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How to campaign for... - Treat Me Right

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Cymru
How to
campaign for...
Access to MS
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How to campaign for... Access to MS medicines in Wales
Cymru
3 Foreword
4 Introduction
5 About MS medicines
• Reliable and independent information about MS medicines
• MS medicines approved for use
8 Part 1: Access to MS medicines
approved by NICE
• Know your rights
• Getting access: know your facts
• How to “get loud”
16
Part 2: Access to MS medicines prescribed
under the NHS Risk Sharing Scheme
18
Part 3: Access to MS medicines without
NICE approval
• Know your rights
• Know the facts: Individual funding requests and
“exceptional circumstances”
• Appealing decisions
• After an appeal – “getting loud” if refused
22 Inspiration from others
• Pauline (Pembrokeshire)
23 The MS Society and Access to medicines
24 Template Letters
28 Useful sources and links
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How to campaign for... Access to MS medicines in Wales
Foreword
“The MS Society believes that everyone with MS in the UK should receive
the right medicine or treatment at the right time.
The next few years represent an exciting period for people affected by
MS. More MS treatments are being licensed and we hope the choice
of treatments available to help modify the progression and symptoms of MS will
increase still further.
The MS Society supports people affected by MS across the UK in campaigning
for access to treatments which have been proven safe and effective based on
accurate and impartial information. The key to people getting the MS treatments
they need is an understanding of how the NHS decides what treatments to make
available. This guide is intended to make it easier to do just that.
So whether you’re someone living with MS, a carer, or a friend or family member of
someone with MS, I hope this guide is helpful in your efforts to get the appropriate
treatment.”
Michelle Mitchell Chief Executive, MS Society
April 2014
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About this guide
The MS Society believes that people with MS
should have access to proven medicines for
their condition no matter where they live in
the UK. However, not everyone with MS gets
access to the right treatment at the right time,
and in some cases (as you will read later in this
guide) some people with MS have been denied
access altogether. This even includes those
treatments where there is a statutory obligation
on health authorities to fund prescriptions for a
particular MS medicine.
This guide contains useful information on how
medicines are made available on the NHS, how
to navigate local NHS systems and how to get
loud! We hope this guide will enable you to get
access to the right medicine for you, at the right
time. Whilst the MS Society does not provide
individual advocacy support, your experiences
are extremely valuable to our campaigning work;
please consider sharing your story with us.
This guide covers the NHS in
Wales and is for you if:
• you have not been assessed for a particular
MS medicine, but believe you might be eligible
• you have been told you are eligible for an MS
medicine, but you can not get the treatment,
for whatever reason
• you have been told you are not eligible for an
MS medicine, and want to question this
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The guide is split into three parts;
Part 1 looks at medicines approved for use
on the NHS by the National Institute for Health
and Care Excellence (NICE) or by the All Wales
Medicines Strategy Group (AWMSG)
Part 2 looks at disease modifying treatments
prescribed under the MS Risk Sharing Scheme
Part 3
looks at drugs which are licensed for
MS, but are not approved by NICE or AWMSG
guidance for use in the NHS
This guide has been inspired by people
affected by MS who have campaigned for
access to MS medicines.
The MS Society and the organisations who
have worked with us on this guide do not
support or endorse one product over any
other. The MS Society follows a strict policy
when working with industry.
How to campaign for... Access to MS medicines in Wales
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About MS
medicines
Reliable and independent
information about MS medicines
The MS Society believes that everyone with MS
should get the right medicine at the right time. To
help make this a reality, two things need to happen:
If you are thinking about your treatment options,
the following resources below might be helpful.
They are a useful starting point before you
discuss things in depth with your neurologist or
MS specialist nurse.
• you need information about the full range of
1. Get informed
options available, so you can make an informed
choice
• you need to know how local systems and
processes work – so you can get the treatments
to which you are entitled to
By 2015, the number of medicines available
specifically for treatment of MS may have
increased from 8 to 14. As choice increases,
it is crucial that people with MS are provided
with a full and informed choice of both licensed
medicines and those approved by NICE.
Read the MS Society’s information booklet on
disease modifying drugs.
The MS Society also produces a number
of information booklets on managing MS
symptoms, such as muscle spasm and stiffness
and bladder problems.
2. Keep up to date
New medicines are being developed all the
time - make sure you are aware of the latest
approved MS treatments as well as those in the
pipeline. This includes both disease modifying
treatments and those to manage symptoms:
The MS website is regularly updated with details
of these new medicines.
3. Weigh up the pros and cons
To make an informed choice, you need to
compare the risks and benefits of different
treatment options.
These resources should help you to identify a
range of MS medicines including the pros and
cons of each, and to understand the choice
of treatments potentially available to you when
talking to your consultant neurologist or MS
specialist nurse.
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MS medicines
approved for use
Before a medicine is approved for use it goes through
a long process, which takes a number of years.
Clinical trials – after initial toxicology and pharmaceutical studies, the
medicine is tested in patients for efficacy, to prove that it works, and for
safety.
Technical Approval - the evidence from clinical trials is assessed by
the Medicines and Healthcare products Regulatory Agency, working with
the European Medicines Evaluation Agency. The agencies look at all the
scientific data relating to the safety, efficacy and quality of each new
medicine.
