OBJECTIVES : Since 2001, all new pharmaceutical products have been assessed by the Scottish Medicines Consortium (SMC) prior to approval for use in Scotland. SMC requires the demonstration of an ICER of less than £20,000 - £30,000/QALY to achieve approval. The influence of SMC decisions extends beyond Scotland, as the expedited HTA process is one of the earliest assessments of a product’s cost-effectiveness.

METHODS : We have reviewed SMC decisions from the past decade to identify criteria that determine a successful outcome.

RESULTS : In 2009/10, 29% of submissions resulted in acceptance of the product within its licensed indication, with a further 39% being accepted with additional restrictions applied (total 68%). 32% of submission were rejected as not being approved for use in NHS Scotland. In most cases, rejection was due to a failure to demonstrate adequate cost effectiveness. In 2018-19, 44% of submissions were accepted, with a further 41% being accepted with restrictions (total 85%). 16% were rejected.

The reasons for this change are likely to be multifactorial. One obvious difference is an increase in the use of Patient Access Schemes (PAS). These normally take the form of a confidential discount applied to the list price of the drug, in order to bring the ICER within the acceptable range. In 2009/10, a PAS was offered in 7% of submissions, while in 2018/9 this had risen to 58%. If minor license extensions are excluded, the rate of PAS offered for full new drug submissions has increased to 71%.

CONCLUSIONS : A combination of rising new drug costs and commercial pragmatisms amongst manufacturers has made the use of discounts integral to most HTA submissions. We present a detailed analysis of the data, in order to further understand the trends and help guide a practical approach to future submissions, to maximise the chances of acceptance by SMC.