Are Turkish pharmaceutical pricing strategies an access barrier to oncology medicines for Türkiye?

Objectives: Cancer diagnosis is increasing day by day all over the world. Deaths due to cancer are among the most common causes of death. Access to cancer drugs is a priority of health policies. The aim of this study is to evaluate access to cancer drugs through drug box sales data by modeling population growth, cancer incidence, and Fixed Euro Exchange (FEE) rate parameters used in drug pricing in Türkiye. Methods: Access to cancer drugs was evaluated by drug box sales figures obtained from IQVIA. Box sales data were classified according to diagnosis codes (ICD-10), reference, or generic status. Consumption of cancer drugs was examined over time with panel regression analysis, taking into account variables of population growth, cancer incidence, and the FEE rate in drug pricing in Türkiye. Results: The incidence of cancer in Türkiye was 215.1 in 2010 and 223.1 (per hundred thousand) in 2017. Whereas there was a 127.02% increase in the real euro exchange rate, there was an 89.6% increase in the FEE rate. With the regression approach, there is a negative relationship between the real and fixed exchange rate difference (RFED) and reference and generic drug consumption data. Medicine access is affected depending on diagnosis codes at different levels. Colorectal cancer medicine sales had negative correlations for each variable, namely, exchange rate, population growth, and cancer incidence. On the contrary, there was a positive correlation between non-small-cell lung cancer and relevant variables. Innovative medicine groups such as monoclonal antibodies and protein kinase inhibitor consumption showed a negative correlation. Conclusion: According to our results, pricing strategy may be an access barrier for oncology medicines in Türkiye. It should be reviewing the pricing policy that is beneficial for oncology medicine access in Türkiye.

Italian Guidelines for the Management of Sporadic Primary Hyperparathyroidism.

AIM: This guideline (GL) is aimed at providing a clinical practice reference for the management of sporadic primary hyperparathyroidism (PHPT) in adults. PHPT management in pregnancy was not considered. METHODS: This GL has been developed following the methods described in the Manual of the Italian National Guideline System. For each question, the panel appointed by Associazione Medici Endocrinology (AME) and Società Italiana dell'Osteoporosi, del Metabolismo Minerale e delle Malattie dello Scheletro (SIOMMMS) identified potentially relevant outcomes, which were then rated for their impact on therapeutic choices. Only outcomes classified as "critical" and "important" were considered in the systematic review of evidence. Those classified as "critical" were considered for the clinical practice recommendations. RESULTS: The present GL provides recommendations about the roles of pharmacological and surgical treatment for the clinical management of sporadic PHPT. Parathyroidectomy is recommended in comparison to surveillance or pharmacologic treatment in any adult (outside of pregnancy) or elderly subject diagnosed with sporadic PHPT who is symptomatic or meets any of the following criteria: • Serum calcium levels >1 mg/dL above the upper limit of normal range. • Urinary calcium levels >4 mg/kg/day. • Osteoporosis disclosed by DXA examination and/or any fragility fracture. • Renal function impairment (eGFR <60 mL/min). • Clinic or silent nephrolithiasis. • Age ≤50 years. Monitoring and treatment of any comorbidity or complication of PHPT at bone, kidney, or cardiovascular level are suggested for patients who do not meet the criteria for surgery or are not operated on for any reason. Sixteen indications for good clinical practice are provided in addition to the recommendations. CONCLUSION: The present GL is directed to endocrinologists and surgeons - working in hospitals, territorial services or private practice - and to general practitioners and patients. The recommendations should also consider the patient's preferences and the available resources and expertise.

The pharmacoeconomic impact of follitropin alpha biosimilars in IVF therapy in Europe: a report of the literature.

Introduction: To study the impact of biosimilars in assisted reproductive treatments, we performed a review of the literature. Biosimilars are a bioequivalent chemical drug referred to the original. Their production is strongly requested in order to reduce drug cost and reduce health economic impact on national health system. In assisted reproductive treatments different gonadotropin biosimilars are being produced.Areas covered: For this reason, we performed a review of the literature on follitropin alfa Gonal-F biosimilar, Ovaleap and Bemfola, to assess their cost efficacy in national health system. Cost effective (CE) analysis and incremental cost-effectiveness ratio (ICER) were used as parameters for biosimilar impact evaluation in the national health system economy. In particular, they had only slight impact on cost reduction of recombinant follitropin alfa products in Europe.Expert opinion: considering cost-effective analysis, Gonal-F remains the first choice for national health systems. However, well-designed powered methods are strongly needed to assess biosimilars cost-effectiveness.

