OBJECTIVES:

To identify number of risk-sharing agreements manufacturers underwent with regulatory bodies across EU5 and US in last five years (Jan 2020 to Dec 2020).

METHODS : Secondary research was conducted to find number of risk-sharing agreement in pharma newsletters, company websites and HTA regulatory authority websites. Search terms such as managed-entry agreements (MEAs), patient access schemes (PAS) and creative pricing arrangements were used to avoid missing any of the findings. Search was restricted by English language and by year from Jan 2020 to Dec 2020.

RESULTS : Total 68 such agreement were signed. Highest number of such agreements were conducted in the UK (n=64) followed by Germany (n=2) and the USA (N=2). Roche underwent highest number of such agreement (n=12), followed by AstraZeneca (n=5) and Novartis (n=5), Sanofi (n=4) and Johnson & Johnson (N=4). Upon dividing based on the therapeutic area, highest number of agreements were around Lung cancer [Non-small cell lung cancer (NSCLC) small cell lung cancer (SCLC)] (n=9), followed by Breast cancer (HER2+/-) (n=5). Out of 68, 63 were finance based agreement whereas only five agreements were signed based on the performance of therapy.

CONCLUSIONS

: Significantly less number (n=68) of risk-sharing agreements were conducted in year 2020, around COVID-19 pandemic, compared to the year 2019 (n=162). Potential reason could be exhausted healthcare budget and delay in HTA assessment procedure.