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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsBlue Cross Blue Shield NM Pharmacy Coverage Update…
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    CurrentBlue Cross Blue Shield - New MexicoPolicy N/A

    Pharmacy Drug List and Coverage Guidance (Formulary with Utilization Management)

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    This document is the Blue Cross Blue Shield of New Mexico pharmacy drug list and accompanying coverage guidance for members and providers, including specialty drug processes, prior authorization, step therapy, quantity limits, and exception processes. It affects BCBSNM members and their prescribing providers.

    Policy Summary
    PayerBlue Cross Blue Shield - New Mexico
    PolicyPharmacy Drug List and Coverage Guidance (Formulary with Utilization Management)
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization when 'PA' is indicated on a drug line before dispensing to avoid denial.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    ~140distinct drug entries in fragments
    PAPrior authorization present
    QLQuantity limits present
    Accredospecialty pharmacy services
    NMapplicable state

    Coverage Criteria and Product Listings

    General outpatient drug coverage with utilization management

    Coverage and utilization management (tiering, PA, QL, SP) as listed per product

    Formulary listing: Individual drugs are listed with a Drug Tier and Requirements/Limits; coverage is determined by the drug's tier and any listed requirements (PA, QL, SP, AC).

    Each product line specifies its own flags; see product entry.

    Per-drug formulary coverage

    Coverage is determined per-drug according to listed Drug Tier and Requirements/Limits fields

    Per-drug coverage: Drug is covered according to its Drug Tier but only when any listed Requirements/Limits (PA, QL, SP, AC) are metas listed per drug

    Individual drugs list exact QL and PA flags

    Policy Summary
    PayerBlue Cross Blue Shield - New Mexico
    PolicyPharmacy Drug List and Coverage Guidance (Formulary with Utilization Management)
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization when 'PA' is indicated on a drug line before dispensing to avoid denial.
    SourceLink
    On This Page
    Coverage Criteria and Product ListingsFormulary Entries and Code GroupsProvider Requirements, Prior Authorization, and DocumentationInitial Therapy, Starter and Titration Pack ControlsStep Therapy Programs and TablesQuantity Limits and Supply RulesSite of Care and Specialty Pharmacy RoutingDefinitions and AbbreviationsBackground and Scope

    Formulary-based coverage controls

    Coverage is governed by drug tier and specific Requirements/Limits listed per product

    Formulary coverage controls: Drugs listed include a Drug Tier and may have Requirements/Limits indicating PA, QL, and SP; adherence to those controls is required for coverage.

    No specific diagnosis-level criteria present in these chunks

    Formulary entries with utilization controls

    Coverage and utilization controls are listed per product; coverage is implied by formulary tier and presence/absence of PA/QL flags.

    Formulary entry: Each drug line lists the product name, strength, Drug Tier, and Requirements/Limits (e.g., PA, QL, SP). Coverage requires adherence to those utilization controls.

    No clinical criteria or detailed medical necessity rules are present in these chunks.

    Formulary coverage controls (excerpt)

    Coverage and utilization controls are applied as listed per product

    Formulary control tags: Each product entry includes a Drug Tier and Requirements/Limits (AC, PA, QL). Coverage requires compliance with those controls.

    No clinical criteria tree provided in this excerpt

    Listed drugs with requirement flags

    Drug coverage entries with conditions when specified

    example_entry: Many drugs are listed with tier and, where present, Requirements/Limits such as PA, QL (with specific quantities/periods), and SP (specialty).

    This section enumerates products and their authorization/limitation flags; no explicit clinical criteria provided in this part.

    General coverage with utilization management

    Covered when meeting plan requirements noted (PA, QL, SP as applicable).

    Formulary coverage conditions: Drug is covered subject to the Requirements/Limits field which may include prior authorization (PA), quantity limits (QL), and specialty pharmacy (SP).

    See individual drug entry for specifics.

    Coverage contingent on utilization management

    Covered when PA and QL requirements (if listed) are met for the specific drug

    Formulary coverage preconditions: Prescriber must follow drug-specific utilization management: obtain prior authorization when PA is listed; adhere to quantity limits (QL) per period; follow step therapy (ST) sequences if specified.

    Examples: IMCIVREE (PA, QL, SP); WEGOVY (PA, QL); FANAPT titration packs (QL, ST).

    Coverage conditions (administrative)

    Coverage requires adherence to listed claim controls for each product

    Formulary coverage conditions: For a listed drug to be covered, the claim must meet the product's listed requirements/limits (e.g., PA must be obtained when 'PA' is indicated; quantity billed must not exceed QL).

    This fragment does not include medical necessity clinical criteria or step failure definitions; it only lists controls.

    Coverage exclusions include products that are cosmetic in use, non–FDA‑approved drugs, repackaged medications, and some compounded preparations. The formulary also notes that prescription products with available over‑the‑counter equivalents may not be covered; members should consult plan materials for specifics. (Examples and flags are presented on the drug list and benefit documentation.)

    When a drug is listed on the formulary, its coverage is determined by the listed Drug Tier and any Requirements/Limits shown on that product line (for example: PA, QL, SP, AC). Coverage is therefore product‑specific and contingent on meeting those utilization controls noted for the exact formulation and strength.

    If a product’s listed Requirements/Limits include administrative controls (e.g., PA or QL), coverage is contingent on satisfying those requirements; failure to obtain required prior authorization or to adhere to the stated quantity limits may result in denial of coverage until the requirements are met.

    Formulary product lines identify tiering and requirement flags for each listing. Examples from the drug list include items marked with PA (prior authorization), QL (quantity limits such as 8 tablets/180 days or 14 vials/28 days), SP (specialty pharmacy), and ST (step therapy) where applicable; the specific QL values and flags are shown on the product line for the exact presentation.

    The extract does not provide broad ‘not medically necessary’ exclusion language for clinical scenarios. Instead, vaccine and biologic entries may show administrative review flags (e.g., AC) that indicate clinical review is required for coverage of those products.

