Rituximab Gets Nod in ICER MS Report — and It's Not FDA-Approved for MS

Rituximab is cheaper and just as effective as the other monoclonal antibodies used to treat MS, says an ICER report that came out today.

Payers should remove barriers to rituximab prescriptions for multiple sclerosis (MS) even though it has not been approved by the FDA as a treatment for MS, says the Institute for Clinical and Economic Review (ICER). Rituximab is cheaper and just as effective as the other monoclonal antibodies used to treat MS, says an ICER report that came out today.

Citing lack of evidence of difference among the monoclonal antibodies used to treat relapsing-remitting multiple sclerosis (MS), the Institute for Clinical and Economic Review (ICER) said in a report today that payers should remove barriers to access to rituximab, including three biosimilars of the drug.

Rituximab has not approved by the FDA as treatment for MS but is prescribed off-label for the disease and works to damp down inflammation in the way that is similar to monoclonal antibodies that have approved as MS treatments, including Ocrevus (ocrelizumab), Kesimpta (ofatumumab) and recently approved Briumvi (ublituximab).

The report touches on the increasingly controversial topic of formulary placement and rebates: “Payers should not be swayed by rebates for more expensive, branded monoclonal antibodies when tiering (monoclonal antibodies).”

Broader use of rituximab as a treatment for MS could lead to better health outcomes, reduce financial toxicity and narrow health inequities, the report says. ICER suggest that clinical specialty groups such as the American Academy of Neurology change their treatment guidelines to “make clear that off-label rituximab is reasonable first option for treatment” and that include information on efficacy, harm and cost information on rituximab and its biosimilars.

The ICER warns against switching patients to rituximab unilaterally. The report points to a switching program at Kaiser Permanente that was is voluntary and involves extensive coordination and communication with clinicians and patients,

Rituximab is sold in the U.S. under the brand name Rituxan by Genentech and Biogen under a co-marketing agreement. But there are also three biosimilars to Rituxan now on the U.S.

market: Truxima (rituximab-abbs), Riabni (rituximab-arrx) and Ruxience (rituximab-pvvr).

It is now old drug; the initial FDA approval was in 1997. The FDA has approved it as treatment for non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis and two rare condition.

The ICER report mentions the large economic burden of MS: $63 billion in direct medical costs and $22 billion in indirect cost. The costs are partly a reflection of the fact that the MS affects people in their 20s and becomes a lifelong condition. The treatment of MS has changed dramatically over the past two decades, notes the report, to where there are now 20 “disease modifying” treatments that affect the cause of MS, an abnormal immune system response that triggers inflammation that damages the myelin sheath that surrounds nerve fibers in the brain and spinal cord.

The ICER recommendations about encouraging the use of rituximab were in a 13-page policy recommendations report separate from the main, 171-page report delineating ICER’s cost-effectiveness calculation that often gets technical.

ICER’s cost-effectiveness analysis found that prices of the monoclonal antibodies used to treat MS would need to be discounted by between 45% and 84% if the drugs were priced to meet commonly used cost-effectiveness thresholds. The report lumps the monoclonal antibodies together because the ICER analysis found no difference in their clinical benefits.

Using whole sale acquisition price, ICER analysis says that a year of treatment with Briumvi, Ocrevus, Kesimpta and Tysabri (natalizumab) costs between $59,000 and $102,128. Using a cost-effectiveness threshold of between $100,000 and $150,000 per quality-adjusted life year gained, ICER said the prices should be between $16,500 and $32,700.

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