Cost-utility analysis of certolizumab pegol in combination with methotrexate in patients with moderate-to-severe active rheumatoid arthritis in Greece.

We aimed to evaluate the cost-effectiveness of certolizumab pegol (CZP), a pegylated fc-free anti-TNF, as add-on therapy to methotrexate (MTX) versus etanercept, adalimumab, or golimumab in patients with moderate-to-severe active rheumatoid arthritis (RA) not responding to the conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). A Markov model (6-month cycle length) assessed health and cost outcomes of CZP versus other anti-TNFs recommended for RA in Greece over a patient's lifetime. Following discontinuation of first-line anti-TNF, patients switched to second anti-TNF and then to a biologic with another mode of action. Sequential use of csDMARDs followed third biologic. Clinical data and utilities were extracted from published literature. Analysis was conducted from third-party payer perspective in Greece. Costs (drug acquisition, administration, monitoring, and patient management) were considered for 2014. Results presented are incremental cost-effectiveness ratios (ICERs) per quality-adjusted life year (QALY). Probabilistic sensitivity analysis (PSA) ascertained robustness of base-case findings. Base-case analysis indicated that CZP+MTX was more costly and more effective compared with Etanercept+MTX (base-case ICER: €3,177 per QALY), whilst versus adalimumab/golimumab, CZP was dominant (less costly, more effective). For all comparisons, CZP treatment resulted in greater improvements in life expectancy and QALYs. PSA indicated that at the willingness-to-pay threshold of €34,000/QALY, CZP+MTX was associated with a 71.6, 97.9, or 99.2% probability of being cost-effective versus etanercept, golimumab, or adalimumab, respectively, in combination with MTX. This analysis demonstrates CZP+MTX to be a cost-effective alternative over Etanercept+MTX and a dominant option over Adalimumab+MTX and Golimumab+MTX for management of RA in Greece.

Comprehensive taxonomy and worldwide trends in pharmaceutical policies in relation to country income status.

BACKGROUND: Rapidly evolving socioeconomic and technological trends make it challenging to improve access, effectiveness and efficiency in the use of pharmaceuticals. This paper identifies and systematically classifies the prevailing pharmaceutical policies worldwide in relation to a country's income status. METHODS: A literature search was undertaken to identify and taxonomize prevailing policies worldwide. Countries that apply those policies and those that do not were then grouped by income status. RESULTS: Pharmaceutical policies are linked to a country's socioeconomics. Developed countries have universal coverage and control pharmaceuticals with external and internal price referencing systems, and indirect price-cost controls; they carry out health technology assessments and demand utilization controls. Price-volume and risk-sharing agreements are also evolving. Developing countries are underperforming in terms of coverage and they rely mostly on restrictive state controls to regulate prices and expenditure. CONCLUSIONS: There are significant disparities worldwide in the access to pharmaceuticals, their use, and the reimbursement of costs. The challenge in high-income countries is to maintain access to care whilst dealing with trends in technology and aging. Essential drugs should be available to all; however, many low- and middle-income countries still provide most of their population with only poor access to medicines. As economies grow, there should be greater investment in pharmaceutical care, looking to the policies of high-income countries to increase efficiency. Pharmaceutical companies could also develop special access schemes with low prices to facilitate coverage in low-income countries.

Cost effectiveness of cardiac resynchronization therapy in Greece: an analysis based on the CArdiac REsychronization in Heart Failure trial.

AIMS: Health economic considerations have become increasingly important in healthcare. The aim of this study was to investigate the incremental cost effectiveness of cardiac resynchronization therapy (CRT) plus medical therapy compared with medical therapy alone in the Greek health-care system. METHODS AND RESULTS: The health economic analysis was based on the CARE-HF trial, a randomized clinical trial estimating the efficacy of adding CRT (n = 409) to optimal pharmacological treatment (n = 404) in patients with moderate-to-severe heart failure with markers of cardiac dyssynchrony. Health care resource use from CArdiac REsychronization in Heart Failure was combined with costs for CRT implantation and hospitalization from publicly available sources. The analysis was based on a lifetime perspective, with the life expectancy estimated from the clinical trial data. Shorter time horizons were explored in the sensitivity analysis. The cost per quality-adjusted life year (QALY) gained with CRT was €6,045 in Greece, with a 95% confidence interval for the cost-effectiveness ratio of €4,292-9,411 per QALY gained. CONCLUSIONS: The results of the economic evaluation of CRT in Greek health-care setting indicate that it is a cost-effective treatment compared with traditional pharmacological therapy. Cardiac resynchronization therapy can therefore be recommended for routine use in patients with moderate-to-severe heart failure and markers of dyssynchrony.

Economic evaluation of docetaxel-gemcitabine versus vinorelbine-cisplatin combination as front-line treatment of patients with advanced/metastatic non-small-cell lung cancer in Greece: a cost-minimization analysis.

