Cancer Chemotherapy / Therapy Guidelines
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Defines medical necessity and coverage criteria for oncology medications and select related therapies for Baylor Scott & White Health Plan members, including criteria for FDA-labeled and compendium-supported uses and requirements for continuation and prior authorization.
No material clinical or coverage changes in this revision.
Coverage Criteria and Clinical Requirements
Medical necessity criteria
Covered when ALL of the following are met:
Abstracts and case reports are excluded; any supporting peer‑reviewed literature for off‑label uses must be supplied.
Failure of preferred biosimilars does not meet medical necessity for non‑preferred drug requests.
See Appendix A for drug/class specific authorization limits (e.g., PD‑1/PD‑L1 inhibitors for metastatic NSCLC).
Any peer‑reviewed medical literature supporting off‑label use must be submitted with the request.
Approval duration will be the shortest of the clinically appropriate duration, 12 months, or the requested duration.
Oncology medications and therapies that received FDA accelerated approval but whose indications were subsequently withdrawn by the U.S. Food and Drug Administration are not considered medically necessary. The policy states that clinical benefit for withdrawn accelerated-approval indications has not been established and therefore these uses are excluded from coverage regardless of NCCN, compendia, or peer-reviewed literature status. Authorization duration rules (the shortest of clinically appropriate duration, 12 months, or the requested duration) remain applicable for approved uses.
Uses designated as NCCN Category 3 are considered unproven and not medically necessary under this policy. The policy treats NCCN Category 1 or 2A recommendations as acceptable bases for medical necessity but explicitly excludes Category 3 recommendations from coverage without further review.
| Regimen | Indication | Limit / Authorization |
|---|---|---|
Billing and Coding
| A9600-A9699 | HCPCS oncology medications range |
| J9000-J9999 | J-code range for antineoplastic agents |
| CPT Codes: | CPT codes applicable (not enumerated) |
| ICD-10 codes | Relevant diagnosis codes (not enumerated) |
Provider Requirements, Prior Authorization, and Denial Triggers
Prior Authorization Required
Prior authorization is required for oncology medications and therapies billed under HCPCS ranges A9600–A9699 and J9000–J9999, and for other select oncology drugs and interventions covered by this policy. Refer to the member's Evidence of Coverage/Summary Plan Description for plan-specific prior authorization procedures and to applicable Medicare NCDs/LCDs or Texas Medicaid guidance when relevant.
- Applies to HCPCS codes: A9600–A9699, J9000–J9999
- Medicare: follow NCD/LCD when available; if none, apply criteria below
- Medicaid (Texas): confirm coverage per TMHP/TMPPM; HB154 applicable
Step Therapy / Preferred Agent Trial Required
For non-preferred oncology medications, an adequate trial and failure of preferred medications in the same class — or documented clinically significant intolerance or contraindication — is required prior to approval. See BSWHP Step Therapy policies 306 (Commercial) and 307 (Medicare) for detailed step-therapy rules.
- Step-therapy requirement applies when a therapeutically appropriate preferred alternative exists
- Document prior trials: drug name, dose, duration, outcome, and reason for discontinuation
Documentation Requirements for Authorization
Requests must include documentation that dosing and frequency are consistent with FDA labeling, NCCN guidance, or accepted compendia, or that peer-reviewed literature supports the requested regimen. For continuation requests, submit evidence of clinical benefit and no disease progression. For off-label uses, include full-text peer-reviewed publications (prospective phase 2/3 or CMS-supported journals) when not supported by FDA/NCCN/compendia.
- Include full product labeling or NCCN/compendia citation that supports requested dose/frequency
- For off-label requests, attach full-text articles from accepted journals; abstracts and case reports are excluded
- See Appendix A for drug/class specific authorization limits (e.g., PD‑1/PD‑L1 inhibitors for metastatic NSCLC)
Denial Triggers / Not Medically Necessary
Requests for uses that are not FDA‑labeled and not supported by NCCN Category 1 or 2A (or sufficient high‑quality peer‑reviewed evidence) will be denied as not medically necessary. Uses supported only by NCCN Category 2B require detailed literature review and may be subject to denial; Category 3 is considered unproven and not medically necessary. Oncology indications previously granted accelerated approval but subsequently withdrawn by the FDA are not medically necessary.
- Denial triggers: lack of FDA label AND lack of NCCN Category 1/2A support or adequate peer‑reviewed evidence
- Category 2B uses require additional review; Category 3 uses are not covered
- Off‑label requests lacking high‑quality full‑text literature will be denied
Background and Rationale
The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology provide comprehensive, regularly updated treatment guidance developed by multidisciplinary expert panels and apply to the majority of cancer patients. This policy uses NCCN designations to determine acceptable indications: Category 1 or 2A recommendations in the NCCN Drugs & Biologics Compendium support medical necessity, while Category 3 does not. Separately, accelerated approvals granted by the FDA require post-approval verification of clinical benefit; if that benefit is not confirmed and the indication is withdrawn, such accelerated-approval uses are excluded from coverage.
Key Definitions and Compendia Categories
Policy Revision History
Policy updated with new effective date and incorporated oncology coverage criteria and authorization rules (Cancer Chemotherapy / Therapy Guidelines, Policy No. 219).
Clinical review completed prior to effective date to confirm criteria, continuation requirements, and appendix limits including PD-1/PD-L1 therapy duration for metastatic NSCLC.
(Archived entry) Documentation and step-therapy requirements refined; references to compendia and accepted journals clarified.
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