To identify differences in decision-making in the presence of uncertainty between English (National Institute for Health and Care Excellence – NICE) and French (Haute Autorité de Santé – HAS) authorities, and to assess how drugs that were included in the UK Cancer Drugs Fund (CDF) have been evaluated in France.

Drugs/indications that are currently included in the CDF (v1.136) and their corresponding assessments from the French Transparency Committee (TC) were identified. Three outcomes were extracted from the TC notices: actual clinical benefit, clinical added value (CAV) and request for a submission of complementary data.

Excluding drugs/indications that transitioned from the older to the new version of the CDF, 28 managed access schemes were identified for 16 drugs. Published TC opinions were identified for 24 of these schemes, with two indications being merged into one single opinion in two cases. Two opinions (9%) did not recommend reimbursement for the strategy (insufficient actual clinical benefit). Six (27%) of the TC opinions assessed a ‘moderate added value’ (CAV III), acknowledging the innovative nature of the strategy in a population comparable to that detailed in the CDF (despite small discrepancies in selection criteria regarding patients’ baseline characteristics). In the remainder (N=14, 64%), the TC recommended reimbursement without recognising any significant improvement compared to current practice (nine ‘no added value’ [CAV V] and five ‘minor added value’ [CAV IV]). When reimbursement was recommended (N=20), the TC required complementary data to subsequently update the decision in 65% of cases (N=13), without correlation to CAV level (P=0.42, Fisher’s exact test).

Strategies for which English authorities underlined uncertainty and preferred to gather more data through the CDF directly received favourable reimbursement conditions from the French authorities in 27% of cases. This decision was generally, but not systematically, conditional upon obtaining complementary data in the future.