Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Amyotrophic lateral sclerosis (ALS)

Treatment: Radicava ORS (oral suspension)

The insurer denied coverage for Radicava ORS (oral suspension)

The denial is overturned


The patient is an adult female with a diagnosis of bulbar onset amyotrophic lateral sclerosis (ALS). The patient has bulbar symptoms, speech and saliva issues. The request is for Radicava, which is under medical necessity review.

The amyotrophic lateral sclerosis (ALS) functional rating scale should be not used with bulbar ALS as the effects are different. Radicava ORS (oral suspension) is approved for all patients with ALS. Radicava ORS is considered medically necessary for this patient. The patient has bulbar onset amyotrophic lateral sclerosis (ALS) and is expected to experience symptoms such as loss of useful speech and excess saliva. Radicava ORS is approved for all patients with ALS. An exception should be made due to Bulbar type ALS. 

"Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neuromuscular disease affecting approximately 5 out of every 100,000 individuals living in the United States. ALS is associated with 50% (percent) mortality within 30 months of initial symptom onset. The rarity of the disease, along with the significant inter- and intra-patient variability in clinical course and a lack of reliable biomarkers, have rendered the development of effective agents to treat ALS a challenge. Because oxidative stress is considered a contributing factor to ALS onset and progression, drugs that eliminate free radicals may protect motor neurons from damage potentially caused by free-radical and oxidative stress. Edaravone is an antioxidant free-radical scavenger approved by the FDA (Food and Drug Administration) in 2017 for the treatment of ALS." (Brooks, B. R., et al. 2018). 

"Amyotrophic lateral sclerosis (ALS) is a progressive fatal disorder that affects all skeletal muscles, leading to death, mostly within 2-4 years from onset. To date, the anti-glutamatergic drug riluzole is the only drug that has been approved for the treatment of this disease; however, its efficacy is modest. Oxidative stress is considered to be involved in the pathology of ALS, and in this regard, the free radical scavenger edaravone, which was originally developed for the treatment of acute ischemic stroke, has also been developed for the treatment of ALS. Areas covered: This review describes the pharmacological properties of edaravone and the progress of clinical trials conducted to evaluate the efficacy of this drug in the treatment of ALS. Expert commentary: Edaravone is the first drug to show effective inhibition of the motor function deterioration experienced by ALS patients with early-stage probable and definite types. In order to effectively prolong the quality of motor function, edaravone treatment should be initiated as soon as the diagnosis has been confirmed; however, the respiratory function should be carefully monitored when a deterioration in breathing capacity is detected." (Yoshino H. 2019).



Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for Radicava ORS (oral suspension) is substantiated.