Sophie Marbaix

Cost-effectiveness of varenicline compared with nicotine patches for smoking cessation--results from four European countries.

BACKGROUND The aim of this study was to evaluate and compare the cost-effectiveness of varenicline with nicotine replacement therapy (NRT) for smoking cessation in four European countries (Belgium, France, Sweden and the UK). METHODS Markov simulations, using the Benefits of Smoking Cessation on Outcomes (BENESCO) model, were performed. We simulated the incidence of four smoking-related morbidities: lung cancer, chronic obstructive pulmonary disease, coronary heart disease and stroke. The model computes quality-adjusted life-years gained and incremental cost-effectiveness ratios. Incremental cost-utility ratios were calculated, adopting a lifetime perspective. Efficacy data were obtained from a randomized open-label trial: Week 52 continuous abstinence rates were 26.1% for varenicline and 20.3% for NRT. RESULTS The analyses imply that for countries analysed, smoking cessation using varenicline versus NRT was associated with reduced smoking-related morbidity and mortality. The number of morbidities avoided, per 1000 smokers attempting to quit, ranged from 9.7 in Belgium to 6.5 in the UK. The number of quality-adjusted life-years gained, per 1000 smokers, was 23 (Belgium); 19.5 (France); 29.9 (Sweden); and 23.7 (UK). In all base-case simulations (except France), varenicline dominated (more effective and cost saving) NRT regarding costs per quality-adjusted life-year gained; for France the incremental cost-effectiveness ratio was 2803. CONCLUSION This cost-effectiveness analysis demonstrated that since varenicline treatment was more effective, the result was increased healthcare cost savings in Belgium, Sweden and the UK. Our results suggest that funding varenicline as a smoking cessation aid is justifiable from a healthcare resource allocation perspective.

Cost effectiveness of varenicline in Belgium, compared with bupropion, nicotine replacement therapy, brief counselling and unaided smoking cessation: a BENESCO Markov cost-effectiveness analysis.

AbstractBackground and Objective: Varenicline is a nicotinic acetylcholine receptor partial agonist that is approved for use as an aid to smoking cessation. Randomized clinical trials show that its efficacy is superior to that of other current smoking cessation therapies. This study set out to determine the cost effectiveness of varenicline relative to other smoking cessation interventions (bupropion and nicotine replacement therapy [NRT]) as well as brief counselling alone and unaided cessation in a cohort of Belgian adult smokers making a one-time quit attempt, from the perspective of the healthcare payer (public and private). Methods: A Markov model, the Benefits of Smoking Cessation on Outcomes (BENESCO) model, was applied to calculate the long-term health and economic benefits of smoking cessation. Cost effectiveness was expressed as cost per life-year (LY) gained and cost per quality-adjusted life-year (QALY) gained. Clinical and economic model inputs were obtained from the literature and public healthcare databases. Costs were discounted at 3% and health outcomes at 1.5%. A probabilistic sensitivity analysis and a one-way sensitivity analysis were performed to test the robustness of the results. Results: Varenicline is associated with a reduction of smoking-related morbidity and mortality as well as with a decrease in healthcare costs compared with the pharmacological agents bupropion and NRT. Varenicline also leads to additional LYs and QALYs compared with brief counselling alone and unaided cessation over a lifetime period. Varenicline is a dominant strategy compared with bupropion and NRT. Compared with brief counselling alone and unaided cessation, varenicline presents a cost/QALY of €240 and €1656, respectively. Conclusion: Varenicline is a cost-effective alternative to brief counselling and unaided cessation, and is a cost-saving treatment in comparison with bupropion and NRT, in a Belgian population of smokers willing to quit.

Voriconazole treatment of invasive aspergillosis: real-world versus health-economic model results.

