Academic journal article Applied Health Economics and Health Policy

A Critical Systematic Review of Budget Impact Analyses on Drugs in the EU Countries

Academic journal article Applied Health Economics and Health Policy

A Critical Systematic Review of Budget Impact Analyses on Drugs in the EU Countries

Article excerpt

Published online: 26 October 2013

© Springer International Publishing Switzerland 2013

Abstract

Background Budget impact analysis (BIA) is a relatively recent technique that is supposed to be complementary to more established economic evaluations (EEs).

Objective We reviewed the BIAs published on drugs in the EU since December 2008, to assess whether these studies have improved in quality in the last few years.

Methods We conducted a literature search on the international databases PubMed and EMBASE. The selected articles were screened using a two-step approach to assess (1) their main methodological characteristics and (2) the level of adherence to the latest BIA definition. The assessment was made by two independent reviewers and any disagreement was resolved through discussion.

Results Eventually, 17 articles were reviewed. Thirteen referred to a stand-alone BIA not accompanying a full EE, only nine focussed on a new treatment, 15 were sponsored by the manufacturer of the drug of reference, all but one claiming savings for healthcare budgets. The quality of methods was poor in many of the studies, and only a few of them attempted to estimate real local costs in a credible way. Therefore, the crucial items that in theory make a BIA different from other types of EEs were often the major points of weakness of the studies reviewed.

Conclusions Our review confirmed that the BIA is not yet a well-established technique in the literature and many published studies still fail to reach an acceptable quality. In particular, BIAs funded by pharmaceutical companies appear to be tailored to show short-term savings induced by new, highly priced products.

1 Introduction

Budget impact analysis (BIA) is a relatively recent technique that is supposed to be complementary to more established economic evaluations (EEs), and to provide useful additional information for health technology assessment. Its main aim should be to assess the financial consequences of the introduction of a new technology in the short term in a specific setting, to assess its sustainability [1].

Although some public authorities have issued national guidelines on BIAs in different countries [2] and a few articles have contributed to building up the BIA method [1-3], none has provided an exhaustive definition. Moreover, only one comprehensive review assessed the method of published BIAs up to November 2008 [4]. The authors found fairly good agreement between published studies and International Society for Pharmacoeconomics and Outcomes Research methodological guidelines [2] within the scope of perspective, comparator, costs included and data sources, although some specific issues (reporting format, sensitivity analysis and discounting) needed to be addressed and/or improved. The review concluded that BIAs have appeared with increasing frequency in peer-reviewed journals and, although many studies failed to reach the desired quality, the situation should improve in the future as a result of good research practice principles.

In the light of growing demand from budget holders in many European countries, we recently published an editorial where we tried to provide a 'stand-alone' definition of BIA based on the international articles focusing on methodology [5]. Our main goal was to find a more specific place for BIA among EEs available in healthcare, trying to embed it more homogeneously in the regulatory requirements of public authorities that decide to adopt it.

We defined BIA as an economic evaluation conducted on a new technology: (1) according to the budget holders' perspective; (2) with a short time horizon (up to 3 years), (3) within a clearly specified setting; (4) where results are expressed as undiscounted cost differences between the new scenario (including the new technology) and the current scenario; (5) taking account of the potential trade-offs in healthcare resources induced in case of short-term effectiveness of the new technology; and (6) examining the results using sensitivity analyses responsive to the uncertainty surrounding future market developments (like a scenario analysis), and making it easy for budget holders to understand (like the analysis of extremes). …

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