Ambetter Prescription Drug Formulary — Coverage Criteria
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Defines the Ambetter prescription drug formulary tiers, coverage notes (prior authorization, step therapy, quantity and age limits), specialty pharmacy handling, and opioid fill limits for members under this plan.
No material clinical or coverage changes in this revision.
Formulary Coverage Criteria
Formulary coverage criteria
Formulary coverage and restrictions are defined by tiers and per-product limits/requirements
See Drug List Key for tier definitions
Flags (PA/ST/QL/AL/SP) appear inline on formulary rows
Applies across opioid product entries
Coverage conditions for adalimumab products (formulary entries)
Formulary listing shows coverage with quantity limits and prior authorization for multiple adalimumab biosimilars and starter kits when conditions below are met:
Starter kits and certain package presentations limited to 1 fill per 180 days; PA required as indicated on line items
Coverage conditions for specialty injectables
Specialty injectables (e.g., ARIKAYCE, ACTEMRA) are listed with PA and QL restrictions.
Site-of-care/SP handling may be required for some antineoplastics and specialty biologics
Coverage for PDE4 inhibitor (OTEZLA)
OTEZLA entries include age limits, quantity limits, and PA.
Starter/package presentations may also have max‑fill per 180 days and PA flags
Step therapy/first-line requirement for certain ACTEMRA entries
Some ACTEMRA formulations note a drug trial requirement.
The formulary line does not specify duration or failure criteria; document trial in PA request
Formulary coverage controls (partial)
Coverage and utilization controls observed in this segment (examples follow):
Appears repeatedly across hydromorphone, meperidine, methadone, morphine, acetaminophen‑codeine, hydrocodone combinations
Limits vary by product and strength and are shown on each formulary row
PA flags appear adjacent to specific entries and must be followed
Refer to tier on product row for preferred ordering and potential step requirements
Formulary coverage summary (excerpt)
Coverage and utilization management rules in this excerpt are conveyed by tier assignment, quantity limits, and PA indicators.
Formulary is not exhaustive; consult full plan documents for benefit‑specific rules
Formulary product lines (cardiovascular combinations)
Coverage statements as formulary entries (tier, ILimits, PA noted where present).
Tier placement may vary (1A/1B/3) across formulations
Anti-infectives
Anti-infective and antiprotozoal agents with tiers and limits.
Some formulations require PA or have per‑course QLs
Antimalarials - restricted use
Antimalarial agents are flagged as 'Covered for malaria treatment only' with fill-frequency and quantity limits for several products.
PA may be required for some antimalarial combinations
Chemotherapy agents (PA/SP controls)
Antineoplastic agents and supportive oncology drugs with tiers, QL, SP and PA controls.
Site-of-care and specialty routing may apply for multiple antineoplastic agents
Covered with utilization controls
Coverage for listed drugs is subject to utilization controls
Medical necessity and full clinical criteria (if any) are maintained in separate authorization policies
Formulary product coverage (partial)
Formulary coverage entries and utilization rules (partial list) — each product entry includes tier, limits, and utilization management indicators.
Examples include clindamycin phosphate combinations, tretinoin, calcipotriene‑betamethasone lines
General PA requirement for non‑FDA uses
Coverage and authorization notes present in excerpt
Appears for multiple topical, diagnostic and other product groups
The Formulary lists FDA‑approved brand and generic medications covered under the prescription drug benefit and indicates that generics are preferred when available. It is intended as a coverage guide; generics should be considered first‑line where available, and preferred brand drugs are identified for situations where a generic is not suitable.
The extract reviewed does not include any explicit clinical exclusion or ineligibility conditions (e.g., specific diagnoses or patient populations that are categorically excluded) within the cited formulary lines. Coverage statements in this segment focus on tiering, quantity limits (QL), age limits (AL), and prior authorization (PA) flags rather than listing clinical exclusions.
Non‑FDA‑approved uses of several topical and diagnostic products require prior authorization. When an item is noted as requiring PA for non‑FDA uses, providers must submit supporting documentation of medical necessity per the payer's prior authorization process before those uses will be considered for coverage.
The reviewed segments do not contain explicit statements labeling any product or formulation as 'Not Medically Necessary.' Formulary lines in these chunks instead record coverage attributes such as tier assignment, QL/AL values, and PA or ST flags; absence of an explicit NMN designation in these extracts does not imply NMN language is not present elsewhere in the full policy.
Within the examined extract there are no explicit 'not medically necessary' determinations applied to specific products. Coverage information is conveyed through utilization controls (e.g., PA, QL, AL, ST) rather than explicit NMN statements in these chunks.
