Coverage with evidence development programs: a scoping review on characteristics and patient access.

Area of Science:

• Health Services Research
• Health Technology Assessment
• Health Economics

Background:

• Coverage with Evidence Development (CED) programs aim to facilitate early patient access to novel health technologies while generating evidence.
• The actual impact of CED programs on accelerating patient access and integrating technologies into standard care is not well understood.

Purpose of the Study:

• To evaluate the characteristics of CED programs.
• To determine the timelines from application to coverage decisions.
• To identify key factors influencing patient access within CED frameworks.

Main Methods:

• A comprehensive scoping review of peer-reviewed articles and grey literature was performed.
• Study eligibility and data extraction involved independent review by multiple researchers.
• Analysis included an in-depth comparison of the longest and shortest CED programs across different health technology types.

Main Results:

• The review examined 136 finalized CED programs across eight countries (1995-2025).
• The average time from application to coverage decision was 73.7 months, with significant variation (6-215 months).
• Eighteen factors influencing patient access were identified; early uncertainty identification, horizon scanning, and stakeholder engagement accelerated processes, while slow patient accrual caused delays.

Conclusions:

• CED program effectiveness in patient access varies significantly due to implementation delays.
• Systematic identification of decision uncertainties and streamlined evaluation are critical for optimizing CED.
• Five recommendations are proposed to enhance CED efficiency for faster and more equitable patient access to health technologies.