Qualified Health Plan (QHP) Prescription Drug Formulary Coverage Criteria
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Governs the prescription drugs covered for HAP Qualified Health Plans (ACA-compliant), including formulary tiers, prior authorization, quantity limits, step therapy, specialty pharmacy requirements, and exclusions; affects members and prescribing providers for HAP QHP products.
No material clinical or coverage changes in this revision.
Coverage criteria and formulary conditions
General coverage conditions
Covered when ALL of the following are met:
Tier placement determines cost sharing (Tier 1–Tier 7).
PA = Prior Authorization; QL = Quantity Limits; ST = Step Therapy; SP = Specialty Pharmacy (Pharmacy Advantage).
Medical-administered drugs follow medical benefit rules and may require specialty procurement per formulary notes.
Exceptions for non-formulary drugs
Exception requests and handling:
Requests must be submitted to HAP for clinical review; if approved, non-formulary medications process at the highest applicable copayment (highest non-specialty or highest specialty copayment as applicable).
Non-formulary specialty drugs when approved may be required to be dispensed by Pharmacy Advantage and limited to 30-day supplies.
Formulary utilization controls
Coverage subject to the utilization controls listed on each formulary entry:
Examples include fidaxomicin (DIFICID), XENLETA, and XIFAXAN formulations; PA criteria are defined in PA policy documents.
Requests exceeding QL may be denied or require additional review.
Pharmacy Advantage contact and up to 30‑day supply guidance provided in formulary legend.
ST is defined in the formulary legend; specific step sequences are applied per product where noted.
Specialty product coverage with utilization controls
Specialty injectables and other specialty biologics are covered only when utilization controls and specialty distribution requirements are met:
Tier placement determines member cost share; see individual product lines for exact QL, PA, and SP status.
Formulary controls (PA, QL, SP, ST)
Apply the NOTES flags on each product line; coverage requires compliance with any of the following as annotated:
Apply PA and SP requirements per product NOTES field (examples: ENTRESTO sprinkle — PA; EVKEEZA — PA and SP; icatibant, VYNDAQEL — PA, SP, QL).
Examples: ENTRESTO sprinkle QL 2 tablets/day; VYNDAQEL QL 4 capsules/day; TD applies to some combination products.
ALT indicates covered alternatives are listed on the formulary entry and should be considered prior to exception requests.
Formulary product-level coverage conditions
Product-level coverage requires ALL applicable product-level conditions be met:
Apply these conditions exactly as annotated on the product line; see individual entries for precise QL values, ST/TD rules, and PA documentation requirements.
The formulary excludes certain categories of products from coverage. Specifically, drug products used for cosmetic purposes, over-the-counter medications (unless specifically listed), experimental drugs or drugs used experimentally, and replacement of lost or stolen medication are not covered under the outpatient formulary as stated in the benefit limitations.
Drugs designated Non‑Formulary are not on the preferred outpatient formulary and therefore have limited or no preferred coverage; providers or members may request a formulary exception. If an exception is approved by a HAP clinical specialist, the non‑formulary drug may be covered but typically at the higher non‑formulary or specialty cost sharing applicable to that product, and specialty non‑formulary agents when approved are often required to be dispensed via Pharmacy Advantage with standard supply limits (e.g., up to a 30‑day supply).
Certain antimalarial agents are listed with an indication-specific limitation: these products are Covered for Malaria Treatment, not prophylaxis. Examples in the formulary explicitly state this restriction and include quantity limits tied to the treatment indication rather than prophylactic use.
Examples of products listed as Non‑Formulary in the outpatient formulary include inhalation/nebulization therapies and other specialized agents such as TOBI PODHALER inhalation capsule (noted Non‑Formulary with QL/SP) and MESNEX oral tablet 400 mg (Non‑Formulary). The listing also contains Non‑Formulary examples among antihistamines and branded allergy products.
Several branded products are shown as Non‑Formulary or otherwise non‑preferred in the listing; examples include branded oral combo packs and antibiotics such as DIFICID (fidaxomicin) 200 mg entries (Non‑Formulary notation appears in nearby lines) and other branded oncology/topical agents identified as non‑formulary in the document.
