered medically necessary for this patient.
The Food and Drug Administration states that Radicava and Radicava ORS are indicated for the treatment of amyotrophic lateral sclerosis. Current peer-reviewed medical literature notes that based upon clinical trials, evidence has shown that treatment with intravenous edaravone was associated with prolonged overall survival compared with not using the medication. Evidence has shown that the intravenous formulation of edaravone has been shown to slow the rate of physical functional decline in ALS.  

Given the nature of the disease that has no cure, it is reasonable to allow for the use of Radicava ORS to treat the patient's condition now rather than wait for disease progression.  As such, the request for Radicava ORS 105 mg/5mL injection is medically necessary.

The health plan did not act reasonably, with sound medical judgment or in the best interest of the patient.

The insurer's denial of coverage for the Radicava ORS 105 mg/5mL injection is overturned. Medical necessity is substantiated.