Step Therapy - Standard and Performance Prescription Drug Lists (Employer Group Plans)
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Defines Cigna's step therapy requirements for employer group prescription drug lists (Standard and Performance), including which drugs require prior authorization and conditions for medical necessity determinations for coverage.
Added Jornay PM as a Step 3 medication to the Attention Deficit Hyperactive Disorder (ADHD) therapeutic category.
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 (ST006).
Updated the Auvelity requirement and removed several products (e.g., Prozac Weekly, Sarafem) from listings.
Removed Farxiga and Xigduo XR from the Diabetes Care therapeutic category.
Coverage and Step Therapy Criteria
inv-01: Coverage with step therapy criteria
Cigna approves coverage when specified conditions are met
Applies to brand name drugs listed on Employer Group Prescription Drug Lists.
inv-02: Step therapy requirements and exceptions
Coverage of medications on the lists is governed by plan-specific step requirements; exceptions apply per listed conditions.
Exceptions described below
Referenced for multiple classes
From chunk 25
inv-03: Step therapy criteria by drug class
Covered when plan-specific step requirements are met
examples: Wixela Inhub (fluticasone-salmeterol), AirDuo Digihaler
examples: atorvastatin, ezetimibe-simvastatin, fluvastatin (ER), lovastatin, pitavastatin
examples: risedronate, ibandronate, Boniva, Fosamax, Binosto
inv-04: Initial Step Therapy Requirements
Coverage is conditioned on completing required Step 1 agents as follows:
Step 1 examples include Wixela Inhub/fluticasone-salmeterol and AirDuo Digihaler
Listed Step 1 agents include atorvastatin, ezetimibe-simvastatin, fluvastatin/ER, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin
Listed Step 1 agents include risedronate, ibandronate, Boniva, Binosto, Fosamax, Fosamax Plus D
inv-05: General Step Therapy Coverage
Coverage depends on meeting the plan-specific step requirements
Document lists specific agents per step but this excerpt is repetitive; individual drug-to-step mapping appears in the lists.
inv-06: Plan-level step requirements
Coverage subject to meeting the following plan-specific step requirements
applies to multiple generic statins listed
Wixela Inhub/fluticasone-salmeterol and AirDuo Digihaler examples
risedronate, Fosamax, Boniva examples
document lists Topical Inflammatory as requiring three Step 1 agents in some entries
inv-07: Step therapy coverage criteria (excerpt)
Coverage is subject to meeting the following plan- and class-specific step therapy requirements:
examples of Step 1 agents listed: atorvastatin, simvastatin, pravastatin, rosuvastatin, lovastatin, pitavastatin, fluvastatin, ezetimibe-simvastatin.
examples listed include Wixela Inhub/fluticasone-salmeterol and AirDuo Digihaler.
Topical inflammatory class referenced; specific Step 1 agents not legibly enumerated in this excerpt.
Examples listed: Fosamax; Fosamax Plus D.
inv-08: Class-level step therapy requirements (excerpted classes)
Coverage of later-step medications within listed classes is contingent on prior trials as specified below for each plan type.
Step 1 statins listed in document include atorvastatin, ezetimibe-simvastatin, fluvastatin (including ER), lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, Altoprev, Lescol
Document lists Wixela Inhub/fluticasone-salmeterol and AirDuo Digihaler as examples
Class name appears as 'Topical Inflammatory' with Step 1 requirement of three agents
Agents listed include Fosamax and Fosamax Plus D
inv-09: Plan- and class-specific step requirements
Step therapy requirements by therapeutic class and plan type (as listed in document excerpts).
Step 1 medication list includes atorvastatin, ezetimibe-simvastatin, fluvastatin/ER, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, Altoprev, Lescol.
Step 1 medications include Wixela Inhub/fluticasone-salmeterol (generic Advair Diskus) and AirDuo Digihaler.
Specific Step 1 agents not fully listed in these excerpts.
