Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Multiple Sclerosis.

Treatment: Vumerity.

The insurer is denied coverage of a formulary exception for Vumerity.

The denial is overturned. 

This female patient has been diagnosed with multiple sclerosis. Her neurologist noted that the patient was found to have a positive John Cunningham virus (JCV) test. The neurologist also noted that the patient reported horrible diarrhea related to Tecfidera and that she was itchy all over so she had to stop the medication. The plan was to start Vumerity. The neurologist indicated that the other medications on the insurer's formulary are contraindicated due to the prior patient's history of atopic dermatitis and carcinoma in situ of the exocervix.

Upon review of the literature, Naismith, R. T. et al. (2020) concluded: "[Diroximel fumarate (DRF)] demonstrated an improved gastrointestinal tolerability profile compared with DMF, with less severe gastrointestinal events and fewer days of self-assessed gastrointestinal symptoms, fewer gastrointestinal adverse events, and lower discontinuation rates because of gastrointestinal adverse events." 

Palte, M. J. et al. (2019) concluded: "We suggest that the distinct chemical structure of DRF contributes to the observed low rates of GI TEAEs and GI-associated treatment discontinuations, possibly due to a combination of several factors.  We hypothesize that these factors may include less reactivity with off-target proteins and/or lower production of a methanol leaving group that may contribute to GI irritation. A direct comparison of GI tolerability with DRF versus DMF is being evaluated in the EVOLVE-MS-2 study."

Jonasson, E., & Sejbaek, T. (2020) reports: "Diroximel fumarate (DRF) is a new emerging therapy for patients with multiple sclerosis. The levels of its active metabolite, monomethyl fumarate, are bioequivalent to the levels generated from dimethyl fumarate (DMF) treatment. The efficacy and safety profiles of DRF are expected to be similar to the well-established profiles of DMF. The metabolism of DRF leads to lower concentration of methanol in the small intestine than with DMF and thus reduced severity and frequency of gastrointestinal adverse events. DRF seems a promising alternative to DMF and other first-line therapies for multiple sclerosis. The current review is based on the two existing Phase III trials of DRF: the interim analysis of the EVOLVE-MS-1 trial and the completed EVOLVE-MS-2 trial." 

The formulary drug(s) is likely to cause the patient an adverse reaction, as the patient has atopic dermatitis and injectables would be of a concern. She has a history of cancer and strong immunosuppressive medications would be a risk.      

The requested drug would be safer as the patient has multiple sclerosis and that she was on Tecfidera with gastrointestinal side effects and itching skin. The attending provider noted that the other medications on the formulary are contraindicated to the prior history of atopic dermatitis and the carcinoma in situ of the exocervix.

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

The medical necessity is substantiated. The carrier's denial of coverage for Vumerity is overturned.