ModifiedCignaPolicy 1801

Standard and Performance Prescription Drug Lists (Step Therapy requirements) — Employer Group Plans

Defines step therapy tiers and coverage rules for brand and generic outpatient prescription drugs for Cigna-administered Employer Group Plans; affects providers submitting authorization requests and members under those plans.

Policy Summary

PayerCigna

PolicyStandard and Performance Prescription Drug Lists (Step Therapy requirements) — Employer Group Plans

Policy CodePolicy 1801

Change TypeMultiple material updates (additions, removals, relocations, clarifications)

Effective Date05/01/2026

Next Review Date

Key ActionWhen requesting Step 2 or Step 3 medications, document prior trials of required Step 1 agents and obtain prior authorization when initiating a Step 3 agent.

SourceLink

POLICY UPDATE CHANGES

Removed Aciphex, Altace, Avapro, Cozaar, Fanapt, and Zestril from the policy, effective 1/1/2025.

Clarified the current Anti-Parkinsonism Drugs step therapy requirements apply to Monoamine Oxidase Type B (MAO-B) Inhibitors.

Added a new Ophthalmic Corticosteroids section with Inveltys 1% ophthalmic suspension, Lotemax 0.5% ophthalmic ointment, and Lotemax SM 0.28% ophthalmic gel as Step 3 medications, effective 7/1/2025.

Removed the Non-Steroidal Topical therapeutic category and relocated to a new policy, Topical Agents for Atopic Dermatitis Step Therapy Policy (ST005).

Removed the Anti-Parkinsonism Drugs (Carbidopa and Levodopa Products) section and relocated to a new policy, Parkinson's Disease - Carbidopa-Levodopa (Oral) Step Therapy Policy for Employer Plans (ST006), effective 4/01/2026.

Added Jornay PM as a Step 3 medication to the Attention Deficit Hyperactive Disorder (ADHD) therapeutic category, effective 05/01/2026.

Step 1/2/3therapy tier structure

Employer Plansplan population

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Coverage Criteria and Scope

General Step Therapy Coverage

Coverage is approved when specified step therapy requirements are met

Primary coverage conditions: Coverage approved when there is documented failure, inadequate response, contraindication per FDA label, or intolerance to the number of Step 1 and/or Step 2 drugs as specified by the table for the relevant drug class.

Applies to brand name drugs subject to step therapy

Exceptions

Exceptions to Step Therapy

Exception criteria: An exception to Step Therapy 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) or when specific clinical exceptions listed for particular drug classes are met.

See class-specific exception statements in the therapeutic category tables.

Step therapy coverage criteria by therapeutic category

Coverage of medications is contingent on meeting the following plan-specific step therapy requirements:

Hypnotics: Complete and Essential Plans: require trial of ONE Step 1 agent prior to authorization of higher-step hypnotics. Limited Plan: N/A.

Step 1 agents include doxepin (Silenor), eszopiclone (Lunesta), ramelteon (Rozerem), zaleplon (Sonata), zolpidem (Ambien/Intermezzo) and zolpidem ER (Ambien CR). Step 3 includes Dayvigo and Sonata.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Complete and Essential Plans: require trial of TWO Step 1 agents prior to higher-step NSAIDs. Limited Plan: N/A.

Step 1 NSAID agents listed include celecoxib, diclofenac, diclofenac/misoprostol, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, sulindac. Step 3 lists specified higher-step NSAID products.

Inhaled ICS with LABA: Complete and Essential Plans: require trial of ONE Step 1 agent prior to Step 3 ICS/LABA products. Limited Plan: N/A.

Examples of Step 3 products include Wixela Inhub (fluticasone-salmeterol) and AirDuo Digihaler.

Topical Inflammatory:

Services billed with diagnosis or procedure codes that are not covered under the applicable Coverage Policy will be denied as not covered. Coverage Policies apply to administration of health benefit plans and are not clinical treatment guidelines; in some markets, delegated vendor guidelines may also inform medical necessity and coverage determinations.

The Non‑Steroidal Topical therapeutic category has been removed from this policy and relocated to a separate policy titled Topical Agents for Atopic Dermatitis Step Therapy Policy (ST005). This relocation is documented in the policy revision history and is effective per the Revision Details.

Claims for services that are not submitted with covered code(s) under the applicable Coverage Policy will be denied as not covered. Interpreted for billing and clinical operations, this means providers must submit the most appropriate diagnosis and procedure codes that correspond to services governed by the Coverage Policy; failure to do so may result in denial for lack of a covered service.

Coding and Billing Guidance

Coverage/Billing Guidancemixed

No codes listed

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization tied to step therapy

Prior authorization follows the plan's step therapy tiers. When a Step 3 medication is requested, prior authorization is required unless the member has met the plan-specific Step 1 (and Step 2 when applicable) trial requirements or an allowed exception is documented. If the prescriber elects to initiate treatment with a Step 3 agent, an authorization request must be submitted and approved before coverage is provided.

