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

BACKGROUND

Coverage with Evidence Development (CED) programs aim to balance early patient access to promising health technologies with robust evidence generation. However, whether these programs truly accelerate access and facilitate swift integration of health technologies into standard care remains unclear.

OBJECTIVES

This study evaluates CED characteristics, timelines from application to coverage decisions, and key factors influencing patient access.

METHODS

We conducted a scoping review. Study eligibility was assessed by one reviewer and verified on a random sample by a second reviewer. Data extraction was performed independently by two reviewers. From the existing literature on patient access in CED programs, we identified factors affecting timely access. Additionally, we conducted an in-depth analysis of the longest and shortest CED programs for each type of health technology.

RESULTS

Our search identified 2,839 peer-reviewed articles and grey literature sources. We examined 347 sources in this review, revealing 136 finalized CED programs across eight countries (1995-2025). The average time from application to coverage decision was 73.7 months (range: 6-215 months, SD: 36.6). We identified 18 factors influencing patient access, with early identification of decision uncertainties, horizon scanning, and active stakeholder engagement helping to accelerate the evaluation process. However, slow patient accrual often delayed early access.

CONCLUSIONS

CED programs vary widely in effectiveness, with delays in implementation affecting patient access. Systematic identification of decision uncertainties and streamlining evaluation processes are crucial for optimizing these programs. This study provides five key recommendations to enhance the efficiency of CED programs, ensuring that promising health technologies reach patients faster and more equitably.