Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Multiple sclerosis

Treatment: Kesimpta

The insurer denied coverage for Kesimpta

The denial is upheld

The patient was seen by his neurologist for follow up regarding multiple sclerosis (MS). The patient was diagnosed with MS at age 30. He stopped Tecfidera and Vumerity due to side effects. The patient had no side effects on the brand Tecfidera and was interested in restarting that. He noted that the plan was to give Tecfidera, brand name, and if that was not available to consider Kesimpta. 

The insurer denied coverage of Kesimpta. 

The Neurologist submitted an appeal letter in response to the denial of coverage of Kesimpta. He noted that the patient has a highly active and/or aggressive form of MS and needed to be on high efficacy drugs. He noted that the patient failed Tecfidera, dimethyl fumarate, and Vumerity.    

Kesimpta is not considered medically necessary for this patient. The patient has a diagnosis of MS and was diagnosed at age 30. The patient had stopped Tecfidera and Vumerity due to side effects. It was noted that the patient did not have any side effects with brand name Tecfidera and was interested in restarting that. The plan was to give Tecfidera and if that was not available Kesimpta would be considered. The treating provider notes that the patient has a highly active and/or aggressive form of multiple sclerosis and needed to be on high efficacy drugs. He noted that the patient failed Tecfidera, dimethyl fumarate, and Vumerity. The patient has not tried and failed other medications on the plan's formulary alternatives list, such as Gilenya, which can also be considered.

Therefore, the request for Kesimpta is not considered medically necessary at this time.

"Fingolimod (FTY720, Gilenya) was the first Food and Drug Administration approved oral therapy for relapsing forms of MS. Fingolimod's direct central nervous system (CNS) activities likely contribute to its efficacy in MS, with particular relevance to treating progressive disease stages and forms that involve neurodegeneration. The evolving understanding of fingolimod's mechanism of action (MOA) has provided strategies for developing next-generation compounds with superior attributes, suggesting new ways to target sphingosine 1-phosphate (S1P) as well as other lysophospholipid (LP) receptor modulators for novel therapeutics in the CNS and other organ systems." (Chun, J., et al. 2019)

"Fingolimod (fin gol' i mod) is an immunomodulatory agent that is believed to act by its interaction and binding to S1P receptors. Fingolimod was approved for use in relapsing multiple sclerosis in the United States in 2010 and was the first oral, disease modifying agent approved in this condition. Fingolimod is available in capsules of 0.25 and 0.5 milligrams (mg) under the brand name Gilenya. The recommended dose in adults is 0.5 mg orally once daily." (LiverTox, 2021)

"GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability." (Gilenya Package Insert)

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient. There are medications on the preferred list that can be considered in this patient's case, such as Gilenya.   

The insurer's denial of coverage for Kesimpta is upheld.