Development of a core evaluation framework of value-added medicines: report 1 on methodology and findings.

Background: Medicines that are based on known molecules and are further developed to address healthcare needs and deliver relevant improvement for patients, healthcare professionals and/or payers are called value-added medicines (VAMs). The evaluation process of VAMs is heterogeneous across countries, and it has been primarily designed for originator pharmaceuticals with confirmatory evidence collected alongside pivotal clinical trials. There is a mismatch between evidence requirements by public decision-makers and evidence generated by manufacturers of VAMs.

Development of a core evaluation framework of value-added medicines: report 2 on pharmaceutical policy perspectives.

Background: A core evaluation framework that captures the health care and societal benefits of value added medicines (VAMs, also often called repurposed medicines) was proposed in Report 1, aiming to reduce the heterogeneity in value assessment processes across countries and to create incentives for manufacturers to invest into incremental innovation. However, this can be impactful only if the framework can be adapted to heterogeneous health care financing systems in different jurisdictions, and the cost of evidence generation necessitated by the framework takes into account the anticipated benefits for the health care system and rewards for the developers.

Areas Covered: The framework could potentially improve the pricing and reimbursement decisions of VAMs by adapting it to different country specific decision-contexts such as deliberative processes, augmented cost-effectiveness frameworks or formal multi-criteria decision analysis (MCDA); alternatively, some of its domains may be added to current general evaluation frameworks of medicines.

Incidence and cost of bleeding events requiring hospitalization in patients with atrial fibrillation treated with acenocoumarol in Greece.

Background: To estimate the incidence of hemorrhagic events in patients with atrial fibrillation (AF) treated with acenocoumarol, and the management cost of those requiring hospitalization in Greece.

Methods: A nationwide telephone survey was conducted between December 2017 and January 2018, to identify cardiologists who treat AF patients with acenocoumarol. A total of 300 cardiologists were selected and reported the number of AF acenocoumarol-treated patients during the past 12 months and the number of those who experienced a hemorrhagic event.

An Evaluation of Diagnosis-Related Group (DRG) Implementation Focused on Cancer DRGs in Greek Public Hospitals.

Objectives: The main aims of this study were to evaluate the Greek version of the diagnosis-related group reimbursement system (KEN-DRG) and to compare the KEN-DRG prices with the average actual cost of each group of study cases. Along with other aspects, the differences between the KEN-DRG average length of stay (ALOS) and the actual ALOS was evaluated in selected cases.

Methods: In the first part of this study, the top-down costing approach was selected in order to break down the total operating costs of the hospital, by hospital department.

The Economic Burden of Asthma in Greece: A Cross-Sectional Study.

Background: The high prevalence rates of asthma worldwide and the chronic nature of the disease make asthma a major cause of morbidity, imposing a significant socio-economic burden in many countries. Specifically in Greece, the self-reported prevalence of asthma reached 9% in 2017.

Objectives: The objective of this study was to estimate the total management cost of asthma in Greece and its potential determinants.

Development of multi-criteria decision analysis (MCDA) framework for off-patent pharmaceuticals - an application on improving tender decision making in Indonesia.

Background: Off-patent pharmaceuticals (OPPs) hold vital importance in meeting public health objectives, especially in developing countries where resources are limited. OPPs are comprised of off-patent originals, branded generics and unbranded generics; nonetheless, these products are not identical and often there are differences in their equivalence, manufacturing quality standards and reliability of supply. This necessitates reconsideration of the lowest price policy objective in pharmaceutical decision making.

Economic evaluation of trifluridine and tipiracil hydrochloride in the treatment of metastatic colorectal cancer in Greece.

Aim: To evaluate the cost-effectiveness of trifluridine and tipiracil hydrochloride (FTD/TPI) compared with best supportive care (BSC) or regorafenib for the treatment of patients with metastatic colorectal cancer who have been previously treated with or are not considered candidates for available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents and anti-EGFR agents in Greece.

Methods: A partitioned survival model was locally adapted from a third-party payer perspective over a 10 year time horizon. Efficacy data and utility values were extracted from published studies.

The Economic Burden of Chronic Obstructive Pulmonary Disease in Greece.

Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of disability and death worldwide, imposing a substantial socioeconomic burden on societies and patients due to the long-term management required.

Objective: To assess the economic burden of COPD in Greece and its potential determinants.

Methods: A population-based, random-digit dialled, telephone nationwide survey was conducted to recruit patients with COPD in Greece (N = 351).

Treating EGFR-Mutated Oncogene-Addicted Advanced Non-Small-Cell Lung Cancer in the Era of Economic Crisis in Greece: Challenges and Opportunities.

