Sanja Stanisic

Prolonged Prophylaxis With Valganciclovir Is Cost Effective in Reducing Posttransplant Cytomegalovirus Disease Within the United States

Background. Cytomegalovirus (CMV) disease in transplant patients is known to have a substantial clinical and economic burden, and its prevention is expected to have long-term benefits. Evidence from the Improved Protection Against CMV in Transplant trial proved that prolonged prophylaxis of 200 days with valganciclovir compared with 100 days significantly reduces the incidence of CMV in high-risk kidney transplant seropositive donors/seronegative recipients. The aim of this study was to develop a cost-effectiveness model to evaluate prolonged prophylaxis of 200 days with valganciclovir and its long-term economic impact. Methods. An economic model was designed to simulate long-term costs and outcomes of prolonged prophylaxis with valganciclovir (200 vs. 100 days) in a cohort of 10,000 high-risk renal transplant patients over 5 and 10 years. The first year of the model was based on the results of the Improved Protection Against CMV in Transplant trial and the extension to the long-term periods (5 and 10 years); and quality of life data were based on evidence retrieved through a systematic literature search. This analysis was conducted from the US healthcare payer perspective. Results. For the 5-year time horizon, the incremental cost-effectiveness ratio of US

Societal cost savings through bevacizumab-based treatment in non-small cell lung cancer (NSCLC).

14,859/quality-adjusted life year (QALY) suggests that 200-day valganciclovir prophylaxis is cost effective over the 100-day regimen considering a threshold of US

Is Testosterone Replacement Therapy in Males with Hypogonadism Cost-Effective? An Analysis in Sweden

50,000/QALY. The 10-year analysis revealed the 200-day prophylaxis as cost saving with a 2380 QALY gain and simultaneously lower cost. Conclusion. Prolonged prophylaxis with valganciclovir reduces the incidence of events associated with CMV infection in high-risk kidney transplant recipients and is a cost-effective strategy in CMV disease management.

Alirocumab in the management of primary hypercholesterolaemia or mixed dyslipidaemia: A budget impact analysis – Italian perspective

Bevacizumab in combination with platinum-based chemotherapy is associated with increased survival outcomes compared to chemotherapy alone in patients with non-squamous metastatic non-small cell lung cancer (mNSCLC). The objective of this study was to estimate potential economic benefits from a societal perspective in patients returning to work when treated with bevacizumab-based combination therapy. These economic benefits were assessed with respect to reduced productivity losses and described in terms of per patient cost savings. The analysis was conducted for France, Germany, Italy and Spain. Clinical outcomes in terms of progression-free survival (PFS) were based on two phase III clinical trials (E4599 and AVAiL) comparing bevacizumab + chemotherapy vs. chemotherapy alone. Potential cost savings due to reduction in productivity losses were assessed in progression-free patients who return back to work (human capital approach). It was assumed that 20% of all progression-free patients with performance status 0 or 1 and below 55 years of age would return back to work after the induction therapy maintaining their prior employment status (60% part-time, 40% full-time). Savings were calculated over 1 and 1.5 year time horizons. Mean savings, per progression-free patient ranged from 12,401 euro in Spain at year 1 to 39,001 euro in France at year 1.5. Respective findings proved to be fairly sensitive to the change of employment patterns and labour costs. This analysis shows that bevacizumab-based treatment can result in substantial cost savings in progression-free patients with mNSCLC.

Epidemiology and economic impact of moderate and severe neurotrophic keratopathy in Italy

