EUnetHTA project plan for the 24-hour blood pressure measurement device with the built-in pulse wave velocity algorithm published

In early January 2020, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA24 “The 24-hour blood pressure measurement device Mobil-O-Graph® with the built-in pulse wave velocity algorithm ARCSolver® to measure arterial stiffness for the optimization of hypertension treatment and assessment of cardiovascular risk”.

This project is being executed by the Main Association of Austrian Social Security Institutions (HVB) and the Catholic University of the Sacred Heart (UCSC/Gemelli), Italy. The dedicated reviewers are the Health Information and Quality Authority (HIQA), Ireland, and Galician Agency for HTA (AVALIA-T), Spain.

The rationale of this assessment is to collaboratively produce structured (rapid) core HTA information on other technologies. Also, the aim is to apply this collaboratively produced assessment in the national or regional context.

This rapid assessment addresses the research question of whether the pulse wave analysis device Mobil-O-Graph® with the ARCSolver® algorithm (MOGARC) in the outpatient setting is more effective and/or safer in patients at risk of cardiovascular events or in diagnosing and monitoring hypertension, compared to current standard practice. For patients at risk of cardiovascular events, both primary and secondary prevention will be examined, comparing MOGARC to other pulse wave analysis devices, conventional 24-hour blood pressure monitoring devices, and risk scores. For diagnosis, treatment, and monitoring of hypertension, MOGARC will be compared to other pulse wave devices and conventional 24-hour blood pressure monitoring devices.

This topic was chosen based on a request from the Ministry of Health in Austria (Main Association of Austrian Social Security Institutions) who commissioned EUnetHTA to evaluate Mobil-O-Graph® and ARCSolver® algorithm, which measures pulse waves from blood pressure values (a measure of vascular aging, or vascular stiffness) to identify people at risk of cardiovascular events or of hypertension. It is currently unclear if pulse wave analysis in the outpatient and primary care setting achieves better management of hypertension and/or leads to avoidance of cardiovascular events. It is also unclear to what extent the commercially available pulse wave analysis devices are interchangeable.

For all domains, the selection of assessment elements will be based on the HTA Core Model For Rapid Relative Effectiveness Assessments version 4.2. The clinical effectiveness (EFF) and safety (SAF) domains will focus on identifying and monitoring hypertension (response to hypertension therapy) and primary and secondary prevention of cardiovascular events.

The final version of this rapid assessment is expected to be published at the end of May 2020.

The full details in English can be found here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.