Timeframe of Drug Approval to Reimbursement Lags in US Compared With Europe

The time spent between a drug’s approval and its reimbursement noticeably lags in the US compared with European countries. These findings were based on a research report recently published in Annals of Internal Medicine. This comparative analysis began in 2011 and surveyed the state of approval-to-reimbursement in the US, France, Germany, Switzerland, and England until 2022.¹

The process for regulatory approvals varies by country and may impact patient access to medication | image credit: thanksforbuying - stock.adobe.com

Each country has a different approach to the regulatory approval of new drugs before they hit the market. For example, in the US, an FDA approval occurs after a multistep, multiyear process that includes lab testing, an Investigational New Drug Application, multiple phases of clinical trials, a final New Drug Application, and a facility inspection.² If the research, data, and evidence derived from these trials showcases a drug’s continual safety and efficacy for its intended use, then it becomes available to patients. Additionally, after being made available, the FDA continues to monitor the effectiveness and safety of a drug.

This process benefits those behind the drug’s manufacturing by making their product commercially available; however, patient access to these medications depends on insurance reimbursement.¹ For this reason, considering different regulatory approaches remains an important venture as it can influence a drug’s availability.

To investigate these different processes, the authors evaluated approval-to-reimbursement timeframes using information from the FDA, European Medicines Agency (EMA), Swissmedic, and Medicines and Healthcare products Regulatory Agency (MHRA) databases. Advanced therapy medicinal products, pediatric drugs, and diagnostics were excluded from the analysis.

A drug was considered reimbursed if it was included in coverage under Medicare Part D or listed under Part B (in the US), recommended by the National Institute for Health and Care Excellence, commissioned by the National Health Service (NHS), or included in the NHS Drug Tariff list (England). Health technology assessment (HTA) data helped extract information on reimbursement dates in France. The timeframe between approval and a decision by the Federal Joint Committee was used to evaluate Germany, and Switzerland was assessed according to the time of the Federal Office of Public Health’s decision.

The regulatory bodies incorporated into this analysis (FDA, MHRA, Swissmedic, EMA) yielded results for 290 approved drugs. The findings revealed that Switzerland had the fasted approval-to-reimbursement time, occurring at an average of just under 6 months (95% CI, 4.5-7). Germany demonstrated the second-fastest timeframe (7.4 months; 95% CI, 7.2-7.6), followed by the US (9.2 months; 95% CI, 8.3-10.1), and then France (12.9 months; 95% CI, 10.6-15.4). The longest timeframe was observed in England, with an average period of 17.7 months (95% CI, 13.8-24.9).

Further analysis showed that, 1 month after an approval, the highest reimbursement rates occurred in France (25.9%; 95% CI, 20.6% to 30.7%), the second-highest rate occurred in Switzerland (9.7%; 95% CI, 6.2% to 13%), followed by England (0.7%; 95% CI, 0% to 1.6%). Notably, neither Germany nor the US reimbursed a single drug in the month following its approval.

Alternatively, after 1-year post-approval, the highest reimbursement rates were seen in Germany (74.3%; 95% CI, 68.7% to 78.9%), the US (70.7%; 95% CI, 65% to 75.5%), and Switzerland (62.8%; 95% CI, 56.8% to 67.9%). Respectively, England and France had reimbursement rates of 37.1% (95% CI, 31.3% to 42.5%) and 49.0% (95% CI, 42.9% to 54.4%).

“Reimbursement bodies are often criticized as delaying patient access to drugs. However, we found that even among countries that use HTA for reimbursement, duration from approval until reimbursement was approximately half a year (Switzerland and Germany)," the authors concluded. "Notably, approval in these countries was faster than in the United States, which does not use such assessments or price negotiation processes."

However, they added that these overall results “suggest that incorporation of an HTA system and drug negotiation process in the United States would not necessarily result in longer time until reimbursement.”

References

1. Glaus CEG, Serra-Burriel M, Dusetzina SB, Vokinger KN. Time from approval to reimbursement of new drugs: a comparative analysis between the United States, England, Germany, France, and Switzerland (2011-2022). Ann Intern Med. 2024. doi:10.7326/ANNALS-24-00614

2. Overview of our role regulating and approving drugs | Video series. Fda.gov. Updated August 7, 2024. Accessed September 3, 2024. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/overview-our-role-regulating-and-approving-drugs-video-series#:~:text=If%20the%20FDA%20team%20determines,quality%20for%20years%20to%20come