OBJECTIVES

: This analysis aims to determinate whether an early access program (ATU) may potentially impact the market access pathway of Oncology drugs in France.

METHODS

: Based on Prismaccess database and ANSM website, we compared the results on several criteria between products with and without ATU.

The analysis includes all HTA assessments for Oncology drugs from January 2016 to May 2021 (56 initial inscriptions). Generics and biosimilars were excluded.

RESULTS

: Two thirds of oncology drugs were granted an ATU (36).

Positive HTA assessments are more frequently observed on these products compared to the ones without ATU: Important Clinical Benefit in 75% vs 70%; Moderate Clinical Added Value (ASMR III), in 28% vs 5%.

Previous granted ATU does not guarantee access and funding for the drug: 9 products with previous ATU were finally not available for patients. Nevertheless, reimbursement and/or funding is more frequently denied to products without ATU (35% vs 25%).

As expected, the medical need is more often “not covered” for drugs with previous ATU (25% vs 10%).

Post-inscription studies have been required only for ATU drugs (15). Indeed, clinical trials for ATU drugs have been considered less robust: 33% vs 5% of non-comparative studies.

The median time from EMA approval to reimbursement is the same (529 days with ATU, 516 without). HTA time is shorter for ATU products (209 days vs 255), but price negotiation seems to be longer (337 days vs 201). Nevertheless, during evaluation and negotiation periods, ATU drugs are available for patients.

CONCLUSIONS

: There are differences between ATU and non-ATU drugs, probably linked to the drugs rather than to the process. Two key objectives of the early access reform are to improve data collection, and to accelerate access. This could change the current picture in terms of complementary data request and timings for early access drugs.