Budget impact analysis of medicines: updated systematic review and implications

Abstract

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.

Towards a Transparent, Credible, Evidence-Based Decision-Making Process of New Drug Listing on the Hong Kong Hospital Authority Drug Formulary: Challenges and Suggestions

“…Firstly, improvement in the transparency of the decision-making process, including the disclosure of the rules of making decisions in terms of costeffectiveness, declarations of conflicts of interest from submitters, and engagement of key external stakeholders would support the credibility and accountability of the decisions made by the DAC. Secondly, the adoption of a budget-impact analysis framework from international guidelines would enhance the standardization and improve the quality of budget-impact analysis [38], and thus present a better picture of the budget impact to healthpolicy makers. Detailed information on costs of new and alternative drugs and healthcare services due to the uptake of new drugs, and other condition-related healthcare services and important aspects within the framework of budget-impact analysis would allow the DAC to better understand the value of new and alternative drugs.…”

Inflammatory Bowel Diseases (Crohn´s Disease and Ulcerative Colitis): Cost of Treatment in Serbia and the Implications

“…We have also sought to address some of the concerns with studies such as cost-of-illness studies and budget impact analysis [31] by using patient-level data, local costings and avoiding conflicts of interest. We acknowledge though that we did not check the accuracy of respondent answers.…”

Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries

“…• Taking into account potential trade-offs in terms of healthcare resources taking account of the potential variable effectiveness of the new medicine in different populations, especially if there are likely to be differences in the patient populations in routine clinical care compared with the Phase III trials. There are concerns though with the majority of published BIAs including issues of bias, which negatively impacts on their current usefulness to health authorities [134].…”