Step therapy criteria for formulary medications
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Defines step therapy (ST) requirements for medications on Independent Health 2026 formularies and explains when prior authorization is required based on prescription history; affects prescribers, pharmacies, and members covered by Independent Health formularies.
No material clinical or coverage changes in this revision.
Coverage Criteria by Product
Aczone (dapsone 7.5%)
Aczone (dapsone gel 7.5%)
applies to dapsone gel 7.5% external
Antidiabetic GLP-1 medications
GLP-1 antidiabetic products
applies to listed GLP-1 agents (e.g., Ozempic, Rybelsus, Trulicity, Mounjaro)
Aprepitant (EMEND) requirements
Aprepitant products
applies to aprepitant products (e.g., Emend)
Belsomra
Belsomra (suvorexant) products
applies to Belsomra tablets
Binosto
Binosto (effervescent alendronate)
applies to Binosto 70 mg effervescent
Bromfenac ophthalmic
Bromfenac ophthalmic solution
applies to bromfenac 0.07% solution
Carac
Carac (fluorouracil topical)
applies to Carac
Entacapone / ONGENTYS
Entacapone / ONGENTYS
applies to entacapone and ONGENTYS
Diclofenac (migraine)
Diclofenac potassium (migraine)
applies to diclofenac potassium 50 mg packets
Point-of-sale coverage condition
Covered at point-of-sale when ALL of the following are met for the specific product:
If this condition is not met the claim routes to prior authorization.
Clotrimazole/Fluconazole/Nystatin routing
Covered/routed online when the following is documented in pharmacy history
If met, prescription routes online; if not met, prior authorization required
Oxcarbazepine routing
Covered/routed online when prior fill documented
If met, prescription routes online; otherwise prior authorization required
Methylphenidate ER routing
Covered/routed online when prior fill documented
If met, prescription routes online; otherwise prior authorization required
Aliskiren routing
Covered/routed online when prior fills documented
If both fills present, prescription routes online; otherwise prior authorization required
Sancuso routing
Covered/routed online when prior fill documented
If met, prescription routes online; otherwise prior authorization required
Serevent routing
Covered/routed online when concurrent therapy documented
If present, prescription routes online; otherwise prior authorization required
Tazarotene routing
Covered/routed online when prior topical retinoid fill documented
If met, prescription routes online; otherwise prior authorization required
Tramadol ER routing
Covered/routed online when prior immediate-release tramadol fill documented
If met, prescription routes online; otherwise prior authorization required
Trintellix routing
Covered/routed online when prior SSRI fill documented
applies to Trintellix (vortioxetine)
Febuxostat (Uloric) routing
Covered/routed online when prior allopurinol fill documented
applies to febuxostat (Uloric)
Initial routing / step-therapy conditions
Covered when the following routing/history conditions are met (product-specific):
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Starting listed high‑potency extended‑release opioid products in a patient who is narcotic‑naive (defined by no documented narcotic fills in the prior 120 days) is not permitted to process at point‑of‑sale. These agents pose serious risks when initiated without recent opioid exposure; therefore the claim will only route online for processing if the patient's Independent Health prescription history documents narcotic medication fills within the previous 120 days. If that documentation is absent, prior authorization is required.
The policy does not list separate clinical exclusions beyond the absence of the specified prior fills or concurrent therapies that trigger prior authorization. For products that require documented concurrent use (for example, an inhaled corticosteroid or tiotropium for certain inhaled products), if the pharmacy profile does not show the required therapy, the claim is routed to prior authorization per the stated criteria.
No additional explicit exclusions are specified in these sections. When a required prior therapy or concurrent‑use condition (for example, documented phosphate binder use for XPHOZAH within the prior 120 days) is not evident in the Independent Health prescription history, the prescriber may submit a request for prior authorization through the standard authorization process.
