1547P - Time from approval to reimbursement of new cancer and non-cancer drugs: A comparative analysis between the US, England, Germany, and Switzerland (2011-2022)

Background

Approval enables market entry of new drugs, however, reimbursement determines patients’ access at large, especially high-priced cancer drugs. Our objective was to analyze time from approval to reimbursement of new cancer vs non-cancer drugs in the US, England, France, Germany, and Switzerland.

Methods

We identified all new drugs approved in the US, the EU and Switzerland between 2011 and 2022 based on publicly available databases (FDA, EMA, MHRA, and Swissmedic). Reimbursement information was extracted until December 2023 for each country (focus on Medicare for the US). We used descriptive statistics (means, medians, and IQRs), and Kaplan-Meier estimators to describe time from approval to reimbursement.

Results

290 drugs were approved by all regulatory bodies. 93 (32%) were cancer, and 197 (68%) non-cancer drugs. Median time until reimbursement was fastest in Switzerland with 5.78 months (95%CI[4.50-7.03]), followed by 7.43 months (95%CI[7.20-7.57]) in Germany, 9.18 months (95%CI[8.33-10.07]) in the US, 12.90 months (95%CI[10.57-15.37]) in France, and 17.7 months 95%(CI([3.77-24.90]) in England. When comparing cancer drugs vs non-cancer drugs, all countries were faster in reimbursing cancer drugs, with the exception of Switzerland (median time of 7.13 (95%CI([.9-12.8]) months for cancer vs 4.47 (95%CI[3.1-6.3]) months for non-cancer drugs). Median time until reimbursement for cancer drugs vs non-cancer drugs was 8.13 (95%CI[7.57-9.2]) months vs 9.57 (95%CI[8.8-10.63]) months in the US; 14.4 (95%CI[11.43-33.9]) months vs 21.07 (95%CI[13.83-29.37]) months in England; 6.8 (95%CI[6.76-7.0]) months vs 7.87 (95%CI[7.57-8.97]) months in Germany; 7.40 (95%CI[0.17-10.8]) months vs 14.43 (95%CI[13.0-20.5]) months in France.

Conclusions

In most countries, time to reimbursement was faster for cancer than non-cancer drugs despite an increasing number of drugs approved through accelerated pathways, which introduce uncertainties about benefits and risks, challenging reimbursement bodies in their assessment. The findings also indicate that incorporation of an HTA system and drug negotiation process in the US would not result in longer time duration until reimbursement.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Swiss National Science Foundation.

Disclosure

M. Serra-Burriel: Financial Interests, Funding: EU Horizon. S. Dusetzina: Non-Financial Interests, Advisory Role: Midwest Comparative Effectiveness Advisory Council for the Institute for Clinical and Economic Review (ICER). K.N. Vokinger: Financial Interests, Funding: Swiss National Science Foundation (SNSF). All other authors have declared no conflicts of interest.