CurrentCentenePolicy HIM.PA.109

Step Therapy

Defines drugs that require step therapy and the documentation and trials required for approval under Centene-affiliated health plans; applies to providers requesting coverage for listed medications.

Policy Summary

PayerCentene

PolicyStep Therapy

Policy CodePolicy HIM.PA.109

Change TypeNo material changes

Effective DateAug 1, 2017

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing prior trial of required step agents or documentation of contraindication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical approval duration

manydrugs listed

IL HB 5395IL exemption

through 2025references updated

Coverage Criteria

Initial Therapy

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Covered when ALL of the following are met:

Initial approval: Requester documents prior trial of the required step-through agent(s) as specified in the step therapy table OR documents contraindication to required agent(s).prior trial or contraindication

Requests must not exceed maximum indicated dose and stated quantity limit; approval duration 12 months.

Required step agents: Specific required step-through agents are listed per drug in the step therapy table (examples include: candesartan/irbesartan/losartan for azilsartan; carbamazepine IR for carbamazepine SR; sumatriptan/rizatriptan/naratriptan for certain triptans; topical benzoyl peroxide or topical antibiotics for topical acne agents; diclofenac or ketorolac ophthalmic for nepafenac).see table entries

Age limits and maximum dose/quantity limits are specified per drug.

Continuation Therapy

Continued therapy coverage requires ONE of the following:

Continued therapy conditions: a) Member is currently receiving medication via Centene benefit or previously met initial approval criteria; b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; OR c) Documentation supports member has been receiving medication for selected serious conditions (heart failure, seizures, HIV infection, psychiatric conditions, depression, cancer, or organ transplant) for at least 30 days.one condition met

If request is for dose increase, new dose must not exceed FDA maximum and quantity limit; approval duration 12 months.

Per Illinois House Bill 5395, the step therapy requirements in this policy do not apply to Illinois HIM requests effective 1/1/2026. For any requests originating under Illinois HIM, providers should follow the statute and state-mandated procedures rather than the step therapy edits described in this policy.

Template updates and P&T/SDC actions have revised continued therapy language and the step therapy table over time. Notably, Cimduo/Temixys template changes were applied to continued therapy, and multiple product-specific edits (for example, clarifications for Ubrelvy and additions/removals of certain agents) were made during annual reviews. The 2Q2024 and 2Q2023 reviews removed some agents from EST requirements (for example, venlafaxine SR and other listed discontinued products), reflecting that continued therapy criteria and the set of required step agents have been updated and refined.

Requests that do not include the required supporting clinical documentation — such as office chart notes, laboratory results, or other clinical information demonstrating prior trial(s) of required step agents or documented contraindications — may be considered not medically necessary and may be denied. Incomplete requests also risk return for missing information; providers should include documentation that the member has met all approval criteria to avoid denial.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for drugs subject to step therapy. Requests must document that all step therapy criteria are met; approvals are typically granted for up to 12 months when prior therapy requirements have been satisfied or when a member has a documented contraindication to required step-through agents.

Prior authorization required for step-therapy drugs (may be approved up to 12 months when criteria met or contraindication documented)

Documentation Required

Documentation Requirement

Providers must submit supporting clinical documentation with prior authorization requests. Acceptable documentation includes office chart notes, relevant laboratory results, and other clinical information that demonstrates the member has met all approval criteria.

Submit office chart notes, lab results, or other clinical information demonstrating trials of required agents or documented contraindications

Step Therapy

Step Therapy Enforcement

The policy enforces step therapy edits for numerous drugs listed in the step therapy table. Providers must follow the specified step-through agents and quantity/age limits; exceptions apply only when documented contraindications exist or when continuity of care provisions (e.g., for certain chronic serious conditions) apply.

Follow the step therapy table: prior trials of specified required agents, maximum dose/quantity limits, and age limits where stated
Exceptions: documented contraindication to required agents or applicable continuity-of-care rules

Denial Risk

Denial Risk for Noncompliance

Failure to provide required documentation or to adhere to step therapy requirements may result in denial or delay of the authorization request or payment. Providers and members are bound by the terms of their contracts and the Health Plan's policy when submitting claims or prior authorization requests.

