| Managing the challenges of paying for gene therapy: strategies for market action and policy reform in the United States |
Payment innovation designs, Policy |
Publications |
November 15, 2024 |
| Implementation Brief: Innovative contracting 101 |
Implementation, Payment innovation designs |
Implementation Briefs |
August 22, 2024 |
| Implementation Brief: Access considerations for innovative treatments |
Implementation, Payment innovation designs |
Implementation Briefs |
July 16, 2024 |
| Implementation Brief: Key terms for payment innovation |
Implementation, Payment innovation designs |
Implementation 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 |
Implementation 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 |
Implementation 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, RWE |
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, RWE |
|
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 |
| Extending the vision of adaptive point-of-care platform trials to improve targeted use of drug therapy regimens: An agile approach in the learning healthcare system toolkit |
Learning health system, RWE |
Publications |
August 29, 2023 |
| Innovating methods for planning, producing, and using real-world evidence |
Implementation, Outcomes tracking, RWE |
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, RWE |
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, RWE |
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, RWE |
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, RWE |
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, RWE |
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, RWE |
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, RWE |
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, RWE |
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, RWE |
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, RWE |
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, RWE |
Whitepapers |
May 25, 2009 |