AbstractObjective: The objective of this study was to assess, in a real-world setting, the predictive validity (in terms of clinical outcome and treatment cost) of the voriconazole arm of a health-economic model applied in the Belgian reimbursement submission for use of voriconazole in the treatment of invasive aspergillosis. Methods: A non-interventional study was designed to prospectively collect clinical response and direct costs data related to the treatment of invasive aspergillosis with voriconazole (oral, intravenous) in real-world practice. The outcomes of this study were compared with the inputs and outputs of the health-economic model. For the analysis, unit costs of 2002 from the public payer’s perspective, as used in the model, were applied. Results: Data from 116 patients with invasive aspergillosis starting treatment with voriconazole were collected. At 12 weeks, there were similar rates of satisfactory clinical response for the observational study and the model, the latter based on the results of a clinical study (50% vs 53%, respectively). Overall mortality rates at 84 days were 42% in the observational study and 29% in the model. Average total healthcare cost associated with voriconazole treatment was lower in the observational study compared with the model for all patients. When the cost for all hospitalization days from the start until the end of the fungal infection was included in the analysis, the average total cost was €19 674. When the cost for only those hospitalization days solely related to the fungal infection was included in the analysis, the average total cost was €12 376. These costs are below the cost predicted by the model of €21 298. Conclusions: This analysis demonstrates that the results provided in the voriconazole arm of the health-economic model were valid estimates with regard to real-world outcomes but with a slightly better survival rate and higher costs than in real life.

A cost-utility analysis of pregabalin in the management of peripheral neuropathic pain

Abstract OBJECTIVES: To assess the cost per QALY (quality-adjusted life years) of pregabalin in the management of peripheral neuropathic pain. METHODS: We compared pregabalin on top of “usual care” with “usual care” alone. In this study, usual care was defined as a mix of drug therapies, excluding anti-epileptic drugs (AEDs), because the latter represented only 9% of current use, and clinical evidence of pregabalin was demonstrated versus usual care without anti-epileptic drugs. A Markov model was developed to simulate the evolution of a patient cohort over 1 year, and applied cycles of 4 weeks. During each cycle, patients remained in 1 out of 4 possible states: severe, moderate or mild pain, and therapy withdrawal. The health care payers perspective was taken into account. Clinical data were obtained from a trial comparing usual care plus placebo to usual care plus pregabalin, at either 150, 300, or 300/600 mg/day (the latter depending on clearance of creatinin). Resulting effects on pain were transformed into transition-probabilities between different pain levels. Cost and SF36 utility data of pain levels were obtained from a 1-month observational study in 88 patients. RESULTS: Usual care resulted in a yearly cost of € 6,200 compared to € 5,984 for an all dose pregabalin-mix, meaning a cost saving of € 216 per patient. Utility increase was 0.01 for the pregabalin-mix (QALY 0.510 usual care; 0.520 pregabalin-mix). MonteCarlo analysis showed cost savings were not significant. However, the utility gain, albeit small, was statistically significant. CONCLUSIONS: Based on this analysis, it may be concluded, that in the considered patient population, at the specialist level, pregabalin is at least cost neutral to current usual care (without AEDs) and offers a slight but significant increase in quality of life.

An economic evaluation based on a randomized placebo-controlled trial of varenicline in smokers with cardiovascular disease: results for Belgium, Spain, Portugal, and Italy.

Background: An estimated 17.2% of patients continue to smoke following diagnosis of cardiovascular disease (CVD). To reduce the risk of further morbidity or mortality in cardiovascular patients, smoking cessation has been shown to reduce the risk of mortality by 36% and myocardial infarction by 32%. The objective of this study was to evaluate the long-term health and economic consequences of smoking cessation in patients with CVD. Design and methods: Results of a randomized clinical trial comparing varenicline plus counselling vs. placebo plus counselling were extrapolated using a Markov model to simulate the lifetime costs and health consequences of smoking cessation in patients with stable CVD. For the base case, we considered a payer’s perspective including direct costs attributed to the healthcare provider, measuring cumulative life years (LY) and quality adjusted life (QALY) years as outcome measures. Secondary analyses were conducted from a societal perspective, evaluating lost productivity due to premature mortality. Sensitivity and subgroup analyses were also undertaken. Results were analysed for Belgium, Spain, Portugal, and Italy. Results: Varenicline plus counselling was associated with a gain in LY and QALY across all countries; relative to placebo plus counselling. From a payer’s perspective, incremental cost effectiveness ratios were €6120 (Belgium), €5151 (Spain), €5357 (Portugal), and €5433 (Italy) per QALY gained. From a societal perspective, varenicline in addition to counselling was less costly than placebo and counselling in all cases. Sensitivity analyses showed little sensitivity in outcomes to model assumptions or uncertainty in model parameters. Conclusions: Varenicline in addition to counselling is cost-effective compared to placebo and counselling in smokers with CVD.

Cost effectiveness of atorvastatin in patients with type 2 diabetes mellitus: a pharmacoeconomic analysis of the collaborative atorvastatin diabetes study in the belgian population.

