Budget impact analysis of medicines: updated systematic review and implications.

This evaluation determines whether published studies to date meet the key characteristics identified for budget impact analyses (BIA) for medicines, accomplished through a systematic review and assessment against identified key characteristics. Studies from 2001-2015 on 'budget impact analysis' with 'drug' interventions were assessed, selected based on their titles/abstracts and full texts, and their characteristics checked according to key criteria. Out of 1,984 studies, 92 were subsequently identified for review. Of these, 95% were published in Europe and the USA. 2012 saw the largest number of publications (16%) with a decline thereafter. 48% met up to 7 out of the 9 key characteristics. Only 22% stated no conflict of interest. The results indicate low adherence to the key characteristics that should be considered for BIAs and strong conflict of interest. This is an issue since BIAs can be of fundamental importance in managing the entry of new medicines including reimbursement decisions.