Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe.

Background: The reimbursement of orphan drugs (OD) is an increasingly important for country policymakers, and still insufficiently understood, especially in Central and Eastern Europe. The aim of this research was to provide a comprehensive description of country-specific health technology assessment (HTA) policies as well as evaluate the percentage of HTA recommendations and reimbursement decisions for oncology OD. In addition, the study was designed to elucidate the impact of reimbursement of these drugs on the public budget and the agreement between HTA recommendations and reimbursement decisions in the analysed countries.

Reimbursement Legislations and Decision Making for Orphan Drugs in Central and Eastern European Countries.

Background: Reimbursement policies influence access of patients to orphan drugs in the European countries.

Objectives: To provide a comprehensive description of orphan drug reimbursement policies and to assess reimbursement decision-making process in the EU-CEE countries as well as the impact of the type of approval and disease on reimbursement decisions.

Methods: For each drug, the information regarding conditional approval or approval under exceptional circumstances was obtained from the EMA website.

Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment.

To assess shares of reimbursed orphan drugs and agreement in reimbursement decision-making in different European Union member states as well as to define odds for reimbursement influenced by the presence of conditional approval or exceptional circumstances granted by the European Medicines Agency (EMA) or by type of the disease. The list of authorized drugs with current orphan designations was collected from the website of the EMA. For each drug, the information regarding conditional approval or approval under exceptional circumstances was collected.

Trends and determinants in reimbursement decision-making in Poland in the years 2013-2015.

Objective: To assess changes in the involvement of advisory bodies in the reimbursement decision-making process in Poland, and to evaluate variables that influenced HTA recommendations in the years 2013-2015.

Research Design And Methods: Two independent contributors reviewed the statements of the TC, recommendations issued by the president of the AOTMiT and reimbursement decisions of the MoH for the years 2013-2015. We collected data on the type of recommendations and variables influencing the HTA recommendations.

Impact of patient outcomes and cost aspects on reimbursement recommendations in Poland in 2012-2014.

The aim of this study was to assess the influence of different factors on the final reimbursement recommendations for drugs in Poland and to identify the correlation between these factors and the probability of a positive reimbursement recommendation for an applicant drug issued by the President of the Agency for Health Technology Assessment and Tariff System (AOTMiT). We analysed all recommendations for the period of 2012-2014 in Poland, three years following the launch of the new Reimbursement Act of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices. For each recommendation we collected data on efficacy, safety, cost of therapy, cost-effectiveness, quality of evidence, orphan drug status and others.

The definition of prices for inpatient care in Poland in the absence of cost data.

The health reform of 1999 in Poland introduced market-like relations in the health care sector. The oligopsonic and the current monopsomic position of the payer makes prices for health care products purchased in this quasi-market low and does not usually take into account the costs of production. Despite a long history of cost calculation in the system, a systematic and reliable assessment of costs is still lacking which would help in setting up fair financing.

Definition of the "health benefit basket" in poland.

The subject of "health benefit basket" has been hotly debated for years among the Polish public, but until recently the debate has tended to be largely theoretical and abstract and therefore has lacked an effect on public policy. The situation changed in 2004, for two reasons: first the verdict of the Constitutional Tribunal invalidating the existing health insurance law and, second, Poland's accession to the European Union. The first problem was solved in part by defining a list of specific exclusions in the law and a promise to establish an institution for health technology assessment.