Publications and media

CBSD produces original white papers, research briefs, and free downloadable tools to help stakeholders learn about and implement innovative strategies. We also publish in peer-reviewed journals and industry articles. Additionally, CBSD hosts Paying for Cures, a comprehensive resource for research and strategies to make innovative cell and gene therapies accessible to patients and sustainable systemwide.

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Title Topics Type Date
Implementation Brief: Access considerations for innovative treatments Implementation, Payment innovation designs Research Briefs July 16, 2024
Implementation Brief: Key terms for payment innovation Implementation, Payment innovation designs Research Briefs June 19, 2024
Implementation Brief: Considerations for developers in applying the Multiple Best Price (MBP) rule to improve access to novel therapies Implementation, Monitoring, Policy Research Briefs May 21, 2024
BioCentury OpEd: Biomedical Innovation Requires Health System Innovation Collaboration, Overviews Articles May 13, 2024
Implementation Brief: Understanding access issues for new therapies Implementation, Monitoring Research Briefs April 25, 2024
Managing the Challenges of Paying for Gene Therapy: Strategies for Market Action and Policy Reform Payment innovation designs, Policy Publications, Whitepapers April 23, 2024
Better Outcomes Tracking: A First Step In Improving Access To New Treatments Outcomes tracking Articles, Publications April 8, 2024
Emerging market solutions for financing and reimbursement of gene therapies for sickle cell disease: Why do payment innovation? Monitoring, Payment innovation designs Research Briefs February 28, 2024
Ask PAM: “How many?” Pipeline January 11, 2024
Analyzing 340B and ASP interactions: Do Federal program rules disincentivize the use of VBCs, despite Medicaid Best Price reform? Monitoring, Policy Research Briefs October 19, 2023
Are Cell and Gene Therapy programs a better bet? Implementation, Monitoring, Pipeline Research Briefs October 11, 2023
Innovating methods for planning, producing, and using real-world evidence Implementation, Outcomes tracking Research Briefs July 20, 2023
Payer and developer perspectives on alternative payment models Implementation, Overviews, Payment innovation designs Publications July 14, 2023
A practical approach for defining outcomes and thresholds for predictive healthcare algorithm development using real-world dataOut Outcomes tracking Whitepapers March 28, 2023
Medicaid best price reforms to enable innovative payment models for cell and gene therapies Monitoring, Overviews, Policy Publications December 29, 2022
How can self-insured employers prepare for the portfolio impact of highcost gene therapies coming to market? Implementation, Monitoring, Overviews, Payment innovation designs, Pipeline Research Briefs April 28, 2022
Broadly Engaged Team Science Comes to Life in a Design Lab Collaboration, Overviews Publications February 27, 2022
Data for modelling US projections of product approvals, patients treated, and product revenues for durable cell and gene therapies Monitoring, Pipeline Publications February 11, 2022
Durable cell and gene therapy potential patient and financial impact: US projections of product approvals, patients treated, and product revenues Monitoring, Pipeline Publications December 24, 2021
Precision Reimbursement for Precision Medicine: Using Real-World Evidence to Evolve From Trial-and-Project to Track-and-Pay to Learn-and-Predict Learning health system, Outcomes tracking, Payment innovation designs Publications October 30, 2021
Precision for Whom? Partnering with patients to ensure that Precision Medicine targets what matters Collaboration, Overviews Research Briefs September 30, 2021
Tracking the CAR-T Revolution: Analysis of Clinical Trials of CAR-T and TCR-T Therapies for the Treatment of Cancer (1997–2020) Access, Monitoring, Pipeline Publications July 7, 2021
Emerging market solutions for financing and reimbursement of durable cell and gene therapies Access, Implementation, Monitoring, Outcomes, Outcomes tracking, Payment innovation designs, RWE Whitepapers June 16, 2021
Payer perspectives on outcomes tracking for value-based payment arrangements (VBPs) Implementation, Monitoring, Outcomes tracking, Payment innovation designs, RWE Research Briefs March 25, 2021
