Patient Interest Groups
Submission of Evidence Template
Summary Cover Sheet
Name of organisation making submission
MS Society Scotland
Contact/correspondence details
Name
Sarah Ritchie
Designation
Policy,
Press
(Scotland)
Address
Multiple Sclerosis Society
Ratho Park
88 Glasgow Road
Ratho Station
Newbridge
EH28 8PP
Telephone Number
Email address
and
Campaigns
0131 335 4058
sritchie@mssociety.org.uk
Product to which the submission relates
Teriflunomide (Aubagio)
Date of SMC meeting (if known)
07. 01. 2014
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Manager
Section 1: Submitting Organisation
Q1.
Name of organisation (see guidance notes)
MS Society
Q2.
Alternative/previous names of organisation (see guidance
notes)
Date of change
Q3.
Please tell us your organisation’s main or registered address,
including post code.
MS Society Scotland
Ratho Park
88 Glasgow Road
Ratho Station
Newbridge
EH28 8PP
MS Society National Centre (MSNC)
372 Edgware Road
London
NW2 6ND
Q4.
Type of organisation (see guidance notes)
Please tick as appropriate:
Unincorporated organisation

Unregistered charity

Registered charity (Scotland)

Registered charity (UK)

Registration Number
England and Wales (207495)
Scotland (SC016433)
Other organisation type

Please provide details if you have ticked ‘Other’:
Q5.
Please provide a short description of the nature and purpose of
your organisation.
If you are a membership-based
organisation, please indicate the number of members and the
geographical spread.
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There are approximately 100,000 people living with a confirmed diagnosis of MS in the UK
and over 10,500 in Scotland.
The MS Society is the UK’s largest charity for people living with MS, with over 38,000
members and more than 300 branches across the UK. In Scotland the MS Society has
around 4,000 members to date and there are currently 32 local branches.
The MS Society is the UK’s largest charitable funder of research into MS. We are committed
to bringing high quality standards of health and social care within reach of everyone affected
by MS. Our comprehensive range of services cover all aspects of improving the lives of
people affected by MS, from information and support to improving standards of treatment and
care through research, education, campaigning and raising awareness.
Q6.
Please list any pharmaceutical companies that are corporate
members of your organisation.
N/A
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Q7.
Please provide
FULL details of any funding received from
pharmaceutical companies within the last TWO years. Please
note hyperlinks to other documents or website will not be
acceptable.
Pharmaceutical
Company
Amount
funding
provided
of Purpose of funding
Details redacted for
publication
Q8.
Please provide details of any individuals who have had a
significant role in drawing up your submission who have an
interest to declare. Please refer to the guidance notes further
explanation.
Name
Role in Submission
P
O
Description of Interest
Section 2: Experience of patients, carers and their families
Q9.
Please tell us how you have gathered information about the
experience of patients, carers and their families e.g. helpline,
focus groups, published or unpublished research, userperspective literature (e.g. personal stories), one to one
discussions.
The patient perspective contained in this submission is informed by:
- Results of a large-scale survey with 1,000 members on their experiences of relapses
and existing disease modifying treatments (2010)
- Results of the ‘My MS My Needs’ survey, which had 10, 530 respondents, on whether
the care and support needs of people with MS are being met (2013)
- Results of a qualitative survey with 50 people with MS in Scotland on their experiences
of existing disease modifying treatments (November 2013)
- Semi-structured Interview with a patient on their experience of teriflunomide (2013)
- The experiences reported by people with MS via our information line and our network of
branches and support groups in Scotland, as well as regular smaller scale surveys to
members on the impact of MS and experiences of treatment
Q10. Please provide information about how this condition affects the
day-to-day lives of patients, carers and their families. Please
refer to the guidance notes.
Broad impact of living MS and relapses
MS is a devastating, incurable and complex long-term neurological condition that attacks at
random. Symptoms of MS are often distressing and debilitating and can include intense pain,
problems with mobility and co-ordination, severe depression, deadening fatigue, incontinence,
and loss of vision. Most people are diagnosed with MS between the ages of 20 and 40, during
some of the most important, formative – and economically active - years of their lives.
