The National Institute for Healthcare Value and Technology in Slovakia (NIHO) has formally recommended against the full categorization of Risankizumab (Skyrizi) for treating adults with moderate to severe active Crohn’s disease. This decision hinges on the drug not meeting the necessary cost-effectiveness criteria unless significant price adjustments are made by the manufacturer.
NIHO’s Cost-Effectiveness Criteria Not Met
In its comprehensive evaluation, NIHO scrutinized the clinical efficacy and safety of Skyrizi compared to existing biologic treatments like Ustekinumab and Vedolizumab. While Skyrizi demonstrated favorable outcomes in achieving clinical remission during the induction phase, it fell short in other key efficacy indicators. Moreover, the cost-effectiveness analysis revealed that Skyrizi’s current pricing does not align with the stringent economic standards required for public healthcare funding in Slovakia.
Recommendation for Price Adjustments and Indication Refinement
NIHO has stipulated that without a substantial discount—specific reductions were outlined—the Institute cannot endorse the inclusion of Skyrizi in the list of reimbursed medications. Additionally, NIHO suggests refining the treatment indications to better target patients who have not responded to or are intolerant of other biological therapies. This adjustment aims to optimize resource allocation within the Slovak healthcare system, ensuring that funds are directed towards treatments that offer the most significant health benefits per cost.
– Skyrizi shows promise in induction remission but lacks comprehensive efficacy across all measures.
– Current pricing of Skyrizi is not justified by its clinical benefits when compared to existing treatments.
– Price reduction is essential for Skyrizi to meet cost-effectiveness standards and secure reimbursement.
The decision underscores NIHO’s commitment to maintaining a sustainable healthcare system by prioritizing treatments that offer both clinical effectiveness and economic viability. Patients currently relying on Skyrizi may need to explore alternative therapies or wait for potential price negotiations to make the drug a viable option within the Slovak public healthcare framework. This move reflects a broader trend of stringent drug evaluation processes aimed at balancing innovation with fiscal responsibility in healthcare provision.
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