Evidence submitted by the MS Society (NICE
65)
EXECUTIVE SUMMARY
The MS Society welcomes this inquiry. We are
the largest charity dedicated to supporting people living with
MS. Our most recent involvement with a NICE appraisal has been
the Tysabri STA which is ongoing at the time of writing.
In our submission we draw attention to the tension
between NICE's economic and utilitarian principles and patient
representative groups' duty to support the individual in accessing
the best treatments, regardless of how much these cost. We also
raise concerns about the accountability of NICE and the lack of
transparency in some of its processes. We urge NICE to enter into
genuine engagement with patient groups and to take into greater
consideration the wider cost impact treatments may have on NHS
and social care demands.
We contributed to a previous Health Select Committee
session on NICE in 2002. Many of the points we made at that time
with regard to the transparency of the NICE process and a lack
of clarity about its operations still apply.
At the end of our submission we make the following
recommendations:
— There should be greater clarity and
transparency in NICE's decision making process. This would include
revising the appeal system to ensure it is truly independent.
This would go some way to restoring faith in NICE.
— Greater weight should be given to
improvements in patients and carers' quality of life arising from
new treatments. Other costs associated with a disease should be
included in the cost model used by NICE.
— NICE should either publicly inform
patient groups it is not interested in their input, or should
try to engage more constructively with them. The current mood
of hostility does no-one any good. We would welcome a patient
organisation seminar with NICE and with other charities so that
they can clearly set out what they see as our role. We would then
undertake to communicate this to our members so that their expectations
of NICE were more clearly informed.
— Central government should take more
responsibility for ensuring that the laudable MS guideline from
NICE is not let down at local implementation level.
ABOUT MULTIPLE
SCLEROSIS AND
THE MS SOCIETY
1. Multiple sclerosis (MS) is an autoimmune
disease in which the central nervous system comes under attack
from the immune system. This causes damage to myelin (the coating
on nerve fibres), leaving scars known as lesions or plaques. This
myelin damage disrupts messages travelling along nerve fibres,
slowing and distorting them if they get through at all.
2. The damage caused in MS leads to a range
of symptoms, including loss of sight and mobility, pain, fatigue
and depression. While life expectancy with MS is close to normal,
the quality of life with the condition is often very poor. There
is no cure for MS and few effective treatments, but living with
MS can be made more bearable with proper information and support.
3. Our annual income is £27.8 million,
with three-quarters of our income from voluntary donations. In
2005, we received £329k from the pharmaceutical industry
(1.2% of our total income), principally to fund the MS nurse scheme
which we manage at the request of the Association of British Neurologists.
Our role is to act as an independent conduit for these funds to
ensure they are put into MS nurse posts in the most appropriate
locations. We declare all donations of more than £10,000
in our Annual Report and Accounts.
Why NICE's Decisions are Increasingly Being Challenged
4. One of the key principles underlying
NICE appraisals is that they should:
"Assess the clinical and cost effectiveness
of treatments or management approaches" [our emphasis]. The
Single Technology Appraisal, which is designed for the appraisal
of a single product, device or other technology, "considers
evidence on the health effects, costs and cost effectiveness of
a health technology in comparison with current standard treatment
in the NHS in England and Wales". Health effects include
both benefits and harms (side effects). This includes the impact
on health-related quality of life (for example, relief of pain
and disability), and the probable effects on mortality. It also
considers estimates of any associated costs, concentrating particularly
on costs to the NHS and Personal Social Services. [95]
5. This basis for NICE's decision-making
process flies in the face of government rhetoric about patient
choice in health care. For example:
"Giving people more choice and control over
the treatment and services they receive will... remain a key priority
as we continue to develop health and social care services that
put the patient first" (Choice Matters, 2006). [96]
6. The concept of patient choice puts the
individual at the centre of their health care. It suggests an
entitlement for an individual to be involved in their health care
decisions and to have some control of the treatment and services
they receive.
7. But in reality, treatment choice is often
limited by NICE guidance on drugs. This is a particular problem
in complex conditions like MS where drug treatments are expensive,
and where efficacy data is far from overwhelming or clear cut.
8. As a result, we have NICE using economic
and utilitarian principles to assess the viability of drug treatments
in direct tension with choice in health care reform. You can only
choose what is available to you; if the only drug treatments that
suit your condition are ruled out on cost, you have no choice
at all.
9. Mixed signals are also sent out about
NICE's independence. In theory, it can make its decisions outside
of the current political agenda. But political interventions,
such as the Secretary of State for Health's comments on Herceptin,
suggest that NICE does respond to political pressure. This strengthens
the perception that NICE's decisions are influenced by external
factors and encourages organisations like ourselves to challenge
NICE. The Herceptin case (and the beta interferon campaign in
MS) suggests that if you shout loud enough, NICE will listen.
