ModifiedmhnPolicy CP.CPA.83

Clinical Policy: Step Therapy

Defines drugs on the commercial formulary that require step therapy, required prior agents, and maximum doses/quantity limits; applies to providers submitting requests under the payer's commercial lines.

Policy Summary

Payermhn

PolicyClinical Policy: Step Therapy

Policy CodePolicy CP.CPA.83

Change TypeMaterial updates — multiple drug additions (HIV products, Provigil) and continuation language added

Effective DateSep 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation of prior trial of required step-through agents or documented contraindication; include chart notes or lab results to support criteria.

SourceLink

POLICY UPDATE CHANGES

Added Atripla, Odefsey, and Complera to policy requiring step-through Symfi for treatment-naïve members and added continuation of care language for HIV.

Added Symtuza and Delstrigo to policy requiring step-through Symfi if member is treatment-naïve.

Added Provigil (modafinil) to policy requiring step through Nuvigil (armodafinil).

multipleUpdates over time

multipleDrugs listed

30 daysHIV continuation threshold

Commercial onlyLine of business

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Applicability

Initial Step Therapy (per-table entries)

Covered when ALL of the following are met for a given drug listed in the table:

Step therapy general: 1) Member has had a previous trial of the required step-through agent(s) listed for the specific drug OR has a documented contraindication to the required agent(s). 2) The requested dose does not exceed the maximum indicated dose and stated quantity limit in the step therapy table for the specific drug. 3) Provider submits documentation supporting prior trials or contraindications (e.g., chart notes, labs).

Applies per individual drug entries in the step therapy table; see specific drug rows for required agents and maximum doses/quantity limits.

Continued Therapy

Continued therapy — Step Therapy (must meet all):

Continuation criteria: 1) Member meets one of the following: a) currently receiving the medication via the Centene benefit or previously met initial approval criteria; OR b) documentation verifies the member is currently receiving one of the listed HIV products (Atripla, Cimduo, Complera, Delstrigo, Odefsey, or Symtuza) and has received it for at least 30 days. 2) If the request is for a dose increase, the new dose does not exceed the FDA‑approved maximum recommended dose and the quantity limit as stated in the initial approval criteria for the relevant drug.30 days for HIV continuation

Approval duration: Length of Benefit.

This policy applies to drugs on the payer's Commercial formulary. It defines step therapy requirements for listed products and the documentation needed for prior authorization; providers should follow the formulary when selecting agents subject to step therapy. For drugs that are not on the Commercial formulary, this step therapy policy does not apply — non-formulary drugs are governed by the formulary exception process (see CP.CPA.190).

A disclaimer has been added to the policy clarifying that it does not apply to NF (non-formulary) drugs. When a product is non-formulary, the step therapy rules in this document are not applicable and providers must follow the formulary exception procedures.

Initial Step Therapy Requirements

Initial Therapy

Initial coverage is contingent on prior trial of listed agents or documented contraindication.

Initial step for listed drugs: For each listed drug, the provider must document a prior trial of the required step-through agent(s) specified for that drug (or document a contraindication) before approval. The requested dose must not exceed the stated maximum/quantity limit in the step therapy table.See individual drug rows for max dose/quantity

Examples in the table: Aplenzin, Fetzima, Forfivo XL, Trintellix, Viibryd require trials of two generic antidepressants; many HIV fixed-dose combinations require prior Symfi for treatment‑naïve members; Taclonex requires prior generic topical steroid and topical calcitriol or calcipotriene; Provigil requires prior Nuvigil.

Initial therapy step requirements

Policy additions specify preferred initial agents for treatment‑naïve members.

HIV initial therapy:

Continuation of Therapy

Continuation Therapy for HIV products

Continuation allowed when criteria met

HIV continuation: Members currently receiving listed HIV combination products (Atripla, Cimduo, Complera, Delstrigo, Odefsey, Symtuza) and who have been on therapy for at least 30 days may qualify for continued coverage without re‑stepping, provided doses remain within the stated limits.30 days

Approval duration = Length of Benefit.

Continuation of care for HIV

Continuation of care provisions noted for certain conditions

HIV continuation of care: Continuation of care language was added to allow ongoing therapy for members already receiving certain HIV regimens per the SDC and revision history.

Applies to members already on therapy; operationalized in policy updates.

