The National Institute for Health and Healthcare Excellence (NIHO) in Slovakia has recommended against including the InPen smart insulin pen and its accompanying mobile application into the list of covered medical devices for diabetes patients. This decision follows a comprehensive evaluation of the system’s clinical efficacy and safety compared to existing insulin pens.
Evaluation Findings
NIHO assessed the InPen system, which offers features such as real-time bolus dose calculations, automatic dose tracking, and connectivity with continuous glucose monitoring (CGM) devices via Bluetooth. Despite these advanced functionalities, the institute determined that the manufacturer failed to demonstrate significant clinical benefits in reducing mortality and morbidity among diabetes patients. The submitted clinical study lacked adequate validity due to methodological shortcomings, including the use of historical controls and potential conflicts of interest.
Recommendations and Budget Impact
NIHO advises that unless the manufacturer revises the usage criteria to align with at least subgroup D6.1 and imposes a maximum limit of one device per year, the InPen system should not be funded by public health insurance. The potential budget impact was deemed highly uncertain, with manufacturer estimates likely being underestimated. The institute expressed concern that widespread adoption without proven cost-effectiveness could place an undue financial burden on the healthcare system.
• Lack of demonstrated clinical benefits in mortality and morbidity indicators
• Insufficient validity of submitted clinical studies
• Potential financial strain on public healthcare
• Recommendation to limit usage criteria and device allocation
Given these findings, healthcare providers and patients should remain cautious about adopting the InPen system until further evidence supporting its efficacy and cost-effectiveness emerges. Traditional insulin pens continue to be the standard of care within the Slovak healthcare framework.
NIHO’s decision underscores the necessity of robust clinical evidence and comprehensive cost-benefit analysis in the integration of new medical technologies. Patients and healthcare professionals are encouraged to stay informed about future evaluations and updates regarding smart insulin delivery systems.
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