Fosamax Plus D and Fosamax mentioned in excerpts.
inv-10: Illustrative Step Therapy Criteria
Coverage of drugs is subject to plan-specific step therapy requirements; examples below illustrate the pattern:
source lists of agents shown in chunks 162-170
detailed topical agent lists in chunks 172-173
examples include Wixela Inhub/fluticasone-salmeterol and AirDuo Digihaler (chunks 162, 169)
Services billed for conditions or diagnoses that are not covered under this Coverage Policy will not be reimbursed. Claims submitted without covered diagnosis or procedure codes consistent with this policy are subject to denial as not covered.
The policy notes that the Limited Plan is designated as N/A for many therapeutic classes in the step therapy tables, indicating plan-specific step requirements do not apply or are not included for those classes under the Limited Plan.
In multiple class listings (for example, inhaled corticosteroid/LABA, statins, and osteoporosis), the document shows the Limited Plan column as N/A, meaning step requirements are not applicable for those classes under the Limited Plan.
Throughout the class-level tables, entries for the Limited Plan are repeatedly shown as N/A, reflecting that the Limited Plan does not include the step therapy tiers or requirements for many of the listed therapeutic classes.
Examples in the policy (e.g., ICS/LABA and Statins) indicate the Limited Plan is marked N/A for several classes, confirming no step therapy requirement under the Limited Plan for those entries.
The Revision Details record that the Non‑Steroidal Topical therapeutic category and the Anti‑Parkinsonism Drugs (Carbidopa and Levodopa Products) section were removed from this policy and relocated to separate policies (ST005 and ST006 respectively).
Prior Authorization, Documentation, and Billing Guidance
Authorization required to start Step 3 medications
If initiating treatment with a Step 3 medication, submit a prior authorization request and receive approval before starting therapy; Step 3 agents are identified as requiring Step Therapy and authorization when used first.
Prior authorization under plan-specific step therapy
Many medications listed in this policy require prior authorization when the member's plan applies step therapy; exceptions (therapeutic interchange or clinical exceptions) may be granted when the individual is not a candidate for step therapy.
Implied prior authorization if Step 1 trials not completed
When required Step 1 agents have not been tried as specified by the member's plan, prior authorization is implied for agents subject to step therapy and must be obtained for coverage consideration.
Prior authorization requires completion of required Step 1 trials
Coverage of medications beyond listed Step 1 agents generally requires completion (trial and inadequate response/intolerance) of the required Step 1 agents and may require submission of prior authorization documentation.
Obtain prior authorization when step requirements unmet
If plan-specific step therapy requirements are not met, obtain prior authorization; the policy treats prior authorization as required when step criteria are unmet for the plan and drug class.
Prior authorization when required Step 1 counts not met
Prior authorization is required when the member has not tried the number of Step 1 agents specified by their plan (e.g., one, two, or three trials as shown by drug class and plan).
Authorize only after required Step 1 trial counts met
Coverage for higher-step agents requires evidence that the member met the plan-specific step counts (trial of the required number of Step 1 agents); submit authorization documenting those prior trials when requesting coverage.
Prior authorization requires documented prior Step 1 failures
Certain drugs require documentation that the member has tried and failed the specific number of Step 1 agents for their plan (Complete or Essential) before higher-step coverage will be approved; include this evidence in the prior authorization request.
Request prior authorization if plan step counts unsatisfied
When step therapy counts for the plan and drug class have not been satisfied, prior authorization must be requested; the policy states authorization is required in that scenario.
Follow the plan's prescribed step sequence
Follow the plan-specific step sequence exactly (Complete/Essential/Limited); for example, Complete and Essential plans require the number of Step 1 agents shown per therapeutic category (ONE, TWO, or THREE as listed).
Document failure, intolerance, or contraindication to required Step agents
Coverage of higher-step medications requires documented failure, inadequate response, contraindication per FDA label, or intolerance to the required Step agents; prescribers must document these reasons when requesting advanced-step coverage.
