Tysabri denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A 32-year-old female patient with a diagnosis of multiple sclerosis has requested authorization and coverage for Tysabri. The records document that this patient presents with a history of multiple sclerosis. The patient’s provider has recommended treatment with natalizumab (Tysabri). As noted in the medical literature, multiple sclerosis is a chronic autoimmune and neurodegenerative disease of the central nervous system. The U.S. Food and Drug Administration (FDA) has approved Tysabri for the treatment of patients with multiple sclerosis. One study noted that the evidence for clinical benefits of early treatment with disease-modifying therapies suggests that early use of high-efficacy therapies in patients with multiple sclerosis is emerging.

Findings: The physician reviewer found that The patient has requested authorization and coverage for Tysabri infusion administered at 300 mg every four weeks. Multiple sclerosis is an immune-mediated inflammatory demyelinating disease of the central nervous system that is associated with various disabilities. The patient’s provider has recommended treatment with Tysabri. The U.S. Food and Drug Administration (FDA) has approved Tysabri for the management of patients with multiple sclerosis. Tysabri is a disease-modifying therapy that reduces the relapse rate for patients with multiple sclerosis. Systematic review trials have shown Tysabri to significantly reduce relapse risk as well as progression risk. One study found that their 10-year interim analysis further supports the robust real-world effectiveness and well-established safety profile of Tysabri.

Where the denial was upheld

A 41-year-old female enrollee has requested Tysabri injections for treatment of her multiple sclerosis. Findings: The physician reviewer found that although the patient has a diagnosis of multiple sclerosis, the submitted records do not include confirmatory evidence to support the diagnosis. Based upon the information submitted, the patient is not currently assessed with a relapsing form of multiple sclerosis. The patient’s neurologist ordered several tests, the results of which have not been provided. Before it can be determined if a change in therapy is indicated, the diagnosis of multiple sclerosis must be confirmed, neuromyelitis optica should be ruled out and documentation of recent relapse should be provided. In the absence of such evidence, Tysabri is not medically necessary for treatment of the patient’s medical condition.

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 Tysabri, then check the rights and deadlines that apply to your plan.