    Within the contraceptive and related product listings in this excerpt, coverage is shown by tier and administrative annotations (e.g., AC, QL, PA where listed); no separate explicit exclusion criteria are provided in these chunks.

    The portions of the formulary in this excerpt list products with tier and utilization flags but do not state standalone exclusion rules; coverage decisions are driven by whether product‑level Requirements/Limits are satisfied.

    Several entries in the vaccine and biologic sections are annotated with administrative review or specialty flags (e.g., AC, SP), but the excerpt does not include explicit medical necessity criteria — the lines are administrative in nature.

    Certain products in the formulary are designated NP or Non‑Preferred for specific formulations; where a product is non‑preferred the drug line still relies on the same Requirements/Limits annotations (PA, QL, SP) to govern coverage.

    This fragment contains many product entries but does not include explicit exclusion statements; the listings focus on tiering and utilization controls rather than listing conditions that are categorically excluded.

    No explicit clinical exclusion lists are present in these chunks; rather, coverage is tied to fulfillment of the advertised utilization controls (for example, obtaining PA, staying within the stated QL, or routing via SP when indicated).

    The available fragments primarily show administrative controls for each product (PA, QL, SP, AC, ST) and do not provide additional clinical exclusion language in this excerpt; coverage is therefore contingent on meeting those controls.

    The formulary explicitly states that non–FDA‑approved drugs are not covered under the pharmacy benefit. Providers and members should verify coverage for such products in plan materials.

    See per‑product entries for tier and Requirements/Limits; coverage is determined by the specific drug line and whether the noted utilization management controls (PA, QL, SP, AC) are met. The document does not include additional fallback clinical criteria in these excerpts.

    The extract does not include discrete ‘not medically necessary’ determinations for specific drugs. Coverage guidance in this fragment is presented as product lines with utilization control flags rather than NMN statements.

    Across the included segments there are no explicit ‘not medically necessary’ (NMN) rulings in the extract; the listings use administrative requirement flags (PA, QL, AC) to control coverage.

    The sampled formulary lines in this extract do not present standalone NMN statements; product coverage is governed by the listed utilization controls and specialty handling instructions.

    In these chunks no explicit ‘not medically necessary’ determinations are present; the document relies on product‑level utilization controls (PA/QL/SP) to define coverage conditions.

    Review of the fragment shows no NMN declarations; rather, coverage is tied to fulfillment of plan requirements for the listed products (e.g., prior authorization, quantity limits, step therapy where flagged).

    This excerpt does not include ‘not medically necessary’ statements. Product coverage and limitations are presented as tier and Requirements/Limits fields that must be met for benefit payment.

    There are no explicit ‘Not medically necessary’ determinations in the fragment; formulary control flags (PA, QL, SP, ST, AC) govern coverage at the product level.

    Formulary Entries and Code Groups

    Provider Requirements, Prior Authorization, and Documentation

    Prior Authorization

    Prior authorization required

    Prior authorization (PA) is required for many drugs in this Drug List. When a medication is designated with a "PA" in the Special Requirements column, an approved prior authorization must be obtained before the medication is eligible for coverage. Requests without the required PA may be denied.

    • PA flag indicates prior authorization is required before coverage
    • Many specialty and antineoplastic agents are PA- and SP-flagged (specialty pharmacy)
    • Select high-cost biologics, vaccines and inhaled therapies carry AC or PA flags
    Prior Authorization

    Prior authorization required where marked 'PA'

    Prior authorization is required for drugs marked with "PA" in the Special Requirements column. Providers must submit a prior authorization request per the plan process before dispensing. Failure to obtain PA where indicated can result in a claim denial or full member liability.

    • Look for "PA" next to product entries (Special Requirements column)
    • Some plans may require PA for additional medications beyond those listed — verify member-specific benefits
    Prior Authorization

    Prior authorization required for many specialty/antineoplastic drugs

    Many specialty, high-cost, and antineoplastic (oncology) drugs require prior authorization and are often managed through a specialty pharmacy (SP). Examples in this list include targeted therapies, PARP inhibitors, kinase inhibitors, and other oncology agents. Quantity limits (QL) commonly apply to these products.

    • Oncology/specialty agents frequently show PA, QL, and SP flags
    • Examples: ALUNBRIG, ERLEADA, VENCLEXTA, RUBRACA, STIVARGA, many others
    Prior Authorization

    Prior authorization required for multiple specialty drugs

    Prior authorization is required for multiple specialty drugs across therapeutic categories (e.g., biologics, enzyme replacement, gene or rare disease therapies, and high-cost injectables). These entries are often flagged SP and may have additional QL requirements.

    • Specialty (SP) flag indicates specialty pharmacy management
    • Many specialty products also require PA and have specific quantity limits
    Prior Authorization

    Prior authorization required for specific products

    Certain specific products are called out with PA requirements (examples include selected contraceptives, GLP-1 agents for diabetes and weight management, and others). Review the Special Requirements column for AC (access control), PA, and QL notes for each product.

    • Examples: ELLA, certain contraceptives (AC/PA), MOUNJARO, OZEMPIC, TRULICITY, SAXENDA, WEGOVY, ZEPBOUND
    • AC indicates access control/coverage criteria may apply in addition to PA
    Prior Authorization

    Prior authorization required for listed PA entries

    A number of listed PA entries across the Drug List require prior authorization. Providers should check each product's Special Requirements column; entries showing PA must have authorization approved prior to coverage.

    • If an entry shows "PA" — submit PA prior to dispensing
    • Some entries show combinations (PA, QL, SP, AC) — all listed requirements must be met
    Prior Authorization

    PA required for select products

    Select products require PA (examples throughout the list include UPTRAVI, NUCALA, TRIKAFTA and other high-cost therapies). When PA is indicated, documentation supporting medical necessity and prior treatment history may be requested.

