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[Authorization and reimbursement of orphan drugs in an international comparison].
- Source :
-
Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany)) [Gesundheitswesen] 2011 Aug; Vol. 73 (8-9), pp. 504-14. Date of Electronic Publication: 2010 Sep 16. - Publication Year :
- 2011
-
Abstract
- Background: This paper analyses schemes to promote the authorisation of and reimbursement for orphan drugs.<br />Methods: 8 countries - Australia, Canada, Germany, Great Britain, France, Netherlands, Switzerland, USA - were studied to compare specific regulations for orphan drugs regarding drug admission, health technology assessment (HTA), decision-making for reimbursement, and off-label and compassionate use. Information was obtained by reviewing published and grey literature. Expert interviews were also conducted.<br />Results: The comparison of orphan drug legislation reveals that the EU and the USA offer the greatest incentives for the development of orphan drugs, whereas there is a tendency for Australia and Switzerland to profit from incentives in other countries. Although not explicitly stated, economic evaluation of orphan drugs takes the special circumstances for orphan drugs into account. In addition to common reimbursement practices, special schemes or programmes for the reimbursement of high-priced orphan drugs exist in all countries that were analysed. Therefore access to orphan drugs seems to be warranted. However, due to co-payments of 5%, the USA may form an exception.<br />Conclusion: On the one hand, the use of special criteria for drug admission, HTA, and reimbursement promotes R&D for orphan drugs. On the other hand, high opportunity costs arise, because huge efforts are made for a minority of patients. A solution for this moral dilemma may be the application of "rule of rescue" or of "no cure, no pay" programmes.<br /> (© Georg Thieme Verlag KG Stuttgart · New York.)
- Subjects :
- Australia
Canada
Cost-Benefit Analysis
Drug Industry economics
European Union
Humans
International Agencies
Rare Diseases economics
Rare Diseases epidemiology
United States
Cross-Cultural Comparison
Drug Approval economics
Drug Approval legislation & jurisprudence
Insurance Coverage economics
Insurance Coverage legislation & jurisprudence
Insurance, Pharmaceutical Services economics
Insurance, Pharmaceutical Services legislation & jurisprudence
National Health Programs economics
National Health Programs legislation & jurisprudence
Orphan Drug Production economics
Orphan Drug Production legislation & jurisprudence
Rare Diseases drug therapy
Subjects
Details
- Language :
- German
- ISSN :
- 1439-4421
- Volume :
- 73
- Issue :
- 8-9
- Database :
- MEDLINE
- Journal :
- Gesundheitswesen (Bundesverband der Arzte des Offentlichen Gesundheitsdienstes (Germany))
- Publication Type :
- Academic Journal
- Accession number :
- 20848380
- Full Text :
- https://doi.org/10.1055/s-0030-1262864