Cigna step therapy coverage update

Coverage Criteria and Step Therapy Rules

inv-01: General Step Therapy Coverage Criteria

Cigna approves coverage when ALL of the following are met:

General step therapy criteria: Documented failure, inadequate response, contraindication per FDA label, or intolerance to the number of Step 1 and/or Step 2 drugs specified for the drug class.

Exceptions described elsewhere

inv-02: Anti-Parkinsonism exceptions

Anti-Parkinsonism (MAO-B inhibitors / Carbidopa-Levodopa products) coverage conditions:

Crexont/Rytary exception: Exception to Step Therapy will be provided when the patient is currently taking Crexont capsules or Rytary capsules.

Applies to Anti-Parkinsonism Drugs (MAO-B inhibitors and Carbidopa-Levodopa products)

inv-03: Stabilization/therapeutic interchange exception

Exceptions for stabilized patients:

Stabilized on therapy: An exception to the criteria 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).

Applies at minimum to ADHD and Atypical Antipsychotic sections

inv-04: Metformin step exceptions and approval criteria

Diabetes care metformin-specific exceptions:

Metformin exceptions: Approve Farxiga or Jardiance if the patient is initiating dual therapy with metformin and Farxiga or Jardiance; has a contraindication to metformin; has heart failure (reduced or preserved ejection fraction); has chronic kidney disease; or has atherosclerotic cardiovascular disease or, per the prescriber, at least two cardiovascular risk factors.

The metformin step requirement applies to new starts only.

inv-05: Step therapy coverage criteria

Coverage requires completion of specified Step 1 agent(s) as listed for each section and plan before higher-step agents are covered.

Non-Steroidal Topical: Complete and Essential Plans: requires ONE Step 1 agent (examples: pimecrolimus cream, tacrolimus ointment, prescription topical corticosteroid).

Exception: Eucrisa Step Therapy may be waived if patient is < 2 years of age; Step 3 includes Eucrisa and Zoryve 0.15% cream.

Osteoporosis: Complete and Essential Plans: requires ONE Step 1 agent (examples: alendronate, ibandronate) before Step 2/3 agents.

Step 3 medications listed include Atelvia, Binosto, risedronate (Actonel/Atelvia), Boniva, Fosamax, Fosamax Plus D.

Inhaled Corticosteroid with LABA: Complete and Essential Plans: requires ONE Step 1 agent (examples: Wixela Inhub/fluticasone-salmeterol, AirDuo Digihaler).

Limited Plan: N/A.

This Coverage Policy does not replace or override the terms of a customer's specific benefit plan document (for example, Group Service Agreement, Evidence of Coverage, Certificate of Coverage, or Summary Plan Description). In the event of a conflict between this Coverage Policy and a member's benefit plan document, the plan document supersedes the Coverage Policy. Coverage determinations depend on the applicable benefit plan language in effect on the date of service, relevant laws and regulations, collateral source materials, and the specific facts of the request.

This policy has been revised to remove or clarify specific products and sections. Notable changes include the removal of Fanapt, Jentadueto, Jentadueto XR, Tradjenta (effective 1/1/2025), the removal of Celebrex (effective 7/1/2025), removal of Actonel, Adderall, Evekeo, Fetzima, and Invega as Step 3 medications, addition of Zoryve 0.15% cream as a Step 3 medication in the Non‑Steroidal Topical section, clarification that Anti‑Parkinsonism step therapy requirements apply to MAO‑B inhibitors, and removal of the Antidepressants section. The revisions also add step therapy requirements for Carbidopa/Levodopa products (Crexont and Rytary).

Reimbursement will not be provided for services billed for conditions or diagnoses that are not covered under this Coverage Policy. Claims submitted without appropriate covered diagnosis or procedure codes consistent with the applicable Coverage Policy will be denied as not covered.

Coding Notes and Code Tables

No explicit billing codes in this sectionmixed

No codes listed

Metformin step requirement — applies to new starts only

ThresholdMetformin step requirement applies to new starts only.

Applies toDiabetes Care Step Therapy (Complete and Essential Plans require ONE Step 1 agent).

Exceptions allowing bypassInitiating dual therapy with metformin + Farxiga or Jardiance; contraindication to metformin; heart failure (reduced or preserved EF); chronic kidney disease; ASCVD or ≥2 cardiovascular risk factors per prescriber.

Examples of covered Step 3 agentsFarxiga, Jardiance, Glyxambi, Janumet, Janumet XR, Januvia, Jardiance, Synjardy, Synjardy XR, Trijardy XR, Xigduo XR.

Prior Authorization, Documentation, and Billing Guidance

Documentation Required

Required documentation for step therapy exceptions

Coverage determinations require documentation that demonstrates completion of the required Step 1 agent(s) or a documented exception. Submit clinical records or provider attestation showing prior use, inadequate response, intolerance, or contraindication to the required Step 1 agent(s). Documentation should include drug name(s), dose, dates of therapy, reason for discontinuation (e.g., lack of efficacy, adverse reaction), and any relevant clinical testing or notes supporting the exception.

Include medication name, dose, start and stop dates, and clinical reason for failure/intolerance/contraindication.
If relying on a contraindication, include prescriber rationale and pertinent clinical information (e.g., diagnosis, lab results).
For metformin Step requirements: note that the metformin step applies to new starts only; if an exception is claimed (e.g., contraindication, dual therapy initiation, heart failure, chronic kidney disease, ASCVD or ≥2 CV risk factors), include supporting documentation.