Prior authorization required for Step 3 agents when step trials not met
If prescriber starts treatment with a Step 3 agent, prior authorization must be obtained

Denial Risk

Step therapy completion requirement

The member must complete the required number of Step 1 agent trials for their specific plan before a Step 2 or Step 3 medication will be approved. Failure to meet the plan’s required number of Step 1 agents may result in denial of coverage for higher-step agents.

Background and Policy Scope

This policy governs a multi‑tier step therapy approach for outpatient prescription medications for Employer Group Plans administered by Cigna. It defines three tiers—Step 1 (preferred/automatically covered, no prior authorization), Step 2 (listed agents, typically brand, described here as automatically covered), and Step 3 (higher‑tier agents that generally require prior authorization when initiating). Coverage for Step 3 medications is approved only when plan‑specific step requirements are met (documented trial and failure, intolerance, or contraindication to the required number of Step 1 and/or Step 2 agents) or an approved exception is present.

Definitions and Step Labels

Step 1 Medications

DefinitionMedications that do not require Step Therapy, are automatically covered, and do not require prior authorization.

Typical examplesGeneric or preferred agents commonly listed as first-line (see class-specific Step 1 lists in policy tables).

Coverage implicationNo prior authorization required when prescribed as initial therapy under applicable plan benefits.

Step 2 Medications

DefinitionUsually brand name medications. These medications do not require Step Therapy, are automatically covered, and do not require prior authorization.

Terminology noteTerminology and use may vary by plan; some plans may not use all Step Therapy classes listed.

Initial Therapy Definitions and Requirements

Initial therapy definitions

Definition of initial step therapy

Initial step definitions: Step 1 medications do not require prior authorization and are considered the initial agents for step therapy; Step 2 medications are listed and described in this document as not requiring prior authorization; Step 3 medications require Step Therapy and prior authorization if initiating therapy at this step.

Exact required number of Step 1 failures varies by therapeutic class and plan (e.g., some classes require ONE Step 1 trial, others require TWO or THREE as specified in class tables).

Initial therapy step requirements

Initial step therapy expectations by therapeutic category

Hypnotics Initial: Complete and Essential Plans: require trial of ONE Step 1 agent prior to authorization of higher-step hypnotics. Limited Plan: N/A.

Step 1 hypnotic agents include doxepin, eszopiclone, ramelteon, zaleplon, zolpidem and zolpidem ER.

