Early Health Technology Assessment of the Ultrasound Photoacoustic Needle for guiding a ventricular catheter

Real-time image guidance of a ventricular catheter to optimize the placement in the ventricles may increase correct ventricular catheter placement in hydrocephalus patients. To achieve this, a forward-looking Ultrasound Photoacoustic Needle (USPAN) was proposed. This USPAN is also expected to lower the number of insertions required to place the ventricle catheter inside the ventricle. However, no assessment has been performed on this device’s suitability for the current market. Therefore, an early health technology assessment (HTA) could help to inform the developers about the current fit of the USPAN for the market. The early HTA starts with an analysis of the clinical conditions, after which the headroom is determined. The goal of this research was to determine the headroom of the USPAN in the Netherlands, resulting in the main research question: What is the headroom of the USPAN for hydrocephalus patients who undergo a shunting procedure in the Netherlands? To answer this question, first, the clinical conditions of hydrocephalus patients undergoing a shunting procedure were determined with a literature study. The hydrocephalus population is mainly classified into two age groups: paediatric patients and adults. The paediatric patient population is approximately 1.3x smaller than the elderly population. However, the number of revisions, and thus the total number of surgeries, is higher in paediatric patients than in adults. Considering that the USPAN impacts the surgical procedure, we expect the USPAN to have the highest impact in the paediatric patient group, as the highest impact factor is the total number of surgeries required. The USPAN can potentially reduce the number of insertion attempts required for placing the ventricle catheter. However, the effects of this are inconclusive in the literature. Literature was also inconclusive about post-operative complications due to shunting surgery. Expert elicitation was performed based on a questionnaire to quantify the complications due to shunting surgery or complications induced by the number of catheter insertion attempts. The questionnaire showed that post-operative complications are less than 20%. No conclusive results were found about the complications caused by the number of catheter insertion attempts. A semi-Markov model was developed to obtain the costs and QALYs related to both surgical strategies: current care (free-hand technique) and with use of the USPAN. The model structure was based on the care pathway of hydrocephalus patients, which was derived from interviews with neurosurgeons. Moreover, the model structure was verified by a neurosurgeon. Subsequently, model parameters were derived from literature and expert elicitation. Model simulations were performed to obtain the QALYs and costs for both strategies over a time horizon of 5, 10 and 20 years. The simulation outcomes determined the Δcosts and Δ quality adjusted life years (QALYs) between both strategies to calculate the headroom. The headroom for the maximum reimbursable price (MRP) with a WTP threshold of AC50,000 for a time horizon of AC9,420, AC14,219, and AC20,905. Taking into account the prevalence of paediatric hydrocephalus in the Netherlands, the headroom is AC4.5 million, AC6.8 million and AC10.0 million, respectively. If the manufacturing costs are considered, the headroom lowers compared to the MRP. The most probable manufacturing costs are AC1200, resulting in a headroom of AC7602. When the probability of optimal placement is considered with the same manufacturing costs, the headroom is positive for all optimal catheter tip placement probabilities above 0.71. Altogether, this research shows that the USPAN might have benefits in the clinic based on the headroom calculations. However, the headroom is an iterative process, so the model parameters need to be updated and more accurately determined to get a more accurate outcome for the headroom.