Step therapy tier mechanics and requirement for prior Step trials
Drugs are organized into Step 1, Step 2, and Step 3 tiers with plan-level requirements; coverage of a higher-step medication generally requires trial and failure of the required number of Step 1 agents unless an exception applies.
Members must trial and fail required Step 1 agents before advancing
Members must try and fail the specified number of Step 1 agents (number varies by plan and drug class) before higher-step medications will be covered; Complete and Essential plans commonly require one Step 1 agent for some classes and two for statins.
Select agents consistent with the plan's required step
Before prescribing a higher-step agent, ensure the prescriber selects agents consistent with the plan's required step (use the Step 1 agent lists in the policy) and document prior trials accordingly.
Complete/Essential plans: one Step 1 required for many respiratory and osteoporosis classes
Complete and Essential plans commonly require ONE Step 1 agent for respiratory ICS+LABA and osteoporosis classes; check the policy's plan-specific lists to confirm the required Step 1 agents to be trialed.
Review plan-specific step therapy edits by drug class
Step therapy edits vary by plan tier (Complete, Essential, Limited); review the class-specific step counts and listed Step 1 agents in the policy to determine required trials and applicable edits.
Adhere to class- and plan-specific Step 1 trial counts
Edits apply by class and plan: members must have tried the specified number of Step 1 agents for their plan type (Complete or Essential) prior to coverage of higher-step medications; Limited plan often marked N/A.
Ensure required Step 1 trials have been completed and documented
Providers must ensure members have trialed and failed the required number and type of Step 1 agents (varies by therapeutic category and plan) before prescribing Step 2 or Step 3 medications; include that documentation with any prior authorization.
Use appropriate billing codes and submit covered codes
Use the most appropriate billing codes as of the submission effective date; reimbursement is only provided if the requested service is submitted in accordance with relevant criteria including covered diagnosis and/or procedure codes.
Document metformin contraindication to bypass metformin step
For diabetes agents with a metformin Step 1 requirement (applies to new starts only), prescriber documentation of a contraindication to metformin may justify bypassing the metformin step and support approval of the requested agent.
- Examples of contraindications include acute or chronic metabolic acidosis, including diabetic ketoacidosis.
Document prior Step 1 use/failure for Step 2/3 requests
When requesting Step 2 or Step 3 coverage, prescribers must document prior use and failure, intolerance, or contraindication to the required number of Step 1 agents per the member's plan.
Include prior Step 1 trial details (agent names and outcomes) in authorization requests
Prescribers should include specific documentation of prior trials of the required Step 1 agents (agent names and outcomes) when submitting a prior authorization for a higher-step medication.
Provide documentation of required Step 1 trials for Complete/Essential plans
Document trials of the required number of Step 1 agents for the applicable plan (Complete or Essential) and therapeutic class to support coverage of higher-step medications; failure to document required trials may lead to denial.
Claims without covered codes will be denied
Claims for services not submitted with covered codes under this policy will be denied as not covered; ensure prior authorization and coding align with the Coverage Policy before submission.
Risk of non-approval when Step 1 preconditions unmet
If the member has not met the Step 1 agent requirements for their plan, the request may not be approved; ensure required Step 1 trials are completed or documented exceptions are provided.
Denial risk if step therapy requirements not met
Coverage may be denied if required step therapy trials (the specified Step 1 agents and counts) are not met for the applicable plan; providers should confirm and document required trials before requesting coverage.
Noncoverage/denial risk for skipping required Step 1 trials
Failure to trial required Step 1 agents before moving to higher-step agents may result in noncoverage or denial at point of dispensing or during prior authorization review.
Denial risk for insufficient Step 1 trial count (e.g., statins)
Requests that do not meet the required number of Step 1 agents for the member's plan (for example, statins requiring two Step 1 agents under Complete/Essential plans) may be denied; include documentation of required trials or exception criteria.
Prior authorization denials possible for unmet Step 1 counts
Prior authorization requests that fail to document the required number of prior Step 1 trials per plan are at risk of denial; ensure the request demonstrates trials and outcomes for the specified Step 1 agents.
