Ewa Stawowczyk

Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries

Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries. Methods: A questionnaire-based survey was conducted between November 2016 and January 2017 among experts from the following CEE countries: Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. The requirements for the pricing and reimbursement of biosimilars were reviewed for each country. Data on the extent of reimbursement of biologic drugs (separately for original products and biosimilars) in the years 2014 and 2015 were also collected for each country, along with data on the total pharmaceutical and total public health care budgets. Results: Our survey revealed that no specific criteria were applied for the pricing and reimbursement of biosimilars in the selected CEE countries; the price of biosimilars was usually reduced compared with original drugs and specific price discounts were common. Substitution and interchangeability were generally allowed, although in most countries they were at the discretion of the physician after a clinical assessment. Original biologic drugs and the corresponding biosimilars were usually in the same homogeneous group, and internal reference pricing was usually employed. The reimbursement rate of biosimilars in the majority of the countries was the same and amounted to 100%. Generally, the higher shares of expenditures were shown for the reimbursement of original drugs than for biosimilars, except for filgrastim, somatropin, and epoetin (alfa and zeta). The shares of expenditures on the reimbursement of biosimilar products ranged from 8.0% in Estonia in 2014 to 32.4% in Lithuania in 2015, and generally increased in 2015. The share of expenditures on reimbursement of biosimilars in the total pharmaceutical budget differed between the countries, with the highest observed value for Slovakia and Hungary and the lowest—for Croatia. Conclusions: The requirements for the pricing and reimbursement of biosimilar products as well as the access of patients to biologic treatment do not differ significantly between the considered CEE countries. Biosimilar drugs significantly influence the reimbursement systems of these countries, and the expenditure on the reimbursement of biosimilars is increasing as they are becoming more accessible to patients.

The indirect costs of multiple sclerosis: systematic review and meta-analysis

The aim of this systematic review is to collect and summarize all current data on the indirect costs related to absenteeism and presenteeism associated with multiple sclerosis. Searches were conducted using Medline, Embase and Centre for Reviews and Dissemination databases. All collected costs were recalculated to average annual cost per patient, expressed in 2014 prices US

Implementation of the 2011 Reimbursement Act in Poland: Desired and undesired effects of the changes in reimbursement policy

using the consumer price index and purchasing power parity (scenario 1) and expressed as proportion of specific gross domestic product in current local currency unit to adjust for country’s development (scenario 2). Identified studies were then analyzed in order to assess their possible inclusion in the meta-analysis. The authors identified 63 records, of which 23 were eligible for meta-analysis. Overall indirect cost per patient calculated in scenario 1 was as high as US

Cost-Utility Analysis of Infliximab with Standard Care versus Standard Care Alone for Induction and Maintenance Treatment of Patients with Ulcerative Colitis in Poland

20,167 with US

Cost-Effectiveness Analysis of 1-Year Treatment with Golimumab/Standard Care and Standard Care Alone for Ulcerative Colitis in Poland.

22,197 in Europe, US

The European challenges of funding orphan medicinal products

17,382 in North America and US

Relationship between physician-based assessment of disease activity, quality of life, and costs of ulcerative colitis in Poland

153 in Asia. Overall indirect cost per patient calculated in scenario 2 was equal to US

Cost-effectiveness of biological treatment of ulcerative colitis – a systematic review

16,939, with US

Disease activity, quality of life, and indirect costs of ulcerative colitis in Poland

19,612 in Europe, US

Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review

11,592 in North America and US