Tuesday, October 14, 2025

Slovak Health Authority Declines Saphnelo for Lupus Unless Price Drops

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The National Institute for Health and Technology Evaluation (NIHO) has recommended against categorizing the drug Saphnelo (anifrolumab) for treating active systemic lupus erythematosus (SLE) in adults unless the manufacturer lowers its reimbursement price. This decision follows a comprehensive cost-effectiveness and budget impact analysis, emphasizing the need for financial adjustments to meet Slovakia’s healthcare criteria.

Cost-Effectiveness Challenges

NIHO’s assessment revealed that at the current reimbursement rate of €886.92 per package, Saphnelo does not meet the necessary cost-effectiveness standards. The institute suggests that a maximum reimbursement of €xxx, representing a discount of xxx%, is essential to align with economic efficiency requirements. Without this price adjustment, the use of Saphnelo could strain public healthcare resources, potentially affecting the quality of other medical services.

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Budget Impact Considerations

The budget impact analysis conducted by NIHO projected significant financial implications over the next five years if Saphnelo is categorized without price modifications. The analysis considered factors such as patient population size, treatment duration, and incremental costs compared to the comparator drug Belimumab (BELI). The findings indicate that without a price reduction, the financial burden on the public health insurance system would be substantial, raising concerns about sustainability and resource allocation.

**Inferences:**

  • Saphnelo’s current pricing exceeds affordability thresholds for cost-effective treatment.
  • Implementing the recommended price reduction could ensure financial sustainability within the public healthcare system.
  • The decision underscores the importance of balancing innovative treatments with economic feasibility.
  • Failure to adjust prices may lead to deprioritization of other essential healthcare services.

NIHO’s recommendation serves as a critical reminder of the delicate balance between introducing advanced medical treatments and maintaining economic viability in healthcare systems. By advocating for a price adjustment, NIHO aims to make effective treatments accessible without compromising the broader integrity of healthcare funding. Stakeholders, including pharmaceutical companies and healthcare providers, must collaborate to address these economic challenges, ensuring that patients receive necessary therapies while safeguarding public health resources.

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