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Market access of gene therapies across Europe, USA, and Canada: challenges, trends, and solutions
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Market access of gene therapies across Europe, USA, and Canada: challenges, trends, and solutions (2020)Market access of gene therapies across Eu…Outcomes-based reimbursement for gene therapies in practice: the experience of recently launched CAR-T cell therapies in major European countries (2020)Outcomes-based reimbursement …Value-Based Pricing for Emerging Gene Therapies: The Economic Case for a Higher Cost-Effectiveness Threshold (2019)Value-Based Pricing for Emerg…The Landscape of Cellular and Gene Therapy Products: Authorization, Discontinuations, and Cost (2019)The Landscape of Cellular and…Estimating the Clinical Pipeline of Cell and Gene Therapies and Their Potential Economic Impact on the US Healthcare System (2019)Estimating the Clinical Pipel…Delivering cellular and gene therapies to patients: solutions for realizing the potential of the next generation of medicine (2019)Delivering cellular and gene …Analytic Considerations in Applying a General Economic Evaluation Reference Case to Gene Therapy (2019)Analytic Considerations in Ap…Defining Elements of Value in Health Care—A Health Economics Approach: An ISPOR Special Task Force Report [3] (2018)Defining Elements of Value in…Cost Utility of Voretigene Neparvovec for Biallelic RPE65-Mediated Inherited Retinal Disease (2018)Cost Utility of Voretigene Ne…Advanced therapy medicinal products and health technology assessment principles and practices for value-based and sustainable healthcare (2018)Advanced therapy medicinal pr…Addressing the Value of Gene Therapy and Enhancing Patient Access to Transformative Treatments (2018)Addressing the Value of Gene …The assessment and appraisal of regenerative medicines and cell therapy products: an exploration of methods for review, economic evaluation and appraisal (2017)The assessment and appraisal …Gene therapy: evidence, value and affordability in the US health care system (2017)Gene therapy: evidence, value…Concise Review: The High Cost of High Tech Medicine: Planning Ahead for Market Access (2017)Concise Review: The High Cost…Overcoming Challenges Facing Advanced Therapies in the EU Market (2016)Overcoming Challenges Facing …Advanced therapy medicinal products: current and future perspectives (2016)Advanced therapy medicinal pr…The special case of gene therapy pricing (2014)The special case of gene ther…Assessing the economic challenges posed by orphan drugs (2007)The High Cost of Cancer Drugs and What We Can Do About It (2012)Economic burden of cancer across the European Union: a population-based cost analysis (2013)Challenges in Advanced Therapy Medicinal Product Development: A Survey among Companies in Europe (2018)Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries (2015)Decentralized manufacturing of cell and gene therapies: Overcoming challenges and identifying opportunities (2017)What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings (2020)Randomized, Controlled Trials, Observational Studies, and the Hierarchy of Research Designs (2000)The green book : appraisal and evaluation in central government (2003)Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan-Meier survival curves (2012)Managed Entry Agreements: Policy Analysis From the European Perspective (2020)Performance-Based Risk-Sharing Arrangements—Good Practices for Design, Implementation, and Evaluation: Report of the ISPOR Good Practices for Performance-Based Risk-Sharing Arrangements Task Force (2013)Clinical development success rates for investigational drugs (2014)Measuring the Value of Prescription Drugs (2015)A systematic review of economic evaluations of advanced therapy medicinal products (2020)HTA methodology and value frameworks for evaluation and policy making for cell and gene therapies (2020)Integrative Review of Managed Entry Agreements: Chances and Limitations (2020)Hedonic Prices and Implicit Markets: Product Differentiation in Pure Competition (1974)Cost-Effectiveness in Health and Medicine (1996)Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses (2016)A Health Economics Approach to US Value Assessment Frameworks—Summary and Recommendations of the ISPOR Special Task Force Report [7] (2018)An Overview of Value, Perspective, and Decision Context—A Health Economics Approach: An ISPOR Special Task Force Report [2] (2018)The Economic Burden of Adults with Major Depressive Disorder in the United States (2019) (2023)Toward a More General Theory of Regulation (1976)Foundations of Cost-Effectiveness Analysis for Health and Medical Practices (1977)Evaluating patient-based outcome measures for use in clinical trials. (1998)The Use of Innovative Payment Mechanisms for Gene Therapies in Europe and the USA (2021)QALYs: The Basics (2009)Legislating against Use of Cost-Effectiveness Information (2010)Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies (2020)Orphan Drugs Offer Larger Health Gains but Less Favorable Cost-effectiveness than Non-orphan Drugs (2020)Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options (2022)The Value of a Statistical Life: A Critical Review of Market Estimates Throughout the World (2003)Updating Cost-Effectiveness — The Curious Resilience of the $50,000-per-QALY Threshold (2014)Cost-Effectiveness in Health and Medicine (2016)Price and reimbursement of advanced therapeutic medicinal products in Europe: are assessment and appraisal diverging from expert recommendations? (2021)The History and Future of the “ISPOR Value Flower”: Addressing Limitations of Conventional Cost-Effectiveness Analysis (2022)Methods for the Economic Evaluation of Health Care Programmes (2005)Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications (2021)
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References

  • 2018Defining Elements of Value in Health Care—A Health Economics Approach: An ISPOR Special Task Force Report [3]544 cited
  • 2016Advanced therapy medicinal products: current and future perspectives171 cited
  • 2016Overcoming Challenges Facing Advanced Therapies in the EU Market135 cited
  • 2017The assessment and appraisal of regenerative medicines and cell therapy products: an exploration of methods for review, economic evaluation and appraisal126 cited
  • 2018Advanced therapy medicinal products and health technology assessment principles and practices for value-based and sustainable healthcare124 cited
  • 2020Outcomes-based reimbursement for gene therapies in practice: the experience of recently launched CAR-T cell therapies in major European countries120 cited
  • 2018Addressing the Value of Gene Therapy and Enhancing Patient Access to Transformative Treatments115 cited
  • 2017Gene therapy: evidence, value and affordability in the US health care system105 cited
  • 2019Value-Based Pricing for Emerging Gene Therapies: The Economic Case for a Higher Cost-Effectiveness Threshold93 cited
  • 2019Analytic Considerations in Applying a General Economic Evaluation Reference Case to Gene Therapy92 cited
  • 2019Delivering cellular and gene therapies to patients: solutions for realizing the potential of the next generation of medicine85 cited
  • 2019The Landscape of Cellular and Gene Therapy Products: Authorization, Discontinuations, and Cost80 cited
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The special case of gene therapy pricing
74 cited
  • 2019Estimating the Clinical Pipeline of Cell and Gene Therapies and Their Potential Economic Impact on the US Healthcare System74 cited
  • 2018Cost Utility of Voretigene Neparvovec for Biallelic RPE65-Mediated Inherited Retinal Disease58 cited
  • 2017Concise Review: The High Cost of High Tech Medicine: Planning Ahead for Market Access58 cited
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