Licensed – after their review the above agencies grant a Product Licence
or Marketing Authorisation which provides information for doctors and
for the patient leaflet, setting out the particular diseases or conditions
approved for the product’s use, how to use it, the dosage, the side
effects, and important safety information
Approved for NHS prescription – the National Institute for Health
and Care Excellence (NICE) or the All Wales Medicines Strategy Group
(AWMSG) have to approve treatments before they can be widely
prescribed on the NHS in Wales. Both organisations take into account the
cost as well as how well the drug appears to work, but
NICE decisions take precedent
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The three types
of MS medicines
Currently, the status of licensed medicines for
MS falls into three main categories: those
approved by NICE, those under the Risk Sharing
Scheme and those without NICE approval.
The medicines that come into these three
categories are:
1 Approved by NICE for prescription
on the NHS
• Tysabri (natalizumab)
• Gilenya (fingolimod)
• Aubagio (teriflunomide)
Even within these categories each medicine
will have its own specific eligibility criteria that
you have to meet.
Each category is discussed separately in the
following parts. This guide does not cover
medicines which are undergoing clinical trials
and have yet to be licensed for MS.
Tecfidera (dimethyl fumarate) and Lemtrada
(alemtuzumab) are two newly licensed
medicines for MS. They are both currently
undergoing NICE technology appraisals,
and this guide will be updated to reflect their
outcomes.
Botox (botulinum botox), while not approved by
NICE is recommended by the AWMSG for use
for MS within NHS Wales.
2 Prescribed under a special Welsh
Government Risk Sharing Scheme
• Copaxone (glatiramer acetate)
• Avonex (interferon-beta 1a)
• Rebif (interferon-beta 1a)
• Betaferon (interferon-beta 1b)
Extavia (interferon-beta 1b) is not listed in
the Risk sharing scheme, but can be prescribed
in a similar way.
3 Licensed medicines for MS
without NICE approval
• Sativex (delta-9-tetrahydrocannabinol
and cannabidiol)
• Fampyra (fampridine-SR)
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Part 1:
What does AWMSG do?
Access to MS
medicines
approved by NICE
or the AWMSG
The All Wales Medicines Strategy Group
was established in 2002 and brings together
NHS clinicians, pharmacists, healthcare
professionals, academics, health economists,
industry representatives and patient advocates
to provide advice on strategic medicines
management and prescribing to the Minister for
Health & Social Services.
What does NICE do?
The Group’s main functions are to:
• Advise the Welsh Government on future
developments in healthcare to assist in its
strategic planning.
• Advise the Welsh Government on the
development and implementation of a
prescribing strategy for Wales.
• Develop timely, independent and authoritative
advice on new medicines.
In England the National Institute
for Health and Care Excellence (NICE) decides
which medicines should be provided by the
NHS. Wales tends to follow this guidance.
NICE makes these decisions based on how
much the medicine will benefit patients in
relation to how much it costs.
If NICE decides the medicine does provide
value for money it is approved for use on
the NHS and they will issue guidance called
a �technology appraisal,’ which the NHS is
obliged to follow.
Until a drug is approved by NICE or
AWMSG, its availability depends on
decisions of individual Health Boards,
or individual patients’ successful requests
for �exceptional treatment’.
Know your rights
It helps to know what you are entitled to and
the policies which support these rights.
Once a medicine is approved, the NHS
across England and Wales has three months
to implement the guidance. After that, patients
are legally entitled to be prescribed the
treatment – so long as they meet the eligibility
criteria. These criteria are set out in the
product’s technology appraisal.
The following policy sets out your right to
access NICE-approved medicines in more
detail:
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Funding regulations
Section 7(6) of the NICE (constitutions
and functions) and the HSCIC (functions)
Regulations 2013 require clinical commissioning
groups, NHS England and local authorities to
comply with NICE technology appraisals within
3 months.
Legally, NHS bodies are responsible for taking
whatever steps are necessary to ensure the
uptake of recommendations. Prescribing
NICE-approved MS medicines to patients who
are eligible is therefore mandatory and takes
precedence over any earlier guidance from
AWMSG
Getting access: know your facts
As well as knowing your rights, it is important
to know the facts about eligibility. How can you
find out if you are likely to be eligible? Where
can you go for an assessment?
You will need to speak about it with your
doctor, i.e. your GP or neurologist. Members of
your local MS Society branch may be able to
help by sharing their knowledge of your local
NHS with you.
Getting an assessment
If you have MS and are exploring treatment
options, you will need to ask for a referral
to your nearest MS specialist centre to be
assessed.
There are three MS specialist centres in Wales
and three further centres in England that serve
people living with MS in Wales:
• If you live in Cardiff, Merthyr Tydfil or Rhondda
Cynon Taff you would be referred to the
University Hospital of Wales in Cardiff
• If you live in Newport, Monmouthshire,
Torfaen, Blaenau Gwent or Caerphilly you
would be typically be referred to the Royal
Gwent in Newport
• If you live in Bridgend, Neath Port Talbot,
Swansea, Carmarthenshire, Ceredigion
or Pembrokeshire you would typically be
referred to Morriston Hosipital in Swansea
• If you live in Anglesey, Gwynedd, Conwy,
Flintshire, Denbighshire or Wrexham you
would typically be referred to the Walton
Centre in Merseyside
• If you live in northern Powys
(Montgomeryshire) you would typically
be referred to the Royal Shrewsbury in
Shropshire. If you live in the south of the
county (Brecon and Radnorshire) you would
typically be referred to the Hereford County
Hospital
Checking eligibility
For every medicine approved by NICE or
AWMSG, there is a guidance document for you
and a more technical version for health care
professionals. Both set out who is eligible for
the treatment.
