Oral Cancer Drugs Requiring Prior Authorization on the Rise

Oral Cancer Drugs Requiring Prior Authorization on the Rise


The use of oral cancer drugs on Medicare Part D formularies requiring prior authorization has increased over the past decade, with the biggest rise occurring for non-specialty brand drugs.


  • Researchers used Medicare Part D formulary files to identify insurance companies’ 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, or generic.

  • For each year in 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, zero specialty generics, 28 non-specialty brands, and eight non-specialty generics —compared with 548 formularies and 249 drugs in 2020 — 139 specialty brands, nine specialty generics, 86 non-specialty brands, and 15 non-specialty generics. 

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

  • For specialty brand drugs, the proportion requiring prior authorization increased from 72.8% to 95.4%; that proportion increased nearly fivefold, from 15.9% to 78.2%, for non-specialty brand drugs, and eightfold, from 1% to 8%, for non-specialty generic drugs.

  • The proportion of drug-dose-formulary combinations for oral oncology drugs requiring quantity limits for specialty brand drugs doubled over the study period — from 31.4% to 62.5%. That proportion increased from 32.7% to 77.8% for specialty generic drugs between 2016 and 2020; and between 2010 and 2020, from 11.8% to 47.3% for non-specialty brand 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 provisional evidence of efficacy,” researchers wrote. “It is less clear why prior authorization is required for highly effective, first-line drugs such as generic imatinib.”


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


  • The study focused on Medicare and oral oncology drugs, and future work could expand the scope.


  • The research was funded by a National Cancer Institute grant. Coauthors received funding from Arnold Ventures and the Commonwealth Fund.

  • Authors reported affiliations 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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