    • UPTRAVI, NUCALA, TRIKAFTA appear with PA/QL/SP flags
    • Specialty pharmacy (SP) may be required for dispensing and administration
    Prior Authorization

    Prior authorization required for selected agents

    Prior authorization is required for selected agents listed in the Drug List (for example: TRIKAFTA, SYMDEKO, CREON, and other specialty products). Providers should follow the plan's PA submission process and include all required clinical documentation.

    • TRIKAFTA and SYMDEKO are PA- and QL-flagged
    • CREON and certain enteric enzyme products may have specific requirements
    Prior Authorization

    Prior authorization required for listed PA drugs

    Many listed PA drugs are high-cost or specialty agents; they are frequently managed with PA, SP, and QL controls. Providers must meet all applicable requirements (PA, QL, SP) shown for a product to avoid coverage denials.

    • High-cost specialty products are commonly PA-required and SP-managed
    • Examples include disease-modifying therapies, specialty injectables, and enzyme replacement therapies
    Documentation Required

    PA/AC/SP flagged products

    Products in the Drug List may carry flags for PA (Prior Authorization), AC (Access Control), and SP (Specialty Pharmacy). Each flag indicates a separate management requirement that must be satisfied for coverage.

    • AC = access control or additional coverage criteria may apply
    • SP = specialty pharmacy management for dispensing and adherence
    Prior Authorization

    Prior authorization and specialty pharmacy flags

    Several entries include both prior authorization and specialty pharmacy flags. When both are present, the provider must obtain prior authorization and use the designated specialty pharmacy channel as required by the plan.

    • Follow specialty pharmacy enrollment and dispensing instructions where SP is indicated
    • Combined PA + SP entries often also include quantity limits
    Denial Risk

    Quantity limit overage

    Quantity limits (QL) apply to many products; dispensing a quantity above the QL may trigger a denial or member liability. Providers should verify QL noted for each product and include rationale and clinical documentation when requesting amounts exceeding limits.

    • QL examples: 60 tablets/30 days, 56 containers/56 days, 120 capsules/30 days
    • Requests exceeding QL typically require supporting documentation and prior authorization
    Prior Authorization

    Authorization required for many vaccines/biologics

    Authorization and coverage controls apply to many vaccines and biologics (AC flag). Providers should confirm whether AC or PA is noted for vaccines/biologics before administering to ensure coverage.

    • Vaccines listed with AC may have coverage criteria or age restrictions
    • Biologics often carry PA, QL, and SP flags — confirm requirements prior to administration
    Denial Risk

    Prior authorization and quantity limit denials

    Prior authorization and quantity limit noncompliance can lead to claim denials or full member financial responsibility. Providers should review Special Requirements and submit PA plus supporting documentation when required.

    • Claims lacking required PA may be denied
    • Dispensing beyond QL without approval may result in no benefits applied
    Prior Authorization

    Prior authorization required for some products

    Some products require PA but are noted only for select formulations or pack sizes. Always review the specific product row and Special Requirements to determine whether PA applies to the exact NDC/formulation being prescribed.

    • Examples: posaconazole formulations, tobramycin nebulized solutions, EPCLUSA formulations may differ in PA status
    Prior Authorization

    PA/SP required for certain listed drugs

    Certain listed drugs (for example LUPRON DEPOT-PED and other specialty injectable agents) are managed with PA and/or SP requirements. Providers must check the product-level notes and follow PA/SP procedures.

    • PA/SP entries commonly include QL and kit/pack limits
    • Pediatric or depot formulations may be SP-managed
    Prior Authorization

    PA/QL triggers for specialty cardiovascular drugs

    PA and QL criteria can be triggers for cardiovascular specialty drugs (e.g., REPATHA, ADEMPAS, UPTRAVI) — these products often require PA with documented diagnoses and may carry QL/pack limits.

    • REPATHA (evolocumab) requires PA and QL limits
    • UPTRAVI and other pulmonary hypertension agents often show PA, QL and SP
    Denial Risk

    PA/SP/QL enforcement

    PA, SP, and QL enforcement is applied across the Drug List. Providers must meet all indicated requirements (PA approval, specialty pharmacy routing, and quantity limits) to avoid denials. Where multiple controls are present, all must be satisfied.

    • All flags shown for a product (PA, QL, SP, AC) must be satisfied for coverage
    • Verify member-specific benefit plan for any additional PA/ST requirements
    Prior Authorization

    Prior authorization required (general)

    Prior authorization is required in general for many entries in this Drug List. Providers should routinely check the Special Requirements column and follow the payer's PA submission and documentation instructions.

    • Verify product-level Special Requirements before prescribing or dispensing
    • Contact the number on the member ID card or use payer portals for PA submission
    Documentation Required

    Exception request documentation and timelines

    Exception requests may be submitted when coverage criteria are not met. The prescriber (or authorized representative) can request a Drug List exception; standard review decisions are issued within three business days. Expedited reviews (for urgent clinical situations jeopardizing life, health, or function) are decided within 24 hours.

    • Standard exception decision timeframe: 3 business days
    • Expedited exception decision timeframe: 24 calendar hours for urgent requests
    • Call the number on the member's ID card to initiate an exception request
    Documentation Required

    Documentation expectations

    Documentation expectations: prior authorization and exception requests should include relevant clinical information such as diagnosis, prior therapies tried (and reasons for failure or intolerance), lab results, and expected duration of therapy. For quantity limit overrides provide dosing rationale and clinical justification.

    • Include prior treatment history and reason alternative therapies are inappropriate
    • Provide lab values, imaging, or test results when applicable
    • State the requested quantity and clinical rationale for exceeding QL
    Documentation Required

    Support for requirements

    Support for requirements: when PA/AC/SP/QL are shown, the plan may request supporting clinical documentation as part of the authorization review. Ensure documentation is contemporaneous and clearly links the requested therapy to medical necessity.