It is worth checking this guidance before your
appointment with a consultant neurologist,
particularly noting the criteria patients need to
meet to be considered eligible for treatment.
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NICE guidance: technology appraisals
The NHS is legally obliged to fund and
resource medicines and treatments
recommended by NICE. All published
technology appraisals for MS are publicly
available and can be read on the NICE
website.
This guidance can be a good prompt for
questions during the consultation. You might
want to ask the neurologist to clarify parts of
the guidance, if you are unsure how they apply
to you.
Once you have had an assessment at an MS
specialist centre, your consultant neurologist
will tell you if they think you are eligible for
treatment.
Challenging a decision
If you are not satisfied with your neurologist’s
decision and the reasons for this decision, you
are entitled to a second opinion.
You can request a second opinion through
your GP, who can refer you to a consultant
neurologist of your choice.
To help you choose:
• ask for your GP’s advice
• approach members of your local MS Society
branch, who might have valuable experience
• use the Dr Foster website:. Simply select
�neurology’ under �speciality,’ type in your
postcode and then hit �find’
Once you have chosen, the GP will write to the
neurologist you have selected and request a
second opinion on your behalf.
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How to
Get Loud!
If you have been assessed as eligible for a
NICE-approved MS medicine but you can not
actually get a prescription for the treatment you
can challenge this by following the MS Society’s
7-step plan on how to �get loud’.
Remember that others have done this before
and succeeded, so do not lose hope if a local
resolution does not work.
Step 1: Seek support
If you have a problem getting hold of a
treatment, the chances are it’s also an issue for
other MS patients in your area.
• Your local MS Society branch or support
team might know of people with the same
problem in your area.
• Talk to your consultant or MS nurse about
helping you and ask about any local issues. It
is important to identify the particular reasons
why the medicine is not available in your area,
so that you can address these directly.
Step 2: Make a formal
complaint but ensure you
follow local procedures
Ask your Health Board for a copy of its
complaints procedure – each has its own.
Remember, usually a complaint must be
made within 12 months of the event you are
complaining about occurring.
Where is there official
support on hand?
If you are unhappy with a decision and
would like confidential advice, support and
information on health-related matters, then
the local Community Health Council (CHC)
can offer support.
Often, a complaint is written as a letter to the
Chief Executive of the Health Board. To make
quite sure it gets logged as an official complaint
copy your letter into the complaint form used
by the Health Board.
You can find a template letter and further
guidance for writing to your Health Board on
page 24 (Letter template A)
Some handy tips!
1. Keep your complaint succinct – only
explain what is necessary.
2. You may find it helpful to detail events
chronologically – this might help with the
structure of your complaint.
3. Attach any supporting evidence such as
letters, emails and any relevant notes to
the end of the form.
Step 3: Seek local resolution
Ask the Health Board to meet with you to help
resolve your complaint.
If they will not do this, and do not address your
concerns in writing to your satisfaction, then it
is time to involve your local AM .
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Step 4: Involve your local
Step 5: Share your story
AMs can put pressure on the Health Board and
on Welsh Ministers regarding your situation.
With your permission, they can help promote
your case in the media and raise it in the
National Assembly for Wales. More importantly,
they might act on your behalf and speak
directly to the Health Board about your case.
Involving the media in your campaign to
access MS medicines can be a good way to
create greater awareness of the issue and put
pressure on Health Boards, but the media
spotlight might not be for everyone. Journalists
will want to know your full name, age, where
you live and specific details about your MS –
so it is important to consider this before going
down this route.
Assembly Member (AM)
Find your local AM by entering your postcode
on the National Assembly for Wales website or
call the information line on 0845 0105500.
Copy your AM into the complaint letter you
send to the Health Board. In your cover letter,
make sure you include the following details:
• Who you are and where you live (so that they
can verify you are a constituent)
• Your contact details
• A brief outline of your case and your efforts to
gain access to MS medicines
• Copies of key documents from the Health
Board or clinician
• What you would like your AM to do for you –
this could include asking your AM to act on
your behalf
There is a template for this kind of letter on page
27 (letter template C).
Many AMs hold surgery sessions where
constituents can raise their particular local issues.
There is no substitute for a face-to-face meeting
with an AM – no matter how brief. So if you can
arrange a time to meet them, it is worth doing.
Remember to keep in touch with your AM and let
them know if your situation changes.
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with the media
If you feel you may want to share your story
with the media, you should consider the
following guidance:
• Telling your story in the media should be a
last resort in your campaign; your story will
be stronger if you have already taken all
reasonable steps to raise the issue with your
medical professionals and the Health Board.
Going to the media too soon may be counterproductive, but if you have taken these steps
and have still been frustrated in your efforts
to access an MS medicine, then approaching
the media may be appropriate and can be
very powerful
• At the MS Society, we always need strong
examples of injustice to strengthen our
campaigning, so we would be happy to
speak to you about your story before you
contact the media. In the first instance, you
should contact MS Society Cymru, and if
appropriate, they may put you in touch with
our Press Office. It may be that your story
highlights a wider issue, and our Press Office
may be able to support you in speaking to
the media on this basis.
