OBJECTIVES: Costs associated with Adverse Events (AEs) observed during treatment of cancer are an important component of economic evaluation (EE) of drugs. In France, current EE guidelines do not specify how AEs should be included. The objective of this study was to review incorporation of AEs in models used for economic opinions of HAS.

METHODS: All economic opinions in oncology publicly available before April, 30th RESULTS: Out of 54 available opinions, 21 assessed anti-cancer drugs: 14 in solid tumors and 7 in hematology. All EE considered grade 3-4 AEs. Only 2 EE included additional grade 1-2 AE. Six opinions were restricted to ‘drug-related AEs’ but in the remaining opinions, cause was not specified. Twelve EE considered common AEs (≥1%) based on different thresholds of incidence (1%, 2%, 3% or 5%) and 4 used other criteria for AEs selection (5 not reported). Number of AE types ranged from 4 to 31 per EE. Unit cost of the most frequent grade 3-4 AEs ranged from €37 to €3,016 for diarrhea (N=15), €0 to €7,330 for asthenia/fatigue (N=12), €1,479 to €5,558 for anemia (N=12), €81 to €7,138 for neutropenia (N=12). Twelve EE incorporated AEs as a lump sum at the start of the model and 7 considered constant probabilities. Median number of HAS technical questions per opinion was 3 in 2014-2015 (N=9) and 9 in 2016-2017 (N=12). Overall, HAS raised reservations on AEs in 62% of the opinions (14 ‘minor’ and 6 ‘important’ reservations).

CONCLUSIONS: Incorporation and valuation of AEs appeared heterogeneous leading to increased attention of HAS. Expected update of the guidelines may present methodological framework on this topic.