Step Therapy Tables by Therapeutic Class

Therapeutic category	Plan requirements (Complete / Essential / Limited)	Step 1 (examples)	Step 2 (examples)	Step 3 (examples)
ACE/ARB (Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptor Blockers)	Complete: Requires TWO Step 1 agents / Essential: Requires TWO Step 1 agents / Limited: N/A	benazepril; benazepril/HCTZ; candesartan; candesartan/HCTZ; captopril; captopril/HCTZ; enalapril; enalapril/HCTZ; eprosartan; fosinopril; fosinopril HCTZ; irbesartan; irbesartan/HCTZ; lisinopril; lisinopril/HCTZ; losartan; losartan/HCTZ; moexipril; moexipril/HCTZ; olmesartan	(Same agents listed under Step 2 in the document for some products)	Accupril; Accuretic; Lotensin; Lotensin HCT; Micardis HCT; Prinivil; valsartan oral solution; Vaseretic; Zestoretic; olmesartan/HCTZ; perindopril; quinapril; quinapril/HCTZ; ramipril; telmisartan; telmisartan/HCTZ; trandolapril; valsartan; valsartan/HCTZ
Fibrates — Standard Dose	Complete: Requires THREE Step 1 agents / Essential: N/A / Limited: N/A	fenofibrate 120mg, 150mg, 160mg; fenofibrate micronized 130mg, 134mg, 200mg; fenofibrate nanocrystallized 145mg; fenofibric acid 105mg; fenofibric acid DR 135mg	(Step 2 lists repeat the same fenofibrate formulations in the source)	Fibricor 105mg Tablet; Lipofen 150mg Capsule; Tricor 145mg Tablet; Trilipix DR 135mg Capsule; Triglide
Fibrates — Low Dose	Complete: Requires THREE Step 1 agents / Essential: N/A / Limited: N/A	fenofibrate 40mg, 50mg, 54mg; fenofibrate micronized 43mg, 67mg; fenofibrate nanocrystallized 48mg; fenofibric acid 35mg; fenofibric acid DR 45mg	(Step 2 lists repeat the same low-dose fenofibrate formulations in the source)	Fibricor 35mg Tablet; Lipofen 50mg Capsule; Tricor 48mg Tablet; Trilipix DR 45mg Capsule
Hypnotics	Complete: Requires ONE Step 1 agent / Essential: Requires ONE Step 1 agent / Limited: N/A	doxepin (Silenor); eszopiclone (Lunesta); ramelteon (Rozerem); zaleplon (Sonata); zolpidem (Ambien, Intermezzo); zolpidem ER (Ambien CR)	(Same agents listed under Step 2 in the source)	Dayvigo; Sonata
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)	Complete: Requires TWO Step 1 agents / Essential: Requires TWO Step 1 agents / Limited: N/A	celecoxib (Celebrex); diclofenac (Voltaren XR); diclofenac/misoprostol (Arthrotec); etodolac ER (Lodine); fenoprofen; flurbiprofen (Ansaid); ibuprofen (Motrin); indomethacin; ketoprofen; meclofenamate; mefenamic acid (Ponstel); meloxicam (Mobic); nabumetone; naproxen; oxaprozin; piroxicam; sulindac	(Step 2 lists repeat many of the Step 1 NSAID agents per the source)	Anaprox DS; Arthrotec 50; Arthrotec 75; Daypro; EC-Naprosyn; Feldene; Lodine; Mobic; Nalfon 600mg; Naprosyn tablets; Qmiiz ODT; Voltaren XR
Ophthalmic Corticosteroids	Complete: Requires TWO Step 1 agents / Essential: Requires TWO Step 1 agents / Limited: N/A	(Topical ophthalmic steroid agents listed as Step 1/Step 2 in source: difluprednate ophthalmic emulsion 0.05%; fluorometholone ophthalmic suspension 0.1%; loteprednol ophthalmic gel 0.5%; loteprednol etabonate ophthalmic suspension 0.5%; prednisolone acetate ophthalmic suspension 1%; prednisolone sodium ophthalmic solution)	(Step 2 repeats ophthalmic corticosteroid formulations in the source)	Inveltys 1% ophthalmic suspension; Lotemax 0.5% ophthalmic ointment; Lotemax SM 0.38% ophthalmic gel
Inhaled Corticosteroid (ICS) with LABA	Complete: Requires ONE Step 1 / Essential: Requires ONE Step 1 / Limited: N/A	(Step 1 examples not separately enumerated in Step 1 section in source)	(Step 2 not separately enumerated in source)	Wixela Inhub (fluticasone-salmeterol); AirDuo Digihaler
Topical Inflammatory (by potency)	Complete: Requires THREE Step 1 agents / Essential: Requires THREE Step 1 agents / Limited: N/A	Step 1 agents organized by potency in source (examples across potencies); very high/high/medium/low potency topical steroids listed in document	(Step 2 lists exist in source but are not separately enumerated per potency)	Step 3 includes multiple higher-potency/topical steroid products; source lists very high and high potency product examples (see potency lists)
Statins / Osteoporosis / Antidepressants / ADHD / Atypical Antipsychotics / MAO-B inhibitors (examples)	Plan-specific Step 1 requirements vary by class (see class-specific rows); Limited Plan often N/A	Examples: atorvastatin; rosuvastatin; simvastatin (statins); alendronate; ibandronate; risedronate (osteoporosis); bupropion; citalopram; duloxetine; escitalopram; fluoxetine; sertraline (antidepressants); amphetamine and methylphenidate formulations (ADHD); aripiprazole; lurasidone; olanzapine (antipsychotics)	(Step 2 lists for these classes are provided in the full document)	Step 3 examples vary by class and are itemized in the source Step 3 sections

Requirement	Description	Provider action
Documented trials of required Step 1 agents	Prior authorization or coverage for a Step 2 or Step 3 medication is approved only when there is documented failure, inadequate response, contraindication per FDA label, or intolerance to the number of required Step 1 (and Step 2 when applicable) agents specified for the drug class and the member’s plan.	Document and submit evidence of prior trials, failures, contraindications, or intolerance to the required Step 1 (and Step 2 when applicable) agents when requesting authorization for higher-step medications.
Plan-specific number of Step 1 trials	The required number of Step 1 agent trials varies by plan and therapeutic category (examples: Hypnotics — Complete/Essential require ONE Step 1 agent; NSAIDs — Complete/Essential require TWO Step 1 agents; Topical Inflammatory — Complete/Essential require THREE Step 1 agents).	Check the class-specific step therapy table for the exact number required for the member’s plan and document trials accordingly.
Step 3 prior authorization	Step 3 medications generally require prior authorization if initiating therapy at Step 3 or when step therapy prerequisites are not met; coverage is approved when criteria for prior trials or exceptions are satisfied.	Submit a prior authorization request with documentation of prior step trials or clinical rationale for an exception (e.g., stabilized on therapy, medical contraindication).
Exceptions to step therapy	An exception will be granted when an individual is not a candidate for step therapy (for example, stabilized condition where therapeutic interchange is inappropriate) or when clinical exceptions listed for specific drug classes are met.	Provide clinical justification and supporting documentation when requesting an exception to the step therapy requirement.
Documentation and billing	Providers must use the most appropriate codes as of the submission date and ensure requests include covered diagnosis/procedure codes; failure to meet documentation or coding requirements may result in denial as not covered.	Include appropriate diagnosis/procedure codes and documentation of prior trials when submitting authorization or claim forms.