1. What does the Scottish Medicines Consortium (SMC) do?
The Scottish Medicines Consortium (SMC) is part of NHSScotland and sits within Healthcare Improvement Scotland. We provide advice to NHS boards about the clinical and cost effectiveness of all newly licensed medicines. Our advice benefits patients by helping the health service plan for the quick, uniform introduction of beneficial treatments across NHSScotland.
When a new medicine is licensed and the manufacturing company makes a submission to SMC, we assess it to find out:
- how well the medicine works
- which patients would benefit from it
- whether it is better than or as good as treatments currently being used to treat the condition in Scotland
- whether it is good value for money for NHSScotland.
SMC is a committee of clinicians, NHS board representatives, the pharmaceutical industry and the public. Most of the clinicians have a direct role in patient care, while three volunteer public partners ensure the views of the public, patients and carers are taken into account during decision making. This wide mixture of backgrounds helps ensure that decisions are made from a broad perspective.
No. SMC advises NHSScotland on the costs and benefits of new medicines after they have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA - the licensing body for the UK) or the European Medicines Agency (EMA - the licensing body for the European Union). A medicine must be licensed before it can be considered by SMC.
Any new medicine can be legally prescribed once it has a licence if a clinician feels it is the most suitable treatment for an individual patient. However, it cannot be regularly and routinely prescribed until SMC has advised on it.
Boards are notified of SMC decisions within a week of the SMC Committee meeting so they can put procedures in place for the introduction of accepted medicines. This ensures patients can access them as quickly as possible, and may be able to access them before decisions are made public.
All health boards have procedures in place to consider requests when a clinician feels the most appropriate treatment option for a particular patient is not yet approved by SMC for routine use in Scotland.
After a medicine is licensed, the pharmaceutical company makes a submission to SMC so the medicine can be considered for routine use in NHSScotland.
Our team of pharmacists, health service researchers and economists assess the evidence submitted by the company. Their evaluation is then considered by SMC's New Drugs Committee (NDC). The NDC agrees a draft recommendation about the medicine. This recommendation, together with additional information from patients and carers who have experience of the condition the medicine is intended to treat, is then considered by the SMC Committee. The Committee makes a final decision whether to accept or not recommend the medicine for routine use in NHSScotland.
All elected members of the SMC and NDC committees, SMC clinical experts and SMC staff are required to declare any conflicts of interest before undertaking SMC-related duties.
Following a review of access to new medicines in 2013, SMC has changed its process for considering medicines for end of life and very rare conditions. These changes allow the Committee added flexibility when considering such medicines. Key among the changes is the introduction of our Patient and Clinician Engagement (PACE) process, which gives us a further opportunity to hear additional evidence from patient groups and clinicians about the impact a medicine can have on a condition that may not be provided in the pharmaceutical company's submission.
Pharmaceutical companies are encouraged to keep SMC informed of their plans for introducing a product to the UK market via our Horizon Scanning team. We aim to issue advice to NHSScotland on newly licensed medicines as soon as practical after the medicine is made available.
If the company does not wish to make a submission, SMC issues not recommended advice to NHSScotland once the medicine is available.
Where not recommended advice is issued due to non-submission, the pharmaceutical company still has the opportunity to make a submission for assessment at any point in the future. SMC advice based on a new submission will supercede the initial not recommended advice.
When a medicine is accepted by SMC it may be regularly prescribed by clinicians in NHSScotland for those patients considered suitable for treatment with it.
NHSScotland has limited resources. SMC carefully considers every medicine submitted to make sure it benefits patients and is considered to be an acceptable use of NHS resources. When we assess a medicine we take account of all patients who need treatment, not just those who may be treated with the medicine under consideration. If SMC were to accept for routine use a medicine whose benefits are not clear, it might mean patients with other conditions would lose out.
SMC can make one of three decisions on a medicine:
- accepted with some restrictions (e.g. the medicine should only be used routinely in some patients with the medical condition)
- not recommended
Companies can request that SMC considers a medicine for use in a particular patient group where there is more clinical evidence to demonstrate its benefits or because the medicine is more cost effective when used for that group. This results in a medicine being accepted but restricted to a particular patient group.
For medicines that have not been recommended by SMC, all NHS boards have procedures in place to consider requests when a doctor feels the medicine would be right for a particular patient.
Understanding the experiences of patients, their families and carers and how a medicine impacts on them is a vital part of SMC's process. Hearing the inputs of patients and carers helps our committee members make a fully informed decision on whether or not to recommend a new medicine.
SMC works in partnership with patient groups to capture patient and carer experiences. We accept submissions from all registered patient groups, from small local support groups to large national voluntary organisations. Patient groups are often looking to speak to patients and carers about new medicines which may help them. Interested individual patients and carers are encouraged to contact relevant patient groups so they can contribute to the evidence that they submit to us. You can find details of most patient groups by using the search directory on www.patient.co.uk/directory. Details of patient groups who have already submitted to us can be found on the Patient Group Partners page of our website. Patient groups can also get involved in our PACE process which may be used in the assessment of medicines for very rare and end of life conditions.
For more information on patient group submissions and how your group can get involved with our work, please visit the Public Involvement section of our website or email our Public Involvement team at hcis.SMCPublicInvolvement@nhs.net.
The Scottish Government has publicly stated that "NHSScotland should take account of advice and evidence from SMC and ensure that recommended medicines are made available to meet clinical need."
When prescribing a medicine, clinicians will consider the type of medicine that is needed (for example a medicine for high blood pressure). Sometimes more than one medicine can be used to treat a medical condition. In this instance the clinician will choose the most appropriate medicine for the individual patient. Clinicians should take account of SMC's advice when exercising their clinical judgement, unless there is evidence to justify not doing so because of the particular circumstances of a patient.
16. If I know that SMC have advised the use of a particular medicine and it is not available to me, what should I do?
You should address your concerns directly to the clinician responsible for your care. If you remain dissatisfied with their explanation you may wish to raise the matter with your local NHS health board.
All our advice is published on our website. To find out when a decision on a particular will be published, please visit our forthcoming submissions page.
If you have any additional questions please complete our comment/question form http://www.scottishmedicines.org.uk/General/Contact_Us