CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Drug authorization criteria for formulary exceptions

Defines clinical and administrative requirements for approving drug/product authorizations for Neighborhood Health Plan of Rhode Island members in the Medicaid portion of the FIDE SNP program.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug authorization criteria for formulary exceptions

Policy CodePolicy N/A

Change TypeMinor/administrative

Effective Date01/2026

Next Review DateN/A

Key ActionPrescriber must document indication, dosing within FDA/compendia limits, and explain why formulary alternatives are less effective or likely to cause adverse effects.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4initial criteria

3continuation requirements

12 momax duration

Medicaid FIDE SNPscope

Coverage Criteria

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Initial criteria A–D: A. The requested drug/product is being used for an FDA-approved indication or a medically accepted indication as defined in any one of the following standard reference compendia: American Hospital Formulary Service Drug information (AHFS-DI), Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or peer-reviewed published medical literature indicating that sufficient evidence exists to support use.; B. The prescribed dose and quantity fall within the FDA-approved labeling or within compendia-supported dosing guidelines.; C. The prescriber specifically indicated that the formulary alternatives would be less effective than the requested drug.; D. The prescriber specifically indicated that the formulary alternatives would likely produce ANY adverse effects for the member.

Exact compendia listed: AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or peer-reviewed literature.

Continuation Therapy

Continuation of therapy approved when ALL of the following are met:

Continuation criteria A–C: A. Patient meets all initial criteria in section I.; B. Patient is tolerating treatment and is not experiencing any unacceptable toxicity from the drug.; C. Patient has disease stabilization or improvement in disease (as defined by established clinical practice guidelines).

Use that does not meet an FDA‑approved indication or a medically accepted indication as supported by the listed standard compendia (AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs, or peer‑reviewed literature) is not supported. Additionally, requests where the prescribed dose and quantity fall outside FDA labeling or compendia‑supported dosing, or where the prescriber does not provide a justification that formulary alternatives would be less effective or likely to cause adverse effects for the member, do not meet the policy and may be denied.

Initial Therapy

Initial authorization: Drug must be for an FDA-approved or compendia-supported medically accepted indication as listed in policy; dose and quantity must be within FDA labeling or compendia-supported dosing; prescriber must state formulary alternatives would be less effective; prescriber must state formulary alternatives would likely produce any adverse effects for the member.

Refer to listed compendia: AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or peer-reviewed literature.

Continuation of Therapy

Continuation criteria: Patient meets initial criteria; patient is tolerating treatment without unacceptable toxicity; patient has disease stabilization or improvement per established clinical practice guidelines.

Coverage duration limited as specified in Coverage Duration section.

Provider Actions / Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for the requested drug/product. Authorization will only be considered when ALL of the following criteria (A–D) are met: the medication is for an FDA-approved or compendia-supported indication; dosing and quantity are within FDA labeling or compendium-supported dosing; and the prescriber documents why formulary alternatives are less effective or likely to cause adverse effects.

A. FDA-approved indication or medically accepted indication documented (per AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs, or peer-reviewed literature).
B. Prescribed dose and quantity align with FDA labeling or compendium-supported dosing guidelines.
C. Prescriber documents specific reasons why formulary alternatives would be less effective for this member.
D. Prescriber documents specific reasons why formulary alternatives would likely produce any adverse effects for this member.

Denial Risk

Denial Risk if Criteria Not Met

Requests that do not meet ALL listed criteria (A–D) are subject to denial. Ensure documentation addresses indication, dosing/quantity alignment with labeling or compendia, and prescriber justification for why alternatives are unsuitable.

Missing documentation of indication per listed compendia may trigger denial.
Doses or quantities outside FDA labeling or compendium guidance may trigger denial.
Lack of prescriber justification for why formulary alternatives are less effective or likely to cause adverse effects may trigger denial.

Step Therapy

Step Therapy Expectation

Prior authorization requests must include specific prescriber documentation demonstrating why step therapy was not appropriate or why formulary alternatives are expected to be less effective or cause adverse effects for this member.

Explain prior use and response to formulary alternatives, if any.
Describe anticipated effectiveness concerns with formulary options.
Describe anticipated adverse effects or contraindications to formulary alternatives.

Documentation Required

Documentation Requirements

Required documentation must be submitted with the authorization request to support approval: indication documentation, dosing/quantity aligned with labeling or compendia, and prescriber justification addressing effectiveness and adverse-effect concerns with formulary alternatives.

Clinical indication and supporting reference (AHFS-DI, DrugDex, Clinical Pharmacology, Lexi-Drugs, or peer-reviewed literature).
Prescribed dose and quantity with reference to FDA labeling or compendia guidance.
Prescriber statement explaining why formulary alternatives are less effective or likely to produce adverse effects for this member.

Step Therapy Requirements

Step	Requirement
1	Prescriber must document that formulary alternatives would be less effective than the requested drug (i.e., why alternatives are expected to be less effective).
2	Prescriber must document that formulary alternatives would likely produce ANY adverse effects for the member (i.e., why alternatives are expected to cause adverse effects).
3	Documentation must be provided as part of the prior authorization request to bypass expected use of formulary alternatives.

Dose and Duration Limits

Dose and Quantity Limits

Dose and quantity requirementPrescribed dose and quantity must fall within FDA‑approved labeling or within compendia‑supported dosing guidelines (per AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs, or peer‑reviewed literature).

Applies toAny requested drug or product subject to authorization under this policy.

Source of dosing limitsFDA‑approved labeling or standard reference compendia dosing guidance as listed in the policy.

Coverage Duration

Maximum coverage durationAuthorized therapy may be covered for up to 12 months as determined by FDA guidance and internal policies and procedures.

ApplicabilityApplies to authorized continuous therapy periods for covered drugs under this policy.

Review considerationCoverage duration determined in accordance with FDA guidance and NHPRI internal policies.

Definitions

Medically Accepted Indication — Definition

DefinitionA medically accepted indication is an indication supported by standard reference compendia (American Hospital Formulary Service Drug Information [AHFS‑DI]; Thomson Micromedex DrugDex; Clinical Pharmacology; Wolters Kluwer Lexi‑Drugs) or by peer‑reviewed published medical literature demonstrating sufficient evidence for use.

Accepted sourcesAHFS‑DI; Thomson Micromedex DrugDex; Clinical Pharmacology; Wolters Kluwer Lexi‑Drugs; peer‑reviewed literature.

Use in authorizationAn indication meeting this definition satisfies the policy requirement for a medically accepted indication when requesting authorization.

Background

This policy governs authorization when drugs are used for FDA‑approved or medically accepted indications as evidenced by standard drug compendia or peer‑reviewed literature. Continuation of therapy requires that the patient continues to meet the initial criteria, is tolerating treatment without unacceptable toxicity, and demonstrates disease stabilization or improvement per established clinical practice guidance.