Incomplete or missing clinical documentation may lead to denial or processing delay
Noncompliance with step therapy or contractual terms may result in denial of services or claims

Background

Step therapy is a utilization management strategy that requires a member to try specified preferred or "step" agents before coverage is approved for certain non-preferred medications. The purpose of step therapy is to ensure that prescribers and members have attempted clinically appropriate, often lower-cost, alternatives first. This policy lists the required step-through agents, any applicable age or dose/quantity limits, and documentation expectations, and it establishes conditions under which continued therapy or exceptions (such as documented contraindications) are acceptable.

Definitions and Abbreviations

Abbreviations for release formulations

CRcontrolled release

IRimmediate release

SRsustained release

ERextended release

XLextended release

Initial Therapy — Drug-Specific Criteria

Initial Therapy (drug-specific)

Initial approval criteria per drug

Initial approval (drug-specific): Documentation of prior trial of the specific required step-through agents listed for the requested drug OR documentation of contraindication to required agents; requested dose and quantity must not exceed listed maximums; age limits apply where specified.per-table requirements

Specific required agents, maximum dose/quantity limits, and age restrictions are itemized in the step therapy table entries.

Initial therapy step edits

Policy edits indicate step requirements for treatment-naive members for some HIV single-tablet regimens and step requirements for certain migraine agents.

HIV single-tablet regimen prior step: For certain agents (e.g., Complera, Delstrigo, Symtuza and similar HIV single-tablet regimens), if the member is treatment-naive, require trial of a preferred single-tablet complete regimen or another formulary HIV antiretroviral agent as specified.

Per SDC and clinical guidance revisions (see references).

Continuation / Continued Therapy

Continued Therapy

Continued therapy requirements

Continued therapy: Member currently receiving medication via Centene benefit OR previously met initial approval criteria; OR member is enrolled in applicable continuity of care regulations; OR member has documentation of at least 30 days treatment for selected serious conditions (heart failure, seizures, HIV infection, psychiatric conditions, depression, cancer, or organ transplant).one of listed conditions

Approval duration 12 months.

Continued therapy continuity

Revised continuity allowance to maintain therapy for high-need conditions

Continuity of care allowance: Allows continuity of care for any medication treating heart failure, seizures, HIV infection, psychiatric conditions, depression, cancer, and organ transplant.

Applied in revised Section V per 06.05.24 to facilitate continuity for high-need conditions.

Step Therapy Table and Requirements

Drug	Required step-through agent(s)	Maximum dose / quantity limit	Age limit
Azilsartan medoxomil (Edarbi)
Two of the following: candesartan, irbesartan, or losartan
80 mg daily (1 tablet/day)
N/A
Amlodipine/olmesartan (Azor)
Losartan or irbesartan
10/40 mg daily
N/A
Amlodipine/olmesartan/HCTZ (Tribenzor)
Losartan or irbesartan
10/40/25 mg daily
N/A
Equetro (carbamazepine SR)
Carbamazepine IR
1,600 mg daily
N/A
Eszopiclone (Lunesta)
Zaleplon or zolpidem tartrate
3 mg daily for adults; 2 mg daily for geriatric
≥18 years (adult); geriatric dose specified)
Lisdexamfetamine (Vyvanse)
Generic Adderall XR
70 mg daily (1 tablet/day)
N/A
Almotriptan
Two of the following: naratriptan, rizatriptan, or sumatriptan
25 mg daily (varies by tablet strength)
≥12 years
Eletriptan (Relpax)
Two of the following: naratriptan, rizatriptan, or sumatriptan
80 mg daily
≥18 years
Frovatriptan (Frova)
Two of the following: sumatriptan
7.5 mg daily
≥18 years
Zolmitriptan (Zomig) / Zomig ODT
Two of the following: naratriptan, rizatriptan, or sumatriptan
5 mg per dose, up to 10 mg daily
≥12 years
Aptiom (eslicarbazepine)
Carbamazepine or oxcarbazepine
1,600 mg daily
N/A
Ropinirole ER
Ropinirole IR
24 mg daily
N/A
Topical adapalene (Differin) / adapalene products
Two of the following topical products: benzoyl peroxide, clindamycin, erythromycin, or tretinoin
Apply to affected area daily (quantity per product)
≥12 years
Azelaic acid cream
Two of the following topical products: benzoyl peroxide, clindamycin, erythromycin, or tretinoin
Per product labeling
≥12 years
Clobetasol propionate (Olux)
Listed topical corticosteroids as step agents (e.g., betamethasone)
50 mL/week (foam) or 50 g/week other topicals (varies by formulation)
N/A
Calcipotriene/betamethasone diproprionate (Taclonex)
Calcipotriene and betamethasone diproprionate as separate agents
100 g per week topical (or foam limits as specified)
N/A
Cefixime for suspension (Suprax)
Cefdinir or cefpodoxime
400 mg daily; 8 mg/kg/day if child <45 kg
N/A
Fenoprofen (Nalfon)
Ibuprofen
3,200 mg daily
N/A
Mefenamic acid (Ponstel)
Ibuprofen
1,250 mg daily
N/A
Nevanac (nepafenac ophthalmic)
Diclofenac ophthalmic or ketorolac ophthalmic
0.1%: 3 drops daily each affected eye
N/A
Cimduo (lamivudine/tenofovir disoproxil)
If treatment naive: any formulary HIV antiretroviral agent; if experienced: any HIV antiretroviral agent
Adults and pediatric patients ≥35 kg: 300/300 mg PO QD
N/A
Ubrelvy (ubrogepant)
One SHT/BD-agonist migraine medication (e.g., sumatriptan, rizatriptan, zolmitriptan)
Varies
N/A
Eucrisa (crisaborole) — Fidelis only
One generic topical corticosteroid OR topical calcineurin inhibitor
Per product labeling
Per applicable plan (Fidelis)