BACKGROUND: An economic evaluation was undertaken, alongside a randomized phase III study, to assess docetaxel-gemcitabine (DG) relative to vinorelbine-cisplatin (VC) combination as front-line treatment of patients with advanced/metastatic non-small-cell lung cancer. METHODS: No differences were found in efficacy, thus a cost-minimization analysis was carried out. Treatment cost accounts for the administration of first- and second-line chemotherapy, for concomitant medications, for laboratory and biochemical examinations, and for hospitalizations due to adverse events. Unit prices used reflect 2008 and are common among National Health Service hospitals in Greece. RESULTS: The mean total cost of therapy in the DG group [14045 euros, 95% uncertainty interval (UI) 12628 euros-15390 euros], was significantly higher than in the VC group (8143 euros, 95% UI 7314 euros-9067 euros). CONCLUSIONS: Even though the combination VC has similar effectiveness compared with DG in patients with metastatic lung cancer, it is associated with a lower overall treatment cost and hence, it is preferable from an economic perspective. However, it should be noted that although VC is associated with lower cost, it is also more toxic than DG regimen, a significant parameter that should be considered in clinical decisions.

Economic evaluation of taxane-based first-line chemotherapy in the treatment of patients with metastatic breast cancer in Greece: an analysis alongside a multicenter, randomized phase III clinical trial.

BACKGROUND: An economic evaluation was undertaken alongside a randomized phase III trial comparing three regimens for metastatic breast cancer (MBC). MATERIALS AND METHODS: Trial resource utilization and unit price data were combined to evaluate the cost of chemotherapy, concomitant medications, hospitalizations, diagnostic and laboratory tests. Treatment cost was combined with survival to estimate the incremental cost per life year saved. Quality-of-life data were used to estimate cost per quality-adjusted life year saved. Sensitivity analysis was used to compute results for various subgroups and for discounting cost and effects. RESULTS: The combination of gemcitabine (Gemzar, Eli Lilly, Indianapolis, USA) with docetaxel (Taxotere, Aventis Pharma, Dagenham, UK) (GDoc) is the least costly but least effective treatment. The combination of paclitaxel (Taxol) with carboplatin (Paraplatin, Bristol-Myers Squibb, Princeton, USA) is associated with higher cost and effectiveness compared with GDoc, while weekly paclitaxel (Pw), associated with the highest cost, is the most effective option. The incremental cost per life year saved of Pw versus GDoc was 3660 Euros (95% uncertainty interval dominance-9261). This result remained fairly constant in sensitivity analysis. CONCLUSIONS: The corresponding economic evaluation indicates that Pw represents an attractive treatment option for patients with MBC from an economic perspective in the context of the Greek National Health Service.

A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer: a Hellenic Cooperative Oncology Group study.

BACKGROUND: Effective anthracycline-free combinations need to be evaluated in metastatic breast cancer (MBC), due to the increased number of patients treated with anthracycline-based adjuvant chemotherapy. PATIENTS AND METHODS: Patients with MBC were randomized to paclitaxel and carboplatin (PCb) every 3 weeks or docetaxel and gemcitabine (GDoc) every 3 weeks or weekly paclitaxel (Pw). Trastuzumab was given to patients with HER-2 over-expressing tumors. The primary endpoint of the study was survival. Quality of life (QoL) and cost were assessed. RESULTS: Totally, 416 eligible patients entered the study. Median survival times were 29.9 months for PCb, 26.9 for GDoc and 41.0 for Pw (P = 0.037). According to multivariate analysis, adjuvant chemotherapy, >1 metastatic sites, lack of maintenance hormonal therapy, and worse performance status (PS) were significant adverse prognostic factors for survival, while Pw when compared to GDoc improved survival (P = 0.03), as well as when compared to PCb in the subgroup of patients with PS = 1 (P = 0.01, treatment by PS interaction P = 0.03). No significant differences in terms of time to progression were found. Severe myelotoxicity and mucositis were more frequent with GDoc, while severe neuropathy with PCb and Pw. QoL changes did not differ significantly between treatment groups, while cost analysis favored Pw. CONCLUSIONS: Pw appears to be the most preferable choice among the 3 anthracycline-free taxanes-based regimens tested in the present study.

Economic evaluation of docetaxel/gemcitabine versus docetaxel as frontline treatment of patients with advanced/metastatic non-small cell lung cancer in Greece.

OBJECTIVES: The combination of docetaxel/gemcitabine is an acceptable chemotherapy regimen for the treatment of non-small cell lung cancer. An economic evaluation is undertaken alongside a multi-centre randomized phase III trial, which compares docetaxel/gemcitabine combination with docetaxel monotherapy, in untreated patients with advanced/metastatic non-small cell lung cancer. METHODS: Trial resource utilisation data are combined with unit price data used to evaluate the cost of chemotherapy, concomitant medications, hospitalisations, diagnostic and laboratory tests and second-line chemotherapy. Treatment cost is combined with survival to estimate the incremental cost per-life-year-saved with the combination therapy versus monotherapy. To deal with uncertainty, stochastic analysis is used to plot cost-effectiveness acceptability curves. RESULTS: Median survival is 9.1 months (range 1-36.2) and 8.3 months (range 1-26.8) (p: 0.025) in the combination and monotherapy groups, respectively. The mean total treatment cost of patients with docetaxel is estimated at Euro5736 and with docetaxel/gemcitabine at Euro7417, a difference of Euro1542 (95%CI: Euro499-2561). The incremental cost per-life-year-saved of the combination therapy is euro9538 and the probability to be cost-effective is 91% at a threshold of Euro20,000, 97% at a threshold of Euro35,000 and 98% at a threshold of Euro50,000. CONCLUSIONS: The data support that docetaxel/gemcitabine combination represents a cost-effective treatment option in relation to docetaxel monotherapy for patients with non-small cell lung cancer in the Greek NHS setting.