The National Institute for Health and Technology Assessment (NIHO) has recommended against categorizing Tepotinib (Tepmetko) as a monotherapy for adults with advanced non-small cell lung cancer (NSCLC) characterized by METex14 skipping mutation. This decision follows a comprehensive evaluation of the drug’s clinical effectiveness and economic viability after prior immunotherapy and/or platinum-based chemotherapy treatments.
Clinical Evaluation
NIHO deemed the clinical evidence supporting Tepmetko’s efficacy as insufficient, primarily due to the low validity of indirect comparisons with existing treatments like atezolizumab (ATZ) and docetaxel (DOCE). The sole clinical study, VISION, presented limited comparative data, raising concerns about the drug’s overall survival and progression-free survival benefits. Additionally, the absence of comparative safety and quality of life data further undermines the clinical justification for Tepmetko’s approval.
Economic Assessment
From an economic standpoint, Tepmetko failed to meet NIHO’s cost-effectiveness criteria. The evaluated incremental cost-utility ratios (ICUR) exceeded the established thresholds, indicating that the current pricing of Tepmetko does not provide sufficient health benefits relative to its costs. NIHO highlighted extreme uncertainty in the cost-effectiveness analysis, primarily stemming from the low validity of clinical evidence and unaccounted additional costs for mutation testing.
- Tepotinib’s current pricing exceeds NIHO’s maximum acceptable level by a significant margin.
- Clinical evidence lacks robustness, contributing to high uncertainty in effectiveness claims.
- Additional costs related to genetic mutation testing were not fully considered.
To bridge the gap between Tepmetko’s benefits and its economic implications, NIHO recommends negotiating substantial discounts with the drug manufacturer. Such price adjustments are essential to enhance the drug’s affordability and align it with the institution’s cost-effectiveness standards, thereby potentially allowing its inclusion in the treatment arsenal for advanced NSCLC patients.
The outcome underscores the critical balance between clinical promise and economic feasibility in healthcare decision-making. Patients may face delays in accessing Tepmetko unless manufacturers agree to the proposed pricing adjustments. This decision also emphasizes the need for robust clinical trials and transparent cost analyses to support the introduction of new therapies in the healthcare system.
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