Health technology assessment in middle-income countries: recommendations for a balanced assessment system

Abstract

Because of significant differences in institutional contexts, health technology assessment (HTA) systems that are in place in core pharmaceutical markets may not be suitable, fully or in part, for middle-income countries (MICs) and for other noncore markets. Particular challenges may arise when systems based on the economic evaluation paradigm are conceptualized and implemented in MICs, sometimes with an insufficient level of awareness of the local institutional factors that influence pricing and reimbursement decision making. Focusing on pharmaceuticals, this article investigates possible development directions for HTA systems in MICs and noncore markets bearing similar institutional characteristics, and it provides recommendations for a balanced assessment system (BAS). For this, the main paradigms of HTA have also been reviewed briefly and factors influencing HTA and pricing and reimbursement decisions in MICs and in similar noncore countries have been summarized. The proposed BAS framework takes into account available resources and capabilities and is supposed to facilitate access to new pharmaceuticals while ensuring the transparency of decision-making processes and the stability of the pharmaceutical budget.

• health technology assessment (HTA)
• middle-income countries (MIC)
• balanced assessment
• multi-criteria decision analysis (MCDA)
• pharmaceutical assessment
• reimbursement decisions

Notes

¹In this article, for the reader's ease, we use the terms ‘reimbursement’ and ‘public funding’ interchangeably, although we acknowledge that reimbursement can also be interpreted as a subcategory of public funding.

²Throughout the article, we use the term ‘pharmaceutical company’ to denote the entity requesting reimbursement for a pharmaceutical product. In fact, this is commonly the marketing authorization holder, its local affiliate, or an authorized distributor.

³ http://data.worldbank.org/about/country-classifications [cited 4 January 2014].

⁴See e.g., http://aaz.hr/resources/radionice/29/HTA%20in%20Croatia%20Bratislava%20January%202012_ppt%20%5BCompatibility%20Mode%5D.pdf[cited 30 May 2013].

⁵For an alternative approach to the basis of MCDA see, for example, Kanavos and Angelis (12) or Phillips (2012): Multicriteria decision analysis for appraising benefit-risk, http://www.mhra.gov.uk/home/groups/espolicy/documents/websiteresources/con028321.pdf [cited 4 January 2014].

⁶Before and during the preparation of this article, pricing and reimbursement processes were reviewed for developed markets such as those of Australia, Canada, France, Germany, Italy, New Zealand, Spain, and Sweden, and for selected middle-income countries such as Brazil, Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia, and Turkey, mostly on the basis of PPRI information, EMAUD educational materials, and the author's own research. This article categorically does not intend to set any of the reviewed national systems as a benchmark, and any resemblance to any national systems should be seen as a product of high-level analysis.

⁷We use the term ‘managed entry scheme’ to refer to any contractual agreement between the pharmaceutical company and the payer that aims at reducing the effective net price and/or budget impact of a newly reimbursed medicine. Several classifications exist for managed entry schemes; in-practice rebate schemes, patient-level caps, population-level caps, free cycles, and outcome-based agreements can all be considered managed entry schemes.

⁸This is actually shorter than the 180-day (90 +90) requirement set by the European Union's Transparency Directive. In EU countries, 180 days should be regarded as a legal maximum.