Step therapy criteria and history-based prior authorization for formulary medications
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Defines step therapy requirements for medications on Independent Health 2025 formularies and explains when prior authorization is required based on recent prescription history; affects prescribers, pharmacies, and members covered by Independent Health formularies in NC.
No material clinical or coverage changes in this revision.
Product-specific Coverage Criteria
Aczone (dapsone gel 7.5%) — initial coverage condition
Covered without prior authorization when ALL of the following are met
If not met, prior authorization required
AIRSUPRA — initial coverage condition
Covered without prior authorization when ALL of the following are met
If not met, prior authorization required
ALOCRIL — initial coverage condition
Covered without prior authorization when ALL of the following are met
If not met, prior authorization required
GLP-1 antidiabetics — initial coverage condition
Covered without prior authorization when ANY of the following are met
If not met, prior authorization required
Antiemetics — initial coverage condition
Covered without prior authorization when ALL of the following are met
If not met, prior authorization required
Belsomra — initial coverage condition
Covered without prior authorization when ALL of the following are met
If not met, prior authorization required
Binosto — initial coverage condition
Covered without prior authorization when ALL of the following are met
If not met, prior authorization required
Bromfenac ophthalmic — initial coverage condition
Covered without prior authorization when ALL of the following are met
If not met, prior authorization required
Fluorouracil topical — initial coverage condition
Covered without prior authorization when ALL of the following are met
If not met, prior authorization required
Entacapone / ONGENTYS — initial coverage condition
Covered without prior authorization when ALL of the following are met
If not met, prior authorization required
Ongentys initial edit criteria
Ongentys (entacapone / ONGENTYS): Covered through online processing when ALL of the following are met
If not met, prior authorization required
Diclofenac (migraine) initial edit criteria
Diclofenac potassium (migraine) packet: Covered through online processing when ALL of the following are met
If not met, prior authorization required
Eucrisa initial edit criteria
Eucrisa ointment 2%: Covered through online processing when ALL of the following are met
If not met, prior authorization required
Fetzima initial edit criteria
Fetzima formulations: Covered through online processing when ALL of the following are met
If not met, prior authorization required
Glycopyrrolate initial edit criteria
Glycopyrrolate oral solution: Covered through online processing when ALL of the following are met
If not met, prior authorization required
Gabapentin-class initial edit criteria
Gabapentin once-daily products: Covered through online processing when ALL of the following are met
If not met, prior authorization required
Doxercalciferol initial edit criteria
Doxercalciferol capsules: Covered through online processing when ALL of the following are met
If not met, prior authorization required
Horizant initial edit criteria
Horizant ER products: Covered through online processing when ALL of the following are met
If not met, prior authorization required
Amphetamine-dextroamphetamine initial edit criteria
Amphetamine-dextroamphetamine ER products: Covered through online processing when ALL of the following are met
If not met, prior authorization required
Memanne/Namzaric initial edit criteria
Memanne / Namzaric ER combination products: Covered through online processing when ALL of the following are met
If not met, prior authorization required
Step therapy / Prior authorization per product
Covered with step therapy / prior authorization based on documented prior or concurrent pharmacy fills
Lookback windows vary by product
Serevent Diskus
Serevent Diskus (50 mcg) coverage routing
If not documented, prior authorization is required.
FABIOR / Tazarotene
FABIOR and tazarotene topical products coverage routing
If not documented, prior authorization is required.
Tramadol ER
Tramadol ER products coverage routing
If not documented, prior authorization is required.
Trintellix
Trintellix (vortioxetine) coverage routing
If not documented, prior authorization is required.
Febuxostat (Uloric)
Febuxostat (Uloric) coverage routing
If not documented, prior authorization is required.
XPHOZAH (tenapanor)
XPHOZAH (tenapanor) coverage routing
If not documented, prescriber must request authorization via standard process.
Sublingual zolpidem
Sublingual zolpidem coverage routing
If not documented, prior authorization is required.
Prior Authorization & Documentation Requirements
General step-therapy rule
Prior authorization is required when the member's pharmacy history does not meet the step/history criteria listed below. For history-based edits, the pharmacy profile must document the specified prior fill(s) or concurrent therapy within the stated timeframe; otherwise submit a prior authorization with clinical justification.
