Literature DB >> 26250656

Does conditional approval for new oncology drugs in Europe lead to differences in health technology assessment decisions?

I Lipska1, J Hoekman2, N McAuslane1, H G M Leufkens2, A M Hövels2.   

Abstract

An early access pathway of conditional approval for potentially beneficial medicines is available within the European regulatory framework. However, marketing authorization does not necessarily result in recommendations for public funding by health technology assessment (HTA) agencies. As conditional approval goes along with less than complete data on benefits and risks of a treatment option for a high medical need, this raises the question how HTA decision-making is affected by these uncertainties.
© 2015 American Society for Clinical Pharmacology and Therapeutics.

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Year:  2015        PMID: 26250656     DOI: 10.1002/cpt.198

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN: 0009-9236            Impact factor:   6.875


  8 in total

1.  Development and Validation of the TRansparent Uncertainty ASsessmenT (TRUST) Tool for Assessing Uncertainties in Health Economic Decision Models.

Authors:  Sabine E Grimm; Xavier Pouwels; Bram L T Ramaekers; Ben Wijnen; Saskia Knies; Janneke Grutters; Manuela A Joore
Journal:  Pharmacoeconomics       Date:  2020-02       Impact factor: 4.981

Review 2.  Reinforcing Collaboration and Harmonization to Unlock the Potentials of Advanced Therapy Medical Products: Future Efforts Are Awaited From Manufacturers and Decision-Makers.

Authors:  Tingting Qiu; Shuyao Liang; Yitong Wang; Claude Dussart; Borislav Borissov; Mondher Toumi
Journal:  Front Public Health       Date:  2021-11-25

3.  Real World Data in Health Technology Assessment of Complex Health Technologies.

Authors:  Milou A Hogervorst; Johan Pontén; Rick A Vreman; Aukje K Mantel-Teeuwisse; Wim G Goettsch
Journal:  Front Pharmacol       Date:  2022-02-10       Impact factor: 5.810

4.  The Role of Regulator-Imposed Post-Approval Studies in Health Technology Assessments for Conditionally Approved Drugs.

Authors:  Rick A Vreman; Lourens T Bloem; Stijn van Oirschot; Jarno Hoekman; Menno E van der Elst; Hubert Gm Leufkens; Olaf H Klungel; Wim G Goettsch; Aukje K Mantel-Teeuwisse
Journal:  Int J Health Policy Manag       Date:  2022-05-01

5.  Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies.

Authors:  Lourens T Bloem; Rick A Vreman; Niels W L Peeters; Jarno Hoekman; Menno E van der Elst; Hubert G M Leufkens; Olaf H Klungel; Wim G Goettsch; Aukje K Mantel-Teeuwisse
Journal:  Clin Transl Sci       Date:  2021-05-01       Impact factor: 4.689

6.  A novel method for predicting the budget impact of innovative medicines: validation study for oncolytics.

Authors:  Joost W Geenen; Svetlana V Belitser; Rick A Vreman; Martijn van Bloois; Olaf H Klungel; Cornelis Boersma; Anke M Hövels
Journal:  Eur J Health Econ       Date:  2020-04-04

7.  Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs.

Authors:  Rick A Vreman; Jacoline C Bouvy; Lourens T Bloem; Anke M Hövels; Aukje K Mantel-Teeuwisse; Hubert G M Leufkens; Wim G Goettsch
Journal:  Clin Pharmacol Ther       Date:  2018-11-08       Impact factor: 6.875

8.  Use of Patient Preference Information in Benefit-Risk Assessment, Health Technology Assessment, and Pricing and Reimbursement Decisions: A Systematic Literature Review of Attempts and Initiatives.

Authors:  Lylia Chachoua; Monique Dabbous; Clément François; Claude Dussart; Samuel Aballéa; Mondher Toumi
Journal:  Front Med (Lausanne)       Date:  2020-10-26
  8 in total

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