Purpose: Because of the profound financial crisis that commenced in Greece in 2010, severe cuts in health care spending and other restriction measures led to significant delays in the reimbursement of novel antineoplastic agents. In 2011, the Hellenic Society of Medical Oncology initiated a program of early access to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors for the treatment of patients with advanced, EGFR-mutant non-small-cell lung cancer (NSCLC). We evaluated treatment patterns and clinical outcomes in patients with EGFR-mutant or wild-type disease treated at a large center in Greece throughout the period of financial crisis.

Guidance toward the implementation of multicriteria decision analysis framework in developing countries.

Multiple Criteria Decision Analysis (MCDA) is increasingly used in health care mainly because it moves decision-making from ad hoc to an evidence-based and comprehensive process. Developing countries with more restricted financial and human research capacities, however, should consider their own methods of MCDA development and implementation. Areas covered: An MCDA framework to improve procurement decisions of off-patent pharmaceuticals was developed for developing countries and adapted to Indonesia, Kazakhstan and Vietnam during three policy workshops.

A Targeted Literature Review Examining Biologic Therapy Compliance and Persistence in Chronic Inflammatory Diseases to Identify the Associated Unmet Needs, Driving Factors, and Consequences.

Unlabelled: Chronic inflammatory diseases (CIDs) represent a substantial clinical and economic burden to patients, providers, payers and society overall. Biologics, such as tumor necrosis factor inhibitors (TNFi), have emerged as effective treatment options for patients with CIDs. However, the therapeutic potential of biologics is not always achieved in clinical practice, with results from studies examining the use of biologics in real-world settings suggesting lower levels of treatment effectiveness compared with clinical trial results.

The self-reported prevalence and disease burden of asthma in Greece.

Objectives: The primary objective was to estimate the self-reported prevalence of asthma in Greece. The secondary one was to assess the impact of asthma control on patients' health related Quality-of-Life (HRQoL), productivity loss, daily activities and psychological distress.

Methods: A population-based, random-digit dialing, telephone nationwide survey was conducted to recruit patients with asthma.

An Evidence Framework for Off-Patent Pharmaceutical Review for Health Technology Assessment in Emerging Markets.

Objective: This article introduces an Evidence Framework for Off-Patent Pharmaceutical Review (EFOR), which establishes value-based criteria in a template that manufacturers use to provide evidence showing how their products meet those criteria. Health authorities in emerging markets can then use the evidence presented in the EFOR to evaluate off-patent pharmaceuticals (OPPs) in a consistent, transparent, and evidence-based manner to support policy decisions, including pricing, reimbursement, formulary listing, and drug procurement.

Methods: A literature search found no multi-criteria evidence framework for evaluating OPPs in emerging markets.

Healthcare-resource utilization associated with radiation to bone across eight European countries: Results from a retrospective study.

Background: Bone metastases and lytic lesions due to multiple myeloma are common in advanced cancer and can lead to debilitating complications (skeletal-related events [SREs]), including requirement for radiation to bone. Despite the high frequency of radiation to bone in patients with metastatic bone disease, our knowledge of associated healthcare resource utilization (HRU) is limited.

Methods: This retrospective study estimated HRU following radiation to bone in Austria, the Czech Republic, Finland, Greece, Poland, Portugal, Sweden and Switzerland.

Cost-Effectiveness of Empagliflozin for the Treatment of Patients with Type 2 Diabetes Mellitus at Increased Cardiovascular Risk in Greece.

Background And Objective: Type 2 diabetes mellitus (T2DM) is frequently associated with co-morbidities that exacerbate cardiovascular (CV) risk. CV disease is the leading cause of death in people with diabetes across the world and accounts for approximately half the deaths in the T2DM population. Hence, the objective of present study was to evaluate the cost-effectiveness of empagliflozin, in addition to standard of care (SoC), for the treatment of adult patients with T2DM and high CV risk in Greece.

European Society of Cardiology: Cardiovascular Disease Statistics 2017.

Aims: The European Society of Cardiology (ESC) Atlas has been compiled by the European Heart Agency to document cardiovascular disease (CVD) statistics of the 56 ESC member countries. A major aim of this 2017 data presentation has been to compare high-income and middle-income ESC member countries to identify inequalities in disease burden, outcomes, and service provision.

Methods And Results: The Atlas utilizes a variety of data sources, including the World Health Organization, the Institute for Health Metrics and Evaluation, and the World Bank to document risk factors, prevalence, and mortality of cardiovascular disease and national economic indicators.

