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.

The heart failure pandemic: The clinical and economic burden in Greece.

BACKGROUND: The objective of this study was to identify the epidemiological and clinical characteristics of heart failure (HF) patients in Greece as well as the economic burden and the distribution of costs for the management of the disease. METHODS: Eight Greek secondary and tertiary cardiology centres from different cities have participated in a prospective, observational survey, the ESC HF Pilot Survey. 307 patients with HF, 177 hospitalised and 130 outpatients, have been recruited and monitored for 12months. Clinical and epidemiological data, along with data on mortality, hospitalisations and health care resources used have been collected. The economic evaluation was conducted from the social security system perspective. RESULTS: The annual mortality rate was 24.3% for the hospitalised patients vs 7.7% for the outpatients (P<0.001) and the annual rehospitalisation rate was 42.9% vs 19.2% respectively (P<0.001). Kaplan-Meier analyses revealed that patients with kidney dysfunction, S3 gallop and higher NYHA class have a significantly worse survival. The mean annual economic burden of the social security system per HF patient was estimated at €4411±4764. About two thirds of this cost is due to in-patient care. CONCLUSIONS: Despite the progress in the management of the disease, about one in four hospitalised patients dies and four in ten are rehospitalised in less than one year. Moreover, the disease imposes a significant economic burden for the social security system and national economy. Their findings suggest that there is still need of more effective drug treatment and efficient disease management programs focused in the reduction of the hospital admissions.

A literature review to evaluate the clinical and economic value of olmesartan for the treatment of hypertensive patients.

The objective of the present study was to systematically review the clinical and economic outcomes of olmesartan as monotherapy or in combination with other antihypertensive agents in the treatment of hypertension. A literature search was performed using PubMed and the Cochrane library until December 2015, with no limit on publication date. Eligible studies were selected using predetermined inclusion and exclusion criteria, limiting articles to those published in the English language. Background information of the study, participants' characteristics and study outcomes were collected. Meta-analysis of data was not performed. Fifty-five studies were included, of which fifty investigated the clinical efficacy of olmesartan and five the cost-effectiveness of olmesartan. In general results from clinical trials evaluating the efficacy of olmesartan as monotherapy and as combination therapy demonstrated that olmesartan provided better antihypertensive blood pressure-lowering efficacy and was generally well tolerated compared with other antihypertensive agents. Results from economic evaluations indicated that olmesartan may be more cost-effective than other ARBs such as losartan, valsartan, irbesartan and candesartan, having the potential of decreasing the overall medical costs of care for patients with hypertension. Evidence from the present systematic review confirms the antihypertensive efficacy and good safety profile of olmesartan both as monotherapy and as combination therapy. Olmesartan was also found to be cost-effective compared with other ARBs, though this area has yet relatively poor evidence and needs to further be explored.

Cost of skeletal complications from bone metastases in six European countries.

Objective Patients with bone metastases or lesions secondary to solid tumors or multiple myeloma often experience bone complications (skeletal-related events [SREs]-radiation to bone, pathologic fracture, surgery to bone, and spinal cord compression); however, recent data that can be used to assess the value of treatments to prevent SREs across European countries are limited. This study aimed to provide estimates of health resource utilization (HRU) and cost associated with all SRE types in Europe. HRU data were reported previously; cost data are reported herein. Methods Eligible patients from 49 centers across Austria (n = 57), the Czech Republic (n = 59), Finland (n = 60), Greece (n = 59), Portugal (n = 59), and Sweden (n = 62) had bone metastases or lesions secondary to breast, lung, or prostate cancer, or multiple myeloma, and ≥1 index SRE (a SRE preceded by a SRE-free period of ≥ 6.5 months). SRE-related costs were estimated from a payer perspective using health resource utilization data from patient charts (before and after the index SRE diagnosis). Country-specific unit costs were from 2010 and local currencies were converted to 2010 euros. Results The mean costs across countries were €7043, €5242, €11,101, and €11,509 per radiation to bone, pathologic fracture, surgery to bone, and spinal cord compression event, respectively. Purchasing power parity (PPP)-adjusted mean cost ratios were similar in most countries, with the exception of radiation to bone. Limitations The overall burden of SREs may have been under-estimated owing to home visits and evaluations outside the hospital setting not being reported here. Conclusions All SREs were associated with substantial costs. Variation in SRE-associated costs between countries was most likely driven by differences in treatment practices and unit costs.