This segment does not include explicit 'Not Medically Necessary' (NMN) language for the products shown. Formulary entries here emphasize quantity limits and tier placement without introducing NMN findings in the cited lines.
Formulary Coding, Flags and Limits
| QL(2 EA daily) | Quantity limit examples as shown in drug rows |
| AL(At least 6 yrs old) | Age limit examples as shown in drug rows |
| PA | Prior authorization required as listed in drug rows |
| ST | Step therapy indicator in drug rows |
| SP | Specialty tier indicator |
| No codes listed |
| OTEZLA TABS | Otezla tablets — ILimits QL(2 EA daily); PA; age limits noted |
| ENBREL SURECLICK | Enbrel SureClick — ILimits QL(.146 ML daily); PA |
| ENBREL SOSY 50 MG/ML | Enbrel 50 mg/mL syringe — ILimits QL(0.286 ML daily); SP; PA |
| butalbital-acetaminophen-caffeine CAPS 40 MG-50 MG-325 MG | Butalbital-containing combination capsules — tiers and QL vary; some require PA |
| hydromorphone hcl SOLN IJ 10 MG/ML | Hydromorphone solution — New starts limited to 7 day supply; QL(100 ML daily) |
| hydromorphone hcl TABS | Hydromorphone tablets — New starts limited to 7 day supply; QL noted |
| meperidine hcl SOLN IJ 100 MG/ML | Meperidine solution — PA; New starts limited to 7 day |
| methadone hcl SOLN PO 5 MG/ML | Methadone oral solution — QL(100 ML daily) or other daily QL; PA noted |
| morphine sulfate CP24 | Morphine sulfate controlled-release — New starts limited to 7 day supply; QL limits |
| acetaminophen w/ codeine TABS 15 MG-300 MG | Acetaminophen/codeine tablets — New starts limited to 7 day supply; QL values vary |
| no CPT/HCPCS present | This extract contains drug names, tiers and limits but no procedure or billing codes were listed in these chunks. |
| XARELTO TABS 15 MG | rivaroxaban — Tier and QL entries present |
| enoxaparin sodium 300 MG/3ML | enoxaparin formulations with QL and PA flags |
| fondaparinux sodium 2.5 MG/0.5ML | fondaparinux with QL and tier entries |
| NAYZILAM | nasal midazolam — listed with QL and PA |
| VALTOCO 15 MG/DOSE | diazepam/lorazepam analogs listed with QL |
| DIACOMIT PACK 250 MG / 500 MG | stiripentol products listed with QL |
| BRIVIACT SOLN PO 10 MG/ML | brivaracetam solution with QL; PA |
| BANZEL TABS 200 MG / 400 MG | rufinamide with QL; PA |
| vigabatrin PACK / TABS | vigabatrin with QL; SP; PA |
| SPRAVATO (56 MG/84 MG DOSE) | esketamine nasal — listed with PA and tier info |
| XIFAXAN 200 MG | rifaximin 200 mg (product line referenced with AL and PA constraints) |
| XIFAXAN 550 MG | rifaximin 550 mg (product line referenced with QL and PA) |
| cisplatin SOLN 100 | cisplatin solution 100 (tier 4; ILimits = SP; PA) |
| busulfan SOLN | busulfan solution (ILimits = SP; PA) |
| melphalan hcl IV | melphalan hcl IV (tier 1B; listed) |
| QL(1 EA daily) | Quantity limit example shown for several agents |
| QL(2 EA daily) | Quantity limit example shown for several agents |
| QL(0.143 EA daily) | Quantity limit example shown for agents such as TRAZIMERA and GILOTRIF |
| SP | Specialty Pharmacy indicator |
| PA | Prior Authorization indicator |
| QL(8 EA daily) | quantity limit example for entacapone |
| QL(2 EA daily) | quantity limit example for carbidopa-levodopa TABS |
| QL(0.072 EA dailylPA | quantity limit shown for PERSERIS PRSY (format from doc) |
| AL(At least 18 yrs old) | age limit example |
| PA | prior authorization flag |
| QL(1.67 GM daily) | quantity limit example for betamethasone valerate FOAM |
| QL(8 ML daily) | quantity limit example for betamethasone valerate OINT |
| QL(4 GM daily) | quantity limit example for calcipotriene-betamethasone dipropionate |
| PA | prior authorization flag (appears for multiple entries) |
| ST | step therapy flag (appears for multiple entries) |
| QL(3 GM daily) | quantity limit example for hydrocortisone butyrate OINT |
| QL(15.15 GM daily) | quantity limit example for hydrocortisone topical CREA/SOLN entries |
| QL(2 GM daily) | quantity limit example for clobetasol propionate GEL/CREA |
| QL(3.5 GM daily) | quantity limit example for halobetasol propionate |
| QL(0.082 ML daily) | small-volume QL noted for some DUPIXENT-mapped entries |
Prior Authorization, Step Therapy and Documentation
Prior Authorization Submission, Timing and Required Documentation
Prior Authorization (PA), Step Therapy (ST), Specialty (SP) flags and quantity/age/package limits are applied across the formulary. Providers must submit a completed Prior Authorization form and supporting documentation (clinical rationale, prior treatment history, age/weight information, and package/dispense justification) when PA is indicated. Urgent requests: response within 24 hours of receipt of all necessary information. Non‑urgent requests: response within 72 hours unless state law requires a faster response. Incomplete PA requests may be denied; a denial will explain missing information or clinical reasons.
