CurrentEmblemHealthPolicy N/A

generic_drug_usage_in_cancer_treatment_policy

Defines accepted indications, inclusion/exclusion and investigational criteria for use of generic drugs listed in Attachment A for cancer treatment; references CMS compendia and FDA Orange Book for therapeutic equivalence and requires reviewers to follow compendia for dosing/monitoring. Applies across multiple lines of business including Commercial, CHIP, Exchange, Medicaid, and Medicare Advantage.

Policy Summary

PayerEmblemHealth

Policygeneric_drug_usage_in_cancer_treatment_policy

Policy CodePolicy N/A

Change TypeMultiple attachment updates (additions/removals) and template conversion

Effective Date

Next Review Date

Key ActionAll medication requests for drugs listed in Attachment A must be processed by Evolent; escalate to a Physician Peer Clinical Reviewer if the Initial Clinical Reviewer does not render a determination.

POLICY UPDATE CHANGES

September 2025: Added Clolar (clofarabine), Beizray (docetaxel), and Docivyx (docetaxel); replaced Nolvadex (tamoxifen) with Soltamox (tamoxifen) in Attachment A.

August 2025: Added Tepylute (thiotepa) to Attachment A.

April 2025: Added Endari (L-glutamine) to Attachment A.

March 2025: Converted to new Evolent guideline template; replaces UM ONC_1304 Generic Drugs.

March 2024: Updated NCH verbiage to Evolent; removed Alimta/Pemfexy (pemetrexed) from Attachment A.

~100Drugs listed in Attachment A

5Referenced compendia sources

Coverage Summary

This policy defines accepted indications, inclusion/exclusion, and investigational criteria for the use of generic oncology drugs listed in Attachment A for cancer treatment and applies to multiple lines of business including Commercial, CHIP, Exchange, Medicaid, and Medicare Advantage.

Attachment A contains approximately ~100 listed generic oncology drugs that are covered when criteria are met (see Attachment A list).

Reviewers must reference recognized compendia and regulatory sources for therapeutic equivalence and clinical guidance: the policy references the FDA Orange Book therapeutic equivalence codes (Attachment B) and follows compendia such as NCCN Drugs & Biologics Compendium, Clinical Pharmacology, Lexi-Drugs, Micromedex, and AHFS Drug Information for dosing, indications/inclusion criteria, and monitoring.

Drugs listed in Attachment A~100

Referenced compendia sources5

Review committeeEvolent Specialty Clinical Guideline Review Committee (1)

StatusCURRENT

Last review2025-09-01

Medical Necessity / Exclusions / Investigational Criteria

Inclusion Criteria / Preferred Medication Guidance for Initial Request

Covered when ALL of the following are met:

ALL of the following

Drug is listed in Attachment A and Evolent will follow compendia (NCCN Drugs & Biologics Compendium, Clinical Pharmacology, Lexi-Drugs, Micromedex, AHFS) for dosing, indications/inclusion criteria, and monitoring
Reference compendia: NCCN, Clinical Pharmacology, Lexi-Drugs, Micromedex, AHFS
When applicable, generic alternatives are preferred over brand-name drugs
Preferred medication guidance for initial request
If health plan Medicaid coverage provisions or PDL conflict with this policy, the health plan Medicaid provisions take precedence
Health plan PDL precedence

Coding — Attachment A and Reference Codes

Attachment A - Listed Generic Oncology Drugs (Covered when criteria met)mixedCovered

ADRIAMYCIN	Generic Name = DOXORUBICIN
ADRUCIL	Generic Name = FLUOROURACIL
AFINITOR	Generic Name = EVEROLIMUS
ALKERAN	Generic Name = MELPHALAN
ARIMIDEX	Generic Name = ANASTROZOLE
AROMASIN	Generic Name = EXEMESTANE
ARRANON	Generic Name = NELARABINE
BICNU	Generic Name = CARMUSTINE
BLENOXANE	Generic Name = BLEOMYCIN
BUSULFEX	Generic Name = BUSULFAN

1–10 of 80

1/8

Attachment A - Listed Generic Oncology Drugs (Covered when criteria met)mixedCovered

No codes listed

FDA Orange Book Therapeutic Equivalence Codes (Reference)mixed

AA	No bioequivalence problems in conventional dosage forms
AB	Meets necessary bioequivalence requirements
ABI	Meets bioequivalence requirements to ABl rated reference drug
AB2	Meets bioequivalence requirements to AB2 rated reference drug
AB3	Meets bioequivalence requirements to AB3 rated reference drug
AB4	Meets bioequivalence requirements to AB4 rated reference drug
AN	Solution or powder for aerosolization
AO	Injectable oil solutions
AP	Injectable aqueous solutions
AT	Topical Products

1–10 of 22

1/3

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required for medications

All medication requests for drugs listed in Attachment A must be processed by Evolent. Medications not authorized by Evolent may be deemed not approvable and not reimbursable. Initial Clinical Reviewer will review requests and, if a determination is not rendered, the request will be escalated to a Physician Peer Clinical Reviewer. Requests are reviewed within the contractual timeframe.

Attachment A drugs

Documentation Required

Support for off-label or non-compendia use

Requests for treatment outside FDA labeling or CMS-recognized compendia must follow CMS Medicare Benefit Policy Manual Chapter 15 and include references from recognized compendia or acceptable peer-reviewed literature (e.g., NCCN, Clinical Pharmacology, Lexi-Drugs, Micromedex, AHFS). If such references are not provided, processing of the request may be delayed.

Background and Definitions

The policy is intended to establish a preference for FDA-equivalent generic oncology drugs when available and to ensure consistent clinical review using recognized compendia for dosing, indications, and monitoring.

