CurrentHumanaPolicy N/A

Immediate formulary substitutions for certain brand-name and biological drugs

Humana policy governing immediate formulary removal or tier/restriction changes when a new generic or specified biosimilar version of a previously covered brand-name prescription drug or original biological product is added; affects members and prescribing providers whose medications are impacted.

Policy Summary

PayerHumana

PolicyImmediate formulary substitutions for certain brand-name and biological drugs

Policy CodePolicy N/A

Change TypeImmediate formulary removals/re-tiering

Effective DateN/A

Next Review DateN/A

Key ActionIf a member is impacted by an immediate formulary change, the member or prescriber can request an exception to continue coverage of the original drug.

SourceLink

POLICY UPDATE CHANGES

Immediate substitutions list including Entresto (sacubitril-valsartan), Pomalyst (pomalidomide), and Ofev (nintedanib esylate) with effective dates.

Humana may immediately remove or re-tier a brand-name or original biological product when a new generic or certain biosimilar appears on the same or lower cost-sharing tier with same or fewer restrictions.

3listed immediate substitutions

01/01/2026-05/01/2026effective date range

NCapplicable state

Immediate Formulary Change Criteria

Immediate Formulary Change

Covered when ALL of the following are met:

Immediate substitution conditions: Humana may immediately remove or re-tier a brand-name prescription drug or original biological product when a new generic version or certain biosimilar version of that product is added to the formulary and will appear on the same or lower cost-sharing tier and with the same or fewer restrictions.

Includes addition of interchangeable biosimilars that can be substituted without a new prescription.

Scope of change: The immediate change applies only when Humana is adding a new generic version of a brand-name prescription drug or adding certain new biosimilar versions of an original biological product (for example, an interchangeable biosimilar).

Humana may either remove the original product from the formulary or keep it but move it to a different cost-sharing tier or add new restrictions.

Member notification and recourse: Members currently taking the original product may not receive advance notice before an immediate change; Humana will provide information after the change and members or prescribers may request an exception to continue coverage of the original medication.

Policy Summary

PayerHumana

PolicyImmediate formulary substitutions for certain brand-name and biological drugs

Policy CodePolicy N/A

Change TypeImmediate formulary removals/re-tiering

Effective DateN/A

Next Review DateN/A

Key ActionIf a member is impacted by an immediate formulary change, the member or prescriber can request an exception to continue coverage of the original drug.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Provider and Member Actions When Immediate Changes Occur

Prior Authorization

Immediate formulary changes and re-tiering

Humana may immediately remove a prescription drug from the formulary when we add a new generic version of a brand-name drug or certain new biosimilar versions of an original biological product (for example, an interchangeable biosimilar). When a new version is added, Humana may also keep the original product on the formulary but immediately re-tier it or add new utilization restrictions.

Applies only when the new product appears on the same or a lower cost-sharing tier and has the same or fewer restrictions.
Humana may move the original brand or biological product to a different cost-sharing tier or add prior authorization/other restrictions immediately upon adding the new version.

Documentation Required

Exception requests and notification obligations

If Humana immediately removes a drug because a new generic or biosimilar has been added, members and prescribers may request an exception to continue coverage of the original product. Exception requests must follow Humana's standard exception process. Humana will notify affected members after the change has been made and will provide information on how to request an exception.

Members or prescribers can request an exception to maintain coverage of the removed or re-tiered product.
Humana will provide post-change notification to affected members describing the specific changes and the exception request pathway.

Denial Risk

Exception required to continue coverage

If you or your prescriber do not request an exception after an immediate change, Humana may not continue coverage of the original product. To avoid interruption of therapy, submit an exception request promptly if you need to continue the prior product.

Failure to request an exception may result in noncoverage of the original brand or biological product after the effective date of the change.
Providers should act quickly to initiate exception requests when continuity of care is required.

Criteria to Continue the Original Product

Exception to Continue Original Product

Continuation after an immediate formulary change:

Exception request: If a member is currently taking the original brand-name prescription drug or original biological product that has been removed or re-tiered due to a new generic or qualifying biosimilar, the member or prescriber can request an exception to continue coverage of the original product.

Humana may not provide advance notice prior to the change but will provide information afterward.

Effect of not requesting an exception: Failure to request an exception after an immediate formulary change may result in noncoverage of the original brand-name or biological product.

Providers should submit exception requests per Humana's exception process when continuity of therapy is clinically necessary.

Original product	Action Humana may take	When this applies	Member/provider options
Brand-name prescription drug or original biological product (example: Entresto, Pomalyst, Ofev)	May be moved to a different cost-sharing tier or have new restrictions added	When Humana adds a new generic version or certain biosimilar that will appear on the same or lower cost-sharing tier and with the same or fewer restrictions	Member or prescriber may request an exception to continue coverage of the original product; Humana will provide information to affected members after the change

Background and Rationale

When a therapeutically equivalent generic or a qualifying biosimilar becomes available, payers commonly manage utilization and costs by substituting the new product or changing the original product’s formulary placement. Humana’s policy permits immediate formulary changes—including removal, re‑tiering, or adding restrictions to the original brand‑name or reference biologic—when the new generic or biosimilar appears on the same or a lower cost‑sharing tier and with the same or fewer restrictions.

If a member is currently taking the original product, the member or prescriber may request an exception to continue coverage of that product despite the immediate change; providers should anticipate potential step edits, tier changes, or other utilization management edits consistent with the formulary placement of the new product. Failure to request an exception may result in noncoverage of the original drug.

Key Definitions

Interchangeable biosimilar — definition and related terms

DefinitionAn interchangeable biosimilar is a biosimilar that can be substituted for an original biological product by a pharmacy without a new prescription.

Scope of substitutionHumana may add an interchangeable biosimilar and immediately substitute or re-tier the original biological product when the biosimilar will appear on the same or lower cost‑sharing tier and with the same or fewer restrictions.

Formulary action optionsActions include immediate removal of the original biological product from the formulary, or keeping it but moving it to a different cost‑sharing tier or adding new restrictions.

Member notification and exceptionsHumana may not provide advance notice before making an immediate change but will provide information afterward; members or prescribers can request an exception to continue coverage of the original product.

Limitation on useImmediate substitution or re‑tiering can be performed only when adding a new generic of a brand‑name drug or certain new biosimilar versions (e.g., interchangeable biosimilars) for an original biological product.

OpenPayer