Change date / note	Affected agent(s)	Change made
2Q2022 (per March SDC)
Livalo; Lumigan; Delstrigo; Complera; Temixys; Ponstel; Profeno; Temovate
Removed Livalo and Lumigan as non-formulary; removed Delstrigo and Complera as EST no longer required; added Temixys to align with Cimduo requirements; removed obsolete products
2Q2023 (per 2Q 2023 annual review)
Symtuza; dihydroergotamine; lovastatin SR; clobetasol
Removed Symtuza, dihydroergotamine, lovastatin SR as EST is no longer required; added clobetasol with requirements similar to Olux; clarified Cimduo age limit
05.24.23 / Per SDC
Celecoxib; Ubrelvy; Ilevro; Eucrisa
Added celecoxib requiring step through meloxicam or generic NSAID (later removed); added/clarified Ubrelvy step requirement; removed Ilevro; added Eucrisa for Fidelis requiring topical corticosteroid or calcineurin inhibitor
2Q2024 (03.12.24 & 06.05.24 updates)
Venlafaxine SR; Zolpidem tartrate ER; Ramelteon; Requip products; Zomig-ZMT
Removed venlafaxine SR, zolpidem tartrate ER, ramelteon as EST no longer required; removed discontinued products; revised continued therapy to allow continuity for high-need conditions
2Q2025 (01.22.25; 05.25 P&T)
Cimduo; Ubrelvy; general table
Corrected Cimduo maximum dose per prescribing info; added step therapy bypass for IL HIM per IL HB 5395; references updated

Jurisdiction / law	Effect on step therapy	Supporting note
Illinois — IL HB 5395
Bypass allowed for Electronic Step Therapy requirements for Illinois HIM requests as of 1/1/2026
Policy notes: 'Illinois HIM requests, the step therapy requirements below do not apply as of 1/1/2026 per IL HB 5395.' Additionally, 2Q2025 update: added step therapy bypass for IL HIM per IL HB 5395

Quantity Limits and Examples

Examples of quantity limits across the table

Equetro (carbamazepine SR)Maximum dose 1,600 mg daily

Lunesta (eszopiclone)Maximum dose 3 mg daily (adults); 2 mg daily geriatric

Vyvanse (lisdexamfetamine)Maximum dose 70 mg daily

Nevanac (nepafenac ophthalmic)Maximum dose 0.1%: 3 drops daily per affected eye

Ubrelvy (ubrogepant)Quantity limits: varies by formulation/dosing (see table entries)

Revision History and References

2017-08-01Policy effective

Policy effective date established.

2021-06-02Clinical guidance update

Modified Complera, Delstrigo, and Symtuza to require a preferred single-tablet complete regimen for treatment‑naive members.

2023-02-02Annual review / edits

2Q 2023 annual review: removed Symtuza, dihydroergotamine, and lovastatin SR as EST no longer required; added clobetasol with similar requirements as Olux; template changes applied to continued therapy and references updated.

2024-06-05Continued therapy revision

Revised continued therapy criteria to allow continuity of care for medications treating heart failure, seizures, HIV, psychiatric conditions, depression, cancer, and organ transplant.

2025-01-22State law accommodation addedLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 01/01/2026 for Illinois members).