The formulary identifies multiple agents assigned to higher tiers or explicitly Non‑Formulary / Tier 7 (Medical Coinsurance) status. Examples called out in the listing include agents such as NEXAVAR and other brand oncology products flagged Non‑Formulary or Tier 7, which indicates higher member cost‑sharing or medical‑benefit handling.
Several specialty agents are listed as Non‑Formulary while also carrying specialty sourcing and utilization controls. Illustrative specialty examples in the immunoglobulin and biologics section include ASCENIV 10%, GAMMAGARD products, and GAMUNEX‑C, many of which are annotated with SP (specialty distribution), PA, and QL requirements.
The formulary lists multiple immunoglobulin and vaccine products among Non‑Formulary or specialty entries. Examples include PRIVIGEN, XEMBIFY, and vaccine entries such as TYPHIM VI and VIVOTIF, which are shown as Non‑Formulary or annotated with program notes (HCR, SP) where applicable.
Additional Non‑Formulary examples across the listing include products such as TYPHIM VI intramuscular solution, VIVOTIF oral capsule, and epinephrine auto‑injector brands (EPIPEN entries are noted as Non‑Formulary while auto‑injector QL limits are listed), demonstrating the variety of non‑preferred items captured in the formulary.
The document also lists assorted Non‑Formulary products across therapeutic classes (for example, certain cognitive disorder combinations and cardiovascular agents). These entries (e.g., memantine‑donepezil formulations; TOPROL XL) are marked Non‑Formulary or show ALT/QL notes indicating restricted or alternative coverage approaches.
Further Non‑Formulary examples include multiple high‑cost specialty clotting factor and hemostasis products; the listing shows items such as HYMPAVZI PEN, IDELVION, and REBINYN assigned Non‑Formulary status or Non‑Formulary tiering while also carrying SP, PA, and QL annotations.
Summarizing branded Non‑Formulary examples, the formulary contains many specialty and branded agents (including clotting factors, biologics, and selected cardiovascular or oncology drugs) that are flagged Non‑Formulary and subject to specialty procurement, prior authorization, or quantity limits as annotated per product.
Non‑Formulary coverage may be conditional where a covered alternative (ALT) or a prior authorization is available. The listing shows multiple Non‑Formulary entries with an ALT noted (covered alternatives) or with PA requirements; when an approved ALT or PA exists, the plan may permit coverage under the formulary exception process.
The formulary explicitly states that experimental drugs and drugs used experimentally are not covered. This general exclusion is separate from Non‑Formulary handling and applies across the outpatient formulary.
Within the extracted segment there is no discrete block that uses the phrase 'not medically necessary' to define coverage denial; the document primarily relies on formulary tiering, utilization controls, and explicit exclusion language to indicate coverage limits.
The extract does not include a comprehensive, stand‑alone Not Medically Necessary (NMN) policy statement for specific services or drugs; instead, non‑formulary designation and program flags imply limited coverage or alternative handling where NMN determinations would otherwise apply.
The formulary contains indication‑specific limitations for certain products. For example, the quinidine and several antimalarial entries are annotated as Covered for Malaria Treatment; not prophylaxis. Other entries show similar indication‑level constraints reflected in the NOTES field and in associated quantity limits.
