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					NICE Technology Appraisal Guidance - No. 44

The Health Technology Board for Scotland (HTBS) is delivering this
National Institute for Clinical Excellence (NICE) Guidance to health
professionals in NHSScotland with the following authoritative Comment on
its use in Scotland. This HTBS Comment must be read in conjunction with
the NICE Guidance. (NICE Technology Appraisal Guidance No 44 -
Guidance on the use of metal on metal hip resurfacing arthroplasty).

HTBS advises that the NICE Technology Appraisal Guidance - No.
44 Guidance on the use of metal-on-metal hip resurfacing
arthroplasty is as valid for Scotland as for England and Wales.

The NICE recommendations are shown below.

1.1 Metal on metal (MoM) hip resurfacing arthroplasty is recommended as
one option for people with advanced hip disease who would otherwise
receive and are likely to outlive a conventional primary total hip
replacement. In considering hip resurfacing arthroplasty, it is
recommended that surgeons take into account activity levels of potential
recipients and bear in mind that the current evidence for the clinical and
cost effectiveness of MoM hip resurfacing arthroplasty is principally in
individuals less than 65 years of age.

1.2 When MoM hip resurfacing arthroplasty is considered appropriate, the
procedure should be performed only in the context of the ongoing
collection of data on both the clinical effectiveness and cost effectiveness
of this technology. Ideally, this data collection should form part of a UK
national joint registry.

1.3 This guidance should be read in conjunction with the Institute’s
guidance on devices for total hip replacement (Guidance on the selection
of prostheses for primary total hip replacement: NICE Technology
Appraisal Guidance No 2 April 2000). In that guidance, the Institute
recommended that the best prostheses (using long-term viability as the
determinant) should demonstrate a ‘benchmark’ revision rate (the rate at
which they need to be replaced) of 10% or less at 10 years or, as a
minimum, a 3 year revision rate consistent with this 10 year benchmark.
Establishing and confirming similar benchmarking criteria will be
necessary for MoM hip resurfacing arthroplasty and will be facilitated by a
UK national joint registry. In the interim, the 3 year minimum benchmark
should apply to MoM hip resurfacing devices.

1.4 MoM hip resurfacing arthroplasty should be performed only by
surgeons who have received training specifically in this technique.

1.5 Surgeons should ensure that patients considering MoM hip resurfacing
arthroplasty understand that less is known about the medium- to long-
term safety and reliability of these devices or the likely outcome of
revision surgery than for conventional total hip replacements. This
additional uncertainty should be weighed against the potential benefits
claimed for MoM devices.


HTBS anticipates that implementing this NICE Guidance in Scotland will
have the following implications for NHSScotland:

Service Issues

· In Scotland, there is limited experience of MoM hip resurfacing
arthroplasty and it should be noted that surgeons should not only be
trained, but also competent in the technique. Due to the relatively small
numbers of patients to be treated (who are principally under 65 years
old), it will be important to specify a minimum number of procedures that
should be undertaken annually by a surgeon in order to sustain
competence.

· Local guidelines or care pathways for the multi-professional care of
patients having hip replacement surgery should be available and ensure
that referring clinicians are aware of the MoM hip resurfacing arthroplasty
technology as they consider treatment options for patients with advanced
disease, particularly for younger patients who might otherwise face the
possibility of repeat THR procedures.

· As recommended in section 1.2 of the NICE Guidance, MoM hip
resurfacing arthroplasty should only be performed in the context of
ongoing data collection, to help determine the clinical and cost
effectiveness of the technology. Within Scotland, the procedure should be
coded as resurfacing arthroplasty and submitted to the Scottish
Arthroplasty Project via the SMR01 return to ISD.

· Attention is also drawn to the recommendations for further research
stated in section 5 of the NICE Guidance, particularly those related to the
evaluation of long term safety and survival rates.

· The Clinical Standards Board for Scotland (CSBS) Generic Clinical
Standards published in January 2001 (www.clinicalstandards.org) defines
the standards to which all clinical services should be delivered in
Scotland.

Impact

· Data from Scottish Health Statistics 2000 (Common Services Agency
2001) indicate that there were 3304 total hip replacements in the year. Of
these, 9.5% are likely to eligible for MoM replacements, which is
approximately 320 people. It is assumed that the only difference in the
cost of performing a MoM hip resurfacing anthroplasty compared with a
conventional THR (prosthesis cost:£500 to £2000 plus VAT), is the cost of
purchasing a more expensive MoM prosthesis (£1800 plus VAT).
Consequently, the total budget impact is estimated to be between an
increase of £488,800 per annum (if MoM devices are used instead of THRs
costing £500) and a reduction of £75,200 (if MoM devices are used
instead of THRs costing £2000). However, as patients considered to be
suitable for MoM hip resurfacing anthroplasty are more likely to have been
considered for a THR costing nearer £2000, the budget impact is more
likely to be at the lower end of this range.


NHSScotland should take account of this Comment from HTBS and ensure
that recommended drugs or treatments are made available to meet
clinical need.
This HTBS Comment is the result of a consideration of possible contextual
differences in Scotland, according to the following categories:
· Principles and values of NHSScotland
· Epidemiology (frequency and distribution)
· Structure and provision of services in Scotland
· Other implications for NHSScotland.

No important differences were identified for this NICE Technology
Appraisal Guidance. The process used is available on request or from the
web (www.htbs.co.uk).

An Understanding HTBS Advice is also being distributed on this topic and
is available from this website or office or patient group.

HTBS would like to thank NICE for its cooperation in delivering this
Comment. HTBS is also grateful to the experts in Scotland who provided
input to this Comment.

				
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