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How do new MS medicines get approved in Scotland?

Hannah Maunder

Before a new medicine can be widely prescribed on the NHS it has to be recommended by one of the UK health watchdogs.

In Scotland this responsibility falls to a consortium of Scotland’s Health Boards called the Scottish Medicines Consortium (SMC).

What does the SMC do?

Once a drug company has completed its trials of a new medicine, it applies for a European licence. A licence confirms that the medicine is safe and effective.

Every newly-licensed medicine must then be reviewed and recommended by the SMC before it is made widely available on the NHS in Scotland.

The health watchdogs in other parts of the UK (such as NICE) undertake a very similar process. When deciding whether a medicine should be provided by NHS Scotland, the SMC looks at:

  • whether the medicine is effective
  • which patients would benefit
  • whether it is better than medicines currently available
  • how much it costs
  • whether it represents value for money

What can the MS Society do?

The SMC also asks for views from patient groups about the potential benefits of the medicine, which is why we need to hear your experiences.

We gather evidence from people with MS through surveys, interviews and reported experiences to contribute to the reviews of new MS medicines. These views can make a big difference to the outcome.

For example, the MS Society helped achieve a positive recommendation for Botox.

What happens when the SMC recommends a medicine?

Health Boards are expected to follow SMC advice and include SMC-recommended medicines in their lists of medicines that are approved for prescription, known as local formularies. If a Health Board decides not to take the SMC’s advice it has to clearly justify that decision.

To date, all MS medicines recommended by the SMC have been included on Health Board formularies. This is important as it means that clinicians can prescribe that medicine on the NHS to any patient who meets the criteria and who chooses to take it.

Find out more about disease modifying therapies that are currently available.

What happens if a medicine is not recommended?

There are three situations when a licensed medicine may not have a positive recommendation for use on the NHS:

  1. The drug company has decided not to apply to the SMC for a review of its medicine
  2. The SMC has not yet completed a review of the medicine
  3. The SMC has reviewed the medicine and decided not to recommend it.

In each of these situations, the medicine will not be automatically and widely available on the NHS. This is the case with symptom management treatments Sativex and Fampyra.

It is usually only possible to access a medicine without an SMC recommendation if the local Health Board is willing to pay for the treatment through an Individual Patient Treatment Request (IPTR) or if a patient is going to pay for it themselves.

An IPTR is an application for the medicine that is made by the clinician on the grounds of ‘exceptional circumstances’.

Not all applications for medicines through the IPTR process are successful, but it is an important route to explore if an individual and their clinician believe that a medicine may be of benefit.

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