CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Generic Oncology Drugs Coverage Criteria (Attachment A)

Defines acceptable indications, review process, and preferred-use principles for generic oncology drugs listed in Attachment A; applies to providers submitting medication requests to Evolent on behalf of participating health plans.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyGeneric Oncology Drugs Coverage Criteria (Attachment A)

Policy CodePolicy N/A

Change TypeAttachment A drug list additions (Sep & Dec 2025)

Effective DateDec 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests for Attachment A drugs to Evolent; Initial Clinical Reviewers will determine authorization and may escalate to a Physician Peer Clinical Reviewer.

SourceLink

POLICY UPDATE CHANGES

Added 'Droxia (hydroxyurea)', 'Xromi (hydroxyurea)', and 'Imkeldi (imatinib)' to Attachment A.

Added 'Clolar (clofarabine)', 'Beizray (docetaxel)', and 'Docivyx (docetaxel)' to Attachment A.

~100+drugs listed in Attachment A (oncology generics)

Commercial/Exchange/Medicaidapplicable lines of business

NCCN + compendiaclinical references used for review

FDA Orange Booktherapeutic equivalence framework

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Coverage Criteria

Coverage criteria

Covered when ALL of the following are met:

General coverage conditions: Drug is listed in Attachment A and the requested use is supported by compendia (NCCN, Clinical Pharmacology, Lexi-Drugs, Micromedex, AHFS) for dosing, indications, and monitoring.

Evolent will follow these compendia for updates and accepted uses.

Preferred product preference: When available, generic alternatives are preferred over brand-name drugs unless exceptions apply (drug shortage, disease progression, contraindication, or confirmed intolerance).

Plan-specific PDLs or health-plan Medicaid/Exchange coverage provisions take precedence where applicable; for plans using Evolent UM Oncology Clinical Policies, Evolent recommended agents/regimens apply if no plan PDL exists.

Off-label and investigational use: Off-label or investigational uses require sufficient supporting evidence from CMS-recognized compendia or acceptable peer-reviewed literature. Insufficient evidence (case reports, abstracts without full article, or evidence that does not adequately represent the patient, regimen, or clinically meaningful outcomes) will render the use investigational and not accepted.

ASCO thresholds (e.g., HR < 0.80; OS/PFS benefit ≥ 3 months) are referenced when assessing clinical meaningfulness.

Exclusions: Request for name-brand product when a generic alternative is available; disease progression while receiving the same drug/regimen containing the same drug are not considered medically necessary.

These are exclusion criteria for drugs listed in Attachment A.

Requests for a brand-name product will be denied when an FDA-equivalent generic alternative is available for the requested agent; such requests are listed as an exclusion in this policy. Similarly, requests based on disease progression while receiving the same drug/regimen containing the same drug are not considered medically necessary under the policy. Exceptions to the generic-preferred principle exist when a documented drug shortage, confirmed intolerance, contraindication, or clinically justified disease progression prevents use of the preferred generic and an alternative is supported by a recognized compendium or peer-reviewed literature.

Off-label or investigational uses of generic oncology drugs require adequate supporting evidence from CMS-recognized compendia or acceptable peer-reviewed literature. The policy defines adequacy by whether the published evidence appropriately represents the patient and disease population, the regimen under study, and reports clinically meaningful outcomes (for example, ASCO-referenced thresholds such as hazard ratio < 0.80 or survival benefits of at least 3 months for OS/PFS).

Evidence considered insufficient — and therefore more likely to render a use investigational and not approved — includes uncontrolled case reports, abstracts without a full peer‑reviewed article, or studies that do not adequately represent the patient/population/regimen/outcomes. Providers requesting coverage for off-label use should supply compendia citations or peer-reviewed references to support the request; absence of such documentation may lead to non-coverage.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for medication requests for drugs listed in Attachment A. Evolent is responsible for processing all medication requests submitted by network ordering providers. Medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable. Providers must submit prior authorization requests to Evolent per the plan routing and processing requirements.

Applies to all drugs in Attachment A
All PA determinations and routing are handled by Evolent
Medications not authorized by Evolent may be non-reimbursable

Documentation Required

Supporting Documentation Required

Providers requesting treatment outside the FDA-approved manufacturer labeling or outside CMS-approved compendia must supply supporting references at the time of request. Treatment requests that deviate from accepted labeling/compendia should follow CMS Medicare Benefit Policy Manual Chapter 15. If adequate references are not provided, processing delays may occur and the request may be at increased risk for denial.

Background

This guideline covers the use of generic oncology drugs listed in Attachment A and relies on recognized reference compendia — including the NCCN Drugs and Biologics Compendium, Clinical Pharmacology, Lexi-Drugs, Micromedex, and AHFS Drug Information — for accepted indications, dosing, and monitoring. The policy also uses FDA Orange Book therapeutic equivalence ratings to inform equivalence and generic substitution decisions.

Investigational or off‑label uses are only acceptable when supported by CMS‑recognized compendia or acceptable peer‑reviewed literature; the policy outlines specific evidence quality considerations (representation of patient/regimen, clinically meaningful outcomes, study design, and exclusion of low‑quality evidence such as isolated case reports or abstracts without full publication).

Definitions

Generic Drugs and FDA Orange Book codes

Definition of generic drugA 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 requirements for genericsMust contain the same active ingredients as the innovator drug; be identical in strength, dosage form, and route of administration; have the same indications; be bioequivalent; meet batch requirements for identity, strength, purity, and quality; and be manufactured under FDA good manufacturing practice standards.

Orange Book therapeutic equivalence coding (AA, AN, AO, AP, AT)Designates drug products with no known or suspected bioequivalence problems (codes depend on dosage form).

Orange Book AB codeIndicates actual or potential bioequivalence problems have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence.

Non‑therapeutically equivalent codesCodes such as BC, BD, BE, BN, BP, BR, BS, BT, BX, or B* identify products for which bioequivalence problems have not been resolved.

Initial Therapy

Initial therapy

Preferred medication guidance for initial requests

Plan precedence: When health plan Medicaid or Exchange coverage provisions (including any applicable PDLs) conflict with this drug policy, the health plan provisions take precedence.

Per the Preferred Drug Guidelines.

Evolent policy application: For health plans that utilize Evolent UM Oncology Clinical Policies and no health plan PDL is applicable, Evolent recommended agents/regimens/preferred drugs shall be followed.

Continuation exemption: Continuation requests of previously approved non-preferred medications are not subject to switching to preferred agents at initiation.

Use of alternatives:

Continuation Therapy

Continuation therapy

Continuation requests

Continuation exceptions: Continuation requests of previously approved non-preferred medications are not subject to switching to preferred agents.

Applies when a member is already receiving and has prior authorization for a non-preferred product.

Step Therapy and Preferred Regimens

Preferred selection / requirement	Exceptions (shortage, progression, contraindication, intolerance)	Policy note
Preferred drug/regimen selection should be followed where applicable; generic alternatives are preferred over brand-name drugs when available.	When there is a documented drug shortage, disease progression, a documented contraindication, or confirmed intolerance to a preferred drug/regimen, an alternative product may be used if it is deemed medically appropriate and the indication is supported by a standard reference compendium or accepted peer-reviewed literature.	When health plan Medicaid or Exchange coverage provisions (including PDLs) conflict with this policy, the plan-specific provisions take precedence. Continuation requests for previously approved non-preferred medications are not subject to switching to preferred agents.