ModifiedCignaPolicy 1407

Drugs Requiring Prior Authorization and Individual & Family Plan Non‑Formulary Drug Criteria

Defines medical necessity criteria and prior authorization requirements for drugs that require pharmacy or medical prior authorization and product-specific non-formulary exception criteria for Individual and Family Plans administered by Cigna.

Policy Summary

PayerCigna

PolicyDrugs Requiring Prior Authorization and Individual & Family Plan Non‑Formulary Drug Criteria

Policy CodePolicy 1407

Change TypeMultiple product-specific additions, updates, removals, and documentation revisions

Effective Date

Next Review Date

Key ActionFollow updated product-specific prior authorization criteria and include required documentation labeled as [documentation required] with patient-specific identifying information.

SourceLink

POLICY UPDATE CHANGES

Added Individual and Family Plan product-specific medical necessity criteria for multiple listed drugs (e.g., Airsupra, Bijuva, Bromfenac 0.07%, Cabtreo, and many others).

Removed Individual and Family Plan product-specific medical necessity criteria for Blue Link glucose test strips and later for Glucose Test Strips and Lancets.

Updated the Documentation section to require that documentation noted in criteria be labelled as [documentation required] and include patient-specific identifying information.

Added Individual and Family Plan product-specific medical necessity criteria for multiple products including Firvanq, vancomycin 25 mg/mL oral solution, Ertaczo, and others (effective various dates).

Updated product-specific medical necessity criteria for multiple products including Creon, Pertzye, Zenpep, and others (effective until 12/31/2025 for some).

Added Individual and Family Plan product-specific medical necessity criteria for hydrocortisone 2.5% rectal cream, conjugated estrogens tablets, Tonmya, and others.

Revised Documentation section to require documentation be noted as [documentation required] and to require all documentation include patient-specific identifying information.

Updated Individual and Family Plan product-specific medical necessity criteria for multiple additional drugs including gabapentin ER (Gralise), Vtama, Eucrisa, and others with effective dates (many 3/1/2026).

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12 monthsmaximum approval duration for prior authorization

manyproducts added/updated

dozensproducts with added/updated criteria

requireddocumentation requirement

statewideapplicability

Coverage and Medical Necessity Criteria

Drugs Requiring Prior Authorization - General Criteria

Covered when BOTH of the following are met:

Primary criteria: 1. ONE of the following (A or B): A) Use is approved and listed in the FDA product information (Label) and the dosage, frequency, site of administration, and duration of therapy is not contraindicated or otherwise not recommended in the Label; OR B) Use is supported according to standard medical reference compendia and is not contraindicated or otherwise not recommended in the FDA product information (Label).

Approval duration is up to 12 months.

Therapeutic alternatives: 2. Where available, use of therapeutic alternatives is required unless clinically inappropriate. Prior use of all formulary or covered alternatives meets criteria, unless there are more than five alternatives available (maximum required = five).

Individual and Family Plan Non-Formulary Drug Criteria

Non-formulary drugs are considered medically necessary when product-specific criteria are met:

Non-formulary exceptions: Follow product-specific medical necessity criteria listed in the Individual and Family Plan section (products alphabetized by Therapy Class and Brand Name).

Criteria are product-specific and updated periodically; documentation is required where noted in the product-specific criteria as [documentation required].

Product-specific criteria updates

Updated or added product-specific medical necessity criteria for Individual and Family Plan products (see product lists below).

products_added_or_updated: Multiple products had product-specific medical necessity criteria added or updated with various effective dates as listed in the revision details (see revision detail entries). Examples include additions/updates for Jublia; Rexulti; Bevespi Aerosphere; Duaklir Pressair; Stiolto Respimat; umeclidinium/vilanterol inhalation powder; Dymista and generics; Ryaltris; Omnaris; Qnasl; Premarin tablets; tavaborole 5% topical solution; hydrocortisone 2.5% rectal cream; conjugated estrogens tablets; Firvanq; vancomycin 25 mg/mL oral solution; Ertaczo; gabapentin ER (Gralise); Vtama; Eucrisa; Zoryve; and many others as listed in the revision details.

Specific, product-level coverage criteria and any documentation requirements are contained in the product-specific sections referenced in the revision details.

Any use that does not meet the specified medical necessity criteria in this policy is considered not medically necessary. Coverage for drugs requiring pharmacy or medical prior authorization is only provided when the documented use meets the product-specific or general criteria set forth in this policy.

