Potential Criteria for Frameworks to Support the Evaluation of Innovative Medicines in Upper Middle-Income Countries—A Systematic Literature Review on Value Frameworks and Multi-Criteria Decision Analyses

Abstract

Background: Multicriteria Decision Analysis (MCDA), a formal decision support framework, has been growing in popularity recently in the field of health care. MCDA can support pricing and reimbursement decisions on the macro level, which is of great importance especially in countries with more limited resources. Objectives: The aim of this systematic review was to facilitate the development of future MCDA frameworks, by proposing a set of criteria focusing on the purchasing decisions of single-source innovative pharmaceuticals in upper middle-income countries. Methods: A systematic literature review was conducted on the decision criteria included in value frameworks (VFs) or MCDA tools. Scopus, Medline, databases of universities, websites of Health Technology Assessment Agencies, and other relevant organizations were included in the search. Double title-abstract screening and double full-text review were conducted, and all extracted data were double-checked. A team of researchers performed the merging and selection process of the extracted criteria. Results: A total of 1,878 articles entered the title and abstract screening. From these, 341 were eligible to the full-text review, and 36 were included in the final data extraction phase. From these articles 394 criteria were extracted in total. After deduplication and clustering, 26 different criteria were identified. After the merging and selection process, a set of 16 general criteria was proposed. Conclusion: Based on the results of the systematic literature review, a pool of 16 criteria was selected. This can serve as a starting point for constructing MCDA frameworks in upper middle-income countries after careful adaptation to the local context.

Early Access to Medicines: Use of Multicriteria Decision Analysis (MCDA) as a Decision Tool in Catalonia (Spain)

“…MCDA has been used in a diverse range of health care decisions and levels [ 18 , 32 ]. At the macro level, it has been mostly used by HTA bodies to rank and set priorities among therapeutic alternatives and inform reimbursement decisions [ 20 , 21 , 22 , 23 , 25 , 33 ], and it has also has been proposed for the benefit–risk assessment to support marketing authorisation [ 34 ].…”

Patient and Payer Preferences for Additional Value Criteria

“…Their main concern was the lack of measurement for the criterion. According to an ICER Commentary for their Value Assessment Framework ( Jakab et al, 2020 ), methods for empirically integrating value dimensions like Value of Hope into a value-based price are not well established and are viewed by many health economists as too exploratory for routine incorporation into assessments. On the other hand, ICER mentions that Value of Hope may be tied empirically to the risk attitudes of patient groups that vary widely depending on the severity of the condition and the prospects for future treatments to be effective.…”

“…Almost two-thirds of value assessment frameworks published between January 2013 and March 2019 had no scoring functions and one-third of all frameworks did not have definitions, only the list of criteria names ( Jakab et al, 2020 ). An MCDA tool designed for repeated use with clear definitions, rationale for inclusion, and well-defined scoring functions can provide a solution as we address the need for objective assessment and the challenges of available measurement methods in their infancy.…”

“…Criteria were aggregated from the Memorial Sloan Kettering Cancer Center Drug Abacus ( Djatche et al, 2018 ; Lanitis et al, 2019 ), the ISPOR value flower ( Lakdawalla et al, 2018 ), and the Institute for Clinical and Economic Review’s Other Benefits and Contextual Considerations ( Institute for Clinical and Economic Review (ICER), 2020 ). These three frameworks were selected from the findings of a systematic literature review of value frameworks ( Jakab et al, 2020 ). Those frameworks published from the United States context including any additional value criteria were chosen.…”

A systematic review of pharmaceutical price mark-up practice and its implementation

“…Europe, Organization for Economic Co-operation and Development); by drug category (anticancer drugs, vaccines, innovator or generic drugs) or by income groups (low, middle income countries). 14 , 15 , 16 , 17 , 18 Closer examination of these reviews shows that they do not present particular effects for measures taken to control pharmaceutical pricing in individual countries. They mainly discuss the general application of a price control measure.…”