Coding and Lookback Windows
| oxcarbazepine er tablet 150 mg | oxcarbazepine er tablet extended release 24 hour 150 mg oral |
| oxcarbazepine er tablet 300 mg | oxcarbazepine er tablet extended release 24 hour 300 mg |
| QELBREE 100 mg | QELBREE CAPSULE EXTENDED RELEASE 24 HOUR 100 MG ORAL |
| QELBREE 150 mg | QELBREE CAPSULE EXTENDED RELEASE 24 HOUR 150 MG |
| QELBREE 200 mg | QELBREE CAPSULE EXTENDED RELEASE 24 HOUR 200 MG ORAL |
| QUILLICHEW ER 20 mg | QUILLICHEW ER TABLET CHEWABLE EXTENDED RELEASE 20 MG ORAL |
| QUILLICHEW ER 30 mg | QUILLICHEW ER TABLET CHEWABLE EXTENDED RELEASE 30 MG ORAL |
| QUILLICHEW ER 40 mg | QUILLICHEW ER TABLET CHEWABLE EXTENDED RELEASE 40 MG ORAL |
| QUILLIVANT XR 25 mg/5 mL | QUILLIVANT XR SUSPENSION RECONSTITUTED ER 25 MG/5ML ORAL |
| aliskiren 150 mg | aliskiren fumarate tablet 150 mg oral |
| aliskiren 300 mg | aliskiren fumarate tablet 300 mg oral |
| SANCUSO 3.1 mg/24 hr | SANCUSO PATCH 3.1 MG/24HR TRANSDERMAL |
| Serevent Diskus 50 mcg | SEREVENT DISKUS AEROSOL POWDER BREATH ACTIVATED 50 MCG/ACT INHALATION |
| tazarotene cream 0.05% | tazarotene cream 0.05 % external |
| tazarotene cream 0.1% | tazarotene cream 0.1 % external |
| tazarotene gel 0.05% | tazarotene gel 0.05 % external |
| tazarotene gel 0.1% | tazarotene gel 0.1 % external |
| tramadol hcl er 100 mg | tramadol hcl er tablet extended release 24 hour 100 mg oral |
| tramadol hcl er 200 mg | tramadol hcl er tablet extended release 24 hour 200 mg |
| tramadol hcl er 300 mg | tramadol hcl er tablet extended release 24 hour 300 mg oral |
| TRINTELLIX 5 mg | TRINTELLIX TABLET 5 MG ORAL |
| TRINTELLIX 10 mg | TRINTELLIX TABLET 10 MG ORAL |
| TRINTELLIX 20 mg | TRINTELLIX TABLET 20 MG ORAL |
| febuxostat 40 mg | febuxostat tablet 40 mg oral |
| febuxostat 80 mg | febuxostat tablet 80 mg oral |
| TRINTELLIX TABLET 5 MG ORAL | Product listed in criteria block |
| febuxostat tablet 40 mg oral | Uloric product affected |
| febuxostat tablet 80 mg oral | Uloric product affected |
| XPHOZAH TABLET 20 MG ORAL | Product affected |
| XPHOZAH TABLET 30 MG ORAL | Product affected |
| zolpidem tartrate tablet sublingual 1.75 mg sublingual | Product listed |
| zolpidem tartrate tablet sublingual 3.5 mg sublingual | Product listed |
Provider Actions, Prior Authorization & Routing
Trintellix prior authorization requirement
Claims for TRINTELLIX (vortioxetine) tablets are routed to prior authorization when the pharmacy profile does not document a recent fill of a generic SSRI (e.g., sertraline, fluoxetine, escitalopram) within the previous 90 days. Prior authorization will be required if the lookback criterion is not met.
- Product: TRINTELLIX TABLET 5 MG ORAL
- Lookback: generic SSRI fill within previous 90 days
- Action: Routed to prior authorization when no qualifying SSRI fill found
Pharmacy profile / prior-fill documentation
Pharmacy profile / fill-history documentation is used as the trigger for routing and step edits. The dispensing pharmacy profile must show the required comparator product filled within the specified lookback window for online adjudication to pass. If the pharmacy profile is incomplete or lacks the required prior fill, the claim will route to prior authorization. Providers may submit external documentation of prior fills when the profile does not reflect them.
- Acceptable documentation: pharmacy profile, prescription claim history, or supporting medical record notes showing dates and product names
- Operational note: if documentation is not on the profile, prescriber may request authorization using the standard prior authorization process
Prescriber may request authorization when profile lacks required concurrent use
Prescribers may request prior authorization using the standard authorization process when the patient's Independent Health pharmacy profile does not document the required prior fill or concurrent use. Authorization can be approved based on submitted clinical documentation that demonstrates medical necessity or prior use of the required comparator.
- When pharmacy history lacks required concurrent phosphate binder use for Xphozah, prescriber may submit PA request
- Provide clinical notes, prior dispensing receipts, or other evidence to support lack of documented prior fill
Step therapy enforced via prior-fill requirement
Step therapy for listed products is enforced via a prior-fill requirement: the patient's pharmacy history must document a fill of the specified alternative medication within the stated lookback window before the requested product will adjudicate online. If the prior-fill criterion is not met, the claim routes to prior authorization.
- Mechanism: online routing based on pharmacy fill history
- If no prior fill found within lookback window → claim routes to PA
- Prescribers may provide documentation to request PA if profile is incomplete
Routing summary — each product requires a recent fill of specified alternative within lookback window
Each listed product below requires documentation of a recent fill of the specified alternative (the step) within the product-specific lookback window; absence of that fill routes the claim to prior authorization.
- TRINTELLIX TABLET 5 MG — requires generic SSRI fill within previous 90 days (routes to PA if not found)
- ULORIC (febuxostat tablets 40 mg, 80 mg) — requires allopurinol fill within previous 90 days (routes to PA if not found)
- XPHOZAH (tenapanor 30 mg) — requires concurrent phosphate binder use within previous 120 days (prescriber may request PA if not documented)
- ZOLPIDEM TARTRATE SUBLINGUAL 3.5 MG — requires generic zolpidem fill within previous 90 days (routes to PA if not found)
Trintellix step therapy rule
TRINTELLIX: Step rule — A prescription adjudicates online only if the patient's pharmacy history documents a generic SSRI fill within the prior 90 days. If the lookback criterion is not met, the claim will route to prior authorization.
