Author details
Author Christel Fostier |
Available item(s) by this author (10)
Add the result to your basket Make a suggestion Refine your search Apply to external sources
Beleid voor weesziekten en weesgeneesmiddelen / Alain Denis / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2009)
Beleid voor weesziekten en weesgeneesmiddelen [printed text] / Alain Denis, Author ; Simoens, Steven, Author ; Christel Fostier, Author ; Lut Mergaert, Author ; Irina Cleemput , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2009 . - x, 115 p. : ill. ; 30 cm.. - (KCE Reports A. Health Technology Assessment (HTA); 112A) .
ISSN : D/200/10.273/30 : 0 €
Studie nr : 2008-04
Languages : Dutch (dut) English (eng)
Descriptors: Classification
QV 736 Drug industry. Economics of pharmacy. Advertising
Indexation
2008-04 ; Health Policy ; Legislation, Drug ; Orphan Drug Production ; R112 ; Rare DiseasesLink for e-copy: https://doi.org/10.57598/R112A Format of e-copy: .PDF (859 KB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1592 Copies(0)
Status No copy Budget impact analysis of orphan drugs in Belgium / Alain Denis in Journal of Medical Economics, 13(2010)02 ([05/01/2010])
[article] Budget impact analysis of orphan drugs in Belgium : estimates from 2008 to 2013 [printed text] / Alain Denis, Author ; Lut Mergaert, Author ; Christel Fostier, Author ; Irina Cleemput , Author ; Simoens, Steven, Author . - 2010 . - p. 295-301.
Languages : English (eng)
in Journal of Medical Economics > 13(2010)02 [05/01/2010] . - p. 295-301
Descriptors: Classification
W 1 Serials. Periodicals
Indexation
Belgium ; Budgets ; Drug Costs ; Journal Article ; Orphan Drug Production ; Peer Review ; Policy ; State Medicine ; statistics and numerical data [Subheading]Abstract: OBJECTIVE: This article aims to calculate the impact of orphan drugs on the Belgian drug budget in 2008 and to forecast its impact over the following 5 years. METHOD: The 2008 budget impact was calculated by triangulating information derived from multiple Belgian data sources. The 2008-2013 budget impact analysis was based on three scenarios reflecting different levels of growth in the number of registered orphan drugs in the European Union, the number of drugs reimbursed in Belgium, and the average annual cost per patient per drug in Belgium. RESULTS: The orphan drug budget impact amounted to euro66.2 million (or 5% of the Belgian hospital drug budget) in 2008. The impact would increase to euro130-204 million in 2013, depending on the scenario. CONCLUSIONS: This static analysis measured orphan drug costs only, assuming that other components of health expenditure do not change over time. The analysis showed that the budget impact of orphan drugs in Belgium is substantial and rising, thereby putting pressure on total drug expenditure. Policy options to address the rising budget impact include pricing linked to return on investment, risk-sharing arrangements and re-appraisal of orphan drug status if additional indications are approved. Link for e-copy: https://doi.org/10.3111/13696998.2010.491427 Format of e-copy: PDF [Requires Subscription] Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4105 [article]A comparative study of European rare disease and orphan drug markets / Alain Denis in Health Policy, 97(2010)2-3 ([10/01/2010])
[article] A comparative study of European rare disease and orphan drug markets [printed text] / Alain Denis, Author ; Lut Mergaert, Author ; Christel Fostier, Author ; Irina Cleemput , Author ; Simoens, Steven, Author . - 2010 . - p. 173-179.
Languages : English (eng)
in Health Policy > 97(2010)2-3 [10/01/2010] . - p. 173-179
Descriptors: Classification
W 1 Serials. Periodicals
Indexation
Cost Control ; Drug and Narcotic Control ; Drug Costs ; Europe ; Fees, Pharmaceutical ; Health Policy ; Insurance, Health, Reimbursement ; Journal Article ; legislation and jurisprudence ; Marketing ; Orphan Drug Production ; Peer ReviewAbstract: OBJECTIVES: This article aims to compare regulatory aspects of rare disease and orphan drug markets in Belgium, France, Italy, the Netherlands, Sweden and the United Kingdom. METHODS: Information was derived from the international literature, analysis of legal texts, and a survey completed by national experts. RESULTS: These countries adopted varying approaches towards regulating rare disease and orphan drug markets and, hence, the availability, pricing and reimbursement of orphan drugs vary between countries. Strategies to keep down prices include public procurement in Sweden, profit controls in the United Kingdom, and price comparisons with other countries. To gain reimbursement, the cost-effectiveness and/or budget impact of orphan drugs is considered in some countries. Other societal considerations, such as whether the drug treats a life-threatening disease, are sometimes taken into account. CONCLUSIONS: Extensive government intervention exists in rare disease and orphan drug markets in the countries studied. Our recommendations are to define priorities for research on rare diseases and orphan drugs at the European level, to set up disease and patient registries with a view to investigating the long-term effectiveness and cost-effectiveness of orphan drugs, to assess the profitability of orphan drugs, and to take into account societal considerations when evaluating orphan drugs. Link for e-copy: https://doi.org/10.1016/j.healthpol.2010.05.017 Format of e-copy: PDF [Requires Subscription] Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4095 [article]Critical assessment of Belgian reimbursement dossiers of orphan drugs / Alain Denis in Value in Health, 13(2010)7 ([11/01/2010])
[article] Critical assessment of Belgian reimbursement dossiers of orphan drugs [printed text] / Alain Denis, Author ; Lut Mergaert, Author ; Christel Fostier, Author ; Irina Cleemput , Author ; Frank Hulstaert, Author ; Simoens, Steven, Author . - 2010 . - A409.
