How Do Abbreviated HTA Submissions Impact Reimbursement? A SMC Case Study

OBJECTIVES: The Scottish Medicines Consortium (SMC) introduced from October 2020 new criteria for the abbreviated submission procedure, enabling products in the same therapeutic class as an approved medicine to use the abbreviated pathway. This study aims to assess the impact of this change on uptake of the abbreviated procedure and on the availability of medicines in the National Health Service (NHS) in Scotland.

METHODS: All published SMC appraisals from 1 October 2020 to 1 June 2024 were analysed. All abbreviated submissions published from 1 January 2014 to 1 June 2024 were also analysed. The parameters considered were: submission type, publication date, SMC recommendation, British National Formulary (BNF) chapter and patient access scheme (PAS) status.

RESULTS: From 1 October 2020 to 1 June 2024, the SMC published 324 appraisals, of which 43 were of the ‘therapeutic class abbreviated submission’ type. 27.9% of medicines assessed via this pathway were in the ‘malignant disease and immunosuppression’ BNF chapter, compared with 42.3% across all 324 submissions. For abbreviated submissions published from 1 January 2014 to 1 October 2020, the most common BNF chapter was ‘infections’ (26/113; 23.0%), while 6.2% were for ‘malignant disease and immunosuppression’. From 1 January 2014 to 31 December 2019, an average of 17.8 abbreviated submissions were assessed annually, increasing to 21.6 per year from 1 January 2021 to 31 December 2023. By contrast, the SMC published 94.5 appraisals (all types) per year on average in 2014-2019, falling to 91.0 annually in 2021-2023.

CONCLUSIONS: The new abbreviated submission criteria have had an impact on the volume of such submissions assessed by the SMC but have not resulted in an overall increase in medicines assessed by the SMC. The increase in abbreviated submissions after 1 October 2020 appears to have been driven by medicines in the ‘malignant disease and immunosuppression’ BNF chapter.