Pharmacy Prior Authorization Criteria

High Dollar/Claim Dollar

Indications for Prior Authorization

Criteria

A drug (non-anti-cancer chemotherapeutic regimen) used for an off-label indication or FDA approved indication

**May not apply to all benefit plans.

Administrative

Length of Approval: 12 months, if no PA is on file. Approval duration is granted for length of current PA on file (if existing PA is on file).

• One of the following:
• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
OR
• One of the following:
• Diagnosis is supported as a use in American Hospital Formulary Service Drug Information (AHFS DI) [1]
OR
• Diagnosis is supported in the FDA Uses/Non-FDA Uses section in DRUGDEX Evaluation with a Strength of Recommendation rating of IIb or better (see DRUGDEX Strength of Recommendation table in Background section) [1]
OR
• The use is supported by clinical research in two articles from major peer reviewed medical journals that present data supporting the proposed off-label use or uses as generally safe and effective unless there is clear and convincing contradictory evidence presented in a major peer-reviewed medical journal**
AND
• One of the following:
• The dosage quantity/duration of the medication is reasonably safe and effective based on information contained in the FDA approved labeling, peer-reviewed medical literature, or accepted standards of medical practice
OR
• The dosage/quantity/duration of the medication is reasonably safe and effective based on one of the following compendia:
• American Hospital Formulary Service (AHFS) Compendium
• Thomson Reuters (Healthcare) Micromedex/DrugDex (not Drug Points) Compendium

A drug or biological in an anti-cancer chemotherapeutic regimen

**May not apply to all benefit plans.

Administrative

Length of Approval: 12 months, if no PA is on file. Approval duration is granted for length of current PA on file (if existing PA is on file).

• One of the following:
• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
OR
• One of the following:
• Diagnosis is supported as a use in American Hospital Formulary Service Drug Information (AHFS DI) [2]
OR
• Diagnosis is supported in the FDA Uses/Non-FDA Uses section in DRUGDEX Evaluation with a Strength of Recommendation rating of IIb or better (see DRUGDEX Strength of Recommendation table in Background section) [2]
OR
• Diagnosis is supported as a use in the National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B (see NCCN Categories of Evidence and Consensus table in Background section) [2, B]
OR
• Diagnosis is supported as an indication in Clinical Pharmacology [2]
OR
• Off-label use is supported in one of the published, peer-reviewed medical literature listed below: [2, C]
• American Journal of Medicine
• Annals of Internal Medicine
• Annals of Oncology
• Annals of Surgical Oncology
• Biology of Blood and Marrow Transplantation
• Blood
• Bone Marrow Transplantation
• British Journal of Cancer
• British Journal of Hematology
• British Medical Journal
• Cancer
• Clinical Cancer Research
• Drugs
• European Journal of Cancer (formerly the European Journal of Cancer and Clinical Oncology)
• Gynecologic Oncology
• International Journal of Radiation, Oncology, Biology, and Physics
• The Journal of the American Medical Association
• Journal of Clinical Oncology
• Journal of the National Cancer Institute
• Journal of the National Comprehensive Cancer Network (NCCN)
• Journal of Urology
• Lancet
• Lancet Oncology
• Leukemia
• The New England Journal of Medicine
• Radiation Oncology
OR
• Diagnosis is supported as a use in Wolters Kluwer Lexi-Drugs rated as "Evidence Level A" with a "Strong" recommendation. (see Lexi-Drugs Strength of Recommendation table in Background section) [2, 4, 5]
AND
• One of the following:
• The dosage quantity/duration of the medication is reasonably safe and effective based on information contained in the FDA approved labeling, peer-reviewed medical literature, or accepted standards of medical practice
OR
• The dosage/quantity/duration of the medication is reasonably safe and effective based on one of the following compendia:
• American Hospital Formulary Service (AHFS) Compendium
• Thomson Reuters (Healthcare) Micromedex/DrugDex (not Drug Points) Compendium
• Elsevier Gold Standard’s Clinical Pharmacology Compendium
• National Comprehensive Cancer Network Drugs and Biologics Compendium

P & T Revisions

2024-07-01, 2023-09-21, 2022-10-14, 2022-01-06, 2021-10-26, 2021-09-28, 2021-05-20, 2020-10-11, 2019-10-04

References

1. Center for Medicaid & Medicare Services. Medicare Prescription Drug Benefit Manual. Chapter 6 – Part D Drugs and Formulary Requirements. Section 10.6. Available at: https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/Downloads/Part-D-Benefits-Manual-Chapter-6.pdf. Accessed July 1, 2024.
2. Center for Medicaid & Medicare Services. Medicare Benefit Policy Manual. Chapter 15 - Covered Medical and Other Health Services. Section 50.4.5. Available at: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf. Accessed July 1, 2024.
3. National Comprehensive Cancer Network Categories of Evidence and Consensus. Available at: https://www.nccn.org/professionals/physician_gls/categories_of_consensus.aspx. Accessed September 9, 2021.
4. Center for Medicaid & Medicare Services. Medicare Benefit Policy Manual. Wolters Kluwer Clinical Drug Information Lexi-Drugs Compendium Revision Request - CAG-00443O. Available at: https://www.cms.gov/medicare-coverage-database/details/medicare-coverage-document-details.aspx?MCDId=31#decision. Accessed July 1, 2024.
5. Wolters Kluwer Clinical Drug Information’s Request for CMS evaluation of Lexi-Drugs as a compendium for use in the determination of medically-accepted indications of drugs/biologicals used off-label in anti-cancer chemotherapeutic regimens. Available at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/downloads/covdoc31.pdf. Accessed July 1, 2024.
6. Micromedex Healthcare Series. Recommendation, Evidence and Efficacy Ratings. https://www.micromedexsolutions.com/micromedex2/librarian/ssl/true/CS/6E0ED9/ND_PR/evidencexpert/ND_P/evidencexpert/DUPLICATIONSHIELDSYNC/8B9F5B/ND_PG/evidencexpert/ND_B/evidencexpert/ND_AppProduct/evidencexpert/ND_T/evidencexpert/PFActionId/evidencexpert.IntermediateToDocumentLink?docId=3198&contentSetId=50. Accessed July 1, 2024.

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Revision History

• 2024-07-01: 2024 UM Annual Review. Minor updates without changing clinical intent.
• 2023-09-21: 2023 Annual Review. No changes to criteria.
• 2022-10-14: 2022 Annual Review
• 2022-01-06: Update guideline
• 2021-10-26: Updated references section.
• 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2020-10-11: Annual Review - Addition of Annals of Internal Medicine as one of the references to support off-label anti-cancer use; background and reference updates.
• 2019-10-04: Annual Review. Updated Background/References.

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