Languages : English (eng)
in Value in Health > 13(2010)7 [11/01/2010] . - A409
Descriptors: Classification
W 1 Serials. Periodicals
Indexation
Belgium ; Clinical Trials ; Drug Industry ; Employment ; Insurance, Health, Reimbursement ; Journal Article ; Marketing ; Patient Care ; Peer Review ; Population ; Qualitative Research ; Randomized Controlled TrialsAbstract: BACKGROUND:
Orphan medicinal products are designed to diagnose or treat rare diseases that are serious, life threatening or chronically debilitating and that affect 50 or fewer people in every 100 000 in the EU. In Belgium, the Drug Reimbursement Committee (DRC) evaluates reimbursement requests for orphan drugs based on multiple criteria: the therapeutic value, price and proposed reimbursement tariff; the importance of the drug in clinical practice; and the budget impact of the drug.
OBJECTIVES:
This study aimed to assess reimbursement dossiers of orphan drugs in Belgium and to compare them with the clinical evidence submitted to the European Medicines Agency (EMA).
METHODS:
A qualitative analysis examined all reimbursement dossiers of orphan drugs that were submitted in Belgium between January 2002 and June 2008. The following information was extracted from each dossier: description of the orphan drug; indication; reimbursement status; therapeutic value and needs; budget impact; and number of registered indications. For selected orphan drugs, an in-depth analysis extracted and compared information about the clinical trials, their primary endpoints and results from EMA documents (i.e. the marketing authorization application file, European public assessment report and summary of product characteristics) and the Belgian reimbursement dossiers.
RESULTS:
Reimbursement was awarded to the majority of orphan drugs. In addition to the official criteria, other negotiable factors, such as price adjustments, employment incentives, patient population restrictions and funding of diagnostic tests by the company, seemed to play a role in the reimbursement decision. Despite the low number of patients, randomized controlled trials were conducted for many orphan drugs. Budget-impact analyses were simplistic and did not consider the impact across multiple indications. Some differences were also observed between the clinical evidence submitted to the EMA and that submitted to the Belgian DRC.
CONCLUSIONS:
In addition to the official criteria, other negotiable factors, such as price adjustments and employment incentives, may play a role in Belgian reimbursement decisions of orphan drugs. Some differences have also been noted between the clinical evidence reported in EMA documents and the evidence included in Belgian reimbursement dossiers of orphan drugs. There appears to be a need for further standardization of Belgian reimbursement applications and for European cooperation in sharing clinical evidence of orphan drugs.Link for e-copy: https://doi.org/10.2165/11585980-000000000-00000 Format of e-copy: PDF [Requires Subscription] Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4080 [article]Issues surrounding orphan disease and orphan drug policies in Europe / Alain Denis in Applied Health Economics and Health Policy, 8(2010)5 ([09/01/2010])
[article] Issues surrounding orphan disease and orphan drug policies in Europe [printed text] / Alain Denis, Author ; Lut Mergaert, Author ; Christel Fostier, Author ; Irina Cleemput , Author ; Simoens, Steven, Author . - 2010 . - p. 343-350.
Languages : English (eng)
in Applied Health Economics and Health Policy > 8(2010)5 [09/01/2010] . - p. 343-350
Descriptors: Indexation
drug therapy ; Epidemiology ; Europe ; Health Policy ; Incidence ; Journal Article ; Orphan Drug Production ; Peer ReviewAbstract: An orphan disease is a disease with a very low prevalence. Although there are 5000-7000 orphan diseases, only 50 orphan drugs (i.e. drugs developed to treat orphan diseases) were marketed in the EU by the end of 2008. In 2000, the EU implemented policies specifically designed to stimulate the development of orphan drugs. While decisions on orphan designation and the marketing authorization of orphan drugs are made at the EU level, decisions on drug reimbursement are made at the member state level. The specific features of orphan diseases and orphan drugs make them a high-priority issue for policy makers. The aim of this article is to identify and discuss several issues surrounding orphan disease and drug policies in Europe. The present system of orphan designation allows for drugs for non-orphan diseases to be designated as orphan drugs. The economic factors underlying orphan designation can be questioned in some cases, as a low prevalence of a certain indication does not equal a low return on investment for the drug across its indications. High-quality evidence about the clinical added value of orphan drugs is rarely available at the time of marketing authorization, due to the low number of patients. A balance must be struck between ethical and economic concerns. To this effect, there is a need to initiate a societal dialogue on this issue, to clarify what society wants and accepts in terms of ethical and economic consequences. The growing budgetary impact of orphan drugs puts pressure on drug expenditure. Indications can be extended for an orphan drug and the total prevalence across indications is not considered. Finally, cooperation needs to be fostered in the EU, particularly through a standardized approach to the creation and use of registries. These issues require further attention from researchers, policy makers, health professionals, patients, pharmaceutical companies and other stakeholders with a view to optimizing orphan disease and drug policies in Europe. Link for e-copy: https://doi.org/10.2165/11536990-000000000-00000 Format of e-copy: PDF [Requires Subscription] Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4041 [article]Organisatie en financiering van genetische diagnostiek in België / Alain Denis / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2007)
PermalinkOrganisation and financing of genetic testing in Belgium / Alain Denis / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2007)
PermalinkOrganisation et financement du diagnostic génétique en Belgique / Alain Denis / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2007)
PermalinkPolicies for Orphan Diseases and Orphan Drugs / Alain Denis / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2009)
PermalinkPolitiques relatives aux maladies orphelines et aux médicaments orphelins / Alain Denis / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2009)
Permalink