EU HTA 101 (eBook)

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

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