Academic journal article Bulletin of the World Health Organization

Evaluating the Quality and Use of Economic Data in Decisions about Essential medicines/Evaluer la Qualite et L'utilisation Des Donnees Economiques Dans Les Decisions Sur Les Medicaments essentiels/Evaluacion De la Calidad Y El USO De Datos Economicos En Las Decisiones Sobre Medicamentos Esenciales

Academic journal article Bulletin of the World Health Organization

Evaluating the Quality and Use of Economic Data in Decisions about Essential medicines/Evaluer la Qualite et L'utilisation Des Donnees Economiques Dans Les Decisions Sur Les Medicaments essentiels/Evaluacion De la Calidad Y El USO De Datos Economicos En Las Decisiones Sobre Medicamentos Esenciales

Article excerpt

Introduction

Essential medicines are those that satisfy the priority health care needs of the population. (1) The World Health Organization (WHO) introduced the first Model List of Essential Medicines in 1977. Countries are encouraged to use the model list as a guide for their decisions on pharmaceutical selection and procurement. Between 1977 and 2007, over 130 countries introduced national lists of essential medicines, modifying the WHO model list for their national context. (2)

The model list is updated every two years, following an application and review process by an expert committee. Any individual or institution may submit an application. Before each committee meeting, applications are published on a website for public comment and experts (committee members and external advisors) review each application. (3) These reviews and any public comments are also published on the website before the committee meeting. Since 2002, essential medicines have been selected via an evidence-based process, with due regard to public health relevance, evidence on efficacy and safety and comparative cost-effectiveness. (1) Detailed information on the decision criteria can be found at http://www.who.int/selection_medicines/en/. The model list is divided into a core list and a complementary list. The core list includes medicines that meet the criteria of efficacy, safety and comparative cost-effectiveness, (1) but expensive patented medicines are not necessarily excluded. (3,4) The complementary list includes medicines that may require specialized facilities, that are consistently more costly, or less cost-effective in a variety of settings. (5)

Additions to the model list can have a major impact on global and national decisions, with significant budgetary, ethical and health implications. (6,7) Other studies have examined application processes and criteria for national decisions on adopting new vaccines, (8) national health technology assessment programmes (9-10) and financing decisions for health technologies. (11) A recent study found that applications to the model list for mental health medicines generally provided low-quality and incomplete evidence across several required dimensions. (12) There is no global consensus on how to use economic data in decision-making for medicines and health technologies. (13-17)

Here, we evaluate the extent to which applicants and the expert committee adhere to the instructions and procedures on economic data and analysis for applications to the model list. We assess the application process rather than the substance of decisions (specifically, compliance with instructions for applicants and the quality of data on price and on cost-effectiveness). We also assess whether economic considerations are included in the final report by the expert committee. The overall goal of this study is to improve the quality, transparency and clarity of the process for reviewing applications to the model list.

Methods

Data set

We included applications to the model list for medicines intended for use in adults. We analysed final reports from the twelfth (2002) to nineteenth (2013) meetings of the WHO expert committee; the sixteenth meeting reviewed paediatric medicines only and was not included. We did not review applications for new formulations of existing medicines or applications for reinstatement.

Definition of variables

We assessed the extent to which applicants complied with the instructions provided. The instructions ask applicants to provide "a range of costs of the proposed medicine" that reflect "average generic world market prices", with a clearly specified source of data. The WHO-recommended sources for these data include the International Drug Price Indicator Guide, the United Nations Children's Fund, Medecins Sans Frontieres or WHO itself. We allocated one point for each of the following: price given; offered range of price or average or median price; clear source; WHO-recommended source. …

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