Prior Authorization Required

Many drugs listed in this formulary require prior authorization (PA) before the plan will cover them. Prior authorization may be required for specific high-cost antiviral and hepatitis therapies (for example, EPCLUSA, MAVYRET, MAVYRET pellet packs, VOSEVI, VOSEVI pellet packs, SOVALDI-type regimens) as well as select antifungals. Numerous specialty and limited-access products (marked SP and/or LA) — including many oncology, biologic, gene, and enzyme therapies — also require PA and often have quantity limits (QL) or site-of-care restrictions. Failure to obtain required PA or to adhere to QL/LA/SP requirements may result in claim denial or delay.

• Prior Authorization Required: Drugs annotated 'PA' require approval before dispensing; without approval the plan may not cover the drug.
• High-cost antivirals/hepatitis agents: Examples listed with PA and often QL/SP include EPCLUSA (sofosbuvir-velpatasvir) and MAVYRET (glecaprevir-pibrentasvir) — PA is required for tablets and pellet/packet formulations.
• Selected antifungals: Certain agents (e.g., CRESEMBA/isavuconazonium) are marked PA and require authorization prior to coverage.
• Selected specialty drugs: Many specialty therapies across therapeutic classes (oncology agents, enzyme therapies, biologics, gene therapies) are marked LA, PA, SP and require prior authorization and may have quantity limits.
• PA for specific antiviral/hepatitis therapies: Products such as EPCLUSA, MAVYRET, VOSEVI, MAVYRET pellet packs and VOSEVI pellet packs are subject to PA, QL, and SP designations.
• PA required for many specialty drugs: Examples include numerous antineoplastics and supportive oncology agents (abiraterone/Zytiga, alpelisib/PIQRAY, selinexor/XPOVIO, many targeted oral agents) and immunomodulators — these are frequently LA, PA, QL, SP.
• Products requiring PA/QL: Several products list both PA and specified quantity limits (e.g., EPCLUSA QL 28 tablets/28 days; MAVYRET QL 84 tablets/28 days; many oncology and specialty agents list numeric QLs).
• Prior Authorization required for listed LA/PA/SP drugs: Items flagged LA/PA/SP (for example, ARIKAYCE, TOBI PODHALER, many biologics and enzyme replacements) require PA and may be limited to certain pharmacies or channels.
• Prior Authorization required for select specialty and high-cost agents: Examples include CHOLBAM, BYLVAY-type agents, ENTYVIO PEN, maralixibat/LIVMARLI, and other high-cost orphan or specialty drugs marked LA/PA/SP.
• PA/SP/LA required for specific products: Many products annotated with any combination of PA, SP, LA require submission of authorization per the plan's prior authorization process (examples throughout the formulary).
• Prior authorization may trigger denial: Claims submitted without required PA, or exceeding QL, or not meeting LA/SP conditions, may be denied until authorization/documentation is provided.
• High-cost antiviral requirements: Antiviral/hepatitis regimens (sofosbuvir-based regimens, glecaprevir-pibrentasvir, voxilaprevir combinations) carry PA and SP designations and often QLs; prior approval is expected before dispensing.
• PA/QL/SP requirements for listed specialty drugs: Specialty products commonly require PA plus QL and are often restricted to specialty pharmacies or limited distribution networks (LA).
• PA/LA/SP trigger: Any item labeled PA, LA or SP in the formulary should be treated as requiring prior approval and may have additional site-of-care or dispensing channel requirements.
• PA/LA may trigger denial: Failure to meet PA or LA conditions (for example dispensing outside permitted pharmacies) can lead to claim denial.
• Quantity limit exceedance: Requests exceeding the listed QL (for example XYWAV QL 540 mL/30 days, EPCLUSA QL 28 tablets/28 days) may be denied unless an exception is authorized.
• Authorization risk for flagged products: Coverage is subject to utilization management controls (PA, ST, SP, LA, QL) — providers should verify requirements before prescribing or dispensing.

Provider Documentation and Submission Requirements

When a drug is flagged PA, prescribers must follow the payer's prior authorization process and provide supporting clinical documentation. For LA and SP products, additional documentation (site-of-care justification, distribution channel adherence, specialty pharmacy enrollment) is often required. Documentation should justify medical necessity, prior trials (when step therapy/ST applies), dosing, duration, and reason for any requested QL exceedance. The plan may request PA forms, clinical notes, laboratory results, or prior treatment history to support approval.

• Documentation expectations: Provide clinical rationale, prior treatment history, relevant labs, and any required PA forms to support the PA request.
• Specialty / limited access documentation: For LA/SP products (for example many biologics, enzyme therapies, and orphan drugs), include site-of-care justification and ensure dispensing through approved channels/specialty pharmacies when required.
• PA and QL documentation expected: For drugs with both PA and QL, include dosing schedule and justification for the quantity requested relative to the listed QL (examples: OZEMPIC 1 pen/28 days, EPCLUSA 28 tablets/28 days).
• Documentation for PA: Prescribers must supply clinical evidence and any required forms per the plan's PA procedures; incomplete documentation may delay or result in denial.
• Documentation for PA/QL/LA/SP: Follow the payer's prior authorization process for products marked with these flags; documentation must address all applicable controls.
• Documentation for PA/LA agents: For drugs that are both PA and LA, include information proving appropriateness of limited distribution channel or specialty pharmacy enrollment.
• Documentation for restricted products: The plan may require manufacturer paperwork, prior therapy failure documentation, or specialty pharmacy enrollment to authorize coverage.

Step Therapy

Step therapy (ST) applies to some products. Where ST is indicated, the plan requires trials of specified first-line agents before covering the requested therapy. Not all step therapy details are listed in this excerpt; providers should consult the plan's PA criteria or clinical policy for exact step requirements and allowable exceptions.

• Step therapy requirement: Drugs annotated 'ST' require documented trials of preferred alternatives before the requested agent will be approved.
• Step therapy present for select products: Certain CNS and psychiatric medications, and other classes (examples in the formulary: FETZIMA noted with ST; select antidepressants and antipsychotics have ST annotations).
• Step therapy is not explicitly detailed here: Refer to the payer's clinical prior authorization criteria for specifics on acceptable first-line therapies, trial duration, and documentation required.

Product-Level and Pack-Specific Authorization (e.g., Palforzia)

Some products have multiple levels or kit/pack variants (for example Palforzia starter/level/maintenance packs) that are designated LA and SP and require adherence to the specific product level when requesting authorization. Ensure PA requests reference the exact product level or pack to avoid processing delays.

• Palforzia — product levels listed: Starter, Level 0, Level 1, Level 10, Level 11 (maintenance/titration) are marked LA and SP and require appropriate authorization for the specific level/pack.
• LA/SP implications: Limited availability and specialty designations may impose site-of-care, dispensing pharmacy, or monitoring requirements; include level/pack detail in PA documentation.