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• If you decide to contact the media directly,
you should think through the key points of
your story before you make contact. It is
usually helpful to think about the five Ws:
what, when, who, where and why. It is
not necessary to attempt to write a �press
release’; a short email summarising your case
should suffice, perhaps followed up by a
phone call to the newsdesk of the newspaper
or radio station you want to approach. Ensure
you give them your full contact details so that
they can call you back.
• Before you speak to any journalists it is a
good idea to be prepared: write down what it
is you want to say, the message you want to
get across and stick to the main points.
• It may be helpful to involve your local AM.
They can help generate interest in a story
and support your case in the media.
Our press team is extremely skilled and
experienced in dealing with the media and
may be able to offer further information or
advice. You can contact them by emailing
pressoffice@mssociety.org.uk
Step 6: Take it to the next
level – the Ombudsman
If you have sought local resolution, and got
your local AM on board, and still no progress is
being made, it is time to take things to the next
level – the Public Services Ombudsman
for Wales.
The Ombudsman is independent of NHS Wales
and the Welsh Government. The Ombudsman
has a duty to investigate further if you can show
that the Health Service has not acted properly
or fairly (or has not provided a good service).
To get the Ombudsman to take up your case,
you must have:
• already submitted a complaint to your local
Health Board
• gone through all the appeals and local
resolution opportunities the Health Board
provides
Then, you need to complete a short form. This
will ask:
• for information on the original complaint and
why you are unhappy
• how you have been affected, and what you
would like to happen.
• do not forget to attach any supporting
evidence. This includes letters, emails,
records of meetings, and notes you have
made about the situation.
The Ombudsman does not have to investigate
every complaint. You will need to make it clear
how your complaint fits with the scope of the
Ombudsman’s duties.
The Public Services Ombudsman for Wales can
investigate if:
• there is evidence of administration fault or
service failure
AND
• there has been injustice or hardship caused
as a result
A carer or relative can make the complaint to
the Ombudsman on your behalf.
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If you can show how your case meets these
criteria, the Ombudsman may investigate the
case with the local Health Board. Alternatively,
it might intervene before investigating if it is
considered that the evidence is so clear that
the Ombudsman can seek resolution directly.
The Ombudsman is committed to keeping you
informed at every stage. So call their helpline
(01656 641 150) if at any time you are not clear
about progress in your case.
Making a complaint to the
Ombudsman
Details of the procedure and a complaints
form are available on the Ombudsman
website.
If you do not have access to a computer, call
01656 641150 for further information and a
hard copy of the form.
Step 7: Seek judicial review
A judicial review is a type of court proceeding.
A judge reviews the decision or action made by
a public body, in this case a Health Board, and
decides if it was lawful.
A judicial review challenges the way in which a
decision has been made, rather than the rights
and wrongs of the conclusion reached.
You can only challenge a decision in this way if
it was:
• illegal
• the procedure was unfair
• the decision was so unreasonable that no
reasonable public body could have taken it.
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What happens if NICE reject a medicine
licensed for MS?
NICE decide whether medicines are cost
effective for the NHS to prescribe. If an MS
medicine does not receive NICE approval, it will
not be automatically and widely available on the
NHS.
It will only be possible for people with MS to
access a treatment with a �no’ decision from
NICE if a clinician believes that the medicine
would be effective and if the Health Boards
is willing to pay for the medicine through an
individual patient funding request.
The exceptions to this are those medicines
for MS prescribed under the special Welsh
Government MS Risk Sharing Scheme.
The likelihood of a Health Board granting
access to a medicine that NICE has decided
is not cost-effective is seriously reduced
unless individual circumstances prove to be
exceptional.
How to campaign for... Access to MS medicines in Wales
Flow diagram for accessing NICE or
AWMSG approved medicines for MS
Patient has conversation with consultant neurologist and is presented with
a range of treatment options.
Patient is assessed to determine whether they meet the eligibility criteria for the
MS medicine as set out by NICE or AWMSG.
Neurologist confirms eligibility
Yes
No
Patient referred for treatment
Patient requests second opinion via GP
Treatment available locally
Yes
No
Talk to MS Society Cymru office
Get loud!
If local resolution and
letters do not work –
then the last resort is to
apply public pressure.
You can help raise
awareness through the
local media, which may
help to apply pressure
on the Health Board.
Your AM can also act
on your behalf.
Second opinion and assessment take place
Yes
No
Patient not eligible
Register formal complaint with CEO of
the Health Board – remind them of their
statutory duty. Copy in your AM.
Arrange a meeting with the Health Board
and your local service development
officer to seek local resolution.
If you do not
receive a
satisfactory
answer at
each level
and observe
no action,
move to the
next stage.
Complain to the Public Services
Ombudsman for Wales.
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Part 2:
Access to
medicines
on the Risk
Sharing Scheme
In 2002, NICE did not recommend Avonex,
Betaferon, Rebif and Copaxone for use on
the NHS. NICE had concluded that these
disease modifying treatments (DMTs) would not
represent a cost-effective use of NHS resources
under the arrangements for purchasing
medicines that existed then. The MS Society,
together with many people affected by MS,
campaigned for this decision to be reversed.
Instead, the Welsh Government with the
Department of Health ruled that the four DMTs
for relapsing remitting MS should be prescribed
on the NHS under an arrangement known as
the �MS Risk Sharing Scheme’.
This arrangement with the manufacturers
ensured that the medicines would be provided
on the basis that certain clinical outcomes
would be met. The cost to the NHS would be
adjusted on a sliding scale if outcomes differed
from those agreed.
