The UK's National Institute for Health and Care Excellence (NICE) has opened public consultations for two targeted therapies designed to treat advanced non-small-cell lung cancer (NSCLC) patients with specific genetic mutations. The consultations cover adagrasib for KRAS G12C mutation-positive disease and the combination of encorafenib with binimetinib for BRAF V600E mutation-positive advanced NSCLC.
Adagrasib Consultation for KRAS G12C-Positive NSCLC
NICE is seeking public input on draft guidance for adagrasib in previously treated patients with KRAS G12C mutation-positive advanced non-small-cell lung cancer. The consultation document is available for comment through NICE's online platform, with the consultation period closing at 5pm on June 2, 2025.
The draft guidance represents NICE's preliminary assessment of adagrasib's clinical effectiveness and cost-effectiveness for this specific patient population. Stakeholders can access both the consultation document and accompanying evidence through the committee papers before submitting their comments.
Encorafenib-Binimetinib Combination Under Review
A separate consultation addresses the combination therapy of encorafenib with binimetinib for treating BRAF V600E mutation-positive advanced non-small-cell lung cancer. This consultation has an extended timeline, with comments accepted until 5pm on Tuesday, June 24, 2025.
The dual-drug approach targets a different genetic mutation pathway compared to adagrasib, potentially expanding treatment options for patients whose tumors harbor BRAF V600E mutations.
Consultation Process and Timeline
Both consultations follow NICE's standard appraisal process, requiring stakeholders to create and activate a NICE Account before participating. Comments must be submitted directly through the online consultation platform, though downloadable PDF versions are available for reference.
NICE has emphasized that the current recommendations may change following the consultation period. After each consultation closes, the respective appraisal committees will reconvene to review submitted responses and prepare final draft guidance documents.
Equity Considerations
NICE has specifically requested that respondents consider whether any aspects of the recommendations could lead to unlawful discrimination against protected groups, including considerations based on race, sex, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy, and maternity.
The consultations represent important steps in NICE's technology appraisal process, potentially leading to expanded access to targeted therapies for patients with genetically defined subtypes of advanced non-small-cell lung cancer in England and Wales.
