[IPk] Question for Scottish members
Hi Jackie,
Further to my previous message.
The Scottish Medicines Consortium (SMC) is a consortium of Area Drug and
Therapeutics Committees (ADTCs), set up to advise health boards and ADTCs
about all new drugs. The SMC differs from many other advisory bodies on
medicines in that it aims to get the information out to prescribers and
other health care professionals, at or around the time of the product's
launch. It also aims to prevent duplication and to improve the rigour and
consistency of work among the 15 health boards in Scotland.
In the UK drugs are available for use after receiving a licence in Europe or
the UK. Both the UK Medicines Act 1968 and the EU directive (EEC 65/65)
require products to be of satisfactory quality, safety and efficacy but both
specifically exclude cost and cost-effectiveness as criteria for granting a
marketing authorisation (MA). Although the Scottish Parliament has devolved
responsibility for health matters, drugs are licensed for the whole of the
UK. Once this has happened there are few central restrictions on use.
(highlights mine)
It is understandable therefore that patients, politicians, the media and
indeed the pharmaceutical industry, may consider that if a drug has
successfully progressed through the hurdles of the licensing procedures then
it should be widely available for use. However, this view ignores the fact
that budgets are allocated to the NHS from the Scottish Executive to meet
the health needs of the population locally. Further, although the
requirements for quality, safety and efficacy have been satisfied,
effectiveness and costs have not been considered. It can therefore be argued
that a committee or group within the NHS should undertake this work to
ensure that maximum benefit can be obtained from new medicines. (Highlights
mine)
In Scotland and in many parts of the UK, pharmacists and other clinicians
have been working in committees locally to examine the evidence for new
products and make recommendations for use. This is a highly skilled and
time-consuming task. In a country with a population of 5 million, the
arguments for one national body are clear.
Quality improvement
SMC comes under the umbrella of NHS Quality Improvement Scotland. The SMC
remit states that it will provide advice to NHS Boards and the Area Drug
and Therapeutics Committees (ADTCs) across Scotland about the status of all
newly licensed medicines, all new formulations of existing medicines and new
indications for existing products. (highlights mine)
FAQ page
Can a doctor disregard SMC advice?
Individual clinicians should take account of SMCs advice when exercising
their clinical judgement, unless there is evidence to justify not doing so
in the light of particular circumstances of an individual patient.
(highlights mine)
Can the NHSScotland use a medicine before SMC has given its advice?
Any new medicine can legally be prescribed once it has a licence if it is
thought to be the most suitable treatment for an individual patient.
However NHSScotland would be expected to await the advice from the SMC
before making a new medicine routinely available. The SMC therefore, aims to
issue its advice at the time a new medicine becomes available.
Has the role of SMC changed in any way?
An Executive letter was issued in November 2003 NHS HDL (2003)60. This
letter explains the arrangements being put in place to strengthen the role
of the SMC in addition to outlining new processes to ensure the national
implementation of innovative new drugs.
How do I know that the SMCs advice is up to date?
The SMC has processes to ensure that as new evidence becomes available its
advice can be reviewed.
Must NHS Boards in Scotland comply with SMC advice?
The Minister for Health and Community Care has publicly stated that
NHSScotland should take account of the advice and evidence from the SMC and
ensure that recommended medicines are made available to meet clinical need.
(emphasis mine)
What does the Scottish Medicines Consortium (SMC) do?
SMC is part of NHSScotland. It is a central point of advice to NHS Boards
and their Area Drug and Therapeutics Committees (ADTCs) about the
effectiveness of all newly licensed medicines, all new major formulations of
existing medicines and any major new indications of established medicines.
It will benefit patients by providing NHSScotland with advice about the
value of each new medicine and the patients for whom it would be of most
benefit. SMC advice will help the NHS plan the speedy introduction of
beneficial treatments across Scotland and over time will help reduce
postcode prescribing. (emphasis mine)
What is the difference between SMC and NHS Quality Improvement Scotland (NHS
QIS)?
SMC gives advice, usually shortly after licensing, based on rapid
assessments of the cost and benefits of all medicines when they are
launched. NHS QIS conducts assessments on health interventions when there is
uncertainty about their cost effectiveness, or wide variation in the
provision or outcome of treatment in Scotland, or when they have a major
impact on NHS resources. NHS QIS assessments consider clinical and cost
effectiveness, patient needs and preferences, and organisational issues of
some new and existing health interventions, including medicines.
NHS QIS provides administrative, technical and communication support to SMC.
Hope this answers your question.
Regards
John Davis
.
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