Supplementary memorandum from the Minister
Thank you for the opportunity to talk about
my policy areas on 26 October 2006. I felt it was a good session
and I was grateful to Members for the constructive spirit in which
it was constructed. I committed to write to the Committee on a
number of areas.
How much work is being undertaken by Independent
Treatment Sector Centres (ISTCs) in order to achieve the wait
of 18 weeks?
I attach a table at Annex 1 which gives the
estimated orthopaedic procedure volumes being procured from the
independent sector by scheme for the period 2005-06 to 2008-09.
The independent sector figures are estimated from the indicative
case mix stated in scheme project agreements. To provide context,
the table also shows the reported volumes of NHS & independent
sector trauma & orthopaedics elective activity for 2005-06
by SHA. As requested by Anne Milton, the table expresses the activity
as a percentage.
Was there any added money around to run the (18
weeks) trials as opposed to what is expected of everybody in January
next year?
The Department of Health worked with eight pioneer
health communities during 2006 to develop short term, practical
approaches to 18 weeks measurement and data reporting. Each site
was provided with supporting funding of £25,000 by the Department
in 2006-07 for their involvement in the pioneers work. This money
was tied to key deliverables for each pioneer, which included
the submission of data measuring referral to treatment times on
a monthly basis from May 2006.
Which "groups" are not covered by the
18 week target?
Following a listening exercise in Autumn 2005
the Department published principles and definitions for 18 weeks,
which sets out the circumstances in which an 18 week pathway would
start. This guidance was published as an annex to the 18 weeks
Implementation Framework in May 2006 and is available at
www.18weeks.nhs.uk
18 weeks is focussed on hospital pathways (and
in particular hospital medical consultant pathways) as funded
in the 2004 spending review agreement with the Treasury SR2004.
Audiology, and adult hearing services in particular, are mainly
accessed directly by primary care and are predominantly outside
the scope of the 18 week pathway, which is focused on changing
traditional hospital consultant pathways hearing services, given
that they present a significant challenge to providers and commissioners.
We are working to improve direct access (meaning
direct referrals from GPs to therapies and self-referrals) to
therapies, healthcare science interventions and mental health
services in primary and community settings without a patient needing
to go to hospital, as set out in Our health, our care, our
say.
These direct access pathways are not covered
by the 18 week pathway as the work on the 18 week pathway commitment
focuses on hospital pathways as set out in the NHS Improvement
Plan. Outside the 18 week pathway programme the Department of
Health will be working to support innovation and improve productivity
in those areas with particular problems in access. Direct access
to these services will further be improved as part of the changes
being implemented through the White Paper.
Transparency of NICE methodology
I agreed to provide you with more detail on
the transparency of NICE's methodology. Much more information
is now available for public scrutiny than when this committee
previously looked at it in 2002, including the minutes of appraisal
committee meetings, data from manufacturers that is not commercial
in confidence and details of the committee members involved in
an appraisal's development, as well as their declared interests.
During the development of guidance, the NICE
website is regularly updated. The documents published on the Institute's
website include:
— the name of the Assessment Group
and the final list of consultees/commentators for the appraisal;
— the members of the technology appraisal
project team;
— the evaluation report, including
the manufacturer's submission;
— Appraisal remit and scope;
— the Appraisal Consultation Document
(ACD);
— comments from consultees and commentators
on the ACD;
— summary of comments received via
the web on the ACD;
— table prepared by the Technical Lead,
showing the Institute's responses to comments received on the
ACD;
— the final appraisal determination
(FAD);
— notification of any appeals against
the FAD; and
— the findings of the Appeals Panel.
NICE's website has been significantly reorganised
to facilitate easier access to all relevant information on the
guidance produced by the Institute.
Further to the Committee's comments on NICE's
application of QALY calculations, I thought it would be helpful
to append for your attention extracts from the Institute's Guide
to the Methods of Technology Appraisals published in 2004
which sets out in some detail how such calculations inform the
Appraisal Committee's deliberations. This is included at annex
2.
NICE does need to restrict access to some material
that is commercially confidential, but this is kept to an absolute
minimum.
