The SMC decision making process for PrEP

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Wednesday 8th March 2017

HIV Scotland staff have been working to ensure knowledge and understanding of PrEP is increased in the public and professionals, and that PrEP is made available on the NHS in Scotland for people who need it. We have published several pieces of guidance and evidence, lobbied for and administered expert panels to address PrEP in a way that is appropriate for Scotland, as well as engaged with a diverse range of community members to ensure their needs and concerns were understood and addressed.

On the 7th March, we attended the Scottish Medicines Consortium’s (SMC) committee meeting where they voted on whether to make PrEP available on the NHS. The decision won’t be announced to the public until the 10th April, however, we were able to see how the decision about PrEP is made. As we wait for the public announcement, we wanted share what we’ve learned about the process.

In December, Gilead, the pharmaceutical company who manufactures Truvada (the drug being considered for use as PrEP), submitted an application to the SMC to determine whether it should be made available on the NHS.

When a new drug is submitted it is firstly evaluated by an assessment team made up of pharmacists, health service researchers and health economists, who look at the evidence provided by the pharmaceutical company.

At this stage, a network of multidisciplinary clinical experts including consultant physicians, surgeons, senior specialist pharmacists, general practitioners are also consulted. They give their views on matters such as current prescribing practice, disease prevalence, where there is unmet need and where new products fit into or replace existing treatments. In the case for PrEP, the clinical experts were strongly in favour of making it available on the NHS.

These assessments are then carefully considered by the New Drugs Committee (NDC), a subcommittee of the SMC, which considers all of the clinical and economic evidence and creates a ‘Detailed Advice Document (DAD)’. The NDC then makes a recommendation to the SMC on the drug.

The DAD is then sent to the pharmaceutical company for them to respond, either with additional information or clarifications.

During this time the SMC also considers “Patient Group submissions” which is an opportunity for individuals who may benefit from a drug to make their views known and for community members to influence and contribute to the decision-making process. HIV Scotland with Terrence Higgins Trust Scotland, Waverley Care and National AIDS Trust submitted a joint submission on PrEP that was informed by experiences captured through an online survey and from personal histories we collected.

The NDC recommendation, the DAD and other supporting evidence (which included the report by the Short Life Working Group on PrEP and the Patient Group submission) are then considered by the members of the SMC.

It is at this point that the SMC hold a public meeting. In the meeting we attended, six drugs were being assessed. For each drug, a summary of evidence from the NDC and patient group submissions are read. Consortium members then ask questions which are responded to by the SMC representatives. The pharmaceutical company are invited to reflect on whether they think the summary was fair, or if they wish to clarify any points. For the PrEP discussion, the drug companies highlighted that the sexual risk taking and more STIs were not as big a concern as some members made it out to be in their discussion citing relevant evidence.

Before casting their votes, members are reminded that they are not to consider budgetary impact but rather cost effectiveness. Committee members then cast a secret ballot, which is collected and taken out of the room to count. The decision is made at this meeting but is only released to committee members and not the public.

If PrEP is approved by the committee, they will contact health boards over the next month to inform them of the decision made. Following this each Health Board's Area Drug and Therapeutic committee will review their budgets and decide how to make the drug available, and the manufacturer will be contacted to ensure an adequate supply of the drug can be made. It is possible that during this process obstacles are identified that delay the rollout of an approved drug.

If the decision is no, Gilead will be invited to a feedback meeting with the SMC and able to re-apply.

The decision on PrEP will be made public on the 10th April at 2:00PM on their website. The documents that were used in the decision-making process will also be made available.

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