CurrentBaylor Scott & White Health PlanPolicy 219

Cancer Chemotherapy / Therapy Guidelines

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.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyCancer Chemotherapy / Therapy Guidelines

Policy CodePolicy 219

Change TypeNo material change

Effective DateJun 1, 2026

Next Review DateMay 28, 2027

Key ActionObtain prior authorization for oncology medications in HCPCS ranges A9600-A9699 and J9000-J9999 per plan EOC/SPD.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmaximum authorization duration

2 yearsPD-1/PD-L1 initial max

A9600-A9699, J9000-J9999applicable HCPCS ranges

NCCN Cat 1/2Aaccepted compendia

Coverage Criteria and Clinical Requirements

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Primary acceptance criteria: The requested drug is being used for a medically accepted indication defined by one of the following: (a) FDA labeling consistent with product labeling; OR (b) NCCN Drugs & Biologics Compendium Category 1 or 2A; OR (c) acceptable compendia (Thomson Micromedex DrugDex Recommendation Class IIb+ and Efficacy Class IIa+; Clinical Pharmacology 'Strong For'; AHFS-DI supportive narrative; Wolters Kluwer Lexi-Drugs listed as 'Use: Off-Label' with Evidence Level A); OR (d) peer‑reviewed medical literature published in full text in specified journals demonstrating safety and effectiveness for the requested use).

Abstracts and case reports are excluded; any supporting peer‑reviewed literature for off‑label uses must be supplied.

Step therapy and prior failure: For oncology medications with a non‑preferred status, the member must have failure of an adequate trial of, or clinically significant intolerance or contraindication to, preferred medications in the same class that can be used for the requested indication (see BSWHP policies 306 and 307).

Failure of preferred biosimilars does not meet medical necessity for non‑preferred drug requests.

Dose and frequency are consistent with FDA labeling, NCCN, listed compendia, or indication‑specific peer‑reviewed literature.

See Appendix A for drug/class specific authorization limits (e.g., PD‑1/PD‑L1 inhibitors for metastatic NSCLC).

Prior therapy and off‑label review: Requests for drugs previously tried and discontinued for lack of efficacy may be subject to off‑label review unless supported by NCCN or high‑quality peer‑reviewed literature (prospective phase 2/3 studies published as full manuscripts in listed journals).

Any peer‑reviewed medical literature supporting off‑label use must be submitted with the request.

Continuation of therapy: For continuation requests, documentation must indicate no evidence of disease progression.

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.

Billing and Coding

Applicable HCPCS/HCPCS-J CodesHCPCS

A9600-A9699	HCPCS oncology medications range
J9000-J9999	J-code range for antineoplastic agents

CPT Codes (not enumerated)CPT

CPT Codes:

CPT codes applicable (not enumerated)

ICD-10 (not enumerated)ICD-10

ICD-10 codes

Relevant diagnosis codes (not enumerated)

PD-1/PD-L1 initial therapy duration for metastatic NSCLC — Maximum 2 years

Regimen scopePD-1/PD-L1 inhibitors for metastatic non-small cell lung cancer (includes agents listed in Appendix A: Bavencio, Imfinzi, Jemperli, Keytruda, Keytruda Qlex, Libtayo, Loqtorzi, Opdivo, Opdivo Qvantig, Opdualag)

Maximum initial therapy durationMaximum total length of initial therapy is 2 years

ApplicabilityApplies to initial course of PD-1/PD-L1 inhibitor therapy for metastatic NSCLC; limits described in Appendix A

Reference sectionSee Appendix A - Drug/Class Limits on Authorization for full agent list and limit details

Provider Requirements, Prior Authorization, and Denial Triggers

Prior Authorization

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

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 Required

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 Risk

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

NCCN Category 1 definition

DefinitionRecommendation is based on high-level evidence (e.g., high-powered randomized clinical trials or meta-analyses) and the panel has reached uniform consensus that the recommendation is indicated.

Evidence standardHigh-level evidence such as randomized controlled trials or meta-analyses

Consensus requirementUniform (near unanimous) consensus among panel members; may allow some neutral positions

NCCN Category 2A definition

DefinitionRecommendation is based on lower-level evidence but there is uniform consensus that the recommendation is appropriate.

Evidence examplesLower-level evidence may include phase II studies, large cohort studies, case series, or expert/experience-based observations

GuidanceRecommendations carry recognition they may be superseded by higher-level evidence as it becomes available

Policy Revision History

2026-06-01policy_effectiveLatest

Policy updated with new effective date and incorporated oncology coverage criteria and authorization rules (Cancer Chemotherapy / Therapy Guidelines, Policy No. 219).

2026-05-28policy_review

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.

2025-??-??historical_change

(Archived entry) Documentation and step-therapy requirements refined; references to compendia and accepted journals clarified.