The usage of over-the-counter products by private insured patients in Germany - a claims data analysis with focus on complementary medicine.

BACKGROUND: An important contribution to well-being of human beings can be observed by the use of self-medication products that is reflected in the constantly growing volume of over-the-counter (OTC) drugs. The aim of the current study was to extend the measurement concept for OTCs by exploring the relevance of the peripheral assortment provided by the widely accepted framework of the Anatomical Therapeutical and Chemical (ATC) classification of the WHO. METHODS: The focus was on the prescriptions and drug-related receipts submitted by privately insured persons to 18 private health insurers (PHIs) in Germany from the year 2016. The age- and gender-specific average claims amount per risks of outpatient drug expenditure were used as weights to scale up the relative distributions of the item amounts. The ATC-classification defines the commodity groups and discriminates between the main and the peripheral assortment. A descriptive analysis assessed the OTC frequencies and sum scores of the product groups within the main and peripheral assortment whereby the study group explored and assessed the relevance of each category independently according to the OTCs and integrative medicines. RESULTS: The analysis included 22.1 Mio. packages from the main assortment and examined 10.1 Mio. packages from the peripheral assortment. The latter was examined thoroughly and the commodity groups "Pharmaceutical food products", "Medicinal products for special therapy options" and particular "Hygiene and body care products" meet the defined requirements for OTCs relevant for integrative medicines. A high proportion of OTC products from the peripheral assortment was associated with the categories "medicinal products for special therapy options". Homeopathy and anthroposophy present two special therapy options, which are relevant for the extended OTC measurement. CONCLUSIONS: The analysis of OTC drugs is feasible when the main and the peripheral assortment is available and enable to integrate about 18% of all OTCs, which are neglected by the common ATC-based approach. The presented extended approach may help to identify potential users of OTCs or people in need of OTC use. In case of the highly disputed homeopathy and anthroposophy products, more research among interactions with prescriptions drugs (Rx), nutrition's and other potentially harmful exposures is recommended.

The MYRACLE protocol study: a multicentric observational prospective cohort study of patients with multiple myeloma.

BACKGROUND: Despite recent advances in the treatment of multiple myeloma, the disease constantly relapses and is still considered as incurable. The current knowledge about the biological mechanisms underlying resistance to the different class of drugs in multiple myeloma remains poor. The primary objective of the MYRACLE (Myeloma Resistance And Clonal Evolution) cohort, a multicenter prospective cohort of patients with multiple myeloma, is to address this limitation. We here describe the study background, design and methods used for this cohort. METHODS/DESIGN: All patients (> 18 year old) diagnosed with de novo or relapsed multiple myeloma and treated in two hematology department from west of France are included in the MYRACLE cohort. Patients provide a signed informed to be included in the study. All subjects are followed until refusal to participate in the study or death. The MYRACLE cohort prospectively collects data on socio-economic status, medical status, imaging, prognosis factors, MM therapies and associated events (resistance, safety issues). Patients also complete standardized quality of life questionnaires. In addition, bone marrow samples will be collected at time of diagnosis and relapses to perform biomarkers analysis and functional assays exploring mechanisms underlying drug resistance. DISCUSSION: The "real-life" MYRACLE cohort offers the opportunity to prospectively collect epidemiological, medical, QoL and biological data from MM patients during the course of the disease (at time of diagnosis and subsequent relapses). At mid-tem, this integrative cohort will be unique at producing a large variety of data that can be used to conceive the most effective personalized therapy for MM patients. Additionally, the MYRACLE cohort will allow integrating the medical care of MM patients in a health and pharmacoeconomic perspective.

Shadow cost of oral corticosteroids-related adverse events: A pharmacoeconomic evaluation applied to real-life data from the Severe Asthma Network in Italy (SANI) registry.