Life for a person with MS is unpredictable. Some experience periods of relapse and
remission, for others it follows a progressive pattern from onset. Even those with relapsingremitting MS typically experience increasing disability and morbidity.
During a relapse, people with MS experience an episode of worsening neurological symptoms
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that come on over a short period of time and remain for a number of weeks or months. At
their worst, acute relapses may need hospital treatment, but many relapses are managed at
home, with the support of a GP, MS specialist nurse, and other healthcare professionals.
Although most people recover from relapses, around half of all relapses may leave residual
problems.
MS has more than a physical impact. It can also have a significant emotional and financial
impact on those diagnosed with MS and their carers and family members.
Both the disability and relapses associated with MS have a significant impact on people’s
ability to work. According to our 2013 survey, only a quarter of people with MS who are of
working age are employed, compared to three quarters of the wider UK population.
The emotional impact of MS is also important to mention, with around half of all people with
MS experiencing depression and a similar number suffering anxiety.
More than 90 per cent of people with MS say they ‘need assistance from others’ and more
than 70 per cent rely on support from an unpaid carer to undertake daily activities such as
washing, dressing and getting out and about; and this reliance often increases during a
relapse.
Current treatments
Disease modifying treatment in MS aims to reduce the frequency of relapses and disability
progression. The treatment regime itself also has an impact on the day-to-day lives of people
with MS and their families, particularly as the existing disease-modifying treatments available
on the NHS for newly-diagnosed MS patients involve self-injections several times a week.
Many people with MS report problems with skin indentation and increased difficulty when
injecting over long periods, with over 55 per cent of respondents to our survey finding it
always or often uncomfortable to inject. In some cases, complications with injection sites,
such as ulcers, have resulted in emergency admissions and long inpatient stays. Over 70 per
cent of people in our survey had experienced skin reactions from injecting that caused pain,
bruising or scarring.
Some people with MS rely on carers to help with their injections, for example where they fear
needles or where their MS symptoms or disabilities prevent them from being able to selfinject. Our survey showed that 48 per cent of people always or sometimes required
assistance with injecting:
“The injections are difficult with the numbness in my fingers and hands [a symptom of
MS]”.
Monthly infusions in hospital with Tysabri are a treatment regime for some people with
aggressive forms of MS. Our survey found that nearly 50 per cent of people found it to be a
“constant inconvenience” and 16 per cent had discontinued their treatment.
In total 26 per cent of people had discontinued treatment, citing side effects, injection site
reactions and pain and stress associated with injecting and /or infusions as reasons.
“The stress and anxiety caused by injections has almost as much effect on my quality
of life as the condition itself”.
Disease modifying treatments have a significant impact on the day to day lives of people with
MS. They may help reduce the frequency and severity of relapses but our evidence shows
that many people find them inconvenient and disruptive, with a worrying number choosing to
stop treatment altogether.
Over 95 per cent of our survey respondents said that an oral tablet form of treatment would
make a significant difference to their lives. Gilenya is the first tablet form of disease-modifying
treatment for MS, however it is a second line treatment and is only available for those with
‘highly active relapsing remitting MS’ or those who have failed on other first line treatments. It
is therefore not an alternative for the majority of patients with relapsing remitting MS.
Teriflunomide is associated with a better side-effect profile and comparable clinical
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effectiveness compared to existing options. In addition, as an oral tablet for newly diagnosed
MS it offers a viable and innovative alternative to current practice that has the potential to
make a very positive difference to the lives of people with MS in Scotland.
Q11. Which aspects of living with this condition, NOT MET by
treatments currently available, do patients need most help
with?
Limitations of current treatments
Current treatments for this indication (i.e. first line relapsing-remitting MS) are Avonex, Rebif,
Betaferon, Extavia and Copaxone all of which are self-administered by injection; and Tysabri
which is administered in hospital as a monthly infusion.