Cost Effectiveness of Exenatide Once Weekly Versus Insulin Glargine and Liraglutide for the Treatment of Type 2 Diabetes Mellitus in Greece.

Objective: The objective of this study was to evaluate the long-term cost effectiveness of exenatide once weekly (ExQW) versus insulin glargine (IG) or liraglutide 1.2 mg (Lira1.2mg) for the treatment of adult patients with type 2 diabetes mellitus (T2DM) not adequately controlled on oral antidiabetic drug (OAD) therapy in Greece.

Applying Multi-Criteria Decision Analysis (MCDA) Simple Scoring as an Evidence-based HTA Methodology for Evaluating Off-Patent Pharmaceuticals (OPPs) in Emerging Markets.

Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example.

Cost-Effectiveness Analysis of Rivaroxaban for Treatment of Deep Vein Thrombosis and Pulmonary Embolism in Greece.

Background And Objective: Venous thromboembolism (VTE), comprising deep-vein thrombosis (DVT) and pulmonary embolism (PE), is a major healthcare concern that results in substantial morbidity and mortality with great economic burden for healthcare systems. Hence, the need for effective and efficient treatment of patients with VTE is important for both clinical and economic reasons. The objective of this study was to evaluate the cost effectiveness of rivaroxaban compared to standard of care (SoC) with enoxaparin followed by dose-adjusted vitamin-K antagonists for the treatment of DVT and PE in Greece.

Pathologic fracture and healthcare resource utilisation: A retrospective study in eight European countries.

Background: Skeletal-related events (SREs; pathologic fracture [PF], spinal cord compression and radiation or surgery to bone) are common complications of bone metastases or bone lesions and can impose a considerable burden on patients and healthcare systems. In this study, the healthcare resource utilisation (HRU) associated with PFs in patients with bone metastases or lesions secondary to solid tumours or multiple myeloma was estimated in eight European countries.

Methods: Eligible patients were identified in Austria, the Czech Republic, Finland, Greece, Poland, Portugal, Sweden and Switzerland.

Economic evaluation of trimetazidine in the management of chronic stable angina in Greece.

Background: To evaluate the cost-effectiveness of trimetazidine (TMZ) as add-on therapy to standard-of-care (SoC) compared to SoC alone in patients with chronic stable angina who did not respond adequately to first line therapy with b-blockers, nitrates or calcium channel antagonists in Greece.

Methods: A Markov model with 3-month cycles and 1-year time horizon was developed to assess the comparators. The analysis was conducted from a third-party payer perspective.

The disease burden of chronic obstructive pulmonary disease in Greece.

Background: The objective of the study was to estimate the self-reported prevalence of chronic obstructive pulmonary disease (COPD) in Greece and to quantify its burden on patients' daily activities, productivity, and psychological status.

Methods: A population-based, random digit-dialed telephone nationwide survey was conducted between July 10, 2015 and July 31, 2015 in order to recruit patients with COPD in Greece. Among the 11,471 persons contacted, 3,414 met the inclusion criterion of age ≥40 years and completed the screening questions regarding COPD.

Economic Evaluation of Three Frequently Used Gonadotrophins in Assisted Reproduction Techniques in the Management of Infertility in the Netherlands.

Background And Objective: Subfertility represents a multidimensional problem associated with significant distress and impaired social well-being. In the Netherlands, an estimated 50,000 couples visit their general practitioner and 30,000 couples seek medical specialist care for subfertility. We conducted an economic evaluation comparing recombinant human follicle-stimulating hormone (follitropin alfa, r-hFSH, Gonal-F) with two classes of urinary gonadotrophins-highly purified human menopausal gonadotrophin (hp-HMG, Menopur) and urinary follicle-stimulating hormone (uFSH, Fostimon)-for ovarian stimulation in women undergoing in vitro fertilization (IVF) treatment in the Netherlands.

Cost-Effectiveness of Dapagliflozin as Add-On to Metformin for the Treatment of Type 2 Diabetes Mellitus in Greece.

Background And Objective: Type 2 diabetes mellitus (T2DM) is a chronic progressive disease that has been spread worldwide over the past three decades and associated with increased morbidity and mortality resulting in considerable socioeconomic implications for national healthcare systems. Effective management of disease is highly needed ensuring patients receive the best possible care within the available budget. The objective of this study was to evaluate the long-term cost-effectiveness of dapagliflozin, a sodium-glucose co-transporter-2 (SGLT-2) inhibitor, compared with a sulfonylurea (SU) or a dipeptidyl-peptidase-4 inhibitor (DPP-4i), when added to metformin, in T2DM patients inadequately controlled on metformin alone in Greece.