Formulary indicators, codes, and supply rules
| PA | Prior Authorization |
| QL | Quantity Limits |
| ST | Step Therapy |
| SP | Specialty Pharmacy (Pharmacy Advantage) |
| HCR | Health Care Reform (preventive zero cost share rules) |
| TD | Transition Drug: one 30-day fill in first 90 days for new members |
| PF | Partial Fill Program |
| AG | Age Restriction |
| examples | Formulary drug entries (e.g., acetylcysteine solution, BAQSIMI nasal spray, GVOKE auto-injectors, penicillamine, ELMIRON) with tier and notes (PA, QL, SP, ALT). |
| DIFICID 200 mg | fidaxomicin oral tablet 200 mg (PA; QL 20 tablets per 30 days) |
| linezolid 600 mg | linezolid oral tablet 600 mg (Tier 2; QL 2 tablets per day) |
| XENLETA 600 mg | XENLETA oral tablet 600 mg (PA; QL 10 tablets per 30 days) |
| XIFAXAN 200 mg | XIFAXAN oral tablet 200 mg (PA; SP; QL per 30 days) |
| XIFAXAN 550 mg | XIFAXAN oral tablet 550 mg (PA; SP; QL 60 tablets per 30 days) |
| BAXDELA 450 mg | BAXDELA oral tablet 450 mg (Non-Formulary; QL applies) |
| colistin injection 150 mg | colistin (colistimethate na) injection recon soln 150 mg (Tier 6; QL 2 mL per 28 days of treatment in 180 days; SP) |
| fosfomycin 3 gram | fosfomycin tromethamine oral packet 3 gram (Tier 2; QL 1 packet per 30 days) |
| nitrofurantoin 100 mg | nitrofurantoin macrocrystal 100 mg (Tier 2; QL 4 capsules per day) |
| No codes listed |
| No codes listed |
| No codes listed |
| ENTRESTO SPRINKLE ORAL PELLET 15-16 MG, 6-6 MG | Listed with NOTES = PA; QL (2 tablets per 1 day) |
| sacubitril-valsartan oral tablet 24-26 mg, 49-51 mg, 97-103 mg | DRUG TIER = 2; NOTES = TD; QL (2 Tablet per 1 day) |
| EVKEEZA INTRA VENOUS SOLUTION 150 MGMML | DRUG TIER = Non-Formulary; NOTES = PA; SP |
| icatibant subcutaneous syringe 30 ml mg/3 | DRUG TIER = 5; NOTES = PA; SP; QL (0.01 ML per 1 day) |
| VYNDAQEL ORAL CAPSULE 20 MG | NOTES = PA; SP; QL (4 capsules per 1 day) |
| acetazolamide 500 mg ER capsule | acetazolamide oral capsule, extended release 500 mg (Tier 2) |
| acetazolamide 125/250 mg tablet | acetazolamide oral tablet 125 mg, 250 mg (Tier 2) |
| ASPRUZYO 500/1000 mg | ASPRUZYO SPRINKLE ORAL EXTEND RELEASE GRANULES, PACKET 500 mg, 1000 mg (Non-Formulary; ALT: Ranolazine ER) |
| CAMZYOS 2.5/5/10/15 mg | CAMZYOS ORAL CAPSULE (PA; SP; QL 1 capsule per day) |
| ranolazine ER 500/1000 mg | ranolazine oral tablet extended release 12 hr 500 mg, 1000 mg (Tier 2; QL 2 tablets per day) |
| VYNDAQEL 20 mg | VYNDAQEL ORAL CAPSULE 20 mg (PA; SP; QL 4 capsules per day) |
| CORLANOR 5 mg/5 ml | CORLANOR ORAL SOLUTION 5 mg/5 mL (Non-Formulary; QL applies) |
| ivabradine 5/7.5 mg | ivabradine oral tablet 5 mg, 7.5 mg (Tier 4; QL 2 tablets per day) |
| colchicine 0.6 mg | colchicine oral capsule/tablet 0.6 mg (capsule Non-Formulary with ALT; tablet Tier 2; QL 4 per day) |
| COLCRYS 0.6 mg | COLCRYS ORAL TABLET 0.6 mg (Non-Formulary; ALT listed; QL 4 per day) |
Prior authorization, step therapy, and documentation requirements
Prior Authorization (PA) overview
Certain drugs listed on the formulary are designated "PA" and require prior authorization before coverage; without prior approval the plan may not cover the drug. PA indicators appear in the NOTES field for each product and must be satisfied prior to dispensing.
- PA = Prior Authorization per formulary legend; see NOTES on product lines for PA flags.
Prior authorization required for selected products (examples)
Providers must obtain prior authorization for multiple specific products noted with PA in the NOTES (examples shown include ELMIRON capsules and tobramycin inhalation products).
