A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population

p. 1-8Objective To use patient-level data from the ADVANCE study to evaluate the cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared to medical management (MM) in patients with severe aortic stenosis from the perspective of the UK NHS. Methods A published decision-analytic model was adapted to include information on TAVI from the ADVANCE study. Patient-level data informed the choice as well as the form of mathematical functions that were used to model all-cause mortality, health-related quality of life and hospitalisations. TAVI-related resource use protocols were based on the ADVANCE study. MM was modelled on publicly available information from the PARTNER-B study. The outcome measures were incremental cost-effectiveness ratios (ICERs) estimated at a range of time horizons with benefits expressed as quality-adjusted life-years (QALY). Extensive sensitivity/subgroup analyses were undertaken to explore the impact of uncertainty in key clinical areas. Results Using a 5-year time horizon, the ICER for the comparison of all ADVANCE to all PARTNER-B patients was £13 943 per QALY gained. For the subset of ADVANCE patients classified as high risk (Logistic EuroSCORE >20%) the ICER was £17 718 per QALY gained). The ICER was below £30 000 per QALY gained in all sensitivity analyses relating to choice of MM data source and alternative modelling approaches for key parameters. When the time horizon was extended to 10 years, all ICERs generated in all analyses were below £20 000 per QALY gained. Conclusion TAVI is highly likely to be a cost-effective treatment for patients with severe aortic stenosis

Cost-effectiveness of cardiac resynchronisation therapy for patients with moderate-to-severe heart failure: a lifetime Markov model

1-7Objective To assess the cost-effectiveness of cardiac resynchronisation therapy (CRT) both with CRT-P (biventricular pacemaker only) and with CRT-D (biventricular pacemaker with defibrillator) in patients with New York Heart Association (NYHA) functional class III/IV from a Belgian healthcare-payer perspective. Methods A lifetime Markov model was designed to calculate the cost–utility of both interventions. In the reference case, the treatment effect was based on the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure trial. Costs were based on real-world data. Pharmacoeconomic guidelines were applied, including probabilistic modelling and sensitivity analyses. Results Compared with optimal medical treatment, on average 1.31 quality-adjusted life-years (QALY) are gained with CRT-P at an additional cost of €14 700, resulting in an incremental cost-effectiveness ratio (ICER) of about €11 200/QALY. As compared with CRT-P, CRT-D treatment adds on average an additional 0.55 QALYs at an extra cost of €30 900 resulting in an ICER of €57 000/QALY. This result was very sensitive to the incremental clinical benefit of the defibrillator function on top of CRT. Conclusions Based on efficiency arguments, CRT-P can be recommended for NYHA class III and IV patients if there is a willingness to pay more than €11 000/QALY. Even though CRT-D may offer a survival benefit over CRT-P, the incremental clinical benefit appears to be too marginal to warrant a threefold-higher device price for CRT-D. Further clinical research should focus on the added value of CRT-D over CRT-P

Testing the HTA Core Model: Experiences from two pilot projects

Objectives: The aim of this study was to analyze and describe process and outcomes of two pilot assessments based on the HTA Core Model, discuss the applicability of the model, and explore areas of development. Methods: Data were gathered from HTA Core Model and pilot Core HTA documents, their validation feedback, questionnaires to investigators, meeting minutes, emails, and discussions in the coordinating team meetings in the Finnish Office for Health Technology Assessment (FINOHTA). Results: The elementary structure of the HTA Core Model proved useful in preparing HTAs. Clear scoping and good coordination in timing and distribution of work would probably help improve applicability and avoid duplication of work. Conclusions: The HTA Core Model can be developed into a platform that enables and encourages true HTA collaboration in terms of distribution of work and maximum utilization of a common pool of structured HTA information for national HTA report

