Serplulimab Lung Cancer Treatment: Evaluation of Clinical and Economic Impact in Portugal

Serplulimab lung cancer treatment has received a positive funding recommendation from Portuguese authorities for first-line use in extensive-stage small cell lung cancer (ES-SCLC), despite not demonstrating added therapeutic value over the current standard.

No Added Therapeutic Value Found

The Portuguese public assessment report evaluates Hetronifly (serplulimab), a humanized anti-PD-1 monoclonal antibody, in combination with carboplatin and etoposide. The assessment concludes that serplulimab lung cancer treatment does not demonstrate added therapeutic value compared with atezolizumab plus carboplatin and etoposide. Nevertheless, the committee was convinced of the clinical benefit of serplulimab and recommends its public funding under current legislation.

Economic Advantage Opens the Door

An economic analysis using cost-minimization methodology found serplulimab to be less costly than the comparator. This led to subsequent price negotiations to secure more favorable conditions for the National Health Service (SNS).

Survival Outcomes Show No Clear Superiority

The evaluation determined that serplulimab plus chemotherapy does not provide statistically significant improvements in the most critical outcomes relative to atezolizumab plus chemotherapy. Indirect treatment comparisons consistently showed no significant difference in overall survival (OS). Safety outcomes, including grade ≥3 adverse events, also showed no statistically significant differences between treatments.

Policy Implications for Reimbursement

The decision to proceed with public funding despite no proven incremental benefit reflects the committee’s acceptance of serplulimab’s absolute clinical benefit in a disease with high unmet need and poor prognosis. This outcome illustrates current Portuguese reimbursement policy under Decree-Law 97/2015, whereby a medicine without proven added value may still be funded if it represents an economically advantageous option.

Strategic Lessons for Immuno-Oncology Market Access

The case highlights the importance of robust indirect comparisons and the challenges of demonstrating value in crowded immuno-oncology indications. It also shows that cost-effectiveness relative to the current standard can influence funding decisions in settings with strong cost-containment pressures.