How we make our decisions

Medicines can prolong life, improve the quality of life, or both.

As the health service has limited money to spend, difficult choices have to be made about what treatments can be made routinely available; the decision to make a treatment available for one group of patients may mean that treatments cannot be provided for another patient population.

The SMC Committee takes a range of factors into consideration when deciding whether to accept a new medicine under review. The committee considers the clinical and health economic evidence provided by the submitting company as well as evidence submitted by patient groups to decide whether the medicine provides value for money.

SMC evaluates every medicine submitted in terms of whether the benefits for patients may be considered an acceptable use of NHS resources.

When we talk about value for money or cost effectiveness, this does not just mean how much a medicine costs to buy, but the wider costs and benefits associated with it being regularly used to treat those with a particular condition, for example:

• what benefits the medicine offers compared to other currently available treatments
• the quality of life and amount of extra life that may be gained by patients using the new medicine
• how the medicine is administered (for example, does it require a visit to a clinic or can it be taken by the patient at home?)
• will it save money downstream, for example if the patient will have fewer hospital admissions due to complications from their condition, and
• if there are any additional GP/other healthcare professional visits required.

When a medicine is for end of life or rare conditions, the company can request that SMC convenes a PACE meeting to consider the added benefit of the medicine not captured by the conventional clinical and economic assessment.  The output from a PACE meeting is a major factor in SMC decision making.

Find out more about PACE

Following the Scottish Government's announcement around a new pathway in June 2018, a new approach to the assessment of ultra-orphan medicines is being introduced.

Find out more

Decisions are made by the SMC Committee at their monthly meeting by a majority vote.

Find out who sits on the committee

Streamlining processes

SMC expanded the abbreviated process in October 2020 as part of our strategy to resume business following the pause due to the COVID pandemic. Following a positive stakeholder evaluation, it is now a permanent process.

Find out more about streamlining processes

SMC can make one of three decisions on a medicine:

• accepted
• accepted with a restriction(s) (for example, the medicine can only be recommended in a particular group of patients with the condition. This typically occurs because the company has requested this explicitly in their submission), and
• not recommended.

The committee now also has the opportunity to accept some medicines on an interim basis subject to ongoing evaluation and reassessment.

Find out more about interim acceptance

Common reasons for not being able to recommend a medicine are:

• the medicine is no better than cheaper products already in use, 
• the additional benefits of the medicine do not provide good value for money to the health service and / or
• the case for the medicine is uncertain or not robust enough (for example, there were uncertainties or weaknesses associated with the evidence used to estimate the value for money of the medicine)

Once a decision is made, it is shared in confidence with NHS boards and the pharmaceutical company four weeks before it is published to ensure that Area Drug and Therapeutics Committees (ADTCs) can take steps to prepare for the introduction of the new medicine in health boards.

When SMC accepts a new medicine, NHS boards are expected to make it, or an equivalent SMC-accepted medicine, available. NHS boards publish the medicines included and excluded from their formularies together with the reasons for such decisions. 

Where a medicine is not recommended by SMC, the company can make an improved resubmission at any time.

All NHS boards have procedures in place to consider requests for the use of a medicine in an individual patient when a doctor feels this would be appropriate.

We actively encourage submissions from pharmaceutical companies to ensure medicines can be made available as soon as possible. If a company decides not to make a submission to SMC, we advise health boards that the medicine cannot be recommended for routine use.