Prior Authorization Required — general risk and program flags

Many drugs listed in this formulary require prior authorization (PA) or other program-level controls before the plan will pay. Failure to obtain required PA, specialty routing (SP), limited availability (LA), or to comply with quantity limits (QL) or step-therapy (ST) edits may result in claim denial or non‑coverage.

• Prior authorization (PA) is required for select agents and many specialty, antiviral, hepatitis C, antifungal, weight‑management, neurologic/respiratory, cystic fibrosis (CF) modulators, oncology and targeted therapies.
• Drugs flagged with PA, LA, SP, QL, ACA, or ST in the formulary carry program-level controls — claims may be denied if these controls are not met.

Prior Authorization Required — select antiviral, antifungal and hepatitis C agents

Specific high‑cost or specialty products listed in the formulary require PA and often have additional program flags (QL, SP, LA). Examples from the formulary include high‑cost antivirals and hepatitis C regimens (EPCLUSA, HARVONI, SOVALDI, VOSEVI, MAVYRET), antifungals (CRESEMBA, NOXAFIL, posaconazole, voriconazole), and select antivirals and combination HIV regimens.

• Hepatitis C agents (EPCLUSA, HARVONI, SOVALDI, VOSEVI, MAVYRET) = PA + QL + SP in many presentations.
• High‑cost antifungals (CRESEMBA, NOXAFIL, posaconazole, voriconazole) = PA.
• Many antiviral/HIV combination products include QL and may require PA or ACA designations (e.g., Truvada, GENVOYA, STRIBILD).

Prior Authorization Required — antiviral, specialty and oncology agents

Antiviral, specialty, and many oral specialty oncology agents require prior authorization and specialty routing; consult the formulary Requirements/Limits field and submit PA before dispensing to avoid denials.

• Antivirals and HIV agents commonly show QL and PA designations (e.g., GENVOYA, ISENTRESS, SOVALDI).
• Many oral oncology and targeted agents are LA, PA, QL, SP — see product line items (e.g., ALUNBRIG, ALECENSA, AKEEGA).
• Failure to obtain PA or to route through specialty pharmacy (SP) can block payment.

Prior Authorization Required — specialty/oncology agents

Many specialty oncology and targeted agents are documented with PA, LA, QL and SP flags. These designations mean prior approval, quantity limits, restricted dispensing channel, or limited availability apply; providers must follow these controls.

• Examples include abiraterone (Zytiga), alectinib (ALECENSA), brigatinib (ALUNBRIG), avapritinib (AYVAKIT), erdafitinib (BALVERSA) — all require PA and are often SP/LA with QL.
• Line‑item QL values (e.g., tablets/30 days, syringes/28 days) must be observed to avoid denial.

Prior Authorization Required — listed specialty/oncology and biologic agents

Formulary items flagged with PA/QL/ST/LA/SP require provider action before fill. Commonly listed products with PA include many specialty biologics, CF modulators, and select branded drugs — obtain PA and ensure specialty routing or limits are met.

• CF modulators and orphan/rare disease therapies (e.g., KALYDECO, ORKAMBI, OFEV) = LA, PA, QL, SP.
• Oncology agents in the formulary are frequently LA/PA/QL/SP; confirm approval and the QL prior to dispensing.

Prior authorization required for select branded and GLP‑1 agents

Some branded, commonly prescribed products also require prior authorization. Providers should verify PA needs for these drugs before prescribing or dispensing to members.

• Examples include MYFEMBREE, MOUNJARO, TRULICITY, OZEMPIC which show PA and QL designations in the formulary.
• Weight‑management and GLP‑1 agents (MOUNJARO, OZEMPIC, TRULICITY, RYBELSUS) frequently require PA and have QL per pen/pack/period.

PA and QL for weight‑management and select neurologic/respiratory agents

Weight‑management and certain neurologic/respiratory agents carry combined PA and QL controls. Confirm PA and adhere to the listed quantity limits to prevent claim denials.