    • Attach clinical notes, prior authorization forms, and relevant test results
    • For specialty drugs include prior authorization forms and required specialty pharmacy enrollment
    Documentation Required

    PA/QL/SP requirements for oncology and specialty drugs

    PA, QL, and SP requirements for oncology and specialty drugs commonly demand documentation of diagnosis, line of therapy, prior regimens, biomarker status (if applicable), and treatment intent. Providers should be prepared to submit detailed clinical records for these agents.

    • Provide pathology reports, mutation testing, or biomarker results when relevant
    • Document prior chemotherapy, targeted therapy or immunotherapy and reasons for discontinuation
    Documentation Required

    Documentation to support PA

    Documentation to support PA should be specific and complete: include diagnosis, relevant labs/tests, prior medication trials and dates, intolerances or contraindications to preferred agents, and planned monitoring. Specialty products may also require manufacturer- or payer-specific forms.

    • Use payer-specific PA forms where available
    • Include copies of prior authorization denials or failure documentation for step therapy exceptions
    Documentation Required

    Quantity limits and clinical documentation

    Quantity limits and clinical documentation: when requesting quantities above a QL, submit clinical justification including dosing schedule, weight-based dosing calculations (if applicable), and expected treatment course. Some therapies have pack/kit limits that must be adhered to unless an exception is approved.

    • Examples: pack/kit limits for inhaled treprostinil starter kits, oncology pack limits, and vials/pens per period
    • Provide dosing calculation for weight- or BSA-based regimens
    Documentation Required

    Supportive documentation for PA/SP

    Supportive documentation for PA/SP: for specialty or SP-managed drugs, include prior authorization forms, patient consent (if required), enrollment into a specialty pharmacy (when mandated), and any REMS or monitoring plans required by the manufacturer or payer.

    • Enroll patient in specialty pharmacy when SP flag present
    • Include REMS certification or monitoring plan documentation if applicable
    Documentation Required

    Examples of documentation of PA/QL

    Examples of documentation that support PA/QL: prior therapy records, lab values, pathology reports, genetic or biomarker testing, documentation of intolerance or contraindication to preferred alternatives, and manufacturer-specific forms. For QL overrides include dosing schedule and clinical justification.

    • Pathology or mutation testing (oncology)
    • Prior treatment failure notes and dates
    • Monitoring plans and dosing rationale for QL overrides
    Denial Risk

    Quantity limits enforcement

    Quantity limits are actively enforced; dispensing beyond stated QL without prior approval can lead to denial of coverage or full member financial responsibility. Providers should request PA for any expected ongoing need above the QL with supporting clinical evidence.

    • Common QLs: tablets/capsules per 30 days, kit or cartridge per 30/180 days
    • State the requested duration and clinical justification when requesting overrides
    Documentation Required

    Suspension/packet QL documentation

    Some QL entries reference suspension/packet/kit limits (for example, starter kits, inhalation packs, pellet packets). When those limits exist, supporting documentation for clinical need and dosing schedule should accompany any request to exceed the limit.

    • Starter/titration packs and pellet packets often have specific QL limits
    • Provide clinical rationale if more than the kit/packet limit is clinically necessary
    Step Therapy

    Step therapy not specified / Step therapy requirements

    Step therapy is mentioned as a possible program in benefit plans but specific step algorithms are not detailed in this excerpt. Where "ST" appears in Special Requirements, a step therapy requirement applies and an exception process is available.

    • ST flag indicates step therapy — required trial of preferred agent(s) before coverage of the requested drug
    • If step therapy fails or is contraindicated, prescribers may submit a step therapy exception with supporting documentation
    Documentation Required

    Access control / formulary restrictions

    Access control (AC) and formulary restrictions are used for some products (e.g., select contraceptives, vaccines, or drugs with age/safety restrictions). When AC is shown, additional coverage criteria or age-based limitations may apply and must be met for coverage.

    • AC indicates coverage criteria beyond PA (age limits, indication restrictions, preventive coverage rules)
    • Refer to member benefit materials for ACA preventive coverage exceptions
    Step Therapy

    Step therapy indicated — provider actions

    Step therapy may be required for certain therapeutic classes (not fully enumerated here). Items marked "ST" should be treated as requiring trial and failure of preferred medications before PA for the non-preferred agent will be approved.

    • Examples: certain antipsychotics and antidepressants show ST flags
    • Providers should document prior trials and reasons for failure when seeking exceptions

    Initial Therapy, Starter and Titration Pack Controls

    Initial therapy considerations

    Formulary entries indicate typical outpatient formulations and any management flags for initiation.

    Initiation rules: Initiation of listed outpatient therapies follows formulary tiering; drugs with 'PA' require prior authorization before initiation; drugs with 'QL' have quantity limits at initiation; specialty products flagged 'SP' must be dispensed via specialty pharmacy.

    Specific clinical criteria for PA are not present in this extract; see full policy for PA clinical criteria.

    Initial therapy authorization signals

    Initial coverage/authorization signals

    PA required where listed: If a drug's Requirements/Limits field includes 'PA', prior authorization is required before coverage.

    Specific clinical criteria for PA are not included in these chunks

    Titration pack requirements

    Titration and starter packs have specific QL and ST flags

    Titration pack rules: Titration packs (e.g., FANAPT titration packs) list specific QL limits and are subject to step therapy (ST) where indicated.

    FANAPT Pack A QL 8 tablets/180 days; Pack B QL 1 pack/180 days; Pack C QL 1 pack/180 days.

    Starter/titration pack controls

    Starter packs and titration packs listed with QL/PA where applicable

    Starter/titration pack controls: Starter and titration packs (e.g., MAYZENT STARTER PACK, REBIF TITRATION PACK, MAVENCLAD therapy packs) have PA and specific QL limits as listed and require adherence to those limits for coverage.

    No clinical initiation criteria included in fragment.