The medicines Avonex, Betaferon, Rebif and
Copaxone were made available on prescription
according to the Association of British
Neurologists (ABN) prescribing guidelines, which
have since been revised. The ABN guideline
continues to apply across the UK.
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These guidelines represent a consensus of
medical opinion among consultant neurologists
about when people with MS should begin
treatment. Similarly, they also describe when a
person with MS should end treatment.
Accessing MS medicines under
the Risk Sharing scheme
These four medicines can be prescribed by a
neurologist at most of the MS specialist centres
across the UK. You can find where your nearest
centre is on the MS Society’s website
If you have relapsing remitting MS but have not
been offered a referral to a specialist centre,
speak to your neurologist about a referral and
assessment. Remember, your suitability for
these treatments should be assessed and
discussed alongside other treatment options.
The Health Service Circular’ (2002) is a
policy document covering England, Wales,
Scotland and Northern Ireland. It provides a
legal assurance that:
“All patients with relapsing remitting MS,
and those with secondary progressive MS
where relapses are the dominant clinical
feature, who meet the criteria developed by
the ABN are eligible for treatment under the
scheme.”
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Know your rights
Every Chief Executive of Health Boards in
Wales received a Welsh Government �funding
directive’. This says that people with MS who
meet the prescribing guidelines as set out by
the ABN, should receive the treatment.
This funding directive (known formally as the
Health Service Circular) still applies. No one with
MS who fits the criteria as set out by the ABN
should be denied access to these treatments. If
this is happening to you please do not hesitate to
let the MS Society Cymru office know about it –
mscymru@mssociety.org.uk or 020 8438 0700.
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Part 3:
Access to licensed
MS medicines
without NICE
approval
There are some medicines that are licensed for
MS but have not yet been approved by either
NICE or AWMSG for NHS-wide prescription.
Without this approval, Health Boards are under no
legal obligation to prescribe the medicine. Instead,
Health Boards make the decision themselves,
at a local level. Requests for these medicines go
through a process involving an �individual funding
request’ considered by a panel, which decides if
your case should be treated as an exception.
At the moment, there are two medicines that
falls into this category – Sativex and Fampyra
but other medicines are in the pipeline.
Compared to NICE-approved medicines, there
are fewer policies that support your entitlement to
licensed MS medicines that have not been approved
by NICE. However, you can still make a case for your
individual access to these treatments.
Know the facts
While the Health Board is not legally obliged
to provide every treatment that a patient (or a
group of patients) may request, there will be
procedures for individual funding requests in
exceptional circumstances.
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The Health Board should explain to you how this
system works, since procedures often vary locally.
The Welsh Government has published draft guidance
to Health Boards All Wales policy making decisions
on individual patient funding requests (IPFR).
What is the Usual Process for
Individual Patient Funding Requests?
If your neurologist or GP thinks that you would
benefit from a particular medicine that has not
been approved by NICE or AWMSG, they will
need to put in an individual funding request for
the treatment on your behalf. You and your
neurologist, MS nurse or GP have to show the
exceptional circumstances that apply in your
case, to convince the local individual funding
request panel to approve the treatment for you.
Examples of the kind of points that may help to
convince the panel are given below:
• Show how you are likely to gain significantly
more benefit from the medicine than might
normally be expected for patients with MS.
• Show that you have tried other medications
which have not provided adequate symptom
relief or have caused intolerable side effects.
• Highlight alternative treatment options
available – are these what you would choose
to have? Or are these invasive and associated
with considerable costs to the NHS?
• Illustrate lifestyle factors – for example, taking
a particular medicine might allow you to be
more independent, and lessen the need for
a high level of care provision for certain daily
tasks. This is just one example; many other
factors could be taken into account.
How to campaign for... Access to MS medicines in Wales
Back to
contents
• Show in the request why you and your health
care professional think the medicine will be
effective for you and how it will improve your
quality of life to a greater extent than for the
general population of people with MS. This
is particularly important when it is recognised
that a treatment is not effective for everyone.
Funding requests are not accepted directly from
patients, but it may be possible for you to write
to the panel in support of your case, showing
how any of the points above are relevant to you.
Who considers the funding request?
Your request for NHS funding will be considered
by an Individual Patient Funding Request panel,
which will consist of the Medical Director, Public
Health Director, Director of Therapies and
Clinical Science (or one of their deputies, and
a member nominated by the local Community
Health Council.
Before the request reaches the panel, there is
a screening process intended to “weed out”
cases that are clearly not approvable, or need
to be considered specially (e.g. if they raise
important policy issues). If this applies the
Health Board will send out a standard letter.
Once the panel has considered the request,
a letter will usually be sent to you and your
doctor, containing:
• the panel’s decision
• their reasons for making this decision
What if your funding request
is refused?
If your GP or neurologist feels that there are
problems with the way the decision has been
made, then they may appeal by writing to the
local Individual Funding Request Appeal Panel.
Appeals are not accepted directly from patients.
However, patients can be invited to write to
the panel in support of their case. There is a
template for this kind of letter on page 26 –
(Letter Template B)
Appealing the decision
Your GP or neurologist can appeal the refusal
decision if:
• there is additional and new information
OR
• there is evidence that the process has not
been handled appropriately
If you are thinking about appealing, stay positive
and persevere. Good luck and do not give up!