BACKGROUND: Asthma is one of the most common non-communicable respiratory diseases, affecting about 6% of the general population. Severe asthma, even if afflicts a minority of asthmatics, drives the majority of costs of the disease. The aim of this study is to create a pharmacoeconomic model to predict the costs of corticosteroid-related adverse events in severe asthmatics and applying it to the first published epidemiologic data from the Severe Asthma Network in Italy (SANI) registry. METHODS: The analysis was conducted from the perspective of the Italian National Healthcare System (INHS). Model inputs, derived from literature, included: asthma epidemiology data, frequency of adverse events, percentage of severe asthma treated with OCS and adverse event cost (Diagnosis-Related Group (DRG) national tariffs). We estimated costs per different patient groups: non-asthma controls, mild/moderate and severe asthmatics. Final results report estimated direct cost per patient and total direct cost for overall target population, showing economic impact related to corticosteroid complication. RESULTS: Based on epidemiological data input, in Italy, asthmatic subjects resulted about 3,999,600, of which 199,980 with severe asthma. The number of patients with severe asthma OCS-treated was estimated at 123,988. Compared to the non-asthma control cohort and to that with moderate asthma annual cost per severe asthmatic patient resulted respectively about €892 and €606 higher, showing a corticosteroids shadow cost ranging from 45% to 30%.Applying the cost per patient to the target population identified for Italy, the budget impact model estimated a total annual cost related to OCS-related adverse events of €242.7 million for severe asthmatics. In respect with non-asthmatic and moderate population, an incremental expenditure of about € 110.6 million and €75.2, respectively, were shown. CONCLUSIONS: Our study provides the first estimates of additional healthcare costs related to corticosteroid induced adverse events in severe asthma patient. Budget impact model results highlighted the relevant economic impact of OCS-related adverse events in severe asthma patients. The future extrapolation of additional data from SANI registry will support the development of a model to investigate the role of corticosteroids sparing drugs.

Treatment of early stage chronic hepatitis C virus infection.

INTRODUCTION: Treatment of Hepatitis C Virus (HCV) with direct acting antivirals (DAAs) is able to achieve the cure of infection in almost the totality of patients, independently of the characteristics of the individual and the virus, using short treatment schedules, and without the need of ribavirin. The high cost of DAAs is the main limiting factor for universal treatment of HCV. However, there is a strong evidence that treatment of infection at the early stage of disease may be the most rewarding approach. Areas covered: This review evaluates the aspects underlying the benefit of treating chronic HCV infection at the early stage of disease. It outlines the considerations that have to be taken into account when planning treatment in patients with HCV and minimal liver disease, assessing the positive reflex of viral eradication on several HCV-associated extra-hepatic conditions such as the risk of lymphoma, insulin-resistance and glycaemic control, and renal function. Lastly, it also covers the improvement of patients' quality of life and the pharmaco-economic aspects associated with early treatment. Expert commentary: Treatment of patients with HCV and minimal liver disease is associated with a beneficial, pleiotropic effect of viral eradication that goes beyond the simplistic consideration of the improvement in liver disease-related outcomes.

Cost-efficacy analysis of 3% diclofenac sodium, ingenol mebutate, and 3.75% imiquimod in the treatment of actinic keratosis.

Actinic keratosis (AK) is a clinical condition characterized by keratinocytic dysplastic lesions of the epidermis, affecting individuals chronically exposed to sunlight. Topical therapies allow the treatment of a whole area of affected skin and currently include diclofenac sodium gel, 5-fluorouracil cream, 5-fluorouracil and acetylsalicylic acid solution, imiquimod cream, and ingenol mebutate gel. Due to the comparable efficacy of 3% diclofenac, ingenol mebutate, and 3.75% imiquimod in treating AK multiple lesions, a pharmacoeconomic evaluation of cost-effectiveness of the three treatments was needed. A cost-efficacy analysis comparing 3% diclofenac sodium with ingenol mebutate and 3.75% imiquimod was performed. In this analysis, efficacy data were combined with quality-of-life measurement derived from previous studies as well as the costs associated with the management of these lesions in Italy. Patients' demographics and clinical characteristics were assumed to reflect those from the clinical studies considered.

Gender Medicine and Pharmacoeconomics: A Narrative Review of the International Literature of the Last 5 Years. A Revision of Evidences about the Relationship Between Gender and Economic Consumption in Health.