- ELMIRON oral capsule 100 mg — NOTES = PA; QL (3 capsules per 1 day).
- Tobramycin inhalation/nebulization products — NOTES include PA; SP; QL (280 ampules per 30 days).
Prior authorization requirement (topical/systemic and specialty antifungals)
Topical, systemic and specialty antifungals and similar agents marked 'PA' in their NOTES require prior authorization before coverage and dispensing.
- CRESEMBA oral capsule 186 mg — NOTES = PA; QL (70 capsules per 1 fill).
- NOXAFIL oral suspension — NOTES = PA; QL (105 mL per 1 fill).
Prior authorization required for listed products (CRESEMBA, NOXAFIL, etc.)
Several specific products are listed with PA in the NOTES (examples include CRESEMBA, NOXAFIL, LIVTENCITY and other agents); prescribers must secure PA when those NOTES indicate it.
- CRESEMBA ORAL CAPSULE 186 MG — NOTES = PA; QL 70 capsules per 1 fill.
- NOXAFIL ORAL SUSPENSION 200 MG/5 ML — NOTES = PA; QL 105 mL per 1 fill.
- LIVTENCITY ORAL TABLET 200 MG — NOTES = PA; QL (4 tablets per day).
Prior Authorization required for select agents (DESCOVY, PEGASYS, examples)
Select agents in the antiviral/antiretroviral and other classes are annotated with PA; providers must obtain authorization for those agents prior to dispensing.
- DESCOVY ORAL TABLET 200-25 MG — NOTES = PA; QL (1 tablet per 1 day).
- PEGASYS SUBCUTANEOUS SYRINGE — NOTES = PA; SP; QL (2 mL per 30 days).
PA required for PA-designated drugs (fidaxomicin, XIFAXAN examples)
Drugs designated with PA in the formulary (examples shown include fidaxomicin and XIFAXAN formulations) must have prior authorization obtained before coverage is provided.
- DIFICID (fidaxomicin) ORAL TABLET 200 MG — NOTES = PA; QL (20 tablets per 30 days).
- XIFAXAN ORAL TABLET 550 MG — NOTES = PA; SP; QL (60 tablets per 30 days).
Prior authorization and specialty routing required for many oncology agents
Many specialty oncology agents require prior authorization and, where flagged SP, must be obtained through the Pharmacy Advantage specialty channel; providers must coordinate PA and specialty routing.
- CABOMETYX ORAL TABLET 20 MG — NOTES = PA; SP; QL (30 tablets per 30 days).
- ERIVEDGE ORAL CAPSULE 150 MG — NOTES = PA; SP; QL (30 capsules per 30 days).
Prior authorization required for listed drugs (specialty/oncology)
Numerous specialty and oncology products are annotated with PA in the NOTES; prescribers must obtain prior authorization per the product-level note before dispensing.
- PEGASYS SUBCUTANEOUS SYRINGE 180 MCG/0.5 ML — NOTES = PA; SP; QL (2 mL per 30 days).
- PEMAZYRE ORAL TABLET — NOTES = PA; SP; QL (14 tablets per 21 days).
Prior Authorization required for multiple specialty products (immunoglobulins, vaccines)
Many immunoglobulin products and vaccines in the formulary are flagged PA and/or SP; providers must obtain prior authorization and arrange specialty procurement where NOTES indicate SP.
- GAMMAGARD LIQUID INJECTION SOLUTION 10% — NOTES = PA; SP; QL (1 mL per 28 days).
- CUVITRU SUBCUTANEOUS SOLUTION — NOTES = PA; QL (0.01 mL per 1 day); SP.
Prior authorization required (example: TRELEGY ELLIPTA)
Products marked 'PA' in the NOTES (for example TRELEGY ELLIPTA) require prior authorization before coverage; prescribers must secure PA as indicated.
- TRELEGY ELLIPTA — NOTES = PA; TD; QL (1 device per 30 days).
Prior authorization required (prescriber action reminder)
Prescribers must obtain prior authorization for products annotated with 'PA' in the NOTES prior to dispensing; PA is a required administrative step per formulary legend.
