CurrentPremera BluecrossPolicy N/A

Coverage Criteria for Excluded and Non-Formulary Drugs

Defines when excluded or non-formulary prescription drugs may be covered under the pharmacy benefit and what documentation is required for provider requests. Applies to coverage requests managed by the payer's pharmacy benefit.

Policy Summary

PayerPremera Bluecross

PolicyCoverage Criteria for Excluded and Non-Formulary Drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2026

Next Review DateJun 1, 2026

Key ActionPrescriber must document failure, intolerance, or contraindication to required formulary alternatives when requesting coverage for an excluded or non-formulary drug.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 12 monthsmaximum initial/re-authorization approval length

3circumstances defined where coverage may be considered

N/ACoding section

Appliespolicy application

Coverage Criteria — Excluded and Non-Formulary Drugs

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Initial medical necessity criteria

Covered when one of the following distinct conditions is met and medical review supports necessity:

Primary pathways: One of three pathways must be met: (A) An excluded or non-formulary medication that has one or more formulary alternatives: prescriber has documented treatment failure, intolerance, or contraindication to at least two formulary alternatives (or one if only one alternative exists); medical necessity will be determined by medical review using the drug's labeled indications, contraindications, dosing, and published peer-reviewed evidence if use is off-label. (B) An excluded or non-formulary medication that has no reasonable formulary alternatives: medical necessity will be determined by medical review using the drug's labeled information and published peer-reviewed evidence. (C) An excluded or non-formulary medication that is brand-name with a generic equivalent available: prescriber documents a documented adverse reaction, allergy, or sensitivity to the generic (or therapeutic failure with the generic) plus treatment failure, intolerance, or contraindication to at least one other formulary alternative; or clinical justification that switching to the generic may destabilize the individual; medical records and clinical justification required for review.see node text

Medical necessity in all cases will be evaluated by medical review based on FDA label and published peer-reviewed evidence; approvals may be up to 12 months.

Approval duration

Authorization length and renewals

Authorization period: Initial and re-authorization approvals for non-formulary exception reviews and other reviews under this policy may be approved up to 12 months unless otherwise noted.up to 12 months

Re-authorization criteria same as initial unless noted otherwise.

Not covered: investigational

Investigational agents

Investigational/Experimental exclusions: Excluded or non-formulary drugs or biologic agents considered investigational or experimental are not covered because safety and/or efficacy cannot be established in the published literature.N/A

Medications subject to this policy are subject to the product's FDA dosage and administration prescribing information; determinations follow medical review.

Drugs or biologic agents that are considered investigational or experimental are not covered under this policy because their safety and/or efficacy cannot be established from the published scientific literature. Medical necessity for excluded or non-formulary products will be determined by individualized medical review using the drug's labeled indications, contraindications, dosing, and other label information as well as published peer‑reviewed clinical evidence when off‑label use is proposed.

Excluded or non‑formulary drugs that, after literature review, are deemed investigational/experimental are considered not medically necessary and are not covered. Reviewers will assess medical necessity based on the product labeling and available peer‑reviewed evidence; medications subject to this policy are also subject to the product's FDA dosage and administration prescribing information.

Provider Actions and Documentation Requirements

Step Therapy

Failure of formulary alternatives required

Failure of formulary alternatives is required. For excluded or non-formulary medications that have one or more formulary alternatives, the prescriber must document treatment failure, intolerance, or contraindication to at least two formulary alternatives before the excluded or non-formulary drug will be considered medically necessary. In cases where only one formulary alternative exists, the prescriber must document that the single alternative was ineffective, not tolerated, or contraindicated.

When only one formulary alternative is available, only that agent must be shown ineffective, not tolerated, or contraindicated.
For brand-name drugs with a generic equivalent, the prescriber must document an adverse reaction/allergy/sensitivity to the generic and failure, intolerance, or contraindication to at least one other formulary alternative.

Documentation Required

Required documentation — medical records, clinical rationale, and supporting evidence

Medical records, chart notes, laboratory results, and other clinical information must be provided to support requests for excluded or non-formulary drugs. Medical necessity will be determined by medical review of individual case circumstances and evaluated using the drug's labeled indications, contraindications, dosing, and any relevant published peer-reviewed literature for off-label uses. Requests lacking the required documentation may be denied.

Provide medical records/chart notes and labs as requested by the reviewer.
Include documentation of labeled indications, contraindications, dosing, and supporting literature for off-label use when applicable.
Clinical justification and records required if brand requested to avoid destabilization when switching to a generic.

