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.”

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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.

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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.

Threat to three DMTs removed after manufacturers cut prices

Manufacturers of three relapsing multiple sclerosis drugs have cut prices to remain available to Britain’s National Health Service (NHS). They are all diseases modifying therapies (DMTs).

In January, I brought you news that five such drugs were under threat, having been found to be not cost-effective as long-term therapy options. In a draft recommendation from the National Institute for Health and Care Excellence (NICE). NICE’s role is to provide national guidance and advice to improve health and social care. The NHS in England is legally obliged to fund medicines recommended by NICE, while other parts of the UK have their own approval procedures.

cut pricesIn that draft recommendation, only Extavia (interferon beta 1b) was given the green light. Now, though, the cut prices mean that three more drugs are considered cost-effective. These are:

Although details of the cut prices have not been disclosed, I am delighted that the drugs will now continue to be available to those that need them.

The two medications that NICE is still, as yet, proposing to make unavailable to people who are newly diagnosed, or want to change their treatments, are:

  • Betaferon (interferon beta-1b)
  • Plegridy (peginterferon beta-1a)

Grateful for cut prices

cut prices

Meindert Boysen (Pic: NICE),

NICE director of the centre for health technology evaluation, Meindert Boysen, said: “This is good news for people with relapsing-remitting multiple sclerosis. We are grateful that the companies have been able to agree reductions to the NHS prices of these drugs so they can be made routinely available and ensure that people continue to benefit from a choice of treatment.

“Multiple sclerosis is lifelong condition that can have a negative impact on people’s ability to work, and to engage in social and family life. Having treatments that can delay the progression of the disease is important to help patients get back to their normal lives.”

MS Society head of policy, Phillip Anderson, welcomed NICE’s latest position. He said: “People with MS told us what restricted drug options would mean for them and we’re delighted NICE has listened.

“This decision means people can continue to access a wide range of MS treatments. It’s vital that individuals have that choice, so they can find what best suits their needs and lifestyles.

“This is a great outcome and we’ll keep working to make sure everyone with MS can get the right treatment at the right time.”

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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.

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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.

MS bodies look for NICE support for PPMS treatment

Leading MS organisations are seeking support to gain approval for ocrelizumab (Ocrevus) to treat all primary progressive MS (PPMS). It is already approved for use against early PPMS.

ocrelizumabBoth of the UK’s MS Society and MS Trust are campaigning to get the medication approved for wider use by the country’s National Health Service (NHS). And they are seeking the support of patients, carers, and health professionals in their efforts to influence the National Institute for Health and Care Excellence (NICE).

NICE is currently assessing ocrelizumab for PPMS to decide whether it should be prescribed by the NHS in England and Wales.

The MS Society said: “We’ll be telling NICE why people with both primary progressive and relapsing MS should be able to access ocrelizumab through the NHS.

“We want to hear from people who’d like to take ocrelizumab, to support our submission to NICE.

Tell what it’s like to live with PPMS

“Do you have relapsing MS and think you’d benefit from taking it? Or, if you have primary progressive MS, can you help us tell NICE what it’s like to live with, and why the first treatment option matters to you?”

To give the society your views, you are asked to send an email here.

The MS Trust says it will be explaining to NICE why it thinks ocrelizumab should be made available on the NHS.

The trust also appealed for support. It said: “To help us make a strong case, we want to hear your experiences of living with PPMS, your views on current NHS care for PPMS and your thoughts on ocrelizumab.

“We’d like to hear from you if:

        you have primary progressive MS

        you have a different type of MS, but would like to add your views

       you are a partner / friend / relative / carer of someone with PPMS

      you are a health professional providing care for people with PPMS

“Tell us what you think by completing this short questionnaire by 14 February.”

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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 intended for your general knowledge only and 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 and consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

Cuts proposed to MS treatment options

It cannot be right, it really can’t! People with multiple sclerosis are facing being denied access to five previously approved disease modifying therapies (DMTs). This shocking development would affect people who are newly diagnosed or those wishing to change to a different drug.

The proposal to cut the number of treatment options comes in the form of a draft recommendation from the UK’s National Institute for Health and Care Excellence (NICE). Its preliminary proposal would affect people with MS in England and Wales who receives treatment via the country’s National Health Service (NHS).

NICE’s role is to provide national guidance and advice to improve health and social care.

A consultation period on the proposed recommendation ends this Wednesday, January 24, so very little time remains for patients, doctors, caregivers and others can make their views known. To add your comment, click on this link.

