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Implementing outcomes-based risk-sharing agreements: an integrative review of applications in blood cancer in the UK and beyond

EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH (2023)

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Article Economics

Don't Think Twice, It's All Right: Using Additional Data to Reduce Uncertainty Regarding Oncologic Drugs Provided Through Managed Access Agreements in England

Jiyeon Kang et al.

Summary: This study examines the uncertainties and use of additional data in the Cancer Drugs Fund (CDF) in England. The findings suggest that immaturity of clinical trial data and limited utilization of real-world data (RWD) are the main sources of uncertainty, highlighting the importance of longer follow-up of clinical trials.

PHARMACOECONOMICS-OPEN (2023)

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Article Pharmacology & Pharmacy

Introduction of managed entry agreements in Korea: Problem, policy, and politics

Hyungmin Kim et al.

Summary: Objective of this study was to understand Managed Entry Agreements (MEAs) in Korea using the policy window model, and to analyze its practical management and impact on pricing and reimbursement scheme. Through literature review and descriptive analysis, it was found that MEAs were introduced in Korea as a benefit enhancement plan and as a bypass mechanism to expand insurance coverage. However, the application of MEAs varies across countries, lacking consistency compared to Korea.

FRONTIERS IN PHARMACOLOGY (2023)

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Review Economics

The Challenges of Outcomes-Based Contract Implementation for Medicines in Europe

Natalie Bohm et al.

Summary: The study outlined the challenges of implementing outcomes-based contracts (OBCs) in Europe, revealing multiple barriers that need to be overcome for OBCs to be widely adopted across the region. These challenges were grouped into five key themes: negotiation framework, outcomes, data, administration and implementation, and laws and regulations.

PHARMACOECONOMICS (2022)

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Article Pharmacology & Pharmacy

Critical Reflections on Reimbursement and Access of Advanced Therapies

Steven Simoens et al.

Summary: This manuscript critically reflects on the assessment criteria and access conditions for reimbursement of advanced therapies through a review of the literature. The findings indicate that advanced therapies can be cost-effective at high prices set by manufacturers, but many payers undervalue these products. Additionally, advanced therapies can be affordable and may not require staggered payments. While outcome-based managed entry agreements are theoretically attractive, they present challenges in practice. Lastly, multinational collaborations play a role in managing the reimbursement and access of advanced therapies.

FRONTIERS IN PHARMACOLOGY (2022)

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Article Medicine, General & Internal

Delayed payment schemes in Central-Eastern Europe and Middle-East

Ildiko Adam et al.

Summary: This study aims to address the barriers to implementing delayed payment models in lower income countries of Central and Eastern Europe (CEE) and the Middle East (ME), and provides specific recommendations. Through survey, literature review, and brainstorming, we identified eight barriers and prepared fifteen recommendations to overcome these barriers. These findings are important for facilitating a multistakeholder dialogue on implementing delayed payment schemes in CEE and ME countries.

FRONTIERS IN MEDICINE (2022)

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Article Health Care Sciences & Services

Impact of Managed Entry Agreements on availability of and timely access to medicines: an ex-post evaluation of agreements implemented for oncology therapies in four countries

Olina Efthymiadou et al.

Summary: This study evaluates the impact of Managed Entry Agreements (MEAs) on access to rejected oncology medicines and finds that MEA can increase the likelihood of reimbursement. However, approval with MEA may lead to longer time for final funding decisions.

BMC HEALTH SERVICES RESEARCH (2022)

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Article Medicine, General & Internal

Outcome-based reimbursement in Central-Eastern Europe and Middle-East

Ildiko Adam et al.

Summary: Outcome-based reimbursement models can reduce financial risk to health care payers in cases of uncertainty or heterogeneity. However, in lower income countries, financial based agreements are relied upon to manage uncertainties associated with new therapies. This study explores potential barriers and solutions to outcome-based agreements in Central and Eastern Europe and the Middle East, and presents recommendations for implementing these models.

FRONTIERS IN MEDICINE (2022)

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An Arm and a Leg: The Rising Cost of Cancer Drugs and Impact on Access

Natasha B. Leighl et al.

American Society of Clinical Oncology educational book / ASCO. American Society of Clinical Oncology. Meeting (2021)

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Review Economics

Which Criteria are Considered and How are They Evaluated in Health Technology Assessments? A Review of Methodological Guidelines Used in Western and Asian Countries

Yitong Wang et al.