AbstractBackground and Objective: Patients with type 2 diabetes mellitus have a high risk of developing cardiovascular (CV) disease. The clinical benefit of use of statins in patients with type 2 diabetes has been demonstrated in several randomized, controlled trials, including the CARDS clinical trial. Based on the clinical CARDS data, the favourable cost effectiveness of atorvastatin 10mg in patients with type 2 diabetes has been demonstrated in countries such as the UK and France. This study aimed to estimate the cost effectiveness in the Belgian setting of atorvastatin 10 mg compared with no treatment for the primary prevention of CV events in type 2 diabetes patients without a history of CV disease. Methods: A Markov model with 1-year cycles was developed to simulate the CV event and death risk according to the therapeutic approach initiated. The transition probabilities for CV events in the ‘no statin treatment’ group were derived from the risk equations reported from the large UKPDS. Risk reductions from the CARDS clinical trial were used to adjust these CV event probabilities in the atorvastatin 10 mg treatment group. The characteristics of type 2 diabetes patients without a CV history were derived from the Belgian OCAPI survey. The public healthcare payers’ perspective was taken into account for costing. The direct medical costs of CV events were based on the Public Health Authorities’ hospital database for acute care costs and on the literature for the follow-up costs. The impact on the reimbursement system of generic entry to the market was considered in the drug cost. Costs were valued as at year 2009; costs and outcomes were discounted at 3% and 1.5%, respectively. Results: Based on a 5-year time horizon, atorvastatin was demonstrated to be cost effective with an incremental cost/quality-adjusted life-year (QALY) of €16 681. Over a lifetime horizon (25 years), atorvastatin was demonstrated to be a cost-saving therapeutic intervention. At a threshold of €30 000/QALY, atorvastatin had a 98.8% probability of being cost effective. Conclusion: Compared with ‘no treatment’, use of atorvastatin 10 mg as a primary prevention intervention in Belgian type 2 diabetes patients not only improves CV outcomes, but also appears to be cost saving over a lifetime horizon.

Cost effectiveness of apixaban versus aspirin for stroke prevention in patients with non-valvular atrial fibrillation in Belgium

Background and ObjectiveEvidence indicates that vitamin K antagonists (VKAs) and oral anticoagulant therapy are under-utilised for stroke prevention in patients with non-valvular atrial fibrillation (AF), and patients who decline or cannot tolerate such treatment are often prescribed aspirin instead. Apixaban has been shown in the AVERROES trial to be superior to aspirin in preventing stroke and systemic embolism without significantly increasing the risk of major bleeding among patients with AF who are unsuitable for VKA therapy. This study estimates the economic implications and potential cost effectiveness of apixaban compared with aspirin in such individuals from the perspective of healthcare payers in Belgium.MethodsA Markov model was developed to evaluate the clinical and economic impact of apixaban compared with aspirin in patients unsuitable for VKA therapy. The clinical events modelled include ischaemic and haemorrhagic stroke, systemic embolism, intracranial haemorrhage, other major bleeding, clinically relevant non-major bleeding, myocardial infarction, cardiovascular hospitalisation and treatment discontinuations obtained from AVERROES. Outcomes included life-years and quality-adjusted life-years (QALYs) gained, costs and incremental cost-effectiveness ratios (ICERs) over a lifetime.ResultsApixaban was projected to increase life expectancy and QALYs compared with aspirin, with an associated increase in drug acquisition costs. The estimated ICER was €7,334 per QALY gained with apixaban compared with aspirin.ConclusionsApixaban is a cost-effective alternative to aspirin for patients with AF in Belgium who decline or cannot tolerate VKA treatment.

Changes to the Statin Prescribing Policy in Belgium

AbstractBackground and Objective New policies in Belgium encourage prescribing of generic HMG-CoA reductase inhibitors (statins), but may lead to non-equivalent switching of patients from more potent second generation statins, as has occurred elsewhere. We sought to assess the potential health economic impact of the new policies. Design This was a cost-effectiveness analysis Methods A Markov model was constructed to simulate the onset of cardiovascular disease (CVD) and death among a representative cohort of 80 Belgian patients initially free of CVD and taking atorvastatin. Cardiovascular risks were estimated from calibrated Framingham equations, and utilities and costs from published data. Decision analysis assessed the potential impact of switching all 80 patients to simvastatin. Changes in lipid levels expected to arise from switching were based on a published meta-analysis. Results If the 80 patients remained on atorvastatin, the model predicted that 23 (29%) would develop CVD over 20 years. If they were switched to simvastatin, the predicted number was 25 (31%), equating to a ‘number needed to harm’ of 52. Switching would lead to a net cost saving of € 131 (2012) per subject, but also a loss of 0.03 quality-adjusted life-years (QALYs) per subject. These equated to a decremental cost-effectiveness ratio of €4777 per QALY lost. Sensitivity analyses indicated this result to be robust. Conclusion Recently introduced statin prescribing policies in Belgium are likely, as intended, to reduce statin costs, but also increase the burden of CVD due to non-equivalent switching. It would be cost effective to maintain patients on atorvastatin for primary prevention rather than switch them to simvastatin.