Evolent will follow the listed compendia (NCCN Drugs & Biologics Compendium, Clinical Pharmacology, Lexi-Drugs, Micromedex, AHFS) for determination of appropriate dosing, indications/inclusion criteria, and monitoring for drugs in Attachment A.

The policy excludes requests for brand-name products when a generic alternative is available and excludes treatment considered investigational or off-label when sufficient supporting evidence from CMS-recognized compendia or acceptable peer-reviewed literature is not provided. Disease progression while receiving the same drug/regimen containing the same drug is also listed as not medically necessary.

Requests for medications must be processed by Evolent; medications not authorized by Evolent may be considered not approvable and not reimbursable, and initial reviewers escalate to a Physician Peer Clinical Reviewer if no determination is rendered.

Generic Drugs: A generic drug is defined as identical-or bioequivalent-to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. To be FDA approved, a generic must contain the same active ingredients, be identical in strength, dosage form and route, have the same indications, be bioequivalent, meet batch requirements for identity/strength/purity/quality, and be manufactured under FDA good manufacturing practice standards.

Therapeutic Equivalence (Orange Book codes): FDA therapeutic equivalence codes (e.g., AA, AB, AN, AO, AP, AT, BC, BD, BE, BN, BP, BR, BS, BT, BX, B*, EE, ZZ) describe the FDA's evaluation of bioequivalence status and are summarized in Attachment B.

Medicare Determinations / References

Medicare Reference: Requests for treatment outside FDA labeling or CMS-approved compendia must follow the Medicare Benefit Policy Manual Chapter 15 (CMS) and are classified under an NCD type determination as noted in the policy references.

Off-label requests must include references from recognized compendia or acceptable peer-reviewed literature; lack of such references may delay processing. Evolent requires documentation consistent with Chapter 15 and the policy's compendia list when considering non-labeled or off-compendia uses.

Revision History

2024-03material_change

Updated NCH verbiage to Evolent and removed Alimta/Pemfexy (pemetrexed) from Attachment A.

2025-03template_conversion

Converted to new Evolent guideline template; replaced prior policy UM ONC_1304 Generic Drugs.

2025-04material_change

Added Endari (L‑glutamine) to Attachment A.

Policy Summary

PayerEmblemHealth

Policygeneric_drug_usage_in_cancer_treatment_policy

Policy CodePolicy N/A

Change TypeMultiple attachment updates (additions/removals) and template conversion

Effective Date

Next Review Date

On This Page

If health plan Exchange coverage provisions or PDL conflict with this policy, the health plan Exchange provisions take precedence

Health plan PDL precedence

For health plans utilizing Evolent UM Oncology Clinical Policies with no applicable Health Plan PDL, the Preferred Drug Guidelines shall follow Evolent recommended agents/regimens/preferred drugs

Applies when no Health Plan PDL is available

Continuation requests of previously approved non-preferred medication are not subject to the preferred-medication provision

Continuation/renewal exception

When there is a documented drug shortage, disease progression, contraindication, or confirmed intolerance to a preferred drug/regimen, an available alternative product may be used if medically appropriate and the indication is listed in a standard reference compendium or accepted peer-reviewed literature

Refer to FDA drug shortage listings and compendia/peer-reviewed literature for support

Exclusion Criteria / Not Medically Necessary

Not considered medically necessary when ANY of the following are met:

ANY of the following

Request for brand-name product when a generic alternative is available
Brand requests discouraged when generics available
Disease progression while receiving the same drug/regimen containing the same drug
Progression on same regimen is exclusionary

Investigational / Off-Label Use Exclusions

Considered investigational / not accepted when ALL of the following apply regarding off-label indications lacking sufficient evidence:

ALL of the following

Insufficient evidence defined by any of
- Off-label indication is not supported by CMS-recognized compendia or acceptable peer-reviewed literature
- Clinical characteristics of the patient and cancer are not adequately represented in published evidence
- The administered chemotherapy/biologic/immune/targeted/other oncologic regimen is not adequately represented in published evidence
- Reported study outcomes do not represent clinically meaningful outcomes (ASCO definitions e.g., HR < 0.80; OS/PFS benefit < 3 months)HR < 0.80; OS/PFS benefit < 3 months
  ASCO definition of clinically meaningful outcomes
- Experimental design is inappropriate to address the investigative question
- Evidence consists only of uncontrolled case reports or meeting abstracts without full peer-reviewed publication
- Non-randomized trials lacking sufficient supportive evidence (unless significant subject number provides supportive evidence)
Use in members with high-grade adverse effects/toxicity due to the drug
High-grade toxicity is exclusionary

Billing Rule

Health plan PDL precedence

When health plan Medicaid or Exchange coverage provisions, including any applicable Preferred Drug Lists (PDLs), conflict with this policy, the health plan provisions take precedence per the Preferred Drug Guidelines. For health plans using Evolent UM Oncology Clinical Policies with no applicable Health Plan PDL, the Preferred Drug Guidelines follow Evolent recommended agents/regimens/preferred drugs.

ASCO clinically meaningful outcome definitionHazard ratio < 0.80 and OS/PFS benefit at least 3 months

Compendia referencedNCCN, Clinical Pharmacology, Lexi-Drugs, Micromedex, AHFS

2025-08material_change

Added Tepylute (thiotepa) to Attachment A.

2025-09material_changeLatest

Added Clolar (clofarabine), Beizray (docetaxel), and Docivyx (docetaxel) to Attachment A; replaced Nolvadex (tamoxifen) with Soltamox (tamoxifen) in Attachment A.