[HTML][HTML] Access to orphan drugs: a comprehensive review of legislations, regulations and policies in 35 countries
Objective To review existing regulations and policies utilised by countries to enable patient
access to orphan drugs. Methods A review of the literature (1998 to 2014) was performed to …
access to orphan drugs. Methods A review of the literature (1998 to 2014) was performed to …
[HTML][HTML] HTA decision-making for drugs for rare diseases: comparison of processes across countries
T Stafinski, J Glennie, A Young, D Menon - Orphanet journal of rare …, 2022 - Springer
Introduction Drugs for rare diseases (DRDs) offer important health benefits, but challenge
traditional health technology assessment, reimbursement, and pricing processes due to …
traditional health technology assessment, reimbursement, and pricing processes due to …
[HTML][HTML] Systematic review on the evaluation criteria of orphan medicines in Central and Eastern European countries
Background In case of orphan drugs applicability of the standard health technology
assessment (HTA) process is limited due to scarcity of good clinical and health economic …
assessment (HTA) process is limited due to scarcity of good clinical and health economic …
Reasons for and frequency of off-label drug use
S Goločorbin-Kon, I Iličković, M Mikov - Medicinski pregled, 2015 - doiserbia.nb.rs
Introduction. The application of drugs in accordance with the marketing authorization issued
by the regulatory authority is considered on-label use, while off-label drug use frequently …
by the regulatory authority is considered on-label use, while off-label drug use frequently …
[HTML][HTML] Reimbursement legislations and decision making for orphan drugs in central and eastern European countries
KP Malinowski, P Kawalec, W Trabka… - Frontiers in …, 2019 - frontiersin.org
Background Reimbursement policies influence access of patients to orphan drugs in the
European countries. Objectives To provide a comprehensive description of orphan drug …
European countries. Objectives To provide a comprehensive description of orphan drug …
Access to orphan drugs–comparison across Balkan countries
The aim of this study was to compare orphan drug access in a sample of Balkan countries:
five EU Member States (Bulgaria, Croatia, Greece, Romania, Slovenia) and two EU …
five EU Member States (Bulgaria, Croatia, Greece, Romania, Slovenia) and two EU …
Public spending on orphan medicines: a review of the literature
M Gombocz, S Vogler - Journal of Pharmaceutical Policy and …, 2020 - Taylor & Francis
Background and objective Little is known about how much public payers spend on orphan
medicines. This study aimed at identifying information on orphan medicine expenditure …
medicines. This study aimed at identifying information on orphan medicine expenditure …
[HTML][HTML] Impact of orphan drugs on Latvian budget
Background Number of orphan medicinal products on the market and number of rare
disease patients, taking these usually expensive products, are increasing. As a result …
disease patients, taking these usually expensive products, are increasing. As a result …
[HTML][HTML] Rare diseases and orphan drugs: Latvian story
Background Ten years have passed since Latvia became a Member State of the EU in 2004.
As a result European regulations, including those related to rare diseases and orphan …
As a result European regulations, including those related to rare diseases and orphan …
[HTML][HTML] Comparative analysis of legislative requirements about patients' access to biotechnological drugs for rare diseases in Central and Eastern European …
Objectives: The aim of the study was to compare the access of patients with rare diseases
(RDs) to biotechnological drugs in several Central and Eastern European countries …
(RDs) to biotechnological drugs in several Central and Eastern European countries …