How to prepare for European Health Technology Assessment
E-Book, Englisch, 236 Seiten
ISBN: 978-3-384-03094-8
Verlag: tredition
Format: EPUB
Kopierschutz: 6 - ePub Watermark
Thomas Ecker, CEO of Ecker + Ecker and Accessus Health, possesses over two decades of expertise in HTA and the pricing and reimbursement of pharmaceuticals. With his wealth of experience, including over 100 successful dossier submissions and price negotiations in Germany, he has extended his focus to include EU HTA strategy development and the preparation of EU HTA dossiers.
Autoren/Hrsg.
Weitere Infos & Material
List of figures Figure 1: National market access as the key challenge Figure 2: National market access encompassing both national HTA and national P&R Figure 3: Four phases of national market access Figure 4: EU HTA as a parallel work stream to national market access Figure 5: EU HTA and national market access are linked to each other Figure 6: Three phases of EU HTA work stream Figure 7: EU Market Access Core Model encompassing national market access and EU HTA work stream (overview) Figure 8: National strategy development informs EU strategy development Figure 9: EU dossier development flows from EU strategy development Figure 10: EU assessment flows from EU dossier development Figure 11: National dossier development flows from national strategy development, EU dossier development and EU assessment Figure 12: National assessment flows from EU assessment and national dossier development Figure 13: National price negotiation flows from national assessment and potentially the EU assessment Figure 14: National assessment flows from EU assessment and national dossier development Figure 15: EU Market Access Core Model® (Version 2.4) Figure 16: From work stream to individual work package Figure 17: HTA Core Model® (dark blue: clinical domains; light blue: non-clinical domains) Figure 18: Overview of steps towards the adoption of the EU HTA Regulation Figure 19: Overview of the four domains addressed by EU HTA and the five domains of the HTA Core Model® overseen by the individual member states Figure 20: Schematic overview of the structure of the HTAR Figure 21: Timeline of when EU HTA will apply to different categories of medicinal products Figure 22: Schematic timetable for the adoption of implementing acts as of June 2023 Figure 23: Parallelism of the EMA marketing authorisation procedure (in blue) and the European HTA process (in red). The number of days refers to the EMA timeline. The size and length of the boxes do not necessarily correlate with actual time Figure 24: Differences between regulatory approval and HTA processes Figure 25: Guidelines published by the EUnetHTA 21 consortium Figure 26: Submission dossier template structure Figure 27: Schematic representation of the content of Part 5 Figure 28: Overview of the four subgroups of the Coordination Group Figure 29: Composition of the stakeholder network Figure 30: National strategy development is the first phase of the national market access workstream Figure 31: The ten work packages of national strategy development Figure 32: WP1.1 of national strategy development – Route of reimbursement Figure 33: Topology of national P&R and EU HTA scenarios Figure 34: WP1.2 of national strategy development – PICO simulation Figure 35: Typology of PICOs Figure 36: Components of PICO(S) Figure 37: WP1.3 of national strategy development – Gap analysis Figure 38: Generic final resolution Figure 39: From PICO to probable national assessment outcome Figure 40: From preferred national assessment to required evidence package Figure 41: Spotting the gaps Figure 42: WP1.4 of national strategy development – Price simulation Figure 43: Generic dimensions of P&R – Factors influencing the achievable price Figure 44: Exemplary overview of results of a price simulation Figure 45: Phases of strategic pricing in the product life cycle Figure 46: WP1.5 of national strategy development – Market access strategy Figure 47: Generic determinants of P&R work stream Figure 48: From P&R-determinants to a market access strategy Figure 49: National market access strategy by components and phases of national market access and EU HTA workstreams Figure 50: WP1.6 of national strategy development – Scientific consultation Figure 51: Topology of advice meeting formats Figure 52: WP1.7 of national strategy development – Early Access programmes Figure 53: WP1.8 of national strategy development – Stakeholder management Figure 54: WP1.9 of national strategy development – Monitoring Figure 55: WP1.10 of national strategy development – Strategy update Figure 56: EU strategy development as a second, parallel phase in the overall process Figure 57: Work packages of EU strategy development Figure 58: WP2.1 of EU strategy development – Verification of EU HTA obligation Figure 59: WP2.2 of EU strategy development – Simulation of consolidated PICO Figure 60: WP2.3 of EU strategy development – Gap analysis Figure 61: Process of gap analysis on EU level Figure 62: Spotting the gaps Figure 63: WP2.4 of EU strategy development – Consolidated price simulation Figure 64: Four steps to determine a European P&R strategy Figure 65: Exemplary result matrix of national price potentials Figure 66: Overview of EUnetHTA 21 PICO exercise I on Pluvicto Figure 67: WP2.5 of EU strategy development – EU HTA Strategy Figure 68: WP2.6 of EU strategy development – Scientific consultation Figure 69: Topology of advice meeting formats Figure 70: Timeline of EMA/HTAb Scientific Advice process Figure 71: WP2.7 of EU strategy development – Stakeholder management Figure 72: WP2.8 of EU strategy development – Monitoring Figure 73: WP2.9 of EU strategy development – Strategy update Figure 74: EU dossier development as a third phase in the overall process Figure 75: Work packages of EU dossier development Figure 76: WP3.1 of EU dossier development – Identification of anticipated PICOs Figure 77: WP3.2 of EU dossier development – Statistical feasibility Figure 78: Decision tree to assess the evidence available for each PICO Figure 79: WP3.3 of EU dossier development – EU dossier outline Figure 80: WP3.4 of EU dossier development – EU dossier outline and national alignment Figure 81: WP3.5 of EU dossier development – Statistical analysis Figure 82: WP3.6 of EU dossier development – Dossier draft Figure 83: WP3.7 of EU dossier development – Communication of final PICO Figure 84: Procedural steps during the start of the JCA Figure 85: WP3.8 of EU dossier development – Adaptation of dossier to final PICOs Figure 86: WP3.9 of EU dossier development – Quality assurance Figure 87: WP3.10 of EU dossier development – Dossier submission Figure 88: JCA timelines for a standard regulatory process (three months D120 clock stop and one month D180 clock stop) for new chemical entities based on dates given in the deliverable D5.4 (Version 0.1, 15 March 2023) Figure 89: WP3.11 of EU dossier development – Stakeholder management Figure 90: WP3.12 of EU dossier development – Monitoring Figure 91: EU dossier assessment as fifth phase in the overall process Figure 92: Work packages of EU dossier assessment Figure 93: Procedural steps during the assessment phase of the JCA Figure 94: Content of the JCA report (based on EUnetHTA 21 guidelines D5.2 JCA Report template guidance and Joint Clinical Assessment Report Template and Summary Template as of April 2023) Figure 95: WP5.1 of the EU assessment phase – Factual accuracy check Figure 96: Aspects of the JCA report that can be examined for errors or inaccuracies as part of the factual accuracy check Figure...