- Comparator: generic SSRI (e.g., sertraline, fluoxetine, escitalopram)
- Lookback window: 90 days
- If no qualifying SSRI fill: route to PA
Uloric step therapy rule
ULORIC (febuxostat): Step rule — A prescription adjudicates online only if the patient's pharmacy history documents an allopurinol fill within the prior 90 days. If the lookback criterion is not met, the claim will route to prior authorization.
- Comparator: allopurinol
- Lookback window: 90 days
- If no qualifying allopurinol fill: route to PA
Xphozah step therapy rule
XPHOZAH (tenapanor): Step rule — A prescription adjudicates online only if the patient's pharmacy history documents concurrent use of a phosphate binder within the prior 120 days. If the profile does not document concurrent phosphate binder use, the prescription will route to prior authorization; the prescriber may submit a PA with supporting clinical documentation.
- Comparator: phosphate binder (concurrent use)
- Lookback window: 120 days
- If no documented phosphate binder use: prescriber may request PA using standard process
Zolpidem sublingual step therapy rule
Zolpidem sublingual: Step rule — A prescription adjudicates online only if the patient's pharmacy history documents a generic zolpidem fill within the prior 90 days (some entries reference 365-day windows for other sedative hypnotics; verify product-specific window). If the lookback criterion is not met, the claim will route to prior authorization.
- Product: zolpidem tartrate sublingual 3.5 mg
- Comparator: generic zolpidem immediate-release
- Lookback window: 90 days (note: some Belsomra/Belsomra entries reference 365 days)
- If no qualifying zolpidem fill: route to PA
Initial Therapy / Step Requirements
Opioid initiation requirement — high‑potency opioid initiation restrictions
High-potency opioid initiation
applies to listed high‑potency ER opioids
Trintellix initial therapy
Trintellix prior therapy routing
applies to Trintellix (vortioxetine)
Uloric initial therapy
Febuxostat (Uloric) prior therapy routing
applies to febuxostat (Uloric)
Xphozah initial therapy
Xphozah (tenapanor) concurrent therapy routing
applies to Xphozah (tenapanor)
Zolpidem initial therapy
Zolpidem sublingual prior therapy routing
applies to zolpidem tartrate sublingual tablets
Step Therapy Tables
| Requirement | Lookback window | If not met |
|---|---|---|
| Trial of a specified lower-cost or alternative medication (examples include generic ondansetron for Sancuso, generic zolpidem for Belsomra, alendronate for Binosto, generic NSAID for diclofenac potassium) as indicated per product-specific criteria | ||
| Product-specific (examples shown below range from 30 to 365 days depending on product) | ||
| Prior authorization required when the patient's Independent Health pharmacy profile does not document the required comparator fill within the stated lookback window |
| Product / Comparator required | Required lookback window | Consequence if comparator not documented |
|---|---|---|
| Diclofenac potassium (migraine) — documented generic NSAID (e.g., naproxen, ibuprofen, celecoxib) | ||
| 180 days | ||
| Prior authorization required |
| Requirement | Lookback window | Consequence if not met |
|---|---|---|
| Documentation of a prior fill of a generic methylphenidate slow‑ or extended‑release product | ||
| 120 days | ||
| Prior authorization required if no documented prior fill within 120 days |
| Requirement | Lookback window | Consequence if not met |
|---|---|---|
| Documentation of a prior fill of immediate‑release tramadol | ||
| 90 days | ||
| Prior authorization required if no documented immediate‑release tramadol fill within 90 days |
| Requirement | Lookback window | Consequence if not met |
|---|---|---|
| Documentation of a prior fill of a generic SSRI antidepressant (e.g., sertraline, fluoxetine, escitalopram) | ||
| 90 days | ||
| Prescription routes online if documented; otherwise prior authorization required |
| Condition | Lookback window | Action |
|---|---|---|
| No documented generic SSRI fill in Independent Health prescription history | ||
| 90 days | ||
| Prior authorization required |
| Condition | Lookback window | Action |
|---|---|---|
| No documented allopurinol fill in Independent Health prescription history | ||
| 90 days | ||
| Prior authorization required |
| Condition | Lookback window / requirement | Provider action |
|---|---|---|
| No documented concurrent use of a phosphate binder for Xphozah (tenapanor) | ||
| Concurrent use documented within previous 120 days required | ||
| Prior authorization required; prescriber may request authorization via the standard authorization process if profile lacks documentation |
| Requirement | Lookback window | Consequence if not met |
|---|---|---|
| Documentation of a prior fill of generic zolpidem | ||
| 90 days | ||
| Prior authorization required if no documented generic zolpidem fill within 90 days |
Background and Definitions
Step therapy is a utilization management tool that requires a trial of specified medications (commonly generic or lower‑cost alternatives) or documentation of a relevant diagnosis or concurrent therapy before covering a requested agent. Under this policy, many listed products will route online only when the patient's Independent Health pharmacy history documents the required comparator fill within a defined lookback window; otherwise the prescription is subject to prior authorization.
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