PHP156 - How does a small or medium sized pharmaceutical company prepare for and navigate the scottish market?

Abstract

The Scottish Medicines Consortium (SMC) requires all manufactures to submit clinical and economic evidence for products no later than 3 months after licensing. Any products without a submission are automatically not recommended. Due to the complexity of the UK market access environment, small or medium pharmaceutical enterprises (SMEs) may not have the knowledge or resource to generate submissions for all products. In 2015, the SMC aim to improve early engagement with SMEs. To establish the importance of this engagement, we assess the differences in submissions and recommendations between SMEs and larger companies. Categorizing the top 30 pharmaceutical companies (based on gross revenue) of 2013 as large companies and all other submitting companies as SMEs, SMC recommendations following full, abbreviated or resubmissions were analyzed along with the proportion of non-submissions. Recommendations for co-marketed products were divided evenly between manufacturers. There is a statistically significant relationship between the proportion of positive guidance for large companies and SMEs (75.47% versus 64.62%, p=0.0002). The number of non-submissions from large companies was 14 in 2012, 18 in 2013 and 8 in 2014; from SMEs the number of non-submissions was 11 in 2012, 7 in 2013 and 6 in 2014. There is a relationship between company size, based on revenue, and likelihood of a positive SMC recommendation, but identification of the cause and effect requires further analysis. These results could indicate that large pharmaceutical companies have a greater influence on the decisions of the SMC, or simply more experience and resource to increase the chances of success. In 2014, the 30 largest companies accounted for more non-submissions than all other pharmaceutical companies, suggesting that large companies can afford to pick and choose whether to submit to the SMC or gain reimbursement through alternative channels whilst avoiding the wider impact of negative guidance.