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Balancing Specialty Drug Pricing and Innovation ? A Framework for Sustainable Access and Affordability in the U.S. Healthcare System

Dr. Richard Amissah

Subject area: Management and Commerce  ·  Area of research: Healthcare Management

DOI: 10.64388/IREV8I2-1711831-4391

Abstract

The U.S. healthcare system is facing a serious and unsustainable dilemma between the two-fold purpose of innovation in specialty drugs as an incentive and affordable and equitable access to patients. High prices caused by expensive biologic drugs and transformative cell and gene therapy and present significant access barriers to patients threaten the financial stability of the payers. The following discussion is a summary of a detailed analysis of such sources as IQVIA, the Centers of Medicare and Medicaid Services (CMS), and the Assistant Secretary of Planning and Evaluation (ASPE) to quantify the spending trends, the budget implications, and the multi-faceted character of the correlation between the price, innovation, and accessibility to patients. Two new inter-related systems have to be used to address this systemic issue; a multi-attribute Value-Sustainability Index (VSI) to capture comprehensively the therapeutic, innovative and systemic value of a drug and a National Affordability Threshold (NAT) to provide a base to price debate on macroeconomic reality. These quantitative figures indicate that the increase in the amount of Medicare Part D gross expenditure by 566.5 percent in 2012-2021 resulted in an economic amount exceeding 50 percent of the spending on specialty drugs, with much of that highly concentrated within the top 1 percent of the drugs which have caused over 41 percent of Part D spending.2 Discussion The author concludes the manuscript by pleading to implement the VSI and NAT frameworks through a multi-stakeholder and voluntary Sustainable Access Compact. This small would assist in introducing value-consistent payment models, such as outcomes-based contracting and indication-based pricing, in order to create a predictable and long-term market that does not merely compensate the actual innovation but also brings transformative medicines to the patients that need them.

References

[1] Happe, L. E., Niu, S., & Svensson, M. (2024). Concentration of spending and share of specialty drug spending in Medicare Part D over a 10-year period. Journal of Managed Care & Specialty Pharmacy, 30(12), 1355–1363. https://doi.org/10.18553/jmcp.2024.30.12.1355 Retrieved from https://www.jmcp.org/doi/abs/10.18553/jmcp.2024.30.12.1355

[2] Centers for Medicare & Medicaid Services (CMS). (2024). Concentration of spending and share of specialty drug spending in Medicare Part D. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC11607209/

[3] Doshi, J. A., et al. (2024). The estimated annual financial impact of gene therapy in the United States. American Journal of Managed Care, 30(5), e110–e118. https://doi.org/10.37765/ajmc.2024.88435 Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC10678302/

[4] Brookings Institution. (2024). Addressing the trade-off between lower drug prices and incentives for pharmaceutical innovation. Retrieved from https://www.brookings.edu/articles/addressing-the-trade-off-between-lower-drug-prices-and-incentives-for-pharmaceutical-innovation/

[5] Vogler, S., Paris, V., & Ferrario, A. (2019). The price of innovation: The role of drug pricing in financing pharmaceutical innovation – A conceptual framework. Journal of Pharmaceutical Policy and Practice, 12(1), 15. https://doi.org/10.1080/20016689.2019.1583536 Retrieved from https://www.tandfonline.com/doi/full/10.1080/20016689.2019.1583536

[6] Cohen, J. P., & Han, G. (2024). The price of progress: Understanding innovation and affordability of prescription drugs. American Journal of Managed Care. Retrieved from https://www.ajmc.com/view/the-price-of-progress-understanding-innovation-and-affordability-of-prescription-drugs

[7] Mendoza, Y. L. M., & Baranauskas, M. C. C. (2024). Escalating costs of innovative medicines: Perspectives and proposals. Frontiers in Public Health, 12, 1449707. https://doi.org/10.3389/fpubh.2024.1449707 Retrieved from https://www.frontiersin.org/articles/10.3389/fpubh.2024.1449707/full

