CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Formulary Management and Non‑Formulary Exception Criteria

This policy governs authorization and coverage rules for non-formulary and specialty drug requests (including biologics and biosimilars) for Neighborhood Health Plan of Rhode Island members across applicable products and indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFormulary Management and Non‑Formulary Exception Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 20, 2019

Next Review DateN/A

Key ActionObtain prior authorization showing prescribing is within FDA or accepted compendia dosing and document failure or intolerance to two formulary alternatives (or provide medical rationale if none exist).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsmaximum coverage duration

2 trialstypical step requirement

stabilizationcontinuation condition

Coverage Criteria

inv-01: Initial Therapy

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Initial Approval: (1) The prescribed dose and quantity fall within FDA‑approved labeling or compendia‑supported dosing guidelines; (2) The requested drug/product is for an FDA‑approved indication or a medically accepted indication as defined by standard reference compendia (AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs) or peer‑reviewed medical literature; (3) One of the following: (a) The patient has experienced an inadequate treatment response or intolerance to two comparable formulary alternatives for the same indication (including generic and biosimilar alternatives, if available); (b) If fewer than two comparable formulary alternatives exist, the patient has experienced an inadequate response or intolerance to all available formulary alternatives (including generics/biosimilars, if available); or (c) If there are no comparable formulary alternatives, a rationale is provided explaining why the requested drug/product is medically necessary.

Includes requirement to consider generic/biosimilar alternatives where available

inv-02: Continuation Therapy

Covered when ALL of the following continuation criteria are met

Continuation Therapy: (1) Patient continues to meet all initial approval criteria from Section I; (2) Patient has disease stabilization or improvement as defined by established clinical practice guidelines; (3) Patient is tolerating the treatment and is not experiencing unacceptable toxicity from the drug.

Continuation approvals align with initial criteria plus evidence of benefit and tolerability

This policy governs authorization of non‑formulary and specialty medications and applies when determining coverage for requested drugs. Coverage is provided only when the request meets all elements of the stated approval criteria: prescribed dose and quantity must fall within FDA‑approved labeling or compendia‑supported dosing, the drug must be for an FDA‑approved or medically accepted indication as defined by recognized compendia or peer‑reviewed literature, and the required prior‑therapy or clinical justification conditions are satisfied. When those initial or continuation criteria are not met, coverage is not granted — exclusions are implicit where the specified criteria fail to be satisfied.

Requests that do not provide dosing or indication consistent with FDA labeling or the accepted drug compendia are considered not medically necessary. Specifically, prior authorization will not be granted where the prescribed dose/quantity falls outside FDA‑approved labeling or compendia‑supported dosing, or where the requested use is not an FDA‑approved indication nor supported as a medically accepted indication by AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs, or peer‑reviewed literature. Additionally, requests lacking required documentation of prior trials (typically failure or intolerance to two comparable formulary alternatives, including generics/biosimilars where available), or lacking a clinical rationale when no comparable alternatives exist, may be denied as not medically necessary.

Initial Authorization Criteria

inv-11: Initial

Initial authorization for non-formulary specialty drugs

Initial: Approval requires: dosing within FDA‑approved labeling or compendia‑supported dosing; indication supported by FDA or a medically accepted indication per listed compendia or peer‑reviewed literature; and documented failure/intolerance to formulary alternatives (typically two comparable alternatives including generics/biosimilars) or a clinical rationale when no comparable formulary alternatives exist.

Step Therapy Documentation

Requirement	Detail
Document prior trials, failures, or contraindications
One of the following must be documented: (a) inadequate response or intolerance to two comparable formulary alternatives for the same indication (including generic and biosimilar alternatives, if available); (b) if fewer than two comparable formulary alternatives exist, inadequate response or intolerance to all available formulary alternatives (including generics/biosimilars); or (c) if there are no comparable formulary alternatives, a clinical rationale explaining why the requested drug/product is medically necessary.

