Coverage Criteria for Excluded and Non-Formulary Drugs
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Defines Premera Bluecross pharmacy coverage criteria and related references for drugs that are excluded from or not on the formulary; applies to pharmacy benefit adjudication and prior authorization review processes.
No material clinical or coverage changes in this revision.
Coverage Criteria for Excluded and Non‑Formulary Drugs
Medical necessity criteria
Coverage of an excluded or non-formulary drug may be considered medically necessary under any of the following three circumstances:
Medical necessity will be determined by individual medical review considering the drug's labeled indications, contraindications, dosing, and published peer‑reviewed evidence for off‑label uses.
Medical review considers labeled indications, dosing, contraindications, and literature.
Not covered.
General coverage criteria for excluded and non‑formulary drugs
Coverage determinations for excluded or non‑formulary drugs:
Non‑formulary exception reviews and all other reviews for drugs subject to this policy may be approved up to 12 months as long as medical necessity criteria are met and chart notes demonstrate continued positive clinical response to therapy.
No explicit exclusions are stated in the available extract of this policy. The source text does not list any named drugs, conditions, or situations that are categorically excluded beyond the general formulary status of a product.
Coverage exclusions or limits for excluded and non‑formulary drugs are handled by cross-reference to related Premera policies. See in particular policy 5.01.547 (DAW/dispense-as-written and exchange formulary criteria), 5.01.549 (off‑label use of drugs and biologic agents), and 5.01.560 (excessively high cost drug products with lower‑cost alternatives) for specific exclusion or limiting rules referenced in this policy.
When the document refers to drugs as "excluded and non‑formulary," specific exclusions and any coverage limitations are defined in the referenced policies (for example, 5.01.547, 5.01.549, and 5.01.560); this policy directs reviewers and providers to those policies for the detailed exclusion language.
Excluded or non‑formulary drugs or biologic agents that are considered investigational or experimental are not covered under this policy because safety and/or efficacy cannot be established after review of the published scientific literature.
Drugs or biologic agents determined to be investigational or experimental are not covered. The policy states that such agents are excluded because their safety and/or efficacy cannot be established on the basis of published scientific literature and therefore do not meet coverage criteria.
The provided extract does not include any explicit statements labeled or formatted as "not medically necessary" conditions. No discrete not‑medically‑necessary scenarios are stated in the available chunks.
Determinations that an off‑label use is not medically necessary are governed by the referenced off‑label use policy, 5.01.549; this policy refers providers and reviewers to that document for the criteria used in evaluating off‑label medical necessity.
Excluded or non‑formulary drugs that are investigational or experimental are considered not medically necessary when there is insufficient evidence of safety and/or efficacy in the published scientific literature; such requests will be denied for lack of established safety/efficacy.
Coding
Provider Actions, Prior Authorization, and Documentation
Prior authorization required for excluded/non‑formulary drugs
This policy governs the coverage criteria used in prior authorization review for excluded and non‑formulary drugs under the pharmacy benefit; submit a PA request when seeking coverage for an excluded or non‑formulary medication so the case can be reviewed against these criteria.
Prior authorization governed by referenced policies (5.01.547, 5.01.549)
Follow the referenced formulary and DAW exception review policy (5.01.547) and related policies cited in this document when preparing prior authorization requests; specific PA rules (e.g., DAW, dispensing limits) are governed by those policies.
- Referenced policies include 5.01.547 (DAW/formulary rules) and 5.01.549 (off‑label use).
PA requirements reference external policies for DAW, exchange formulary, and high‑cost alternatives
Prior authorization requirements for DAW exceptions, exchange formulary benefits, and high‑cost alternative considerations are governed by the referenced policies; follow those policies for specific PA criteria and exception processes.
- See policies 5.01.547, 5.01.549, and 5.01.560 for detailed PA rules and exception procedures.
Authorization duration — approvals may be up to 12 months
Non‑formulary exception reviews and other reviews under this policy may be approved for up to 12 months unless otherwise noted; request duration may be granted up to that maximum when submitting the PA.
- Initial approvals may be issued for up to 12 months when medical necessity criteria are met.
Re‑authorization may be approved up to 12 months with documented response
When medical necessity criteria are met and chart notes demonstrate continued positive clinical response, non‑formulary exception reviews and re‑authorizations may be approved for up to 12 months.
- Re‑authorization requires chart notes showing continued positive clinical response.
Documentation required with every medical necessity request
Providers must supply all required clinical documentation with every medical necessity request for an excluded or non‑formulary drug; include medical records/chart notes, lab results, and any additional clinical information requested by the reviewer.
- Include medical records/chart notes, laboratory results, and other clinical information as requested.
Step therapy / lower‑cost alternative rules referenced (5.01.560)
Step therapy or lower‑cost alternative requirements for excessively high cost drugs are governed by policy 5.01.560; when such requirements apply, follow that policy for prior steps and exception criteria.
