Tecfidera denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with relapsing-remitting multiple sclerosis. The records noted that recent magnetic resonance imaging (MRI) demonstrated multiple subcortical and periventricular white matter lesions and a single tiny enhancing lesion in the right cerebellar white matter, radiologically suspicious for multiple sclerosis. The MRI was initially done because of symptoms of hearing loss and intermittent tinnitus. The provider noted that a lumbar puncture confirmed findings consistent with multiple sclerosis with 12 oligoclonal bands in the cerebrospinal fluid. The patient reported right hand/forearm numbness and tingling that began two to three years prior. The provider noted that the patient was John Cunningham (JC) virus antibody negative.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Tecfidera 240 mg twice daily. Tecfidera (dimethyl fumarate) is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) at a starting dose of 120 mg twice daily for one week, followed by maintenance dosage of 240 mg twice daily. The American Academy of Neurology practice guideline recommendations for disease-modifying therapies (DMTs) for adults with MS include respecting and evaluating patient preferences to improve acceptance of and adherence to DMT. Patient preferences may include the safety, route of administration, lifestyle, efficacy, common adverse effects, and tolerability in the choice of DMT.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Tecfidera. Multiple sclerosis is a progressive immune disease affecting the central nervous system, causing neurological dysfunction. It is considered to be one of the most common neurological immunologic diseases. Multifocal inflammation of the central nervous system characterizes the disease and causes impaired nerve conduction, which is what causes the many different symptoms of multiple sclerosis. Multiple sclerosis is not a curable pathology. However, there are several therapies that can manage the disease. The formulary alternatives Copaxone, Extavia, and Gilenya have all been shown to be effective. Additionally, there is limited evidence of head-to-head comparisons indicating superiority of Tecfidera compared to the formulary options.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Tecfidera for treatment of the enrollee’s relapsing remitting multiple sclerosis (RRMS). Findings: The physician reviewer found that the review of the submitted documentation and relevant literature fails to demonstrate the medical necessity of the requested medication. There is a lack of evidence demonstrating that Tecfidera is more effective than the Health Plan’s available formulary agents. Two of the three Health Plan formulary agents are injectable, and the other is an intravenous therapy. In this case, the patient presents with relapsing remitting MS with active disease as evidenced by increased activity on MRI. Thus, changing to another MS disease-modifying agent is indicated.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Tecfidera, then check the rights and deadlines that apply to your plan.