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 We also understand that the SMC submission for ocrelizumab for primary progressive MS has been withdrawn.”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.

Ocrevus blocked again, this time for PPMS, as not cost-effective

 

So, news came out last week that the UK’s National Health Service will not be providing Ocrevus for treating primary progressive MS (PPMS) in England*. But, panic not, the decision is far from being set in stone.

ocrevusWhy is this? Because the decision by the National Institute for Health and Care Excellence, (NICE), was that Genentech’s Ocrevus (ocrelizumab) did not meet its “value for money” criteria as a PPMS treatment. This was despite the fact that NICE’s evaluation committee agreed it is a “step change” for these patients.

The thing is that NICE has a history of reversing initial decisions, once it negotiates a lower purchasing price that makes the drug cost-effective.

Only last month, NICE reversed an earlier decision regarding relapsing-remitting MS (RRMS) patients, and recommended Ocrevus be included in the NHS.

The decision was made after Genentech negotiated with NICE and reached agreement on an undisclosed price for the infusion treatment, which apparently sells in the US at an estimated annual list price of $65,000.

That’s exactly what I expect to happen this time.

A cynic (who me?) might suggest that NICE has made its two decisions to oppose the use of Ocrevus purely to obtain the drug at a lower price.

* Decisions about the availability of drugs for the other parts of the UK, namely Scotland, Wales and Northern Ireland, are made by different organisations.

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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, 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.

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.

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.