Give people with PPMS the treatment they need, MS Society campaign #SpeakupforMS

Blocking of a drug as a treatment for primary progressive multiple sclerosis (PPMS), making it unavailable for use by the UK’s National Health Service (NHS), is being challenged by the country’s MS Society.

And it has coupled its opposition with a call to arms – inviting everyone to #SpeakupforMS.

#SpeakupforMS

Holly (Pic: MS Society).

Holly, from the society’s campaigns community, lives with PPMS. She says: “The first licensed treatment for my condition has been denied approval to be available on the NHS in England and Wales.

#SpeakupforMS“Ocrelizumab (Ocrevus) has proven it can reduce the risk of disability getting worse for people like me with early primary progressive MS.

“But the National Institute for Health and Care Excellence (NICE) has rejected it because it says its (the drug’s) costs are too high for its benefits.

Need to #SpeakupforMS

“We need to speak up together.

“We need to tell Roche, NICE and NHS England: give people with primary progressive MS access to ocrelizumab.”

You can add your voice to the campaign today by signing the MS Society’s petition here

#SpeakupforMSHolly continues: “We‘ve been waiting a lifetime for an effective treatment for primary progressive MS. This decision is crucial.

“Right now, this is just for approval in England and Wales, but any delay in making ocrelizumab available could have knock-on effects across the UK.”

According to the society, every year around 600 people are diagnosed with primary progressive MS in the UK. 

Holly asks for your suppport.

She says: “Join us and #SpeakUpforMS.”

* * * * *

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 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.

* * * * *

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.

MS ’50shadesofsun’ website is Back in Business

back in business

Thanks to all of you who have taken the trouble to get in touch to ask about my health, and if everything is ok generally. Well, the news is that, although there was a small health issue the week before Easter, I am fine. I realise that your concern was triggered by a lack of posts on this site but that was because I have been so busy, and therefore so tired, that something had to give.

Anyway, the good news is that I am as well as multiple sclerosis allows me to be and this site is back in business.

Back in business: My sympathies

Before I go any further, I want to express my sympathies to the family and everyone affected by the death of Kristen Dyson, of Oklahoma, while undergoing HSCT in Moscow.

I am not going to go into detail here; it is enough to say that Kristen developed an extremely rare heart reaction to an element of the treatment. Despite the efforts of intensive care staff, sadly Kristen passed away.

I did talk to Dr Denis Fedorenko, head of transplants for multiple sclerosis patients at the A.A. Maximov centre, after the news broke on Facebook and it was evident that both he and his team had been deeply  affected. He took the time to explain to me what had happened but I see no need to cause more upset to anyone by going through it in detail here.

Back in business: Ocrevus not welcomed universally

On the ‘latest development’ front, we have seen the news of the approval of Ocrevus (ocrelizumab), by the USA’s Food and Drug Administration (FDA) for the treatment of both relapsing and primary progressive forms of MS. The subsequent reactions have varied from something approaching ecstasy that at last a drug has been approved to treat primary progressive, through guarded optimism to concerns over safety. Many have also expressed the opinion that Ocrevus is no better than Rituxan (rituxumab), which is at the end of its patent life and which can only be used for MS as an off-label medication. Manufacturer Genentech has attracted criticism, whether justified or not, that the two drugs are the same.

Now, although the two drugs are very similar and both work in the same way, there is a difference. Rituxumab is a chimeric antibody, meaning that it was produced from the cells of a non-human organism, actually a mouse, while ocrelizumab is a humanised antibody. Humanised antibodies also come from a non-human species, but whose protein sequences have been modified to increase their similarity to antibody variants produced naturally in humans.1

I am not going to join in the Ocrevus argument one way or the other; I’ll leave you to make up your own minds.

Of course the FDA decision only affects the USA and the rest of the world continues to wait. In Europe, the European Medicines Agency (EMA) says the approval ‘clock’ has been stopped as it is still awaiting answers to questions it asked last September. The agency says it is waiting for the company to supply the answers. Once it gets them, the EMA’s approval process will be back in business too.

1 Riechmann L, Clark M, Waldmann H, Winter G (1988). “Reshaping human antibodies for therapy”. Nature. 332 (6162): 332–323. doi:10.1038/332323a0. PMID 3127726.   Queen C, Schneider WP, Selick HE, Payne PW, Landolfi NF, Duncan JF, Avdalovic NM, Levitt M, Junghans RP, Waldmann TA (Dec 1989). “A humanized antibody that binds to the interleukin 2 receptor.”. Proc Natl Acad Sci U S A. 86 (24): 10029–33. doi:10.1073/pnas.86.24.10029. PMC 298637Freely accessible. PMID 2513570.  (This is an early example of the use of the term “humanized antibody”.

* * * * *

ian-skype_edited50shadesofsun.com is the personal website of Ian Franks, who 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

orange

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).

strap-new

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.