10. Several of the high profile challenges
to NICE have been led by or included patient representative charities.
We suggest that this is because organisations like us believe
our individual members have an intrinsic value. We believe each
of them, as a person living with MS, deserves the best possible
treatment and that cost should not be an issue. We do not accept
that a person with MS should be condemned to a lower quality of
life because of the cost of a drug.
11. We understand that NICE helps the NHS
take a rationing approach, and that this is necessary in an environment
with limited funds. But while government policy encourages patient
choice, and while we are mandated by our members to fight on behalf
of individual people with MS who need expensive treatments, we
cannot accept NICE's cost-based decisions without challenge if
they result in MS treatments being limited.
12. Despite being able to sign up as stakeholders,
patient representative groups are often marginalised during NICE's
appraisals. The MS Society found its engagement in the recent
Tysabri STA confusing and our attempt to have reasonable discussions
with NICE was fruitless. The attitude we experienced was one of
hostility and we are aware other charities have met with a similar
response. There is also no clear process for patient representative
groups to follow to express concerns about a NICE decision, other
than through a public challenge.
13. The tight criteria used by NICE when
reviewing evidence means that the collective qualitative experiences
which patient groups can provide are often disregarded. Combined
with the lack of a truly independent appeal process, this means
that patient groups may feel excluded from the official process,
encouraging public lobbying against NICE.
14. One key problem may be that NICE might
not actually be interested in patient groups' opinions, but is
not prepared to say this publicly. In the Tysabri STA, we felt
as though our input was a token gesture by NICE rather than a
two-way consultation. We were concerned that when we urged NICE
to time its appeals process to ensure the consultation over Tysabri
did not clash with Parliamentary recess. NICE was not prepared
to take this into consideration. [97]It
was our opinion that MPs should be able to contribute on behalf
on their constituents living with MS. This experience of NICE
does not suggest an institution with any commitment to stakeholder
engagement.
15. We would urge NICE to either strive
to enter into genuine engagement with patient groups—we
have 44,000 members who mandate us to speak out on their behalf,
and we can also be a channel for information about drugs to our
audience—or to state openly they are only interested in
peer reviewed research. This would save us the extensive effort
and cost involved in taking part in an STA and would allow us
to focus our research and policy priorities to contribute in a
way that NICE could use.
16. The MS Society shares the concerns of
the Alzheimer's Society over the lack of transparency in NICE's
decision making process. The failure of NICE to provide full explanations
for decisions and the difficulty in engaging in a dialogue with
NICE can leave no option but to follow the appeal process. This
is a costly process for charitable patient groups and one that
any organisation would want to avoid if at all possible. However,
when a NICE decision is believed to be counter to patient needs
and the decision has not been justified, then it becomes the patient
group's duty to challenge it.
17. We share the Alzheimer's Society's belief
that more transparency in the decision making process could help
to reduce the number of appeals and would recommend the following
to enable this:
— Representatives of patient groups
should be able to act as non-speaking observers at appraisal committee
meetings at which a relevant technology is discussed.
— A full minute of the meeting should
be available, with sufficient detail so that it is possible to
understand how decisions were reached.
— Fuller explanations should be provided
as to how a decision was reached in FADs and ACDs. "Considered
not appropriate" is not good enough. The provision of a summary
version and more detailed document would allow people to choose
the level of detail they want.
Whether Public Confidence in the Institute is
Waning, and if so Why
18. The public's perception of NICE is influenced
by the press and by communications from charities like ourselves.
A series of decisions by NICE to reject treatments for vulnerable
groups, such as those with dementia, and which are decisions perceived
to be based on cost grounds, contribute to a negative perception
of the Institute. High profile campaigns by established patient
representative groups also contribute to a drop in confidence
in NICE. There is also a risk that such justifiable campaigns
will result in a damaging perception of charities competing with
each other.
19. The lack of clarity as to the accountability
of NICE also damages public confidence. As mentioned above, the
Institute does appear to respond to pressure, whether from patient
groups or high-profile politicians. This is despite NICE's own
assertion that it is an independent organisation. [98]Charities
have to take some of the responsibility for this, but as we have
set out above we are acting in the interests of our members and
we cannot ignore that duty.
Comments on NICE's evaluation process, and whether
any particular groups are disadvantaged by the process; the speed
of publishing guidance; the appeal system
20. We believe the NICE evaluation process
fails to take due consideration of the views of patient representatives
and carers. The economic model is too narrow in its scope, failing
to consider sufficiently wider savings a new treatment might bring.
