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Addressing Challenges to Alternative Payment Models for New Alzheimer’s Disease Therapies for US Commercial Payers

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Abstract

Commercial payers that ultimately decide to cover aducanumab or other Alzheimer’s disease therapies may require innovative payment tools to minimize their financial risk given the uncertain benefits and high cost of such treatments. Drawing on the published evidence, we propose two different types of payment models applicable to disease-modifying therapies in Alzheimer’s disease, and suggest four strategies to overcome challenges in their implementation. Such strategies range from developing best practices for outcome measurement in Alzheimer’s disease, investing in infrastructure to collect real-world data, increasing representativeness of registry data in Alzheimer’s disease, and integrating the diagnostic, treatment, and payment landscape. These important steps could make access to emerging therapies in Alzheimer’s disease more sustainable in the long term, and could serve as a blueprint for better access to novel therapies in other indications in the future.

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References

  1. Centers for Medicare & Medicaid Services. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. Decision Memo 2022 April 7, 2022. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305. Accessed 28 Apr 2022.

  2. Terry M. Biogen’s Aduhelm faces more obstacles as some insurers balking at paying for drug. 2021. https://www.biospace.com/article/biogen-s-aduhelm-faces-more-obstacles-as-some-insurers-balking-at-paying-for-drug/. Accessed 5 Mar 2022.

  3. Hlavka JP, Yu JC, Goldman DP, Lakdawalla DN. The economics of alternative payment models for pharmaceuticals. Eur J Health Econ. 2021;22(4):559–69.

    Article  Google Scholar 

  4. Bohm N, Bermingham S, Grimsey Jones F, Goncalves-Bradley DC, et al. The challenges of outcomes-based contract implementation for medicines in Europe. Pharmacoeconomics. 2022;40(1):13–29.

    Article  Google Scholar 

  5. Neumann PJ, Chambers JD, Simon F, Meckley LM. Risk-sharing arrangements that link payment for drugs to health outcomes are proving hard to implement. Health Aff (Millwood). 2011;30(12):2329–37.

    Article  Google Scholar 

  6. Jicha GA, Abner EL, Arnold SE, et al. Committee on High-quality Alzheimer’s Disease Studies (CHADS) consensus report. Alzheimers Dement. 2021. https://doi.org/10.1002/alz.12461.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Buracchio T, Yasuda SJ, Bastings E, Dunn B. Summary memorandum. Silver Spring, MD: U.S. Food and Drug Administration; 2021.

  8. Harrison JK, Noel-Storr AH, Demeyere N, Reynish EL, et al. Outcomes measures in a decade of dementia and mild cognitive impairment trials. Alzheimers Res Ther. 2016;8(1):48.

    Article  Google Scholar 

  9. US Food and Drug Administration, Silver Spring MD. Early Alzheimer’s disease: developing drugs for treatment guidance for industry. 2018.

  10. DiBenedetti DB, Slota C, Wronski SL, Vradenburg G, et al. Assessing what matters most to patients with or at risk for Alzheimer’s and care partners: a qualitative study evaluating symptoms, impacts, and outcomes. Alzheimers Res Ther. 2020;12(1):90.

    Article  Google Scholar 

  11. Govern P. VUMC awarded $31.7 million to harmonize Alzheimer’s research data. VUMC Reporter 2021. https://news.vumc.org/2021/10/01/vumc-awarded-31-7-million-to-harmonize-alzheimers-researchdata/. Accessed 15 Jan 2022.

  12. Webster L, Groskreutz D, Grinbergs-Saull A, Howard R, et al. Development of a core outcome set for disease modification trials in mild to moderate dementia: a systematic review, patient and public consultation and consensus recommendations. Health Technol Assess. 2017;21(26):1–192.

    Article  Google Scholar 

  13. Vellas B, Andrieu S, Sampaio C, Coley N, et al. Endpoints for trials in Alzheimer’s disease: a European task force consensus. Lancet Neurol. 2008;7(5):436–50.

    Article  CAS  Google Scholar 

  14. Hlavka JP, Kinoshita AT, Fang S, Hunt A. Clinical outcome measure crosswalks in Alzheimer’s disease: a systematic review. J Alzheimers Dis. 2021;83(2):591–608.

