Cost-effectiveness of transcatheter aortic valve replacement in patients ineligible for conventional aortic valve replacement.

OBJECTIVE: To assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) compared with medical management in patients with severe aortic stenosis who are ineligible for conventional aortic valve replacement (SAVR) from the perspective of the UK National Health Service. DESIGN: Probabilistic decision analytical model. METHODS: A decision analytical model was developed to assess the costs and benefits associated with both interventions over a 10-year time horizon. A literature review was performed to identify relevant clinical evidence. Health-related quality of life and mortality were included using data from the PARTNER clinical trial (cohort B). Unit costs were taken from national databases. Costs and benefits were discounted at 3.5% per year, and extensive sensitivity analyses (probabilistic and deterministic) were performed to explore the impact of uncertainty on the cost-effectiveness estimates. MAIN OUTCOME MEASURE: Incremental cost-effectiveness ratio (ICER) with benefits expressed as quality-adjusted life years (QALYs). RESULTS: The base case ICER was approximately £16,100 per QALY gained. At a cost-effectiveness threshold of £20,000 per QALY gained, the probability that TAVI was cost-effective compared with medical management was 1.00. The results were robust to changes in key clinical parameters as well as choice of baseline survival data. The observed PARTNER survival data only have to be extrapolated for 2 years to generate an ICER below £30 000 per QALY gained, which is the upper value of the threshold range used by the National Institute for Health and Clinical Excellence in the UK. CONCLUSIONS: TAVI is highly likely to be a cost-effective treatment for patients with severe aortic stenosis who are currently ineligible for SAVR.

An economic evaluation of an abdominal aortic aneurysm screening program in Italy.

OBJECTIVES: Abdominal aortic aneurysm (AAA) is defined as a localized dilatation of an aortic vessel. Though predominantly asymptomatic, it is a chronic degenerative condition associated with life-threatening risk of rupture. The early diagnosis of AAA, ie, before it ruptures, is therefore important; a simple, effective diagnostic method is ultrasound examination. To assess the benefit of screening in Italy, we developed a cost-effective Markov model comparing screening vs nonscreening scenarios. METHODS: A 13-health-states Markov model was developed to compare two cohorts of 65- to 75-year-old men: the first group undergoing screening for AAA by means of ultrasound (US), the second following the current practice of incidental detection. The following health states were distinguished: no AAA, unknown small AAA (3-3.9 cm), followed-up small AAA (1 year), unknown medium-sized AAA (4-4.9 cm), followed-up medium-sized AAA (6 months), unknown large AAA (>5 cm), elective repair, emergency repair, postelective-repair AAA, postemergency-repair AAA, rejected large AAA, and death. Transitions between health states were simulated by using 6-month cycles. Transition probabilities were derived from a literature review of relevant randomized controlled trial and from a screening program that is currently ongoing at San Martino Hospital in Genoa, Italy. The Italian National Health Service (NHS) perspective was adopted and incremental cost per life-year saved was calculated with a lifetime horizon; costs and health benefits were discounted at an annual rate of 3% from year 2 onward. Uncertainty surrounding the model inputs was tested by means of univariate, multivariate, and probabilistic sensitivity analyses. RESULTS: Considering an attendance rate of 62%, the individual cost per invited subject was €60 (US $83.2); 0.011 additional quality adjusted life years (QALY) were gained per patient in the screened cohort, corresponding to an incremental cost-effectiveness ratio (ICER) of €5673/QALY (US $7870/QALY). The results were sensitive to some parameter variations but consistent with the base case scenario. They suggest that on the basis of a willingness-to-pay threshold of €50,000/QALY, screening for AAA is cost-effective, with a probability approaching 100%. CONCLUSIONS: As in economic evaluations developed in other countries, such as the UK, Canada, and The Netherlands, setting up a screening program for AAA can be considered cost-effective from the Italian NHS perspective.

Cost-effectiveness of the Endeavor stent in de novo native coronary artery lesions updated with contemporary data.

AIMS: The Endeavor zotarolimus-eluting coronary stent has been shown to reduce the restenosis rate compared to bare metal stents and has impacted other clinical measures such as mortality, acute myocardial infarctions (AMI) and target vessel revascularisation (TVR). METHODS AND RESULTS: Using pooled efficacy data from the Endeavor clinical trial programme, a model was developed to compare the cost effectiveness of the Endeavor drug eluting stent (DES) with the Driver bare meal stent (BMS) over a four year time period. Endeavor was more costly but had an improved clinical outcome compared to Driver BMS over four years with a 4% reduction in deaths, 33% reduction in AMI and a 45% reduction in TVR. Late stent thrombosis was the only event showing an increased incidence for Endeavor of 0.2% compared to 0% for Driver. The incremental cost effectiveness ratio was pound3,757/quality adjusted life years (QALY). CONCLUSIONS: Although much controversy has surrounded the appropriate way to assess the cost effectiveness of DES technology, a comprehensive analysis is presented and this suggests that by using extended clinical trial data out to four years, the Endeavor DES in particular, but DES technologies in general, are cost-effective approaches to percutaneous coronary intervention.

Brief report: a quality of life instrument for adolescents with growth disorders.

This study assessed the psychometric properties of a recently developed health-related quality of life (HRQOL) instrument (Vécu et Santé Perçue de l'Adolescent -Malade, VSP-AM) in 172 adolescents receiving growth hormone. The VSP-AM was cross-culturally adapted into English and tested for internal consistency (alpha=0.78-0.89 subscales, 0.74 Summary Score), construct and criterion validity, and responsiveness. Correlations with other scales demonstrated convergent validity. Adolescents who reported HRQOL as high or low had significantly different scores (all p<0.001). Adolescents receiving growth hormone therapy differed significantly from adolescents with medical, surgical or psychiatric disorders. The VSP-AM shows reliability and validity for HRQOL measurement in adolescents with growth disorders.

Development of a growth hormone injection questionnaire for adolescents.

We developed an instrument to assess feelings about self-injection of growth hormone (GH) in adolescents with growth disorders. Summary scores did not differ significantly by cohort, age, gender, or diagnosis. Adolescents who were more comfortable with GH injections had higher health-related quality of life, functional capacity, and self-control.