The National Institute for Health and Technology in Slovakia (NIHO) has concluded its accelerated evaluation of the drug Kyprolis (carfilzomib) combined with lenalidomide and dexamethasone for second-line treatment of multiple myeloma patients with standard cytogenetic risk. Published on June 26, 2025, the assessment highlights critical considerations in the drug’s efficacy and cost-effectiveness within the Slovak healthcare system.
Evaluation Findings and Clinical Impact
NIHO’s assessment revealed that Kyprolis did not demonstrate a significant clinical benefit over the existing treatment regimen Rd (lenalidomide and dexamethasone) in the targeted patient population. The analysis based on the ASPIRE clinical trial showed no substantial improvement in overall survival for patients who had not undergone autologous stem cell transplantation (ASCT) or those without prior bortezomib treatment. Additionally, the proposed expansion lacked robust cost-effectiveness data, failing to justify the increased financial burden on the public healthcare budget.
Implications for Healthcare and Patients
The decision not to approve the expanded use of Kyprolis underscores NIHO’s commitment to ensuring that only treatments offering clear benefits and sustainable economic value are integrated into Slovakia’s healthcare provisions. Patients requiring second-line treatments for multiple myeloma will continue to rely on the currently approved therapies, maintaining the balance between innovative care and fiscal responsibility.
- The expanded indication for Kyprolis lacks sufficient evidence of improved overall survival in the specified patient groups.
- Cost-effectiveness analyses did not support the financial viability of broadening Kyprolis’s use.
- NIHO prioritizes treatments with proven benefits and manageable costs to optimize healthcare resource allocation.
Moving forward, NIHO will continue to monitor emerging clinical data and economic evaluations to reassess Kyprolis’s role in multiple myeloma treatment as new evidence becomes available. This approach ensures that patient care advancements align with both medical efficacy and economic sustainability.
Healthcare providers and stakeholders are encouraged to stay informed about future updates from NIHO, which may influence treatment protocols and patient access to innovative therapies. Patients currently undergoing treatment remain supported by existing approved regimens, ensuring continuity and stability in their care plans.
Conclusion
NIHO’s decision emphasizes the critical balance between adopting new medical technologies and maintaining economic sustainability within the Slovak healthcare system. By rejecting the expanded use of Kyprolis for multiple myeloma patients with standard cytogenetic risk, NIHO demonstrates a cautious and evidence-based approach to healthcare innovation, ensuring that patient care remains both effective and financially responsible.
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