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Paying for Cure Toolkit

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Publications

Payer Perspectives on Reimbursement of One-Time High-Cost Durable Therapies | Pharmaceutical Executive. (n.d.). Retrieved February 12, 2020, from http://www.pharmexec.com/payer-perspectives-reimbursement-one-time-high-cost-durable-therapies
Eichler, H.-G., Baird, L., Barker, R., Bloechl-Daum, B., Børlum-Kristensen, F., Brown, J., … Hirsch, G. (2015). From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients. Clinical Pharmacology & Therapeutics, 97(3), 234–246. https://doi.org/10.1002/cpt.59
Resnick, J. (n.d.). AccessPoint is published twice yearly by QuintilesIMS Real-World Insights, 60. Retrieved from https://www.iqvia.com/-/media/quintilesims/pdfs/accesspoint/quintilesims-rwi-accesspoint-may2017.pdf
Hirsch, G. (2019). Leaping Together Toward Sustainable, Patient‐Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change. Clinical Pharmacology & Therapeutics, 105(4), 798–801. https://doi.org/10.1002/cpt.1237
Barlow, J. F., Yang, M., & Teagarden, J. R. (2019). Are Payers Ready, Willing, and Able to Provide Access to New Durable Gene Therapies? Value in Health, 22(6), 642–647. https://doi.org/10.1016/j.jval.2018.12.004
Trusheim, J. B. R. T. M. (n.d.). Precision Financing of Durable, Potentially Curative Therapies. Retrieved May 24, 2019, from http://www.pharmexec.com/precision-financing-durable-potentially-curative-therapies
How to Design and Implement Pragmatic Trials for Success: Generate Relevant and High-Level Real-World Evidence. (n.d.). Retrieved November 14, 2018, from https://www.healthcore.com/pct/
Eichler, H.-G., Oye, K., Baird, L. G., Abadie, E., Brown, J., Drum, C. L., … Hirsch, G. (2012). Adaptive licensing: taking the next step in the evolution of drug approval. Clinical Pharmacology and Therapeutics, 91(3), 426–437. https://doi.org/10.1038/clpt.2011.345
Orloff, J., Douglas, F., Pinheiro, J., Levinson, S., Branson, M., Chaturvedi, P., … Golub, H. (2009). The future of drug development: advancing clinical trial design. Nature Reviews Drug Discovery, 8(12), 949–957. https://doi.org/10.1038/nrd3025
Baird, L. G., Trusheim, M. R., Eichler, H.-G., Berndt, E. R., & Hirsch, G. (2013). Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development. Therapeutic Innovation & Regulatory Science, 47(4), 474–483. https://doi.org/10.1177/2168479013487355
Papadaki, M., & Hirsch, G. (2013). Curing Consortium Fatigue. Science Translational Medicine, 5(200), 200fs35-200fs35. https://doi.org/10.1126/scitranslmed.3006903
Oye, K., Baird, L. G., Chia, A., Hocking, S., Hutt, P. B., Lee, D., … Salvatore, V. (2013). Legal Foundations of Adaptive Licensing. Clinical Pharmacology & Therapeutics, 94(3), 309–311. https://doi.org/10.1038/clpt.2013.95
Trusheim, M. R., Baird, L. G., Garner, S., Lim, R., Patel, N., & Hirsch, G. (2014). The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions. Health Policy and Technology, 3(4), 241–247. https://doi.org/10.1016/j.hlpt.2014.10.004
Teagarden, J. R., Unger, T. F., & Hirsch, G. (2014). Access and availability of orphan drugs in the United States: advances or cruel hoaxes? Expert Opinion on Orphan Drugs, 2(11), 1147–1150. https://doi.org/10.1517/21678707.2014.947265
Baird, L. G., Banken, R., Eichler, H.-G., Kristensen, F. B., Lee, D. K., Lim, J. C. W., … Hirsch, G. (2014). Accelerated Access to Innovative Medicines for Patients in Need. Clinical Pharmacology & Therapeutics, 96(5), 559–571. https://doi.org/10.1038/clpt.2014.145
Beshansky, J. R., Sheehan, P. R., Klima, K. J., Hadar, N., Vickery, E. M., & Selker, H. P. (2014). A community consultation survey to evaluate support for and success of the IMMEDIATE trial. Clinical Trials, 11(2), 178–186. https://doi.org/10.1177/1740774514526476
Trusheim, M. R., & Berndt, E. R. (2015). The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics. Drug Discovery Today, 20(12), 1439–1450. https://doi.org/10.1016/j.drudis.2015.10.017
Oye, K. A., Jain, G., Amador, M., Arnaout, R., Brown, J. S., Crown, W., … Hirsch, G. (2015). The next frontier: Fostering innovation by improving health data access and utilization. Clinical Pharmacology & Therapeutics, 98(5), 514–521. https://doi.org/10.1002/cpt.191
Bouvy, J. C., Jonsson, P., Longson, C., Crabb, N., & Garner, S. (2016). Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities. Clinical Pharmacology & Therapeutics, 100(6), 594–597. https://doi.org/10.1002/cpt.448
Raju, G. K., Gurumurthi, K., Domike, R., Kazandjian, D., Blumenthal, G., Pazdur, R., & Woodcock, J. (2016). A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer. Clinical Pharmacology & Therapeutics, 100(6), 672–684. https://doi.org/10.1002/cpt.501
Oye, K. A., Eichler, H. G., Hoos, A., Mori, Y., Mullin, T. M., & Pearson, M. (2016). Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan. Clinical Pharmacology & Therapeutics, 100(6), 626–632. https://doi.org/10.1002/cpt.505
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation - Duane Schulthess, Lynn G. Baird, Mark Trusheim, Thomas F. Unger, Murray Lumpkin, Anton Hoos, Sarah Garner, Pamela Gavin, Michel Goldman, Nathalie Seigneuret, Magda Chlebus, Karin Van Baelen, Richard Bergstrom, Gigi Hirsch, 2016. (n.d.). Retrieved November 14, 2018, from https://journals.sagepub.com/doi/10.1177/2168479015618697
Trusheim, M., Shrier, A., Antonijevic, Z., Beckman, R., Campbell, R., Chen, C., … Esserman, L. (2016). PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms. Clinical Pharmacology & Therapeutics, 100(6), 713–729. https://doi.org/10.1002/cpt.514
“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials? - Eichler - 2016 - Clinical Pharmacology & Therapeutics - Wiley Online Library. (n.d.). Retrieved November 14, 2018, from https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.515
Stewart, S. R., Barone, P. W., Bellisario, A., Cooney, C. L., Sharp, P. A., Sinskey, A. J., … Springs, S. L. (2016). Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation. Clinical Pharmacology & Therapeutics, 100(6), 647–653. https://doi.org/10.1002/cpt.504
Leveraging Industry‐Academia Collaborations in Adaptive Biomedical Innovation - Stewart - 2016 - Clinical Pharmacology & Therapeutics - Wiley Online Library. (n.d.). Retrieved November 14, 2018, from https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1002/cpt.504
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need - Hirsch - 2016 - Clinical Pharmacology & Therapeutics - Wiley Online Library. (n.d.). Retrieved November 14, 2018, from https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.509
Read “Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop” at NAP.edu. (n.d.). https://doi.org/10.17226/24829
Ciarametaro, M. T. D. S. M. G. L. W. D. H. M. (n.d.). Improving Management of Gene and Cell Therapies. Retrieved November 13, 2018, from http://www.pharmexec.com/improving-management-gene-and-cell-therapies
Trusheim, M. R., Cassidy, W. M., & Bach, P. B. (2018). Alternative State-Level Financing for Hepatitis C Treatment—The “Netflix Model.” JAMA. https://doi.org/10.1001/jama.2018.15782