    Article  CAS  Google Scholar 

  15. Liu JL, Hlavka JP, Hillestad R, Mattke S. Assessing the preparedness of the U.S. health care system infrastructure for an Alzheimer's treatment. Santa Monica (CA): RAND Corporation; 2017.

  16. Lin GA, Whittington MD, Synnott PG, et al. Aducanumab for Alzheimer’s disease: effectiveness and value. Boston, MA: Institute for Clinical and Economic Review; 2021.

  17. Mattingly TJ 2nd, McQueen RB, Lin PJ. Contextual considerations and recommendations for estimating the value of Alzheimer’s disease therapies. Pharmacoeconomics. 2021;39(10):1101–7.

    Article  Google Scholar 

  18. Anderson TS, Ayanian JZ, Souza J, Landon BE. Representativeness of participants eligible to be enrolled in clinical trials of aducanumab for Alzheimer disease compared with Medicare beneficiaries with Alzheimer disease and mild cognitive impairment. JAMA. 2021;326(16):1627–9.

    Article  Google Scholar 

  19. Franzen S, Smith JE, van den Berg E, Rivera Mindt M, et al. Diversity in Alzheimer’s disease drug trials: the importance of eligibility criteria. Alzheimers Dement. 2022;18(4):810–23.

    Article  CAS  Google Scholar 

  20. National Institutes of Health. NIH unveils new online tool to improve Alzheimer’s clinical trials recruitment. 2021. https://www.nih.gov/news-events/news-releases/nih-unveils-new-online-tool-improve-alzheimers-clinical-trials-recruitment. Accessed 15 Jan 2022.

  21. National Institute on Aging. Registries. Alzheimer's & dementia outreach, recruitment & engagement resources. 2021. https://www.nia.nih.gov/research/alzheimers-dementia-outreach-recruitment-engagement-resources/term/registries. Accessed 15 Jan 2022.

  22. Grill JD, Karlawish J. Addressing the challenges to successful recruitment and retention in Alzheimer’s disease clinical trials. Alzheimers Res Ther. 2010;2(6):34.

    Article  CAS  Google Scholar 

  23. Porter J, Peters A, Sachs J, Costello A, editors. The basics of all-payer claims databases: a primer for states. Princeton, NJ: Robert Wood Johnson Foundation; 2014.

  24. Agency for Healthcare Research and Quality (AHRQ). All-payer claims databases. 2018. https://www.ahrq.gov/data/apcd/index.html. Accessed 15 Jan 2022.

  25. U.S. Centers for Medicare & Medicaid Services. CMS issues final rule to empower states, manufacturers, and private payers to create new payment methods for innovative new therapies based on patient outcomes. 2020. https://www.cms.gov/newsroom/press-releases/cms-issues-final-rule-empower-states-manufacturers-and-private-payers-create-new-payment-methods. Accessed 15 Jan 2022.

  26. The Commonwealth Fund. What is the status of electronic health records? Health system features. 2020. https://www.commonwealthfund.org/international-health-policy-center/system-features/what-status-electronic-health-records. Accessed 15 Jan 2022.

  27. Hurd MD, Martorell P, Delavande A, Mullen KJ, et al. Monetary costs of dementia in the United States. N Engl J Med. 2013;368(14):1326–34.

    Article  CAS  Google Scholar 

  28. National Institute on Aging. The urgent need for increased and diverse participation in studies: report of 2019-2020 scientific advances for the prevention, treatment, and care of dementia 2020. https://www.nia.nih.gov/report-2019-2020-scientific-advances-prevention-treatment-and-care-dementia/urgent-need-increased. Accessed 15 Jan 2022.

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Correspondence to Jakub P. Hlávka.

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Funding for the article was provided by the National Institutes of Health (R01AG060165 and R01AG062277).

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The authors have no conflict of interests to declare.

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Ethical approval was not required for this work as it is based only on published data.

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JPH, TAL, PJN, and PJL participated equally in the drafting and revisions of the manuscript.

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Hlávka, J.P., Lavelle, T.A., Neumann, P.J. et al. Addressing Challenges to Alternative Payment Models for New Alzheimer’s Disease Therapies for US Commercial Payers. PharmacoEconomics 40, 647–652 (2022). https://doi.org/10.1007/s40273-022-01150-w

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