Diagnosis: Relapsing Remitting Multiple Sclerosis.
Treatment: Rituxan.

The insurer denied the Rituxan. The determination is upheld.

The patient was diagnosed with relapsing remitting multiple sclerosis (RRMS). She has been treated with Rituxan (rituximab). Continued treatment with Rituxan is the issue of this review. The health plan denied the therapy because the patient had not tried and failed the generic biosimilars of Truxima and Ruxience.

At issue is whether the Rituxan is medically necessary for this patient.

The Rituxan is not medically necessary. The patient has relapsing remitting multiple sclerosis. She is prescribed Rituxan (rituximab). The drug is off-label for the treatment of RRMS.

In a preliminary randomized trial of 104 adult patients with RRMS, treatment with intravenous (IV) rituximab (1000 milligrams (mg)) given on days 1 and 15 reduced reduction in both total and new gadolinium-enhancing lesions on brain magnetic resonance imaging (MRI) at 24 weeks when compared with placebo. In addition, rituximab treatment reduced the proportion of patients who had a clinical relapse by week 24. Further randomized trials would be needed to establish the long-term effectiveness and safety of rituximab for RRMS, but these trials are unlikely.

In an observational study of 256 patients with stable RRMS who switched to rituximab or fingolimod after stopping natalizumab due to John Cunningham virus (JCV) antibody positivity, the rituximab group had lower rates of clinical relapse, adverse events, and treatment discontinuation compared with the fingolimod group. In another observational study of 494 patients diagnosed with RRMS identified from a Swedish MS registry, rituximab treatment was associated with a lower discontinuation rate compared with other disease modifying therapies, including interferons, glatiramer acetate, dimethyl fumarate, fingolimod, and natalizumab. In addition, rituximab treatment was associated with a lower rate of clinical relapses and MRI measures of disease activity compared with interferons, glatiramer acetate, and dimethyl fumarate. However, the same investigators published a registry-based cohort study of over 6400 patients with RRMS from Sweden that examined the risk of infection associated with exposure to rituximab, natalizumab, fingolimod, interferon beta, and glatiramer acetate. Among these, treatment with rituximab was associated with the highest rate of serious infections.

The plan offers two generic formulations of rituximab: Truxima and Ruxience. The patient has not tried or failed either of these options. She does not have a contraindication to these options. The products are biosimilar and have the same mechanism of action as compared to the brand drug Rituxan. There is no medical or scientific reason why the brand drug is required for treatment of relapsing remitting multiple sclerosis, especially given that the use is off-label.

Therefore, the Rituxan is not medically necessary.