- Required information for PA: diagnosis, prior therapies tried (including step therapy attempts), member age/weight when relevant, requested dose/quantity and justification for package/starter kit limits, and NDC or product name as shown on formulary.
PA and Specialty Routing for Biologics, Injectables and Oncology Drugs
Many high-cost biologics, specialty injectables, oncology agents, and some antivirals require prior authorization and/or specialty routing. PA is required for most adalimumab products and starter kits (package and 180‑day max‑fill limits apply); submit documentation supporting package limits and clinical indication. Antineoplastic agents frequently require both PA and enrollment in a specialty/site program (SP) before coverage; failure to obtain PA/SP can result in claim denial.
- Adalimumab: PA and package/180‑day max fills apply to branded biosimilars and starter kits; documentation must support package/dispense limit and indication.
- Specialty injectables (examples): ARIKAYCE, ACTEMRA, ENBREL, STELARA, benefits often require SP routing and PA.
- Oncology agents: many agents (e.g., cisplatin, busulfan, carmustine, trastuzumab biosimilars) marked SP; PA required and program enrollment may be necessary.
Formulary Flags, Age Limits and Inline PA/Step Indicators
Formulary entries may show inline flags and limits that create operational PA or step edits. Examples include age limits (AL), quantity limits (QL), step therapy (ST), package or max‑fill per period, and explicit 'PA' next to formulations. Providers should verify the formulary line‑item for these flags and include those details in the PA request to avoid denials.
- Age limits: OTEZLA and other agents have age or age‑range conditions noted on formulary lines; include member age in PA.
- XIFAXAN: 200 mg (9 tablets/3 days) and 550 mg (3 tablets) formulations have Age Limit (AL) and PA noted; verify AL (e.g., 'At least 12 yrs old') when requesting PA.
- Topical agents and other select formulations list PA or ST inline (e.g., clindamycin/benzoyl peroxide GEL, tretinoin microsphere) — include formulation and indication in requests.
Quantity, Starter‑Supply and Package Limits
Quantity limits, starter‑supply caps, package limits, and max fills are enforced. New starts for certain opioid and biologic products are limited (for example, 7‑day new‑start limits on many opioid preparations). Exceeding posted quantity/package limits may require PA and could lead to claim denial if not authorized.
- Quantity limits (QL) shown on formulary lines must be supported in the PA request (e.g., per‑day or per‑period QL values).
- Starter kits and package limits: many adalimumab starter kits and some specialty drugs limited to 1 package per 180 days; document clinical need for additional packages.
- New starts: certain opioids and injectables limited to a 7‑day supply for new starts; requests for larger fills require PA.
Non‑FDA Uses and Coverage Exceptions
Non‑FDA (off‑label) or non‑covered uses require prior authorization and clinical justification. Providers must include supporting evidence when requesting coverage for non‑FDA uses.
- Non‑FDA uses: explicitly marked as requiring PA across multiple product groups (e.g., select diagnostic/enzyme products and topical agents).
- Formulary entries marked 'NF' or notes indicating 'Non‑FDA approved uses require Prior Authorization' must be accompanied by clinical rationale and supporting literature.
Step Therapy, Tiering and Required Evidence
Step therapy (ST) and tier placement affect PA requirements. Some lines require trial of preferred agents first (for example, 'Must try ibuprofen' for certain anti‑inflammatory injectables); ST flags and tiers imply step edits though explicit step rules may be in a separate segment. When ST is indicated, document prior trials and outcomes.
- Document prior medication trials and dates when ST is invoked (e.g., trial of ibuprofen before ACTEMRA formulations).
