Applying Multi-Criteria Decision Analysis (MCDA) Simple Scoring as an Evidence-based HTA Methodology for Evaluating Off-Patent Pharmaceuticals (OPPs) in Emerging Markets

Abstract

Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population's health. In addition, many health care systems lack the resources or expertise to evaluate such products, and current assessment methods can be complex and difficult to adapt to a health system's needs. Multicriteria decision analysis (MCDA) simple scoring is an evidence-based health technology assessment methodology for evaluating OPPs, especially in emerging countries in which resources are limited but decision makers still must balance affordability with factors such as drug safety, level interchangeability, manufacturing site and active pharmaceutical ingredient quality, supply track record, and real-life outcomes. MCDA simple scoring can be applied to pharmaceutical pricing, reimbursement, formulary listing, and drug procurement. In November 2015, a workshop was held at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting in Milan to refine and prioritize criteria that can be used in MCDA simple scoring for OPPs, resulting in an example MCDA process and 22 prioritized criteria that health care systems in emerging countries can easily adapt to their own decision-making processes.

Weighing Price and Performance for Decisions for Multisource Pharmaceutical Bidding in Public Hospitals in Thailand

“…The final list of criteria selected in this initial workshop for the resulting MCDA model shows some deviations from the criteria which were previously suggested by an international expert group [2] and which were selected in other countries which adapted the tool to their settings [13]. This reflects the active engagement and contribution of the participants who critically questioned and deliberated each of the proposed criteria in comparison to their current decision processes.…”

“…The workshop started by defining all non-price criteria which may be relevant in the Thai decision process. These were defined starting from the basic decision criteria proposed by international health policy thought leaders [2] and an adapted set of these criteria which had gone through a preliminary adaptation to current Thai decision priorities before the workshop, by the local leadership team of the initiative (Step 1). This involved a detailed moderated discussion of each of the criteria and of the measures used for scoring each of the criteria (Step 2).…”

“…Multiple-criteria decision analysis (MCDA) is a method which has been suggested as a tool for the evidence-based assessment of multisource pharmaceuticals in developing countries [2]. MCDA can help to consider multiple and sometimes conflicting criteria in the evaluation of the available alternatives [3].…”

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

“…To the best of our knowledge, this is the first publication supporting the creation of MCDA for the reimbursement of innovative pharmaceuticals in upper-middle-income countries. Similar publications identified throughout our systematic literature review were a systematic review on the use of methodological frameworks to set health care priorities in lowincome and lower middle-income countries (Wiseman et al, 2016), MCDA tools specific to one certain upper-middle-income country with either a specific or a general scope (Iskrov et al, 2013;Ramli et al, 2013;Youngkong, 2014;Hu et al, 2015;Jaramillo et al, 2016;Radu et al, 2016) and an MCDA tool for emerging countries focusing on the evaluation of off-patent pharmaceuticals (Brixner et al, 2017). The proposed set of 16 criteria provides a comprehensive initial framework that can be adapted to upper-middle-income countries' circumstances based on local priorities.…”

Comparison of weighting methods used in multicriteria decision analysis frameworks in healthcare with focus on low- and middle-income countries

“…Low-and middle-income countries require a simple and pragmatic methodology for OPP decision-making that takes more attributes into account than only the price of the products. As a result, building MCDA frameworks to find transparent, consistent and rigorous solutions for decision making for the area of OPPs in these countries has become an emerging practice [14,15].…”