On 4 November 2026 the Haute Autorité de santé (HAS) gave an unfavourable opinion on reimbursement for Tevimbra (tislelizumab) with etoposide and platinum chemotherapy in first-line extensive-stage small cell lung cancer (ES-SCLC). The service médical rendu (SMR, clinical benefit rating) is "insuffisant", so no ASMR (improvement rating) was assigned. The stated reasons concern the trial population and the existing options rather than whether the drug works.

What HAS wrote

HAS cites one trial, RATIONALE-312. It says the trial population was exclusively of Chinese origin, which it sees as a major limit on transposability to the French population. It adds that alternative treatments are available and reimbursed in this indication, and concludes that Tevimbra has no place in the first-line ES-SCLC strategy on current data. The page omits efficacy figures and comparators.

The result is consistent with how HAS has treated this product before. Its opinion history for Tevimbra shows an unfavourable opinion on the oesophageal squamous cell monotherapy indication on 6 November 2024, and a favourable opinion for gastric or gastroesophageal junction adenocarcinoma on 22 October 2025. The ES-SCLC refusal is the third decision, and the second refusal.

The trial behind the refusal

RATIONALE-312 randomised 457 patients to tislelizumab or placebo, each with platinum and etoposide. Published in 2024, it reported an overall survival (OS) hazard ratio of 0.75 (95% CI 0.61–0.93) and median OS of 15.5 months against 13.5 months. The European Medicines Agency (EMA) has authorised Tevimbra for first-line ES-SCLC, so the regulatory case was accepted. In the text we could read, HAS left the efficacy signal unchallenged and rejected its relevance to French patients.

The serplulimab contrast

A year earlier HAS reached a very different outcome for another PD-1 inhibitor. In November 2025 it rated Hetronifly (serplulimab) ASMR IV in the same setting, with an SMR of important, on the same footing as Tecentriq (atezolizumab) and Imfinzi (durvalumab). Its trial showed an OS hazard ratio of 0.63 (95% CI 0.49–0.82) and median OS of 15.4 months against 10.9 months.

That trial had the same weakness. HAS recorded that 69% of patients were Asian and that European patients were poorly represented. It also flagged a control arm it considered debatable, exploratory progression-free survival and quality-of-life data, unblinding after the first interim analysis, and no patients with ECOG above 1. It still granted ASMR IV, and it asked for the ASTRIDE trial, which compares serplulimab with atezolizumab, to inform a reassessment within two years.

Without the full Tevimbra opinion, we cannot say what separates the two decisions. The pages we read show different outcomes and different weight given to the population concern. Serplulimab's trial was majority Asian; HAS describes Tevimbra's as exclusively Chinese.

What it means for market access teams

  • Population origin is a stated ground for refusal. A pivotal trial run in a single country needs a transposability argument built before the dossier is filed, covering standard of care, patient characteristics and subsequent therapy.
  • The comparator question comes second. In ES-SCLC, HAS already reimburses PD-L1 options. A PD-1 entrant needs either head-to-head data or an indirect comparison it can defend, and the ASTRIDE request for serplulimab shows what HAS wants to see.
  • A regulatory approval does not carry over. The EMA authorised the ES-SCLC indication, and HAS still found the evidence insufficient for reimbursement, which is the regulatory-HTA double gate in practice.
  • Plan the evidence package for each indication. The same product has now had two refusals and one favourable opinion in France, so each indication needs its own population and comparator logic.

For ES-SCLC, with 5,592 patients a year in the target population HAS used for serplulimab, the commercial stakes are real. A resubmission would most plausibly need data in a non-Chinese population or a comparison against the immunotherapies already reimbursed.

To discuss how transposability and comparator evidence will play in your next HAS or EU submission, get in touch.