While many people benefit from these treatments, there are a number of clear disadvantages
as outlined below.
Maintaining independence: Over 90% people with MS already rely on the support of others to
undertake daily activities. Current injection and infusion-based treatments often increase the
reliance on others e.g. in helping with administering injections or driving and accompanying
them to hospital for infusions.
“I can’t inject in some parts of my body myself, so I need to rely on someone else who
isn’t always around”.
Ease of use / remaining in work: Less than a quarter of people with MS who are of working
age are employed compared to 75 per cent of the wider UK population. Having viable
treatment options that help support people to stay in work is a critical factor. Current first-line
options, either injections or infusions, can severely restrict people in what they can do, and
result in people reducing their working hours or stopping employment altogether.
Preferences for an oral tablet: Our research shows that 95 per cent of people with MS would
prefer an oral tablet form of treatment compared to injection or infusion-based treatment. The
current first line treatment options do not enable this choice.
Treatment side-effects and adherence: 26 per cent of people who responded to our survey
and who had been taking currently available treatments chose to stop treatment, mainly
because of side effects, inconvenience and / or fear of needles.
Painful skin reactions were the most commonly experienced side effect, as reported by 70 per
cent of respondents, followed by flu-like symptoms (66 per cent) and headache (56 per cent).
Some of the typical explanations for discontinuing treatment were:
“I injected once a week for over 5 years. I pretty much lost the day I injected as I didn't feel
well then the day after I often still felt unwell. So to have this every week was a nightmare. It
was also starting get more painful to do the injections as my skin was getting tougher at
the injection sites.”
“I found the self injection too stressful. I couldn’t come to terms with it, having a deep
fear of needles”.
“I hated the needle, the bruises and needle marks and the side effects”.
Convenience: Nearly 50 per cent of respondents to our survey told us that they spent a lot of
time planning around their treatment.
“There is all the paraphernalia with the equipment needed. Sharps box, auto injector.
Having to think about taking it all on holiday. Will there be a fridge to keep the Rebif in?
A place to store it at home. Being in when the delivery van comes every month”.
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Lifestyle and impact on carers: The inconvenience of injecting or travelling to hospital has a
major impact on the lifestyle and quality of life of people with MS and their carers. Our survey
found that 77 per cent of those who were injecting and 79 per cent of those receiving
infusions found treatment was a “significant disruption to their daily life”, while both forms of
treatment are associated with a feeling of extra burden on families and friends who may
already be undertaking an unpaid caring role.
Section 3:
Views of patients, carers and their families on the
difference the new medicine will make.
Q12. Please provide details of your sources of information about the
new medicine. Please refer to the guidance notes.
The MS Society believes that the evidence overwhelmingly supports the case for the inclusion
of teriflunomide as a treatment option on the NHS.
People with MS in Scotland have high hopes that this treatment will be approved for use on
the NHS, offering a valuable choice of an effective, oral form of treatment which many people
indicate is their preference.
In addition to the published clinical trial evidence and patient-reported evidence from our
surveys, the MS Society also conducted a semi-structured interview with a patient who had
experience of taking teriflunomide The interview was transcribed and anonymised, and a full
copy is available on request.
Case study: JT
Background
JT was diagnosed with MS in 2006. Since being diagnosed JT has taken the following
treatments for MS: Copaxone, Avonex and Rebif. JT entered the teriflunomide trial in
February 2010.
JT reported that life before MS was typical, “I was working, having fun, walking around
mountains, roller-skating, collecting fossils and going out with friends. I was always cleaning
and decorating. At one time I had four jobs! I was just on the go 24/7.”
JT tried to not let MS impact on her life but inevitably it did. Her life “changed drastically.” The
MS slowed her down: “physically, I’m tired and I’m unstable. I’m not as strong as I used to be.