THE COST-EFFECTIVENESS OF AN EXTENDED COURSE (12+12 WEEKS) OF VARENICLINE PLUS BRIEF COUNSELLING COMPARED WITH OTHER REIMBURSED SMOKING CESSATION INTERVENTIONS IN BELGIUM, FROM A PUBLIC PAYER PERSPECTIVE

Abstract Objective: To evaluate the cost-effectiveness of an extended (12+12 weeks) course of varenicline plus brief counselling compared with the currently reimbursed smoking cessation interventions (in combination with brief counselling) in Belgium, from a public payer perspective. Methods: The previously published version of the BENESCO model which included the extended course of varenicline was updated with recent publically available demographic and cost data from Belgium. Results: The extended course of varenicline plus brief counselling has an incremental cost per quality adjusted life year gained of 1101€ compared with a non-extended 12-week course of varenicline (plus brief counselling). The extended course of varenicline dominates all other comparators in this analysis. Conclusions: The extended course of varenicline (12 weeks followed by 12 weeks maintenance therapy in successful quitters) plus brief counselling is a highly cost-effective alternative to a non-extended (12 weeks only) course of varenicline plus brief counselling. This strategy dominates the other alternative smoking cessation interventions currently reimbursed in Belgium.

Cost-Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine Among Patients Aged 65-84 Years With Co-Morbidities or Immunosuppression In Belgium.

PIN49 Cost-EffECtIvENEss of 13-valENt PNEumoCoCCal CoNjugatE vaCCINE amoNg PatIENts agEd 65-84 YEars WIth Co-morbIdItIEs or ImmuNosuPPrEssIoN IN bElgIum Marbaix S1, Sato R2, Mignon A1, Atwood M3, Weycker D3 1Pfizer sa/nv, Brussels, Belgium, 2Pfizer Inc., Collegeville, PA, USA, 3PAI, Brookline, MA, USA Objectives: In adults, the incidence of S. pneumoniaeinfections and the related mortality increase with age and co-morbidities. The Belgian Superior Health Council recommends use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults with elevated risk of pneumococcal diseases. PCV13 has recently proven efficacious in preventing pneumococcal pneumonia and invasive pneumococcal disease (IPD) in the elderly. We investigated the cost-effectiveness of vaccinating the 65-84 y. old cohort (n= 862,188) that suffer from co-morbidities or immunosuppression MethOds: A cohort model with a Markov-type process was developed to project the lifetime risks and related costs of IPD and nonbacteremic pneumococcal pneumonia. Input data came from various sources (literature, existing databases, and observational studies) and were reviewed by a panel of Belgian experts. PCV13 effectiveness was derived from the recently published CAPiTA clinical trial results for the first 5 years. Protection gradually declined thereafter to zero by year 16. Belgian National Health perspective was taken with costs and quality-adjusted life years (QALYs), discounted annually by 3% and 1.5%, respectively. Sensitivity analyses on key parameters were performed in order to test the robustness of model findings. Results: 58% vaccination coverage with PCV13 in 65-84 year olds suffering from co-morbidities or immunosuppression is expected to prevent 6,798 cases of pneumococcal disease, and 911 disease-related deaths over lifetime compared to no vaccination. PCV13 vaccination cost was fully offset by reduction in diseaserelated costs (€ 61 million), and thus was overall cost-saving. In the one-way sensitivity analysis, results were most sensitive to PCV13 price and parameters related to inpatient pneumonia. In probabilistic sensitivity analysis, PCV13 dominated the no vaccination strategy in 97% of the simulations. cOnclusiOns: PCV13 vaccination of the 65-84 year-old cohort in Belgium would prevent a substantial number of cases and deaths from severe pneumococcal disease and be cost-saving from a healthcare perpective .