[8] Krumholz, H. M., & Anderson, J. L. (2019). Challenges and potential improvements to patient access to pharmaceuticals. Circulation, 139(21), e841–e850. https://doi.org/10.1161/CIRCULATIONAHA.119.044976 Retrieved from https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.119.044976

[9] Godman, B., et al. (2020). Pricing of pharmaceuticals is becoming a major challenge for health systems. BMJ, 368, l4627. https://doi.org/10.1136/bmj.l4627 Retrieved from https://www.bmj.com/content/368/bmj.l4627

[10] Health Affairs Forefront. (2024). What makes a drug special?: Understanding PBMs’ pharmacy definitions. Retrieved from https://www.healthaffairs.org/content/forefront/makes-drug-special-understanding-pbms-pharmacy-definitions

[11] Office of Inspector General (U.S. Department of Health & Human Services). (2024). Specialty drug coverage and reimbursement in Medicaid. Retrieved from https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000255.asp

[12] Wikipedia contributors. (2024). Specialty drugs in the United States. Wikipedia. Retrieved from https://en.wikipedia.org/wiki/Specialty_drugs_in_the_United_States

[13] Academy of Managed Care Pharmacy (AMCP). (2024). Specialty pharmaceuticals. Retrieved from https://www.amcp.org/concepts-managed-care-pharmacy/specialty-pharmaceuticals

[14] Iowa Department of Administrative Services. (2021). Specialty drugs policy guidance. Retrieved from https://das.iowa.gov/media/2021/download

[15] The Commonwealth Fund. (2023). 340B drug pricing program: How it works and why it’s controversial. Retrieved from https://www.commonwealthfund.org/publications/explainer/2023/340b-drug-pricing-program-how-it-works-and-why-its-controversial

[16] Kaiser Family Foundation (KFF). (2023). Explaining the prescription drug provisions in the Inflation Reduction Act. Retrieved from https://www.kff.org/medicare/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act

[17] The Hospitalist. (2024). Understanding the Inflation Reduction Act’s impact on prescription drug costs. Retrieved from https://www.the-hospitalist.org/hospitalist/article/38496/critical-care/understanding-the-inflation-reduction-acts

[18] IQVIA Institute. (2024, September). The impact of the Inflation Reduction Act on the economic lifecycle of a pharmaceutical brand. Retrieved from https://www.iqvia.com/locations/united-states/blogs/2024/09/impact-of-the-inflation-reduction-act

[19] PhRMA (Pharmaceutical Research and Manufacturers of America). (2024). Inflation Reduction Act policy issues. Retrieved from https://phrma.org/policy-issues/government-price-setting/inflation-reduction-act

[20] Kaiser Family Foundation (KFF). (2024). How will the prescription drug provisions in the Inflation Reduction Act affect Medicare beneficiaries? Retrieved from https://www.kff.org/medicare/how-will-the-prescription-drug-provisions-in-the-inflation-reduction-act-affect-medicare-beneficiaries

[21] University of Pennsylvania LDI (Leonard Davis Institute). (2024). What does the Inflation Reduction Act really mean for drug pricing? Retrieved from https://ldi.upenn.edu/our-work/research-updates/what-does-the-inflation-reduction-act-really-mean-for-drug-pricing

[22] Cooke, C. E., & Lee, H. Y. (2014). Cost management through care management, part 2: The importance of managing specialty drug utilization in the medical benefit. American Journal of Managed Care, 20(4), e130–e136. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC4031694/

[23] Pharma Manufacturing. (2024). Innovation in quality metrics. Retrieved from https://www.pharmamanufacturing.com/home/article/11315900/innovation-in-quality-metrics

[24] European Federation of Pharmaceutical Industries and Associations (EFPIA). (2024). A value-based approach to pricing – An EFPIA position paper. Retrieved from https://www.efpia.eu/media/677284/a-value-based-approach-to-pricing-2.pdf

[25] Hartung, D. M., & Johnston, K. A. (2023). Specialty drug price trends in the federal 340B drug discount program. Health Services Research and Managerial Epidemiology, 10(1), 2333392823112327. https://doi.org/10.1177/2333392823112327 Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC10398214/

