CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Generic oncology drugs guideline — coverage criteria

Defines accepted indications, review process, and compendia-based coverage approach for generic oncology drugs used in cancer treatment for Neighborhood Health Plan of Rhode Island members administered/managed under Evolent's UM processes.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGeneric oncology drugs guideline — coverage criteria

Policy CodePolicy N/A

Change TypeTemplate conversiondrug list additions and removals

Effective DateApril 2025

Next Review DateN/A

Key ActionSubmit compendia references with prior authorization requests; initial reviewer will escalate to a Physician Peer Clinical Reviewer if needed.

SourceLink

POLICY UPDATE CHANGES

Added 'Endari (l-glutamine)' to list of drugs on guideline.

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

Removed 'Alimta/Pemfexy (pemetrexed)' from list of drugs in Attachment A.

Apr 2025Implementation month

Attachment ADrug list

CompendiaPrimary references

Commercial/Medicaid/ExchangeLines of business

Coverage Criteria for Generic Oncology Drugs

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Coverage criteria for generic oncology drugs

Covered when ALL of the following are met

Compendia support: Indication, dosing, and monitoring are consistent with recognized compendia (NCCN, Clinical Pharmacology, Lexi-Drugs, Micromedex, AHFS).

Reference compendia required for review

Generic therapeutic equivalence: Drug is generic and considered therapeutically equivalent per FDA/Orange Book designations or otherwise supported by compendia.

Attachment B summarizes Orange Book codes

Non-investigational use: Use is not investigational/off‑label without sufficient evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature (see criteria for adequate evidence).

See evidence sufficiency criteria in policy (study design, clinically meaningful outcomes per ASCO, population representation).

No brand request when generic available: Request is not for a name‑brand product when a generic alternative is available.

Requests for brand-name product when a generic alternative is available are excluded.

Authorization and review: Initial Clinical Reviewer determines medical necessity; if unresolved, escalate to Physician Peer Clinical Reviewer. Reviews completed within contractual timeframes.

Initial reviewer will escalate if determination is not rendered.

Requests for a brand-name product when a generic alternative is available are excluded and are not considered medically necessary. The policy explicitly prefers generic alternatives over brand products when available, except in limited circumstances such as documented drug shortage, disease progression, contraindication, or confirmed intolerance to the preferred product. In those exception cases an alternative product may be used if it is deemed medically appropriate and the indication is supported by a recognized compendium or accepted peer-reviewed literature.

Use of generic drugs for investigational or off‑label indications that lack sufficient supporting evidence is not covered. “Sufficient evidence” is defined by whether the patient and regimen are adequately represented in the published literature, whether study outcomes are clinically meaningful (for example, ASCO‑recommended thresholds such as a hazard ratio < 0.80 or survival benefit ≥ 3 months for OS/PFS), and whether study design and size provide robust support. Case reports or meeting abstracts without full peer‑reviewed articles generally do not constitute adequate evidence. Coverage decisions for such indications rely on CMS‑recognized compendia or acceptable peer‑reviewed literature.

Provider Actions, Prior Authorization and Documentation

Denial Risk

Authorization and reimbursement risk

Prior authorization required. All medication requests must be processed by Evolent; medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable.

All medication requests from network ordering providers are processed by Evolent.
Medications not authorized by Evolent may be considered not approvable and not reimbursable.

Prior Authorization

Compendia-based prior authorization

Decisions follow recognized compendia for dosing, indications, and monitoring. Evolent will reference NCCN Drugs & Biologics Compendium, Clinical Pharmacology, Lexi-Drugs, Micromedex, and AHFS Drug Information when determining medical necessity.

Primary compendia: NCCN Drugs & Biologics Compendium, Clinical Pharmacology, Lexi-Drugs, Micromedex, AHFS.
Compendia guidance used for dosing, indications/inclusion criteria, and monitoring.

Prior Authorization

Preferred medication/order of preference

Preferred medication guidance and order of preference must be followed. Health plan-specific coverage provisions (including PDLs) take precedence where applicable; otherwise Evolent recommended agents/regimens apply. Generic alternatives are preferred over brand-name drugs unless continuation of previously approved non-preferred therapy applies.

When health plan Medicaid or Exchange coverage provisions (including PDLs) conflict with this policy, the health plan provisions take precedence.
If no Health Plan PDL applies and the plan uses Evolent UM Oncology Clinical Policies, follow Evolent preferred agents/regimens.
Continuation requests for previously approved non-preferred medications are not subject to preference changes.
Generic alternatives are preferred over brand-name products.
Requests for brand when a generic alternative is available are considered not medically necessary.

