Appeal type: Formulary Exception
Decision: Overturned

Diagnosis: Relapsing Multiple Sclerosis.
Treatment: Mavenclad 10 mg (milligrams) (8) Pak.
The insurer denied coverage for Mavenclad 10 mg (8) Pak.
The denial is overturned.

This case involves an adult female diagnosed with relapsing multiple sclerosis, who was being recommended Mavenclad 10 mg (8) Pak.  The treating physician responded stating that the patient was diagnosed with multiple sclerosis and subsequently started on Copaxone. When the current physician took over care, the patient was switched to Aubagio 40 mg oral daily because of breakthrough disease while on Copaxone.  Over the past years, the patient experienced breakthrough disease on Aubagio and required use of a walker for support due to weakness of the legs and balance problems. Because of disease progression, the physician felt the patient needed to be switched to another, more potent, disease modifying agent. The physician went on to state that the patient was positive for Polyomavirus (JCV) antibody making Tysabri an invalid option for treatment. This was due to the increased risk for progressive multifocal leukoencephalopathy (PML), a known serious and frequently fatal complication. 

Mavenclad (Cladribine) was selected for its beneficial effect on the relapse rate, magnetic resonance imaging (MRI) parameters, and disability progression shown in the clinical trials.  PML cases have not been reported in patients treated with medical lead.  Studies during the COVID-19 (2019 novel coronavirus disease) pandemic provided information on the relative safety of this immunosuppressive medication in patients who are infected with COVID-19 virus. It is believed to be due to the more selective effect on different lymphocytic subsets.

The Food and Drug Administration states that Mavenclad is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing remitting disease and active secondary progressive disease, in adults. Because of the safety profile, use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, and alternate drug indicated for the treatment of MS. The treating physician provided sufficient information to rule out use of Aubagio, Copaxone, Tysabri, Betaseron, Rebif, Gilenya, Tysabri, Mayzent, and Vumerity.  Medical literature notes that Mavenclad is an effective and safe treatment for relapsing forms of MS. In taking the information provided by the treating physician into consideration, it was determined that the patient was a suitable candidate for use of Mavenclad, given that formulary drugs are likely to cause the patient an adverse reaction. At least 2 of the formulary drugs have been ineffective based on the patient's clinical history with breakthrough disease while on Aubagio and Copaxone.  It was felt that the requested drug would be more effective than the formulary drugs, given that Mavenclad is less likely to cause adverse effects while adequately treating the patient's condition.  As such, the request for Mavenclad 10 mg (8) Pak is medically necessary.

The formulary drugs are likely to cause the patient an adverse reaction. At least 2 formulary drugs have been ineffective based on the patient's clinical history as noted by breakthrough disease while on Copaxone and Aubagio.

It is likely that the requested drug would be more effective than the formulary drugs, given that Mavenclad is less likely to cause adverse effects while adequately treating the patient's condition.

The carrier's denial of Request for Formulary Exception for Mavenclad 10 mg (8) Pak to treat multiple sclerosis is overturned.