Benefits from effective treatments to a person with MS, their
family and carers, stretch extensively beyond the health service.
For example, caring for someone with severe MS can effectively
be a full time job. This means two people are out of work, claiming
benefits, paying less tax and so on. Early, effective interventions
can support people's independence and maintain their ability to
contribute (financially and otherwise) to society.
21. While NICE does acknowledge that benefits
to carers and so on should be considered, we believe this aspect
of a treatment is undervalued in their assessments. It would surely
be possible for the evaluation to look at, as a minimum, other
governmental costs incurred by a condition like MS, particularly
as paid out through the benefits system. NICE bases all of its
argument on an economic footing, but the model ignores massive
and obvious costs associated with conditions like MS.
22. It should also be noticed that there
is a risk that NICE's evaluation process, with a perceived rise
in negative decisions, may discourage research investment in the
UK and in conditions like MS in general. If a pharmaceutical company
invests tens of millions in an MS treatment, only to see it rejected
on cost grounds in England and Wales, the disease area becomes
less attractive (for example, spending on HIV and cancer treatments
massively outweighs spending on neurology; why, then, should a
company invest in MS when there are better returns elsewhere?)
This could have a knock on effect on UK clinical trials, and this
will in turn have a detrimental impact on early patient access
to new therapies.
23. There is the wider issue of UK drugs
pricing, which falls outside the scope of this investigation.
But we would draw the Committee's attention to the Office of Fair
Trading's recommendation that the Pharmaceutical Price Regulation
Scheme (PPRS) should be reformed to deliver better value for money.
The implementation of NICE guidance, both technology
appraisals and clinical guidelines (which guidance is acted on,
which is not and the reasons for this).
24. We would refer the Committee to the
MS Trust/Royal College of Physicians audit of the NICE guideline
for MS. [99]The
guideline is an excellent toolkit and we warmly welcome it; along
with the NSF for long term conditions, government policy on the
care of MS is praiseworthy. We are, however, concerned about implementation.
Central policies need to be enacted locally, but local management
of NHS trusts and strains on budgets mean expensive long term
conditions often struggle to get adequate support.
25. The Department of Health has said that
implementation of NICE guidance "does not fall to any single
body; rather, what is needed is a broad partnership to ensure
that patients get ready access to the quality of care recommended
by NICE." [100]The
MS Society agrees that partnership working is integral to the
implementation of NICE. However, the lack of a single body to
oversee implementation results in more examples of postcode lottery
care. There are insufficient timeframes to ensure that primary
care trusts do fulfil NICE guidance as quickly as possible. When
challenged on implementation difficulties, the government is able
to refer the matter to local commissioners who are in turn able
to point to NHS deficits. We would urge the government to take
more responsibility for ensuring that laudable national policies
are not let down at local implementation level.
RECOMMENDATIONS FOR
FUTURE ACTION
BY THE
GOVERNMENT
We recommend that:
— There should be greater clarity and
transparency in NICE's decision making process. This would include
revising the appeal system to ensure it is truly independent.
This would go some way to restoring faith in NICE.
— Greater weight should be given to
improvements in patients and carers' quality of life arising from
new treatments. Other costs associated with a disease should be
included in the cost model used by NICE.
— NICE should either publicly inform
patient groups it is not interested in their input, or should
try to engage more constructively with them. The current mood
of hostility does no-one any good. We would welcome a patient
organisation seminar with NICE and with other charities so that
they can clearly set out what they see as our role. We would then
undertake to communicate this to our members so that their expectations
of NICE were more clearly informed.
— Central government should take more
responsibility for ensuring that the laudable MS guideline from
NICE is not let down at local implementation level.
Matthew Trainer
MS Society
March 2007
95 NICE, Guide to the single technology appraisal
(STA) process (2006). Available at http://www.nice.org.uk/page.aspx?o=
STAprocessguide Back
96
Department of Health, Choice Matters: Increasing Choice Improves
Patients' Experiences (2006). Back
97
Email from Meindert Boysen, Associate Director STA at NICE, to
MS Society 1 March 2007. Back
98
NICE, A Guide to NICE (2005). Available at http://www.nice.org.uk/page.aspx?o=guidetonice. Back
99
Royal College of Physicians, MS Trust. NHS services for people
with multiple sclerosis: a national survey. London: RCP; 2006. Back
100
Lord Warner, Department of Health, Implementation of NICE guidance
Available at http://www.dh.gov.uk/en/Publications andstatistics/Lettersandcirculars/Dearcolleagueletters/DH_4083904
Accessed 20 March 2007. Back
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