CurrentCignaPolicy 1603

Step Therapy Individual and Family Plans Coverage Policy

Defines step therapy requirements for prescription drugs on Cigna Individual and Family Plans Prescription Drug List, specifying which drugs are Step 1 vs Step 2/Step 3 and the medical necessity exceptions/criteria for coverage when step requirements are not met.

Policy Summary

PayerCigna

PolicyStep Therapy Individual and Family Plans Coverage Policy

Policy CodePolicy 1603

Change TypeAdditions and removals to Step 2 listings (2025-2026)

Effective DateJan 1, 2026

Next Review Date

Key ActionIf physician determines treatment should begin with a Step 2 or Step 3 medication, submit a request for authorization and document required prior trials or exceptions.

SourceLink

POLICY UPDATE CHANGES

Added Insulin Aspart as an Insulin, short-acting Step 2 product.

Added Insulin Aspart Pro Mix 70-30 Pen as an Insulin, short-acting Step 2 product.

Added Insulin Aspart Pro Mix 70-30 Vial as an Insulin, short-acting Step 2 product.

Added Pulmicort as an Inhaled Corticosteroid (single entity) Step 2 Medication and added inhaled corticosteroid exceptions.

Removed Myrbetriq as an Over Active Bladder (OAB) Step 2 Medication.

multipleTherapeutic groups listed

Step 1→Step 2Common requirement

3Revisions noted (2025-2026)

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Defines step therapy requirements for prescription drugs on Cigna Individual and Family Plans Prescription Drug List and the medical necessity exceptions/criteria for coverage when step requirements are not met. Cigna approves coverage when there is documented failure, inadequate response, contraindication per FDA label, or intolerance to the number of Step 1 and/or Step 2 drugs specified for the therapy group or as otherwise specified.

Coverage is approved only when required prior trials have failed or exceptions are documented. Receipt of sample product does not satisfy criteria requirements for coverage.

Policy metadata

Policy TitleStep Therapy for Individual and Family Plans (drug step edits)

PayerCigna

Policy Number1603

Effective Date2026-01-01

Last Review2026-01-01

StatusCURRENT

Common requirementStep 1 required before Step 2

Initial Therapy Criteria (Step requirements)

General Step Therapy Medical Necessity

Cigna approves coverage when there is documented failure, inadequate response, contraindication per FDA label, or intolerance to the number of Step 1 and/or Step 2 drugs specified for the therapy group or as otherwise specified.

Patient has tried and had documented failure, inadequate response, contraindication per FDA label, or intolerance to the required number of Step 1 (and Step 2 when applicable) medications for the drug group.

Receipt of sample product does not satisfy criteria requirements for coverage.

Samples are not acceptable as prior trials.

Atypical Antipsychotic (example group)

An exception will be provided when an individual is not a candidate (e.g., stabilized condition where therapeutic interchange is inappropriate) for the step therapy requirements.

ALL of the following

Step 1 medications (any one)
- Aripiprazole
- Clozapine/ODT
- Olanzapine/ODT
- Paliperidone
- Quetiapine
- Risperidone/ODT
- Ziprasidone
Step 2 = Vraylar®

Note: receipt of samples does not satisfy criteria requirements for coverage.

Insulin, short-acting

Step therapy listing for short-acting insulins.

ALL of the following

Step 2 (examples listed)
- Humalog® Cartridge, Kwikpen; Humalog® 50-50 Kwikpen, Vial; Humalog® 75-25 Kwikpen, Vial
- Apidra®; Apidra® Solostar; Insulin Aspart Pen, Vial; Insulin Aspart Pro Mix 70-30 Pen; Insulin Aspart Pro Mix 70-30 Vial
- Novolog® Cartridge, Flexpen, Vial; Novolog® Mix 70-30 Flexpen, Vial

Note: Added Insulin Aspart and Insulin Aspart Pro Mix 70-30 formulations as Step 2 products per recent revisions.

Inhaled Corticosteroid (single entity)

Step therapy and documented exceptions.

Requires one Step 1 before Step 2 (Step 2 = Asmanex® / Pulmicort® Flexhaler / others as listed)

Exception: approve Pulmicort Flexhaler when A OR B is met:

ANY of the following
- A: The patient is being treated for chronic graft-versus-host disease with lung involvement (approve Pulmicort Flexhaler).
- B: The patient is pregnant and is currently receiving the requested product for asthma (approve the requested Step 2 product).