Requirement

Detail

Document prior trials, failures, or contraindications

One of the following must be documented: (a) inadequate response or intolerance to two comparable formulary alternatives for the same indication (including generic and biosimilar alternatives, if available); (b) if fewer than two comparable formulary alternatives exist, inadequate response or intolerance to all available formulary alternatives (including generics/biosimilars); or (c) if there are no comparable formulary alternatives, a clinical rationale explaining why the requested drug/product is medically necessary.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization may be granted when ALL of the following are met: the prescribed dose and quantity are within FDA‑approved labeling or accepted compendia dosing; the requested drug is for an FDA‑approved indication or a medically accepted compendia/peer‑reviewed indication; and required step‑therapy or alternative‑failure criteria are satisfied.

Prescribed dose and quantity must fall within FDA‑approved labeling or compendia‑supported dosing guidelines (e.g., AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs).
Requested use must be an FDA‑approved indication or a medically accepted indication supported by standard reference compendia or peer‑reviewed literature.

Step Therapy

Step Therapy Requirements

Step therapy must be documented unless fewer than two comparable formulary alternatives exist or alternatives are contraindicated. Provide documentation of inadequate response or intolerance to required formulary alternatives.

Patient must have an inadequate response or intolerance to two comparable formulary alternatives for the same indication, including available generic and biosimilar alternatives.
If fewer than two comparable formulary alternatives exist, the patient must have an inadequate response or intolerance to all available formulary alternatives.
If there are no comparable formulary alternatives, provide a clinical rationale explaining why the requested drug is medically necessary (e.g., prior trials, contraindications, intolerance).

Documentation Required

Required Documentation

Provide documentation to support dosing, indication, and prior treatment history. Include records of prior trials, responses, intolerances, contraindications, and rationale when formulary alternatives are unavailable.

Document the prescribed dose and quantity consistent with FDA labeling or compendia dosing.
Provide evidence of prior trials of formulary alternatives, including dates, agents used, duration, and reason for discontinuation (e.g., lack of efficacy, adverse effect, contraindication).
For non‑formulary or specialty autoimmune drug requests, include clinical rationale when formulary alternatives are not suitable or available.

Denial Risk

Triggers for Denial

Requests that fail to meet the criteria will be denied. Common denial triggers include dosing/quantity outside FDA or compendia guidance, unsupported indication, and insufficient evidence of prior trials or intolerance to formulary alternatives.

Prescribed dose or quantity outside FDA‑approved labeling or accepted compendia dosing.
Requested indication is not FDA‑approved and lacks support in accepted compendia or peer‑reviewed literature.
Insufficient documentation of prior trials, inadequate response, intolerance, or contraindication to required formulary alternatives.
No clinical rationale provided when there are fewer than two or no comparable formulary alternatives.

Definitions

Medically accepted indication — definition and use

DefinitionAn FDA-approved indication or one supported by standard reference compendia: American Hospital Formulary Service (AHFS-DI), Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or peer-reviewed published medical literature showing sufficient supporting evidence.

Accepted compendiaAHFS-DI; Thomson Micromedex DrugDex; Clinical Pharmacology; Wolters Kluwer Lexi-Drugs; peer-reviewed published medical literature.

Role in coverage decisionsRequested drug must be for an FDA-approved or medically accepted indication (per listed compendia or literature) for authorization to be granted.

When compendia/literature requiredUsed to support indications that are not FDA-approved — peer-reviewed literature must demonstrate sufficient evidence to support use.

Implication if not metRequests lacking an FDA- or compendia-supported indication are considered not medically necessary per policy criteria.

Background

This policy describes the process for formulary exception review and the continuation criteria for ongoing therapy. It emphasizes use of FDA labeling and recognized drug compendia to define a medically accepted indication and appropriate dosing, and requires documentation of prior trials of formulary alternatives (typically two comparable alternatives) or a rationale when no comparable alternatives exist. Continuation of therapy requires that the patient continues to meet the initial approval criteria and demonstrates disease stabilization or improvement while tolerating treatment without unacceptable toxicity.