Dr Alan MacDonald: Decisions on medicines are difficult – but we do our best to benefit everyone

Medicines are evaluated before being offered to the public

As medicine technologies develop and we move towards a future where medicines can be more personally tailored to a patient’s condition, these costs will only increase. But how do doctors, other clinicians, pharmacists and the public know which medicines are effective – and a good use of limited NHS resources?

That is our important and challenging task at the Scottish Medicines Consortium (SMC). As part of Healthcare Improvement Scotland, we review all newly-licensed medicines and advise on which offer clinical and cost-effectiveness for the NHS in Scotland.

In 2017 alone, we issued 100 pieces of advice, and, since the introduction of Patient and Clinician Engagement (PACE), we have accepted around 80 per cent of new medicines submitted to us for consideration.

The conditions we consider medicines for vary enormously, from very rare genetic conditions to cancer and arthritis. Our advice is likely to affect most of the population in Scotland at some point in their lives. This is a huge responsibility, and therefore we take great care that the decisions we reach come after a thorough examination of the best evidence available to us.

The SMC process is key to ensuring that the people of Scotland have early access to medicines which offer real benefits at acceptable cost. Sometimes, however, there may be too much uncertainty as to the overall benefits, or the high costs may not seem justified.

We recently published advice not recommending two very high profile medicines: ivacaftor-lumacaftor (Orkambi) and ivacaftor-tezacaftor (Symkevi). Both of these are novel treatments for cystic fibrosis, a severe genetic disease with potentially devastating effects on the lungs and digestive system. These were not easy decisions to make, and it can be difficult for the public to fully understand the reasons why the committee is unable to accept some medicines.

Our committee members, many of whom are clinicians who speak with patients and carers every day, do their best to make fair and impartial decisions based on the evidence presented by patients, clinicians and pharmaceutical companies.

This evidence is extensive, detailed and the interpretation requires very careful judgement. In order to ensure we give every medicine equal consideration, these decisions are based on this evidence alone – not what has been in the media, or a petition or a campaign. The views of patients and their carers play a key role in our decision making, as only they know the reality of living with a condition. We take great care in the committee to understand their perspective on the benefits of a new medicine.

Last year, our Public Involvement team actively engaged with 155 patient groups, resulting in 93 per cent of our medicine appraisals including a patient group submission, compared to 65 per cent in 2014. Involving patient groups in discussions on the likely impact of a new medicine has enriched our deliberations and consequently the decisions committee members make.

It is incumbent on us to ensure the decision process is fair and equitable. We have to take into account all patients who might need treatment, not only those who might be treated by a particular medicine. We have to make sure that decisions are based on making best use of limited NHS resources.

Our committee members want to be able to accept the medicines that will prolong and improve people’s lives. As clinicians we know how difficult it is to tell a patient that a treatment can’t be provided on the NHS.

Making decisions about whether or not patients should routinely access new medicines is a difficult and complex job. Our members know that there will be a range of views about our decisions but we strive to make them based on the best available evidence and taking the views of patients and clinicians into account.

Dr Alan MacDonald is a consultant rheumatologist with NHS Grampian and chair of the Scottish Medicines Consortium.