CURRENT ENVIRONMENT FOR INTRODUCING HEALTH TECHNOLOGY ASSESSMENT IN GREECE.

OBJECTIVES: The aim of this study was to describe the current regulatory environment in Greece to evaluate the potential introduction of health technology assessment (HTA) for medicinal products for human use. METHODS: Data sources consist of national legislation on pricing and reimbursement of health technologies to identify the potential need of establishing HTA and its relevant structure. RESULTS: The pricing procedure regarding medicinal products for human use is based on an external reference pricing mechanism which considers the average of the three lowest Euorpean Union prices. Currently, a formal HTA procedure has not been applied in Greece, and the only prerequisite used for the reimbursement of medicinal products for human use is their inclusion in the Positive Reimbursement List. To restrict pharmaceutical expenditure, a variety of measures-such as clawback mechanisms, rebates, monthly budget caps per physician, generics penetration targeting-have been imposed, aiming mainly to regulate the price level rather than control the introduction of medicinal products for human use in the Greek pharmaceutical market. CONCLUSIONS: Greece has the opportunity to rapidly build capacity, implement, and take advantage of the application of HTA mechanisms by clearly defining the goals, scope, systems, context, stakeholders, and methods that will be involved in the local HTA processes, taking into account the country's established e-prescription system and the recently adapted legislative framework.

Drug Utilization Patterns and Costs of Erythropoiesis-Stimulating Agents in an Outpatient Setting in Greece.

UNLABELLED: Anemia in the elderly is often related to a higher prevalence of chronic diseases such as chronic kidney failure, arthritis, and malignancy. Erythropoiesis-stimulating agents (ESAs) have been used for years to effectively treat anemia and when used appropriately can substantially improve the health status and quality of life of older adults. Following the 2008 recession in Greece, the government introduced ESA price control restrictions, but no prescribing restrictions, in an effort to reduce drug expenditure. OBJECTIVE: ESA prescribing patterns and treatment costs were analyzed to determine inappropriate or appropriate use of these agents and related health care resources in Greece. METHOD: A retrospective register-based drug utilization study was carried out using data from prescriptions dispensed at the public pharmacy of the largest social insurance fund (IKA-ETAM), for patients receiving ESAs over a six-month period. For each patient, demographic data, ESA dosage regimen, treatment indication and cost, prescriber specialty, and prescription origin were recorded. RESULTS: A total of 14,387 prescriptions from 6,074 patients (median age 74 years) were reviewed. A substantial number of patients (13.5%) were treated for off-label indications, for which the average cost per patient per indication was higher. ESA dosage/frequency of administration varied but was in accordance with recommendations. The percentage of patients who received innovator and biosimilar erythropoietin (EPO) was 88% and 12%, respectively. CONCLUSION: For the optimization of ESA utilization and the reduction of treatment costs, strict ESA prescription monitoring, development of registries, and criteria for off-label indications and biosimilar use in naive patients under the umbrella of risk-sharing agreements should be proposed.

Reducing patient copayment levels for topical and systemic treatments in plaque psoriasis as a case for evidence-based, sustainable pharmaceutical policy change in Greece.

AIM: Psoriasis is a chronic inflammatory skin disease that requires treatment to manage co-morbidities and improve patient quality-of-life. This study estimated the budget impact to National Organization for Health Care Services Provision (EOPYY) of changing reimbursement of psoriasis treatment with topical and systemic, non-biologic, agents (75%) to bring it on par with that of biologic agents (100%) in Greece. METHODS: The Business Intelligence database of EOPYY was used to identify and provide analytics on patients with plaque psoriasis. Permission for use of anonymized data was obtained by the administration of EOPYY. EOPYY is responsible for funding healthcare and pharmaceutical care services for ∼95% of the permanent population in the country. Pre-defined ICD-10 codes were applied to identify patients with plaque psoriasis and at least one reimbursed prescription between 1 June 2014 and 31 May 2015. Age, gender, medications, and cost were recorded for these patients. RESULTS: Of the 45,581 unique patients identified through completely anonymized data on the e-prescription system, 72% were on treatment with topicals only and accounted for 5% of EOPYY psoriasis expenditure. Another 9% of patients were on methotrexate or a per os (POS, orally administered) systemic agent and accounted for 2.35% of total expenditure. Approximately 12% of total patients were on treatment with a biologic-containing regimen and accounted for almost 90% of psoriasis expenditure. Patients on biologics were younger than patients on topical and systemic treatments. The burden to EOPYY of adjusting reimbursement levels for topical and systemic, non-biologic, treatments to 100% of their cost was estimated at €2.05 per patient per month for topical treatments (monotherapy) and an additional €9.5 per patient per month for treatment with methotrexate, POS systemic agents, and their combinations with topical agents. This additional cost is expected to be offset by averting 200 earlier than clinically necessary switches from topical and systemic, non-biologic, treatments to expensive biologics a year. CONCLUSION: In circumstances of severe funding constraints for social health insurance in Greece, bringing patient copayment levels for psoriasis treatment on par with each other may aid proper clinical management of the condition, whilst achieving adequate treatment outcomes at optimal cost.

