Dabigatran - a case history demonstrating the need for comprehensive approaches to optimize the use of new drugs.

BACKGROUND: There are potential conflicts between authorities and companies to fund new premium priced drugs especially where there are safety and/or budget concerns. Dabigatran, a new oral anticoagulant for the prevention of stroke in patients with non-valvular atrial fibrillation (AF), exemplifies this issue. Whilst new effective treatments are needed, there are issues in the elderly with dabigatran due to variable drug concentrations, no known antidote and dependence on renal elimination. Published studies have shown dabigatran to be cost-effective but there are budget concerns given the prevalence of AF. There are also issues with potentially re-designing anticoagulant services. This has resulted in activities across countries to better manage its use. OBJECTIVE: To (i) review authority activities in over 30 countries and regions, (ii) use the findings to develop new models to better manage the entry of new drugs, and (iii) review the implications for all major stakeholder groups. METHODOLOGY: Descriptive review and appraisal of activities regarding dabigatran and the development of guidance for groups through an iterative process. RESULTS: There has been a plethora of activities among authorities to manage the prescribing of dabigatran including extensive pre-launch activities, risk sharing arrangements, prescribing restrictions, and monitoring of prescribing post-launch. Reimbursement has been denied in some countries due to concerns with its budget impact and/or excessive bleeding. Development of a new model and future guidance is proposed to better manage the entry of new drugs, centering on three pillars of pre-, peri-, and post-launch activities. CONCLUSION: Models for introducing new drugs are essential to optimize their prescribing especially where there are concerns. Without such models, new drugs may be withdrawn prematurely and/or struggle for funding.

Annual costs of rheumatoid arthritis in Turkey.

Objective of the present study is aimed to determine costs of rheumatoid arthritis (RA) based on reimbursement agencies perspective [Social Security Institution (SSI)] in Turkey. The international clinical guidelines for RA are followed for analysing the direct costs. Data were collected from hospital bills, social security institution price lists, and Ministry of Health drug price list. Direct costs of RA patients were estimated as euro 2,669.14 patient/year. Outpatient costs were found to be euro 240.40. Routine tests during the year were calculated as euro 98.85. Ten percent of patients are hospitalized per year, and 0.62% of these patients received arthroplasty and/or other interventions. The cost during hospital stay was euro 87.76. euro 2,238 was determined as being paid per year for medication alone (including anti-TNF) and euro 4 is spent on auxiliary materials annually. Our data show a remarkable economic impact of RA over society. We hope that the cost of RA studies will help package price practices for reimbursement agencies.

[Quality of life in major depressive disorder: a cross-sectional study]. / Major Depresif Bozuklukta Yasam Kalitesi: Kesitsel Bir Calisma.

OBJECTIVE: To investigate quality of life and its association with depression in patients with major depressive disorder. METHOD: The study included 74 patients diagnosed with major depressive disorder according to DSM-IV. The Hamilton Depression Rating Scale (HAM-D) was used to assess the severity of depression; and the, Medical Outcomes Study Short Form-36 (MOS SF-36) and EuroQol 5-D (EQ-5D) were used to measure quality of life. RESULTS: In the assessment of quality of life, it was determined that Patients with major depressive disorder scored significantly lower on all domains of MOS SF-36 compared to Turkish normative data. The depressive disorder patients had lower EQ-5D health utility index scores, in comparison to Turkish normative data. There was a significant negative correlation between mean HAM-D score and all domains of MOS SF-36 and EQ-5D health utility index scores. When quality of life in depressive patients was compared according to episode type, patients with recurrent type major depressive disorder had lower quality of life in terms of physical functioning, general health perception, and physical component summary score than patients with single episode type major depressive disorder. CONCLUSION: All domains of quality of life were lower in patients with major depressive disorder and quality of life decreased as severity of depression increased. Physical health perception was impaired to a greater degree in patients with recurrent major depressive disorder when compared with single episode depressive patients.