INTRODUCTION: The influence of patient gender on the economic impact of health care has increasingly been examined in the recent literature. Gender appears to have an impact on healthcare resource consumption, due to possible differences in the patient's response to a chosen therapeutic management strategy or to a healthcare intervention. OBJECTIVE: The present work is aimed at collecting and reviewing evidences about the relationship between gender and economic consumption in health based on worldwide scientific literature published in the last 5 years. METHOD: We conducted a narrative review of evidence from an initial pool of 904 articles, selecting information about gender-specific economic impact in any therapeutic area. RESULTS: After title, abstract and full text review, 111 articles were relevant to the paper scope. The reviewed studies seem to be confirming that a difference exists between males and females in the economic implications of healthcare management and that those differences are particularly relevant for cardiovascular and metabolic pathologies. Preliminary evidence suggests overall healthcare costs are slightly higher in females than males, while some specific and non-quantitative items of resource consumption, such as quality of prescriptions, might favour male patients. Results do not allow to clearly claiming an overall cost shift towards males or females, since their polarization varies depending on the considered cost item or event category. CONCLUSION: Studies suggested the presence of a gender difference in overall healthcare resource consumption and costs. Nevertheless, these aspects still lack thorough examination in literature and further analyses would be required on longer time periods.

A Cost Saving and Waste Minimization Study About Handling of the Antineoplastic Agents.

OBJECTIVES: As a cancer treatment option, chemotherapy costs make up a large part of the budgets of social insurance foundations and related expenditures are increasing continuously annually. Cost saving and waste minimizing strategies are required to reduce the expenditures in the field of oncology. The study aimed to reduce the amount of wasted antineoplastic drugs and medical supply consumption. MATERIALS AND METHODS: The study explains why vials with a larger size and drugs in liquid form should be preferred over various smaller sizes and powder forms of antineoplastic preparations. RESULTS: Amounts of drug wastage, vial adaptor, and transfer set consumption data were recorded regularly for a period of seven months. The average vial adaptor consumption per patient in the last three months decreased from 5 to 3.3. The preference of liquid forms as much as possible instead of powder forms, which has a shorter stability time after dilution, and the choice of larger package sizes of frequently used drugs decreased vial adaptor consumption. Potential savings were calculated as around 31.660 USD annually. Costs of total wasted doses were 8.699.87 USD, and the whole antineoplastic drug consumption was 515.500 USD during the study. A decrease of 0.58 USD was observed per capita when the first and last three-month periods were compared in terms of waste costs. CONCLUSION: These values indicate that the reduction of wasted drugs have potential annual savings of 3.375 USD. It is shown that total potential savings of 35.000 USD could be made per year. By implementing the same principles in all hospitals in Turkey, approximately 2.8 million USD could be made annually. The pharmaceutical industry and hospital pharmacists have important responsibilities in this issue.

Evaluation of a pharmacogenetic-based warfarin dosing algorithm in patients with low time in therapeutic range - study protocol for a randomized controlled trial.

BACKGROUND: Time in therapeutic range (TTR) is a measurement of quality of warfarin therapy and lower TTR values (<50%) are associated with greater risk of thromboembolic and bleeding events. Recently, we developed a pharmacogenetic-based warfarin dosing algorithm specifically calibrated for a Brazilian patient sample. The aims of this study are: to evaluate the impact of a genetic-based algorithm, compared to traditional anticoagulation, in the time to achieve the therapeutic target and in TTR percentage; and to assess the cost-effectiveness of genotype-guided warfarin dosing in a specific cohort of patients with low TTR (<50%) from a tertiary cardiovascular hospital. METHODS/DESIGN: This study is a randomized controlled trial in patients (n = 300) with atrial fibrillation with TTR < 50%, based on the last three INR values. At the first consultation, patients will be randomized into two groups: TA group (traditional anticoagulation) and PA group (pharmacogenetic anticoagulation). For the first group, the physician will adjust the dose according to current INR value and, for the second group, a pharmacogenetic algorithm will be used. At the second, third, fourth and fifth consultations (with an interval of 7 days each) INR will be measured and, if necessary, the dose will be adjusted based on guidelines. Afterwards, patients who are INR stable will begin measuring their INR in 30 day intervals; if the patient's INR is not stable, the patient will return in 7 days for a new measurement of the INR. Outcomes measures will include the time to achieve the therapeutic target and the percentage of TTR at 4 and 12 weeks. In addition, as a secondary end-point, pharmacoeconomic analysis will be carried out. Ethical approval was granted by the Ethics Committee for Medical Research on Human Beings of the Clinical Hospital of the University of São Paulo Medical School. DISCUSSION: This randomized study will include patients with low TTR and it will evaluate whether a population-specific genetic algorithm might be more effective than traditional anticoagulation for a selected group of poorly anticoagulated patients. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02592980 . Registered on 29 October 2015.