Step Therapy Tables

Drug	Required step-through agents	Maximum dose / quantity limit
Aliskiren (Tekturna) / Aliskiren/HCTZ (Tekturna HCT)
ARB or ARB combination product (e.g., olmesartan, olmesartan/hctz, irbesartan, losartan, candesartan, telmisartan, valsartan)
Tekturna: 300 mg/day; Tekturna HCT: 300/25 mg/day

Drug	Required step-through agents / initial-agent changes	Continuation / notes
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
If treatment-naïve: Symfi or Symfi Lo (efavirenz/lamivudine/tenofovir disoproxil fumarate); if treatment-experienced: any HIV antiretroviral agent
Policy revised to add Atripla requiring step through Symfi for treatment-naïve members; continuation of care language added for HIV (members on therapy ≥30 days may continue)
Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate)
If treatment-naïve: Symfi or Symfi Lo; if treatment-experienced: any HIV antiretroviral agent
Added to require step through Symfi for treatment-naïve members; continuation allowances for established therapy per policy
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate)
If treatment-naïve: Symfi or Symfi Lo; if treatment-experienced: any HIV antiretroviral agent
Added to require step through Symfi for treatment-naïve members; continuation allowances for established therapy per policy
Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide)
If treatment-naïve: Symfi or Symfi Lo; if treatment-experienced: any HIV antiretroviral agent
Added to require step through Symfi for treatment-naïve members (per revision history); continuation language applies
Cimduo (lamivudine/tenofovir disoproxil fumarate)
If treatment-naïve: Truvada (emtricitabine/tenofovir) as initial agent
Cimduo added requiring use of Truvada for treatment-naïve members (per revision history); continuation allowances noted
Provigil (modafinil)
Required step-through agent: armodafinil (Nuvigil)
Provigil was added to require step through Nuvigil (per revision log); continuation per standard criteria
Azor / Tribenzor
Step-through: generic or formulary-preferred ARB or ARB combination product
Azor and Tribenzor were added to require step through preferred ARB products (revision notes); policy does not apply to non-formulary drugs
Seebri Neohaler / Tudorza Pressair
Use preferred Spiriva or Incruse Ellipta prior to these products
Seebri Neohaler and Tudorza Pressair added to require preferred LAMA options first; continuation allowances apply for established therapy

Maximum Doses and Quantity Limits

Quantity limits — per-drug maximum doses and availability

Tekturna (aliskiren)Maximum dose 300 mg/day (tablets: 150, 300 mg)

Tekturna HCT (aliskiren/HCTZ)Maximum dose 300/25 mg/day (available tablets include 150/12.5, 150/25, 300/12.5, 300/25 mg)

Taclonex (calcipotriene-betamethasone) — ointment/suspensionMaximum dose 100 g/week (equivalent to 2 g/day); available in 60 g and 100 g containers

Cimduo (lamivudine/tenofovir DF)Maximum doses: Adults and pediatric ≥35 kg: 200/300 mg PO QD; pediatric 17 to <35 kg: weight-based dosing (e.g., 17–<22 kg: 100/150 mg PO QD; 22–<28 kg: 133/200 mg PO QD; 28–<35 kg: per table)

Provigil (modafinil)Maximum dose 200 mg/day for shift work disorder; 400 mg/day for all other indications (tablets: 100 mg, 200 mg)

Symtuza (darunavir/cobicistat/emtricitabine/TAF)

Provider Requirements and Prior Authorization

Documentation Required

Documentation Requirement

Providers must submit documentation (such as office chart notes, lab results, or other clinical information) demonstrating that the member has met all approval criteria. Failure to submit sufficient supporting documentation may result in denial of the prior authorization request.

Acceptable documentation: office notes, diagnostic test results, prior medication trials records, allergy/contraindication documentation
Insufficient documentation: no chart notes, missing prior trial details, no contraindication evidence

Step Therapy

Step Therapy Requirements

Step therapy requirements mandate that treatment-naïve members begin therapy with specified preferred or formulary-preferred agents (the required step-through agents) before coverage of non-preferred or later-line drugs will be approved. Requests must document a trial of the required agent(s) or a documented contraindication or intolerance to the required agent(s).

A request without evidence of a prior trial and response to the required step-through agent(s) should include clear contraindication/intolerance documentation

Policy Background

This step therapy policy covers multiple drug classes and specific products across therapeutic areas, including antidepressants, ARB and ARB-combination antihypertensives, HIV fixed-dose combination regimens, transplant immunosuppressants, topical dermatologic agents, ophthalmic antihistamines, wakefulness-promoting agents, inhaled bronchodilators for COPD, bisphosphonates, and leukotriene inhibitors. The policy lists required step-through agents and quantity/dose limits by drug and includes continuation provisions for members already receiving certain HIV combination therapies.

Abbreviations and Terms

Definition — ARB

Termangiotensin receptor blocker (ARB)

DefinitionARB = angiotensin receptor blocker (see Appendix A)

ContextUsed as required step-through agents for certain ARB or ARB combination products (e.g., olmesartan, losartan, valsartan)

Definition — HCTZ

TermHCTZ

DefinitionHCTZ = hydrochlorothiazide (see Appendix A)

ContextAppears in combination products (e.g., Tekturna HCT, olmesartan/amlodipine/HCTZ) with specified maximum daily doses in the table

Policy Revision History

2018-05-15policy_created

New Step Therapy policy created from CP.CPA.219 (Antidepressant Step Therapy) and CP.CPA.185 (General Step Through Criteria).