Prior Authorization

Prior authorization duration and review

Non-formulary exception reviews and other reviews for drugs subject to this policy may be approved for up to 12 months unless noted otherwise. Prior authorization duration decisions will follow this standard approval length.

Typical approval length: up to 12 months for non-formulary exception reviews.

Denial Risk

Documentation required or risk denial

Requests may be denied if required clinical documentation is not provided or if the medication is investigational/experimental. Excluded or non-formulary drugs considered investigational — where safety and/or efficacy cannot be established in the published literature — are not covered.

Denial risk if requested clinical documentation (medical records, labs, chart notes) is not submitted.
Investigational or experimental excluded/non-formulary drugs are not covered.

Background

Formularies are a list of drugs approved by the Pharmacy and Therapeutics Committee for routine use and are designed to meet the needs of most individuals, but they do not always include the optimal therapeutic option for every patient. This policy defines when an excluded or non‑formulary drug may be covered: determinations rely on individualized medical review of the drug's labeled information and the published peer‑reviewed literature, and approvals under this policy may be granted for up to 12 months unless otherwise noted.

Definitions

Formulary

DefinitionA list of drugs approved by the Pharmacy and Therapeutics Committee (P&T) for routine use; drugs not on the list are referred to as excluded or non-formulary.

Alternate nameFormulary drug (also known as a preferred drug) — drugs on the formulary list.

PurposeProvides an adequate drug selection to meet the treatment needs of most individuals while allowing for exceptional cases where a non-formulary drug may be the best choice.

Actionable noteDrugs not on the formulary list are considered excluded or non-formulary and require medical review/exception for coverage.

Formulary alternative

DefinitionA drug that is not generically equivalent to the reference product but is expected to produce similar treatment outcomes in the majority of individuals with a condition.

Formulation typesFormulary alternatives may be either brand-name or generic drugs.

Use in policyRequired documentation must show failure, intolerance, or contraindication to formulary alternatives when seeking an exception for an excluded/non-formulary drug.

Generic equivalent

DefinitionAn FDA-approved generic demonstrated by pharmacokinetic studies to deliver similar amounts of active ingredient with comparable concentration-time profiles to the brand.

Source of equivalence determinationsGeneric equivalence evaluations are published by the FDA in the Orange Book.

Implication for brand requestsWhen a generic equivalent exists, brand use may require documentation of adverse reaction/allergy/sensitivity to the generic or therapeutic failure with the generic plus required alternative failures.

Initial Therapy Criteria

Initial therapy rules

Initial coverage pathways

When coverage may be considered: Coverage may be considered when the excluded/non-formulary drug meets one of the following: (A) Has one or more formulary alternatives and the prescriber documents treatment failure, intolerance, or contraindication to at least two formulary alternatives (or one if only one alternative exists), with medical review using label and peer-reviewed evidence; (B) Has no reasonable formulary alternative and medical review of the individual case (label and peer-reviewed evidence) supports use; (C) Is brand-name with a generic equivalent available and the prescriber documents a documented adverse reaction/allergy/sensitivity to the generic (or therapeutic failure with the generic) plus failure/intolerance/contraindication to at least one other formulary alternative, or provides clinical justification that switching to the generic may destabilize the individual, with medical records required for review.see text

Medical review will evaluate FDA label and published peer-reviewed evidence.

Step Therapy

Step	Requirement	Documentation required
1	Prescriber must document prior trials and specific clinical reasons for exception: treatment failure, intolerance, or contraindication to at least two formulary alternatives (or one if only one alternative exists). For brand-name requests when a generic equivalent exists, prescriber must document a documented adverse reaction/allergy/sensitivity to the generic plus failure/intolerance/contraindication to at least one other formulary alternative.	Clinical documentation should include medical records/chart notes and evidence showing treatment failure, intolerance, or contraindication to the required number of formulary alternatives; for brand-versus-generic requests include documentation of the adverse reaction/allergy/sensitivity to the generic. Medical necessity will be evaluated by medical review using the drug label and published peer-reviewed evidence.

Policy Summary

PayerPremera Bluecross

PolicyCoverage Criteria for Excluded and Non-Formulary Drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2026

Next Review DateJun 1, 2026

Key ActionPrescriber must document failure, intolerance, or contraindication to required formulary alternatives when requesting coverage for an excluded or non-formulary drug.

SourceLink

On This Page

OpenPayer

Coverage Criteria for Excluded and Non-Formulary Drugs

Coverage Criteria — Excluded and Non-Formulary Drugs

Coding

Provider Actions and Documentation Requirements

Background

Definitions

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy