Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Multiple Sclerosis

Treatment: Vumerity

The insurer denied coverage for Vumerity

The denial is overturned

This is a patient with a diagnosis of multiple sclerosis.  

There was a letter from the insurance which was the final adverse determination for denial of coverage of Vumerity. It stated that the plan only covers this medication when the patient meets one of these criteria: A) The patient tried other drugs that the plan covers and they did not work well for the patient, or B) The doctor gives a medical reason why the patient cannot take the other drugs. The preferred alternatives are Aubagio, Betaseron, Copaxone, dimethyl fumarate, fingolimod, glatiramer, Glatopa, and Tysabri. The patient may need to try three preferred drugs including dimethyl fumarate.

In response, there was a letter by the patient's treating physician to appeal the denial of Vumerity. The provider noted that the patient's diagnosis was relapsing remitting multiple sclerosis. It was noted that the patient had intolerance to Dimethyl fumarate.

The formulary drug(s) are likely to cause the patient an adverse reaction. The patient had side effects from Dimethyl fumarate. Further, it is noted the patient is of childbearing age. Aubagio and Fingolimod are not good options as the patient is contemplating pregnancy.

"Multiple sclerosis (MS) is an autoimmune-mediated neurodegenerative disease of the central nervous system characterized by inflammatory demyelination with axonal transection. MS affects an estimated 900 000 people in the United States. MS typically presents in young adults (mean age of onset, 20-30 years) and can lead to physical disability, cognitive impairment, and decreased quality of life" (McGinley et al., 2021).

"Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS). MS affects 2.1 million individuals every year and is also considered a major cause of economic health burden around the world. Genetics and environmental factors both play a role in the pathogenesis of MS by activating the immune response and causing inflammation. Patients with MS can have various clinical courses, but the most common pattern seen is relapsing-remitting multiple sclerosis (RRMS). Newer treatment options that have been recently approved to control MS symptoms and suppress the inflammation are glatiramer acetate and siponimod. Infusion therapies consisting of monoclonal antibodies and immunosuppressive drugs have also been studied in the recent past. Some trials have been conducted on the use of stem cells for RRMS patients" (Saleem et al., 2019).      

The formulary drug(s) are ineffective based on the patient's clinical history. The patient had side effects from Dimethyl fumarate. Vumerity (diroximel fumarate) was shown to have less gastrointestinal (GI) side effects compared to Dimethyl fumarate (Tecfidera). Further, Copaxone, glatiramer, Glatopa, and Betaseron are low efficacy medications compared to the requested Vumerity.     

The requested medication is more effective than the formulary drugs. Copaxone, glatiramer, Glatopa, and Betaseron are low efficacy medications compared to the requested Vumerity. Aubagio and Fingolimod are not good options as the patient is contemplating pregnancy. The provider noted that the patient failed dimethyl fumarate due to side effects. Vumerity (diroximel fumarate) was shown to have less gastrointestinal (GI) side effects compared to Dimethyl fumarate (Tecfidera). Therefore, Vumerity would be more effective for this patient than the formulary drug. 

The formulary drugs are expected to cause adverse effects. 

The formulary drugs were not tried, and the patient did not have an adverse reaction or contraindication.

The formulary drug is expected to be ineffective.

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 Vumerity to treat Multiple Sclerosis is reversed.