Cost of nosocomial pneumonia: the example of vancomycin versus linezolid-shorter stay or fewer complications?

Hospital and national committees often focus on drug acquisition costs when taking decisions on the use of new drugs, but antimicrobial agent costs represent a minor part of the bill compared with the indirect costs of hospitalization or loss in days of productivity in working people. Although reducing the length of stay should be a main priority in the USA due to the indirect costs associated with hospitalization, adverse events, such as renal failure, have a major impact on healthcare resource use and costs. However, where hospital reimbursement is based on closed budgets, the paradox is that treating more patients due to reductions in length of stay may not be attractive to administrators, because the cost of discharging patients earlier is not compensated by the increase in severity in replacing stays of newer patient admissions. Furthermore, neuropsychological, physical, and immune impairment caused by sepsis has an extreme impact on long-term quality of patient life and health care resource consumption. Future research is warranted to further explore the potential impact of newer therapies for infections and sepsis, taking into account the costs of complications, effects on long-term quality of life, and particularly an international perspective, which requires customization for each national payer's system.

Cost-effectiveness analysis of pemetrexed and gemcitabine treatment for advanced nonsmall cell lung cancer in Turkey.

BACKGROUND/AIM: The purpose of the study is to determine the cost-effectiveness of the chemotherapy medications that contain gemcitabine and pemetrexed, which are used in the treatment of advanced nonsmall cell lung cancer (NSCLC). MATERIALS AND METHODS: The study evaluated the effectiveness and cost of platinum-based pemetrexed and gemcitabine treatments as the first-line treatment of advanced NSCLC with the use of the Markov model, and from the perspective of the Social Security Institution. NSCLC costs calculated on the basis of experts' opinions and the effectiveness values calculated by administering the EQ-5D questionnaire to the patients were analyzed. All direct medical costs were included in the model. RESULTS: While the life-long cost of gemcitabine/cisplatin treatment was determined to be 10,347.45 Turkish lira per patient, it was determined as 17,783.34 for pemetrexed/cisplatin treatment. The incremental cost of pemetrexed/cisplatin treatment is 220,754 per quality-adjusted life year. CONCLUSION: Although there is no official threshold value in Turkey, due to the fact that the incremental cost effectiveness ratio exceeds the threshold value calculated on the basis of GDP per capita, it is understood that pemetrexed/cisplatin is not cost-effective in the first-line treatment of advanced NSCLC.

Indirect and direct costs of treating patients with ankylosing spondylitis in the Brazilian public health system.

INTRODUCTION: Patients with ankylosing spondylitis require a team approach from multiple professionals, various treatment modalities for continuous periods of time, and can lead to the loss of labour capacity in a young population. So, it is necessary to measure its socio-economic impact. OBJECTIVES: To describe the use of public resources to treat AS in a tertiary hospital after the use of biological medications was approved for treating spondyloarthritis in the Health Public System, establishing approximate values for the direct and indirect costs of treating this illness in Brazil. MATERIAL AND METHODS: 93 patients selected from the ambulatory spondyloarthritis clinic at the Hospital de Clínicas of the Federal University of Paraná between September 2011 and September 2012 had their direct costs indirect treatment costs estimation. RESULTS: 70 patients (75.28%) were male and 23 (24.72%) female. The mean age was 43.95 years. The disease duration was calculated based on the age of diagnosis and the mean was 8.92 years (standard deviation: 7.32); 63.44% were using anti-tumour necrotic factor drugs. Comparing male and female patients the mean Bath Ankylosing Spondylitis Disease Activity Index was 4.64 and 5.49 while the mean Bath Ankylosing Spondylitis Functional Index was 5.03 and 6.35 respectively. CONCLUSIONS: The Brazilian public health system's spending related to ankylosing spondylitis has increased in recent years. An important part of these costs is due to the introduction of new, more expensive health technologies, as in the case of nuclear magnetic resonance and, mainly, the incorporation of anti-tumour necrotic factor therapy into the therapeutic arsenal. The mean annual direct and indirect cost to the Brazilian public health system to treat a patient with ankylosing spondylitis, according to our findings, is US$ 23,183.56.

