OBJECTIVES: Off-patent pharmaceuticals (OPPs) play a vital role in meeting public health objectives, especially in developing countries with high budgetary constraints. Despite a high need for minimizing acquisition cost, additional criteria matter and therefore, Multiple Criteria Decision Analysis (MCDA) can support prioritization. The objective of our work was to develop an approach which can be easily adapted and implemented by decision makers in developing countries in order to improve the evidence base, robustness and transparency of policy decisions related to OPPs.

METHODS: A spreadsheet was developed based on previously suggested decision criteria for OPPs (Brixner et al, ViHRI 2018). This is complemented by a policy workshop with representatives of multiple stakeholder to set local priorities and define requirements to be met by manufacturers of OPPs. A pilot workshop was conducted in Indonesia in order to test and improve the spreadsheet and workshop format.

RESULTS: The format was implemented successfully to adapt the MCDA framework to the specific local decision requirements for OPP tenders. The key success factors are: (1) all important stakeholder groups were represented in the 2-day workshop (2) a local health-policy leader was the owner of the process (3) the international academic moderators guided the participants through the process but did not influence the local priority setting (4) realistic case studies helped to test and fine-tune the initial MCDA tool. The criteria selected for OPP tenders in Indonesia were acquisition cost (40% weight), manufacturing quality (18.8%), equivalence with the reference product (12.2%), product formulation and stability (12.2%), supply reliability (8.4%), real-world outcomes (4.2%) and pharmacovigilance (3.6%).

CONCLUSIONS: A standardized interactive format can be implemented in developing countries to support decision makers in establishing value-driven off-patent pharmaceutical policies.