NICE Opposes Ocrevus as PPMS Treatment in UK’s Public-funded Health System

NICE Opposes Ocrevus as PPMS Treatment in UK’s Public-funded Health System

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.

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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. CanadaAustraliaSwitzerland 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.

The Scottish Medicines Consortium (SMC) is currently reviewing Ocrevus as a NHS-covered therapy for RRMS in that country. Its decision is expected on July 9.

Vijaya Iyer is a freelance science writer for BioNews Services. She has contributed content to their several disease-specific websites, including cystic fibrosis, multiple sclerosis, muscular dystrophy, among others. She holds a PhD in Microbiology from Kansas State University, where her research focused on molecular biology, bacterial interactions, metabolism, and animal models to study bacterial infections. Following the completion of her PhD, Dr. Iyer went on to complete three postdoctoral fellowships at Kansas State University, University of Miami and Temple University. She joined BioNews Services to utilize her scientific background and writing skills to help patients and caregivers remain abreast with important scientific breakthroughs.
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Vijaya Iyer is a freelance science writer for BioNews Services. She has contributed content to their several disease-specific websites, including cystic fibrosis, multiple sclerosis, muscular dystrophy, among others. She holds a PhD in Microbiology from Kansas State University, where her research focused on molecular biology, bacterial interactions, metabolism, and animal models to study bacterial infections. Following the completion of her PhD, Dr. Iyer went on to complete three postdoctoral fellowships at Kansas State University, University of Miami and Temple University. She joined BioNews Services to utilize her scientific background and writing skills to help patients and caregivers remain abreast with important scientific breakthroughs.
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4 comments

  1. James Joyce says:

    My Neurologist started me on Ocrevus in October ’16. I have had nine Urinary Tract Infections my PPMS has worsened. Please let me know if you hear of any class-action suits against Biogen.

  2. Senator says:

    I thought that usually the US and the FDA in particular, were slow to approve new drugs. Ocrevus was fast tracked then approved quickly by the FDA which made myself and many others in the Primary Progressive realm of MS`ers very happy. I am wheelchair bound. My first two half doses were in Sept.`17, and first full dose in March `18. Ocrevus has alleviated pain in feet and calves so I no longer need Solumedrol treatments for five straight days every qtr. It is calming my jittery hands so I can write legibly again. It is giving me more energy so I only lay down for 1 1/2 hrs now instead of 4 hrs, and it has also given me the ability to sweat again. I was not able to tolerate heat very well, so outside activities when hot, say over 80 deg F were short lived. Being able to sweat, I believe, gives back ability to tolerate heat better, therefore, not so physically tired. I hope Ocrevus approval is revisited and approved.

  3. poppy says:

    Does anyone else with PPMS feel we have been neglected. Ocrelizumab was described as the game changer for PPMS, yet it is not subsidised in Australia. I can come up with the money for one dose(although I no longer work) to try it, but my neurologist said my symptoms are not bad enough. If losing my job, no longer being able to walk the dog and also taking a day to vacuum the house (5 minutes intervals with half hour rest) is “not bad enough” he is lucky I am too tired to find a cliff from which to jump.

    I didn’t know that an inability to sweat/perspire was associated with MS. Heat sensitivity makes sense if this is true. Cheers, AK

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