Here are some pointers to help you through the
appeals process:
1 Talk to your consultant or MS nurse about
any local issues. It is important to identify
the particular reasons why treatment is
not available in your area, so that you can
address these directly.
2 Make sure you know how your Health
Board’s appeals process works. This will vary
depending on where you live. Details of the
process should be available on request from
the Health Board – the person who sent you
the refusal letter should be able to help with
this. The process might also be available
from the Health Board’s website.
3 There will be a time limit for appealing. After
this, the Health Board might not consider
an appeal. Make sure that the decision
is appealed within the specified number
19
How to campaign for... Access to MS medicines in Wales
Back to
contents
of days after receipt of the refusal letter
otherwise the Health Board has the right
not to consider your appeal. The time limit
should be stated clearly in the refusal letter.
If no time limit is specified, it is still a good
idea to check this with your Health Board.
4
If you decide to write directly to the Panel in
support of your case, make sure you include
as much information as possible about
why you think the drug concerned will be
beneficial for you.
5 Y ou might be invited to speak to the panel
to support your written statement. This can
sometimes strengthen your appeal, so take
the opportunity if you can. But you should
not feel under any pressure to appear before
the panel if you think this might cause
you additional stress or anxiety. The panel
might allow someone else to make the
presentation on your behalf.
6 H ealth Boards vary in how often their appeals
panels meet. For example, some meet every
month, some every three months.
7 T he appeal panel will usually be a group
of people who had no involvement in your
original request for the medicine.
You should receive a letter shortly after the
appeal, telling you:
• the panel’s decision
• a clear explanation of how it reached its
decision
20
After an appeal: “Getting Loud”
if refused
Local Health Boards are not under the same
obligation to fund prescriptions as for a NICE or
AWMSG approved medicine. However there are
still ways you can challenge your Health Board’s
decision if the answer is still �no’ after the
appeal. If you still feel that you have a strong
case, then it’s time to “get loud”.
Firstly, try to resolve it locally by making a formal
complaint to your local Health Board. If this
does not work you may consider contacting
your AM or approaching the local press. If you
feel that your appeal for exceptional treatment
has not been handled fairly you can complain to
the Public Services Ombudsman for Wales. This
process is described in Part 1, steps 1-6.
Remember, if you are being denied access to
an MS medicine share your story with the MS
Society.
How to campaign for... Access to MS medicines in Wales
Flow diagram for accessing licensed MS
medicines without NICE approval
Following consultation with Neurologist patient is recommended for treatment with a
product that has not been approved by NICE
Neurologist submits an “Individual Patient Funding Request” to
the Health Board
Request considered by Individual Patient Funding Request panel
Refused
Granted
Neurologist may appeal
in writing to the |Panel
Consider if you want to write
directly in support of your case
Appeal
Refused
Appeal
Granted
Prescription can be
issued by Neurologist
Get loud!
If you have not succeeded even after appeal – then the last resort is to apply
public pressure.
• Write to your AM who can also act on your behalf.
• You can raise awareness through the local media, which may help to apply pressure on the
Health Board.
• If your appeal has been unfairly handled you could complain to the Public Services
Ombudsman for Wales.
21
How to campaign for... Access to MS medicines in Wales
Inspiration
from others
Back to
contents
Pauline
(Pembrokeshire)
How the campaign started
Sativex was first suggested by her Consultant
Neurologist in 2010. Her GP contacted the
Health Board but they rejected the request.
Pauline’s life was hell with the spasms in her
legs, it felt as if she was being tortured every
day and nothing seemed to help. She became
depressed, her husband felt helpless and there
seemed to be nothing that either of them could
do to improve the situation.
What happened next?
Pauline’s neurologist referred her to see a
Consultant for Rehabilitation Medicine. Over
the previous 33 years she had seen many
neurologists and doctors and tried a variety of
different medicines, but nothing had helped.
After considering different treatment options
the Consultant for Rehabilitation Medicine sent
a request to Hywel Dda Health Board for a
prescription of Sativex.
Pauline had not heard anything for weeks and
so decided to get in touch with her local MP
and local AM. She explained her situation and
their office took up the case - writing letters and
putting pressure on the Health Board.
Pauline also involved her MS nurse and
Consultant Neurologist. However both the MS
team and the Consultant for Rehabilitation
Medicine were from separate Health Boards,
so her case was referred to the Welsh Health
Specialist Service Committee (an all-Wales
body for prescribing specialist medicines and
treatments).This led to a further period of waiting.
22
As a result of the campaign
After battling for almost a year, with the support
of professionals and her local MP, Pauline was
finally told that she would be given an Individual
Patient Placement for Sativex for a trial period of
3 months.
Sativex has had a very positive effect on
Pauline’s quality of life. The spasms have
reduced enormously and her fatique has
reduced.
Pauline remains concerned that the Health
Board could end the treatment at any point,
so she has been working with the Consultant
for Rehabilitation Medicine to document her
progress and build up evidence that it is having
a positive effect.
Pauline’s advice to anyone else in a similar
situation is simply, “Do not give up and be
persistent”
How to campaign for... Access to MS medicines in Wales
The MS Society and
Access to Medicines
MS Society Cymru is working hard to improve
local and national efforts to implement NICE
technology appraisals for MS and to improve
access to MS medicines across Wales.
We want to see all responsibility for reviewing
new medicines and guidance in Wales
transferred from NICE to AWMSG. The current
review process with two organisations creates
unnecessary duplication and has seen guidance
of Welsh experts later over turned by the UK
Department of Health.
