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News and Opinions about MS, Health & Disability

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.

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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.

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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.

 

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

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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.

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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.

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New drugs to face affordability test

Proposed changes to the UK’s drug approval process should be the subject of an honest debate according the country’s Multiple Sclerosis Society.

The changes will mean the National Health Service (NHS) in England will assess how much it can afford to pay for new drugs.

Under the plan, new drugs that are expected to cost the NHS more than £20 million a year would be subject to a ‘budget impact test’.

If drugs are considered to be cost effective by the National Institute for Health and Care Excellence (NICE)  but expensive for NHS England’s budget, they could face delays or restrictions on being introduced. To me, this seems to turning the clock back on health care by several years.

Pic: MS Society.

Pic: MS Society.

Based on what is so far known about the plans now, the MS Society believe it’s unlikely that existing MS treatments available on the NHS would be affected by these changes. However, it wants to make sure that any new MS treatments aren’t rationed or restricted due to their cost.

On the society’s website, it says that an affordability test would be a big change in the way new treatments are assessed. It continues: “Currently, new drugs are tested for value for money. This means the potential benefits of a new drug are considered in relation to its cost. How much the NHS can afford to pay for the drug is not tested.”

The society’s assistant director of external affairs Ian Fannon at the said: “People with MS need access to effective treatments as quickly as possible – this is essential to managing the condition, slowing progression and improving quality of life. Not only does this prevent avoidable harm, it reduces cost for the NHS in the long term.

“We do understand the NHS is under financial pressure but the case for increasing investment in the NHS grows stronger by the day. Ever tightening rationing could have serious consequences for those who could benefit from new treatments. We need an honest debate about this.

“Equally, this poses a challenge to the pharmaceutical industry to ensure the price they offer the NHS for their drugs is fair and reasonable.

“We need to examine the details of these proposals more closely and will be responding in full to the consultation.”

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ian profile50shadesofsun.com is the personal website of Ian Franks, who is Managing Editor (columns division) of BioNews Services. BioNews is owner of 50 disease-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.

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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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MS cannabis spray not available from NHS in England – and recognising EDS as a chronic painful illness

satifex use

A word of explanation about the cannabis spray that was the cause of the unfortunate script in ITV’s Coronation Street last Friday.

The spray goes by the name of Sativex and is licensed for use in the UK to treat muscle spasms and stiffness in people with MS. It is important to note that it is not, yet, licensed for the treatment of any other condition.

Furthermore, despite the license, the National Institute for Health and Care Excellence (NICE) decided that the spray was not cost effective and that its costs outweighed its advantages. Therefore, Sativex is not available on the National Health Service in England, Scotland or Northern Ireland – not even for people with MS. And, as Coronation Street is set in the English city of Manchester, it would not be available there even if Izzy did have MS instead of Ehlers-Danlos Syndrome (EDS).

In Wales, it is technically available because the recommendation of the All Wales Medical Strategy Group (AWMSG) to approve access to the treatment has been ratified at ministerial level in the Welsh Government. However, many Welsh people with MS are reporting difficulties in getting the treatment. “Having MS is not a golden pass,” one such person commented.

While Sativex is currently approved solely for the treatment of MS-related muscle spasticity, the drug is also being trialled for a number of other conditions. Besides cancer pain trials in the US, Sativex is being studied in the UK as an add-on treatment for brain cancer. Previous studies have also suggested benefits in treating arthritis and neuropathic pain.

My brief description of EDS Hypermobility type in the last blog caused some upset among people with EDS. For that, I am sorry. I did not intend to diminish the illness but did over simplify it; double-jointedness is involved but at the least serious end of the spectrum.

So, I’ll now try to put the situation right. EDS is a group of inherited connective tissue disorders, caused by various defects in the synthesis of collagen. It is known to affect men and women of all racial and ethnic backgrounds.

There are six distinct types of the illness currently identified. All share joint laxity, soft skin, easy bruising, and some systemic manifestations. Each type is thought to involve a unique defect in connective tissue, although not all of the genes responsible for causing EDS have been found. These types are: Hypermobility; Classical; Vascular; Kyphoscoliosis; Arthrochalasia and Dermatosparaxis.

Joint hypermobility is the dominant clinical manifestation. Generalized joint hypermobility that affects large (elbows, knees) and small (fingers, toes) joints is evident in the Hypermobility Type. Recurring joint subluxations and dislocations are common occurrences. Certain joints, such as the shoulder, patella and temporomandibular joint dislocate frequently. The skin involvement (smooth velvety skin with or without hyperextensibility) as well as bruising tendencies in the Hypermobility Type are present but quite variable in severity.

Chronic pain is a well-established and cardinal manifestation of Hypermobility EDS and it is common for pain to be out of proportion to physical and radiological findings. The origin of the pain is not clearly understood, but some of the likely causes include muscle spasm (tender points are sometimes present) and degenerative arthritis; neuropathic pain is also common.

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