Denial risk for noncompliance with plan-specific step therapy
Coverage may be denied for prescriptions that do not meet plan-specific step therapy requirements (e.g., skipping required Step 1 agents on Complete or Essential plans); confirm plan tier requirements before prescribing.
Key Terms and Definitions
Initial Step (Step 1) Therapy Requirements
inv-71: Initial therapy step requirements
Initial step requirements by plan and class
Limited plan: N/A
Limited plan: N/A
inv-72: Designated Step 1 agents
Designated Step 1 agents to be trialed prior to higher-step medications
Limited Plan: N/A
inv-73: Initial (Step 1) therapy requirements
Initial preferred agents per class
Specific Step 1 agent names listed in the document.
Listed under respiratory class.
Document enumerates multiple generic statins as Step 1 agents.
inv-74: Initial therapy requirements
Initial preferred therapy per plan
See plan-level requirements
inv-75: Initial therapy step requirements
Initial step requirements per plan and class
Step 1 examples listed in document.
Examples: Wixela Inhub/fluticasone-salmeterol, AirDuo Digihaler.
inv-76: Initial therapy step counts by class
Plan-tiered initial step therapy requirements for selected classes
List of Step 1 statins provided in document
Examples include Wixela Inhub and AirDuo Digihaler
Class labeled 'Topical Inflammatory' with three required Step 1 agents
Fosamax and Fosamax Plus D listed
inv-77: Initial therapy
Initial therapy requires trial of specified Step 1 agents per plan and therapeutic category.
examples in chunks 162-169
Step Therapy Tables and Class Examples
| Step Tier | Coverage Summary |
|---|---|
| Step 1 | |
| Step 1 and Step 2 medications are generally covered without prior authorization; Step 3 medications require submission and approval of a prior authorization request if initiating treatment with a Step 3 agent. |
| Example Class | Step 1 Example Agents |
|---|---|
| ACE inhibitors / ARBs | |
| benazepril; benazepril/HCTZ; candesartan; candesartan/HCTZ; captopril; captopril/HCTZ; enalapril; enalapril/HCTZ; eprosartan; fosinopril; fosinopril/HCTZ; irbesartan; irbesartan/HCTZ; lisinopril; moexipril; moexipril/HCTZ; olmesartan; olmesartan/HCTZ; perindopril; quinapril; quinapril/HCTZ; ramipril; telmisartan; telmisartan/HCTZ; trandolapril; valsartan; valsartan/HCTZ (examples listed as Step 1 agents) |
| Plan Type | Antidepressants Step Requirement |
|---|---|
| Complete Plan | |
| Requires ONE Step 1 agent prior to higher-step antidepressant agents unless specified otherwise. | |
| Essential Plan | |
| Requires ONE Step 1 agent prior to higher-step antidepressant agents unless specified otherwise. | |
| Limited Plan | |
| N/A (Limited Plan: not applicable for this class). |
| Plan Type | ADHD Step Requirement / Notes |
|---|---|
| Complete Plan | |
| Listed as N/A for some entries or may have differing requirements by product; some Complete Plan lines indicate no Step 1 requirement. Refer to class-specific listings. | |
| Essential Plan | |
| May require up to FOUR Step 1 agents for certain ADHD listings; select branded products (e.g., Azstarys) require trial of ONE Step 1 medication; Jornay PM added as Step 3 in revisions. | |
| Limited Plan | |
| N/A (Limited Plan: not applicable for ADHD step therapy in these excerpts). |
| Topic | Diabetes Step Requirement / Notes |
|---|---|
| Metformin Step | |
| Metformin is listed as the Step 1 medication for Diabetes Care; the metformin step requirement applies to new starts only. Exceptions permit bypass (e.g., initiating dual therapy with metformin and Jardiance; contraindication to metformin; heart failure; chronic kidney disease; ASCVD or >=2 risk factors) as described in the policy. |
| Therapeutic Class | Step 1 Example / Plan Count Notes |
|---|---|