Research briefs

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How can self-insured employers prepare for the portfolio impact of highcost gene therapies coming to market?

April 28, 2022

Payer perspectives on outcomes tracking for value-based payment arrangements (VBPs)

March 25, 2021

The resource navigation challenges for patients and caregivers

January 29, 2021

Updated projection of US durable cell and gene therapies product-indication approvals based on December 2019 development pipeline

July 29, 2020

Impact of FDA Guidelines on Communication between Developers and Payers on Metrics in Performance-Based Agreements

January 22, 2020

Precision Financing challenges for solid tumor adoptive T-cell therapies

December 19, 2019

Tracking Medicaid Coverage of Durable Cell and Gene Therapies

September 26, 2019

State Insurance Regulations Regarding Benefit Design (Deductible and Co-Pay Waivers)

August 23, 2019

Payer Perspectives Survey

June 26, 2019

Pediatric Gene Therapy Launches

May 24, 2019

Patient & Caregiver Themes Survey

March 21, 2019

Incorporation of Value-Based Payment Agreements into the Calculation of Medicaid Drug Rebates

January 24, 2019

Clinical trials and investment trends for novel CAR-T and TCR therapies

December 21, 2018

Model Contracts for Innovative Oncology Therapies

November 29, 2018

Role of COE networks in curative cellular oncology therapies

September 21, 2018

Stop-Loss Insurance or Reinsurance for Multiyear Contracts

July 13, 2018

Impact of Patient Mobility on Annuity/Performance-Based Contracting

June 15, 2018

Orphan Reinsurer Benefit Managers (ORBMs)

May 22, 2018

Impact of Actuarial Risk on Health Plans

April 19, 2018

Designing Precision Financing for Cures

March 15, 2018


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