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Wim Goettsch PhD

Wim Goettsch PhD. Project leader of WP5 of EUnetHTA JA2 on rapid assessments/ Advisor international affairs National Health Care Institute, Diemen, The Netherlands. Introduction. VS. FINANCIAL CRISIS!.

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Wim Goettsch PhD

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  1. Wim Goettsch PhD Project leader of WP5 of EUnetHTA JA2 on rapid assessments/ Advisor international affairs National Health Care Institute, Diemen, The Netherlands

  2. Introduction VS.

  3. FINANCIAL CRISIS! * Health Technology Assessment (HTA) is a multi-disciplinary field of policy analysis that examines the medical, economic, social and ethical implications of the incremental value, diffusion and use of a medical technology in health care (INAHTA). Decrease of the growth of the healthcare budget is necessary in order keep a sustainable total government budget on the long term Instead of non-discriminative budget cuts HTA* will be used to help payers to select health technologies that offer the best value for money and/or help the patients with highest unmet need HTA will also help to identify obsolete and cost-ineffective health technologies that may be delisted for reimbursement and/or deleted from hospital formularies/therapy guidelines etc.

  4. HTA and Health Technology Life-cycle HTA / REA* Disinvestment? Use of technology in health care Early scientific advice RapidREA* Additionaldatacollection Time line of innovation * Relative Effectiveness Assessment (REA) is the extent to which an intervention does more good than harm under the usual circumstance of health care practice, compared to one or more alternative interventions (Pharma Forum 2008

  5. Reasons for European collaboration on HTA • Technologies become more ‘international’ • Patients become more ‘European’ • Decrease duplication on HTA assessments • For some technologies, such as drugs in oncology, assessments are performed simultaneously by different national and regional organisations • Increase consistency between different national HTA assessments • But, NO European health insurance, so decisions on reimbursement should be made on a national level!

  6. Overview by EUnetHTA EUnetHTA reviewed similarities/differences in HTA on pharmaceuticals in Europe Most countries assess relative effectiveness after MA Differences in terminology more common than differences in methodology Also cost-effectiveness assessment important for reimbursement DECREASE OF OVERLAP IS POSSIBLE! http://www.eunethta.eu/outputs/final-version-background-review-relative-effectiveness-assessment

  7. What is value in Europe?

  8. Possible efficiency gains of European collaboration European Commission commissioned report on possible gains: Prepared by ECORYS, published in early 2013. Efficiency gains for industry and HTA agencies (>20 mln Euro) if joint reports Additional gains possible if this leads to more timely access

  9. Pilot joint assessments Started in 2012: Planned 10 pharma and 4 others (mostly med. devices) Until now 2 pharma and 2 others published Implementation in national procedures is key Should lead to quicker and more consistent processes

  10. Synergy between regulation and HTA? Alignment between regulation and HTA Closer synchronization between assessment processes Working together on parallel scientific advice Collaboration on post-market and reimbursement data collection

  11. Flexible value-based access and pricing • One size fits all vs. more tailor-made approach • Risk based approach (only assessment if there are risks (safety, questions on additional benefits, budget-impact, unclear cost-effectiveness) • Conditional reimbursement or Coverage with Evidence • Value of intervention in real-life will be monitored • Managed Entry Schemes more popular: • Pay for performance, risk sharing agreements (value-based schemes) • Price-volume deals, price-caps (cost-based schemes)

  12. Consequences for investments in Europe? • Faster access to very promising technologies (significant value) for patients with a high unmet need • More pressure on pricing, in return for faster access governments, social and private payers will request lower prices (price deals) • Prices for (new) products will probably vary based on a number of factors like: • Estimated value (including perceived uncertainty (i.e. on effectiveness) • Timing of access • Definition of exact population (size) • More emphasis on early HTA, so that decisions to continue or stop with the development of new technologies can prepared earlier.

  13. Consequences for global investments? * Health Technology Assessment (HTA) is a multi-disciplinary field of policy analysis that examines the medical, economic, social and ethical implications of the incremental value, diffusion and use of a medical technology in health care (INAHTA). • Determination of the value of new technologies becomes more dominant: • Outcome-based financing (No cure-no pay….) • Value-based pricing or value-based assessment • But what is value? Relative effectiveness? • Risk-Benefit, Harm-Benefit or Clinical Added Value • Broader HTA* perspective? • Social well-being, Capability

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