- Tiering influences coverage and may trigger PA or step edits; include alternative therapies tried and reasons for failure or intolerance.
Terms and Abbreviations
Initial Therapy and Starter Fill Controls
Initial therapy controls
Initial fill and supply controls
Providers should include justification when requesting coverage beyond initial limits
Initial step requirement
Formulary notes a required trial for at least one product group.
Failure/duration criteria not provided in the extract; include trial evidence in PA request
Initial therapy limits
Initial dispensing constraints observed
Claims exceeding initial supply or QL may require PA or justification
Topical acne/antibiotic initial coverage controls
Formulary utilization controls for topical acne agents
Document patient age and prior treatments when submitting PA
Initial topical therapy constraints (partial)
Examples of initial use constraints appearing in the extract
Per‑product QL/AL values must be followed at dispensing and in PA documentation
Step Therapy Rules and Affected Products
| Example | Policy note |
|---|---|
| Lisdexamfetamine (capsules; chewable) | Listed with ST (step therapy) indicating a required trial of preferred stimulant agent(s) before coverage of lisdexamfetamine. |
| Example | Policy note |
|---|---|
| Specified ACTEMRA formulation entries | 'Must try ibuprofen' is stated as a prerequisite trial prior to coverage for the listed formulation. |
| Example | Policy note |
|---|---|
| Butalbital-containing combination products (various capsules/tablet strengths) | Appear in multiple tiers; some presentations include PA and differing QL entries, indicating tier placement may affect PA/step application. |
| Example | Policy note |
|---|---|
| Tier assignments across product lines | Tier designations (Tier 1A/1B/2/3/4) indicate preferred ordering; explicit step durations or number of required failures are not specified in the excerpt. |
| Example | Policy note |
|---|---|
| NAYZILAM (nasal midazolam) listing | Formulary line shows QL and an 'ST' indicator on one entry, demonstrating presence of an ST flag on the product line. |
| Example | Policy note |
|---|---|
| Insulin sensitizing agents / higher-tier classes | Tiering combined with 'SP; PA' or similar flags implies required programmatic steps (e.g., specialty routing or prior authorization) before accessing higher-tier therapies. |
| Example | Policy note |
|---|---|
| Antihypertensive combination products (multiple combos listed) | Several combination antihypertensives are labeled 'ST' in the formulary, showing ST flags applied to combination products. |
| Example | Policy note |
|---|---|
| Antineoplastic class entries (cisplatin, busulfan, others) | Many antineoplastic entries include 'SP; PA' or 'PA' indicating controlled access pathways (specialty pharmacy/site-of-care and prior authorization) before coverage. |
| Example | Policy note |
|---|---|
| Apomorphine hydrochloride entry | Listed with QL and 'ST.' indicating a step therapy requirement for that agent/formulation. |
| Example | Policy note |
|---|---|
| Verapamil / pulmonary hypertension–related entries; treprostinil/digoxin lines | Entries show 'PA' or 'SP; PA' flags, demonstrating that step or specialty program enrollment and prior authorization are used for some cardiovascular/pulmonary hypertension agents. |
| Example | Policy note |
|---|---|
| Topical combination acne/dermatologic agents (e.g., calcipotriene‑betamethasone dipropionate; clindamycin–benzoyl peroxide) | Some topical combination products are flagged 'ST', indicating step therapy applies to topical combination agents shown in the formulary. |
| Example | Policy note |
|---|---|
| Topical formulations (clindamycin phosphate topical lines, tretinoin, adapalene, etc.) | Multiple topical entries include 'ST' in the ILimits or indicate age/QL constraints, showing topical formulations may be subject to step therapy requirements. |
| Example | Policy note |
|---|---|
| Clobetasol propionate foam and gel formulations | Clobetasol propionate FOAM and GEL lines include QL values and are annotated with 'ST', indicating step therapy flags on these topical corticosteroid formulations. |
| Example | Policy note |
|---|---|
| Higher-tier products and specialty/PA flagged agents | Tier assignments and PA/SP markers indicate preferred agents at lower tiers; higher-tier agents frequently require prior authorization or stepping through preferred alternatives before coverage is allowed. |
Quantity and Age Limits by Product
Specialty Pharmacy, Infusion and Site-of-Care Notes
Policy Background
The Formulary is a guide to FDA‑approved brand and generic medications covered under the prescription drug benefit; it is not a complete list. Not all dosage forms or strengths may be covered, and specific prescription benefit plan designs may exclude certain products or categories even if they appear in this document. Check the member's benefit plan for coverage limitations and member cost‑share.
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