Summary: This study provides a comprehensive description of evaluation criteria and methodological recommendations in health technology assessment (HTA) in Western and Asian countries. A strong consensus on core criteria and more similarities than differences in methodological recommendations were observed among the HTA agencies. Further efforts are needed to validate the incorporation and assessment of identified criteria in real HTA decisions.

APPLIED HEALTH ECONOMICS AND HEALTH POLICY (2021)

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Review Oncology

Novel agents and regimens for hematological malignancies: recent updates from 2020 ASH annual meeting

Jing-Zhou Hou et al.

Summary: Antibodies and CAR-T cells are increasingly used in cancer immunotherapy for hematological malignancies. Small molecule inhibitors targeting oncoproteins and enzymes have been approved for several major hematological malignancies. Updates on novel agents and regimens from clinical trials were presented at the recent ASH annual meeting and other conferences.

JOURNAL OF HEMATOLOGY & ONCOLOGY (2021)

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Article Oncology

Describing Sources of Uncertainty in Cancer Drug Formulary Priority Setting across Canada

Kristina Jenei et al.

Summary: The study reveals that decision makers are dealing with a significant amount of uncertainty in funding decisions for cancer drugs, largely stemming from methodological limitations in clinical trials. There is a critical need for transparent priority-setting processes and mechanisms to reevaluate drugs to ensure benefit.

CURRENT ONCOLOGY (2021)

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Review Health Care Sciences & Services

Risk sharing in managed entry agreements-A review of the Swedish experience

Emelie Andersson et al.

HEALTH POLICY (2020)

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Review Economics

Integrative Review of Managed Entry Agreements: Chances and Limitations

Carolina Zampirolli Dias et al.

PHARMACOECONOMICS (2020)

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Article Health Care Sciences & Services

Improving Access to High-Cost Technologies in the Asia Region

Linda Mundy et al.

INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE (2019)

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Article Health Care Sciences & Services

CHARACTERISTICS OF MANAGED ENTRY AGREEMENTS IN AUSTRALIA

Maxine F. Robinson et al.

INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE (2018)

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Review Economics

The Australian Managed Entry Scheme: Are We Getting it Right?

Haitham W. Tuffaha et al.

PHARMACOECONOMICS (2018)

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Review Economics

Risk-Sharing Agreements in the EU: A Systematic Review of Major Trends

Trevor Jozef Piatkiewicz et al.

PHARMACOECONOMICS-OPEN (2018)

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Article Economics

Health Technology Assessment (HTA) Case Studies: Factors Influencing Divergent HTA Reimbursement Recommendations in Australia, Canada, England, and Scotland

Nicola Allen et al.

VALUE IN HEALTH (2017)

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Article Economics

Towards Integrated Health Technology Assessment for Improving Decision Making in Selected Countries

Wija Oortwijn et al.

VALUE IN HEALTH (2017)

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Article Pharmacology & Pharmacy

Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future

Kim Pauwels et al.

FRONTIERS IN PHARMACOLOGY (2017)

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Article Health Care Sciences & Services

Performance-Based Risk-Sharing Arrangements for Pharmaceutical Products in the United States: A Systematic Review

Justin S. Yu et al.

Journal of Managed Care & Specialty Pharmacy (2017)

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Article Economics

Do the Current Performance-Based Schemes in Italy Really Work? Success Fee: A Novel Measure for Cost-Containment of Drug Expenditure

Andrea Navarria et al.

VALUE IN HEALTH (2015)

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Review Economics

Current Status and Trends in Performance-Based Risk-Sharing Arrangements Between Healthcare Payers and Medical Product Manufacturers

Josh J. Carlson et al.

APPLIED HEALTH ECONOMICS AND HEALTH POLICY (2014)

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Article Economics

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

Louis P. Garrison et al.

VALUE IN HEALTH (2013)

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Article Health Care Sciences & Services

Informing a decision framework for when NICE should recommend the use of health technologies only in the context of an appropriately designed programme of evidence development

K. Claxton et al.

HEALTH TECHNOLOGY ASSESSMENT (2012)

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Review Health Care Sciences & Services

Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers

Josh J. Carlson et al.

HEALTH POLICY (2010)

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Article Health Care Sciences & Services

Coverage with Evidence Development: Applications and issues

Paul Trueman et al.

INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE (2010)

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Article Oncology

Uncertainty in Assessing Value of Oncology Treatments

C. Daniel Mullins et al.

ONCOLOGIST (2010)

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