The National Institute for Health and Care Excellence, known as NICE, has decided against recommending that Ocrevus be part of public-funded treatments for adults with primary progressive multiple sclerosis (PPMS).
The National Health Service (NHS) is the subsidized, publicly funded healthcare system for England, with similar structures in other parts of the U.K. A positive NICE opinion obligates the service to offer the therapy at no or low cost.
NICE decisions are based on the results of a cost-effectiveness assessment. According to NICE, Ocrevus (ocrelizumab, developed by Genentech) did not meet its “value for money” criteria as a PPMS treatment in the NHS, although the evaluation committee agreed it is a “step change” for these patients.
Studies have shown that Ocrevus had promising results in slowing disease progression of patients with PPMS, the most debilitating form of the disease found in about 14 percent of all MS patients.
“We’ve been waiting a lifetime for an effective treatment for primary progressive MS, and it is simply unacceptable to deny people a treatment they urgently need,” Genevieve Edwards, director of external affairs for the U.K.’s MS Society, said in a news article written by Serena McKee.
“Thankfully this isn’t the end of the road, and we know the manufacturers are talking to NICE and NHS England about their options. We urge both sides to come together and find a solution that allows everyone who could benefit, access to ocrelizumab as soon as possible,” Edwards added.
In June, NICE reversed an earlier decision regarding relapsing-remitting MS (RRMS) patients, and recommended Ocrevus be included in the NHS for these adult. The reversal was made after Genentech, part of the Roche group, worked with NICE to reach agreement on an undisclosed price for the infusion treatment, which sells in the U.S. at an estimated annual list price of $65,000.
Ocrevus is a humanized monoclonal antibody against a specific immune cell – CD20 positive B lymphocytes – that play a crucial role in myelin and nerve cell damage. It suppresses the immune system and dampens the inflammation.
Ocrevus was approved by the European Commission in January 2018 to treat both RRMS and PPMS, making it the first approved PPMS treatment in Europe. The U.S. Food and Drug Administration approved Ocrevus to treat both MS forms in March 2017. Canada, Australia, Switzerland and countries in the Middle East and South America followed.
Results from the long-term, Phase 3 ORATORIO study (NCT01194570) evaluating the efficacy of Ocrevus in PPMS patients contributed to the approval. According to the study, Ocrevus is the first treatment to cause a 25 percent reduction in disease progression in patients with PPMS.
A more recent analysis presented evidence that Ocrevus treatment slows disability progression in PPMS, and may even delay a patient’s need for a wheelchair for up to seven years.