The resource navigation challenges for patients and caregivers Collaboration, Overviews, Payment innovation designs Research Briefs January 29, 2021
Warranty Model: A potential precision financing solution for durable cell and gene therapies Access, Outcomes, Outcomes tracking, Payment innovation designs, RWE Whitepapers October 30, 2020
Updated projection of US durable cell and gene therapies product-indication approvals based on December 2019 development pipeline Monitoring, Pipeline, Policy Research Briefs July 29, 2020
Tracking the CAR-T revolution: Analysis of clinical trials of CAR-T and TCR therapies for the treatment of cancer Monitoring, Pipeline Whitepapers June 25, 2020
Payer Perspectives on Gene Therapy Reimbursement Monitoring Articles April 1, 2020
Downstream Innovation Part II Collaboration, Overviews Research Briefs February 27, 2020
Impact of FDA Guidelines on Communication between Developers and Payers on Metrics in Performance-Based Agreements Implementation, Outcomes tracking, Overviews, Payment innovation designs, Policy, RWE Research Briefs January 22, 2020
Payer Perspectives on Reimbursement of One-Time High-Cost Durable Therapies Monitoring, Payment innovation designs Articles January 9, 2020
Precision Financing challenges for solid tumor adoptive T-cell therapies Overviews, Payment innovation designs Research Briefs December 19, 2019
Downstream Innovation Part I Collaboration, Overviews Research Briefs November 27, 2019
Tools for Implementation of Precision Financing Solutions Within Medicaid Plans Access, Implementation, Payment innovation designs, Policy Whitepapers November 21, 2019
Advancing Healthcare through Innovation and Collaboration Collaboration, Overviews Whitepapers November 6, 2019
Payer Perspectives on Financing and Reimbursement of One-time High-cost Durable Treatments Implementation, Monitoring, Policy Whitepapers October 11, 2019
Tracking Medicaid Coverage of Durable Cell and Gene Therapies Monitoring, Policy Research Briefs September 26, 2019
Transforming Real-World Evidence in Biomedical Innovation: Advancing the Design of Collaborative Disease-Focused Learning Ecosystems Collaboration Research Briefs September 26, 2019
The Role of Stop-Loss Insurance and Reinsurance in Managing Performance-Based Agreements Outcomes tracking, Overviews, Payment innovation designs, RWE Whitepapers September 16, 2019
State Insurance Regulations Regarding Benefit Design (Deductible and Co-Pay Waivers) Monitoring, Payment innovation designs, Policy Research Briefs August 23, 2019
Baking the Cake: A decision driven framework for planning fit-forpurpose evidence across stakeholders Outcomes tracking, Overviews Research Briefs August 22, 2019
Payer Perspectives Survey Monitoring, Overviews, Payment innovation designs Research Briefs June 26, 2019
Estimating the Clinical Pipeline of Cell and Gene Therapies and Their Potential Economic Impact on the US Healthcare System Payment innovation designs, Pipeline Articles June 1, 2019
Are Payers Ready, Willing, and Able to Provide Access to New Durable Gene Therapies? Monitoring, Payment innovation designs Articles June 1, 2019
Massachusetts Pilot Disease Selection Outcomes tracking, Overviews Research Briefs May 24, 2019
Pediatric Gene Therapy Launches Monitoring, Pipeline, RWE Research Briefs May 24, 2019
Patient & Caregiver Themes Survey Monitoring, Outcomes tracking, Overviews, RWE Research Briefs March 21, 2019
Precision Financing of Durable, Potentially Curative Therapies Monitoring, Overviews, Payment innovation designs Articles January 27, 2019
Precision Financing Solutions for Durable / Potentially Curative Therapies Overviews, Payment innovation designs Whitepapers January 24, 2019
Incorporation of Value-Based Payment Agreements into the Calculation of Medicaid Drug Rebates Overviews, Payment innovation designs, Policy Research Briefs January 24, 2019
Clinical trials and investment trends for novel CAR-T and TCR therapies Monitoring, Pipeline Research Briefs December 21, 2018
Model Contracts for Innovative Oncology Therapies Monitoring, Outcomes tracking, Overviews, Payment innovation designs Research Briefs November 29, 2018
Leaping Together Toward Sustainable, Patient‐Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change Collaboration, Overviews Articles November 2, 2018
