CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Non-Formulary Exception

Defines criteria and requirements for granting prior authorization/exception requests for non-formulary drugs for Commercial and Medicaid members, including autoimmune-specific requirements. Covers initial approval, continuation, and duration.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyNon-Formulary Exception

Policy CodePolicy N/A

Change TypeClarified (review dates updated)

Effective DateApr 1, 2019

Next Review Date

Key ActionSubmit a non-formulary exception request documenting FDA-approved or compendia-supported indication, appropriate dosing, required prior trials/failures of formulary alternatives (two comparable agents when available) or rationale when none exist; for commercial autoimmune requests document trials/contraindications to at least one product of each mechanism of action.

SourceLink

POLICY UPDATE CHANGES

Reviewed dates updated through 05/2026 with multiple review entries listed.

Up to 12 monthsMaximum Approved Duration

2Required trialed formulary alternatives

Commercial, MedicaidScope

Coverage Summary

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Policy stance: covered with criteria for non-formulary drug exceptions for Commercial and Medicaid members. Initial approvals require evidence of FDA-approved or compendia-supported indication, dosing within labeling or compendia guidelines, and prior trials/failures of formulary alternatives per the criteria. Continuation approvals require meeting initial criteria, tolerability, and disease stabilization or improvement. Coverage is authorized for up to 12 months.

Initial Approval (Criteria for Approval)

An authorization may be granted when all the following criteria are met:

ALL of the following

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.
The prescribed dose and quantity fall within the FDA-approved labeling or within compendia-supported dosing guidelines.
One of the following
- The patient has experienced an inadequate treatment response or intolerance to two comparable formulary alternatives for the same indication, including the generic and biosimilar alternative, if available.
- If there are less than two comparable formulary alternatives available for the same indication, the patient has experienced an inadequate treatment response or intolerance to all of the formulary alternatives, including the generic and biosimilar alternative, if available.
- If there are no comparable formulary alternatives, rationale provided for why requested drug/product is medically necessary.
Autoimmune-specific commercial exception (when applicable)
- For Commercial autoimmune non-formulary exception requests (e.g., Taltz, Tremfya, Otezla, Bimzelx, Ilumya, Sotyktu, Skyrizi for Psoriasis or Psoriatic Arthritis, etc.): The patient has tried, failed, or has a contraindication to all products (at least one product of each mechanism of action e.g., an anti-TNF, an IL-12/23 inhibitor, an IL-17 inhibitor, etc.) indicated to treat the patient's autoimmune condition available on the formulary.

Provider Actions & Requirements

Prior Authorization

Non-formulary exception prior authorization required

Providers must submit a non-formulary exception (prior authorization) request that documents the requested drug is being used for an FDA‑approved indication or a medically accepted indication supported by an accepted compendium or peer‑reviewed literature; that the prescribed dose and quantity are within FDA labeling or compendium‑supported dosing; and that the patient has had prior trials, inadequate response, or intolerance to two comparable formulary alternatives for the same indication (including generic/biosimilar when available). If fewer than two comparable formulary alternatives exist, document inadequate response or intolerance to all available formulary alternatives; if no comparable alternatives exist, provide rationale for medical necessity. For commercial autoimmune non‑formulary exception requests, document trials, failures, or contraindications to at least one product of each mechanism of action (e.g., an anti‑TNF, an IL‑12/23 inhibitor, an IL‑17 inhibitor) available on the formulary.

Indication: FDA‑approved or compendia/peer‑review supported
Dosing: within FDA labeling or compendia dosing guidelines
Prior trials: two comparable formulary alternatives (include generic/biosimilar when available) or all available alternatives if <2
No alternatives: provide medical necessity rationale
Commercial autoimmune: trial/failure/contraindication to at least one product of each mechanism of action

Documentation Required

Document efficacy and tolerability for continuation

For continuation requests, document that the patient met all initial approval criteria, is tolerating the treatment without unacceptable toxicity, and demonstrates disease stabilization or improvement as defined by established clinical practice guidelines.

Billing Rule

Coverage duration limit

Approvals are granted for up to 12 months in accordance with FDA guidance and internal policies and procedures.

Background & Definitions

This policy establishes the non-formulary exception prior authorization process and the evidence and documentation required for approval. Requests must demonstrate the drug is being used for an FDA-approved indication or a medically accepted indication supported by one of the listed standard reference compendia or peer-reviewed literature, and that the prescribed dose and quantity fall within FDA labeling or compendia-supported dosing. Providers must document prior trials or inadequate response/intolerance to formulary alternatives (typically two comparable agents when available) or provide rationale when no alternatives exist. For continuation, providers must document tolerability and clinical benefit. For Commercial autoimmune non-formulary exception requests, additional mechanism-of-action trial requirements apply: the patient must have tried, failed, or have a contraindication to all formulary products representing each relevant mechanism of action (e.g., at least one anti-TNF, IL-12/23 inhibitor, IL-17 inhibitor, etc.).

Medically accepted indication: An indication supported by one of the listed standard reference compendia (AHFS-DI, DrugDex, Clinical Pharmacology, Lexi-Drugs) or peer-reviewed medical literature.

Quick Facts

ScopeCommercial, Medicaid

Maximum Approved DurationUp to 12 months

Required trialed formulary alternatives (typical)2

Revision History

2019-04-01effective_date

Policy Effective Date: 2019-04-01 (as listed in revision history).

2019-11revised

Policy Revised: 11/2019 (as listed in revision history).

2026-01-01review

Reviewed entry: 01/2026 listed in revision history; multiple review entries noted.

2026-05-01reviewLatest

Reviewed entry: 05/2026 listed in revision history. Reviewed dates updated through 05/2026 with multiple review entries listed.