Out-of-pocket healthcare expenditures of Turkish households living with rare diseases.

Introduction: This study aims to determine the out-of-pocket health expenditures of households in Turkey where individuals with rare diseases are residing. Methods: The research population consisted registered members of associations who are members of the Rare Diseases Network. In addition to the general analysis including all participants, expenditures based on characteristics of disease holders were also calculated. Results: A total of 439 participants were included in the analysis. We determined that special nutrition was the highest expenditure group and emergency departments were the lowest expenditure group. When all the participants were evaluated, the average cost of rare diseases was found to be L22,743 (€2,877). A significant relationship was found between income status and out-of-pocket health expenditures (p = 0.012). Discussion: Policy makers should consider inclusion of special nutritional products and medical/non-medical devices used in treatment of rare diseases within the scope of reimbursement and the development of orphan drug legislation as the first actions to be taken.

Cost-Effectiveness Analysis of the Triclip™ Transcatheter Tricuspid Valve Repair System in Patients with Tricuspid Regurgitation.

BACKGROUND: Tricuspid regurgitation is a condition that affects 1.6 million patients in the United States and is independently associated with morbidity and mortality. The TriClip™ procedure repairs the tricuspid valve without the need for open-heart surgery. The aim of this study is to evaluate the cost-effectiveness of TriClip™ treatment in patients with advanced tricuspid regurgitation from the Turkish reimbursement agency perspective. METHODS: Within the scope of this study, the general literature was searched in order to reach data on tricuspid regurgitation. The utilization of health care services used in the expert panel was re-calculated with the current reimbursement costs to determine the cost of heart failure in Turkey. In this study, Markov analysis, Tornado analysis, cost-effectiveness analysis, and partitioned survival analysis have been performed to determine whether TriClip™ is an effective treatment method compared to medication treatment. RESULTS: In according to calculations, 5-year survival rate was found as 49.91% for medication treatment and 57.64% for TriClip™ treatment. According to the analysis performed, the cost of medication treatment was calculated as €3879.72 and TriClip™ Transcatheter Tricuspid Valve Repair System treatment as €25 661.15 for a 60-month period in patients with tricuspid regurgitation and New York Heart Association III-IV. In the calculation, it was found that TriClip™ treatment gave patients an average of 1.64 life years and it was found to be cost-effective compared to medication treatment. CONCLUSIONS: Considering the positive effect of TriClip™ treatment on patients with tricuspid regurgitation in terms of mortality and regression of the heart failure stage, as recommended in the guidelines, widespread of its use has great importance.

Analysis of patient access to orphan drugs in Turkey.

BACKGROUND: Rare diseases are life-threatening, serious, and chronic conditions that require complex care and have a low prevalence. An estimated one in 15 people worldwide are affected by rare diseases. This study aims to analyze the accessibility, reimbursement status, licensed status, and Anatomical Therapeutic Chemical (ATC) codes of drugs that the European Medicines Agency (EMA) in Turkey considers to be "orphan" pharmaceuticals. METHODS: The drugs included in this analysis were obtained from the list of orphan drugs published by the EMA. Orphan drugs' accessibility and licensing status in Turkey were obtained from the Health Implementation Communiqué published by the Social Security Institution (SGK) and the List of Abroad Active Substance and List of Licensed Products published by the Turkey Pharmaceuticals and Medical Devices Agency (TITCK). Descriptive analysis was applied to determine the accessibility status of orphan drugs identified by the EMA in Turkey. RESULTS: Based on the EMA, 105 pharmaceuticals were approved with "orphan drug" status except for drugs that have lost orphan drug status, decommissioned in the European Union and withdrawn from the European Community Register by January 2020. Of the 105 rare drugs on the EMA list, 34 were inaccessible in Turkey. Of the 71 available drugs, 23 (32%) were licensed and 48 (68%) were unlicensed in Turkey. 17 (74%) of licensed products and 17 (35%) of unlicensed products were covered by reimbursement. When orphan drugs' ATC codes were examined, the most common ATC group was found to be "L-Antineoplastic and Immunomodulatory" agents. CONCLUSION: An orphan drug incentive policy is very important to ensure early access to the drugs used to treat rare diseases. Considering the capacity and prices for orphan drugs in Turkey, it can be said that many patients with rare diseases have difficulty in their treatment. It is obvious that such a policy must prepare for the regulation of orphan drugs in Turkey.