• Weight‑management products (SAXENDA, WEGOVY, ZEPBOUND, ZEPOSIA entries for different classes) = PA + QL (pens or mL per days).
• Neurologic agents and special respiratory biologics (e.g., FASENRA, TEZSPIRE) include PA and QL designations and may be routed as SP.

Prior authorization risk — denial triggers

Prior authorization risk: drugs that require PA may not be covered if approval is not obtained. Always check the formulary Requirements/Limits flags (PA, QL, LA, SP, ST, ACA) and obtain authorizations before dispensing.

• Absence of PA at the time of claim submission is a common denial trigger.
• Program flags (LA/PA/QL/SP/ST/ACA) are enforceable controls — noncompliance can result in non‑payment.

Coverage controls and denial triggers

Coverage controls and denial triggers: claims may be denied for not meeting program requirements (PA, exceeding QL, wrong dispensing channel if SP or LA applies, or failing ST sequence). Providers should confirm eligibility and authorization prior to dispensing.

• Exceeding a listed QL (e.g., tablets/30 days, pens/28 days) can lead to denial.
• Failure to follow step‑therapy (ST) where specified or to obtain prior authorization will commonly result in claim denial.

PA/QL/SP required for many specialty agents

Many specialty products require PA, QL and SP routing. Obtain necessary approvals and dispense through the indicated channel to avoid denials and to meet clinical monitoring/handling requirements.

• Specialty routing (SP) is required for many oncology, biologic, and rare disease products (line items include SP).
• Adhere to QL values and PA requirements for specialty products when submitting claims.

Failure to meet PA/QL/SP — potential denial

Failure to meet PA, QL, SP or LA requirements may result in denial of payment. Ensure prior authorization is approved, quantity limits are respected, and specialty channel requirements are followed.

• If PA is required and not obtained, the drug may not be covered.
• Specialty and limited availability products must be dispensed through the approved channel to be eligible for coverage.

Failure to meet PA/QL/LA triggers denial

Some formulary entries note that lack of PA, SP, or LA will trigger denials or non‑coverage. Providers must confirm all program flags and approvals before prescribing or dispensing.

• Absence of PA or exceeding QL/LA designations are explicit denial triggers in the formulary.
• Confirm approvals for listed products such as MYFEMBREE, ORIAHNN, MOUNJARO, TRULICITY, OZEMPIC prior to fill.

Prior authorization required for specified products

The formulary includes specific products with PA noted on their line items. Providers should verify PA status for these products and obtain approval before dispensing.

• Selected examples with PA in the formulary: CRESEMBA, EPCLUSA, HARVONI, SOVALDI, VOSEVI, MOUNJARO, OZEMPIC, TRULICITY, MYFEMBREE.

Quantity limits may trigger denial if exceeded

Quantity limits (QL) are enforced across many drug categories. Claims exceeding the stated QL may be denied — review the product line‑item QL (units per days) and request exceptions if clinically indicated.

• Example QLs: QL (28 tablets/28 days), QL (30 tablets/30 days), QL (4 pens/28 days), QL (6 syringes/28 days).
• If medically necessary dosing exceeds QL, submit a PA request with supporting documentation or an exception request.

Authorization‑required drugs — provider action

Drugs flagged PA/LA/SP require authorization steps. Providers must follow the formulary Requirements/Limits and submit PA requests per payer instructions before dispensing.

• Authorization‑required examples: ACTHAR, GALAFOLD, GENOTROPIN, OPFOLDA and many enzyme/rare disease therapies.
• LA indicates limited dispensing; SP indicates specialty channel — verify where the drug must be dispensed.

Failure to meet listed requirements — follow Requirements/Limits field

If the formulary line item indicates specified requirements (PA, LA, QL, SP), providers must meet those requirements or the request may be denied. Follow the Requirements/Limits field on each line item.

• Examples: OPFOLDA, VOXZOGO, YORVIPATH and many others show LA, PA, QL and SP designations — confirm approvals and channel before dispensing.