Indirect and direct costs of treating patients with ankylosing spondylitis in the Brazilian public health system / Custos diretos e indiretos do tratamento de pacientes com espondilite anquilosante pelo sistema público de saúde brasileiro

ABSTRACT Introduction: Patients with Ankylosing Spondylitis (AS) require a team approach from multiple professionals, various treatment modalities for continuous periods of time, and can lead to the loss of labour capacity in a young population. So, it is necessary to measure its socio-economic impact. Objectives: To describe the use of public resources to treat AS in a tertiary hospital after the use of biological medications was approved for treating spondyloarthritis in the Health Public System, establishing approximate values for the direct and indirect costs of treating this illness in Brazil. Material and methods: 93 patients selected from the ambulatory spondyloarthritis clinic at the Hospital de Clínicas of the Federal University of Paraná between September 2011 and September 2012 had their direct costs indirect treatment costs estimation. Results: 70 patients (75.28%) were male and 23 (24.72%) female. The mean age was 43.95 years. The disease duration was calculated based on the age of diagnosis and the mean was 8.92 years (standard deviation: 7.32); 63.44% were using anti-TNF drugs. Comparing male and female patients the mean BASDAI was 4.64 and 5.49 while the mean BASFI was 5.03 and 6.35 respectively. Conclusions: The Brazilian public health system's spending related to ankylosing spondylitis has increased in recent years. An important part of these costs is due to the introduction of new, more expensive health technologies, as in the case of nuclear magnetic resonance and, mainly, the incorporation of anti-TNF therapy into the therapeutic arsenal. The mean annual direct and indirect cost to the Brazilian public health system to treat a patient with ankylosing spondylitis, according to our findings, is US$ 23,183.56.

RESUMO Introdução: Os pacientes com espondilite anquilosante (EA) exigem uma abordagem de equipe com vários profissionais e várias modalidades de tratamento, continuamente; além disso, a doença pode levar à perda da capacidade de trabalho em uma população jovem, de modo que é necessário medir o seu impacto socioeconômico. Objetivos: Descrever o uso de recursos públicos para o tratamento da EA em um hospital terciário após o uso dos fármacos biológicos ter sido aprovado para o tratamento das espondiloartrites pelo Sistema Público de Saúde e estabelecer valores aproximados para os custos diretos e indiretos do tratamento dessa doença no Brasil. Material e métodos: Foram estimados os custos de tratamento diretos e indiretos de 93 pacientes com EA do ambulatório de espondiloartrite do Hospital de Clínicas da Universidade Federal do Paraná, entre setembro de 2011 e setembro 2012. Resultados: Dos pacientes, 70 (75,28%) eram do sexo masculino e 23 (24,72%) do feminino. A idade média foi de 43,95 anos. A duração da doença foi calculada com base na idade do diagnóstico e a média foi de 8,92 anos (desvio padrão: 7,32); 63,44% dos indivíduos usavam fármacos anti-TNF. Na comparação dos pacientes dos sexos masculino e feminino, a média no Bath Ankylosing Spondylitis Disease Activity Index (Basdai) foi de 4,64 e 5,49, enquanto a média no Bath Ankylosing Spondylitis Functional Index (Basfi) foi de 5,03 e 6,35, respectivamente. Conclusões: Os gastos do sistema público de saúde brasileiro relacionados com a espondilite anquilosante aumentaram nos últimos anos. Uma parte importante desses custos deve-se à introdução das novas tecnologias de saúde, mais dispendiosas, como no caso da ressonância nuclear magnética e, principalmente, da incorporação da terapia anti-TNF ao arsenal terapêutico. O custo médio anual direto e indireto do sistema público de saúde brasileiro para tratar de um paciente com espondilite anquilosante, de acordo com os resultados deste estudo, é de US$ 23.183,56.