Changes in Catastrophic Health Expenditures Depending on Health Policies in Turkey.

Without any financial protection out of pocket health expenses are essential both because their increase causes difficulties in accessing higher quality health services for households and more importantly because it complicates access to most basic health services. As a result of the Health Transformation Program in practice in the Turkish healthcare system since 2003, significant changes have been done in all layers of the health system. Turkish Statistics Institute (TurkStat) publishes the ratio of households that bear catastrophic health expenditures since 2002. According to TurkStat data, the ratio of households with catastrophic expenditure has fallen from 0.81% in 2002 to 0.17% in 2011 with the health transformation project. However, it has started to rise since 2012 and has reached 0.31% in 2014. This study aims to evaluate the expenditure items that may have caused the rise of the ratio of households with catastrophic health expenditures since 2012, which had previously dropped with the Health Transformation Program that has caused fundamental changes in health policies. Methodology and definitions presented in the article named "Distribution of health payments and catastrophic expenditures: Methodology" by Ke Xu published by the World Health Organization in 2005 have been used. Percentages of health expenditure items among the total expenditure of households with positive health expenditure and households with catastrophic health expenditure between 2007 and 2014 have been evaluated using descriptive analysis. Findings have been interpreted in light of the health policies in practice between 2007 and 2014. An overview of the impact of the health policies reveals that medicine expenditures have decreased both for household and public health expenditures. Despite the impact of policies on the pharmaceutical industry was criticized by the industry, the positive impact can be seen by the decrease in the spending on medicine for households spending on health. Hospital service with positive health expenditure is seen to decrease health expenditure. The reasons for the increase in households with catastrophic health expenditure need further research. As a result, the study strives to discuss the possible policy reasons for the observed effects.

Impact of Health Policy Changes on Trends in the Pharmaceutical Market in Turkey.

BACKGROUND: The implementation phase of the Turkish Health Transformation Program (HTP) began in 2003, with the aim of organizing, financing, and delivering health care services effectively, efficiently, and equally. The HTP impacted all clinical and economic outcomes of health, including pharmaceutical sales, by improving access to health services. OBJECTIVES: To understand the impact of five selected major policy changes that made an impact on supply, demand, or price in the pharmaceutical market between 1998 and 2012. METHODS: Monthly sales data (in units and value in US $) of a total of 180 pharmaceuticals covering the period between 1998 and 2012 were used for statistical analysis. Five major policies that could affect health expenditures and the demand and supply of pharmaceuticals were selected and led by the Ministry of Health. A P value of less than 0.05 was considered as the cutoff value for statistical significance. RESULTS: There was a growing trend in pharmaceuticals value and units in years, possibly as a result of the HTP implementation. Supply- and demand-related policies had a negative impact on the trends for value, whereas the pricing policy had a positive impact. CONCLUSIONS: It could be said that the HTP had an impact on units for improved access to health care services. Although this access increased the consumption of pharmaceuticals in units, the policies implemented were successful in controlling pharmaceutical expenditures.

Cost-effectiveness analysis of oral anti-viral drugs used for treatment of chronic hepatitis B in Turkey.

