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What is the SMC and how does it work?

This page explains the work of the Scottish Medicines Consortium (SMC). There is information about

 

What the SMC is

SMC stands for the Scottish Medicines Consortium. It is an independent organisation that advises the NHS Boards about medicines in Scotland. The advice aims to make sure that people have the same access to treatment wherever they live in Scotland.

The SMC assesses how well each new medicine works and how cost effective it is. It looks at new medicines as they are licensed and decides which patients would benefit from them and whether they should be available on the NHS in Scotland.

 

Scottish medicines organisations

There are 3 different organisations in Scotland working together to improve healthcare. They each have a separate role. The SMC assesses individual new medicines.

NHS Quality Improvement Scotland (NHS QIS) was set up by the Scottish government to advise, support and assess NHS Boards in Scotland.

The Scottish Intercollegiate Guidelines Network (SIGN) develops guidelines about how particular conditions should be treated. It became part of NHS QIS in 2005.

 

How the SMC works

When a new drug is licensed, the SMC asks the manufacturer for details about it. A licence means that the medicine works and is safe for a particular illness. But it does not necessarily mean that it is good value or works any better than current treatments. You can find out more about how medicines are licensed in the cancer treatment question and answer section.

The SMC membership includes health professionals from the NHS Boards in Scotland, patient representatives, health service managers and members of the Association of the British Pharmaceutical Industry (ABPI).

The SMC make their decisions based on

  • Evidence about how well the drug works
  • Cost effectiveness
  • Contributions from patient organisations, health professionals, experts, and other interested parties

So they look at whether the new treatment is better than the current treatment. And at how much value it delivers for the NHS and patients. This includes looking at information about the quality of life adjusted year (QALY).

A QALY is a tool that takes into account how a treatment affects

  • Quantity of life
  • Quality of life

Quantity of life means how long someone lives. Quality of life is more about how the treatment affects you. It includes

  • How well you are
  • Whether you can work
  • Whether you can care for yourself
 

How the SMC makes decisions

First the SMC make a draft assessment. They then pass the assessment on to the New Drugs Committee (NDC) which looks at all the scientific evidence. The NDC is made up of health professionals. Their view is taken to the monthly SMC meeting. At this meeting the whole committee considers all the issues. This includes hearing from patient organisations as well as looking at the cost effectiveness of the new medicine. Within 4 weeks of making a decision the SMC publishes it in a document called a Detailed Advice Document, which they put on their website. The whole process usually takes about 18 weeks.

The SMC aims to assess new medicines as soon as possible. They may start the process even before the medicine has been marketed. The SMC actively checks which drugs are likely to be licensed and contacts the drug companies at an early stage. They aim to assess each new medicine before it becomes available or at least within 3 months of licensing.

 

Doctors and the SMC’s advice

Once the SMC makes a decision, the NHS Boards in Scotland are expected to take this into account when they decide which medicines are available in their area. But the NHS Boards in Scotland don’t have to follow the SMC decision. Doctors can use their clinical judgement to make a decision based on an individual patient’s situation. In reality doctors usually follow the SMC's advice.

If you haven’t been offered a particular medicine and the SMC have agreed it should be available within the Scottish NHS, you should talk to your specialist. You can ask why they have not offered it to you. If you aren’t happy with their explanation you can contact your local NHS Board.

 

Appeals

If the SMC decides not to recommend a medicine for use in Scotland, an independent review panel can look at the data again and may come to a different decision. The manufacturer can also send in new data and the SMC will consider the medicine again.

 

Getting drugs before an SMC decision

Once a drug is licensed doctors can legally prescribe it. NHS Scotland expects doctors to wait for the SMC to assess a new medicine before they prescribe it. Because the SMC tries to assess all new medicines before they are available, this is rarely a problem.

 

How the SMC works with NICE

The National Institute for Health and Clinical Excellence (NICE) decides which drugs and treatments should be available within the NHS in England and Wales. NICE also publishes guidelines on the treatment of particular conditions in England and Wales.

NICE and the SMC are separate. However, the Multiple Technology Appraisals that NICE produce may apply in both areas. The NHS Quality Improvement Scotland reviews the appraisals and may decide they should apply in Scotland.

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Updated: 5 September 2012