Towse us and eu comparison slides
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This document compares the comparative effectiveness research (CER) and relative effectiveness (RE) evidence environments in the US and Europe. It identifies critical factors and likely scenarios for each region by 2020. Both regions will see increasing demands for CER/RE evidence from payers to demonstrate value. The US will make greater progress in data and analytics capabilities while Europe increases harmonization between regulators and health technology assessors. Adaptive licensing will be implemented in Europe but not the US.
Towse us and eu comparison slides
- 1. COMPARING THE CER/RE EVIDENCE ENVIRONMENTS IN THE US AND EUROPE Adrian Towse and Donna Messner
- 2. Futurescapes: expectations in Europe for relative effectiveness evidence for drugs in 2020: http://www.futuremedicine.com/doi/pdf/10.2217/cer.15.7 Futurescapes: evidence expectations in the USA for comparative effectiveness research for drugs in 2020: http://www.futuremedicine.com/doi/pdf/10.2217/cer.15.6 The future of comparative effectiveness and relative efficacy of drugs: an international perspective: http://www.futuremedicine.com/doi/pdf/10.2217/cer.15.8
- 3. US CRITICAL KEY FACTORS IDENTIFIED -- DEFINITIONS TOP TWO CRITICAL KEY FACTORS SECOND TWO CRITICAL KEY FACTORS Integration of Health Systems: Extent to which hospitals, multispecialty care delivery and other services, and coverage become integrated into a comprehensive system for delivering care to members Big Data: Advancements in technology and techniques to facilitate analysis and utilization of rapidly growing, large repositories of unstructured or semi- structured health information (incl. lab data, information on biospecimens, genomic or biomarker data, etc.) EHR: Degree to which electronic health records are standardized, in terms of both nomenclature and interoperability, allowing accessibility for research purposes Role of patients: The degree to which the activities of organized patient groups will impact drug development and expectations for CER
- 4. MOVEMENT TOWARD INTEGRATION OF HEALTH SYSTEM IN THE US ACA and private payers driving investment in ACOs Increasing data systems ability to produce quality measures Federal investments to improve research infrastructure/methods/processes Risk-based payments move towards capitation Increasing willingness and ability to invest in EHRs and desire to reduce system costs Changing locus of decision-making providing opportunities for new partnerships Transition from most likely scenario to most conducive scenario
- 5. EUROPE CRITICAL KEY FACTORS IDENTIFIED -- DEFINITIONS TOP TWO CRITICAL KEY FACTORS SECOND TWO CRITICAL KEY FACTORS Regulatory change: New pharmaco-vigilance regulation enables the EMA to seek “efficacy” data in addition to “safety” (at first authorisation or post-authorisation) in order to inform a benefit-risk assessment of a medicine. Adaptive Licensing: prospectively planned, flexible approach to regulation with iterative phases of evidence gathering to reduce uncertainties followed by regulatory evaluation and license adaptation Coordination between regulatory and HTA bodies: Interaction between regulatory and HTA bodies can in principle cover one or more of: • the offering of scientific advice both pre- and post-launch leading to • the possible coordination and/ or agreement on evidence requirements (e.g. type of study design and type of end points to be included) HTA change: Assessment of clinical evidence by bodies/payers at launch identifying incremental effectiveness of a new medicine (compared to current practice) based on clinical trial data and modelling techniques Demand for post-launch RE studies by HTA bodies/payers Studies requested by HTA bodies/payers to demonstrate benefits in real world setting Infrastructure and methods: The extent to which: • improvements in research infrastructures and in the availability of data are made • robust methodologies to analyse evidence produced by RE studies will be developed and agreed by key stakeholders
- 6. MOVEMENT TOWARD GREATER EVIDENCE “HARMONIZATION” IN EUROPE Post-authorisation efficacy studies (PAES) implemented Greater HTA and EMA coordination pre-launch Disease registries in some countries , and progress in EHRs Coordination across HTA bodies in demand for P-L studies, often linked to CED, P4P schemes Collaborations across large registries Full use of EHRs Good progress in methods Public-private partnerships have a major role AL applied to a variety of drugs Joint HTA and EMA coordination for pre-and post- launch Transition from most likely scenario to most conducive scenario
- 7. SIMILARITIES BETWEEN US AND EU MOST LIKELY SCENARIOS FOR COMPARATIVE EFFECTIVENESS RESEARCH (CER) AND RELATIVE EFFECTIVENESS (RE) EVIDENCE • Cost pressures require increasing focus on efficiency and on value. • Payers/Health Technology Assessment (HTA) bodies will impose greater demands for CER/RE evidence for access, preferential tier placement/favorable pricing; how does this: • work in my population? • compare with existing alternatives? • affect resource use/ cost? • Payers/HTA bodies will still require Randomized Controlled Trial (RCT) or Pragmatic Controlled Trial (PCT) -based evidence for initial market access. • Progress on the development of Electronic Health Records (EHRs), patient/disease registries and on creating a more data rich environment. • Food and Drug Administration (FDA) and European Medicines Agency (EMA) both seeking to achieve earlier licensing of products. • Policies and incentives to achieve better vertical integration within health systems, together with greater data and evidence sharing between systems.
- 8. DIFFERENCES BETWEEN US AND EU MOST LIKELY SCENARIOS FOR COMPARATIVE EFFECTIVENESS RESEARCH (CER) AND RELATIVE EFFECTIVENESS (RE) EVIDENCE • The US makes greater progress than the EU in creating a data rich environment and exploring the potential of Big Data: conducive for conduct of RCTs in only select systems; largely for higher quality observational research • Greater US policy focus on and investment in increased capacity to conduct CER. In the US payers/providers conduct Real World Evidence (RWE) research. In the EU, industry is expected to fund/collect RWE. • EU reduces differences across (national) payer and HTA bodies evidence requirements. • FDA has no interest in adaptive licensing while the EMA is seeking to implement this. • EMA and HTA bodies demand active comparators. FDA does not demand active comparators • Structured scientific interaction between EMA and HTA bodies. No formal process to account for payer evidence needs in early FDA advice. • US focus on patient-centered research prominent. In EU patient influence is a less important driver.
- 9. QUESTIONS • How plausible do you find this description of the future? • Is it consistent with trends you see taking shape now? • How much might happen by 2020? • In terms of their effects on future CER and RE, do the US and EU futures create any synergies? Conflicts? Opportunities? • What are the implications for drug dvelopment?