The prevalence and treatment patterns of diabetes in the Greek population based on real-world data from the nation-wide prescription database.

AIMS: Epidemiological data regarding diabetes in Greece are based on regional, small-scale studies. We aimed to identify all citizens with prescribed pharmacological treatment for diabetes, to further explore type 1 diabetes prevalence and describe pharmacological treatment patterns in type 2 diabetes. METHODS: The electronic prescription database of the National Organization for Health Care Services Provision was used to identify individuals who received at least two prescriptions with an ICD-10 code relevant to diabetes, dispensed between June 1st, 2014 and May 31st, 2015. Type-1 diabetes was defined in those receiving at least two fully-reimbursable insulin prescriptions with an ICD-10 code of E10 (insulin-dependent diabetes). RESULTS: The study population consisted of 10,222,779 individuals, accounting for 95% of the Greek population. Prevalence of medication-prescribed diabetes was 7.0% (720,764 individuals), ranging from 0.08% in children and adolescents, to 8.2% in adults, and 30.3% in those ⩾75years old. Prevalence of type 1 diabetes was 0.24%, with a clear male predominance and more than half of cases developing after 14years of age. Metformin was the most frequently prescribed medication (77.4%) in type-2 diabetes followed by DPP-4 inhibitors (44.8%) and sulphonylureas (34.5%), while insulin was used by 19.4% of patients. CONCLUSIONS: This nation-wide real-world data analysis on medication-prescribed diabetes demonstrates that the current prevalence in Greece is 7.0%, with wide age variation and high figures in older adults. Identification of pharmacological patterns among patients with type 2 diabetes is a valuable guide in policy-makers' efforts to balance a cost-effective, quality-acceptable disease management.

Greek National E-Prescribing System: Preliminary Results of a Tool for Rationalizing Pharmaceutical Use and Cost.

BACKGROUND: In Greece, due to the ongoing economic crisis a number of measures aiming at rationalising expenditure implemented. A new e-prescribing system, under a unified healthcare fund was the main pillar of these reforms focus on monitoring and auditing prescribing patterns. OBJECTIVE: Main objective of this study was to document the Greek experience with the new national e-prescribing system. METHODS: We analyse the dispensed prescriptions over the period 2013-2014, stratified into four levels: therapeutic subgroup, patent status, physician's specialty and geographical region. RESULTS: Data analysis offered a comprehensive insight into pharmaceutical expenditure over the timeframe and revealed discrepancies regarding composition of spending, brand-generic substitution within certain therapeutic subgroups, physicians' prescribing behaviour based on medical specialty, therapeutic subgroup as well as regional per capita measures. CONCLUSIONS: E-prescribing system is a valuable tool providing sound information to health policymakers in order to monitor and rationalize pharmaceutical expenditure, in value and volume terms.

Access to Care for Multiple Sclerosis in Times of Economic Crisis in Greece--the HOPE II Study.

BACKGROUND: While there is currently no cure for multiple sclerosis (MS), treatment with biologic disease-modifying drugs (bDMDs) can reduce the impact of the condition on the lives of patients. In Greece, the regulatory change in the distribution system of bDMDs, limited their administration through the designated pharmacies of the National Organization for Healthcare Services Provision (EOPYY) or the National Health System (ESY) hospitals, thus potentially impacting access to MS treatment. In this context, the aim of this paper was to assess the barriers to bDMDs, by recording MS patients' experiences. METHODS: A survey research was conducted between January and February 2014 in Athens and 5 other major Greek cities with the methods of personal and telephone interview. A structured questionnaire was used to elicit socio-economic and medical information, information related to obstacles in accessing bDMDs and medical treatment, from MS patients that visited EOPYY pharmacies during the study period. RESULTS: During the last year 69% of 179 participants reported that the distribution system of bDMDs has improved. Thirteen percent of participants encountered problems in accessing their medication, and 16.9% of participants in accessing their physician, with the obstacles being more pronounced for non-Athens residents. Frequent obstacles to bDMDs were the distance from EOPYY pharmacies and difficulties in obtaining a diagnosis from an EOPYY/ESY physician, while obstacles to medical care were delays in appointment booking and travel difficulties. CONCLUSION: Even though the major weaknesses of the distribution system of bDMDs have improved, further amelioration of the system could be achieved through the home delivery of medicines to patients living in remote areas, and through the development of a national MS registry.