Now Ocrevus blocked from health service in Scotland

Hot on the heels of NICE rejecting Ocrevus (ocrelizumab) as a treatment of PPMS by the National Health Service (NHS) in England, it has been blocked as a therapy for relapsing MS in Scotland.

The Scottish Medicines Consortium (SMC) says it does not consider ocrelizumab to be cost effective for the NHS in Scotland  as a treatment for relapsing MS in comparison to the existing disease modifying drugs. The SMC states that Roche, parHot on the heels of NICE rejecting Ocrevus (ocrelizumab) as a treatment of PPMS by the National Health Service (NHS) in England, it has been blocked as a therapy for relapsing MS in Scotland.ent company of Genentech – the manufacturer of the drug, did not present a sufficiently robust economic assessment of the drug’s use for it to be accepted. 

MS organisations in the UK have been quick to react. The MS Trust issued a statement that it is very disappointed in the SMC’s decision.

It added: “We anticipate that Roche will continue to work with the SMC with the aim of changing this initial decision. We also understand that the SMC submission for ocrelizumab for primary progressive MS has been withdrawn.”

Ocrevus first to slow PPMS progress

ocrevusMS Trust’s director of development, Jo Sopala, said: “We are very concerned at the continuing delay for people with MS to access ocrelizumab in Scotland.  For people with relapsing MS, it expands the range of MS treatments by offering a different dosing schedule, a different mode of action, minimal monitoring and a low risk of side effects compared to existing disease modifying drugs. 

“In primary progressive MS, ocrelizumab is the first treatment which has been shown to slow down progression.  We will continue to make the strongest possible case for NHS Scotland approval of ocrelizumab for both relapsing and primary progressive MS. 

Certainly, all is not lost as NICE initially made the same decision, for the same reason, about the use of Ocrevus to treat relapsing MS in England. Then, last month, after some negotiations on price, recommended its use. Now it has blocked its use for treating PPMS.

Now, we can look forward to further negotiations which I am sure will lead to the eventual approval of Ocrevus by NICE and SMC – for both types of MS.

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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, so 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.

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.

* * * * *

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.

* * * * *

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.

New MS drug approval delayed by three months

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People with MS who have been looking forward to the long-awaited US Food and Drug Administration (FDA) approval of the MS drug Ocrevus (ocrelizumab) are disappointed now it has been delayed. This is because, although a decision had been promised for late December 2016, an 11th-hour decision means the approval hearing has now been put back to late March 2017. I can understand that disappointment.

Manufacturer Genentech, said: “The extension is the result of the submission of additional data by Genentech regarding the commercial manufacturing process of Ocrevus, which required additional time for FDA review. The extension is not related to the efficacy or safety of Ocrevus.”ocrelizumab

Across the Atlantic, ocrelizumab is currently being reviewed for licensing in Europe as a treatment for both primary progressive and relapsing MS. Its long-term safety profile will need to be investigated, in further trials and in the real world. A decision by the European Medicines Agency (EMA) is expected in late 2017.

The full results of the latest ocrelizumab US trials have been published in the New England Journal of Medicine. These results have previously been presented at conferences, but this is the first time they have been published in a peer-reviewed journal, which is the gold standard in academic research.

Both the UK’s MS Society and MS Trust welcomed publication of the trial data prior to the FDA delay being announced.

MS Society head of clinical trials Dr Aisling McMahon said: “This (trial data) is really big news for people with the primary progressive form of multiple sclerosis. It’s the first time a treatment has shown the potential to reduce disability progression for this type of MS, which offers a lot of hope for the future.

“MS can be challenging and unpredictable and the 15,000 people in the UK living with primary progressive MS currently have no treatments available to slow the worsening of their condition. Before this treatment is available on the NHS it needs to be licensed by the European Medicines Agency and assessed for cost-effectiveness.”

MS Trust chief executive Pam Macfarlane said: “This is very encouraging news for people with PPMS. There has never been a positive result in a phase III trial of this kind and it is cause for greater hope that there is a treatment that could have an effect on disability.  We look forward to hearing more detail about the trial and whether the positive effects on disability can be sustained over the longer term.”

If ocrelizumab is licensed in Europe, the UK’s National Institute and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) will then decide whether to make it available on the National Health Service (NHS).

This decision will be based on how cost effective the treatment is. NICE will look at both the price and how much it can help people. Ocrelizumab is also being considered for licensing by the US Food and Drug Administration in the USA.

• Ocrelizumab is being developed for both relapsing and primary progressive MS. This research is notable for being the first large scale study to report a reduction in disability progression in primary progressive MS. 160 of the 487 people in the ocrelizumab group had confirmed progression at 12 weeks, compared to 96 of the 244 people in the placebo group. In relapsing remitting MS, ocrelizumab reduced the number of relapses by 50 percent compared to interferon beta 1a (Rebif).

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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.

Drug ´breakthrough´ for primary progressive MS

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Everyone living with primary progressive multiple sclerosis should be excited by the fact a drug being developed for treatment of that particular type of MS has been given ´breakthrough´ designation by the USA´s Food and Drug Administration (FDA).

The special status means that the drug, called ocrelizumab, could be approved more quickly following positive phase three trial results.

Breakthrough Therapy Designation exists to speed up the development and review of medicines intended to treat serious or life-threatening diseases. Fast tracking the approval process helps to ensure people have access through the US drug approval pathway as soon as possible.

The timing of any final approval is not yet known but once the FDA grants ocrelizumab a licence this means it will be available for doctors to prescribe in the US. Though the UK is part of a separate licensing process in Europe this is still a significant step forward.

The ´breakthrough designation has been granted based on top line results presented by pharmaceutical company Roche.

Ocrelizumab is the very first treatment to have shown positive results in a phase three clinical trial for people with primary progressive MS.

Treatment with ocrelizumab led to a reduction in the progression of clinical disability by 24% compared to placebo. This reduction was sustained for at least 12 weeks and was measured by the Expanded Disability Status Scale (EDSS).

In relapsing remitting MS, ocrelizumab reduced the number of relapses, by 46% in one trial and 47% in another when compared to Rebif.