In a recent decision, Slovakia’s National Institute for Health Technology Assessment (NIHTA) has recommended against approving the extension of Ultomiris (ravulizumab) for adult patients suffering from the rare autoimmune disorder neuromyelitis optica spectrum disorder (NMOSD). This decision hinges primarily on the drug’s cost-effectiveness and pricing.
Evaluation Conclusion
NIHTA assessed Ultomiris under the accelerated evaluation process, focusing on its efficacy and safety compared to existing treatments. The institute concluded that while Ultomiris shows potential benefits in reducing relapse rates, its current pricing does not meet the cost-effectiveness criteria set for 2025. Consequently, for Ultomiris to be considered for reimbursement, the manufacturer must reduce the cost per package to a maximum threshold, reflecting a significant discount from the public pharmacy price.
Cost-Effectiveness Analysis
A comprehensive economic model revealed that, at the proposed price, Ultomiris does not offer sufficient value for money within the Slovak healthcare system. The analysis highlighted that the drug’s incremental costs remain high relative to the healthcare benefits it provides. NIHTA emphasized the need for additional discounts to mitigate uncertainties regarding long-term cost savings and treatment adherence among patients.
- NIHTA found that the current pricing model for Ultomiris poses budgetary challenges.
- A required discount of over 50% is necessary to align the drug with cost-effectiveness standards.
- Failure to adjust pricing may limit access to this potentially life-improving treatment for NMOSD patients.
The decision underscores the delicate balance between ensuring access to advanced therapies and maintaining sustainable healthcare financing. Stakeholders are now anticipating negotiations for price adjustments, which are crucial for Ultomiris to become a viable option for patients in need.
Patients and advocacy groups have expressed concern over the decision, emphasizing the severe impact NMOSD has on quality of life and the urgent need for effective treatments. They are hopeful that price negotiations will pave the way for eventual approval and reimbursement.
Should the manufacturer comply with the recommended price reduction, Ultomiris may undergo re-evaluation for approval, potentially offering a new treatment avenue for those affected by NMOSD. This development highlights the ongoing challenges in healthcare systems worldwide to incorporate innovative but expensive treatments.
Slovakia’s approach serves as a case study for other nations grappling with the integration of high-cost therapies into their healthcare frameworks, ensuring that patient needs are met without compromising financial sustainability.
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