The National Institute for Health and Health Technology Assessment (NIHO) in Slovakia has assessed the MRI contrast agent gadopiklenol, branded as Vueway, and determined that it cannot be categorized for diagnostic use in adults and children aged two and older unless the pricing is adjusted to meet cost-effectiveness criteria. This decision impacts the potential reimbursement and accessibility of Vueway within the Slovak healthcare system.
NIHO’s Evaluation Highlights Cost Concerns
The evaluation focused on the clinical efficacy and safety of Vueway compared to existing contrast agents such as gadobutrol and gadoteridol. Clinical studies PROMISE and PICTURE demonstrated that Vueway is non-inferior to gadobutrol in visualizing lesions during MRI scans. However, the cost analysis revealed that the proposed pricing does not align with the budgetary constraints and cost-effectiveness standards set by NIHO.
Recommendations Include Pricing Adjustments
NIHO recommends that the manufacturer reduce the prices of Vueway to maximum allowable levels outlined in their assessment. Failure to adjust the pricing would result in Vueway not being included in the list of categorized medications, thereby limiting its reimbursement by public health insurance and affecting its availability to patients.
• Vueway offers comparable safety and efficacy to existing contrast agents in adult populations.
• Current pricing poses significant cost-effectiveness challenges for widespread adoption.
• Adjusting prices could facilitate Vueway’s inclusion and enhance patient access to advanced diagnostic imaging.
To ensure efficient allocation of healthcare resources, NIHO emphasizes the importance of cost-effective options. The proposed price adjustments aim to balance clinical benefits with economic sustainability, ultimately benefiting patients who require enhanced diagnostic imaging for various pathologies.
By addressing the cost concerns, the manufacturer can pave the way for Vueway to become a reimbursable option, potentially improving diagnostic capabilities in Slovak medical facilities. This move would not only align with national healthcare budgetary requirements but also expand access to high-quality imaging services for the population.
Adhering to NIHO’s recommendations will be crucial for Vueway’s integration into the Slovak healthcare system. Stakeholders, including the manufacturer and healthcare providers, should collaborate to implement the necessary pricing adjustments to facilitate the successful adoption of this diagnostic tool.
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