Skip to Content

Navigating Step Therapy: Education, Advocacy and Resources To Support Patient-Centered Oncology Care

Published Date:

When coverage rules override an individualized treatment plan, patients and oncology teams can face delays, repeated appeals, and added uncertainty. In the Fall 2026 issue of Oncolytics Today, Lucio N. Gordan, MD, and Jay Seemann examine how step therapy and prior authorization affect treatment access, care team workload, and the patient experience.

The authors propose an “oncology ecosystem equilibrium,” outlining shared responsibilities across the healthcare system to support timely, evidence-based cancer care. From faster clinical exceptions to more transparent approval processes, they explore practical reforms that balance responsible cost management with each patient’s treatment needs.

DOWNLOAD ARTICLE

Explore the Fall 2026 edition of Oncolytics Today

Lucio N. Gordan, MD, is President and Managing Physician, Florida Cancer Specialists & Research Institute in Gainesville, Florida.

Jay Seemann is Vice President, Market Access & Value: US & Shared Services (Ex China), BeOne Medicines, Raleigh-Durham, North Carolina.

 

1. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71.

2. Mariotto AB, Enewold L, Zhao J, Zeruto CA, Yabroff KR. Medical care costs associated with cancer survivorship in the United States. Cancer Epidemiol Biomarkers Prev. 2020;29(7):1304- 1312. doi:10.1158/1055-9965.EPI-19-1534.

3. Rucker JA, Beinfeld MT, Enright D, Liljas B, Chambers JD. Trends in utilization management for oncology therapies amongst US commercial health plans: 2017-2024. JCO Oncol Pract. Published online May 21, 2026. doi:10.1200/OP-25-01096.

4. Karmarkar T, Dubois RW, Graff JS. Stakeholders find that step therapy should be evidence-based, flexible, and transparent: assessing appropriateness using a consensus approach. J Manag Care Spec Pharm. 2021;27(2):268-275. doi:10.18553/ jmcp.2021.27.2.268.

5. Hanna TP, King WD, Thibodeau S, et al. Mortality due to cancer treatment delay: systematic review and meta-analysis. BMJ. 2020;371:m4087. doi:10.1136/bmj.m4087.

6. Chavez-MacGregor M, Clarke CA, Lichtensztajn DY, Giordano SH. Delayed initiation of adjuvant chemotherapy among patients with breast cancer. JAMA Oncol. 2016;2(3):322-329. doi:10.1001/jamaoncol.2015.3856.

7. Hall H, Tocock A, Burdett S, et al. Association between time-to-treatment and outcomes in non-small cell lung cancer: a systematic review. Thorax. 2022;77(8):762-768. doi:10.1136/thoraxjnl-2021-216865.

8. Maurer MJ, Ghesquières H, Link BK, et al. Diagnosis-to-treatment interval is an important clinical factor in newly diagnosed diffuse large B-cell lymphoma and has implication for bias in clinical trials. J Clin Oncol. 2018;36(16):1603- 1610. doi:10.1200/JCO.2017.76.5198.

9. Franco S, Padam P, Korula A, et al. Prognostic impact of time from diagnosis to treatment initiation in patients with acute myeloid leukemia: a systematic review and meta-analysis. Cancer. 2023;129(19):2975-2985. doi:10.1002/cncr.34894.

10. Lehmann S, Ravn A, Carlsson L, et al. Continuing high early death rate in acute promyelocytic leukemia: a population-based report from the Swedish Adult Acute Leukemia Registry. Leukemia. 2011;25(7):1128-1134. doi:10.1038/leu.2011.78.

11. Langerbeins P, Zhang C, Robrecht S, et al. Ibrutinib in early-stage chronic lymphocytic leukemia: the randomized, placebo-controlled, double-blind phase III CLL12 trial. J Clin Oncol. 2025;43(4):392-402. doi:10.1200/ JCO.24.00975.

12. Gordan L, Mehring K, Wenk DT, Eaves J, Ciarrocchi R. Shining a light on payer management in medical-benefit oncology: a call for action to prioritize patient care. J Clin Pathways. 2026;12(2):e001. doi:10.25270/jcp.2026.03.001.

13. Kyle MA, Keating NL. Prior authorization and association with delayed or discontinued prescription fills. J Clin Oncol. 2024;42(8):951-960. doi:10.1200/JCO.23.01693.

14. Shin JY, Chino F, Cuaron JJ, et al. Insurance denials and patient treatment in a large academic radiation oncology center. JAMA Netw Open. 2024;7(6):e2416359. doi:10.1001/ jamanetworkopen.2024.16359.

15. Bingham B, Chennupati S, Osmundson EC. Estimating the practice-level and national cost burden of treatment-related prior authorization for academic radiation oncology practices. JCO Oncol Pract. 2022;18(6):e974-e987. doi:10.1200/OP.21.00644.

16. Chino F, Baez A, Elkins IB, Aviki EM, Ghazal LV, Thom B. The patient experience of prior authorization for cancer care. JAMA Netw Open. 2023;6(10):e2338182. doi:10.1001/jamanetworkopen.2023.38182.

17. Lichtenstein MRL, Beauchemin MP, Raghunathan R, et al. Association between copayment assistance, insurance type, prior authorization, and time to receipt of oral anticancer drugs. JCO Oncol Pract. 2024;20(1):85-92. doi:10.1200/ OP.23.00205.

18. Wyatt H, Peter M, Zuckerman AD, et al. Assessing the impact of limited distribution drug networks based on time to accessing oral oncolytic agents at an integrated specialty pharmacy. J Hematol Oncol Pharm. 2020;10(4):198-205.

19. Mattingly TJ II, Hyman DA, Bai G. Pharmacy benefit managers: history, business practices, economics, and policy. JAMA Health Forum. 2023;4(11):e233804. doi:10.1001/jamahealthforum.2023.3804.

20. Yeung K, Dusetzina SB, Basu A. Association of branded prescription drug rebate size and patient out-of-pocket costs in a nationally representative sample, 2007-2018. JAMA Netw Open. 2021;4(6):e2113393. doi:10.1001/jamanetworkopen.2021.13393.

21. Beinfeld MT, LaMountain F, Phillips GA, Hughes T, Chambers JD. Drug prices, rebates, and health plan coverage restrictions. JAMA Netw Open. 2026;9(2):e2558872. doi:10.1001/jamanetworkopen.2025.58872.

22. Centers for Medicare & Medicaid Services. Medicare Advantage and Part D drug pricing final rule (CMS-4180-F). Published May 16, 2019. Accessed July 29, 2026. https://www.cms.gov/ newsroom/fact-sheets/medicare-advantage-and-part-d-drug-pricing-final-rule-cms-4180-f.

23. Chen WC, Huynh E, Kabarriti R, et al. Integrating prior authorization into clinical workflows for care access and practitioner experience. JAMA Netw Open. 2025;8(12):e2549093. doi:10.1001/jamanetworkopen.2025.49093.

24. Centers for Medicare & Medicaid Services. CMS Interoperability and Prior Authorization Final Rule CMS-0057-F. Published January 17, 2024. Accessed July 29, 2026. https://www.cms.gov/ newsroom/fact-sheets/cms-interoperability-prior-authorization-final-rule-cms-0057-f.

25. Centers for Medicare & Medicaid Services. 2026 CMS Interoperability Standards and Prior Authorization for Drugs Proposed Rule (CMS- 0062-P). Published April 10, 2026. Accessed July 29, 2026. https://www.cms.gov/newsroom/ fact-sheets/2026-cms-interoperability-standards-prior-authorization-drugs-proposed-rule.