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Prioritizing Early Disease Intervention

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Abstract

Scholars and practitioners have described how investing in health care earlier rather than later can be beneficial, from how “biomarkers” offer promise for early disease detection to healthcare system “incentives” that can promote early preventive medicine. Work by health economists has also made clear that the “health capital” of an individual depreciates over time in the absence of investments in health. Yet, our current policy makers and healthcare system continue prioritizing care of late-stage complex symptomatic illness, often when cure is impossible and disease reversal is improbable, thus exacerbating public health burdens. Critically missing are predicates to address this challenge include the following: first, identifying and validating the specific set of presymptomatic biomarkers that will inform the most appropriate intervention timing for those medical conditions amenable to early intervention; second, shifting fundamental health economic incentives to influence the appropriate disease prevention market; and third, formulating and executing a viable economic framework of reimbursement. We examine these predicates and propose actionable policy recommendations that may help align stakeholder interests to improve public health.

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References

  1. Schneider EC, Shah A, Doty MM, Tikkanen R, Fields K, Williams RD II. Mirror, mirror 2021—reflecting poorly: health care in the U.S. compared to other high-income countries. Commonwealth Fund; 2021.

    Google Scholar 

  2. Grossman M. On the concept of health capital and the demand for health. J Polit Econ. 1972;80:223–55.

    Article  Google Scholar 

  3. Caicedo HH, Hashimoto DA, Caicedo JC, Pentland A, Pisano GP. Overcoming barriers to early disease intervention. Nat Biotechnol. 2020;38(6):669–73.

    Article  CAS  PubMed  Google Scholar 

  4. Darrow JJ. Luxturna: FDA documents reveal the value of a costly gene therapy. Drug Discov Today. 2019;24(4):949–54.

    Article  PubMed  Google Scholar 

  5. Herold KC, Bundy BN, Long SA, Bluestone JA, DiMeglio LA, Dufort MJ, et al. An anti-CD3 antibody, Teplizumab, in relatives at risk for type 1 diabetes. New Engl J Med. 2019. https://doi.org/10.1056/NEJMoa1902226.

    Article  PubMed  Google Scholar 

  6. Korde N. Treatment of high-risk smoldering myeloma. Semin Oncol. 2016;43(6):695–6.

    Article  PubMed  Google Scholar 

  7. Mateos MV, Hernandez MT, Giraldo P, de la Rubia J, de Arriba F, Corral LL, et al. Lenalidomide plus dexamethasone versus observation in patients with high-risk smouldering multiple myeloma (QuiRedex): long-term follow-up of a randomised, controlled, phase 3 trial. Lancet Oncol. 2016;17(8):1127–36.

    Article  CAS  PubMed  Google Scholar 

  8. Administration USFaD. FDA approves first drug that can delay onset of type 1 diabetes, November 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-can-delay-onset-type-1-diabetes

  9. de Andrade LO, Pellegrini Filho A, Solar O, Rigoli F, de Salazar LM, Serrate PC, et al. Social determinants of health, universal health coverage, and sustainable development: case studies from Latin American countries. Lancet. 2015;385(9975):1343–51.

    Article  PubMed  Google Scholar 

  10. Marmot M. Social determinants of health inequalities. Lancet. 2005;365(9464):1099–104.

    Article  PubMed  Google Scholar 

  11. Public TL, Education H. a neglected social determinant of health. Lancet Public Health. 2020;5(7):e361.

    Article  Google Scholar 

  12. Murray DM, Cross WP, Simons-Morton D, Engel J, Portnoy B, Wu J, et al. Enhancing the quality of prevention research supported by the National Institutes of Health. Am J Public Health. 2015;105(1):9–12.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Huang DT, Dee DL, Ko J, Cole JG, Houston K, Sircar KD, et al. Seven prevention priorities of USPHS scientist officers. Am J Public Health. 2017;107(1):39–40.

    Article  PubMed  PubMed Central  Google Scholar 

  14. Amur S, LaVange L, Zineh I, Buckman-Garner S, Woodcock J. Biomarker qualification: toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization. Clin Pharmacol Ther. 2015;98(1):34–46.

    Article  CAS  PubMed  Google Scholar 

  15. Zhang AD, Puthumana J, Downing NS, Shah ND, Krumholz HM, Ross JS. Assessment of clinical trials supporting us food and drug administration approval of novel therapeutic agents, 1995–2017. JAMA Netw Open. 2020;3(4):e203284.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Roep BO, Peakman M. Surrogate end points in the design of immunotherapy trials: emerging lessons from type 1 diabetes. Nat Rev Immunol. 2010;10(2):145–52.

    Article  CAS  PubMed  Google Scholar 

  17. Tooley JE, Herold KC. Biomarkers in type 1 diabetes: application to the clinical trial setting. Curr Opin Endocrinol Diabetes Obes. 2014;21(4):287–92.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  18. Hait WN, Lebowitz PF. Disease interception: myths, mountains, and mole hills. Cancer Prev Res. 2016;9(8):635–7.

    Article  CAS  Google Scholar 

  19. Noubar A, Darzi A. We need health security, not just health care. The Boston Globe, April 2020. www.bostonglobe.com/2020/04/08/opinion/we-need-health-security-not-just-health-care/

  20. Muennig PA, Quan R, Chiuzan C, Glied S. Considering whether Medicaid is worth the cost: revisiting the Oregon Health Study. Am J Public Health. 2015;105(5):866–71.

    Article  PubMed  PubMed Central  Google Scholar 

  21. Meltzer MI. Introduction to health economics for physicians. Lancet. 2001;358:993–8.

    Article  CAS  PubMed  Google Scholar 

  22. Topol E. The creative destruction of medicine: how the digital revolution will create better health care. Basic Books; 2012.

    Google Scholar 

  23. FDA. Guidance for industry: enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products. Washington: FDA; 2019.

    Google Scholar 

  24. Lynch HF, Robertson CT. Challenges in confirming drug effectiveness after early approval. Science. 2021;374(6572):1205–7.

    Article  CAS  PubMed  Google Scholar 

  25. The National Association of Insurance Commissioners & The Center for Insurance Policy and Research. Action on model laws, guidelines, and white papers. Spring National Meeting; 2018.

    Google Scholar 

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Acknowledgements

Our perspective has been enhanced by conversations with esteemed colleagues, including D.A. Hashimoto, G.P. Pisano, B. Wiegand, K. Wildenhaus, R. Hendricks, A. Stern, S. Hey, J. Shrager, K. de la Haye, A. Sarpatwari, and reviewers.

Funding

JD has received research support from Arnold Ventures, the Commonwealth Fund, the Greenwall Foundation, the Harvard-MIT Center for Regulatory Science, Health Action International Program on addressing the challenge and constrains of insulin sources and supply, the Kaiser Permanent Institute for Health Policy, the National Institutes of Health, and West Health, and under a Novo Nordisk Foundation Grant for a scientifically independent collaborative research program (Grant NNF17SA0027784).

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Correspondence to H. Hugo Caicedo.

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Caicedo, H.H., Darrow, J.J., Caicedo, J.C. et al. Prioritizing Early Disease Intervention. Ther Innov Regul Sci 57, 1148–1152 (2023). https://doi.org/10.1007/s43441-023-00569-3

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