Prior Authorization

Prior authorization and step completion requirements

Background and Purpose

Step therapy is a utilization management approach used by Cigna to manage access to certain medications. Under step therapy, patients must generally try and have documented failure, intolerance, or a contraindication to specified lower‑step medications (Step 1, and Step 2 when applicable) before coverage is approved for higher‑step, typically brand‑name, agents. Exceptions may be granted when a patient is not a candidate for step therapy (for example, when clinically stabilized on a current therapy) or when documented contraindications/intolerance exist.

Definitions and Potency Categories

Step Therapy (ST) definition

DefinitionStep Therapy (ST) is a utilization management approach where patients must try specified Step 1 (and Step 2 when applicable) medications before coverage is approved for Step 3 medications unless an exception applies.

PurposeManage access to certain brand-name medications by requiring trial and failure or contraindication/intolerance to lower-step therapies before covering higher-step agents.

When prior authorization is requiredIf prescriber opts to begin with a Step 3 medication or plan design requires Step Therapy, a request for authorization must be submitted and approved.

Documentation neededSubmit documentation showing prior use/failure, contraindication, or intolerance to required Step 1/2 agents; receipt of sample does not satisfy requirements.

Topical Inflammatory potency categories

Initial Therapy and Step 1 Access

inv-23: Step 1 medication access

Step 1 medications are generally automatically covered and do not require prior authorization.

Step 1 coverage: Step 1 medications do not require Step Therapy and are automatically covered per plan definitions.

Not all plans use all Step Therapy classes; receipt of sample product does not satisfy criteria.

inv-24: Initial therapy step requirements

Initial step therapy requirements

Non-Steroidal Topical initial: Complete and Essential Plans require ONE Step 1 agent (examples: pimecrolimus cream, tacrolimus ointment, prescription topical corticosteroid).

Eucrisa step therapy may be waived if patient is < 2 years of age.

Step Therapy Tables and Class-Specific Requirements

Section / Drug Class	Complete Plan Step 1 requirement	Essential Plan Step 1 requirement	Limited Plan Step 1 requirement
{"text":"Non-Steroidal Topical","status":""},{"text":"Requires ONE Step 1 agent","status":""},{"text":"Requires ONE Step 1 agent","status":""},{"text":"N/A","status":""}
{"text":"Osteoporosis (Bisphosphonates)","status":""},{"text":"Requires ONE Step 1 agent","status":""},{"text":"Requires ONE Step 1 agent","status":""},{"text":"N/A","status":""}
{"text":"Inhaled Corticosteroid with LABA (ICS/LABA)","status":""},{"text":"Requires ONE Step 1 agent","status":""},{"text":"Requires ONE Step 1 agent","status":""},{"text":"N/A","status":""}
{"text":"Topical Inflammatory (topical corticosteroids)","status":""},{"text":"Requires THREE Step 1 agents","status":""},{"text":"Requires THREE Step 1 agents","status":""},{"text":"N/A","status":""}
{"text":"Fibrates (standard and low dose)","status":""},{"text":"Varies by plan — Complete Plan: Requires THREE Step 1 agents","status":""},{"text":"N/A","status":""},{"text":"N/A","status":""}

Drug Group	Plan	Step 1 requirement (number of agents)	Notes / Examples
{"text":"Fibrates - Standard Dose","status":""},{"text":"Complete Plan","status":""},{"text":"Requires THREE Step 1 agents","status":""},{"text":"Examples of Step 1 agents listed: fenofibrate (various formulations) and fenofibric acid formulations; Step 3 branded fibrates include Fibricor, Lipofen, Tricor, Trilipix DR, Triglide (per policy).","status":""}
{"text":"Fibrates - Low Dose","status":""},{"text":"Complete Plan","status":""},{"text":"Requires THREE Step 1 agents","status":""},{"text":"Examples of Step 1 agents listed: lower‑dose fenofibrate formulations and fenofibric acid 35mg/DR45mg; Step 3 branded fibrates include Fibricor 35 mg, Lipofen 50 mg, Tricor 48 mg, Trilipix DR 45 mg (per policy).","status":""}

Requirement	What must be documented	Applies to which plans	Policy source / note
{"text":"Documented trials of specified number of Step 1 agents are required prior to approval of higher‑step agents","status":""},{"text":"Clinical documentation showing prior use and failure, inadequate response, contraindication per FDA label, or intolerance to the required Step 1 (and Step 2 when applicable) agents","status":""},{"text":"Complete and Essential Plans (as specified by drug class); Limited Plan: N/A where noted","status":""},{"text":"Coverage approved when ALL criteria met; receipt of sample does not satisfy criteria; documentation must show trials as specified in step therapy table within the policy.","status":""}

Revision History and Policy Changes

2026-03-01policy_effectiveLatest

Policy revision effective 03/01/2026 added new step therapy requirements for Carbidopa and Levodopa products (Crexont and Rytary) and removed the Antidepressants section.

2026-01-01removal

Removed Actonel, Adderall, Evekeo, Fetzima, and Invega as Step 3 medications.

2025-07-01removal

Removed Celebrex from the policy.

OpenPayer

Step therapy requirements for selected prescription drugs