The 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.
Researchers tracked new drugs approved between January 2014 and December 2024, using FDA, European Medicines Agency, and Swissmedic databases. The cohort included 519 drugs in the US, 412 each in France and Germany, and 395 in Switzerland.
Using Kaplan-Meier estimates, the investigators broke total timelines into three segments: clinical development, regulatory review, and reimbursement review. The median total duration from trial initiation to reimbursement was 9.3 years in the US, 11.1 years in France, 8.9 years in Germany, and 9.8 years in Switzerland.
Clinical development accounted for the largest share of the total timeline in all four 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.
The advantage of expedited pathways, such as accelerated approval and priority review, over standard approval narrowed considerably over the decade.
Drugs approved in the US through standard pathways in the most recent period had a slightly shorter median total duration than those receiving expedited approval.
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 decided to make single-trial approval its new default standard rather than the traditional two-trial requirement.
Cancer drugs consistently reached patients faster than the overall drug cohort, with a median total duration of 7.9 years in the US, 7.5 years in Germany, 9.3 years in Switzerland, and 10.8 years in France.
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The researchers attributed part of this advantage to oncology’s long-standing reliance on single trials for approval.
They cautioned that faster approval based on limited evidence carries its own risk, including possible market withdrawal.
Further research is needed 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.
As the FDA and other regulatory agencies continue to evolve their approval processes, it is worth examining how these changes compare to similar situations in the past, such as the introduction of new drug approval pathways in the 1990s.
In that case, the goal was also to speed up access to new treatments, but the outcome was mixed, with some drugs being approved quickly but later facing safety concerns.
The study’s findings highlight the need to evaluate drug access reforms and consider the potential consequences of speeding up the approval process.
By analyzing the factors that contribute to the median duration of new drugs, researchers can help policymakers make informed decisions about how to balance safety with speed.
They acknowledged their study’s limitations, including the fact that the primary analysis did not limit the study cohort to commonly approved drugs in all three jurisdictions.
Consequently, they suggested areas for further research, such as analyzing the impact of policy changes on drug access timelines.