Mentally, I’m exhausted. I’m fed up as I am constantly pushing myself. Socially, I only go out
with my dad or very close friends. We go to quiet pubs with few people. I get stressed in
social situations. I become uneasy in crowds as my brain can’t cope. I have to leave and go
home. “JT became uncertain of her limits. She often wondered if she “might wake up unable
to walk.” Despite this JT has been able to carry on working because she refuses to give in to
the MS, although has reduced her hours.
Before MS JT was very independent – “I never asked for help or needed it.” However when
she was diagnosed her husband cared for her; helping her most days with dressing, cooking,
cleaning, washing and general help.
Experience of current first-line treatments
JT used Copaxone in 2007 for about a year but “the daily injections caused skin problems
from the outset – some quite severe.” JT was then offered Avonex. However this made her ill
for at least 24 hours after administering the injection. This “impacted on my job…in a very
busy environment I was barely able to function.” JT experienced three relapses in a row after
being on Avonex for a year and was subsequently offered Rebif as an alternative. However
JT still experienced the same side-effects and was ill most of the time. After six months on
Rebif JT came off the treatment deciding that she would “rather have a relapse that might last
for a few days or months than constantly feel like I did.” Coming off the medication made JT
feel like a weight had been lifted off her shoulders and she felt like the old her was coming
back. JT recognised that although the decision to come off treatment was a big one to make,
at the same time it was easy because, “the effect of injecting three times a week or everyday
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with Copaxone was really horrendous.”
Experience of teriflunomide
JT was placed on the teriflunomide trials in 2010 and has been on the treatment for three
years. JT was made fully aware of the risks and side-effects associated with teriflunomide but
felt she had “nothing to lose” as her quality of life “could not get any worse than it was.” From
the information she was provided the “side-effects seemed minimal compared to previous
medications. Taking one tablet a day seemed like a dream.” The outcome that was most
important to JT was a reduction in relapses. She expected that she may still experience the
odd relapse and symptoms but nothing as severe – “I just wanted to make my life bearable.”
Since being on teriflunomide JT has not experienced a relapse and has noticed
improvements in some symptoms, specifically with numbness on her left-hand side and is
able to manage her fatigue. JT reports her whole health as being better. Overall JT said, “I
feel it has made a vast difference to my life. I can honestly say sometimes I don’t think I
have MS.” Although her life is not back to where it was the teriflunomide has made a big
difference. She said she no longer has to get a letter from her doctor if she is going away to
say she is bringing needles onto a flight. If she is staying at a hotel she no longer has to ask
for a room with a fridge, so she can store the needles – “I don’t have to think about it
anymore. I’ve forgotten. I’ve completely wiped out life before teriflunomide. It’s gone.”
JT believes, from her experience, that teriflunomide would change the lives of people with MS
if it was made available on the NHS. She explained: “Injecting takes away your
identity…Teriflunomide gave me my life back and it would be a great shame if it wasn’t
approved. Teriflunomide would give people with MS some quality of life back…give
people a chance to regain some control over this disease. It could change so many
lives like it has mine.”
Q13. Please advise us of the views of patients, carers and their
families on what the advantages or disadvantages of the new
medicine might be compared to existing treatments.
Existing Treatment
*Our response to this is
covered in questions
10,11,12 and 14
Advantages of new Disadvantages of
medicine
New medicine
Q14. To what extent will this new medication help to address the
unmet needs you have previously highlighted in Q11? Please
refer to guidance notes.
The MS Society strongly supports the approval of teriflunomide. We believe it offers a
genuine step change in the treatment of MS from both the clinical and wider patient benefit
standpoint, and has the potential to make a meaningful difference to the quality of life of
people with MS in Scotland.
We believe it has a number of clear advantages over existing treatments and will substantially
help address the existing unmet needs for this patient population that we highlighted in Q11.
Maintaining independence: As an oral tablet teriflunomide would significantly help people with
MS maintain their independence and fit around their lifestyles with minimum disruption. It is
particularly important in this respect compared to currently available treatments for this
indication which our research shows to affect many people’s ability to remain independent.
