Presentation (CTI)

OBJECTIVES: Examine trends, drivers and rationale of manufacturers whose products achieved faster than usual times between regulatory approval and standard reimbursed access in the EU4 and UK.
METHODS: Examined 98 new molecular entities, formulations, and combinations approved by the European Commission (EC) between January 2019 and December 2021. Oncology products were excluded due to many countries’ availability of alternative funding pathways. Analysis focused on products that achieved >25% quicker time to market compared to the average for the country (77 products did not meet this criteria).For the remaining 21 products, France and Italy were chosen for initial focus based on their similarities and differences in driving factors for fast time to market in a preliminary assessment. All data was gathered from official national HTA agencies and P&R bodies.
RESULTS: In France and Italy, the 21 products fell into three cohorts for faster than usual time to market in both countries or just one of the two. Drivers of quick access emerged such as: Competitive categories (e.g., RA, MS) exhibited quicker time to market in both France and Italy. This was likely due to the existing known list and net price benchmarks setting the stage for expedited negotiations. Faster access in these cases was often also seen in Germany, UK, and Spain. In France, products with ASMR V often achieved faster access as limited pricing flexibility and manufacturers willingness to negotiate helped achieve quicker access. In Italy, some orphan therapies made it to market quicker probably due to a special pathway allowing the submission of clinical data prior to regulatory approval.
CONCLUSIONS: Manufacturers’ knowledge, agile tactics, and willingness to negotiate directly impacts time to market. Various underlying factors drive these differences by country including competition, HTA outcomes, early evidence submissions, and availability of alternative pathways.