| Fibrates | |
| Multiple fenofibrate and fenofibric acid formulations listed as Step 1; Complete Plan may require THREE Step 1 agents for some fibrate groupings (per listings). | |
| Hypnotics | |
| Step 1 includes doxepin, eszopiclone, ramelteon, zaleplon, zolpidem; Complete Plan: Requires ONE Step 1 agent; Limited Plan: N/A. | |
| NSAIDs | |
| Numerous generic NSAIDs listed as Step 1 agents; Complete and Essential Plans: typically require TWO Step 1 agents for NSAIDs where noted. | |
| Ophthalmic agents | |
| Topical ophthalmic corticosteroids listed as Step 1 (e.g., dexamethasone ophthalmic, difluprednate, fluorometholone, loteprednol, prednisolone acetate); exceptions for Lotemax ointment noted. |
| Class | Complete / Essential Plan Step 1 Requirement |
|---|---|
| Osteoporosis (bisphosphonates) | |
| Complete and Essential Plans: Require ONE Step 1 agent (examples: alendronate/Fosamax; ibandronate/Boniva; risedronate/Actonel, Atelvia). | |
| Respiratory (ICS + LABA) | |
| Complete and Essential Plans: Require ONE Step 1 agent (examples: Wixela Inhub/fluticasone-salmeterol; AirDuo Digihaler). | |
| Statins | |
| Complete and Essential Plans: Generally require TWO Step 1 agents unless specified otherwise (examples of Step 1 statins listed: atorvastatin; simvastatin; pravastatin; rosuvastatin; fluvastatin; lovastatin; pitavastatin; ezetimibe-simvastatin). |
| Requirement | Trial & Failure Expectation |
|---|---|
| Step 1 trial requirement (Complete/Essential) | |
| Member must trial and have documented failure, inadequate response, contraindication, or intolerance to the specified number of Step 1 agents per the Complete or Essential plan rules before higher-step agents are covered. |
| Plan | Designated Step 1 Agents Must Be Tried |
|---|---|
| Complete Plan | |
| Designated Step 1 agents listed for each class (e.g., Wixela Inhub and AirDuo Digihaler for ICS/LABA; multiple generic statins for statin class) must be tried per plan prior to Step 2/3 coverage. | |
| Essential Plan | |
| Mirrors Complete Plan: designated Step 1 agents listed must be tried prior to higher-step coverage. |
| Member Requirement | Number of Step 1 Agents to Trial (Example) |
|---|---|
| Respiratory (ICS+LABA) | |
| Member must try ONE Step 1 agent (Complete and Essential Plans). | |
| Statins | |
| Member must try TWO distinct Step 1 statin agents (Complete and Essential Plans) unless specified otherwise. | |
| Topical Inflammatory | |
| Some Topical Inflammatory entries require THREE Step 1 agents (Complete and Essential Plans where noted). |
| Requirement | Member Step 1 Trial Count |
|---|---|
| General rule | |
| Member must have tried the prescribed number of Step 1 agents (1, 2, or 3 depending on therapeutic class and plan) prior to coverage of Step 2/3 medications. |
| Plan & Class | Complete & Essential Prior Trial Requirement |
|---|---|
| Statins | |
| Complete & Essential Plans: Require TWO Step 1 statin trials unless specified otherwise. | |
| ICS + LABA | |
| Complete & Essential Plans: Require ONE Step 1 ICS/LABA trial. | |
| Topical Inflammatory | |
| Complete Plan: May require THREE Step 1 agents; Essential Plan mirrors where indicated. |
| Plan Type | Member Trials Required Before Higher-Step Coverage |
|---|---|
| Complete Plan | |
| Members must trial the number of Step 1 agents shown for each class (examples: statins = 2; ICS/LABA = 1; Topical Inflammatory = 3; Osteoporosis = 1). | |
| Essential Plan | |
| Essential Plan generally mirrors Complete Plan requirements for the classes shown. |
| Class | Step 1 Trial Count / Notes |
|---|---|
| Statins | |
| Requires TWO Step 1 agents for Complete and Essential plans unless specified otherwise; multiple generic statins are listed as Step 1 options. | |
| ICS+LABA | |
