# Beyond the Pill: Mapping Process-Oriented Decision Support Models in Pharmaceutical Policy

## TL;DR

This paper reviews decision support models used in pharmaceutical policy to improve decision-making processes, focusing on transparency and stakeholder engagement.

## Contribution

The paper provides a narrative synthesis of process-oriented decision support models in pharmaceutical policy, highlighting their potential and limitations.

## Key findings

- QoDoS is the only tool applied across regulatory, HTA, and industry settings, evaluating individual- and organizational-level practices.
- WHO-INTEGRATE emphasizes equity and legitimacy but lacks a structured format for implementation.
- Adoption of these tools remains limited, especially in low- and middle-income countries.

## Abstract

Background: The quality of decision-making processes is increasingly recognized as critical to public trust and policy sustainability. Objectives: This narrative review aims to identify and describe process-focused decision support models (DSMs) applied in pharmaceutical policy, and to examine their potential contributions to improving procedural quality in decisions related to pricing, reimbursement, and access to medicines. Methods: Relevant peer-reviewed and gray literature published between 2000 and 2025 was considered, drawing from key databases (e.g., PubMed and Scopus) and international policy reports (e.g., WHO, ISPOR, and HTA agencies). Studies were included if they provided insights into DSMs addressing at least one dimension of decision process quality. Results: Findings are synthesized narratively and organized by tool type, application context, and key quality dimensions. Frequently referenced tools included the Quality of Decision-Making Orientation Scheme (QoDoS), WHO-INTEGRATE, and AGREE II. QoDoS emerged as the only tool applied across regulatory, HTA, and industry settings, evaluating both individual- and organizational-level practices. WHO-INTEGRATE highlighted equity and legitimacy considerations but lacked a structured format. Overall, most tools demonstrated benefits in promoting internal consistency, transparency, and stakeholder engagement; however, their adoption remains limited, especially in low- and middle-income countries. Conclusions: Process-focused DSMs offer promising avenues for enhancing transparency, consistency, and legitimacy in pharmaceutical policy. Further exploration is needed to standardize evaluation approaches and expand the use of DSMs in diverse health systems.