The MS Society Cymru Manifesto for the
Welsh General Election 2011 called for the
establishment of a new body, Medicines WalesMeddyginiaethau Cymru, to replace AWMSG
and NICE in Wales. The manifesto also called on
this new organisation to review the 2003 NICE
guidelines for MS with a view to updating them
for a Welsh context.
It is really important for us to understand whether
this guide has helped you to campaign for
access to MS medicines. Please help us to
understand this by getting in touch with the MS
Society Cymru office and let us know what you
think of the guide at mscymru@mssociety.org.uk
or 020 8438 0700.
If you would like to support the work of MS
Society Cymru or find out what local campaigns
are happening in your area, then sign up to our
campaigns community.
23
How to campaign for... Access to MS medicines in Wales
Template letter A
- To submit a formal complaint about lack of access to NICE-approved medicines
To copy and paste this letter or to download this letter as a word document, please visit:
http://www.mssociety.org.uk/ms-resources/formal-complaint-campaigns-template-letter-A-wales
Insert your name
Your address
Post code
Name of Chief Executive of Health Board
Address and postcode
Insert date
Dear, [insert name of Chief Executive]
Formal complaint: Access to [insert name of drug]
As a patient with MS and/or as a member of the local MS Society branch, I am extremely
concerned that [insert name of medicine], which is approved by the National Institute for Health
and Care Excellence (NICE) as a treatment for multiple sclerosis, is not being prescribed by [insert
name of Health Board]. I would therefore like to register this letter as a formal complaint.
[insert name of medicine] is licensed for use in the UK and was approved by NICE in [insert date] for
patients with [insert type of MS] MS. As you will be aware, technology appraisals from NICE carry a
three month implementation period; after this period the Health Board has a legal obligation to fund
the approved treatment. The directions enforcing this provision derive from Section 97 of the NHS
Act 1977 as amended by the Health Act of 1999.
The Secretary of State has directed that the NHS provides funding and resources for medicines and
treatments recommended by NICE technology appraisals. I would urge the Health Board to review
tools developed by NICE to help organisations implement its guidance on [insert name of medicine].
• If you have been told you are eligible for treatment (or know of others who are eligible) but for
whatever reason, there is a problem providing the drug locally, state the reasons you have been
told/have heard. For e.g. lack of space within the Health Board to set up an infusion unit, lack of
capacity in terms of nursing staff to run an infusion unit or lack of resources.
• Use this space to write down your concerns - a lengthy delay could mean that you as a patient,
no longer fulfil the clinical criteria set out by NICE. Therefore use this as an opportunity to state
clearly, in a few sentences, what this delay means to you as someone living with MS concerned
about disability progression.
24
How to campaign for... Access to MS medicines in Wales
• If you are a branch member and know of others in your area who are being denied treatment;
state this here.
I would appreciate a response detailing why the treatment has not been made available to patients
with MS in [insert location] area. In the response, I would like the Health Board to outline what
actions it will take, how and when to resolve this situation as soon as possible. I hope this issue will
be addressed as a matter of urgency.
Yours sincerely,
[Insert signature and full name]
MS Society Cymru recommends that you consider copying your letter to the following key influential
people who can help to resolve your case:
CC. Name and address of consultant neurologist
CC. Name and address of your local AM
CC. Name and address of your Community Health Council
To make absolutely sure that your letter is logged as an official complaint, copy and paste your
letter into an official CHC complaints form to ensure your letter is registered under the NHS formal
complaints procedure. The form should be available on each CHC website – to find your local CHC,
visit http://www.chc.wales.nhs.uk
Don’t forget to send a copy of your letter to MS Society Cymru by emailing: mscymru@mssociety.
org.uk or send a hard copy of your letter to: MS Society Cymru, Temple Court, Cathedral Road,
Cardiff, CF11 9HA
25
How to campaign for... Access to MS medicines in Wales
Template letter B
To submit to an Individual Funding Request Appeal Panel
To copy and paste this letter or to download this letter as a word document, please visit:
www.mssociety.org.uk/ms-resources/individual-funding-request-campaigns-template-letter-b-wales
Insert your name
Your address
Post code
Chair
[title of local panel]
Address and postcode
Insert date
Dear, [insert name of Panel Chair]
Letter in support of application to prescribe [insert name of drug]
As a person living with multiple sclerosis I have been advised by my [neurologist/GP] that [insert
name of medicine] should be prescribed for me. My doctor submitted an individual funding request
for [insert name of medicine] on [insert date]. However I have been informed that their request
has been refused. I am writing to you in support of an appeal by my [neurologist/GP] against this
decision and would ask you to consider the following in support of my case.
• Demonstrate here how the treatment would be significantly beneficial to you over other available
treatments and why your case should be treated as an exception. If you have tried other
treatments which have not worked/produced side-effects mention this here.
• It is important to highlight the wider impact a treatment can have on your life, for example, the treatment
may allow you to be more independent and reduce the need for high level care provision.
• Use this space to write down your concerns – e.g. a lengthy delay might mean you progress
beyond the point where you would likely benefit or your symptoms might have a major impact on
your quality of life
I am distressed at being denied a treatment that has been advised as being suitable for me and I hope the
panel will reconsider their decision to refuse me [insert name of medicine] in light of this letter of support.