[The Competence Network Parkinson (CNP)]. / Das Kompetenznetz Parkinson (KNP).

The Competence Network Parkinson (CNP) is a research infrastructure for disease-oriented translational and clinical research in the field of Parkinson syndromes (PS). It was initiated in 1999 and funded until 2008 by the German Ministry for Education and Research (BMBF). The CNP created a highly frequented website with information on PS for the general public and for experts. The CNP designed and established one of the first electronic internet-based data entry systems (secuTrial®) - fulfilling the legal standards of data safety and security - a material bank for genetic research on Parkinson's disease (PD), implemented and investigated new methods for early diagnosis of PD and related atypical PS including in vivo dopamine transporter imaging (DAT SPECT), established the German Parkinson Study Group (GPS-Pharma) with 40 certified trial centres for pharmacotherapeutical trials and the German interdisciplinary Parkinson Study Group (neurology and neurosurgery) for deep brain stimulation (GPS-DBS), and carried out several pharmacoeconomic and health care studies on PD in Germany. Sustainability of the infrastructure CNP has in part been achieved in form of the GPS-Pharma and the GPS-DBS, as well as in the German Study Group on REM Sleep Behaviour Disorder (RBD), a prodromal phase of PD. Part of the CNP activities, such as genetic research and research on cohorts of PD patients, have been incorporated into the German Center for Neurodegenerative Disorders (DZNE). Furthermore, topics such as health care research are funded within projects of the EU research program. The article describes problems in setting up a competence network from scratch and contains recommendations how to avoid them in the future.

Cost of Treatment in HBeAg-Negative Chronic Hepatitis B Patients with 10-Years Projection Analysis.

OBJECTIVE: Chronic hepatitis B infection has to be treated effectively due to its major complications. The aim of this study is to investigate and compare the therapy alternatives' treatment costs for hepatitis B e antigen (HBeAg) negative patients with 10-year projection analysis according to current reimbursement guideline in Turkey. MATERIALS AND METHODS: All testing that should be done before the treatment and during follow-up was determined according to the guideline. Medicinal costs were calculated according to 2014 prices. Cost calculation was performed on 100 hypothetical HBeAg negative, 35 years old patients whose alanine aminotransferase value was >2 X upper limit of the normal laboratory level by taking into consideration the risks of resistance seen during the treatment. Switching to tenofovir scenario was concocted when resistance to lamivudine and telbivudine was developed. In pegylated-interferon non-responders, alternative scenarios have been edited and evaluated. RESULTS: The total cost of patients whose treatment was started with pegylated-interferon and switched to lamivudine and tenofovir due to non-response was found 2,662,504 TL. Treatment cost of patients whose therapy was passed to tenofovir after initiation with lamivudine or telbivudine was 2,444,175 TL and 3,061,869 TL, respectively. From the beginning of treatment in patients taking entecavir or tenofovir, the 10-year cost of treatment was 3,924,960 TL and 3,884,040 TL, respectively. CONCLUSION: As a result, when assessing the cost of the treatment of chronic hepatitis B not only medicine box costs, but also drug resistance and laboratory testing costs, should be considered. In our country, on the basis of 10 years cost; pegylated-interferon and lamivudine therapy has been found advantageous in patients with low viral load, and tenofovir has been found advantageous in patients with high viral load.

Pharmacoeconomy: an indispensable tool for the rationalization of health costs / Farmacoeconomia: uma ferramenta indispensável para a racionalização dos custos de saúde

Due to the considerable increase in public expenditure with health issues, mainly regarding drugs, several countries, including Australia and England, have already implemented, or are in the process of discussing the adoption of measures to ensure the quality of health care provided to the population. One of the less harmful strategies, rarely used in Brazil, is the adoption of economic techniques applied to health, more specifically, pharmacoeconomic analysis. This paper aims to contribute to the dissemination of concepts and techniques of economic analysis with a view to incorporate these into policy decisions of expenditure rationalization and the search for clinical efficiency. It includes a literature review covering the types of costs and benefits in health issues, the methodologies of pharmacoeconomic analysis, cost-minimization, cost-benefits, cost-effectiveness and cost-utility analysis, as well as its main characteristics, advantages, disadvantages and applicability.