BACKGROUND: All international guidelines suggested that Tenofovir and Entecavir are the primary drugs at the first line therapy for the treatment of chronic hepatitis B (CHB). However, in Turkey these medications reimbursed at the second line therapy according to the Healthcare Implementation Notification. The aim of this study is to compare the cost effectiveness of oral antiviral treatment strategies in CHB for Turkey using lamuvidine, telbuvidine, entecavir, and tenofovir as medications. METHODS: The analysis was conducted using Markov models. The analysis scenarios based on first line treatment options with Lamuvidine, Telbuvidine, Entecavir, and Tenofovir as the medications. In the analysis, inadequate response or resistance after receiving 12 months of the treatment with Entecavir and Telbivudine were compared to the results found from switching from Entecavir to Tenofovir or from switching from Telbuvidine to Tenofovir. In additional, inadequate response or resistance after receiving 6 months of the treatment for Lamivudine was compared to the results found from switching from Lamivudine to Tenofovir. The study population included men and women, who were 40 years of age. The patients` compliance was estimated 100 % for all of the therapy options. The model duration was constructed to evaluate, treatment strategy duration of 40 years. The cost of medications, examinations/follow-ups and complications were included in the model. Years of Potential Life Lost was used as the health outcome. An incremental cost-effectiveness ratio analysis has been conducted. RESULTS AND DISCUSSION: While the minimum years of life lost was found as 0.22 with tenofovir treatment in 5 years, treatment cost was calculated as 12,169 TL. These values were detected as 0.56 years and 7727 TL, 0.37 years and 12,770 TL, respectively for lamuvidine and telbuvidine treatments. The maximum years of life lost and treatment cost was with lamuvidine treatment were detected as 1.60 years and 18,813 TL and, secondly 0.89 years and 24,007 TL for lamuvidine-tenofovir treatment during 10 years. The minimum years of life lost and cost are 0.54 year and 35,821 TL for tenofovir treatment during 10 years. The minimum years of life lost and cost were determined as 1.21 years and 52,839 TL for tenofovir treatment strategy during 20 years. During 30 years period, tenofovir treatment was found to have the minimum years of life lost (1.73 years) and minimum cost (84,149 TL). When the results of 40 years period were analyzed, years of life lost and costs are 2.06 years and 119,604 TL, 2.13 years and 162,115 TL, 2.13 years and 161,642 TL, 6.52 years and 147,245 TL, 3.20 years and 132,157 TL, 4.10 years and 151,059 TL and 3.05 years and 138,182 TL for tenofovir, entecavir, entecavir-tenofovir, lamuvidine, lamuvidine-tenofovir, telbivudine and telbivudine-tenofovir. CONCLUSIONS: In the model presented in this study, in cost effectiveness analysis about CHB treatments, Tenofovir was found to be one of the cost effective methods in comparison with other treatment strategies different time intervals. Beyond this achievement Tenofovir has shown to reduce cumulative treatment cost in first line CHB treatment when compared with regard to 40 year cumulative treatment cost.

An Overview of the Orphan Medicines Market in Turkey.

BACKGROUND: The health policies of many countries and regions have already defined orphan drugs for rare diseases. Although there is no official definition of orphan drugs in Turkey, all orphan drugs are covered by reimbursement, regardless of their market authorization status. Thus, a pharmacoeconomic analysis does not have to be presented to the Social Security Institution (Sosyal Güvenlik Kurumu) for reimbursement decisions on orphan drugs. OBJECTIVE: The aim of this study was to shed light on the use of orphan drugs to aid classifications of rare diseases and assessments of orphan drugs in Turkey. METHODS: Data for sales of authorized orphan drugs and all other drugs were extracted from the IMS Turkey for 2008, 2009, and 2010. Nonauthorized orphan drug sales data were extracted from records of the Turkish Pharmacists' Association for the same years. Government prices were obtained from the Sosyal Güvenlik Kurumu. RESULTS: The European Medicines Agency has classified more than 60 orphan drugs for rare diseases. Of these, 50 entered the Turkish market in recent years, half of which were authorized. The remaining drugs were imported through the early access procedure. Antineoplastic agents accounted for the largest percentage of orphan drugs, with 58% of the total market share. In 2010, there were 18 such agents in use, at a cost of €120 million. CONCLUSIONS: Although legislation is not yet in place for orphan drugs in Turkey, recognized pricing and reimbursement policies are in operation. This situation facilitates an analysis of orphan drug prices and reimbursement policies in Turkey.

Can we reduce the cost of illness with more compliant patients? An estimation of the effect of 100% compliance with hypertension treatment.

INTRODUCTION: The current study was designed to calculate the direct cost of noncompliance of hypertensive patients to the US health system. Understanding these expenses can inform screening and education budget policy regarding expenditure levels that can be calculated to be cost-beneficial. METHOD: The study was conducted in 3 parts. First, a computer search of National Institutes of Health Web sites and professional society Web sites for organizations with members that treat hypertension, and a PubMed search were performed to obtain the numbers required for calculations. Second, formulas were developed to estimate the risk of noncompliance and undiagnosed hypertension. Third, risk calculations were performed using the information obtained in part 1 and the formulas developed in part 2. RESULTS: Direct risk reduction for stroke caused by hypertension, heart attack, kidney disease, and heart disease was calculated for a 100% compliant strategy. Risk, case, and cost reduction for a 100% compliant strategy for hypertension were 32%, 8.5 million and US$ 72 billion, respectively. DISCUSSION: Our analysis means that the society can spend up to the cost of noncompliance in screening, education, and prevention efforts in an attempt to reduce these costly and traumatic sequelae of poorly controlled hypertension in the light of published analysis.