NICE is to meet again on March 6 to review comments received, and discussions it has had with the drugs’ manufacturers, before it makes its final recommendation.

treatment optionsThe good news is that, under the preliminary proposal, anyone with MS who is already on one of these treatments would be able to continue to take them.

NICE’s draft recommendation, if confirmed, would mean the cheapest drug Extavia (interferon beta-1b) would continue to be available on the NHS for new patients. But five others would no longer be treatment options because of costs.

The five medications that NICE is proposing to make unavailable to people who are newly diagnosed, or want to change their treatments, are:

  • Avonex (interferon beta-1a)
  • Betaferon (interferon beta-1b)
  • Copaxone (glatiramer acetate)
  • Plegridy (peginterferon beta-1a)
  • Rebif (interferon beta-1a)

NICE says it has made the draft recommendation because it believes that while all the treatment options have a similar clinical effect, only Extavia is cost-effective.

Treatment options: a step backwards

Both the MS Society and MS Trust are ranged against the proposal.

MS Society director of external affairs Genevieve Edwards says the society doesn’t want to see patient choice limited in this way.

She said: “While people with MS already receiving these treatments can be assured they won’t have to come off them, we’re worried about what this proposal means for the future of patient choice. We have made so much progress on treatment options for people with MS, and it would be a significant step backwards if people with MS were now left with less choice and potentially no effective option.

“We want the companies who make these drugs to keep negotiating and come to a deal with NICE and NHS England so patients don’t lose out. Everyone with MS should be able to get fair and equal access to the right treatments at the right time.”

A statement from the MS Trust says it is very disappointed in the initial decision.

It says: We do not believe that NICE’s recommendations are in the best interests of people with MS or the NHS.  We strongly believe that all current treatments should remain available as treatment options for all eligible patients.

“NICE has acknowledged that all six drugs are equally effective at reducing the number of relapses and slowing down disability progression. The decision to approve Extavia and not the other five drugs all comes down to cost – Extavia is the cheapest option.

“These recommendations would take away choice from people with MS.  In our view, the recommendations do not take account of:

  • the differences in how treatments are administered
  • the diverse lifestyles of people with MS, and how different treatments suit different people
  • the differing tolerances of individuals to the side effects of the drugs”

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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.

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Note: Health-related information available on 50shadesofsun website is intended for your general knowledge only and 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 and consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

 

After Long Wait, Zinbryta Gains Approval in Areas of the UK

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approval

News that daclizumab, brand name Zinbryta, has been given the go-ahead to be available through the U.K.’s National Health Service (NHS) for treating relapsing MS, at least in part of the country, is good news. But why has the decision taken so long?

Possibly, because the first decision, last September, was ‘no.’

The latest decision by the National Institute for Health and Care Excellence (NICE) covers only England and Wales. Hopefully, similar announcements will be made for people in Scotland and Northern Ireland in coming months.

The decision means the NHS will have a legal obligation to provide the treatment to people with relapsing MS, whose health care professional prescribes it to them.

But there are conditions.

Patients must have either:

  • “Active” relapsing MS that’s been treated with another disease-modifying treatment, or;
  • “Rapidly evolving severe” MS (defined by at least two relapses in the previous year and an MRI scan showing new lesions)

And it will be available only to people who are unable or unwilling to take alemtuzumab.

Interestingly, the U.S. Food and Drug Administration (FDA) approved Zinbryta early last year and the European Medical Agency (EMA) followed suit in June, but it has taken another nine months for NICE to make up its mind. I find such a delay completely unacceptable.

Isn’t it time that countries around the world got together and presented a united front on new medications being brought out for the use of those of us who need them? Shouldn’t we consider such new treatments and give necessary approvals globally, not on a piecemeal basis, as we do now?

Of course, such revolutionary thinking is never likely to be taken seriously, as it would mean the dismantling of national organizations such as the FDA. Well, why not? On the other side of the Atlantic, there is one body that does the job for nearly 30 countries — the EMA.

If one organization can cover all Europe, why can’t an international one cover the whole world? Reducing the number of approval bodies should cut costs, too.

But it would need its decisions to include that medical insurance companies would have to pay for it to be provided to patients, and for it to be available through the NHS, without further consideration.

Could it work? Of course! Everything is possible. Will it ever happen? Not a chance

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

strap-new

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[You are invited to visit my personal MS, Health & Disability website at 50shadesofsun.com].

50shadesofsun.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.