Ease of use / remaining in work: The oral administration of teriflunomide would be a positive
alternative to existing treatments which can prove problematic for social and working
situations. As a clinically effective treatment in reducing the risk of relapses and disability
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progression, it also has the potential to enable people with MS to remain in work for longer.
Preference for an oral tablet: It meets the need of 95% of people who told us they would
prefer an oral tablet form of treatment.
Reduction in treatment side-effects and improved adherence: The ease of taking a tablet
rather than self-injecting or going to hospital for infusions makes it more likely that adherence
will be higher. In addition to the difficulty of injecting, people with MS report developing painful
skin reactions, flu-like symptoms and headache. Teriflunomide is associated with a more
favourable side-effect profile, causing less disruption to the daily lives of those who take it.
Convenience: The convenience of having a MS treatment administered via tablet is favoured
by the majority of people living with MS (95%).
Lifestyle and impact on carers: As a convenient and effective tablet, teriflunomide would
support people with MS to maintain their lifestyle and quality of life, and that of their families
and carers. The impact on lifestyle and carers must not be underestimated and our evidence
shows that current treatments cause significant concern and disruption to both patients and
carers.
Effect on relapses and quality of life: In addition to the above benefits over existing
treatments, the clinical studies showed that teriflunomide was clinically effective in reducing
the frequency of relapses and risk of disability progression. These results are as effective or
superior to the data for existing drugs for newly diagnosed patients and therefore the MS
Society believes it to be an important breakthrough in the treatment of MS that will have a
major impact on outcomes for patients.
Section 4: Additional Information
Q15. In NO more than 5 bullet points please summarise the key
aspects of your submission that you feel are most important.
The MS Society strongly supports the introduction of teriflunomide as a treatment for people
with MS in Scotland.
-
The first oral tablet for this indication, teriflunomide offers a major step change in the
treatment of relapsing remitting MS, and is supported by our evidence on patient
preference (95 per cent said they would prefer a tablet form of treatment over
injections and infusions). Reasons cited for this preference are: added convenience;
physical and psychological barriers to injecting; freedom from injection site
reactions; ease of administration and less dependence of a friend, family
member or carer.
-
Teriflunomide meets accepted definitions of health-related innovation, including
those named by Prof Kennedy in 2009. In this case: the ability to offer a different (and
indeed preferable) mode of administration; the opportunity to be treated at home; the
offer of greater dignity and independence; and the ability to minimise the social
visibility of disease or care.
-
Teriflunomide offers many important advantages over currently available treatments:
for all the reasons outlined in this submission it is likely to result in improved quality
of life, greater independence, better treatment adherence, and support people
with MS to remain in work.
-
Teriflunomide has a more favourable side effect profile than existing treatment
options. Our evidence from patients shows that complications and side effects from
current treatments can cause distress, complications that need further management
and / or discontinuation.
-
The advantages of approving teriflunomide as a treatment option in Scotland are farreaching: improving clinical and quality of life outcomes for people with MS, as well as
reducing the costs for informal carers and the health and social care system.
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Q16. Please provide any additional information which you
believe would be helpful to SMC.
References:
MS Society. Perspectives of people with MS on relapses and disease modifying drugs (2010)
The Work Foundation. Ready to work? Meeting the employment and career aspirations of
people with Multiple Sclerosis (2011)
MS Society. My MS My Needs survey of people living with MS (2013)
If your organisation does not wish to be listed as a
contributor, please tick this box
Thank you for your submission of evidence.
Please email your completed form to maureen.stark@nhs.net or
catherine.tait@nhs.net. A hard copy should also be sent by post. If
this is the first time you have made a submission using this template,
please also provide a copy of your governing document to:
Scottish Medicines Consortium Secretariat
Delta House 50 West Nile Street
GLASOW G1 2NP
For further assistance, please telephone 0141 225 6989
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