The National Institute for Health and Clinical Excellence (NICE) conducted a Single Technology Appraisal (STA) for gefitinib, a drug used for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations. Gefitinib, marketed as IRESSA, is a protein kinase inhibitor (ATC code: L01XE0) approved by the European Medicines Agency (EMEA) in 2009. It is indicated for adult patients with NSCLC who have EGFR mutations and is expected to be available in the UK by September 2009. The drug is available as 250 mg film-coated tablets, with a proposed dose of 250 mg daily until disease progression. The NHS list price is £2167.71, and it will be available through the Single Payment Access (SPA) scheme. Gefitinib is intended for first-line treatment of NSCLC patients with EGFR mutations. It is administered orally, offering a less toxic alternative to doublet chemotherapy, which is associated with significant side effects. Clinical trials, such as the IPASS study, showed that gefitinib improved progression-free survival (PFS) and quality of life in patients with EGFR mutations compared to doublet chemotherapy. However, its efficacy is limited to those with specific mutations, highlighting the need for EGFR mutation testing. The appraisal also addressed equity issues, ensuring access for all patients regardless of socioeconomic status. The clinical evidence primarily comes from randomized controlled trials (RCTs), including IPASS, INTEREST, and ISEL. These studies demonstrated that gefitinib is more effective in patients with EGFR mutations, with improved PFS and quality of life. However, its use in patients without these mutations is less effective. The appraisal also considered cost-effectiveness, noting that gefitinib could reduce the burden on chemotherapy services and hospital admissions. Overall, gefitinib represents a targeted therapy with significant benefits for a specific subset of NSCLC patients.The National Institute for Health and Clinical Excellence (NICE) conducted a Single Technology Appraisal (STA) for gefitinib, a drug used for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating EGFR mutations. Gefitinib, marketed as IRESSA, is a protein kinase inhibitor (ATC code: L01XE0) approved by the European Medicines Agency (EMEA) in 2009. It is indicated for adult patients with NSCLC who have EGFR mutations and is expected to be available in the UK by September 2009. The drug is available as 250 mg film-coated tablets, with a proposed dose of 250 mg daily until disease progression. The NHS list price is £2167.71, and it will be available through the Single Payment Access (SPA) scheme. Gefitinib is intended for first-line treatment of NSCLC patients with EGFR mutations. It is administered orally, offering a less toxic alternative to doublet chemotherapy, which is associated with significant side effects. Clinical trials, such as the IPASS study, showed that gefitinib improved progression-free survival (PFS) and quality of life in patients with EGFR mutations compared to doublet chemotherapy. However, its efficacy is limited to those with specific mutations, highlighting the need for EGFR mutation testing. The appraisal also addressed equity issues, ensuring access for all patients regardless of socioeconomic status. The clinical evidence primarily comes from randomized controlled trials (RCTs), including IPASS, INTEREST, and ISEL. These studies demonstrated that gefitinib is more effective in patients with EGFR mutations, with improved PFS and quality of life. However, its use in patients without these mutations is less effective. The appraisal also considered cost-effectiveness, noting that gefitinib could reduce the burden on chemotherapy services and hospital admissions. Overall, gefitinib represents a targeted therapy with significant benefits for a specific subset of NSCLC patients.