- General rule: Attempted step(s) or required concurrent therapy must be documented in the member's Independent Health pharmacy history within the timeframe noted for each product or a prior authorization will be required.
- When pharmacy-history criteria are met the claim will process online; when not met the pharmacy will obtain prior authorization.
- Prescribers may request authorization via standard prior authorization channels and should include documentation of prior therapy, reason for failure/intolerance, or clinical rationale for bypassing step therapy.
Ongentys PA requirement
Ongentys (opicapone) requires prior authorization when the member's pharmacy profile does not document concurrent use of a levodopa/carbidopa product. Additionally, some Ongentys edits check for prior entacapone or levodopa/carbidopa-entacapone use — ensure relevant concurrent or recent therapy is documented.
- Products affected: ONGENTYS CAPSULE 50 MG ORAL
- Required history: Concurrent use of a levodopa/carbidopa product (documented in pharmacy history).
- Related check: Entacapone/levodopa-carbidopa-entacapone history in past 180 days may be used for routing.
Eucrisa PA requirement
Eucrisa requires prior authorization when the pharmacy profile does not document a recent topical calcineurin inhibitor or topical corticosteroid (tacrolimus, pimecrolimus, or topical corticosteroid) fill within the previous 365 days.
- Products affected: topical crisaborole products (Eucrisa).
- Required history: Fill for tacrolimus, pimecrolimus, or a topical corticosteroid within the previous 365 days.
Fetzima PA requirement
Fetzima (levomilnacipran) requires prior authorization when the patient's pharmacy history does not document a recent venlafaxine extended-release fill within the previous 90 days.
- Products affected: FETZIMA CAPSULE EXTENDED RELEASE 24 HOUR (various strengths).
- Required history: Venlafaxine ER fill within previous 90 days or submit PA with clinical rationale.
Gabapentin-class PA requirement
Gabapentin-class products (and specific branded gabapentin formulations) require prior authorization when the pharmacy profile does not document a gabapentin fill within the previous 90 days.
- Products affected: branded and extended-release gabapentin products (e.g., once-daily gabapentin 600 mg, HORIZANT).
- Required history: Gabapentin fill within previous 90 days.
Doxercalciferol PA requirement
Doxercalciferol and other vitamin D analogs require prior authorization when the pharmacy profile does not document a calcitriol fill within the previous 90 days.
- Products affected: doxercalciferol capsule 2.5 mcg and similar agents.
- Required history: Calcitriol fill within previous 90 days.
Horizant PA requirement
Horizant (gabapentin enacarbil) requires prior authorization when the pharmacy profile does not document a gabapentin fill within the previous 90 days.
- Products affected: HORIZANT TABLET EXTENDED RELEASE 600 MG ORAL
- Required history: Gabapentin fill within previous 90 days.
Memanne/Namzaric PA requirement
Memantine/donepezil combination products (Namzaric / memanne + donepezil formulations) require prior authorization when the pharmacy profile does not document a recent donepezil or memantine fill within the previous 90 days.
- Products affected: MEMANNE HCL-DONEPEZIL HCL ER CAPSULE, NAMZARIC CAPSULE EXTENDED RELEASE.
- Required history: Donepezil or memantine fill within previous 90 days; documentation of prior fills should be included with PA requests.
Trintellix: PA when no recent SSRI
Trintellix requires prior authorization when the patient's pharmacy history does not document use of a generic SSRI within the previous 90 days.
- Products affected: TRINTELLIX TABLET 5 MG ORAL (and other strengths).
- Required history: Fill for a generic SSRI (e.g., sertraline, fluoxetine, escitalopram) within previous 90 days.
Febuxostat: PA when no recent allopurinol
Febuxostat (Uloric) requires prior authorization when the patient's pharmacy history does not document an allopurinol fill within the previous 90 days.
- Products affected: FEBUXOSTAT TABLET 40 MG ORAL, 80 MG ORAL.
- Required history: Allopurinol fill within previous 90 days.