2018-12-07hiv_additions

Added Atripla, Odefsey, and Complera to require step-through Symfi for treatment-naïve members and added continuation-of-care language for HIV.

2018-12-19hiv_addition

Added Symtuza to require step-through Symfi for treatment-naïve members.

Policy Summary

Payermhn

PolicyClinical Policy: Step Therapy

Policy CodePolicy CP.CPA.83

Change TypeMaterial updates — multiple drug additions (HIV products, Provigil) and continuation language added

Effective DateSep 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation of prior trial of required step-through agents or documented contraindication; include chart notes or lab results to support criteria.

SourceLink

On This Page

For treatment‑naïve members, certain fixed‑dose HIV regimens require step through Symfi or Symfi Lo (efavirenz/lamivudine/tenofovir disoproxil fumarate) prior to approval (examples: Atripla, Odefsey, Complera, Delstrigo, Symtuza where treatment‑naïve). Cimduo requires use of Truvada as the required initial agent for treatment‑naïve patients.

Added per SDC and revision history.

COPD inhaler initiation: Seebri Neohaler and Tudorza Pressair require use of preferred Spiriva or Incruse Ellipta prior to approval.

Added per SDC and prior clinical guidance.

ARB combination initiation: Azor and Tribenzor (and Tekturna/Tekturna HCT entries) require step through a generic or formulary‑preferred ARB or ARB combination product prior to approval.

Per policy updates adding ARB step requirements.

Wakefulness‑promoting agents: Provigil (modafinil) was added to require prior trial of armodafinil (Nuvigil) before approval.

Added during 2Q 2019 annual review.

Maximum dose 800/150/200/10 mg daily (1 tablet/day)

Step therapy applies across multiple drug classes as listed in the policy table (e.g., ARB step for Tekturna, antidepressant step for multiple agents, HIV regimens requiring Symfi for treatment-naïve members)

Denial Risk

Failure to Step Through Preferred Agents

Coverage may be denied when a member has not stepped through preferred or formulary-preferred agents as required by this policy. Prior authorization requests for non-preferred products must include documentation of prior trials of the preferred agents or documented medical reasons (contraindication/intolerance) why the preferred agent(s) cannot be used.

Examples: requests for Azor/Tribenzor require prior trial of generic or formulary-preferred ARB or ARB combination products; requests for Seebri Neohaler or Tudorza Pressair require use of preferred Spiriva or Incruse Ellipta
If prior trials are not documented, include rationale such as adverse reaction, intolerance, or clinical contraindication

Documentation Required

Documentation and Medical Necessity

Providers should follow standard medical necessity documentation practices. This policy was developed from evidence, guidelines, and clinician input; requests must establish medical necessity through clinically relevant information and prior treatment history.

Include clinical indication, prior therapies tried (dates, doses, response), relevant labs/imaging, and rationale for why the requested agent is medically necessary
Reference applicable guideline-based indications where relevant

Documentation Required

Supporting Documentation

Supporting documentation must accompany prior authorization requests for drugs subject to step therapy. Acceptable supporting documents include office chart notes documenting prior trials and outcomes, medication fill history, laboratory results, and allergy or intolerance documentation.

Medication history should specify drug name, dose, duration, and reason for discontinuation (e.g., lack of efficacy, adverse event)
Lab results or specialist notes supporting contraindications (e.g., hepatic impairment, hypersensitivity) when applicable

Prior Authorization

Step Therapy Prior Authorization Requirement

Prior authorization requests for drugs listed in the step therapy table will only be approved when documentation demonstrates either: (1) a prior trial and inadequate response to the listed required step-through agent(s), or (2) a documented contraindication or intolerance to the required agent(s). Requests should not exceed the maximum indicated dose and stated quantity limits.

Approval is length of benefit when criteria met
Requests must adhere to maximum dose/quantity limits shown in the policy table

2019-02-01hiv_addition

Added Delstrigo to require step-through Symfi for treatment-naïve members.

2019-03-05annual_review

2Q 2019 annual review: added Provigil (modafinil) to require step through Nuvigil (armodafinil) and updated references; P&T approval recorded 05.19.

2019-05-06arb_updates

Added Azor and Tribenzor to require step through generic or formulary-preferred ARB/ARB combination products; added Tekturna and Tekturna HCT to require step through ARB products and retired CP.CPA.61 and CP.CPA.07.

2019-10-07copd_inhalers

Added Seebri Neohaler and Tudorza Pressair requiring use of preferred Spiriva or Incruse Ellipta per SDC and prior guidance; retired CP.CPA.150 and added disclaimer that policy does not apply to non-formulary drugs.

2020-03-05annual_review

2Q 2020 annual review: no significant changes noted; P&T approval dated 05.20.

2020-04-27hiv_additionLatest

Added Cimduo requiring use of Truvada for treatment-naïve members per April SDC and prior clinical guidance.