Coronary artery bypass grafting with minimal versus conventional extracorporeal circulation; an economic analysis.

BACKGROUND: This study aims to develop a methodological framework for the comparative economic evaluation between Minimal Extracorporeal Circulation (MECC) versus conventional Extracorporeal Circulation (CECC) in patients undergoing coronary artery bypass grafting (CABG) in different healthcare systems. Moreover, we evaluate the cost-effectiveness ratio of alternative comparators in the healthcare setting of Greece, Germany, the Netherlands and Switzerland. METHODS: The effectiveness data utilized were derived from a recent meta-analysis which incorporated 24 randomized clinical trials. Total therapy cost per patient reflects all resources expensed in delivery of therapy and the management of any adverse events, including drugs, diagnostics tests, materials, devices, blood units, the utilization of operating theaters, intensive care units, and wards. Perioperative mortality was used as the primary health outcome to estimate life years gained in treatment arms. Bias-corrected uncertainty intervals were calculated using the percentile method of non-parametric Monte-Carlo simulation. RESULTS: The MECC circuit was more expensive than CECC, with a difference ranging from €180 to €600 depending on the country. However, in terms of total therapy cost per patient the comparison favored MECC in all countries. Specifically it was associated with a reduction of €635 in Greece, €297 in Germany, €1590 in the Netherlands and €375 in Switzerland. In terms of effectiveness, the total life-years gained were slightly higher in favor of MECC. CONCLUSIONS: Surgery with MECC may be dominant (lower cost and higher effectiveness) compared to CECC in coronary revascularization procedures and therefore it represents an attractive new option relative to conventional extracorporeal circulation for CABG.

Economic evaluation of therapies for patients suffering from relapsed-refractory multiple myeloma in Greece.

BACKGROUND: Multiple myeloma is a hematologic malignancy that incurs a substantial economic burden in care management. Since most patients with multiple myeloma eventually relapse or become refractory to current therapies (rrMM), the aim of this study was to assess the cost-effectiveness of the combination of lenalidomide-dexamethasone, relative to bortezomib alone, in patients suffering from rrMM in Greece. METHODS: An international discrete event simulation model was locally adapted to estimate differences in overall survival and treatment costs associated with the two alternative treatment options. The efficacy data utilized came from three international trials (MM-009, MM-010, APEX). Quality of life data were extracted from the published literature. Data on resource use and prices came from relevant local sources and referred to 2012. The perspective of the analysis was that of public providers. Total costs for monitoring and administration of therapy to patients, management of adverse events, and cost of medication were captured. A 3.5% discount rate was used for costs and health outcomes. A Monte Carlo simulation was used to estimate probabilistic results with 95% uncertainty intervals (UI) and a cost-effectiveness acceptability curve. RESULTS: The mean number of quality-adjusted life years (QALYs) was 3.01 (95% UI 2.81-3.20) and 2.22 (95% UI 2.02-2.41) for lenalidomide-dexamethasone and bortezomib, respectively, giving an incremental gain of 0.79 (95% UI 0.49-1.06) QALYs in favor of lenalidomide-dexamethasone. The mean cost of therapy per patient was estimated at €80;77,670 (95% UI €80;76,509-€80;78,900) and €80;48,928 (95% UI €80;48,300-€80;49,556) for lenalidomide-dexamethasone and bortezomib, respectively. The incremental cost per life year gained with lenalidomide-dexamethasone was estimated at €80;29,415 (95% UI €80;23,484-€80;37,583) and the incremental cost per QALY gained at €80;38,268 (95% UI €80;27,001-€80;58,065). The probability of lenalidomide-dexamethasone being a cost-effective therapy option at a threshold three times the per capita income (€80;60,000 per QALY) was higher than 95%. The results remained constant, without altering the conclusions, under several hypothetical scenarios. CONCLUSION: The combination of lenalidomide and dexamethasone may represent a cost-effective choice relative to bortezomib monotherapy for patients in Greece with previously treated multiple myeloma.