Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies.

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Decision Science

Background:

• Evaluating decision-making quality in pharmaceutical companies for medicine reimbursement evidence generation.
• Assessing health technology assessment (HTA) agencies' appraisal recommendation decision-making processes.

Purpose of the Study:

• To compare and contrast decision-making processes between pharmaceutical companies and HTA agencies.
• To identify similarities and differences in evidence generation and appraisal recommendation processes.
• To explore perceptions on measuring decision quality and addressing biases.

Main Methods:

• Development and piloting of two questionnaires for content validation.
• Distribution of questionnaires to pharmaceutical companies and HTA agencies.
• Analysis of responses from participating organizations.

Main Results:

• Identified similarities: use of committees, mixed decision-making systems, lack of systematic quality assessment, infrequent use of formal frameworks.
• Observed differences: diverse final decision-making approaches (consensus, majority vote, individual).
• Consensus: decision quality is measurable, biases are pertinent, and improvement is needed.

Conclusions:

• Findings align with regulatory process studies, highlighting the need for consistent, predictable decision-making in medicine lifecycle.
• Recommendations include capacity building, systematic quality evaluation, and promoting formal decision-making frameworks.
• Enhancing decision-making quality can improve evidence generation and appraisal recommendations for new medicines.