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Requirements for benefit assessment in Germany and England : overview and comparison

Ivandic, Victor - In: Health economics review 4 (2014) 12, pp. 1-14

Federal Joint Committee/Institute for Quality and Efficiency in Health Care (G-BA/IQWiG; Germany) and the National Institute … approach taken by NICE seems to be more open and less restrictive as compared with G-BA/IQWiG. Any kind of potentially relevant … sensitivity analyses before making a recommendation regarding reimbursement. By contrast, G-BA/IQWiG bases its assessment and …

Persistent link: https://www.econbiz.de/10010528485

Relevance of indirect comparisons in the German early benefit assessment and in comparison to HTA processes in England, France and Scotland

Lebioda, Andrea; Gasche, David; Dippel, Franz-Werner; … - In: Health economics review 4 (2014) 31, pp. 1-14

Early benefit assessment in Germany under the legislative framework of AMNOG (Arzneimittelmarktneuordnungsgesetz … assess the additional benefit of the new drug. However, the Institute for Quality and Efficiency in Health Care (IQWiG …

Persistent link: https://www.econbiz.de/10010526947

Different interpretation of additional evidence for HTA by the commissioned HTA body and the commissioning decision maker in Germany : whenever IQWiG and Federal Joint Committee di...

Dintsios, C. M.; Worm, F.; Ruof, Jörg; Herpers, M. - In: Health economics review 9 (2019) 35, pp. 1-15

(FJC) to the HTA body (IQWiG) and their agreement with FJC decisions and to identify potential additional decisive factors … to descriptive statistics, differences between IQWiG and FJC were tested and explored by agreement statistics (Cohen … of the appropriate comparative therapy had a high influence on FJC’s appraisals deviating from IQWiG’s addenda …

Persistent link: https://www.econbiz.de/10012162522

How can a joint European health technology assessment provide an "additional benefit" over the current standard of national assessments?

Julian, Elaine; Gianfrate, Fabrizio; Sola-Morales, Oriol de - In: Health economics review 12 (2022) 1, pp. 1-12

Objectives: We conducted a multi‑stakeholder survey to determine key areas where a joint European health technology assessment (HTA) could provide "additional benefit" compared to the status quo of many parallel independent national and subnational assessments. Methods: Leveraging three...

Persistent link: https://www.econbiz.de/10013329416

Shaping a research agenda to ensure a successful European health technology assessment : insights generated during the inaugural convention of the European Access Academy

Julian, Elaine; Pavlovic, Mira; Sola-Morales, Oriol de; … - In: Health economics review 12 (2022) 1, pp. 1-15

Objectives: Key challenges for a joint European Health Technology Assessment (HTA) include consolidated approaches towards the choice of adequate comparator(s), selection of endpoints that are relevant to patients with a given disease, dealing with remaining uncertainties as well as transparent...

Persistent link: https://www.econbiz.de/10013492801

Leveraging EUnetHTA's conceptual framework to compare HTA decision drivers in France, Italy, and Germany from a manufacturer’s point of view

Giuliani, Giovanni; Chassagnol, Frederic; Traub, David; … - In: Health economics review 8 (2018) 24, pp. 1-11

Background: Health Technology Assessments (HTA) procedures differ substantially across the various European countries. We reviewed recent appraisals of a pharmaceutical manufacturer in three major European markets (France; Italy; Germany) and identified and categorized related decision drivers....

Persistent link: https://www.econbiz.de/10011942836

Patient relevant endpoints in oncology : current issues in the context of early benefit assessment in Germany

Dabisch, Inna; Dethling, Jürgen; Dintsios, … - In: Health economics review 4 (2014) 2, pp. 1-8

The German AMNOG healthcare reform includes a mandatory early-benefit-assessment (EBA) at launch. As per German social … unveiled issues regarding the acceptance of some patient-relevant endpoints as G-BA and IQWiG are grading the endpoints …

Persistent link: https://www.econbiz.de/10010528451

"Market withdrawals" of medicines in Germany after AMNOG : a comparison of HTA ratings and clinical guideline recommendations

Staab, Thomas R.; Walter, Miriam; Mariotti Nesurini, Sonja - In: Health economics review 8 (2018) 23, pp. 1-11

Background: According to the AMNOG act, the German Federal Joint Committee (G-BA) determines the additional benefit of … appraisals of medicines that were withdrawn from the German market since the introduction of AMNOG in 2011. Methods: Medications …-BA (average ‘no additional benefit’ rating for all AMNOG products: 47%). Of the 22 medicines, 15 (68%) were recommended by at …

Persistent link: https://www.econbiz.de/10011942830

Patient-reported data informing early benefit assessment of rare diseases in Germany : a systematic review

Babac, Ana; Damm, Kathrin; Schulenburg, Johann-Matthias … - In: Health economics review 9 (2019) 34, pp. 1-17

Background: Since the implementation of the Regulation on Patient Integration (2003), the Act on the Reorganization of the Pharmaceutical Market (2011), and the Patient Rights Law (2013), the inclusion of patient perspectives has been further anchored in the German early benefit assessment...

Persistent link: https://www.econbiz.de/10012162513