CurrentFlorida BluePolicy N/A

Responsible Steps Program (step therapy) for prescription drugs

Defines the Responsible Steps step-therapy program for multiple therapeutic drug categories and prerequisite drug requirements that affect pharmacy coverage and prior authorization for Florida Blue members.

Policy Summary

PayerFlorida Blue

PolicyResponsible Steps Program (step therapy) for prescription drugs

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date4/1/24

Next Review DateN/A

Key ActionCheck member benefit inclusion in the Responsible Steps Program and document prior paid claims to satisfy or waive step-therapy requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipledrug classes covered

requiredprerequisite use

requiredbenefit check

P&T reviewnew-to-market

Step Therapy Coverage Criteria

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General program rule: Member must be included in the Responsible Steps Program and the prerequisite drug use (as specified for the target drug/therapeutic category) must be documented; prior approval by another health plan with documentation of a paid claim may waive step requirements

Check member benefits to confirm inclusion in program

Anti-infectives Example

Examples — Anti-infectives (tetracyclines/minocycline/doxycycline):

Doxycycline/Minocycline prerequisites: For listed tetracycline/minocycline target drugs, previous use of both generic doxycycline AND generic minocycline capsules or tablets is required (minocycline ER is not a prerequisite for certain target products)

Applies to multiple listed branded and single-source doxycycline and minocycline products

Antidepressants

Antidepressants examples:

Antidepressant prerequisites: Many branded antidepressants require previous use of a generic version of any of the following: bupropion, citalopram, desvenlafaxine ER, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, paroxetine, sertraline, venlafaxine (or venlafaxine ER)

For certain indications alternative prerequisite lists apply (e.g., neuropathic pain, fibromyalgia, chronic musculoskeletal pain where specified generics such as amitriptyline, gabapentin, cyclobenzaprine, tramadol, NSAIDs, etc., may satisfy prerequisites)

Pain/Neurologic Agents

Neurologic/pain agents and pregabalin examples:

Lyrica/Savella prerequisites: Lyrica and Savella require previous use of a generic version of one of the listed agents (amitriptyline, cyclobenzaprine, desipramine, duloxetine, gabapentin, imipramine, nortriptyline, pregabalin IR, tramadol, or venlafaxine). Lyrica for treatment of a seizure disorder is excluded from the prerequisite drug requirement.

Lyrica CR and pregabalin ER require previous use of BOTH a listed generic antidepressant/neuropathic agent (e.g., amitriptyline, desipramine, duloxetine, gabapentin, imipramine, nortriptyline, or venlafaxine) AND pregabalin IR

Cardiovascular / GI / Renal

Cardiovascular, GI, renal and related drug examples:

ARB/ACE/renin prerequisites: Certain ARB/renin inhibitor products require previous use of ANY of the following: a generic ACE inhibitor, a generic angiotensin receptor blocker (ARB), or a generic renin inhibitor. Similarly, statins and GI agents require prior use of generic statins or two or more generic proton pump inhibitor (PPI) agents as listed.

Specific product groups and allowed substitutes are listed per therapeutic category (see program lists)

Topical Corticosteroids

Topical corticosteroids:

Topical corticosteroid group requirements: Topical corticosteroids are grouped by potency. Coverage of higher-potency or brand topical corticosteroids requires previous use of two or more generic versions of listed lower-potency or equivalent agents within the specified groups before coverage is authorized.

Specific group lists and examples (by potency group and product) are provided in the program documents

For members subject to the Responsible Steps Program, most target drugs require documented prior use of specified generic or alternative medications before coverage is authorized. However, Lyrica (pregabalin) when prescribed for the treatment of a seizure disorder is excluded from the prerequisite drug requirement and does not require prior use of the listed prerequisite agents.

