Resources
NEWDIGS 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 publications (see below). Additionally, NEWDIGS 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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Paying for Cures
Our free interactive resource helps you explore challenges and plan solutions to financing new cell and gene therapies.
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Publications
Quinn, C., Ciarametaro, M., Sils, B., Phares, S., & Trusheim, M. R. (2023). Value-based performance arrangements for chronic conditions: an economic simulation of Medicaid Drug Rebate Program reforms. Expert Review of Pharmacoeconomics & Outcomes Research, 0(0), 1–12. https://doi.org/10.1080/14737167.2023.2193331
Schaumberg, D., Larholt, K., Apgar, E., Pashos, C. L., & Hirsch, G. (2023). Examining Endpoint Concordance in Clinical Trials and Real-World Clinical Practice to Advance Real-World Evidence Utilization. Therapeutic Innovation & Regulatory Science. https://doi.org/10.1007/s43441-022-00492-z
Quinn, C., Ciarametaro, M., Sils, B., Phares, S., & Trusheim, M. (2023). Medicaid best price reforms to enable innovative payment models for cell and gene therapies. Expert Review of Pharmacoeconomics & Outcomes Research, 23(2), 191–203. https://doi.org/10.1080/14737167.2023.2159813
Eichler, H., Trusheim, M., Schwarzer‐Daum, B., Larholt, K., Zeitlinger, M., Brunninger, M., Sherman, M., Strutton, D., & Hirsch, G. (2022). Precision Reimbursement for Precision Medicine: Using Real‐World Evidence to Evolve From Trial‐and‐Project to Track‐and‐Pay to Learn‐and‐Predict. Clinical Pharmacology & Therapeutics, 111(1), 52–62. https://doi.org/10.1002/cpt.2471
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., Chua, R., Del Signore, S., Dugan, U., Ferguson, J., Garner, S., Goettsch, W., Haigh, J., Honig, P., Hoos, A., Huckle, P., Kondo, T., Le Cam, Y., Leufkens, H., … 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. 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.). HealthCore. 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., Ferguson, J., Garner, S., Honig, P., Hukkelhoven, M., Lim, J. C. W., Lim, R., Lumpkin, M. M., Neil, G., O’Rourke, B., Pezalla, E., Shoda, D., Seyfert-Margolis, V., Sigal, E. V., … 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., Ette, E., Gallo, P., Hirsch, G., Mehta, C., Patel, N., Sabir, S., Springs, S., Stanski, D., Evers, M. R., Fleming, E., Singh, N., Tramontin, T., & 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., Norwalk, L., & 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., Lim, R., Longson, C., Pezalla, E., Salmonson, T., Samaha, D., Tunis, S., Woodcock, J., & 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., Ferguson, J., Pezalla, E., Rassen, J. A., Selker, H. P., Trusheim, M., & 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., Flaherty, K., Loewy, J., Lacombe, D., Madhavan, S., Selker, H., & 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., Natesan, S., & 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