Why Are There Differences In Hta Recommendations Across Countries? A Systematic Comparison of Hta Decision Processes for A Sample of Orphan Drugs In Four Countries
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چکیده
منابع مشابه
Oncology drugs for orphan indications: how are HTA processes evolving for this specific drug category?
Orphan drugs (ODs) are intended for the diagnosis, prevention, or treatment of rare diseases. Many cancer subtypes, including all childhood cancers, are defined as rare diseases, and over one-third of ODs are now intended to treat oncology indications. However, market access for oncology ODs is becoming increasingly challenging; ODs are prone to significant uncertainty around their cost-effecti...
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BACKGROUND The aim of this study was to review and compare types of reimbursement recommendations for orphan drugs issued by eight European health technology assessment (HTA) agencies and the reimbursement status of these drugs in the corresponding countries. Separate calculations were also performed for three sub-groups: ultra-orphan drugs, oncology orphan drugs and other (non-ultra, non-oncol...
متن کاملOrphan Drugs Assessment in Germany: A Comparison with Other International HTA Agencies.
• Germany did not issue any negative recommendations for any of the 20 Orphan Drug assessments – However, 7 assessments (35%) where the additional benefit was not quantifiable would have been negative if the products did not have an EMA Orphan Drug designation and a legislated «implicit additional clinical benefit» – Potential changes to the German drug assessment mechanism could impact this on...
متن کاملA Comparison of Reimbursement Recommendations by European HTA Agencies: Is There Opportunity for Further Alignment?
Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains ...
متن کاملTrends and Key Decision Drivers For Rejecting An Orphan Drug Submission Across Five Different HTA Agencies.
Orphanet database (www.orpha.net) was searched for orphan drugs with a marketing authorization between 2002 and July 2014. Rare diseases for which two or more orphan drugs were available were selected. Decisions from five HTA agencies were considered: AWMSG (Wales), CADTH (Canada), NICE (England), PBAC (Australia), and SMC (Scotland). Assessments that resulted in a rejection were examined for k...
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ژورنال
عنوان ژورنال: Value in Health
سال: 2014
ISSN: 1098-3015
DOI: 10.1016/j.jval.2014.08.1737