The Committee may also be interested to know
that NICE will be conducting a review of its Technology Appraisal
methodology in 2007. The processes and methods by which NICE makes
its assessments of clinical and cost-effectiveness are both sophisticated
and transparent. NICE has published full details of the process
it undertakes, including the kind of methodologies it uses and
the various factors the Appraisal Committee will consider in reaching
their conclusions. That process is not static. As part of NICE's
normal business, it is subject to periodic review which includes
a public consultation. NICE's process was last subject to such
a review in 2003-04, and I understand that NICE will be undertaking
a further scheduled review next year. This will I believe involve
active engagement with key stakeholders—including patient
groups and academics—and a period of public consultation.
NICE will be publishing details of this review in due course.
Access to the NICE economic model
The Committee raised the issue of access to
the economic model used in NICE's technology appraisal work particularly
in respect of its appraisal of drugs for the treatment of mild
to severe Alzheimer's Disease. As I indicated in my response to
the Committee, this is a complex issue.
I would want to dispel any impression that NICE
is denying any access to the economic model its Appraisal Committee
uses in its appraisal work. Indeed as part of its process in developing
guidance NICE invites stakeholders to apply for a copy of the
cost effectiveness model it has used in particular appraisal.
The model that NICE supplies is a "read only"
non-executable model and I think this is the crux of the point
at issue. This issue was fully explored as part of the public
appeal that took place in July 2006. The Appeal Panel's detailed
findings "published" on NICE's website
(http://www.nice.org.uk/page.aspx?o=appraisals.inprogress.alzheimersdisease).
I can confirm that the fully executable model
is protected by Intellectual Property Rights and contains commercial-in-confidence
information. In the case of the appraisal of drugs for Alzheimer's
Disease the model was produced by the University of Southampton.
The University is protectd by the terms of the contract by which
it undertakes this work.
Impact of Alzheimer's drugs on carers
I believe that I may have given a confusing
answer in my response to this question, and some clarification
is probably in order: I was asked about NICE's assessment of the
impact of Alzheimer's drugs on carers, and in part of my response
I said:
"On Alzheimer's, particularly, I asked
if a different model that gave greater weight to carers' costs
and carer's benefit would have produced a different outcome, in
terms of the model. Then, I was assured it would not have done."
On re-reading this, I realise that my answer
has blurred the important and related issues of carer benefits
and social care costs. As you may be aware, in assessing the costs
of caring for people with Alzheimer's NICE has, in accordance
with its published methodologies, explicitly included social care
costs met from the public purse—which it estimates at around
70% of total costs—but not the 30% of costs it estimates
are met privately. I asked officials whether it would have made
any difference to the outcome if NICE had taken account of 100%
of social care costs, and was advised that it would not. The point
on carers is subtly different. Here NICE has acknowledged that
it is appropriate to take account of the benefit of these drugs
to carers, but there has been debate about whether it has attached
sufficient weight to these benefits. Again this issue is addressed
in the Appeal Panel's published findings.
Implementation of NICE guidance
As I did not have the information to hand at
the time, I agreed to outline in more detail the Department of
Health's implementation requirements for NICE clinical guidelines,
and specifically in relation to infertility.
Clinical guidelines are not subject to the three-month
funding direction that applies to technical appraisals, as they
are often complex and contain a substantial number of recommendations.
Implementing them takes longer than technology appraisals. The
Audit Commission report you referenced "Managing the financial
implications of NICE guidance" recognised this and noted
that there are good reasons for clinical guidelines to be excluded
from the funding direction. The report states:
"Most notable are the substantial changes
to care pathways that are often involved in implementing clinical
guidelines and therefore the length of time required, which makes
issuing a funding direction more difficult."
However, you are right to highlight the 2004
infertility guideline as an exception. The guideline on the assessment
and treatment for people with fertility problems, published in
February 2004, makes recommendations on the range of fertility
investigations and treatments, but the general focus since its
publication has been on the provision of IVF, which many couples
with fertility problems see as giving them the best chance of
having a much wanted child.
The Secretary of State, then John Reid, welcomed
the guideline. He said that the Department of Health would be
looking to primary care trusts who provide no IVF treatment to
meet a minimum national level of provision of one cycle of IVF
by April 2005. He also said that the NHS would be expected to
make progress to full implementation of the guideline in the longer
term. This recognised that implementation could not be overnight.
The Department's assessment of the current position
is that we are closer to having a national level of provision
than we were in 2004, but that the current level is one cycle
of IVF rather than the three recommended by the guideline. We
recognise also that there are, as the British Fertility Society
describes it, "black holes" where there is no provision
or provision has been temporarily suspended as part of programmes
to restore financial balance.