Safety of percutaneous aortic valve insertion. A systematic review

<p>Abstract</p> <p>Background</p> <p>The technique of percutaneous aortic valve implantation (PAVI) for the treatment of severe aortic stenosis (AS) has been introduced in 2002. Since then, many thousands such devices have worldwide been implanted in patients at high risk for conventional surgery. The procedure related mortality associated with PAVI as reported in published case series is substantial, although the intervention has never been formally compared with standard surgery. The objective of this study was to assess the safety of PAVI, and to compare it with published data reporting the risk associated with conventional aortic valve replacement in high-risk subjects.</p> <p>Methods</p> <p>Studies published in peer reviewed journals and presented at international meetings were searched in major medical databases. Further data were obtained from dedicated websites and through contacts with manufacturers. The following data were extracted: patient characteristics, success rate of valve insertion, operative risk status, early and late all-cause mortality.</p> <p>Results</p> <p>The first PAVI has been performed in 2002. Because of procedural complexity, the original transvenous approach from 2004 on has been replaced by the transarterial and transapical routes. Data originating from nearly 2700 non-transvenous PAVIs were identified. In order to reduce the impact of technical refinements and the procedural learning curve, procedure related safety data from series starting recruitment in April 2007 or later (n = 1975) were focused on. One-month mortality rates range from 6.4 to 7.4% in transfemoral (TF) and 11.6 to 18.6% in transapical (TA) series. Observational data from surgical series in patients with a comparable predicted operative risk, indicate mortality rates that are similar to those in TF PAVI but substantially lower than in TA PAVI. From all identified PAVI series, 6-month mortality rates, reflecting both procedural risk and mortality related to underlying co-morbidities, range from 10.0-25.0% in TF and 26.1-42.8% in TA series. It is not known what the survival of these patients would have been, had they been treated medically or by conventional surgery.</p> <p>Conclusion</p> <p>Safety issues and short-term survival represent a major drawback for the implementation of PAVI, especially for the TA approach. Results from an ongoing randomised controlled trial (RCT) should be awaited before further using this technique in routine clinical practice. In the meantime, both for safety concerns and for ethical reasons, patients should only be subjected to PAVI within the boundaries of such an RCT.</p

What is the evidence in favor of percutaneous aortic valve insertion?

p. 575Feasibility and initial results of percutaneous aortic valve implantation including selection of the transfemoral or transapical approach in patients with severe aortic stenosis

Percutaneous heart valve implantation in congenital and degenerative valve disease. A rapid Health Technology Assessment. : a Rapid Health Technology Assessment

vi, 79 p.ill

Health technology assessment on catheter ablation of atrial fibrillation in Belgium

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Effectiveness of catheter ablation of atrial fibrillation in Belgian practice : a cohort analysis on administrative data

663-668Aim To assess the outcome and cost of catheter ablation of atrial fibrillation (AF) in Belgium. Methods and results From a nationwide health insurers' database, we retrieved claims data of all patients that underwent a catheter ablation of AF from November 2007 through December 2008. Based on data on reimbursed procedures and drugs, we assessed AF recurrence using different models. Costs related to the index hospitalization were calculated. During the observation period, 830 patients underwent a first catheter ablation of AF. Two-year follow-up data were available for all patients, with an average follow-up of 30.2 months. Seventy-seven percent of patients were treated for paroxysmal AF. Recurrence of AF was defined as the occurrence of one of the following events: a repeat catheter ablation, an electric cardioversion or an antiarrhythmic drug (AAD) prescription, the latter two taking into account a blanking period of 3 months. Atrial fibrillation recurred in 59.8% of patients after 1 year and in 65.9% of them after 2 years. If AAD prescription was considered as an indicator for ablation failure only if it occurred after a 1 month AAD-free period, recurrence of AF occurred in 37.3% of patients after 1 year and in 49.9% after 2 years. Based on the prescription of rate and rhythm control drugs before the ablation, we conclude that up to 15.8% of patients underwent catheter ablation as first-line therapy. Catheter ablation of AF in Belgium on average costs about €9600 for the initial intervention. Conclusion Since the effectiveness of catheter ablation of AF appears to be less favourable in real-world practice as compared with results reported in clinical trials, and given the high initial cost of the procedure, we suggest to strictly limiting the intervention to patients in whom it is currently believed to be most beneficial, i.e. those with severely symptomatic and drug-refractory paroxysmal AF with no or minimal structural heart disease

Thérapie de resynchronisation cardiaque : Un rapport d’évaluation de technologie de santé

IX, 199 p.ill.Mise au point il y a une dizaine d’années, la thérapie de resynchronisation cardiaque (CRT) s’adresse aux patients atteints d’insuffisance cardiaque. Il s’agit d’un traitement particulier qui stimule la fonction de pompe du cœur au moyen d’une sorte de pacemaker. Annuellement, environ 530 appareils CRT sont implantés chez de nouveaux patients belges. Ce chiffre est encore appelé à augmenter dans le futur. L’INAMI a demandé un avis au Centre fédéral d’expertise des soins de santé (KCE) avant de se prononcer sur le remboursement intégral de ce traitement. Le KCE estime que la CRT diminue le nombre de décès ainsi que le nombre d’hospitalisations chez les patients insuffisants cardiaques. Toutefois, il n’est pas démontré que l’appareil le plus cher (21.000 €) fonctionne mieux que le moins cher (7.000€). L’implantation est techniquement difficile et est suivie de problèmes sérieux chez 1 patient sur 5. Le KCE recommande dès lors d’autoriser les implantations uniquement dans les hôpitaux qui réalisent au moins 20 interventions par an

Percutane hartklep implantatie bij congenitale en degeneratieve klepletsels : een rapid Health Technology Assessment

viii, 79 p.ill