INTRODUCTION Testosterone replacement therapy (TRT) has been recommended for the treatment of primary and secondary hypogonadism. However, long-term implications of TRT have not been investigated extensively. AIM The aim of this analysis was to evaluate health outcomes and costs associated with life-long TRT in patients suffering from Klinefelter syndrome and late-onset hypogonadism (LOH). METHODS A Markov model was developed to assess cost-effectiveness of testosterone undecanoate (TU) depot injection treatment compared with no treatment. Health outcomes and associated costs were modeled in monthly cycles per patient individually along a lifetime horizon. Modeled health outcomes included development of type 2 diabetes, depression, cardiovascular and cerebrovascular complications, and fractures. Analysis was performed for the Swedish health-care setting from health-care payers and societal perspective. One-way sensitivity analyses evaluated the robustness of results. MAIN OUTCOME MEASURES The main outcome measures were quality-adjusted life-years (QALYs) and total cost in TU depot injection treatment and no treatment cohorts. In addition, outcomes were also expressed as incremental cost per QALY gained for TU depot injection therapy compared with no treatment (incremental cost-effectiveness ratio [ICER]). RESULTS TU depot injection compared to no-treatment yielded a gain of 1.67 QALYs at an incremental cost of 28,176 EUR (37,192 USD) in the Klinefelter population. The ICER was 16,884 EUR (22,287 USD) per QALY gained. Outcomes in LOH population estimated benefits of TRT at 19,719 EUR (26,029 USD) per QALY gained. Results showed to be considerably robust when tested in sensitivity analyses. Variation of relative risk to develop type 2 diabetes had the highest impact on long-term outcomes in both patient groups. CONCLUSION This analysis suggests that lifelong TU depot injection therapy of patients with hypogonadism is a cost-effective treatment in Sweden. Hence, it can support clinicians in decision making when considering appropriate treatment strategies for patients with testosterone deficiency.

Costo-Efficacia di cabozantinib nel trattamento di seconda linea del tumore a cellule renali metastatico (mRCC) in Italia

Recent evidence suggests that adding protein convertase subtilisin/kexin type 9 inhibitors to current lipid-lowering therapies may result in unprecedented reductions in low-density lipoprotein cholesterol. The objective of this study was to assess the potential pharmaceutical financial impact of including the protein convertase subtilisin/kexin type 9 inhibitor, alirocumab, in the Italian National Health Service budget. The budget impact of adding alirocumab as a lipid-lowering therapy treatment option was assessed among the population defined by the AIFA reimbursement criteria. Data from the IMS/CEGEDIM national electronic database were used to estimate the size of the potentially eligible population. Drug costs were estimated according to dosing schedule and published prices. Alirocumab annual uptake was assumed at 7%, 9% and 10% for years 1, 2 and 3, respectively, considering a 20% treatment drop-out rate. Sensitivity analyses tested the impact of model inputs on the results. The annual estimated incremental cost of alirocumab treatment was €5106/patient. Treating an eligible population of 843 patients with alirocumab in the first year resulted in a total National Health Service budget impact of €4.30 million. Assuming growth of the alirocumab-treated population of 2105 and 2819 patients in the second and third years, the budgetary impact would be €10.75 and €14.10 million, respectively. Sensitivity analysis suggested that financial impact is most sensitive to the uptake of alirocumab in the population. The uptake of alirocumab results in an overall modest budgetary impact to the Italian National Health Service when added to conventional lipid-lowering therapies in a carefully selected population compared to the total lipid-lowering therapy pharmaceutical expenditure in Italy (€1 billion).

Rapid Relative Effectiveness Assessment of Pharmaceuticals: Transferability and Completeness of Information Derived From Global Value Dossiers To Complete A Eunethta Submission

Neurotrophic keratopathy is a rare corneal disease caused by impaired corneal innervation. There is a paucity of published evidence on neurotrophic keratopathy with no published studies on the economics of neurotrophic keratopathy in the Italian or international literature. This cost analysis aimed at assessing the economic impact of moderate (persistent epithelial defect) and severe (corneal ulcer without perforation) neurotrophic keratopathy from the perspective of the National Health Service and patients in Italy. Treatment algorithm and health resource use information were collected from a panel of nine experts from Italian centres specialized in ocular/corneal conditions. National ambulatory and inpatient hospital tariffs were applied to units of service, and Agenzia Italiana del Farmaco (AIFA) published prices to pharmaceuticals. Mean annual per patient cost was derived as an average cost weighted by the proportion of patients on each respective treatment and length of the treatment. The National Health Service + patient perspective additionally included patients’ out-of-pocket expenses. The mean annual estimated National Health Service cost of treatment was €5167 (persistent epithelial defect) and €10,885 (corneal ulcer without perforation) per patient. Costs were largely driven by ambulatory visits and hospital interventions. The mean annual estimated National Health Service + patient cost was €5731 (persistent epithelial defect) and €11,478 (corneal ulcer without perforation) per patient, including cost of out-of-pocket expenses for pharmaceuticals and therapeutic contact lenses. Mean annual cost of neurotrophic keratopathy in Italy doubles with disease severity. Further research is warranted to provide more insight especially into societal costs.

