Background: The patient access scheme (PAS) has been implemented as a formal part of the pricing and reimbursement environment in the United Kingdom (UK) since 2009, which aims to improve cost-effectiveness and enable patients to gain access to high-cost drugs and treatments. This study was to investigate the impact of the patient access scheme on the appraisals for the innovative medicines in Scottish Medicines Consortium (SMC) between 2011 and 2020.

Methods: Innovative medicines were defined as the medicines that contained an active substance or combination of active substances that had not been authorised before. All appraisals for innovative medicines in SMC from 2011 to 2020 were screened to extract the data on the SMC decisions and PAS details.

Results: A total of 246 appraisals for innovative drugs were made by SMC between 2011 and 2020, among which, 117 (47.6%) were recommended, 95 (38.6%) were recommended for restricted use and 34 (13.8%) were not recommended. Among them, 141 appraisals applied for the PAS, of which, 78 (55.3%) were recommended, 61(43.3%) were recommended for restricted use and 2 (1.4%) were not recommended; and 105 appraisals did not apply for the PAS, of which, 39 (37.1%) were recommended, 34 (32.4%) were recommended for restricted use and 32 (30.5%) were not recommended. The application rates of PAS have increased dramatically since 2014, from 23.1% in 2013 to 50.0% in 2014. In 2020, the application rate of PAS reached to 86.2% and only 4 of 29 appraisals didn’t apply the PAS.

Conclusions: The application of PAS has become a popular trend for the innovative medicines in Scotland, which could significantly decrease the rejection rates in SMC.

Keywords: innovative medicines, patient access schemes, Scotland