    Step Therapy Programs and Tables

    Policy elementSummary
    Step therapy (ST)Step therapy programs may require trying a first-line, cost‑effective medication before coverage is available for a non‑preferred drug. If a step therapy is commonly required it is generally noted with 'ST' in the Special Requirements column. Prescribers may submit a step therapy exception request if the preferred agent is not appropriate.
    ExceptionsProviders may request a step therapy exception; the prescriber (or authorized representative) must submit the request for review.
    Policy elementSummary
    Overlap with PA/AC/SPCertain agents are managed with prior authorization (PA), access control (AC) or specialty program (SP) designations; these utilization controls may be applied alongside step therapy where indicated, though specific step sequences are not detailed in the formulary extract.
    ExamplesSelected high‑cost anti‑infective and antiviral agents (e.g., tobramycin nebulized preparations, posaconazole, EPCLUSA) show PA and/or SP flags indicating PA/AC/SP management may accompany step requirements.
    Policy elementSummary
    Step therapy presenceStep therapy sequences are not explicitly enumerated for hepatitis C (HCV) or HIV agents in these chunks. Several HCV/HIV products are marked with PA and/or SP, which suggests they are subject to utilization management but without defined ST algorithms in this excerpt.
    ExamplesEPCLUSA and MAVYRET list PA and QL and SP; emtricitabine and other HIV agents show QL/AC flags—no step‑by‑step algorithm provided here.
    Policy elementSummary
    Oncology / specialty entriesMany oncology and specialty agents list prior authorization (PA), quantity limits (QL) and are designated SP. These flags imply the drugs are managed as specialty products and may be subject to step or specialty routing, though explicit ST sequences are not shown in the excerpt.
    ExamplesAgents such as abiraterone, alectinib, and alunbrig include PA, QL and SP designations indicating specialty management alongside utilization controls.
    Policy elementSummary
    Explicit ST stepsThe provided document fragments do not include explicit step therapy step definitions or the required prior agents/failure criteria. The formulary lists ST flags on specific products but not the underlying step algorithms in these chunks.
    ImplicationWhere 'ST' appears on a product line it indicates a plan‑defined sequence must be followed; details are available in benefit plan materials or full policy documentation.
    Policy elementSummary
    GLP‑1 and related agentsStep therapy specifics are not provided for GLP‑1/GLP/GIP agents in the excerpt. Several agents (e.g., MOUNJARO, OZEMPIC, RYBELSUS) include PA and QL flags, indicating prior authorization and quantity controls apply, but ST algorithms are not detailed.
    Provider actionObtain PA where listed and consult benefit plan materials for any step therapy requirements or exception processes.
    Policy elementSummary
    Access control (AC)Some products (e.g., raloxifene) are listed with 'AC' (access control) in Requirements/Limits; AC may reflect an administrative/clinical review or access step that must be satisfied prior to coverage and can function similarly to a step/access requirement.
    ImplicationAC‑flagged products require documentation or review per the formulary entry; consult the plan's authorization process for specifics.
    Policy elementSummary
    Fallback guidanceWhen step therapy is not specified in the extract, coverage is determined by the drug tier and any listed Requirements/Limits (PA, QL, SP, AC). Providers should follow the drug‑specific flags and submit PA or request exceptions as needed.
    ActionRefer to benefit plan materials or contact the payer for full step therapy algorithms or exception procedures when ST details are not present.
    Policy elementSummary
    PA/QL without STSome products have prior authorization (PA) and quantity limits (QL) but no explicit ST flag in the excerpt. For example, CIMZIA (certolizumab) is shown with PA and QL (2 kits/28 days) and SP but no ST designation in the referenced chunk.
    ImplicationCoverage requires meeting PA and QL requirements; absence of an ST flag in the excerpt means step therapy sequencing is not indicated for that line in these chunks.
    Policy elementSummary
    Antipsychotics/antidepressants STStep therapy (ST) is explicitly applied to certain antipsychotics and antidepressants. Multiple aripiprazole formulations, FANAPT titration packs, risperidone ODT lines, and clozapine ODT/suspension entries carry ST designations in the formulary fragments.
    Examples and limitsAripiprazole formulations show QL and ST (e.g., QL 60 tablets/30 days; solution QL 900 mL/30 days). FANAPT titration packs list specific QL and ST flags. Risperidone ODT and clozapine ODT entries also list QL and ST as applicable.
    Policy elementSummary
    ST applies to select productsWhen an 'ST' flag appears on a product line, step therapy applies and the prescriber must follow the plan‑defined sequence before the non‑preferred agent will be covered. The ST flag is shown next to affected products in the Special Requirements column.
    ExamplesExamples in the extract include antipsychotic titration packs (FANAPT) and multiple aripiprazole/clozapine formulations marked with ST; full step sequences are not provided in these fragments.
    Policy elementSummary
    Specific products marked STCertain products such as Gralise (gabapentin once‑daily formulations) are marked 'ST' in the formulary extract, indicating step therapy applies. The fragment lists the ST flag but does not define the required prior agents or failure criteria.
    Coverage noteCoverage for ST‑marked products requires adherence to plan‑defined step therapy rules; providers should submit exception requests when a first‑line agent is inappropriate.

