Scottish Medicines Consortium
There are a number of key differences between the work of the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). Read on to find out how these two separate organisations differ.
What is the Scottish Medicines Consortium?
The Scottish Medicines Consortium (SMC) is an independent organisation established to help NHS boards in Scotland spend their money wisely by informing them which medicines show value for money. SMC is a consortium of Area Drug and Therapeutic Committees (ADTCs). ADTCs make decisions on many aspects of medicine use within individual NHS boards across Scotland and there is an ADTC in every NHS board in Scotland.
SMC's membership includes members with a clinical background such as doctors and pharmacists, and representatives from healthcare management and finance. Additionally, there are three public partner members to ensure that the public voice is part of the decision-making process and three members nominated by the Association of the British Pharmaceutical Industry (ABPI). SMC helps to ensure that important medicines are available across Scotland and to minimise differences in their availability between NHS boards.
What does it do?
SMC reviews a submission from the manufacturer of every new medicine. The submission describes how effective each individual medicine is and provides evidence outlining whether the medicine is good value for money compared to treatments already in use in NHS Scotland. Where a treatment appears to offer clinical advantages compared with existing treatment and at an acceptable extra cost (if any), then the medicine will be accepted for use within NHS Scotland.
If the clinical benefits are inadequate or insufficient to justify any extra cost then the medicine will not be recommended for use within NHS Scotland. This process is similar to that of NICE's Single Technology Appraisal which develop recommendations in the form of NICE guidance on the use of new and existing medicines,.
What work does NICE do that does not fall under the remit of the SMC?
NICE technology appraisals develop recommendations on new and existing medicines, but also products and treatments in the NHS. These include medical devices (for example hearing aids), diagnostic techniques (tests used to identify diseases, measure the severity of the disease or the progession of the disease) and surgical procedures. NICE also issues public health guidance on how to improve people's health and prevent illness and disease, clinical guidelines on the diagnosis, treatment and management of medical conditions, and quality standards.
How does the SMC make its decision?
SMC undertakes a detailed review of information submitted by the medicine's manufacturer. Following an initial review by SMC staff, the data are reviewed by the SMC's New Drugs Committee, which undertakes a purely scientific review function in assessing the facts surrounding the new medicine. The view from the New Drugs Committee then comes to the full Scottish Medicines Consortium committee which can take a wider societal perspective in coming to its final conclusion as to whether a new medicine should be accepted for use within NHS Scotland. SMC undertakes its review in 18 weeks following submission of information from the manufacturer, aiming to publish its advice as soon as possible after the new medicine comes to the marketplace.
What happens if SMC accepts a medicine for use in NHS Scotland?
SMC informs the medicine's manufacturer, and also NHS Scotland, that the medicine has been accepted for use. Information appears on the SMC website and it is expected that NHS boards will take account of this advice when deciding which medicines should be made available to patients within their NHS board area.
How does the decision making process differ between NICE and SMC?
SMC issues guidance on all newly licensed medicines. NICE's technology appraisal programme is prioritised to where guidance is most needed.
Before topics are referred to NICE, stakeholders are consulted on the remit and scope of the appraisal to ensure that its coverage is appropriate. Comments received from stakeholders on the remit and scope are fed back to Ministers before a topic is finally referred to NICE.
In the SMC process, a standard review is carried out of a structured application from the manufacturer of each new medicine.
NICE includes contributions from stakeholders throughout its technology appraisal process. All NICE technology appraisals (both single and multiple) include a public consultation on the draft recommendations and the opportunity for stakeholders to appeal. The Scottish Medicines Consortium does not publicly consult on its draft advice but provides access for relevant patient interest groups and clinical experts to bring their knowledge, expertise and informed opinions into the decision making process.
If a new medicine is not recommended for use in NHS Scotland the manufacturer can resubmit new data or analysis at any time and the medicine will be reconsidered within the standard 18 week timeframe. In addition, there is a mechanism for an Independent Review Panel to look at data already submitted and suggest to SMC that it might come to a different conclusion.
NHS organisations in England should fund and resource medicines and treatments recommended by NICE, usually within three months of guidance being issued. NHS Scotland boards and directors are expected to take account of SMC advice when deciding which medicines should be prescribed, but it is not mandatory.
Where does SMC guidance apply?
SMC guidance only applies within NHS Scotland. NHS Scotland is expected to take account of the advice and evidence and to ensure that recommended medicines are available to meet clinical needs. The Department of Health has however, indicated that the Scottish Medicines Consortium is one source of advice that primary care trusts and others within NHS England may consult, especially if new medicines have not been subject to NICE technology appraisal.
When does NICE guidance apply in Scotland?
NICE does not give official advice to NHS Scotland on medicines and NICE Single Technology Appraisals of new medicine do not apply in Scotland. NICE Multiple Technology Appraisals are reviewed by NHS Quality Improvement Scotland and, if appropriate, deemed to apply within the Scottish context. NICE Multiple Technology Appraisal recommendations replace published SMC advice. Clinical guidelines and public health guidance published by NICE do not apply in Scotland.
How can I find out more about SMC?
For more information, visit www.scottishmedicines.org.uk
This page was last updated: 16 July 2010