XPHOZAH: PA when no recent phosphate binder
Xphozah (tenapanor) requires prior authorization when the pharmacy profile does not document concurrent use of a phosphate binder within the previous 120 days. If the pharmacy history does not show a phosphate binder, the prescriber may submit a prior authorization with clinical justification for review.
- Products affected: XPHOZAH TABLET 30 MG ORAL
- Required history: Concurrent use of a phosphate binder within previous 120 days; prescriber can request authorization if history is not documented.
AMPH-DEX prior fill check
Amphetamine-dextroamphetamine extended-release products require prior authorization when the member's pharmacy history does not document prior fills for amphetamine-dextroamphetamine ER within the previous 90 days.
- Products affected: AMPH-DEX ER capsules (multiple strengths).
- Required history: Amphetamine-dextroamphetamine ER fill within previous 90 days.
Entacapone / ONGENTYS
Entacapone / levodopa-carbidopa-entacapone history is checked for certain Parkinson's disease adjunct therapies. Prior authorization is required when the pharmacy profile does not document concurrent or recent use as specified in the product-specific criteria.
- Products affected: ONGENTYS and related adjunctive Parkinson's agents.
- Required history: Concurrent entacapone or levodopa-carbidopa-entacapone use within product-specified timeframe (often past 180 days).
Xphozah step rule
Xphozah step rule: authorization routing is based on documented concurrent phosphate binder use within 120 days. If not documented, the claim will require prior authorization and the prescriber must supply clinical justification for use without a documented binder.
- Step rule: Concurrent phosphate binder documented = claim routes online; no documented binder = PA required.
- Operational note: Prescribers may request authorization and should include prior therapy or rationale.
Affected Products & Coding Notes
| SEREVENT DISKUS AEROSOL POWDER BREATH ACTIVATED 50 MCG/ACT INHALATION | Product listed in policy excerpt |
| No codes listed |
| FABIOR FOAM 0.1 % EXTERNAL | Product listed in policy excerpt |
| tazarotene cream 0.05 % external | Product listed in policy excerpt |
| tazarotene cream 0.1 % external | Product listed in policy excerpt |
| tazarotene gel 0.05 % external | Product listed in policy excerpt |
| tazarotene gel 0.1 % external | Product listed in policy excerpt |
| tramadol hcl (er biphasic) tablet extended release 24 hour 100 mg oral | Product listed in policy excerpt |
| tramadol hcl (er biphasic) tablet extended release 24 hour 200 mg oral | Product listed in policy excerpt |
| tramadol hcl (er biphasic) tablet extended release 24 hour 300 mg oral | Product listed in policy excerpt |
| TRINTELLIX TABLET 10 MG ORAL | Product listed in policy excerpt |
| TRINTELLIX TABLET 20 MG ORAL | Product listed in policy excerpt |
| TRINTELLIX TABLET 5 MG ORAL | Product listed in policy excerpt |
| febuxostat tablet 40 mg oral | Uloric product listed |
| febuxostat tablet 80 mg oral | Uloric product listed |
| XPHOZAH TABLET 20 MG ORAL | Product listed in policy excerpt |
| XPHOZAH TABLET 30 MG ORAL | Product listed in policy excerpt |
| zolpidem tartrate tablet sublingual 1.75 mg sublingual | Product listed in policy excerpt |
| zolpidem tartrate tablet sublingual 3.5 mg sublingual | Product listed in policy excerpt |
Initial Therapy and Start-of-Care Rules
inv-133: GLP-1 antidiabetics initial therapy
Initial use conditions for GLP-1 antidiabetics
If not met, prior authorization required
inv-134: Initial therapy pharmacy-history requirements
Initial dispensing allowed without prior authorization only when the required prior fill(s) are present in Independent Health prescription history within the stated look-back periods; otherwise prior authorization is required.