    Quantity Limits and Supply Rules

    maintenance medications — standard 30-day supply; up to 90-day for maintenance
    Standard covered supply for outpatient medsMost plans provide coverage for up to a 30-day supply; maintenance medications may be covered up to a 90-day supply (plan dependent)
    Maintenance medication definitionMaintenance medications are drugs taken on an ongoing basis for conditions such as hypertension, diabetes, or high cholesterol
    Plan exceptionsSome plans may exclude certain categories (e.g., erectile dysfunction, weight loss) or limit coverage by age or other plan rules
    Multiple quantity limit examples by product
    Multiple QL examples (summary)Varies by product — e.g., QL 60 tablets/180 days; QL 28 tablets/30 days; QL 235.2 mLs/28 days; QL 30 tablets/30 days
    Product-specific limitsEach formulary line lists exact QL values where applicable — refer to product entry for precise limit
    EnforcementDispensing beyond QL may result in member responsibility for full cost or claim denial unless PA/override is obtained
    DOVATO quantity limit example
    DOVATO (dolutegravir-lamivudine)Requirements/Limits = AC, QL (30 tablets/30 days)
    Formulation noteListed as Drug Tier = P with QL indicated for outpatient dispensing
    Coverage conditionCoverage requires adherence to the listed QL and any AC requirements
    EMTRIVA solution QL example
    EMTRIVA (emtricitabine) oral solutionRequirements/Limits = QL 720 mLs/30 days
    Formulation detailSolution presentation has a milliliter-based QL rather than tablet count
    Coverage implicationClaims must not exceed the listed mL limit without prior authorization/override
    MAVYRET QL example
    MAVYRET (glecaprevir-pibrentasvir)Requirements/Limits = PA, QL 90 tablets/30 days (pellet pack variants may show alternate QL)
    Packet pack noteSome presentations listed as pellet/packet may have different QLs (e.g., 140 tablets/28 days) and specialty routing
    Coverage requirementPA and QL must be met for benefit coverage
    SUNLENCA QL example
    ContextSmall tablet counts reflect dosing/regimen-specific QL rather than monthly supply
    Coverage noteAdhere to listed QL and PA/SP where indicated for specialty regimens
    NORVIR powder packets QL example
    NORVIR powder packetsRequirements/Limits = QL 360 packets (per listed period)
    FormulationPacket formulations are assigned packet-based QL rather than tablet counts
    Coverage implicationClaims must respect packet QL or may require PA for excess quantities
    Oncology specialty QL examples
    Oncology/specialty titration or starter packsMany specialty oncology products have PA and pack-based QLs (e.g., UPTRAVI TITRATION PACK QL pack/180 days)
    Sample: ERIVEDGE cap 150 mgRequirements/Limits = PA, QL 30 capsules/30 days, SP
    High-cost oncology QLsExamples include QL 60–240 tablets/30 days depending on agent (e.g., ALUNBRIG, SCEMBLIX)
    ERIVEDGE cap 150 mg QL example
    ERIVEDGE (vismodegib) cap 150 mgRequirements/Limits = PA, QL 30 capsules/30 days, SP
    Therapy contextListed as Drug Tier = P with PA and QL
    Coverage implicationPA and QL required for coverage of this oncology agent
    TALZENNA QL examples
    TALZENNA (talazoparib)Requirements/Limits = PA, QL examples include 30–120 tablets/30 days depending on presentation
    RUBRACA (rucaparib)Requirements/Limits = PA, QL 120 tablets/30 days
    SCEMBLIX (asciminib) 40 mgRequirements/Limits = PA, QL 240 tablets/30 days
    RUBRACA QL example
    RUBRACA (rucaparib camsylate)Requirements/Limits = PA, QL 120 tablets/30 days
    Formulation noteHigh tablet-count QLs are applied to some PARP inhibitors and require PA
    Coverage implicationClaims beyond QL may be denied without PA
    SCEMBLIX QL example
    SCEMBLIX (asciminib) 40 mgRequirements/Limits = PA, QL 240 tablets/30 days
    Other strengthsASCIMINIB also listed with QL 60 and 120 tablets/30 days for other strengths
    Specialty routingSP designation shown for many oncology entries
    TAGRISSO QL example
    TAGRISSO (osimertinib)Requirements/Limits = PA, QL 30 tablets/30 days
    Coverage requirementPA and QL must be met for benefit coverage
    Formulary contextListed among oncology targeted therapies with SP where applicable
    TALZENNA talazoparib QL example (capsules)
    TALZENNA talazoparib (capsule presentation)Requirements/Limits = PA, QL 30 capsules/30 days (selected listing)
    Packaging noteCapsule vs tablet presentations may have different QLs per product line
    Coverage implicationPA required for many PARP inhibitors with specified QLs
    TRUQAP capivasertib QL example
    TRUQAP (capivasertib)Requirements/Limits = PA, QL 64 tablets/28 days, SP
    Therapy pack noteTherapy pack presentations include pack-based QLs (e.g., 64 tablets/28 days)
    Coverage implicationPA and SP routing indicated for many therapy-pack oncology drugs
    VITRAKVI oral solution QL example
    VITRAKVI oral solutionRequirements/Limits = PA, QL 300 mLs/30 days
    VITRAKVI 25 mg capsulesRequirements/Limits = PA, QL 180 capsules/30 days
    VITRAKVI 100 mg capsulesRequirements/Limits = PA, QL 60 capsules/30 days
    VITRAKVI 25 mg capsules QL example
    VITRAKVI 25 mg capsulesPA, QL 180 capsules/30 days
    Pack/capsule distinctionsDifferent capsule strengths have distinct QLs listed per product line
    Specialty routingSP designation present for many targeted agents
    VITRAKVI 100 mg capsules QL example
    VITRAKVI 100 mg capsulesPA, QL 60 capsules/30 days
    Therapy contextHigh-cost oral oncology agents commonly have PA and SP flags alongside QL
    Claims implicationAdherence to listed QL required or claim may be denied
    XTANDI QL example
    XTANDI (enzalutamide)Requirements/Limits = PA, QL 120 tablets/30 days for 40 mg presentation
    Alternate strength80 mg listed with PA and QL 60 tablets/30 days
    Specialty designationSP may be shown for oncology agents where administration or handling differs
    ALORA patch QL example
    ALORA estradiol transdermal patchRequirements/Limits = QL 30 patches/30 days
    Patch dispensingTransdermal patches are subject to patch-count QLs per month
    Plan implicationExceeding QL may require PA or result in member cost responsibility
    Most oral contraceptives QL example (28)
    Most oral contraceptivesRequirements/Limits = AC, QL 28 tablets (typical packaging/period)
    Extended-cycle formulationsSome 84/91-tablet regimens are listed but QL references still show 28 tablets/21 days packaging conventions
    Coverage noteAC flags indicate authorization/clinical review may apply in addition to QL
    Levonorgestrel emergency QL example (2)
    Levonorgestrel (emergency contraception)Requirements/Limits = AC, QL 2 tablets/365 days
    Coverage implicationEmergency contraceptive QL is annual (2 tablets per 365 days) as listed
    Authorization noteAC flags present for some contraceptive entries indicating clinical review may be required
    GLP-1/antidiabetic pens and some insulins QL varies
    GLP-1 and insulin pen/solution limitsQL varies by product — examples include QL 4 pens/28–180 days for tirzepatide/semaglutide products and QL 100 mLs/30 days for some insulins
    HUMALOG / LYUMJEV / NOVOLOGRequirements/Limits = QL 100 mLs/30 days for many pen/solution presentations
    Weight-management injectablesMOUNJARO/OZEMPIC/ZEPBOUND/WEGOVY show PA and product-specific QLs (e.g., 1–4 pens per period)
    MENOPUR QL example
    MENOPUR (menotropins)Requirements/Limits = QL 60 vials/30 days, SP