- Prescribers must secure PA for drugs annotated PA in NOTES before dispensing to avoid non-coverage.
PA required for many specialty hematologic agents
Many specialty hematologic agents are noted with PA and often SP; prior authorization must be obtained and specialty channel arranged where indicated.
- NEUPOGEN injection syringes — NOTES = PA; SP; QL (4 syringes per 1 fill).
- Eltrombopag products — NOTES = PA; SP; QL as shown per presentation.
Prior Authorization required for many specialty products
Many listed injectable and specialty products require prior authorization before coverage; check product-specific NOTES for PA requirements and applicable quantity limits.
- Hemofil M, Jivi, Novoseven RT and similar products — NOTES = PA; SP; QL (commonly 1 unit per day or product-specific unit rules).
Prior authorization required for selected specialty drugs
Certain specialty drugs (e.g., ENTRESTO sprinkle pellet, EVKEEZA IV, icatibant) are flagged PA in NOTES and require prior authorization; specialty channel enrollment is required when SP is noted.
- ENTRESTO SPRINKLE ORAL PELLET — NOTES = PA.
- EVKEEZA INTRAVENOUS SOLUTION — NOTES = PA; SP.
Prior authorization, QL, and ST requirements summarized
Some products listed with NOTES include PA plus QL and/or ST; providers must obtain prior authorization and ensure quantity limits and step therapy requirements (where annotated ST) are met for coverage.
- ATTRUBY, CAMZYOS, VYNDAQEL — NOTES indicate PA; QL; SP where applicable and ST when shown in legend.
Step Therapy (ST) overview
Step therapy (ST) is indicated in the formulary legend and may require trial of specified drugs before coverage of alternative agents; providers must follow ST edits where an individual product is annotated with ST.
- ST = Step Therapy Required per formulary legend; specific step sequences are noted on product entries where applicable.
Step therapy - legend present
The formulary legend defines ST (Step Therapy Required); providers should check product-specific NOTES for ST flags and follow required step edits before requesting coverage for later-line drugs.
- ST flag appears in legend; check individual product NOTES for ST designation.
Step therapy program flag (provider must follow step edits)
The formulary uses an ST program flag for some drugs; when a product is annotated with ST the prescriber must demonstrate trials of required first-line agents per the step edit before the alternative will be covered.
- Example: certain amlodipine-atorvastatin combinations include ST in NOTES and require satisfying step therapy edits.
Step therapy present (provider obligation)
Step therapy controls apply to some formulary drugs; providers must document prior trials and failures of required agents when submitting coverage requests for ST-designated products.
- ST indicated in legend — documentation of prior step drug trial is required for coverage of ST-marked products.
Step therapy referenced in legend
The formulary legend references Step Therapy (ST); where an entry is annotated ST providers must follow the step edit sequence specified in the full formulary to obtain coverage.
- ST is defined in the legend; verify product NOTES for ST designation and required prior agents.
Step therapy program note (follow step edits)
Items annotated 'ST' require completion of specified prior steps before coverage; providers must follow those step therapy requirements and include documentation of prior therapy when requesting coverage.
- WELCHOL packet (example) — NOTES = ST; QL (7 tablets per 1 day).
Step therapy present (examples: combination products)
Some products are marked ST in product entries (for example certain combination antihypertensive products); providers must satisfy step therapy edits before alternatives will be covered.
- Amlodipine-atorvastatin entries — NOTES = TD; ST; QL (1 tablet per day) for some strengths.
How to request prior authorization or exception
Submit prior authorization or formulary exception requests using the forms available at hap.org/providers; the request must include clinical justification and supporting documentation.
- Use HAP provider forms at hap.org/providers to request PA or exception and include clinical rationale.
Required documentation and administrative contact
When submitting PA or dispensing claims, providers and pharmacies must follow the formulary legend: PA = Prior Authorization; QL = Quantity Limits; SP = obtain via Pharmacy Advantage (contact provided).
- Pharmacy Advantage specialty contact: (800) 456-2112 for SP items.
