France Funded Two Cancer Drugs the Same Week. One Was Rated Therapeutic Progress, One Was Not.
- French ministers added Accord‘s Hetronifly (serplulimab) and Roche‘s Columvi (glofitamab) to the list of medicines approved for hospital use and to the liste en sus, the list of products billable to the insurer in addition to hospital tariffs. JORF issue 0194 of 21 August 2026 carried arrêtés of 19 and 20 August covering both lists.
- The liste en sus matters more than the approval. Hospital care in France is paid by fixed tariff, so a medicine not on this list must come out of that tariff. Listing is what makes an expensive hospital drug commercially viable, and it is granted by indication rather than by marketing authorisation.
- HAS judged Hetronifly, a PD-1 inhibitor given with carboplatin and etoposide in first-line extensive-stage small cell lung cancer, to represent therapeutic progress in the care strategy. The same opinion records that no comparative data exist, so its place against other first-line immunotherapies is unknown, with no data above ECOG performance status 1 and limited data in brain metastases.
- HAS reached the opposite verdict on Columvi, a CD20 by CD3 bispecific, finding no therapeutic progress. Its favourable opinion covers monotherapy only in relapsed or refractory diffuse large B-cell lymphoma after at least two systemic lines, in patients who have failed or cannot receive CAR-T. For the other licensed situations the opinion was unfavourable.
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Two oncology products onto the same two lists in the same week, and the assessments behind them point in opposite directions. Read together they show what the French system is actually paying for, and it is not novelty.
- France prices position in the pathway, not molecular innovation. A fourth checkpoint inhibitor in first line counted as progress because it adds an option where the strategy is chemotherapy plus immunotherapy. A first-in-class bispecific in third line did not, because after 2 lines and CAR-T failure an alternative already exists.
- Listing is scoped to the indication, not the licence. Columvi is funded for 1 situation and refused for the rest of its authorisation. Anyone modelling French revenue from an EMA label is using the wrong denominator. Build the forecast from the HAS opinion wording, not the SmPC.
- A progress rating survived an explicit absence of comparative evidence. HAS granted Hetronifly therapeutic progress in 2025 while recording in the same opinion that its place relative to existing first-line immunotherapies is unknown. Useful precedent for any sponsor entering a crowded class without a head-to-head.