[26] Mulcahy, A. W., et al. (2023). Understanding payer perspectives on value in the use of pharmaceuticals in the United States. Health Affairs, 42(6), 1059-1069. https://doi.org/10.1377/hlthaff.2023.00021 Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC10397793/

[27] Khandelwal, N., & Chambers, J. D. (2023). The current status of outcomes-based contracting for manufacturers and payers: An AMCP membership survey. Journal of Managed Care & Specialty Pharmacy, 29(5), 463–472. https://doi.org/10.18553/jmcp.2023.29.5.463 Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC10397909/

[28] Commonwealth Fund. (2024). Medicare drug price negotiations: All you need to know. Retrieved from https://www.commonwealthfund.org/publications/explainer/2024/may/medicare-drug-price-negotiations-all-you-need-know

[29] Office of the Assistant Secretary for Planning and Evaluation (ASPE). (2023). International prescription drug price comparisons: Estimates using 2022 data. Retrieved from https://aspe.hhs.gov/sites/default/files/documents/8e057b0a094e6f9b9d01171fce6698f4/international-price-comparisons.pdf

[30] Office of the Assistant Secretary for Planning and Evaluation (ASPE). (2023). International prescription drug price comparisons: Estimates using 2022 data. Retrieved from https://aspe.hhs.gov/sites/default/files/documents/277371265a705c356c968977e87446ae/international-price-comparisons.pdf

[31] Carlson, J. J., & Sullivan, S. D. (2023). Outcomes-based contracting experience: Research findings from U.S. and European stakeholders. Journal of Health Economics and Outcomes Research, 11(2), 153–164. https://doi.org/10.36469/jheor.2023.153 Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC10398222/

[32] Chernew, M. E., et al. (2023). Outcomes-based contracting with value-based insurance design: Opportunities to drive more health per pharmacy dollar. University of Michigan V-BID Center. Retrieved from https://vbidcenter.org/outcomes-based-contracting/

[33] ForHealth Consulting (University of Massachusetts Medical School). (2024). Exploring the trend of value-based contracts in the United States. Retrieved from https://forhealthconsulting.umassmed.edu/exploring-the-trend-of-value-based-contracts-in-the-united-states/

[34] Office of Health Economics (OHE). (2023). Indication-based pricing. Retrieved from https://www.ohe.org/topic/indication-based-pricing/

[35] Lyfegen. (2024). Indication-specific pricing to make inroads in the U.S. Retrieved from https://www.lyfegen.com/post/indication-specific-pricing-to-make-inroads-in-the-u-s

[36] Institute for Clinical and Economic Review (ICER). (2016). Indication-specific pricing of pharmaceuticals in the United States health care system. Policy Summit Report. Retrieved from https://icer.org/wp-content/uploads/2021/01/Final-Report-2015-ICER-Policy-Summit-on-Indication-specific-Pricing-March-2016_revised-icons-002.pdf

[37] IQVIA Institute. (2023). Success multiplied: Launch excellence for multi-indication assets. Retrieved from https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/iqvia-launch-excellence-for-multi-indication-assets-02-23-forweb.pdf

[38] Umbrex. (2024). Global drug launch strategy and sequencing. Retrieved from https://umbrex.com/resources/industry-analyses/how-to-analyze-a-pharmaceutical-company/global-drug-launch-strategy-and-sequencing/

[39] Oregon Health Authority. (2024). Oregon value-based payment compact: Final report 2024. Retrieved from https://www.oregon.gov/oha/HPA/dsi-tc/Documents/VBP-Compact-2024-Final-Report.pdf

[40] Organisation for Economic Co-operation and Development (OECD). (2019). Pharmaceutical innovation and access to medicines. OECD Publishing. https://doi.org/10.1787/9789264307391-en Retrieved from https://www.oecd.org/en/publications/pharmaceutical-innovation-and-access-to-medicines_9789264307391-en.html

