Abbreviated submissions

SMC introduced the abbreviated (therapeutic class) process as an interim measure in October 2020. This process is for medicines where alternatives within the same therapeutic class are already available for the same indication. It was part of SMC’s strategy to resume business following the pause due to the COVID pandemic. The aim was to reduce demand on committee members by streamlining decisions on certain medicines. Following a positive stakeholder evaluation, it is now a permanent process.

• Faster access to new medicines for patients.
• Provides savings in resources and time for the SMC assessment teams, SMC committees, Patient Group Partners and the pharmaceutical industry.
• Allows SMC committees to focus on medicines expected to have a substantial impact on treatment pathways, including innovative medicines.

• The company makes contact with the SMC secretariat. Advice on submission requirements is available by completing a Company Information Request Form.
• The company submits an abbreviated submission to the SMC secretariat. The company must demonstrate that the medicine provides an alternative to other medicines in the same therapeutic class that are available for use in NHSScotland and that their medicine has similar clinical effectiveness and overall cost to NHSScotland (limited net budget impact). Usually the comparator will be medicines that have been accepted for use (or restricted use) by SMC.
• The SMC assessment team review the abbreviated submission using a submission checklist, and a Product Update template is drafted.
• Patient Group Partners are given the opportunity to provide comment on the medicine in the indication under review.
• Representatives from the SMC Executive consider the evidence and make a decision whether the medicine can be accepted for use.
• If the medicine is accepted for use, the Product Update document is shared with health boards, Patient Group Partners and published on the SMC website.

• If, following the SMC’s Executive review, a medicine is not considered suitable for the abbreviated process advice will not be issued at this stage.
• The submitting company may resubmit once more via the abbreviated process or, alternatively, they have the option to complete a full submission, which will be considered in the usual way.