Cost-effectiveness of levodopa/carbidopa/entacapone (Stalevo*) compared to standard care in UK Parkinson's disease patients with wearing-off
ABSTRACT A Markov model was developed to evaluate the cost-effectiveness of levodopa/carbidopa/entacapone (LCE;Stalevo), in the treatment of patients with Parkinson's disease (PD) and end-of-dose motor fluctuations (wearing-off). LCE, with or without other antiparkinsonian medications, was compared to UK standard care, comprising traditional levodopa/ dopa-decarboxylase inhibitor (DDCI) with other antiparkinsonian medications (e.g. selegiline or dopamine agonists) added as needed. The costs and outcomes of both treatments were projected over a period of 10 years from the perspective (a) of society as a whole and (b) of the UK National Health Service (NHS). Sensitivity analyses, including second-order Monte Carlo simulations, were performed to assess the confidence level of the primary results.
Treatment with LCE produced an average gain of +1.04 quality-adjusted life-years (QALYs) per patient (2.57 vs. 1.53) in the base-case analysis (discount rate 3.5%). This gain was accompanied by a reduction in the total 10-year direct cost of care to society of 10198 pounds per patient ( approximately E14800). From the societal perspective, therefore, LCE was dominant, producing better clinical outcomes with lower costs. This dominance was reiterated in all sensitivity analyses of society-focused analysis, including a shortening of the time-frame to 5 years. Although treatment with LCE resulted in an increase in direct costs per patient of 3239 pounds (25756 pounds versus 22517 pounds) to the NHS over the 10-year period analysed, the incremental cost-effectiveness ratio (ICER) of LCE was only 3105 pounds per QALY gained (approximately E4500). All ICERs to the NHS remained below 3800 pounds per QALY gained in univariate sensitivity analyses applying different discount rates. When a shorter, 5-year, time-horizon was analysed, the NHS-related ICER for LCE was 6526 pounds per QALY gained. All these ICERs are within the range usually considered to indicate acceptable or highly acceptable cost effectiveness (defined as < 30000 pounds per QALY gained). The results of the Monte Carlo simulations indicated that the likelihood of LCE being either 'dominant' or more effective at an 'acceptable cost' from either the societal or the NHS perspective was high, exceeding 96% in the base-case sensitivity analysis, and was 93% even when all the uncertainties associated with the model were taken into consideration simultaneously. In particular, compared to standard care, the probability that LCE would provide better outcomes at a lower cost to society as a whole was 77% in the base-case sensitivity analysis and 72% in the scenario involving the highest degree of uncertainty.
In the UK the use of LCE to treat PD patients with wearing-off is beneficial to individual patients and likely to offer money savings to society as a whole, compared with UK standard therapy. The added cost of the medication itself is exceeded by the savings made in other direct costs of PD, mainly those relating to social care or PD-related private expenditures.
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ABSTRACT: Parkinson's disease (PD) is a chronic, neurodegenerative disease that places a substantial burden on patients, their families and carers, as well as on society as a whole. PD can severely affect the health-related quality of life (HR-QOL) of both patients and their carers and, as the disease progresses, HR-QOL deteriorates. This review aims to critically evaluate the literature on a number of important aspects that influence HR-QOL in relation to PD. Factors associated with a negative impact and ways to improve HR-QOL are highlighted, and tools for HR-QOL assessment reviewed. The economic impact of PD and related cost-effectiveness studies are also reviewed. Over the course of the disease, patients with PD experience changes in their HR-QOL that are affected by factors such as depression, motor complications, education and surgery. However, a lack of uniformity in the choice of HR-QOL tools used in studies makes comparison of results difficult. Research on motor fluctuations and dyskinesias has shown conflicting results, whereas it is clear from the available data that depression needs to be more clearly recognised and treated. Inequality in the numbers of men and women receiving surgery still needs to be addressed and, again, in this area there is a lack of uniformity with respect to assessment for surgery. Education programmes have been shown to be successful in improving HR-QOL, although more research is needed about how to introduce such programmes to all PD patients. In particular, there has been little detailed research into young-onset PD and juvenile patients to assess the true impact of the disease on their HR-QOL. The literature has also shown that PD can affect the HR-QOL of the carer, which may have a 'knock-on' effect for the patient. The HR-QOL of carers needs more attention because these individuals can significantly reduce the burden that would otherwise fall on the health services in terms of cost and care. Research shows that the economic costs of PD are high, particularly for patients in advanced stages of the disease and those with motor complications. Although carer burden is a major source of costs, this is not factored into cost-effectiveness analyses. Furthermore, because too few studies use quality-adjusted life years as their health outcome, particularly in studies of the costs of surgery, comparison of costs of treatments is difficult. The review highlights the need for HR-QOL tools such as the EuroQol-5D to be used together with disease-specific tools to provide the most comprehensive picture of the costs and impact of PD.A recent upsurge in published literature on PD resulting from increased interest in HR-QOL issues has led to an at times overwhelming amount of new information. The present review assembles the most important points relating to HR-QOL in PD raised in the literature, adds value to previously covered issues, and examines areas of HR-QOL in PD that have not previously been reviewed, such as education, carer burden and surgery, highlighting where more research is warranted.Drugs & Aging 02/2006; 23(9):693-721. DOI:10.2165/00002512-200623090-00001 · 2.84 Impact Factor
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ABSTRACT: The triple combination levodopa/carbidopa/entacapone tablet provides the clinical benefits of adding entacapone therapy to carbidopa/levodopa while affording the convenience of fewer pills. Entacapone is a catechol-O-methyl transferase inhibitor that slows the peripheral metabolism of levodopa, thereby increasing its central bioavailability. Clinically, the addition of entacapone to levodopa/carbidopa in Parkinson's disease patients with wearing-off fluctuations increases 'on' time, improves motor function and activities of daily living, and allows for a reduction of the levodopa dose. Levodopa/carbidopa/entacapone is indicated for use in patients with idiopathic Parkinson's disease who are being treated with immediate-release levodopa and experiencing the signs and symptoms of end-of-dose wearing-off. Clinical trial data in levodopa-treated Parkinson's disease patients who are not experiencing wearing-off demonstrate that the addition of entacapone is associated with a mild but significant improvement in activities-of-daily-living and quality-of-life measures. Entacapone is well tolerated and safe and, unlike the catechol-O-methyl transferase inhibitor tolcapone, does not require liver function test monitoring. Levodopa/carbidopa/entacapone is available in 50, 100 and 150 mg levodopa tablets that also contain carbidopa in a 1:4 ratio to levodopa, plus entacapone 200 mg. Based on preclinical studies demonstrating that concomitant administration of entacapone with levodopa/carbidopa delays the development of dyskinesias, a worldwide multicenter trial is in progress comparing the initiation of levodopa/carbidopa/entacapone versus levodopa/carbidopa in Parkinson's disease patients who require levodopa treatment.Aging Health 04/2006; 2(2):209-219. DOI:10.2217/1745509X.2.2.209