Documentation Required

Documentation and review process

Documentation requirements for requests outside FDA labeling or compendia: providers must supply references and supporting clinical information per CMS Medicare Benefit Policy Manual Chapter 15. Failure to provide required references may delay processing.

Treatment requests outside approved FDA manufacturer labeling or CMS-approved compendia must follow CMS Medicare Benefit Policy Manual Chapter 15.
If supporting references are not produced, processing delays may occur.

Denial Risk

Brand request when generic available

Brand product requests when a generic exists are not medically necessary and will be denied.

Requests for name brand product when a generic alternative is available will be considered not medically necessary.
Disease progression while receiving the same drug/regimen containing the same drug is an exclusion.

Definitions and Equivalence Codes

Generic Drug — definition and FDA criteria

DefinitionA generic drug is identical or bioequivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

FDA approval requirementsContains same active ingredients as the innovator; identical strength, dosage form, and route; same indications; demonstrated bioequivalence; meets batch identity/strength/purity/quality; manufactured under FDA GMP standards.

Therapeutic equivalence conceptDrugs considered therapeutically equivalent are pharmaceutically equivalent products with no known or suspected bioequivalence problems (designated AA, AN, AO, AP, AT) or products whose bioequivalence problems have been resolved with adequate evidence (designated AB).

Non-equivalent designationsProducts with unresolved or documented bioequivalence problems are designated BC, BD, BE, BN, BP, BR, BS, BT, BX, or B* and are not considered therapeutically equivalent.

FDA Orange Book therapeutic equivalence codes

AANo bioequivalence problems in conventional dosage forms.

ABMeets necessary bioequivalence requirements; actual/potential problems have been resolved with adequate in vivo and/or in vitro evidence.

AN / AO / AP / ATAN = solution or powder for aerosolization; AO = injectable oil solutions; AP = injectable aqueous solutions; AT = topical products (all indicate no known bioequivalence problems for those dosage forms).

BC / BD / BE / BN / BP / BR / BS / BT / BX / B*Designations indicating various bioequivalence concerns or insufficient data (e.g., controlled‑release issues, documented problems, enteric‑coated forms, aerosol delivery, potential problems, suppositories/enemas, insufficient testing, topical issues, or requiring further FDA investigation).

Other codesEE = evaluated by FDA but rating not available for this labeler’s product; ZZ = FDA standard with no Orange Book code.

Initial Therapy Requirements

Initial therapy

Initial request requirements

Compendia-supported indication: Initial requests must be consistent with CMS-recognized compendia (NCCN, Clinical Pharmacology, Lexi-Drugs, Micromedex, AHFS) or acceptable peer‑reviewed literature for the specified cancer indication.

If references are not produced, processing delays may occur.

Preferred medication guidance applies: When applicable, generic alternatives are preferred over brand-name drugs; health plan PDLs (Medicaid or Exchange) take precedence when they conflict with this policy. Continuation requests of previously approved non-preferred medications are exempt from preferred-med provision.

Preferred Drug Guidelines and plan-specific PDLs govern precedence.

Exceptions for shortage/progression/contraindication/intolerance: If there is a documented drug shortage, disease progression, contraindication, or confirmed intolerance to a preferred drug/regimen, an alternative product may be used if compendia-supported and deemed medically appropriate.

Refer to FDA drug shortage resources when applicable.

Documentation for initial review: Provide citations to compendia or acceptable peer‑reviewed literature supporting the indication, dosing, and monitoring; lack of adequate references may delay processing.

Initial Clinical Reviewer will review submitted references and may escalate per contractual timeframes.

Preference / Rule	Details	Exceptions / Notes
Order of preference
When health plan Medicaid or Exchange coverage provisions (including applicable PDLs) conflict with this drug policy, the health plan's coverage provisions take precedence per the Preferred Drug Guidelines; if no plan PDL applies and the plan uses Evolent UM Oncology Clinical Policies, Evolent recommended agents/regimens/preferred drugs apply.
Applies to initial requests; continuation requests of previously approved non-preferred medications are exempt from preferred-medication provision.

Background and Scope

This guideline defines the scope and purpose for authorizing generic oncology drugs used in cancer care under Evolent’s utilization management for Neighborhood Health Plan of Rhode Island. It emphasizes reliance on recognized compendia (NCCN, Clinical Pharmacology, Lexi‑Drugs, Micromedex, AHFS) for determinations of appropriate indications, dosing, and monitoring, and it highlights the policy preference for therapeutic equivalence—favoring generics when equivalence is demonstrated—while outlining exceptions (shortage, progression, contraindication, intolerance) and the requirement for compendia or peer‑reviewed support when considering non‑labeled or investigational uses.