Download how the national institute for health and clinical

AGENDA ITEM
BOURNEMOUTH AND POOLE PRIMARY CARE TRUST
PAPER FOR HEALTH AND SCRUTINY PANEL APRIL 2007
HOW THE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (NICE)
DEVELOPS GUIDANCE ON THE USE OF NEW AND EXISTING DRUGS WITH SPECIFIC RELATION TO THE TREATMENT OF ALZHEIMERS DISEASE
(NICE TECHNOLOGY APPRAISAL TA 111, NOVEMBER 2006)
1.
BACKGROUND
1.1
This short paper is intended to provide members with an overview of some important
issues in relation to the treatment of Alzheimer’s disease with medical therapies. It
draws on the recent technology appraisal by the National Institute for Health and
Clinical Excellence (NICE). The institute reviewed its guidance in November 2006 on
the use of three drugs known as acetyl cholinesterase inhibitors for treatment of
Alzheimer’s disease, donepezil, galantamine and rivastigmine, plus a newer drug,
memantine, for moderate to severe Alzheimer’s disease.
1.2
The main purpose of this paper is to summarise the NICE guidance, by which all
PCTs are bound by in making decisions about effectiveness and cost-effectiveness
of health technologies.
2.
WHAT DID THE NICE TECHNOLOGY APPRAISAL FIND?
2.1
All three of the acetyl cholinesterase inhibitors (donepezil, rivastigmine and
galantamine) appeared to benefit patients with mild to moderately severe Alzheimer’s
disease when assessed for signs of improved cognition and global function. But
these improvements were small and few trials assessed the effects beyond 26
weeks. In general, higher doses of all the drugs appeared to be more beneficial than
lower doses.
2.2
None of the drugs was shown consistently to improve measures of mood, quality of
life, improve activities of daily living or behaviour – which may be more important
than cognition in terms of overall everyday function.
2.3
Most trials included a range of patients (from extremely mild to severe disease) and
drug doses. This meant that it was difficult to compare effects directly between mild
patients and those with more severe disease, and between patients on different dose
regimens.
2.4
None of the drugs was found to be cost-effective for treatment of mild to moderate
Alzheimer’s disease. NICE uses a measure called a QALY (quality adjusted life year)
to set a benchmark of cost-effectiveness, which enables different health technologies
to be compared. When a QALY costs more than £30,000 the intervention is not
considered cost-effective. The three drugs ranged from £58,000-80,000 per QALY.
2.5
The trials suffered from a number of problems with their methods that could lead to
biases that may overestimate the effectiveness of the drugs. The most important
problems were a lack of blinding (i.e. the investigators were often aware which
patients were taking the drugs, and which were not), and drop out of participants
because of side effects of the drugs.
2.6
NICE recommended in view of these findings that the drugs are used as options in
the management of people with moderately severe Alzheimer’s disease. Only
-1-
5
specialists should initiate treatment, and patients should be reviewed at least every
six months.
Sam Crowe MFP
Specialist Trainee in Public Health
Bournemouth and Poole PCT
2
BOURNEMOUTH AND POOLE PRIMARY CARE TRUST
3.
INTRODUCTION
3.1
The Primary Care Trust has a decision making process for whether NICE technology
appraisal is relevant to the organisation. The information about relevance of
guidance is entered onto the Primary Care Trust database and a summary is
produced on CD for practices and relevant Trust staff.
3.2
At present, Members of the Clinical Governance Committee have responsibility for
implementation, in their area as outlined in the NICE Implementation Policy. This
requires Action Plans for implementation, and horizon scanning to be in place for all
relevant guidance. Arrangements are in place to review and monitor implementation
action plans when NICE guidance is applicable to services provided directly by the
Trust.
3.3
NSF Local Implementation Teams have been set up and ensure that national
guidance is followed as appropriate in the specific disease areas.
Independent Contractors
3.4
HSC (2003/011) requires Clinicians to inform the Primary Care Trust Clinical
Governance Committee if they intend to introduce new interventional procedures,
which he/she has not used before, or has only used outside the NHS. All GPs have
been notified of their obligations under HSC 2003/011.
3.5
Practices are asked to complete a questionnaire to notify the Trust of their
compliance levels. This data is entered onto the Primary Care Trust database and
monitored.
3.6
GMS/GDS Contracts and all new SLAs have incorporated a statement of compliance
with national guidance including NICE.
Commissioned Service
3.7
All new contracts have compliance with NICE guidance written into them.
3.8
NICE implementation database is under constant review at the Poole Hospital NHS
Trust Clinical Governance Committee and Clinical Audit and Effectiveness Group
monitor the implementation of NICE guidance. The quality monitoring group reviews
the compliance of RBCH with all new interventional procedures. There is cross
representation on all these groups.
Giselle Thornton
Clinical Governance Manager
06 May 2017
3