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1.  A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population 
BMJ Open  2012;2(3):e001032.
Background
Patients with severe aortic stenosis and coexisting non-cardiac conditions may be at high risk for surgical replacement of the aortic valve or even be no candidates for surgery. In these patients, transcatheter aortic valve implantation (TAVI) is suggested as an alternative. Results of the PARTNER (Placement of AoRTic TraNscathetER Valve) trial comparing the clinical effectiveness of TAVI with surgical valve replacement and standard therapy were published. The authors assessed the cost-effectiveness of TAVI in Belgium.
Methods
A Markov model of incremental costs, effects (survival and quality of life) and incremental cost-effectiveness of TAVI was developed. The impact on survival, number of events and quality of life was based on the PARTNER trial. Costs per event were context specific.
Results
In high-risk operable patients, even if the minor differences in 30-day and 1-year mortality are taken into account, the incremental cost-effectiveness ratio (ICER) remains on average above €750 000 per quality-adjusted life-year (QALY) gained (incremental cost: €20 400; incremental effect: 0.03 QALYs). In inoperable patients, an ICER of €44 900 per QALY (incremental cost: €33 200; incremental effect: 0.74 QALYs) is calculated, including a life-long extrapolation of the mortality benefit. This result was sensitive to the assumed time horizon. The subgroup of anatomically inoperable patients had better outcomes than medically inoperable patients, with ICERs decreasing more than €10 000/QALY.
Conclusions
It is inappropriate to consider reimbursement of TAVI for high-risk operable patients. Reimbursing TAVI in inoperable patients in essence is a political decision. From an economic perspective, it would be prudent to first target patients that are inoperable because of anatomical prohibitive conditions. In the search for evidence, the authors identified non-published negative results from a randomised controlled TAVI trial. The study sponsor should be more willing to share this information to allow balanced evaluations and policy recommendations. Payers should require these data before taking reimbursement decisions.
Article summary
Article focus
To assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) for Belgian patients.
Key messages
In high-risk operable patients, surgical aortic valve replacement and TAVI are associated with similar mortality rates at 1 year. However, there is a twice as high rate of stroke after TAVI. From an economic point of view, the less invasive nature of the TAVI procedure does not weigh against the extra costs of about €20 000 per patient.
In inoperable patients, TAVI significantly reduces the rate of death from any cause as compared with a non-surgical approach. The ICER is about €45 000 per QALY gained. Nevertheless, a distinction should be made between inoperability for anatomic versus medical reasons. TAVI offers more value for money in the former patient group with ICERs decreasing more than €10 000 per QALY.
If policy makers are willing/able to pay the relative high price for TAVI, it is advised to focus in the first place on the anatomic inoperable patients.
Strengths and limitations of this study
Hospital billing data of 183 Belgian patients treated with the Edwards SAPIEN valve were at our disposal for cost calculations.
Next to the published pivotal PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a non-published randomised controlled trial (RCT) with TAVI was identified. This Continued Access trial was performed according to the same study protocol of the pivotal PARTNER trial. The mortality outcomes of this Continued Access RCT, disfavouring TAVI, were included in our analysis.
An unbalance in patient characteristics was observed in the inoperable patients of the PARTNER trial, favouring the TAVI group. A subgroup analysis showed a greater improvement for anatomic inoperable patients versus those inoperable for medical reasons.
The most important limitation of our analysis is the non-availability of all relevant study outcomes, especially for the negative non-published Continued Access RCT. The study sponsor should be willing to reveal this information in due time. Payers should require access to these non-published data before deciding on reimbursement.
doi:10.1136/bmjopen-2012-001032
PMCID: PMC3358616  PMID: 22561354
2.  Cost-effectiveness of cardiac resynchronisation therapy for patients with moderate-to-severe heart failure: a lifetime Markov model 
BMJ Open  2011;1(2):e000276.
Objective
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.
Article summary
Article focus
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).
Key messages
CRT-P can be recommended for reimbursement for New York Heart Association class III and IV patients if there is a willingness to pay more than €11 000/quality-adjusted life-year.
Current evidence is insufficient to show the superiority of CRT-D over CRT-P. With a threefold-higher device cost, CRT-D's cost-effectiveness is questionable.
Strengths and limitations
Hospital billing data of 342 Belgian CRT implantations were at our disposal for cost calculations.
The results of the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure trial were used to model the treatment effect. This happens to be the only trial that compared CRT-P as well as CRT-D versus optimal pharmacological treatment, allowing an indirect comparison to be made between CRT-P and CRT-D.
Following health economic theory, CRT-D is compared with CRT-P, not with optimal pharmacological treatment (ie, working on the cost-efficiency frontier).
A direct estimate of the added value of CRT-D versus CRT-P in patients with moderate to severe heart failure is lacking. This may be an interesting topic for further research in a randomised controlled trial, especially because of the threefold higher price for a CRT-D device versus CRT-P.
Generic utility instruments to measure quality of life are not always used in clinical trials. To support economic evaluations, it would be useful to include more systematically a generic utility instrument in the study protocol.
doi:10.1136/bmjopen-2011-000276
PMCID: PMC3211050  PMID: 22021894

Results 1-2 (2)