- Policy 5.01.560 defines rules when lower‑cost alternatives are required for excessively high cost drug products.
Step therapy cross‑reference to exchange formulary and high‑cost policies
Step therapy considerations and any exchange formulary or high‑cost alternative requirements are governed by the referenced exchange/formulary policies; consult those policies when step requirements are implicated.
- See referenced exchange formulary and high‑cost alternative policies for step therapy details.
Document failure/intolerance/contraindication to formulary alternatives (≥2, or ≥1 if only one exists)
When formulary alternatives exist, the prescriber must document treatment failure, intolerance, or contraindication to at least two formulary alternatives (or to the single alternative if only one exists) before an excluded or non‑formulary drug will be considered medically necessary.
- If only one formulary alternative exists, documentation that that agent was ineffective, not tolerated, or contraindicated is sufficient.
When no reasonable formulary alternative exists — submit full evidence for individual review
If no reasonable formulary alternative exists, coverage will be determined by individual medical review considering the drug's FDA‑approved labeling and published peer‑reviewed clinical evidence for off‑label uses.
- Medical review will evaluate labeled indications, contraindications, dosing, and relevant literature.
Documentation must follow referenced policy requirements (5.01.547, 5.01.549, 5.01.560)
Follow documentation and submission requirements specified in the referenced policies (5.01.547, 5.01.549, 5.01.560) when requesting coverage for excluded or non‑formulary drugs; these referenced policies outline required forms, evidence, and submission procedures.
- Documentation expectations align with 5.01.547 (DAW/dispensing limits), 5.01.549 (off‑label use), and 5.01.560 (high‑cost alternatives).
Clinical documentation must include FDA labeling and peer‑reviewed evidence for off‑label uses
Medical review will evaluate the drug's FDA‑approved labeling (indications, contraindications, dosing) and published peer‑reviewed clinical evidence when assessing medical necessity for excluded or non‑formulary drugs, especially for off‑label uses.
- Include label information and relevant peer‑reviewed literature with the request to support off‑label uses.
Missing documentation or failure to follow referenced submission rules may trigger denial
Provide the specific clinical records and evidence cited above; failure to include required documentation or evidence per the referenced policies risks denial of the request.
- Required items include chart notes, labs, and any literature supporting off‑label use or lack of formulary alternatives.
Denial risk if request does not meet referenced policy criteria (5.01.547, 5.01.549)
Requests that do not meet the criteria in the referenced policies (for example, 5.01.547 for DAW/formulary rules or 5.01.549 for off‑label use) are at risk of denial; ensure the request aligns with those policies.
- Nonconformance with DAW, off‑label, exchange formulary, or high‑cost alternative policies may lead to denial.
Denial triggers include excluded/non‑formulary status and referenced policy rules
Coverage denials may be triggered when a drug is excluded or not on the formulary and when DAW/off‑label/exchange formulary or high‑cost alternative rules (per the referenced policies) apply; check formulary status and referenced policy rules before submitting a PA.
- Confirm formulary status and applicable referenced policy rules prior to submission to reduce denial risk.
Investigational/experimental excluded or non‑formulary drugs are not covered (denial expected)
Excluded or non‑formulary drugs or biologic agents that are considered investigational or experimental are not covered and will be denied; do not submit a PA for investigational uses unless requested evidence supports a different determination.
- These agents are not covered because safety and/or efficacy cannot be established after reviewing the published scientific literature.
Initial Authorization Criteria
Initial authorization
Initial authorization considerations
Re-authorization / Continuation Criteria
Re-authorization
Re-authorization rules
Unless noted otherwise.
Re‑authorization
Re‑authorization expectations
Step Therapy and Cost-Alternative Rules
| Requirement | Reference / Action |
|---|---|
| When an excluded or non-formulary drug is excessively high cost and lower-cost formulary alternatives exist | |
| Follow policy 5.01.560 (Excessively High Cost Drug Products with Lower Cost Alternatives) for rules requiring step therapy or lower-cost alternatives prior to coverage of the higher-cost product |
| Coverage requirement | Documentation expected from prescriber |
|---|---|
| Prescriber must document prior treatment failure, intolerance, or contraindication to formulary alternatives before an excluded or non-formulary drug is considered | |
| Medical record/chart notes documenting failure, intolerance, or contraindication to at least two formulary alternatives (or to one if only one alternative exists); clinical rationale for non-formulary selection |
Background
A formulary is intended to meet the needs of most individuals; therefore, excluded or non‑formulary drugs are normally not covered under the pharmacy benefit. However, the policy recognizes that such products may be appropriate for specific individuals when formulary agents are ineffective, not tolerated, or contraindicated, and medical necessity may be granted after individual case review.
Definitions
Site of Care
Pharmacy benefit management
Managed under the pharmacy benefit; this policy applies only to pharmacy benefit adjudication for formulary exclusion or non‑formulary drugs (site of care is not specified here).
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