Analisi costi-efficacia dell’adozione dei pacemaker leadless rispetto ai pacemaker tradizionali

[Autom. eng. transl.] Objectives - To estimate the cost-effectiveness of leadless pacemakers (PL) compared to traditional pacemakers (PT) in the population eligible for PL and PT implantation from the perspective of the National Health Service (NHS). Methodology - A Bayesian decision tree was calibrated for a hypothetical cohort of patients divided equally into the PL arm and PT arm, adopting the NHS perspective. After the patient has been implanted, he may incur a complication with predetermined probabilities. The target population consisted of patients eligible for PL and PT implantation and who are implanted with one of the two types of devices. The model parameters were obtained from the scientific literature. In particular, the costs of the devices, the average cost of complications associated with them and the transition probabilities were derived respectively from a US state report [1], a French national economic study [2] and a systematic review with meta-analysis [3]. The costs and benefits were discounted at an annual rate of 3%. To guide the decision-making process on which alternative to support, the Eurozone threshold was chosen, which varies from €30,000 to €50,000. The impact of uncertainty on model parameters was explored through a probabilistic sensitivity analysis (PSA), calculating the cost-effectiveness acceptability curve (CEAC) and the cost-effectiveness acceptability frontier (CEAF), and an analysis of the value of information (VOI), estimating instead the expected value of perfect information (EVPI). Bayesian inference was supported by a series of algorithms known as Markov Chain Monte Carlo (MCMC), including the Gibbs sampler. The performance of the selected algorithm was also evaluated through the use of some diagnostic techniques (i.e., traceplot, density plots, Gelman-Rubin diagnostics, chain autocorrelation functions). The results of the cost-effectiveness analysis were expressed as absolute costs and effectiveness and as an incremental cost-effectiveness ratio per complication avoided. Results - The adoption of PLs in the population eligible for the implantation of PLs and PTs would result in an absolute cost for the NHS of €341,662,460, compared to €247,187,180 resulting from the adoption of PTs. The absolute effectiveness of LPs would result in 12,767 complications avoided, compared to 9,606 for PTs. In the initial scenario, compared to PTs, PLs showed an ICER of €29,882 per complication avoided. The PSA confirmed the robustness of the base case results for the chosen threshold. The contour graph highlighted that 64% of the simulations are located in the northeast quadrant of the cost-effectiveness plan, where PLs provide greater benefits at higher costs than PTs. The CEAC and CEAF have highlighted that PLs have a 60% chance of being cost-effective compared to PTs. The EVPI amounts to €5,862 per patient. Finally, diagnostic techniques indicated that the MCMC produced robust results, with converging chains, high effective sample sizes and well-estimated posterior distributions, ensuring robustness in the validity and reliability of the results obtained.