Prior authorization required for some drugs (documented)
Products flagged 'PA' require prior authorization documentation before coverage; include clinical support and reference the product NOTES when submitting requests.
- PA flag on product NOTE indicates authorization is required prior to coverage.
EUA exception for Paxlovid
The EUA-approved PAXLOVID product is noted as not requiring an authorization days prior; providers should note this exception when ordering PAXLOVID under EUA.
- PAXLOVID DOSE PACK — NOTES = PA; QL (5 courses per 180 days); EUA-approved product does not require an authorization days prior.
Specialty pharmacy sourcing documentation
Drugs marked SP must be obtained through Pharmacy Advantage; providers must arrange specialty pharmacy sourcing and may need to document the dispensing source with PA submissions.
- SP = This drug can only be obtained at Pharmacy Advantage: (800) 456-2112; up to 30-day supply per fill.
- Examples: EVKEEZA, many IVIGs and clotting factors are SP and require Pharmacy Advantage procurement.
PA and QL documentation (provider/pharmacy responsibilities)
When requesting PA or submitting claims for PA/QL items, prescribers and pharmacies must provide documentation supporting the PA and ensure quantities do not exceed the QL specified for the product.
- Examples: CRESEMBA QL = 70 capsules per 1 fill; DIFICID QL = 20 tablets per 30 days — claims exceeding these limits may be denied without supporting documentation.
Required routing and documentation for SP items
Prescribers and pharmacies must route SP-designated prescriptions through Pharmacy Advantage and comply with product-specific PA and QL notes; contact Pharmacy Advantage for specialty ordering.
- Pharmacy Advantage phone: (800) 456-2112; SP items limited to up to 30-day supply per fill.
Legend and program flags (use on submissions)
Refer to the formulary legend when submitting PA or claims: PA = Prior Authorization; QL = Quantity Limits; SP = Pharmacy Advantage specialty distribution; ST = Step Therapy Required; TD = limited initial 30-day fill for new members.
- Providers must reference these legend flags on PA submissions and claims.
Claims documentation must follow Notes flags
Pharmacy claims must reflect applicable NOTES flags (PA, SP, QL) and adhere to the product-specific quantity limits; noncompliance may result in claim denial or rejection.
- Examples of QL formats: '1 ML per 28 days', '1 vial per 30 days', '0.01 ML per 1 day'.
Prior authorization and specialty pharmacy procurement
When NOTES include PA or SP, the provider must obtain prior authorization and/or arrange specialty pharmacy supply through Pharmacy Advantage as specified for the product.
- ENTRESTO SPRINKLE — NOTES = PA; EVKEEZA IV — NOTES = PA; SP; VYNDAQEL — NOTES = PA; SP; QL (4 capsules per day).
PA and SP documentation (provider responsibilities)
Prescribers must supply clinical documentation to support PA requests where PA is indicated; for SP items verify member status (TD) and supply limits as needed for initial fills.
- TD = For new to HAP members only: one 30-day fill in the first 90 days of enrollment — verify member status when applicable.
Prior Authorization requirement — failure to obtain may result in non-coverage
Failure to obtain prior authorization when required may result in the drug not being covered; providers must secure PA for PA-flagged products to avoid non-coverage.
- PA required per formulary legend; absence of PA can lead to non-coverage.
Denial triggers from formulary status and flags
Drugs marked Non-Formulary or annotated with PA or SP flags may trigger denial or require special procurement; providers should request exceptions or PA where appropriate to avoid denial.
- Examples: MESNEX 400 mg — Non-Formulary; VISTOGARD oral granules — Non-Formulary with SP.
Quantity limits and special sourcing may trigger denial
Requests exceeding stated quantity limits (QL) or not obtained via the designated specialty channel (SP) may be denied; verify QL and sourcing before submission.
- Example: CRESEMBA QL = 70 capsules per 1 fill; SIRTURO QL rules shown per treatment course.
Requests for drugs listed with 'Non-Formulary' — denial risk
Requests for drugs listed as Non-Formulary or lacking required PA may be denied or processed under non-formulary rules; obtain PA or request an exception where clinically justified.