Societal savings in patients with advanced non-squamous non-small-cell lung cancer receiving bevacizumab-based versus non-bevacizumab-based treatments in France, Germany, Italy, and Spain.

Introduction: Renal cell carcinoma (RCC) is the most common form of kidney cancer with >30% already metastatic at diagnosis. For patients who fail tyrosine kinase inhibitor (TKI) therapy, the Italian Medical Oncology Association recommends (level IA) nivolumab and cabozantinib. The aim of this study was to compare the cost-effectiveness of cabozantinib with nivolumab for treatment of adult patients with mRCC following prior TKI therapy in Italy. Methods: A partitioned survival (area under the curve) model was developed for the Italian medical environment. Cost-effectiveness was assessed from the Italian National Healthcare Service (SSN) perspective over a 30-year time horizon (annual discount: 3% rate). In the absence of head-to-head studies, clinical evidence was based on results of network meta-analysis. Health-state-related utilities were informed by EQ-5D data from the METEOR study. Resource use and costs were obtained from published sources. Results: Treatment with cabozantinib dominates nivolumab across a 30-years time horizon. In the reference case, treatment with cabozantinib results in an incremental 0.268 quality-adjusted life years (QALY) and an incremental 0.349 life years (LY) gained with a total saving, for the Italian SSN, of €5,605 compared to nivolumab over 30 years. Cabozantinib is associated with gains in quality adjusted life years versus nivolumab, in all analyses. Results were shown to be sensitive to drug prices variation and robust when altering other parameters. Discussion: Cabozantinib represents an efficient option in the management of mRCC after initial TKI-therapy in Italy. Drug prices impact final results, and this must be carefully considered, especially considering the confidential discounts and outcome/financial-based agreements currently in place in Italy.

Cost-Effectiveness Analysis of OnabotulinumtoxinA (BOTOX®) for the Management of Urinary Incontinence in Adults with Neurogenic Detrusor Overactivity: A UK Perspective

of the HTA process in Japan, which is excluded from this analysis. NICE, PBAC and the SMC all require the number of patients with the indicated disease and a clear statement of patient numbers eligible for treatment per year for 5 years. Beyond this, the requirements of the Australian PBC and the SMC were similar, specifying prevalence, incidence and mortality data, whereas NICE requires a measure of disease burden (not clearly defined) and life expectancy among those with the disease. The epidemiology requirements did not differ by disease area. ConClusions: HTA bodies stipulate the inclusion of epidemiological data to estimate economic impact of interventions. Some requirements are common to all agencies, but there are also some important differences. Specific epidemiological data needs for individual agencies must be considered by drug developers when planning and gathering information for HTA submissions.

OnabotulinumtoxinA in the treatment of overactive bladder: a cost-effectiveness analysis versus best supportive care in England and Wales

Background The purpose of this study was to investigate the savings accrued using bevacizumab-based treatment for non-small-cell lung cancer from the societal perspective, taking only public costs into account, in France, Germany, Italy, and Spain. Methods Societal costs were estimated by collecting and analyzing labor costs, carer costs, sickness benefits, disability benefits, and home care benefits. Cost inputs were derived from publicly available databases or from the published literature. Expert opinion was only used if no other source was available. Efficacy data from two randomized clinical trials were used. The time horizon in the health economic model was lifetime. Efficacy and costs were discounted by 3.5%. All main model parameters were tested in deterministic and probabilistic sensitivity analyses. Results Mean incremental savings to society per patient ranged from €2277 in Italy to €4461 in Germany. The results were most sensitive to the change in proportion of patients working fulltime and the proportion of patients who were able to return to work. Conclusion This analysis shows that bevacizumab-based treatment in non-small-cell lung cancer is associated with more savings to society compared to standard chemotherapy in terms of increased productivity and decreased social benefits paid to patients who are able to work in France, Germany, Italy, and Spain.