Researchers find similar drug development to reimbursement timelines for major markets
Time between a drug’s entry into clinical trials and its approval for reimbursement was similar in four major markets, according to a cross-sectional analysis published in JAMA Health Forum.
Researchers looked at all drugs approved in the US (519), France (412), Germany (412), and Switzerland (395) between 2014 and 2022, and evaluated how long it took for those drugs to progress from initial clinical investigation to reimbursement. Median time to reimbursement was 8.9 years in Germany, 9.3 years in the US, 9.8 years in Switzerland, and 11.1 years in France.
The researchers broke down the drug approval timelines and reimbursement periods for the periods 1 January 2014 to 31 August 2017, 1 September 2017 to 30 April 2021, and 1 May 2021 to 31 December 2024. They also analyzed drug approvals based on standard approvals and those that used at least one expedited pathway.
Regulatory agencies and reimbursement bodies face significant pressure to approve and reimburse drugs quickly, especially from patients and patient advocacy groups who want treatments for unmet needs, the researcher noted. To understand the effect of such agencies on drug timelines, they evaluated the three key phases: clinical development, regulatory review, and reimbursement review. They found that the shortest timeline was attributable to the US regulatory review process and the German and Swiss reimbursement review processes, but the difference in timelines between the countries evaluated was not significantly different.
"The findings of this study suggest that the overall median duration from clinical development until reimbursement of new drugs showed only minimal variation over time," said the researchers. "Given recent efforts to accelerate new drug approvals, future research should evaluate potentially modifiable factors that increase clinical development durations.
"This could help to better target policies to accelerate access to new drugs, ideally adequately balancing safety with speed," they added.
Overall, all the countries except Germany saw a slight increase in their median total duration between 2014 and 2024. For instance, the median total duration from clinical trial initiation until reimbursement increased in the US from 9 years between January 2014 and August 2017 to 9.35 years in May 2021 and December 2024, which the researchers attributed mostly to lengthier clinical development and reimbursement review phases. In Germany, however, the median total duration decreased from 9.27 years in January 2014 and August 2017 to 8.7 years in May 2021 and December 2024.
"In all 4 countries, the median total duration was shorter for drugs granted at least one expedited approval pathway vs those granted standard approval," said the researchers. "However, this gap decreased over time.
"In the US, in the most recent period, drugs following standard approval have even a slightly lower median total duration compared with drugs following at least one expedited approval pathway," they added.
Drugs that were approved through the standard route in the US between 2014 and 2017 took 9.17 years compared to 8.93 years for drugs that were given at least one expedited approval pathway, according to the researchers. However, between 2021 and 2024, standard drugs took 9.22 years, and those with at least one expedited approval took 9.35 years.
When looking at drugs with expedited pathways, the researchers found that cancer drugs had shorter timelines, especially in the US and Germany. While 80% of accelerated approvals are granted to cancer drugs, they also have faster timelines under standard approval pathways.
"Indeed, even before the FDA’s announcement in February 2026 that a one-trial requirement (instead of two) will be the FDA’s new default standard, the FDA has historically granted oncology approvals based on a single premarket study," said the researchers. "This could be one possible driver for more rapid access of cancer drugs compared with all drugs.
"However, rapid approval of products with limited evidence can increase risks to patients and, in some cases, result in their withdrawal after they have entered the market," they added.