PHP38 - ENZYME REPLACEMENT THERAPIES WITHIN THE GERMAN HTA (AMNOG) PROCESS
نویسندگان
چکیده
منابع مشابه
HTA - Algorithm or Process? Comment on "Expanded HTA: Enhancing Fairness and Legitimacy".
Daniels, Porteny and Urrutia et al make a good case for the idea that that public decisions ought to be made not only "in the light of" evidence but also "on the basis of" budget impact, financial protection and equity. Health technology assessment (HTA) should, they say, be accordingly expanded to consider matters additional to safety and cost-effectiveness. They also complain that most HTA re...
متن کاملA biochemical and pharmacological comparison of enzyme replacement therapies for the glycolipid storage disorder Fabry disease.
Fabry disease is a lysosomal storage disease arising from deficiency of the enzyme alpha-galactosidase A. Two recombinant protein therapeutics, Fabrazyme (agalsidase beta) and Replagal (agalsidase alfa), have been approved in Europe as enzyme replacement therapies for Fabry disease. Both contain the same human enzyme, alpha-galactosidase A, but they are produced using different protein expressi...
متن کاملHTA – Algorithm or Process?; Comment on “Expanded HTA: Enhancing Fairness and Legitimacy”
Daniels, Porteny and Urrutia et al make a good case for the idea that that public decisions ought to be made not only “in the light of” evidence but also “on the basis of” budget impact, financial protection and equity. Health technology assessment (HTA) should, they say, be accordingly expanded to consider matters additional to safety and cost-effectiveness. They also complain that most HTA re...
متن کاملPredictors of German Amnog Decisions and GKV Rebate Negotiations: A Database Analysis.
In Germany, with the introduction of the new Arzneimittelmarktneuordnungsgesetz (AMNOG) in 2011, the pricing regulations for newly authorized pharmaceuticals and their reimbursement by statutory health insurance providers has changed. Now, there are three main stakeholders: the Joint Federal Committee (G-BA1), the Institute for Quality and Efficiency in Health Care (IQWiG2) and the National Ass...
متن کاملTowards a more transparent HTA process in Poland: new Polish HTA methodological guidelines
Introduction: Health technology assessment (HTA) in Poland supports reimbursement decisions via the Polish HTA Agency (AOTMiT), whose guidelines were updated in 2016. Methods: We identified key changes introduced by the update and, before guideline publication, analysed discrepancies between AOTMiT assessments and the submitting marketing authorisation holders (MAHs) to elucidate the context of...
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ژورنال
عنوان ژورنال: Value in Health
سال: 2018
ISSN: 1098-3015
DOI: 10.1016/j.jval.2018.09.934