| Requires ONE Step 1 agent for Complete and Essential plans (examples: Wixela Inhub, AirDuo Digihaler). | |
| Topical Inflammatory | |
| Some entries require THREE Step 1 agents under Complete and Essential plans. |
| Class | Statins / Other Specific Rules |
|---|---|
| Statins | |
| Complete and Essential plans generally require TWO Step 1 statin trials (agents listed include atorvastatin, simvastatin, pravastatin, rosuvastatin, fluvastatin, lovastatin, pitavastatin, ezetimibe-simvastatin, Altoprev, Lescol). | |
| ICS+LABA and Osteoporosis | |
| ICS+LABA: ONE Step 1 required; Osteoporosis: ONE Step 1 required for Complete and Essential plans. |
| Enforcement | Policy Requirement |
|---|---|
| General enforcement | |
| Members must trial and fail the required Step 1 agents per therapeutic category and plan (Complete, Essential, Limited) before Step 2/3 medications are covered; prior authorization is required when step criteria are not met for initiation of higher-step agents. |
Background and Scope
This policy organizes drugs into three step therapy tiers: Step 1 (preferred initial agents, generally covered without prior authorization), Step 2 (alternate agents), and Step 3 (typically require prior authorization if initiated first). Examples of therapeutic classes and Step 1 agents include generic ACE inhibitors/ARBs, multiple statins (e.g., atorvastatin, simvastatin, pravastatin, rosuvastatin), respiratory ICS+LABA agents (e.g., Wixela Inhub/fluticasone‑salmeterol, AirDuo Digihaler), and osteoporosis bisphosphonates (e.g., risedronate, ibandronate, Fosamax).
Policy Revision History
Policy 1801 effective date set to 08/15/2026 and incorporated multiple prior revisions through this date.
Removed Januvia and Janumet from the Diabetes Care therapeutic category (listed with review date 07/09/2026 and effective 08/15/2026).
Clarified strengths of Zenzedi subject to step therapy in the ADHD therapeutic category (clarification noted 06/01/2026).
Review date recorded for clarification of Zenzedi strengths subject to step therapy in the ADHD category (review date 05/14/2026).
Removed Farxiga and Xigduo XR from the Diabetes Care therapeutic category (entry dated 05/01/2026).
Removed Farxiga and Xigduo XR from the Diabetes Care therapeutic category (entry dated 04/16/2026).
Added Jornay PM as a Step 3 medication to the Attention Deficit Hyperactive Disorder (ADHD) therapeutic category (entry dated 04/01/2026).
Added Jornay PM as a Step 3 medication to the Attention Deficit Hyperactive Disorder (ADHD) therapeutic category (entry dated 03/26/2026).
Removed the Non-Steroidal Topical therapeutic category and relocated to new policy ST005; removed Anti-Parkinsonism Drugs section and relocated to new policy ST006 effective 04/15/2026; added Jornay PM as a Step 3 medication to the ADHD category (entry dated 02/26/2026).
Updated the Auvelity requirement and removed Prozac Weekly and Sarafem (entry dated 02/12/2026).
Updated the Auvelity requirement and removed Prozac Weekly and Sarafem (entry dated 01/01/2026).
Added Auvelity as an Antidepressant Step 3 medication and removed several products from Step 3 listings (entry dated 11/06/2025).
Added Zoryve 0.15% cream as a Step 3 medication to the Non-Steroidal Topical section (entry dated 07/01/2025).
Added Auvelity as an Antidepressant Step 3 medication and removed multiple products from Step 3 listings (entry dated 05/15/2025).
Revision details identify content removals and relocations: the Non‑Steroidal Topical category was removed and moved to a new Topical Agents policy (ST005), and the Anti‑Parkinsonism Drugs (Carbidopa/Levodopa) section was removed and moved to a Parkinson's disease step therapy policy (ST006). These changes are listed in the policy's Revision Details.
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