Alternative State-Level Financing for Hepatitis C Treatment—The “Netflix Model” Payment innovation designs Articles October 29, 2018
Role of COE networks in curative cellular oncology therapies Implementation, Learning health system, Monitoring, Outcomes tracking Research Briefs September 21, 2018
Improving Management of Gene and Cell Therapies: The Orphan Reinsurer and Benefit Manager (ORBM) Payment innovation designs Articles September 10, 2018
Improving Management of Gene and Cell Therapies Implementation, Monitoring, Pipeline Articles September 10, 2018
Designing financial solutions to ensure affordable access to cures Collaboration, Overviews, Payment innovation designs Whitepapers August 23, 2018
Stop-Loss Insurance or Reinsurance for Multiyear Contracts Implementation, Overviews, Payment innovation designs Research Briefs July 13, 2018
Impact of Patient Mobility on Annuity/Performance-Based Contracting Overviews, Payment innovation designs Research Briefs June 15, 2018
Orphan Reinsurer Benefit Managers (ORBMs) Overviews, Payment innovation designs Research Briefs May 22, 2018
Impact of Actuarial Risk on Health Plans Monitoring, Overviews, Payment innovation designs Research Briefs April 19, 2018
Designing Precision Financing for Cures Monitoring, Overviews, Payment innovation designs Research Briefs March 15, 2018
The heterogeneity of health care payers suggests that durable therapies need precision financing targeted to each payer segment Overviews Research Briefs February 16, 2018
Payers Open to Innovative Financing Mechanisms for High Cost Gene Therapies Monitoring, Payment innovation designs, Policy Research Briefs December 15, 2017
Adaptive Pathways create win-win scenarios for patients and pharma Monitoring Articles May 1, 2017
Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop Implementation, Learning health system Publications March 8, 2017
Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation Collaboration, Overviews Articles December 1, 2016
Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan Monitoring, Payment innovation designs Articles December 1, 2016
A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer Outcomes tracking, Policy Articles December 1, 2016
Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities Monitoring, Overviews Articles December 1, 2016
“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials? Outcomes tracking Articles September 21, 2016
PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms Implementation, Learning health system, Monitoring Articles September 19, 2016
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need Collaboration, Overviews Articles September 14, 2016
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation Collaboration, Implementation Articles December 10, 2015
The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics Overviews Articles December 1, 2015
The next frontier: Fostering innovation by improving health data access and utilization Outcomes tracking Articles November 1, 2015
From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients Articles March 1, 2015
The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions Collaboration, Implementation, Monitoring, Policy Publications December 1, 2014
Accelerated Access to Innovative Medicines for Patients in Need Collaboration, Overviews Articles November 1, 2014
Access and availability of orphan drugs in the United States: advances or cruel hoaxes? Monitoring Articles November 1, 2014
A community consultation survey to evaluate support for and success of the IMMEDIATE trial Collaboration, Implementation Articles April 1, 2014
Legal Foundations of Adaptive Licensing Overviews Publications September 1, 2013
Curing Consortium Fatigue Collaboration, Overviews Publications August 28, 2013
Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development Monitoring, Overviews Publications July 1, 2013
Adaptive licensing: taking the next step in the evolution of drug approval Implementation, Overviews Publications March 24, 2012
Catalyzing the Transformation of Healthcare Innovation Implementation, Overviews Whitepapers January 25, 2010
The future of drug development: advancing clinical trial design Overviews Publications December 1, 2009
Drug Safety Futures 2020 Policy Whitepapers May 25, 2009