Long Acting Anticholinergic (COPD) / Long Acting Beta Agonist / Other respiratory groups

Step therapy requirements and exceptions described; exceptions available when not a candidate for step therapy.

Examples

ANY of the following
- Incruse® Ellipta® (Step 2 = Tudorza® Pressair®)
- Striverdi® Respimat® (Step 2 = Arcapta™ Neohaler™ Serevent® Diskus®)
- Nasal Steroids: Requires three Step 1 before Step 2 (examples: Flunisolide, Fluticasone, Mometasone). Step 2 examples: Beconase AQ®, Zetonna®

When applicable, one Step 1 is required before Step 2 for long-acting respiratory agents.

Exceptions and Notable Approvals

SSRI / SSNRI groups

Step therapy requirements and exceptions; exceptions available when not a candidate for step therapy.

Group B: Requires one Step 1 before Step 2

Step 1 options (any)
- Bupropion/XL/SR
- Citalopram
- Desvenlafaxine/ER
- Duloxetine
- Escitalopram
- Fluoxetine
- Fluvoxamine/ER
- Mirtazapine/ODT
- Paroxetine
- Sertraline
- Venlafaxine/ER
- Vilazodone
Step 2 = Trintellix®

Note: receipt of samples does not satisfy criteria requirements for coverage.

An exception will be provided when an individual is not a candidate for the step therapy requirements (for example, a stabilized condition where therapeutic interchange is inappropriate).

Additional exception details: specific groups list clinical circumstances where exceptions are allowed (for example, Pulmicort Flexhaler may be approved for chronic graft-versus-host disease with lung involvement or for a pregnant patient currently receiving the requested asthma product). The policy repeats that exceptions apply when a patient is not a candidate (e.g., stabilized on therapy) and that receipt of samples does not satisfy trial requirements.

Provider Actions

Prior Authorization

Prior authorization required for Step 2/Step 3 drugs

If the physician determines treatment should begin with a Step 2 or Step 3 medication, a request for authorization must be submitted and approved; coverage is approved when required prior trials have failed or exceptions are documented.

Affected steps: Step 2 and Step 3

Documentation Required

Document trial/failure or contraindication

Providers must document failure, inadequate response, contraindication per FDA label, or intolerance to required Step 1 (and Step 2 when applicable) medications; receipt of samples is not acceptable evidence of trial.

Samples do not satisfy trials

Background & Definitions

Step Therapy is a prior authorization program that encourages use of lower-cost therapeutic alternatives (Step 1) before higher-cost medications (Step 2/3). Therapeutic alternatives are determined from FDA-approved product information and compendia. Exceptions are allowed when a patient is not a candidate for step therapy (for example, stabilized on therapy) and are intended to ensure clinically appropriate access when therapeutic interchange is inappropriate.

Term	Definition
Step 1 Medications
Medications that do not require Step Therapy, are automatically covered and do not require prior authorization.
Step 2 Medications
Usually brand name medications that require Step Therapy and prior authorization if treatment begins with them.
Step 3 Medications
Usually brand name medications that require Step Therapy and prior authorization if treatment begins with them.

Revision History

03/01/2025added

Added Insulin Aspart as an Insulin, short-acting Step 2 product. (material change)

07/01/2025added

Added Insulin Aspart Pro Mix 70-30 Pen as an Insulin, short-acting Step 2 product. (material change)

09/01/2025added

Added Insulin Aspart Pro Mix 70-30 Vial as an Insulin, short-acting Step 2 product. (material change)

01/01/2026addedLatest

Added Pulmicort as an Inhaled Corticosteroid (single entity) Step 2 Medication and added inhaled corticosteroid exceptions. (material change)

01/01/2026removedLatest

Removed Myrbetriq as an Over Active Bladder (OAB) Step 2 Medication. (material change)

OpenPayer

Step Therapy Individual and Family Plans Coverage Policy

Coverage Summary

Initial Therapy Criteria (Step requirements)

Continuation Therapy Criteria

Exceptions and Notable Approvals

Provider Actions

Applicable Codes

Background & Definitions

Clinical Evidence

Revision History