MS drug Ocrevus could be barred from health service

Ocrevus may have taken the worldwide multiple sclerosis community by storm but it seems set for a rocky ride in the United Kingdom. It’s quite possible that it will not be available through the country’s National Health Service (NHS).

ocrelizumabAlthough the drug1, known by the non-brand name, ocrelizumab, was licensed by the European Medicines Agency (EMA) in January as an MS treatment, that is not the end of the story. It was licensed to treat both people with relapsing and early primary progressive MS.

However, before a treatment is allowed to be available through the NHS in England and Wales2, it has to be evaluated by the National Institute for Health and Care Excellence (NICE). Disappointingly, it has provisionally decided NOT to recommend ocrelizumab for people with relapsing MS on the NHS.

Fortunately, this is not its final decision. You can let them know what you think through the NICE website before Wednesday April 25, so there is no time to lose. NICE is due to reach its final decision in May.

Should we blame pharmaceutical company Roche for the mess? Well, maybe. NICE has said the evidence submitted by Roche is not enough to show it’s more clinically and cost effective than other treatment options for relapsing MS.

Turn decision around

MS Society director of external affairs Genevieve Edwards said: “Naturally we’re very disappointed by the NICE guidance. But the decision isn’t set in stone, and we’ll be speaking to NICE and the drug manufacturers to make sure we get the right outcome for everyone living with MS.

“Over 100,000 people have MS in the UK, and we’re working hard to make sure they can all access more and better treatments. We’ve been here before and turned it around.”

The review of ocrelizumab as a treatment for primary progressive MS is taking place separately and is not affected by any decision regarding the relapsing form of the disease.

Edwards said: “For us and thousands of others, ocrelizumab also offers immense hope in progressive MS. We’re yet to know what NICE recommends here, and will be continuing our efforts to make sure everyone who could benefit can access the drug. There are still people with MS who don’t have any options for treatment, and addressing this is our absolute priority.”

Anyone who is already receiving Ocrevus through the NHS, should not panic. NICE said its recommendation is not intended to affect treatment that was started before this guidance was published.

“People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop,” it said.

Notes:

1 Ocrelizumab is an intravenous infusion taken every six months. It was licensed to treat both people with relapsing and early primary progressive MS by the European Medicines Agency (EMA) in January this year.

2 The Department of Health in Northern Ireland is expected to make a decision on ocrelizumab for relapsing MS soon. Its decisions are usually based on those made by NICE. The Scottish Medicines Consortium (SMC) is currently carrying out a separate appraisal for people in Scotland.

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

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50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

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Note: Health-related information available on 50shadesofsun website is for your general knowledge only. It is not a substitute for medical advice or treatment for specific medical conditions. I am not a doctor and cannot and do not give you medical advice. You should seek prompt medical care for any specific health issues. Also, consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

Ocrevus: Counting Down to Expected FDA Approval

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There is now less than a month until the U.S. Food and Drug Administration (FDA) is expected to approve Ocrevus, generic name ocrelizumab, for use as a therapy for multiple sclerosis.

Clinical trials have shown Genentech’s drug to be a promising therapy for relapsing MS and, significantly, the primary progressive form of the disease for which there is no approved treatment.

ocrevusThe FDA is due to make its decision known March 28, which is quite poetic really, in that it is MS Awareness Month.

So, if everything works out, it looks as if Ocrevus, although not a cure, has all the makings of a wonder drug for MS, at least for most people who have the disease. That is because the vast majority of people with MS have the relapsing form, some 85% worldwide are diagnosed with this type..

However, if, like me, you have secondary progressive MS, then it seems Ocrevus will not be available. No claims have been made of Ocrevus having any effectiveness for our form of MS.

All drugs have side effects and this new one is no exception, but it seems that in all studies the most frequent side effects were mild-to-moderate reactions and infections related to the treatment’s injection.

But that is not enough information for me, and it should not be for you. I decided to dig a little deeper.

The UK’s MS Society says that not one of the Phase 3 trials reported any unexpected adverse side effects and in the Phase 2 relapsing remitting trial, serious side effects were rare and were comparable for all groups.

Wait a minute. Serious side effects?

The UK’s MS Trust also says they are rare and adds that opportunistic infections have not been reported in ocrelizumab MS trials.

Furthermore, in his article “Genentech’s Ocrevus: Pioneering The Progressive MS Therapy Landscape”, on Pharmaceutical Online, John Crowley, PhD, of Decision Resources Group, said: Ocrevus’ safety profile in MS program is very strong, but some question marks remain.”

It looks to me that, overall, the Ocrevus story is a very positive one.

This article, written by me, was first published by Multiple Sclerosis News Today.

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ian-skype_edited50shadesofsun.com is the personal website of Ian Franks, who is Managing Editor (columns division) of BioNews Services. BioNews is owner of 50 disease/disorder-specific news and information websites – including MS News Today. Ian has enjoyed a successful career as a journalist, from reporter to editor, in the print media. During that career he gained a Journalist of the Year award in his native UK. He was diagnosed with MS in 2002 but continued working until mobility problems forced him to retire early in late 2006. He now lives in the south of Spain. Besides MS, Ian is also able to write about both epilepsy and cardiovascular matters from a patient’s perspective and is a keen advocate on mobility and accessibility issues.

Just two weeks to fight for MS treatment

Anyone wishing to take issue with the draft recommendation to not make daclizumab1 (Zinbryta) be made available as a treatment on the NHS in England and Wales has just 15 days to do so. Comments must be received by Friday October 21.

So, if you want a change of heart, don’t delay. The time to stand up for MS patients is now!

The UK’s National Institute for Health and Care Excellence (NICE) is responsible for evaluating new drugs and treatments, along with their costs. It then makes recommendations as to whether or not they should be available through the country’s National Health Service (NHS) in England and Wales. Other parts of the UK have their own guidance bodies.

daclizumabIn a document published on the NICE website, the appraisal committee’s preliminary recommendation states: “Daclizumab is not recommended within its marketing authorisation for treating relapsing forms of multiple sclerosis in adults.”

The committee was critical of the analysis submitted by the manufacturer of the cost effectiveness of daclizumab, compared with other disease modifying treatments.

The NICE appraisal committee is scheduled to have another meeting on November 2. It is expected to review the comments received together with further evidence from the manufacturer.

NICE is expected to publish its final guidance next year.

1 Daclizumab is an experimental drug treatment being developed for relapsing MS. It is taken as an injection under the skin, once a month. In clinical trials, daclizumab reduced relapse rates by approximately 50% compared to placebo and by 45% compared to beta interferon. The drug was licensed in Europe in July 2016.

Serious infections, serious skin reactions and impaired liver function occurred more frequently in people treated with daclizumab than in other treatment groups.

 

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