    Fertility injectablesMany require SP routing and have vial/syringe-based QLs
    Coverage implicationPA/SP and QL must be met for benefit coverage of reproductive therapies
    OVIDREL QL example
    OVIDREL (choriogonadotropin alfa)Requirements/Limits = QL 2 syringes/30 days, SP
    Fertility injectables packagingSyringe-based QLs are commonly applied to clinician- or specialty-dispensed fertility agents
    Coverage notePA or SP may also be required per product line
    SOMAVERT QL example
    SOMAVERT (pegvisomant)Requirements/Limits = PA, QL 30 vials/30 days, SP
    High-cost endocrine injectablesOften require PA and are managed via specialty pharmacy with vial-based QLs
    Claims implicationAdhere to listed QL or seek PA for quantities exceeding limits
    TYMLOS QL example
    TYMLOS (abaloparatide)Requirements/Limits = PA, QL 1.56 mLs/30 days
    Injectable volume-based QLsSome pen/solution products have mL-based QLs rather than count-based limits
    Specialty routingSP designation common for these biologic/peptide therapies
    YORVIPATH QL example
    YORVIPATH (palopegteriparatide)Requirements/Limits = PA, QL 2 pens/28 days, SP
    Pen-count QLSome long-acting peptide therapies use pen-count QLs per 28-day period
    Coverage implicationPA and SP routing typically required
    REPATHA 140 mg syringe QL example
    REPATHA 140 mg prefilled syringeRequirements/Limits = PA, QL 6 syringes/28 days
    REPATHA PUSHTRONEX 420 mgRequirements/Limits = QL 2 cartridges/30 days
    Specialty injectablesSyringe/cartridge QLs applied and PA/SP often required
    REPATHA PUSHTRONEX 420 mg QL example
    REPATHA PUSHTRONEX 420 mg systemRequirements/Limits = QL 2 cartridges/30 days
    Dose form noteCartridge-based systems have cartridge-count QLs rather than syringe counts in some listings
    Coverage implicationPA may be required for some presentations
    NEXLETOL QL example
    NEXLETOL (bempedoic acid)Requirements/Limits = PA, QL 30 tablets/30 days
    Oral cardiovascular agentsMany have 30-tablet-per-month QLs listed
    Coverage notePA indicated for select lipid-lowering specialty agents
    Bosentan QL example
    Bosentan (Tracleer)Requirements/Limits = PA, QL 60 tablets/30 days, SP
    PAH agent QLsPA and high tablet-count QLs (e.g., 60–120 tablets/30 days) commonly applied to PAH therapies
    Specialty routingSP designation often accompanies PA for PAH agents
    VYNDAMAX QL example
    VYNDAMAX (tafamidis) 61 mgRequirements/Limits = PA, QL 30 capsules/30 days
    VYNDAQEL (tafamidis meglumine) 20 mgRequirements/Limits = PA, QL 120 capsules/30 days
    Coverage implicationPA and QL required for tafamidis cardiac indications
    VYNDAQEL QL example
    VYNDAQEL tafamidis meglumine 20 mgRequirements/Limits = PA, QL 120 capsules/30 days
    Higher QL for some cardiac formulationsListed QL reflects long-term dosing and packaging differences
    Specialty routingSP designation present for tafamidis products
    ORENITRAM titration kit QL example
    ORENITRAM titration kitRequirements/Limits = PA, QL 1 pack/180 days
    Titration kit contextTitration/starter kits have pack-based QLs over extended periods (e.g., 180 days)
    Coverage notePA and SP often accompany titration kits
    FUROSCIX QL example
    FUROSCIX furosemide subcutaneous cartridge kit 80 mgRequirements/Limits = QL 8 kits/180 days
    Home-administered cartridge kitsLonger period QLs reflect infrequent dispensing cycles
    Coverage implicationPA/SP may be required depending on product
    UPTRAVI TITRATION PACK QL example
    UPTRAVI TITRATION PACKRequirements/Limits = PA, QL pack/180 days, SP
    Titration pack notePack-based QLs and PA shown for selexipag titration packs
    Coverage requirementAdhere to QL and PA for claim coverage
    ADVAIR HFA QL example
    ADVAIR HFA inhalerRequirements/Limits = QL 1 inhaler/30 days
    Inhaler dispensing limitsMany inhalers list QL per 30-day period (1–3 inhalers/30 days depending on product)
    EnforcementClaims exceeding inhaler QL may be denied or require PA
    NUCALA QL example
    NUCALA (mepolizumab)Requirements/Limits = PA, QL 3 mL/28 days or 1 syringe/28 days depending on presentation, SP
    Dose/presentation dependent QLSyringe vs multi-mL vial presentations have different QLs listed
    Coverage implicationPA and SP commonly required for biologic injectables
    TRIKAFTA QL example (packets/28 days)
    TRIKAFTA (packet presentations)Requirements/Limits = PA, QL 56 packets/28 days for certain presentations, SP
    Packet QL noteSome TRIKAFTA presentations list packet-based QLs (56 packets/28 days)
    Coverage requirementPA and QL must be met for coverage of CF modulators
    TRIKAFTA (packets) QL example (56 packets)
    TRIKAFTA (packet) typical QLQL 56 packets per 28 days for listed packet presentations
    Specialty routingSP designation accompanies many cystic fibrosis modulators
    PA requirementPA noted for many TRIKAFTA listings
    SYMDEKO QL example
    SYMDEKO (tezacaftor-ivacaftor)Requirements/Limits = PA, QL 60 tablets/30 days, SP
    CF modulator QLsCommonly 60 tablets/30 days or packet-based QLs depending on formulation
    Coverage implicationPA and SP routing often required
    MOVANTIK QL example
    MOVANTIK (naloxegol)Requirements/Limits = QL 30 tablets/30 days
    Oral GI specialty agentsMany GI agents list 30-tablet monthly QLs
    Coverage noteAdhere to QL or seek PA for larger quantities
    ENTYVIO PEN QL example
    ENTYVIO PEN (vedolizumab)Requirements/Limits = PA, QL 2 pens/28 days
    Biologic pen QLsPen-count QLs are applied to many self-injectable biologics
    Specialty routingSP designation commonly accompanies these entries
    TREMFYA INDUCTION PACK QL example
    TREMFYA INDUCTION PACKRequirements/Limits = PA, QL 3 kits/180 days, SP
    Induction/titration kit QLInduction kits often have QLs over 180-day windows
    Coverage implicationPA and SP routing required for induction kits listed
    ZYMFENTRA formulations QL example
    ZYMFENTRA formulations (infliximab-dyyb)Requirements/Limits = PA, QL 2 kits or 2 syringes/28 days, SP
    Prefilled syringe/kit QLsSome biosimilar auto-injector kits list kit- or syringe-based QLs
    Specialty routingSP designation and PA commonly apply
    Aripiprazole/clozapine QL examples
    Aripiprazole solutionRequirements/Limits = QL 900 mLs/30 days
    Clozapine ODT/tablets (various strengths)Requirements/Limits = QL 90–270 tablets/30 days depending on strength — most actionable: ensure dispensing aligns with the listed tablet-range QL
    ST flagMany entries include ST indicating step therapy applies to select behavioral health agents
    Various QL examples across products
    Examples across CNS and behavioral healthCommon QLs include 30 tablets/30 days; 60 tablets/30 days; 90 tablets/30 days; some suspensions list mL-based QLs (e.g., 540 mLs/30 days)
    FANAPT titration packsQL examples: Pack A QL 8 tablets/180 days; Pack B/C QL 1 pack/180 days; ST applies
    Sodium oxybate (XYWAV)Requirements/Limits = PA, QL 540 mLs/30 days, SP
    Multiple QL examples (see code groups)
    Formulary QL variabilityQuantity limits vary by product and presentation — see each product entry (examples: vials, pens, syringes, tablets, mLs, packets)
    Specialty product enforcementMany specialty products list PA and SP along with QL — documentation required for PA/overrides
    Time windowsQL periods include 28 days, 30 days, 180 days, 301 days and 365 days depending on product