Therapeutic category / Target drug examples	Prerequisite drugs required
Anti‑infectives (examples: Acticlate, Doryx MPC, branded doxycycline products, Targadox, Vibramycin, Coremino, Minocin, Minolira, Solodyn, Ximino, Seysara, Tetracycline)	Previous use of BOTH generic doxycycline AND generic minocycline capsules or tablets (note: minocycline ER is NOT a prerequisite for some minocycline products)
Ophthalmic anti‑infective (example: Xdemvy)	Previous use of oral ivermectin
Antidepressants (example: Cymbalta and other listed branded antidepressants)	Previous use of listed generic antidepressants (e.g., bupropion; citalopram; desvenlafaxine ER; duloxetine; escitalopram; fluoxetine; fluvoxamine; mirtazapine; paroxetine; sertraline; trazodone; venlafaxine or venlafaxine ER) OR indication‑specific alternatives (e.g., for neuropathic pain: amitriptyline, desipramine, gabapentin, imipramine, nortriptyline; for fibromyalgia: amitriptyline, cyclobenzaprine, desipramine, gabapentin, imipramine, nortriptyline, tramadol; for chronic musculoskeletal pain: acetaminophen, amitriptyline, cyclobenzaprine, desipramine, gabapentin, imipramine, nortriptyline, NSAID, or tramadol)
Atypical antipsychotics (examples: Abilify, Caplyta, Invega, Seroquel, Zyprexa, others)	Previous use of TWO OR MORE generic versions of listed antipsychotics (e.g., aripiprazole, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone) (Caplyta requires only one generic)
Neurologic / pain agents and pregabalin products (examples: Lyrica, Savella, Lyrica CR, pregabalin ER, Gralise, Horizant)	Previous use of a generic from the listed options (e.g., amitriptyline, cyclobenzaprine, desipramine, duloxetine, gabapentin, imipramine, nortriptyline, pregabalin IR, tramadol, venlafaxine). For Lyrica CR and pregabalin ER, previous use of BOTH a listed generic AND pregabalin IR is required. Note: Lyrica when used for seizure disorder is excluded from the prerequisite requirement.
Angiotensin receptor blockers / renin inhibitors, statins, gastrointestinal agents (examples: Altoprev, Crestor, Ezetimibe/Rosuvastatin, Aciphex, Dexilant, Nexium, Prevacid, Prilosec, Protonix)	Previous use of ANY of the following as applicable: a generic ACE inhibitor OR a generic ARB OR a generic renin inhibitor (for ARB/renin group); previous use of any generic statin or statin combination (for statins); previous use of two or more generic proton pump inhibitors (for listed GI agents)
Renal / diabetes / metabolic agents and phosphate binders (examples: various SGLT2 combinations, insulin/metformin combinations, Velphoro)	Previous or current use of brand or generic insulin or metformin as applicable; previous use of BOTH a non‑targeted generic phosphate binder (e.g., calcium acetate, calcium carbonate, sevelamer) AND Velphoro for phosphate binder group
Topical corticosteroids (grouped by potency; examples listed for Super‑High, High, Medium‑High potency groups)	Previous use of TWO OR MORE generic versions of listed lower‑potency or equivalent topical corticosteroids from the specified groups prior to coverage of higher‑potency/brand products

Provider Actions and Documentation Requirements

Step Therapy

Step therapy and new-to-market review

Step therapy requirements apply per the Responsible Steps Program; check member benefit documentation to determine whether the member is included in the Responsible Steps Program and to confirm coverage status of drugs in the program. Certain drugs may be excluded from coverage for certain members.

Refer to the Responsible Steps New to Market Drug List for newly marketed medications.
Step therapy may not apply if the medication was previously approved by another health plan and documentation of a paid claim by the prior health plan is submitted.

Step Therapy

Prerequisite drug requirements

Many target drugs require documented prior use of specified generic or alternative agents. Confirm and document prior use according to the program-specific prerequisite drug lists before submitting a prior authorization request.

Examples of prerequisite requirements are listed in the Responsible Steps Program drug-specific guidance (e.g., antidepressants, anti‑infectives, gabapentin, insulin combinations, topical corticosteroids).
Some targets require use of two or more generics; others require specific combinations (see program documents for exact prerequisites).

Documentation Required

Member benefit and prior PA documentation

Check member benefit documentation to determine inclusion in the Responsible Steps Program and include proof of prior therapy when required. If the drug was previously approved and dispensed under another health plan, submit documentation of a paid claim from that plan to avoid step-therapy enforcement.

Include member benefit confirmation in the prior authorization submission.
Attach documentation of paid claims from a prior health plan when asserting prior approval under that plan.

Denial Risk

Documentation-related denial risk

Failure to document member inclusion in the Responsible Steps Program or failure to provide required prior-use documentation (including a paid-claim from a prior health plan when applicable) may result in denial of the request.

Omissions commonly leading to denial: missing member benefit verification, absent prior paid-claim evidence, or incomplete prerequisite drug history.
If a newly marketed drug has not yet been reviewed by the Pharmacy & Therapeutics Committee, requests may be denied until coverage and tiering are established.

Definitions

Responsible Steps Program

DefinitionA step-therapy program managed by Florida Blue that requires prior use of specified prerequisite drugs or documentation of prior coverage to authorize certain target drugs.

Member benefit checkCheck member benefit documentation to determine inclusion in the Responsible Steps Program; certain drugs may be excluded for some members.

Waiver by prior approvalStep therapy requirements may be waived if the medication was previously approved by another health plan and documentation of a paid claim by the prior health plan is submitted.

New-to-market reviewNewly marketed prescription medications may not be covered until the Pharmacy & Therapeutics Committee reviews the medication to determine coverage and tier assignment.

PurposeRequires prior use of specified prerequisite drugs (often generic versions or alternatives) before coverage of higher-tier or brand target drugs.

Background

This document is an administrative pharmacy step-therapy guide that lists target drugs and the required prerequisite medications—typically generic equivalents or specific alternative agents—that must have been used before coverage of higher-tier or brand products. It applies across multiple therapeutic categories (for example, anti‑infectives, antidepressants, neurologic/pain agents, cardiovascular/GI/renal agents, and topical corticosteroids) and is intended to guide prior authorization and coverage decisions under the Responsible Steps Program.