- Non-Formulary status often requires an exception or will be subject to non-formulary handling.
Prior authorization, quantity limits, and specialty distribution can trigger denial
Coverage for products labeled PA can be restricted unless prior authorization is obtained; QL or SP flags can also cause denials if limits or specialty sourcing requirements are not met.
- DESCOVY ORAL TABLET 200-25 MG — NOTES = PA; QL (1 tablet per day) — absence of PA or QL noncompliance could limit coverage.
Prior authorization required for PA-designated drugs (denial risk)
PA-designated drugs may be denied if prior authorization is not obtained; ensure PA is in place for PA-flagged products to prevent claim denials.
- DIFICID (fidaxomicin) — NOTES = PA; QL (20 tablets per 30 days) — secure PA to prevent denial.
Specialty sourcing requirement (claims may be denied if off-channel)
Specialty-only drugs (SP) must be obtained through Pharmacy Advantage; claims may be denied or redirected if dispensed outside the designated specialty channel.
- SP = This drug can only be obtained at Pharmacy Advantage (800-456-2112); examples include many IVIG and clotting-factor products.
Triggers for denial (PA, QL, SP noncompliance)
Requests involving products marked PA, exceeding QL, or obtained outside Pharmacy Advantage (SP) are among common triggers for denial; providers should verify all notes before prescribing.
- Examples: oncology agents with PA/SP/QL flags — absence of PA or SP routing or QL overage can cause denial.
Prior authorization triggers (examples)
Claims may be denied or require prior authorization when product NOTES list PA (examples include PEGASYS, PIQRAY, POMALYST); obtain PA to avoid claim delays or denials.
- PEGASYS — NOTES = PA; SP; QL (2 mL per 30 days).
Specialty pharmacy requirement (use Pharmacy Advantage)
Drugs marked 'SP' must be obtained from Pharmacy Advantage; failure to use the designated specialty pharmacy may lead to coverage or dispensing issues.
- IVIG products and many biologics show NOTES = SP; obtain via Pharmacy Advantage to ensure coverage.
Prior Authorization and Specialty Distribution required for many products
Coverage or dispensing may be denied or restricted if PA is not obtained for products marked 'PA' or if specialty distribution (SP) requirements are not followed; providers must comply with both PA and SP notes.
- Examples include many IVIG and specialty biologics — NOTES include PA and SP; both must be satisfied.
Quantity limits (exceedance triggers potential denial)
Quantity limit exceedance may trigger denials; providers must ensure dispensed quantities do not exceed QL (examples: epinephrine autoinjectors QL = 4 pens per 30 days).
- EPIPEN 2-PAK — NOTES = QL (4 units per fill).
- Epinephrine auto-injector entries — QL (4 pens per 30 days).
PA and SP requirements (denial risk)
Drugs marked PA and those with SP (Pharmacy Advantage specialty distribution) may trigger denial if authorization or specialty sourcing requirements are not met; obtain both PA and SP routing where indicated.
- Products with combined PA and SP flags require both prior authorization and specialty procurement to avoid denial.
Quantity limit denials (examples)
Products with QL may be denied if requests exceed specified limits (for example ADVAIR DISKUS QL = 60 units per 30 days; PROAIR RESPICLICK QL = 2 inhalers per 30 days).
- ADVAIR DISKUS — NOTES = QL (60 units per 30 days).
- PROAIR RESPICLICK — NOTES = QL (2 inhalers per 30 days).
Formulary restriction risk (Non-Formulary / PA / QL / SP)
Requests for Non-Formulary products or products with PA/QL/SP/ALT notes may be denied or require authorization; providers should pursue exceptions or alternatives when appropriate.
- Non-Formulary items may require exception requests; ALT indicates covered alternatives to consider.
Potential denial triggers for specialty injectables
Specialty injectable clotting-factor products and similar biologics list PA, SP and QL in NOTES; providers must obtain PA and use Pharmacy Advantage as required to avoid denial for these specialty injectables.
- NOVOSEVEN RT, JIVI, KOGENATE, etc. — NOTES = PA; SP; QL (commonly 1 unit per 1 day).
