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Scottish Medicines Consortium (SMC)

The SMC is an independent organisation. It advises the NHS Health Boards about medicines in Scotland.

What the SMC does

The SMC aims to make sure that people have the same access to treatment wherever they live in Scotland. It 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
  • whether they should be available on the NHS in Scotland

The SMC is part of Healthcare Improvement Scotland (HIS), which was set up in 2010. HIS supports the Scottish Government's healthcare strategy. HIS develops guidance for clinical practice and supports the improvement of healthcare.

The Scottish Intercollegiate Guidelines Network (SIGN) is also part of HIS. It develops evidence based guidelines on the treatment of conditions like cancer.

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 mean that it is good value or works better than current treatments.

How the SMC makes decisions

The SMC looks at several factors when reviewing a new medicine for use in NHS Scotland. They look at the clinical and health economic evidence.

The company who makes the new drug or equipment provides this information. The SMC also looks at the evidence as provided by patient groups. This way, they can decide whether the medicine is value for money.

The SMC makes its decisions based on:

  • what benefits the medicine has compared to other available treatments
  • the quality of life and amount of extra life you may have by using the new medicine - Quality Adjusted Life Years (QALYs)
  • how you have the medicine, for example, do you have to go to the hospital or can you have it at home?
  • will it save money, for example, will you have fewer hospital admissions or side effects?
  • will you need visits by your GP or other healthcare professionals?
Quality Adjusted Life Years (QALYs)

QALYs show the benefits that a treatment has. It measures it in the length of life, and quality of life you might have.

Quality of life includes:

  • how well you are
  • whether you can work
  • whether you can care for yourself

QALYs look at, for example, how well you can carry out your daily activities. That is with and without treatment. Also, how the treatment affects your pain and mental wellbeing.

Where the SMC gets advice from

When making decisions, the SMC asks for advice from:

  • clinical experts (physicians, surgeons, GP's and clinical nurse specialists)
  • representatives from the NHS Boards in Scotland
  • members of the public
  • health economists
  • pharmacists
  • pharmaceutical industry
  • Public Involvement Network (patient and carer groups)

Reviewing cancer treatments

The SMC aims to review new medicines as soon as possible. It might start the process even before the medicine is for sale. It checks which drugs are likely to be licensed and contacts the drug companies at an early stage.

New Drugs Committee (NDC)

First, the SMC makes a draft assessment. Then it passes the assessment on to the New Drugs Committee (NDC). They look at all the scientific evidence.

The NDC consists of:

  • clinicians
  • pharmacists
  • pharmaceutical industry representatives

The initial assessment by the SMC looks at the strengths and weaknesses of the treatment. The NDC then offers preliminary advice to the company. This allows them to provide feedback and look at uncertainties.

Only then the SMC will consider the medicine. The SMC then also look at evidence from patient groups. Sometimes it also includes the Patient and Clinician Engagement (PACE).

Using the SMC’s advice

Once the SMC makes a decision, the NHS boards in Scotland take this into account. It helps them to decide which medicines are available in their area. But they don't have to follow the SMC decision.

Doctors can use their clinical judgement. They can make a decision based on an individual patient's situation. In reality, doctors usually follow the SMC's advice.

Talk to your doctor if they have not offered you a particular treatment that the SMC recommended. 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

An independent panel can look at the data again if the SMC decides not to recommend a medicine for use in Scotland. The panel might 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. But 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 Care Excellence (NICE) decides on the availability of drugs and treatments on the NHS in England. NICE also publishes guidelines on the treatment of conditions including cancer.

NICE and the SMC are separate. Previously, the multiple technology appraisals (MTAs) that NICE produced, applied to both areas. These appraisals, published from October 2017 onwards, have no status in NHS Scotland.

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