Yours sincerely,
[Insert signature and full name]
Consider copying your letter to the following key influential people who can help to resolve your case:
CC. Name and address of consultant neurologist / GP
CC. Name and address of your local AM
CC. Name and address of your CHC
26
How to campaign for... Access to MS medicines in Wales
Template letter C
Template for writing to your AM
To copy and paste this letter or to download this letter as a word document, please visit:
http://www.mssociety.org.uk/ms-resources/cover-letter-mp-campaigns-template-letter-c-wales
Your name
Your address
AM’s name
National Assembly for Wales
Cardiff Bay
CARDIFF
CF99 1NA
Date
Dear [insert name of AM]
[drug name]
My name is [insert name] and I live [insert constituency and address]. I am writing as a person with multiple
sclerosis patient who has recently been told that [insert name of Health Board] will not prescribe me [insert
name of medicine], which has been approved by the National Institute for Health and Care Excellence.
I have written a formal letter of complaint to the Health Board and I include a copy for your reference.
• briefly describe what the medicine is and for what symptom/condition it has been licensed to treat
• briefly explain how the new treatment may benefit you and if other treatments have not worked or
been appropriate for you
• briefly explain what steps you have taken so far to gain access to the medicine
I am distressed at being denied a licensed treatment by my local Health Board when the efficacy and safety
has been reviewed and approved by the relevant authorities. [If you are aware that the treatment has been
made available to other patients in your area or in other areas, then mention this too on the basis that you
feel it is potentially unfair to have treatments like this restricted on a regional basis].
In light of this and bearing in mind the problems I face I now seek your support in asking [insert name
of Health Board] to review its decision on the provision of [insert name of medicine]. I would be very
grateful if you could raise my concerns with [insert name of chief executive of Health Board] and I look
forward to your response.
Yours sincerely,
Your name
NB It is suggested that you keep the whole letter to just 2 pages
Remember to include copies of key documents from your Health Board or Clinician
27
How to campaign for... Access to MS medicines in Wales
Useful Sources and Links
MS Society Cymru
Temple Court
Cathedral Road
Cardiff
CF11 9HA
Tel: 020 8438 0700
MS Society
MS National Centre
372 Edgware Road
London
NW2 6ND
Tel: 020 8438 0700
MS Society Scotland
National Office
Ratho Park
88 Glasgow Road
Ratho Station
Newbridge
EH28 8PP
Tel: 0131 335 4050
MS Society Northern Ireland
The Resource Centre
34 Annadale Avenue
Belfast
BT7 3JJ
Tel: 02890 802 802
28
The Multiple Sclerosis Society
http://www.mssociety.org.uk/
MS Helpline: The MS Helpline offers
emotional support and information to
anyone affected by MS in the UK. MS
Society documents available on the web
can be requested on the MS helpline.
0808 800 8000
Freephone Helpline number
helpline@mssociety.org.uk
Helpline email service
Open weekdays 9am-9pm (closed bank
holidays)
How to campaign for... Access to MS medicines in Wales
MS Society Documents:
Working with Industry
MS Society Policy Position Statement 1
www.mssociety.org.uk/ms-resources/ms-society-policy-working-medicines-andhealthcare-products-industry
MS Society Research on Beta Interferon, Copaxone and Tysabri
www.mssociety.org.uk/what-is-ms/treatments-and-therapies/beta-interferon-andglatiramer-acetate#beta_interferon
MS Society information on licensed disease modifying drugs
www.mssociety.org.uk/what-is-ms/treatments-and-therapies/licensed-diseasemodifying-drugs
Disease Modifying Drugs
MS Society: MS Essentials 06
www.mssociety.org.uk/ms-resources/ms-essential-06-disease-modifying-drugs
MS Society List of MS Centres around the UK
www.mssociety.org.uk/near-me
Information from other organisations
National Institute for Health and Care Excellence
List of Published NICE Appraisals
NICE Guidelines are downloaded on-line or via telephone on: 0845 003 7783
http://guidance.nice.org.uk/TA/Published
NICE Clinical Guidelines on MS
http://guidance.nice.org.uk/cg8
Dr Foster health and medical Guides – Web-site
www.drfosterhealth.co.uk/
The Public Services Ombudsman for Wales
www.ombudsman-wales.org.uk/
Helpline: - (01656) 641 150
Association of British Neurologists’ guidelines for prescribing in multiple sclerosis
Association of British Neurologists, November 2009
www.theabn.org/abn/userfiles/file/ABN_MS_Guidelines_2009_Final(1).pdf
29
How to campaign for... Access to MS medicines in Wales
Cost effective provision of disease modifying therapies for people with Multiple
Sclerosis
Health Service Circular 2002/004
www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/
Healthservicecirculars/DH_4004332
Community Health Councils (CHCs)
Details of the local CHC may be found by using the on-line directory or contacting
your local hospital or GP
http://www.chc.wales.nhs.uk/
Department of Health and Social Services - Welsh Government
Provides information on health and social services in Wales, including contact
details for local organisations and Welsh Government guidance
www.wales.gov.uk/health
0845 010 3300
30
How to campaign for... Access to MS medicines in Wales
MS Society
MS Society Cymru
Temple Court
Cathedral Road
Cardiff
CF11 9HA
www.mssociety.org.uk
Helpline 0808 800 8000
Multiple Sclerosis Society
Registered charity numbers 1139257 / SC041990
Registered as a limited company in England and Wales 07451571
31
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