Drug Development-to-Reimbursement Timelines Show Little Progress Over a Decade

Despite ongoing policy pressure to speed up patient access, median time from the start of human clinical testing to insurance reimbursement for new drugs has changed little over the past decade in the US, France, Germany, and Switzerland, according to a cross-sectional study recently published in JAMA Health Forum.¹

Tracking Drugs From Clinical Development to Coverage

Researchers noted that rapid access to new drugs that address unmet medical needs depends on 3 key stages: clinical development, regulatory review, and reimbursement review. Although regulatory approval allows a drug to enter the market, reimbursement decisions are often the determining factor in whether patients can actually access treatment. Reimbursement pathways differ across countries, with the US relying on Medicare coverage policies and European countries such as France, Germany, and Switzerland using health technology assessments to evaluate a drug's added clinical benefit and inform reimbursement and pricing decisions.

To better understand how quickly new therapies reach patients across the 4 countries, investigators used FDA, European Medicines Agency, and Swissmedic databases to track new drugs approved between January 2014 and December 2024. The cohort included 519 drugs in the US, 412 each in France and Germany, and 395 in Switzerland.

Drug Access Timelines Held Steady or Lengthened Over the Decade

Using Kaplan-Meier estimates, the investigators broke total timelines into 3 segments: clinical development (start of human testing to regulatory submission), regulatory review (submission to approval), and reimbursement review (approval to coverage decision). The median total duration from trial initiation to reimbursement was 9.3 (95% CI, 9.0-9.8) years in the US, 11.1 (95% CI, 10.2-12.0) in France, 8.9 (95% CI, 8.3-9.5) in Germany, and 9.8 (95% CI, 9.6-10.5) in Switzerland. Clinical development accounted for the largest share of the total timeline in all 4 countries, outweighing time spent in regulatory or reimbursement review.

Total duration increased slightly in the US, France, and Switzerland, whereas Germany was the only country to see a decline. In the US, median total duration rose from 9.0 (95% CI, 8.43-9.90) years in the earliest period studied (January 2014-August 2017) to 9.35 (95% CI, 8.75-11.56) in the most recent period (May 2021-December 2024), driven mainly by longer clinical development and reimbursement review times.

France saw the largest increase, from 9.82 (95% CI, 8.88-11.41) to 12.18 (95% CI, 10.12-14.78) years, with reimbursement review climbing significantly. Meanwhile, Switzerland's total duration grew from 9.42 (95% CI, 8.2-10.17) to 10.05 (95% CI, 9.39-12.32) years, while Germany's fell from 9.27 (95% CI, 7.67-10.6) to 8.7 (95% CI, 7.92-9.57) years. The authors noted that outsourcing of clinical trials and a growing share of trials conducted in emerging markets may be contributing to longer clinical development times, as prior research found that international trials took a median of 9 months longer to complete than domestic ones.²

Expedited Pathways Lost Much of Their Speed Advantage

The advantage of expedited pathways, such as accelerated approval and priority review, over standard approval narrowed considerably over the decade.¹ Drugs approved in the US through standard pathways in the most recent period had a slightly shorter median total duration (9.22 years) than those receiving expedited approval (9.35 years), reversing the earlier pattern. In France, Germany, and Switzerland, expedited pathways still produced shorter total durations than standard approval, but the gap shrank as timelines lengthened.

These findings come as the FDA, under former commissioner Marty Makary, MD, decided in February 2026 to make single-trial approval its new default standard rather than the traditional 2-trial requirement, a shift the agency said would speed drugs to market.³

Cancer Drugs Reached Patients Faster Than Other Therapies

Cancer drugs consistently reached patients faster than the overall drug cohort, with a median total duration of 7.9 (95% CI, 7.4-8.7) years in the US, 7.5 (95% CI, 6.9-8.7) in Germany, 9.3 (95% CI, 8.3-9.9) in Switzerland, and 10.8 (95% CI, 9.2-12.3) in France¹; the gap was most pronounced in the US and Germany.

The researchers attributed part of this advantage to oncology's long-standing reliance on single pivotal trials for approval. They cautioned, however, that faster approval based on limited evidence carries its own risk, including possible market withdrawal.

Findings Underscore Need to Evaluate Drug Access Reforms

The researchers acknowledged their study’s limitations, one being that, in the primary analysis, they did not limit their study cohort to commonly approved drugs in all 3 jurisdictions, meaning the drug cohorts were all different. In addition, reimbursement in the US reflected formulary coverage of a drug by a Medicare Part D plan and may not reflect insurance coverage in the commercial or Medicaid markets. Consequently, the researchers suggested areas for further research.

“Moving forward, it would be beneficial to analyze factors contributing to overall median duration for new drugs, particularly in light of policy changes that have aimed to speed access to new drugs for patients,” they concluded. “This would help to understand which policies would enable [accelerating] access to new drugs, ideally adequately balancing safety with speed.”

References

1. Hediger S, Glaus CEG, Dusetzina SB, Rohr UP, Hwang TJ, Vokinger KN. Clinical development, regulatory, and reimbursement review duration of new drugs in the US and European countries. JAMA Health Forum. 2026;7(7):e262332. doi:10.1001/jamahealthforum.2026.2332
2. Hediger S, Serra-Burriel MS, Vokinger KN. 2281MO Trial duration of cancer drugs: effects of geographic scope and endpoint selection. Ann Oncol. 2025;36:S1172. doi:10.1016/j.annonc.2025.08.2897
3. Bonavitacola J. FDA will require only 1 study to approve new drugs, speeding up process. AJMC^®. February 19, 2026. Accessed July 27, 2026. https://www.ajmc.com/view/fda-will-require-only-1-study-to-approve-new-drugs-speeding-up-process