In our view, we cannot, therefore, say that
there has been consistent and significant progress in the implementation
of the guideline. However, we are not simply sitting back and
waiting in hope. The Public Health Minister, Caroline Flint, met
with the fertility patient support organisation Infertility Network
UK and representatives of the National Infertility Awareness Campaign
in November 2005. She proposed a project which would help fertility
patients to make their voices heard when local services are planned.
Funded by the Department of Heath, the project is now underway,
launched in June this year by a letter from Caroline Flint to
Primary Care Trust Chief Executives asking them to co-operate
with the project. The letter acknowledged that progress in the
provision of fertility services is taking longer in some areas
than in others as it is influenced by local circumstances and
the point from which PCTs are starting. It also carried the reminder
that persistent inequality of provision is hard to bear, and hard
to understand, for those affected.
The project aims to facilitate the sharing of
good practice in the implementation of the NICE guideline. Infertility
Network UK has carried out a baseline survey of PCTs which is
currently being analysed. So far, the analysis suggest that there
are useful messages which can be disseminated to PCTs through
the project, such as the importance of patient representation
in decision making, and the fact the one cycle of IVF does not,
in itself, constitute implementation of the guideline. The next
stage will be for the project team to liaise directly with PCTs,
and Caroline Flint will keep in close touch with progress. I recognise
the Committee's wish to see clinical guidelines implemented, and
concern about the distress caused where patients' expectations
are not met. We will continue to work with PCTs on this matter.
I would also like to explain in more detail
the processes for supporting implementation of clinical guidelines
more generally. Whereas technology appraisals are subject to the
funding direction, performance against clinical guidelines forms
part of the developmental standards. Developmental standards outline
improvements that all trusts are expected to aspire to in order
to improve the quality of care and treatment provided. Trusts
are monitored against the core standards as part of the Healthcare
Commission's annual health check and, although assessment against
the developmental standards will not feed into the overall annual
rating in 2006-07, performance against a sample of them will for
the first time be reported on the Healthcare Commission's website.
This includes, for acute and mental health trusts, assessment
against developmental standard 2(a).
Patients receive effective treatment and care
that:
(a) conform to nationally agreed best practice,
particularly as defined in National Service Frameworks, NICE guidance,
national plans and agreed national guidance on service delivery.
In addition, there is an ongoing dialogue between
NICE and the DH to promote consistency between NICE guidance and
the Quality and Outcomes Framework (QOF) which rewards GP practices
for the provision of quality care, and helps to fund further improvements
in the delivery of clinical care.
Finally, NICE has significantly strengthened
its own mechanisms for supporting the implementation of its clinical
guidelines. NICE has established an Implementation Directorate
and now issues costing templates and advice on implementation
to the NHS. It has also recently introduced tailored commissioning
guides to support NHS commissioners in implementing its guidance.
Disinvestment programme
I agreed to come back to you on the potential
savings that could be gained from the disinvestment programme.
Although it is impossible to judge with any accuracy, we anticipate
that savings in the NHS will be many times the cost of the programme.
NICE has started work on this programme within its existing funding
for 2006-07 and DH will provide additional funding to NICE of
around £1.3 million in 2007-08.
Oxygen Service
In discussing the implementation of the new
Home Oxygen Service, I mentioned that I would be happy to share
the conclusions we draw from this contracting round when preparing
for the next round. I also mentioned that we will shortly conclude
action to transfer the remaining few patients to the new suppliers—with
suppliers providing an integrated service (cylinders, concentrators,
liquid systems) to meet the needs of all patients using oxygen
at home. At that stage, we will be looking again at this service
change, including our response to problems in the initial days
of the new contracts. I will write to the Committee again in early
2007, once I have had an opportunity to assess the key issues
emerging from this contracting round.
Is the Department planning to look at streamlining
the medicines use reviews service so that it has greater buy-in
from GPs and the information gained from that is of benefit to
GPs?
We know from feedback that we need to encourage
better engagement with the medicines use review service (MUR)
by GPs and we are addressing this within our communication strategy.
There is scope to change the MUR form and we have already held
a day seeking views from interested stakeholders. We will be working
with the PSNC on a revised form in the coming months and intend
to pilot this with GPs to obtain their feedback.
I do hope that this further information is helpful.
I am copying this letter to members of the Committee and will
place a copy in the Library.
Andy Burnham MP
Minister of State for Delivery and Quality
20 November 2006
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