Quantity limit exceedance — submit documentation or exception request

Some products have explicit quantity limit exceedance rules captured in the line items (e.g., VOXZOGO QL (30 vials/30 days)). Providers must request exceptions or PA with documentation if greater quantities are required.

• When a QL is specified (vials, tablets, pens per period), claims exceeding that QL can be denied without an approved exception.
• Submit clinical rationale and records to support requests to exceed QL.

Prior authorization and limits noted — check line items

Prior authorization and limits are documented for many products; consult each line item for PA, QL, LA, SP flags and obtain pre‑approval as required.

• Examples include REPATHA (PA, QL), QBRELIS (PA, QL), DIURIL (PA, QL) — ensure PA is in place and QL respected.

PA/LA/QL for CF therapies — documentation needed

Cystic fibrosis (CF) therapies and other modulators are frequently designated LA/PA/QL/SP. Obtain PA and document dosing schedules and member genotype/clinical criteria as part of the authorization request.

• CF modulators (KALYDECO, ORKAMBI) and alpha1‑proteinase products (GLASSIA) are SP and have QL; ensure PA and clinical documentation are submitted.
• Provide genotype, prior therapy, and monitoring plan when requesting PA for CF therapies.

Prior authorization / program flags — interpret and act

Program flags on the formulary (PA, ST, LA, SP, ACA, QL) indicate authorization, step‑therapy, limited availability or specialty routing are required. Providers should interpret these as enforceable controls and act accordingly.

• PA/ST/LA/SP flags require prior action — verify plan‑specific requirements and obtain authorizations.
• ACA indicates Affordable Care Act‑protected coverage for certain products when applicable.

Prior authorization required for select weight‑management and other agents

PA is required for many weight‑management and other select agents listed. Confirm PA status and QL for these products before prescribing to avoid denials.

• Weight‑management examples requiring PA: SAXENDA, WEGOVY, ZEPBOUND, ZEPOSIA (where applicable).
• Some weight‑management agents also have QL per pens or mL per period — verify and obtain PA.

Prior authorization required for listed PA drugs

For any drug line‑item that lists PA in Requirements/Limits, submit a prior authorization request. Requests without PA or required specialty handling may be denied.

• Examples of PA‑listed drugs include REBIF TITRATION PACK, SODIUM OXYBATE, many biologics and specialty injected products.
• If in doubt, contact EmblemHealth to confirm PA procedures and required documentation.

Exceptions and alternative options

Exceptions and alternative options: members can request an exception to a restriction or limit. Providers may request clinical exceptions and should discuss therapeutic alternatives with the member prior to submitting a PA/exception request.

• Submit an exception request with supporting clinical documentation when the QL, PA, or channel requirement would prevent medically necessary therapy.
• EmblemHealth can provide alternate covered drugs that may not require PA or have different limits.

Quantity limit documentation — include dosing and rationale

Quantity limit documentation: when QL is listed, include the member‑specific dosing and justification in the PA or exception request to support approval.

• Include expected dose, duration, and rationale for doses exceeding the QL in the PA submission.
• Provide prior therapy history if QL is related to tapering or titration schedules.

Authorization documentation — what to submit

Authorization documentation: prescribers must supply PA forms and any payer‑required clinical documents when requested. Specialty (SP) products often require additional paperwork and monitoring plans.

• Provide diagnosis, prior treatments, relevant labs/genotype and treatment plan when requesting PA for specialty or oncology therapies.
• Specialty pharmacy documentation and monitoring plans are commonly required for SP agents.

Follow Requirements/Limits field — verify before dispensing

Follow the Requirements/Limits field on each formulary line item. That field lists PA, QL, LA, SP, ST, ACA flags and any numeric limits — complying avoids denials.

• Verify line‑item flags before prescribing or dispensing (PA, QL, LA, SP, ST, ACA).
• If a drug shows LA or SP, confirm the correct dispensing channel or pharmacy network to avoid non‑coverage.

