Reimbursement Legislations and Decision Making for Orphan Drugs in Central and Eastern European Countries
Rattachement africain : pl, bg, hr, cz, ee, lt, sk, ro. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
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. The reimbursement status for analyzed drugs was collected in a questionnaire survey performed in a group of experts in reimbursement policy. The agreement between countries was assessed using the κ coefficient, nominal variables tests were compared using the χ2 test or the Fisher exact test. The impact of the EMA's conditional approval and approval under exceptional circumstances was assessed using logistic regression and presented as an odds ratio (OR). RESULTS: = 0.9583) with GDP per capita was observed. The highest agreement in reimbursement decisions was observed between Estonia and Lithuania, and the lowest - between Estonia and Latvia, with kappa of 0.69 and 0.11, respectively. Significant impact of the type of approval and reimbursement status was observed for Czechia, Lithuania and Slovakia where conditional approval and exceptional circumstances negatively influenced reimbursement decision. Type of disease has significant influence on reimbursement decision in 4 out of 10 analyzed countries with significant outweigh of positive decisions for oncological diseases. CONCLUSION: In considered countries specific regulations on reimbursement of orphan drugs are valid but in Lithuania and Romania no formal HTA process was employed; in case of some countries higher ICER values for orphans are used. The share of reimbursed orphan drugs varied significantly across the countries, but it was not associated with GDP per capita.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Reimbursement Legislations and Decision Making for Orphan Drugs in Central and Eastern European Countries
- Date Crossref
- 08/05/2019
- Éditeur
- Frontiers Media SA
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Jagiellonian University pays non établi dans la noticeUniversité ou école supérieure
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Andrzej Frycz Modrzewski Krakow University pays non établi dans la noticeUniversité ou école supérieure
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Medical University of Sofia pays non établi dans la noticeUniversité ou école supérieure
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National Center of Infectious and Parasitic Diseases pays non établi dans la noticeUniversité ou école supérieure
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University of Rijeka Department of Biotechnology pays non établi dans la noticeUniversité ou école supérieure
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Agency for Medicinal Products and Medical Devices of Croatia pays non établi dans la noticeInstitution
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State Institute for Drug Control Pricing and Reimbursement Regulation Branch pays non établi dans la noticeOrganisme public
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University of Tartu Institute of Family Medicine and Public Health pays non établi dans la noticeUniversité ou école supérieure
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Vilnius University pays non établi dans la noticeUniversité ou école supérieure
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Comenius University Bratislava pays non établi dans la noticeUniversité ou école supérieure
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Titu Maiorescu University pays non établi dans la noticeUniversité ou école supérieure
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Faculty of Health Sciences Institute of Public Health pays non établi dans la noticeUniversité ou école supérieure
Jagiellonian University, Andrzej Frycz Modrzewski Krakow University et Medical University of Sofia, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.