The Scottish Medicines Consortium (SMC) is the body that evaluates all new medicines in Scotland. Its equivalent in England is called NICE. The European Medicines Agency (EMA) is the one that drug companies go to to obtain a licence for marketing a new drug.
It then comes to the SMC to review that new product and decide whether to accept it, partially accept it or reject it, for use within the NHS in Scotland. This licensing is at at end of a long research and development process by drug companies including some clinical trials. However, the license doesn’t say if the new medicine is better than current treatments. Nor does it say if its worth any extra costs to the NHS.
So, the SMC tries to establish its relative effectiveness and its cost as part of its evaluation process. Medicines cost the NHS about £1.5 billion. Good, new medicines tent to be expensive, the SMC needs to be sure new medicines offer value for money. There are questions over what can be funded, what is the maximum health benefit, is it fair for special groups that the SMC attempts to address. It takes 6 to 8 weeks from submission to end of the review process.
From 2002 SMC has reviewed 926 new medicines, 35% accepted, 35% given conditional acceptance and 30% not recommended. Most publicity tend to be given to those that fall into this latter category.
The SMC give the final recommendations to each Health Board in Scotland. Its then up to each Board to decide if they can afford the cost of the new medicines on their budgets and responsibilities. There perhaps may be a “post code” lottery on which new medicines are made available at your GP.
When a drug patient expires, generics are produced but they are not currently reviewed by SMC. Any drug “not recommended” can be resubmitted where new research evidence is found.
The SMC wants to have more people involved in the approval process, or made more aware of their work.
Question: the SMC doesn’t monitor if a new medicine is taken up, perhaps they should do. That process would inform how each Health Board responds and determine if a “lottery” exists.