Required documentation for PA/QL/SP

Required documentation for PA/QL/SP: when PA or QL is invoked include clinical notes, prior medication trials, laboratory or genotype results, and a dosing schedule. Specialty products require evidence of monitoring and handling capability.

• For oncology or specialty agents include staging, biomarker/genotype, prior lines of therapy, and treatment intent.
• For CF and orphan disease drugs include genetic testing and specialist consultation notes.

PA and QL documentation — include approvals and justifications

PA and QL documentation: ensure the PA is submitted and that requested quantities do not exceed the stated QL unless an approved exception/PA to exceed is on file.

• If PA is approved for a quantity above the QL, retain the approval documentation with the claim submission.
• Document member‑specific justification when requesting quantities above line‑item QL.

Documentation for PA/LA/SP — specialty routing and limited availability

Documentation for PA/LA/SP: for medications with LA or requiring specialty dispensing, include justification for the dispensing location and documentation that the pharmacy meets specialty handling requirements.

• When LA applies, indicate why the member must receive the drug from a specific pharmacy or supplier.
• Specialty products (SP) often require distribution via contracted specialty pharmacies — include pharmacy acceptance/arrangement in the PA request.

Supporting documentation for prior authorization

Supporting documentation for prior authorization: provide drug‑specific clinical rationale, dosing schedule, prior therapies, and any monitoring plans. For rare/orphan and oncology drugs include specialty center involvement when applicable.

• Include pathology, treatment history, and specialist notes for oncology PAs.
• For enzyme replacement, genetic or rare disease therapies, include genetic testing and prior authorization from a specialist.

Documentation required for PA and QL

Documentation required for PA and QL: include the requested quantity, intended duration, clinical justification, prior medication history, and relevant lab/genetic results to support approval.

• Follow payer guidance for clinical fields required on PA forms and attach supporting records where indicated.
• If QL is measured in vials, pens, packets, or tablets per period, state the exact number and clinical reason for the requested supply.

Documentation to support PA — dosing and monitoring

Documentation to support PA: include dosing schedule, monitoring plan, and rationale in the PA submission. For biologics and specialty injectables, indicate who will administer and monitor therapy.

• For injectables, state administration setting (clinic, home infusion) and monitoring arrangements.
• Provide expected duration and plan for adverse event monitoring/reporting.

Specialty product documentation — specialty routing and handling

Specialty product documentation: SP products often require LA, PA, and QL designations be addressed in the submission. Use contracted specialty pharmacies and include specialty monitoring plans and handling instructions.

• SP products (many oncology, biologic and orphan drugs) require specialty pharmacy dispensing and additional documentation.
• Ensure the specialty pharmacy is authorized by EmblemHealth when routing SP claims.

Quantity limits and specialty routing — adhere or document exception

Quantity limits and specialty routing: adhere to QL and SP designations; exceeding QL or failing to route through specialty channels may lead to denial. When needed, request exceptions or PA with full supporting documentation.

• If a therapy requires more than the QL or needs to be dispensed via SP, include that justification in the PA or exception request.
• Contact EmblemHealth for guidance on approved specialty pharmacies and exception submission.

Specialty/program requirements — interpret flags

Specialty/program requirements: LA/PA/SP/ACA/ST flags indicate program‑level controls. Review these flags on each line item and follow payer procedures for PA, step‑therapy, limited availability, and specialty dispensing.

• ST (step therapy) is present for select agents and must be followed where shown; some parts of the formulary do not specify step sequences explicitly.
• ACA indicates certain products may be covered under Affordable Care Act protections when applicable.

Step therapy — applicability and notes

Step therapy notes: while many line items include PA/QL/LA/SP flags, explicit step‑therapy sequences are present only for select drugs (ST). Where ST is not specified in this segment, PA/QL/LA/SP remain the primary controls.

• Some drugs include ST annotations (e.g., GRALISE, HORIZANT, specified psychiatric agents); other line items do not list a step sequence.
• If ST applies, document prior failure or intolerance to required first‑line agents when requesting PA for later‑line therapy.