    Site of Care and Specialty Pharmacy Routing

    Note

    Confirm site‑of‑care (medical vs pharmacy benefit) for clinician‑administered drugs

    Site‑of‑care guidance: medications administered by a health care professional may be covered under the medical benefit rather than the pharmacy benefit; confirm benefit routing before ordering or billing.

    Billing Rule

    Route SP‑designated drugs through specialty pharmacy

    Specialty‑designation (SP) indicates the drug is managed through the plan's specialty pharmacy channel; providers should route SP products through the specialty pharmacy as required.

    • When 'SP' appears in Requirements/Limits, coordinate with the plan's specialty pharmacy (e.g., Accredo) for dispensing and support.
    Billing Rule

    Ensure specialty pharmacy dispensing for SP products

    If a drug is designated 'SP' in the formulary, specialty pharmacy dispensing is expected; providers should ensure specialty pharmacy coordination when submitting PA and scheduling delivery.

    Prior Authorization

    Coordinate PA and specialty distribution for SP drugs

    Specialty products marked 'SP' should be routed through the plan's specialty pharmacy channel and require coordination of PA and specialty distribution prior to dispensing.

    Documentation Required

    Confirm specialty handling and distribution for SP biologics

    Specialty‑designated biologic and complex products (SP) often require specialty handling and distribution; providers must confirm SP routing and supply PA documentation as part of the specialty dispensing workflow.

    Billing Rule

    Dispense SP‑designated products through specialty pharmacy and meet PA/QL

    Several listed specialty drugs are designated SP; when SP is shown, providers must ensure these products are dispensed via specialty pharmacy and that PA/QL requirements are met.

    Note

    Verify administration site and route for SP biologics

    Biologic and other specialty products designated SP may require clinic administration or specialty pharmacy dispensing; providers should verify the appropriate site and route claims accordingly.

    Billing Rule

    Coordinate required specialty pharmacy distribution for SP drugs

    When a drug is marked 'SP' specialty pharmacy is required for distribution; providers must coordinate with the specialty pharmacy for authorization and delivery logistics.

    Prior Authorization

    Enroll and coordinate with specialty pharmacy for SP products

    Drugs designated SP in the formulary are expected to be managed through the specialty pharmacy channel; providers should ensure PA and SP program enrollment steps are completed before dispensing.

    Definitions and Abbreviations

    Background and Scope

    Specialty drugs treat complex conditions and may require special handling, support services, or clinician administration. Some clinician‑administered products may be covered under the medical benefit rather than the pharmacy benefit; specialty‑designated drugs (marked SP) should be dispensed through the plan’s specialty pharmacy channel when required.