PA / SP may trigger denial (provider reminder)
Drugs noted with PA or SP may trigger denial if authorization or specialty procurement requirements are not met; ensure PA is obtained and SP items are sourced via Pharmacy Advantage.
- ENTRESTO SPRINKLE — NOTES = PA; EVKEEZA IV — NOTES = PA; SP.
Non-Formulary / PA risk (coverage denial possible)
Non-Formulary tier assignments and missing required prior authorization or unmet step therapy flags may trigger coverage denials if no PA/exception is obtained.
- Non-Formulary items require exception or will be processed under non-formulary rules — absence of PA or unmet ST can cause denial.
Quantity limits and per-fill supply rules
Where drugs are covered and specialty sourcing
Legend and abbreviations
Step therapy program flags and table
| Step Therapy (ST) | Description / Application |
|---|---|
| ST | |
| Step Therapy required as indicated on formulary entries; providers must document prior trials of required agents before coverage of the alternative agent. Specific step sequences are defined in product-level edits elsewhere in the formulary. |
| Legend Code | Meaning |
|---|---|
| ST | |
| ST = Step Therapy Required (legend). Indicates a required trial of specified drug(s) before coverage of the listed agent. |
| ST Flag | Presence / Note |
|---|---|
| ST flag | |
| Formulary includes an 'ST' program flag; some drugs in the listing are subject to step therapy where the ST note appears. |
| ST as Control | Implication |
|---|---|
| Step Therapy (ST) | |
| ST is noted as a utilization control on the formulary; specific step sequences for individual drugs are maintained in product-level edits and not included in this extract. |
| Legend Reference | Text |
|---|---|
| ST (legend) | |
| The formulary legend defines ST = Step Therapy Required; entries annotated with ST must follow the step therapy program as indicated. |
| ST Flag Meaning | Related Requirement |
|---|---|
| ST flag | |
| An ST flag indicates the product may require completion of prior step drugs before the requested agent will be covered; details are specified in product-level rules. |
| Abbreviation | Definition |
|---|---|
| ST | |
| ST = Step Therapy Required (per formulary legend). |
| Program | Existence |
|---|---|
| Step Therapy program | |
| Formulary includes a Step Therapy (ST) program as part of its utilization management toolkit; ST applies where indicated on product entries. |
| ST Flag in Footnote | Note |
|---|---|
| ST footnote | |
| Formulary footnotes and section legends reference ST (Step Therapy Required) as a control that may apply to some products; specific sequences are not shown here. |
| Product | Notes |
|---|---|
| TRELEGY ELLIPTA | |
| Listed with NOTES = PA; TD. ST is present in the formulary legend and may apply to other agents in this therapeutic area. |
| Scope | Application |
|---|---|
| ST applicability | |
| Step Therapy applies where specified on formulary entries; providers must meet ST requirements for coverage of listed agents. |
| Definition Source | Applicability |
|---|---|
| ST defined in legend | |
| ST is defined in the formulary legend as 'Step Therapy Required' and applies to products annotated with ST in the listing. |
| Specialty Products | ST note |
|---|---|
| ST for specialty products | |
| Some specialty products may be subject to ST in addition to PA/SP/QL controls; follow product-level edits and specialty program rules. |
| Example product | ST indicated |
|---|---|
| WELCHOL (colesevelam) 625 mg | |
| Notes in listing: ST (Step Therapy Required); QL (7 tablets per 1 day). This illustrates a product-level ST annotation in the formulary. |
| Combination product | ST presence |
|---|---|
| Amlodipine-atorvastatin combinations | |
| Some combination products (e.g., certain amlodipine-atorvastatin strengths) include TD and ST flags—ST required for some strengths per product notes. |
Policy background and scope
Specialty drugs are biologics or high‑cost medications that require close monitoring for safety and efficacy and therefore are managed through a contracted specialty pharmacy program. The formulary classifies these products into specialty tiers and applies utilization controls (for example, PA, QL, SP, ST) and specialty sourcing via Pharmacy Advantage to ensure appropriate clinical oversight and distribution.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.