Oral cancer drugs that require prior authorization are on the rise


The use of oral cancer drugs on Medicare Part D formularies that require prior authorization has increased over the past decade, with the largest increase occurring for non-specialty drugs.


  • Researchers used Medicare Part D formulary files to identify insurers’ use of prior authorization and quantity limits for each drug-dose formulary combination for oral cancer drugs.

  • Drugs were identified using the 2021 Oncology Care Model drug list.

  • Researchers categorized drugs as specialty — when monthly costs were higher than $600 in 2010-2016 and $670 in 2017-2020 — or non-specialty and brand name or generic.

  • For each year of the study period, which spanned 2010-2020, researchers estimated the enrollment-weighted proportion of drug-dose formulary combinations subject to administrative burdens.

  • Medicare Part D beneficiaries increased from 28,030,290 in 2010 to 47,337,020 in 2020.


  • In 2010, 333 formularies covered 62 oral cancer drugs—26 specialty brands, no specialty brands, 28 non-specialty brands, and eight non-specialty generics—compared to 548 formularies and 249 drugs in 2020—139 specialty brands, nine specialty generics, 86 non-specialty brands, and 15 non-specialty generic drugs.

  • Unique drug-dose-formulary prescription combinations increased from 19,004 to 122,173 between 2010 and 2020; the proportion of drug-dose-formulation combinations requiring prior authorization also increased during that time.

  • For specialty medicines, the proportion requiring prior authorization has increased from 72.8% to 95.4%; this proportion increased almost fivefold, from 15.9% to 78.2%, for non-specialty branded drugs and eightfold, from 1% to 8%, for non-specialty generics.

  • The proportion of drug-dose-formulary combinations for oral oncology drugs requiring specialty drug quantity limits doubled over the study period—from 31.4% to 62.5%. This proportion increased from 32.7% to 77.8% for specialty medicines between 2016 and 2020; and between 2010 and 2020, from 11.8% to 47.3% for non-specialty branded drugs and from 9.7% to 18.8% for non-specialty generic drugs.


  • “Utilization management may be appropriate for some oncology drugs, such as those approved with preliminary evidence of efficacy,” researchers wrote. “It is less clear why prior authorization is required for highly effective first-line drugs such as generics imatinib.”


  • The analysis, led by Michael Anne Kyle, PhD, RN, was published online July 18 in JAMA Network Open.



  • The research was funded by a grant from the National Cancer Institute. Co-authors received support from Arnold Ventures and the Commonwealth Fund.

  • Authors reported affiliation with the Robert Wood Johnson Foundation, Leukemia & Lymphoma Society, Institute for Clinical and Economic Review, West Health, Medicare Payment Advisory Commission, National Cancer Institute, and Centers for Medicare & Medicaid Services.

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