Any other use beyond the product-specific or policy criteria described in this document is considered not medically necessary. Exceptions are only permitted when explicitly detailed in the Individual and Family Plan non-formulary drug criteria or other sections of this policy.

Coding and Billing Codes

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Requirement

Drugs requiring Pharmacy or Medical Prior Authorization for Employer Group Plans and/or Individual and Family Plans (where no other coverage policy or criteria are specified) are considered medically necessary only when they meet FDA label or compendia-supported criteria and other requirements below. Prior authorization is required for these products. Approval duration is up to 12 months.

Prior authorization required for drugs requiring Pharmacy or Medical Prior Authorization where no other policy/criteria are specified
Medically necessary when use is consistent with FDA product labeling or supported by standard medical compendia and not contraindicated
Therapeutic alternatives must be used where available unless clinically inappropriate; prior use of all formulary/covered alternatives may be required (maximum of five alternatives required)
Approval duration: up to 12 months

Prior Authorization

Product-Specific Prior Authorization Updates

Product-specific prior authorization and medical necessity criteria have been added or updated for multiple Individual and Family Plan products. Providers should consult the up-to-date product list for applicable criteria and any effective dates associated with specific products.

Background and Policy Scope

To be eligible for coverage, a drug generally must be FDA-approved, prescribed by a licensed health care professional, purchased from a licensed pharmacy, and meet the policy's medical necessity criteria. Medical necessity determinations incorporate the FDA label, standard medical compendia, and evidence-based literature. Where product-specific criteria apply (for example, non-formulary drugs under Individual and Family Plans), those criteria must be met and any required documentation must be provided and include patient-specific identifying information.

Key Definitions

inv-16: Non-formulary drugs — definition and approval conditions (Individual & Family Plans)

DefinitionNon-formulary drugs are products not on the covered drug list that may be approved for coverage when product-specific medical necessity criteria are met for Individual and Family Plans.

Approval basisApproval for non-formulary drugs is based on product-specific medical necessity criteria that incorporate FDA approved labeling, standard medical reference compendia, and evidence-based literature.

Required prescriber and dispensingTo be eligible for coverage the drug must be prescribed by a health care professional and purchased from a licensed pharmacy, per policy overview.

Documentation and criteriaProviders should follow the product-specific medical necessity criteria listed in the Individual and Family Plan section; documentation is required where noted in the criteria.

Prior authorization linkageNon-formulary exception decisions are handled through the coverage review/prior authorization process described in this policy (see prior authorization criteria and approval durations).

Policy Summary

PayerCigna

PolicyDrugs Requiring Prior Authorization and Individual & Family Plan Non‑Formulary Drug Criteria

Policy CodePolicy 1407

Change TypeMultiple product-specific additions, updates, removals, and documentation revisions

Effective Date

Next Review Date

Key ActionFollow updated product-specific prior authorization criteria and include required documentation labeled as [documentation required] with patient-specific identifying information.

SourceLink

On This Page

New or updated product-specific criteria include (not exhaustive): Carac, Klisyri, Aplenzin, Opvee, prucalopride (generic Motegrity), baclofen oral solution (Ozobax generic), Firvanq, vancomycin oral solution, Ertaczo, and many others as listed in the policy revision history
Several product-specific criteria have specified effective dates (e.g., many entries effective 3/1/2026 or other dates) — verify the product effective date when submitting requests
Refer to the policy's revision history or the 'Drugs Requiring Medical Necessity Review for Individual and Family Plans' list for the current alphabetized product-specific criteria

Documentation Required

Documentation Completeness

Documentation is required where noted in the criteria as [documentation required]. This documentation may include chart notes, laboratory test results, medical test results, claims records, prescription receipts, and/or other supporting information. All documentation must include patient-specific identifying information. Failure to include required documentation or patient identifiers may result in delay or denial of the request.

Include supporting chart notes, labs, medical test results, claims records, prescription receipts as applicable
All documentation must contain patient-specific identifying information
Omissions of required documentation labeled as [documentation required] may result in denial or processing delays

Prior Authorization

Therapeutic Alternatives Requirement

Where available, use of therapeutic alternatives is required prior to approval unless clinically inappropriate or otherwise specified in the product-specific criteria. Prior authorization requests should document reasons why alternatives are not appropriate when seeking an exception.

Therapeutic alternatives must be tried when available unless clinically inappropriate
Document clinical rationale when requesting an exception to therapeutic alternatives requirement
When more than five alternatives exist, only up to five prior alternatives may be required