Prior Authorization, Step Therapy, documentation, and denial risks

Prior Authorization (PA), Step Therapy (ST), Limited Distribution (LD), Quantity Limits (QL), and Specialty (SP) routing are actively used across this formulary to manage access and coverage. Many high-cost, specialty, antiviral, antifungal, hepatitis, antineoplastic, endocrine, biologic, and other specialty-labeled drugs require prior authorization or are subject to step therapy, limited distribution, quantity limits, or specialty pharmacy routing. Failure to obtain required PA, to follow step therapy where specified, or to adhere to LD/SP routing and QL restrictions may result in denial of coverage.

• PA = Prior Authorization required before the plan will cover the drug; lack of PA can result in non-coverage.
• ST = Step Therapy: member must trial specified preferred agents first; exceptions may be requested.
• LD = Limited Distribution: drug may only be available from select pharmacies or supply channels.
• QL = Quantity Limit: maximum units supplied in a specified time period (e.g., 28 tablets/28 days).
• SP = Specialty product — may require specialty pharmacy, special handling, monitoring, or education.

Prior authorization required for selected agents

Selected high-cost antiviral, antifungal, hepatitis B/C, and other specialty agents listed in the formulary explicitly show PA in the Requirements/Limits field. Examples include ledipasvir/sofosbuvir, sofosbuvir-containing products (SOVALDI), sofosbuvir/velpatasvir, MAVYRET (glecaprevir-pibrentasvir), CRESEMBA (isavuconazonium), posaconazole formulations, and many antivirals listed with 'PA'. These products commonly also carry SP and QL flags.

• Hepatitis C agents (e.g., LEDIPASVIR/SOFOSBUVIR, SOFOSBUVIR/VELPATASVIR, SOVALDI, MAVYRET) = PA, QL, SP.
• Selected antifungals (e.g., CRESEMBA, posaconazole) = PA (and may have QL).
• Many antivirals and HBV/HCV agents list PA next to the product — confirm PA prior to dispensing.

Prior authorization and distribution requirements

Numerous specialty products require both PA and limited distribution or specialty routing (LD/SP). Examples include oncology agents, complex biologics, enzyme replacements, cystic fibrosis modulators, and infusions that are designated LD and SP; these programs often restrict where the drug can be dispensed and require PA documentation.

• Oncology agents (many entries) = LD + PA + QL + SP in Requirements/Limits.
• Cystic fibrosis modulators and enzyme therapies (e.g., KALYDECO, ORKAMBI, STRENSIQ) = LD + PA + QL + SP.
• Specialty injectables and infusions (e.g., ACTHAR, ENTYVIO PEN, BYLVAY examples in formulary) require PA and may be limited to specialty channels.

Prior authorization and limits required

Prior authorization is commonly paired with quantity limits and other program flags; several specialty and antineoplastic products list PA plus QL and SP (and often LD). Examples: abiraterone (Zytiga), alectinib (ALECENSA), brigatinib (ALUNBRIG), and many other antineoplastics. When PA is required, the specific Quantity Limit (e.g., 60 tablets/30 days) is listed in the Requirements/Limits field and must be respected.

• Antineoplastics: many require LD + PA + QL + SP.
• PA + QL examples: NEXLETOL and NEXLIZET = PA, QL (30 tablets/30 days).
• Dose pack or packet limits are enforced (e.g., MAVYRET pellet pack QL 140 packets/28 days).

Prior authorization requirement

Many formulary segments explicitly show 'PA' in the Requirements/Limits field for drugs across therapeutic classes — oncology, biologics, specialty endocrine agents, pulmonary antifibrotics, cystic fibrosis therapies, and numerous injectables. Confirm PA prior to dispensing to avoid claim denials.

• Specialty endocrine and metabolic agents (e.g., ACTHAR, SKYTROFA) frequently show LD, PA, SP.
• Pulmonary antifibrotics (e.g., OFEV) and CF modulators (e.g., KALYDECO, ORKAMBI) = LD, PA, QL, SP.
• Biologic agents and many injectables list PA in Requirements/Limits — verify PA status during prior authorization submission.

Utilization management triggers and denial risk

PA, QL, LD, and SP flags are utilization management triggers. Products with these flags can be denied if the documented clinical criteria, PA forms, or distribution channel requirements are not satisfied. Providers should submit clinical justification and supporting documentation matching the Requirement/Limit codes.

• PA/ST/SP may trigger denial when prior steps or documentation are not supplied.
• QL exceedance can result in partial or full denial; documentation must support dose and quantity requested.
• LD and SP items require dispensing through authorized channels — dispensing outside those channels may lead to denial or recoupment.

Documentation for PA, LD, QL, and specialty drugs

Documentation expectations: when a formulary entry lists PA, LD, QL, SP, ST or AC, providers must include supporting clinical documentation with the PA request. Documentation should show diagnosis, prior therapies tried (for ST), rationale for medical necessity, dosing and duration, and any lab or test results required by the PA criteria. For LD/SP products, documentation must also support use of the specialty or limited distributor.

• PA requests should include: patient diagnosis, prior therapy history (relevant to ST), clinical notes, lab results, and proposed dosing.
• For ST: document failure, intolerance, or contraindication to required first-line agents to support an exception.
• QL documentation: justify medical need for quantities exceeding listed QL with clinical evidence.
• LD/SP documentation: include ordering provider details and confirmation of appropriate specialty pharmacy or distributor.

Step therapy and specialty program notes

Step therapy is used selectively in this formulary. While many entries do not show explicit step sequences, select branded agents are flagged with ST and require trial of preferred agents first or documentation of a contraindication/intolerance. Providers may request exceptions with supporting clinical evidence.

• KERENDIA (finerenone) is flagged with ST — ensure step edits are satisfied or document rationale for exception.
• FOSRENOL, FERRIC CITRATE and some renal agents show ST in Requirements/Limits where noted.
• Where ST is not specified, PA, QL, LD, and SP remain the primary management controls.