If not met, prior authorization required
inv-135: High-potency narcotics initial therapy
High-potency opioid initiation
applies to listed high-potency narcotics
inv-136: Memantine/donepezil prior therapy
Memantine/donepezil combination products
applies to memanne/donepezil ER products and Namzaric listing
inv-137: Ongentys prior/concurrent therapy
Ongentys (opicapone) co-therapy requirement
applies to ONGENTYS 25 mg and 50 mg
inv-138: Tramadol ER initial therapy
Tramadol ER initial step requirement
If not met, PA required.
inv-139: Trintellix initial therapy
Trintellix initial step requirement
If not met, PA required.
Step Therapy Matrix
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Aczone (dapsone gel 7.5%) | ||
| Pharmacy profile documents a generic 5% dapsone fill to bypass prior authorization | ||
| 90 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| AIRSUPRA (inhalation) | ||
| Pharmacy profile documents an inhaled corticosteroid or combination fill to bypass prior authorization | ||
| 120 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| ALOCRIL (ophthalmic) | ||
| Pharmacy profile documents a Zaditor or Alaway OTC fill to bypass prior authorization | ||
| 90 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| GLP-1 antidiabetics | ||
| Pharmacy profile documents type 2 diabetes diagnosis OR a trial of any oral antidiabetic (excluding metformin) to bypass prior authorization | ||
| 130 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Selected antiemetics (e.g., ANZEMET, aprepitant products) | ||
| Pharmacy profile documents a generic ondansetron fill to bypass prior authorization | ||
| 180 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Belsomra | ||
| Pharmacy profile documents a generic zolpidem fill to bypass prior authorization | ||
| 365 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Binosto | ||
| Pharmacy profile documents an alendronate fill to bypass prior authorization | ||
| 90 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Bromfenac ophthalmic (0.07%) | ||
| Pharmacy profile documents generic bromfenac ophthalmic solution 0.09% once-daily fill to bypass prior authorization | ||
| 90 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Fluorouracil topical (0.5%) | ||
| Pharmacy profile documents a fluorouracil topical fill to bypass prior authorization | ||
| 90 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Entacapone / ONGENTYS | ||
| Pharmacy profile documents concurrent use of a levodopa/carbidopa product to bypass prior authorization | ||
| Concurrent use (documented) |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Ongentys (entacapone) — online edit | ||
| Independent Health prescription history documents concurrent levodopa/carbidopa use to allow online processing | ||
| Concurrent use documented (per profile) |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Diclofenac potassium (migraine) packet 50 mg | ||
| Independent Health prescription history documents a generic NSAID (e.g., naproxen, ibuprofen, celecoxib) fill to bypass prior authorization | ||
| 180 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Eucrisa ointment 2% | ||
| Independent Health prescription history documents tacrolimus, pimecrolimus, or a topical corticosteroid fill to bypass prior authorization | ||
| 365 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Fetzima formulations | ||
| Independent Health prescription history documents a venlafaxine XR fill to bypass prior authorization | ||
| 90 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Glycopyrrolate oral solution | ||
| Independent Health prescription history documents a generic glycopyrrolate tablet fill to bypass prior authorization | ||
| 90 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Gabapentin once-daily products | ||
| Independent Health prescription history documents a gabapentin fill to bypass prior authorization | ||
| 90 days |
| Medication | Bypass requirement | Lookback / threshold |
|---|---|---|
| Doxercalciferol capsules | ||
| Independent Health prescription history documents a calcitriol fill to bypass prior authorization | ||
| 90 days |
Policy Background
Step therapy is used to promote use of established, typically lower‑cost or first‑line medications (or required concomitant therapies) before covering alternative or higher‑cost products. Independent Health applies product‑specific step therapy rules by checking the member’s prescription history: when the required prior or concurrent fill is documented within the defined lookback window, the claim will route online without prior authorization; when that pharmacy history is not present, prior authorization is required.
This policy ties step requirements to recent prescription fills in the Independent Health pharmacy profile and lists common lookback windows and conditions used to allow online processing (examples include 90 days, 120 days, 130 days, 180 days, and 365 days), as well as product‑specific conditions such as required concurrent therapy (for example, levodopa/carbidopa with entacapone or phosphate binder use with tenapanor). Providers and pharmacies should document the specified prior fill(s) in the member’s prescription history or submit a prior authorization when the lookback criteria are not met.
Key Definitions
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