Patients in Scotland living with extensive-stage small cell lung cancer (ES-SCLC) have been denied access to the immunotherapy serplulimab, also known as HETRONIFLY, after the Scottish Medicines Consortium (SMC) chose not to recommend it for use within NHS Scotland. Accord Healthcare UK confirmed the decision, which applies to serplulimab in combination with carboplatin and etoposide for first-line treatment in adults.

ES-SCLC is the most aggressive form of lung cancer, a disease responsible for the highest number of cancer-related deaths in the UK. Its natural course carries a particularly poor prognosis, with median overall survival of only 2–4 months. Most patients are diagnosed after the cancer has already spread, and despite incremental advances, five-year survival remains below 10%. There are currently few treatment options for agitation, rapid progression and high mortality in this patient population.

Serplulimab has shown meaningful improvements in overall survival when compared with chemotherapy alone. Data from the global Phase 3 study ASTRUM-005 demonstrated median overall survival of 15.8 months for patients receiving serplulimab plus chemotherapy, versus 11.1 months for those on chemotherapy alone. The safety profile was consistent with prior studies, with the most common grade 3 adverse events including neutropenia, leukopenia, thrombocytopenia and anaemia.

Paul Tredwell, global CEO of Accord Healthcare, said: “We believe in the clinical value of serplulimab and its potential to make a meaningful difference for patients living with this terrible, aggressive disease. It is particularly disappointing that people with ES-SCLC in Scotland are unable to access a treatment that is already benefiting patients in other parts of Europe and around the world, helping to extend survival and provide more precious time with family and loved ones. Our focus remains clear: to work in close collaboration with healthcare partners and regulators to ensure that patients across the UK can benefit from innovative treatments like serplulimab as equitably and as quickly as possible.”

Paula Chadwick, chief executive at Roy Castle Lung Cancer Foundation, added: “We are disappointed by the SMC’s decision, particularly given the urgent need for effective treatments for people living with ES-SCLC. This is the second time in recent months that an ES-SCLC treatment has been rejected by the SMC, which highlights the ongoing challenges patients face. While this outcome is not what we had hoped for, we remain optimistic that a compromise can be found for the benefit of patients and their families.”

Lung cancer accounts for 15% of all cancer cases in Scotland and is the leading cause of cancer-related death. ES-SCLC represents roughly one in eight lung cancer cases in the UK, equating to around 400 new diagnoses in Scotland each year. With few effective therapies available, the rejection of serplulimab underscores the ongoing unmet need for this patient population.