Em razão do aumento considerável no gasto público com saúde, principalmente no que tange a medicamentos, vários países, como Austrália e Inglaterra, já implementaram ou estão em fase de discussão da adoção de medidas visando garantir a qualidade do atendimento prestado à população. Uma das estratégias menos danosas, mas ainda incipiente no Brasil, é a adoção de técnicas de análises econômicas, mais especificamente, a avaliação farmacoeconômica. Neste contexto, este trabalho visa contribuir com a disseminação dos conceitos e técnicas de análises econômicas com a perspectiva de que possam ser incorporadas nas decisões políticas de racionalização dos gastos e na busca da eficiência clínica. Para tanto, este artigo apresenta uma revisão bibliográfica contemplando os tipos de custos e benefícios em saúde, as metodologias de análise farmacoeconômicas, quais sejam: análise de minimização de custo, de custo-benefício, de custo-efetividade e de custo-utilidade, assim como suas principais características, vantagens, desvantagens e aplicabilidades.

Pharmacy contribution to the prescription and rational use of human albumin at a large hospital / Contribuição da farmácia na prescrição e uso racional de albumina humana em um hospital de grande porte

Objective: The purpose of this survey was to reduce the use of human albumin 20% in non-supported indications at Hospital Israelita Albert Einstein. Methods: During a 30-day period, in December 2006, a preliminary prospective analysis of medical prescriptions of human albumin 20% and therapeutic indications according to ANVISA RDC 115 guidelines was performed. Based on this analysis, a project was developed. In January 2007, a daily routine to follow up albumin prescriptions by the Hospital pharmacists was established. Results: From January to October 2007, 14,799 vials of albumin 20% were used, out of which 4,191 had non-supported indications, resulting in a R$ 1.36 million loss. In 2008 (from January to October), 13,519 vials of albumin 20% were prescribed, and 1,648 of them had non-supported indications, causing a R$ 535 thousand loss. The ratio between loss risk and consumed amount was 91.99 between January and October 2007. During the same period in 2008, this ratio was 39.60. Between January and October 2007, the average percentage of albumin prescribed for non-supported indications was 28%, whereas this percentage dropped to 13%, i.e., a decrease by 54%, during the same period of 2008. Conclusions: The inclusion of a pharmacist in the process of verifying medicine indications and justification of use was translated into safer processes to patients, ensuring that they received the correct medication for the correct indication, therefore reducing the chance of adverse events and contributing to reduce red-tape procedures and unnecessary expenditures by the institution.

Objetivo: O trabalho teve como objetivo a redução da utilização de albumina humana 20% com indicação não-fundamentada no Hospital Israelita Albert Einstein. Métodos: Durante um período de 30 dias (dezembro, 2006), foi realizada uma análise prospectiva preliminar utilizando-se as prescrições médicas de pacientes com Albumina humana, e avaliaram-se as indicações terapêuticas em relação às diretrizes estabelecidas pela resolução ANVISA RDC 115. A partir dessas informações, foi elaborado um projeto de atuação e foi instituída uma rotina de acompanhamento diário das prescrições pelos farmacêuticos a partir de Janeiro de 2007. Resultados: De Janeiro a Outubro de 2007, foram consumidos 14.799 frascos de albumina 20%. Destes, 4.191 com indicação não fundamentada, correspondendo a uma perda de R$ 1,36 milhões. Em 2008 (de janeiro a outubro), foram prescritos 13.519 frascos de albumina 20%. Destes, 1.648 com indicação não fundamentada, o que responde por uma perda de R$ 535 mil. A relação entre o risco da perda e quantidade consumida de janeiro a outubro de 2007 foi de 91,99. Já no mesmo período de 2008 foi de 39,60. De janeiro a outubro de 2007, a média do percentual de albumina prescrita com indicação não-fundamentada foi de 28%. No mesmo período em 2008, este percentual caiu para 13%. Uma redução de 54%. Conclusões: O envolvimento do Farmacêutico no processo de verificação da indicação e justificativa do uso do medicamento representa processos seguros ao paciente, garantindo que ele receba o medicamento certo para a indicação correta, reduzindo com isto a probabilidade de eventos adversos e contribuindo para diminuir burocracias e gastos desnecessários na instituição.