[41] Khandelwal, N., & Chambers, J. D. (2023). The current status of outcomes-based contracting for manufacturers and payers: An AMCP membership survey. Journal of Managed Care & Specialty Pharmacy, 29(5), 463–472. https://doi.org/10.18553/jmcp.2023.29.5.463 Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC10397909/

[42] Bell, R., Et al. (2023). Delivering the triple win: A value-based approach to pricing. Office of Health Economics. Retrieved from https://www.ohe.org/wp-content/uploads/2023/04/Bell-et-al.-2023-A-Value-based-Approach-to-Pricing.pdf

How to cite this paper

Dr. Richard Amissah "Balancing Specialty Drug Pricing and Innovation ? A Framework for Sustainable Access and Affordability in the U.S. Healthcare System" Iconic Research And Engineering Journals Volume 8 Issue 2 2024 Page 1158-1169 https://doi.org/10.64388/IREV8I2-1711831-4391
Dr. Richard Amissah "Balancing Specialty Drug Pricing and Innovation ? A Framework for Sustainable Access and Affordability in the U.S. Healthcare System" Iconic Research And Engineering Journals, vol. 8, no. 2, Aug. 2024, doi: https://doi.org/10.64388/IREV8I2-1711831-4391
Dr. Richard Amissah (2024). Balancing Specialty Drug Pricing and Innovation ? A Framework for Sustainable Access and Affordability in the U.S. Healthcare System. Iconic Research And Engineering Journals, 8(2). doi: https://doi.org/10.64388/IREV8I2-1711831-4391
Dr. Richard Amissah "Balancing Specialty Drug Pricing and Innovation ? A Framework for Sustainable Access and Affordability in the U.S. Healthcare System" Iconic Research And Engineering Journals, vol. 8, no. 2, Aug. 2024. Crossref, https://doi.org/10.64388/IREV8I2-1711831-4391
@article{1711831,
      author = {Dr. Richard Amissah},
      title = {Balancing Specialty Drug Pricing and Innovation ? A Framework for Sustainable Access and Affordability in the U.S. Healthcare System},
      journal = {Iconic Research And Engineering Journals},
      year = {2024},
      volume = {8},
      number = {2},
      pages = {1158-1169},
      issn = {2456-8880},
      url = {https://www.irejournals.com/formatedpaper/1711831.pdf},
      abstract = {The U.S. healthcare system is facing a serious and unsustainable dilemma between the two-fold purpose of innovation in specialty drugs as an incentive and affordable and equitable access to patients. High prices caused by expensive biologic drugs and transformative cell and gene therapy and present significant access barriers to patients threaten the financial stability of the payers. The following discussion is a summary of a detailed analysis of such sources as IQVIA, the Centers of Medicare and Medicaid Services (CMS), and the Assistant Secretary of Planning and Evaluation (ASPE) to quantify the spending trends, the budget implications, and the multi-faceted character of the correlation between the price, innovation, and accessibility to patients. Two new inter-related systems have to be used to address this systemic issue; a multi-attribute Value-Sustainability Index (VSI) to capture comprehensively the therapeutic, innovative and systemic value of a drug and a National Affordability Threshold (NAT) to provide a base to price debate on macroeconomic reality. These quantitative figures indicate that the increase in the amount of Medicare Part D gross expenditure by 566.5 percent in 2012-2021 resulted in an economic amount exceeding 50 percent of the spending on specialty drugs, with much of that highly concentrated within the top 1 percent of the drugs which have caused over 41 percent of Part D spending.2 Discussion The author concludes the manuscript by pleading to implement the VSI and NAT frameworks through a multi-stakeholder and voluntary Sustainable Access Compact. This small would assist in introducing value-consistent payment models, such as outcomes-based contracting and indication-based pricing, in order to create a predictable and long-term market that does not merely compensate the actual innovation but also brings transformative medicines to the patients that need them.},
      month = {August},
      doi = {https://doi.org/10.64388/IREV8I2-1711831-4391}
  }