Abstract
BackgroundOff-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited. OPPs are comprised of off-patent originals, branded generics and unbranded generics; nonetheless, these products are not identical and often there are differences in their equivalence, manufacturing quality standards and reliability of supply. This necessitates reconsideration of the lowest price policy objective in pharmaceutical decision making. The aim of this study was to develop a Multi-Criteria Decision Analysis (MCDA) framework through a pilot workshop to inform the national procurement of OPPs in Indonesia.MethodsAn initial list of potentially relevant criteria was identified based on previous work and a literature review. In a 2-day pilot policy workshop, twenty local experts representing different stakeholder groups and decision-making bodies selected the final criteria, approved the scoring function for each criterion, and assigned weights to each criterion.ResultsAn MCDA framework was proposed for OPP drug decision making in developing countries, which included price and 8 non-price criteria. Based on the pilot policy workshop 6 + 1 criteria were considered relevant for Indonesia: pharmaceutical price (40% weight), manufacturing quality (18.8%), equivalence with the reference product (12.2%), product stability and drug formulation (12.2%), reliability of drug supply (8.4%), real world clinical or economic outcomes, such as adherence or non-drug costs (4.2%) and pharmacovigilance (3.6%).ConclusionsAccording to the pilot policy workshop, other criteria apart from price need to be strengthened in the tendering process. The introduction of additional criteria for OPP procurement in an MCDA framework creates incentives for manufacturers to invest into improved manufacturing standards, equivalence proof, product quality, reliability of supply or even additional real-world data collection, which ultimately may result in more health gain for the society.
Highlights
Off-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited
Based on local insights the 29-item criteria list was reduced by excluding several criteria 1) with limited relevance for national procurement of OPPs in Indonesia and 2) without explicitly defined scoring functions (MCDA scores should be derived by clearly defined rules or functions aiming to convert performance measurements into scores)
Except for some slight changes, the proposed scoring function was approved by the participants with no further requests for additional criteria
Summary
Off-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited. OPPs are comprised of off-patent originals, branded generics and unbranded generics; these products are not identical and often there are differences in their equivalence, manufacturing quality standards and reliability of supply This necessitates reconsideration of the lowest price policy objective in pharmaceutical decision making. The lowest price is often considered the main efficiency criterion of OPP policies by health care decision makers While this approach assumes that OPPs (comprising off-patent originals, branded generics and unbranded generics) are associated with the same attributes as their reference products in terms of quality, real world effectiveness or stability, there are shortcomings even in developed countries with high regulation standards [5]. These factors necessitate the consideration of multiple criteria in drug decision making especially in developing countries
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