Conclusions and recommendations
Social care and integrated care
1. We
welcome the fact that NICE is to take on responsibility for producing
clinical guidance and quality standards in relation to social
care. There is a real opportunity for NICE to help evolve a different
model of care by creating integrated standards and clinical guidance.
We agree that this should not just be about providing guidance
to people in different disciplines who are treating and caring
for people with a specific condition, but should also involve
advising about the most common associated co-morbidities, including
mental illness. This broader guidance will also need to take account
of what individuals want for themselves. This approach would reflect
an important development of a philosophy which emphasises treatment
of people not conditions (Paragraph 11)
2. One of the key
themes of the Committee's work in this Parliament has been the
need to move to a more integrated system in order to maintain
both quality of care and access to care. As NICE takes on its
new responsibilities in relation to social care, it is important
for it to work with the full range of health and care providers
to ensure that an adequate evidence base is created on which it
can base its guidance. (Paragraph 15)
3. NICE should be
proactive in assessing interventions where evidence exists to
support efficacy and cost effectiveness, and should ensure that
their appraisal of cost effectiveness is based on an assessment
of quality of life as well as increased life expectancy. (Paragraph
16)
4. The Committee has
repeatedly underlined the pivotal role which it believes commissioners
should play in the development of the more integrated care system
which is required. The Committee has also repeatedly stated that
it believes that more integrated care delivery requires more integrated
commissioning. We therefore agree with Sir Michael Rawlins that
NICE should initiate the production of guidance for commissioners
and that the emphasis of that advice should be on how to deliver
integrated care. (Paragraph 18)
Cost effectiveness and value-based pricing
5. There
has been extensive discussion of the principle of value-based
pricing, but it remains a source of concern to the Committee that
so little progress has been made on defining this nebulous concept.
The practical implications of the move to value-based pricing
appear to be relatively modest: with a limited number of health
technology appraisals taking place each year (around 30), the
majority of drugs will for the foreseeable future continue to
be procured under a variant of the current Pharmaceutical Price
Regulation Scheme. (Paragraph 32)
6. The consultation
document on value-based pricing was issued two years ago in December
2010, and the response to the consultation was published in July
2011. The Committee does not regard it as acceptable that the
arrangements for value-based pricing have still not been settled
and that those who will have to work with those arrangements are
still unclear about what value-based pricing will mean in practice.
Industry needs certainty about how it should bring its products
to the NHS, and patient groups and clinicians need to understand
what their role will be and how they can make their views heard.
Given the length of time since the consultation began, the apparently
modest implications of the proposed changes, and the fact that
the new regime is due to be effective from January 2014, we recommend
that the Department of Health should bring this uncertainty to
an end no later than the end of March 2013. (Paragraph 33)
Cancer Drugs Fund
7. The
Cancer Drugs Fund was established to help provide cancer treatments
which would not otherwise be available in the period up to January
2014, when it was considered that the introduction of the new
value-based pricing system, with its perceived greater flexibility
than the current NICE approach, would mean that it would no longer
be required. From the evidence of our inquiry, the Committee considers
that three things need to be done before the Fund ceases to operate:
- There needs to be an assessment
of the outcomes for those patients whose treatment has been paid
for by the Fund, to see what impact it has had;
- If there is clear evidence of beneficial outcomes,
then that evidence needs to be built on in constructing the new
value-based pricing scheme, and applied to treatments for conditions
other than cancer;
- A defined funding mechanism needs to be developed
which will allow drugs which have been paid for by the Fund to
continue to be available to individual patients. (Paragraph 38)
Information about clinical drug trials
8. The
Committee believes there should be both a professional and legal
obligation to ensure that all regulators, including NICE, have
access to all the available research data about the efficacy and
safety of pharmaceutical products. All information arising from
drug trials should be in the public domain in an accessible and
properly anonymised form, including any negative information -
as Stephen Whitehead of the ABPI said, "negative trials often
give you as much information that is helpful as positive trials."
(Paragraph 45)
9. The Committee also
recommends that the pharmaceutical industry should introduce a
new code of practice covering research. This should include an
obligation to make public all data about drugs which are in current
clinical use once they have been through an appropriate peer review
process. These are measures that pharmaceutical companies can
take now without waiting for the new Clinical Trials Regulation
to be approved. (Paragraph 46)
10. The Committee
also recommends that the GMC reiterates its guidance on drug trials
to its members, and reminds them that failure to abide by these
principles could lead to fitness to practice proceedings being
taken against them. (Paragraph 47)
11. The Committee
does not believe it should be either legal or considered ethical
to withhold research data about pharmaceutical products. It is
therefore concerned that this simple principle is not universally
applied in practice, and also concerned by the implication of
Sir Andrew Dillon's evidence that NICE are making appraisals of
drugs without having access to all relevant data. The Committee
welcomes the current review of these issues by the House of Commons
Science and Technology Committee and recommends that Committee
should examine the nature of both the legal and ethical principles
which should cover these issues and how to make those principles
enforceable in practice. (Paragraph 48)
Patient Voice
12. It
is important for the credibility of NICE and for the decisions
that it makes that the patient voice is effectively and openly
represented in all its work. (Paragraph 51)
Clinical guidance
13. We
recommend that NICE clinical guidance should continue to be guidance
rather than instruction. There will always be local variations
and doctors and their patients must be able to come to individual
judgements about what is the best treatment. Clinical guidance
also needs to evolve and allow for innovation. (Paragraph 57)
14. The Committee
does recommend, however, that a clinician or commissioner who
decides to depart from NICE guidelines should be expected both
to report and explain the departure. Local and individual discretion
is valuable and right - but it should be exercised in a disciplined
and accountable manner. (Paragraph 58)
15. We consider that
guidance is a process not an event, and therefore a regular re-examination
of guidance is clearly very important to ensure that it remains
best practice. (Paragraph 60)
Quality standards
16. The
NHS Commissioning Board should ensure that familiarity with and
use of NICE quality standards is included as part of its accreditation
programme for Clinical Commissioning Groups. (Paragraph 61)
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