Prior Authorization Required

Prior Authorization Required: Many products listed across the formulary require prior authorization (PA). This includes selected opioid products (high‑strength, extended‑release, or specific formulations), numerous biologics and specialty injectables (for example NUCALA, XOLAIR, STELARA, TREMFYA, DUPIXENT, enoxaparin preparations), multiple antineoplastic agents (including targeted and hormonal therapies and many specialty oncology agents), selected antivirals (e.g., SOFOSBUVIR‑VELPATASVIR, SOVALDI), pulmonary hypertension therapies (epoprostenol, treprostinil, TYVASO kits, bosentan, OPSUMIT, TRACLEER), topical/ectoparasiticide agents (for example clindamycin‑benzoyl peroxide combos, spinosad, permethrin, malathion), and many other listed specialty or high‑cost agents. PA is also noted broadly for diagnostic and non‑FDA uses.

• Providers must submit the payer Prior Authorization form with clinical rationale and supporting documentation.
• Urgent PA requests: response within 24 hours of receipt of all necessary information; non‑urgent: within 72 hours (or faster if state law requires).
• Denials will include specific reasons; incomplete requests will identify missing material information needed to complete the request.
• Drugs flagged with PA, SP, or QL on the formulary may be denied at claim adjudication if PA or specialty enrollment is not obtained.
• PA triggers include high‑strength/ER opioid formulations, specialty biologics, oncology agents, certain antivirals, pulmonary hypertension meds, and non‑FDA or diagnostic uses.
• Some products show PA together with SP (specialty) indicating additional handling or fill constraints; others combine PA with QL (quantity limits) or ST (step therapy).
• For many opioids new‑start supply limits apply (commonly limited to a 7‑day supply); PA may be required for higher strengths or certain formulations.
• Topical agents and ectoparasiticides may carry QL, ST, or PA (examples: clindamycin‑benzoyl peroxide combos, clobetasol formulations, spinosad, permethrin, malathion).
• Antineoplastic agents frequently require PA and may also be SP and/or QL; include drug name, dose, and indication on the PA request.
• Non‑FDA or off‑label diagnostic uses require PA and may be denied without it.

Quantity Limits, Step Therapy, and Denial Risk

Quantity limits, step therapy, and PA interactions: exceedance of quantity limits (QL) or failure to follow step therapy (ST) or to obtain required PA may result in claim denial. Many formulary entries combine QL, PA and ST flags; providers should verify and document adherence to these rules before claim submission.

• Some formulations include explicit QLs and max‑fill limits (examples: SOLU‑CORTEF 2 max fills per 30 days; various injectables with ML or dose‑based QLs).
• Step therapy may apply to selected anticonvulsants and topical products — where ST is indicated, preferred agents must be tried first or PA must justify bypassing ST.
• Step edits are sometimes implied by tiering and PA/SP flags even when explicit ST sequences are not listed.
• New‑start opioid supplies are commonly limited (e.g., 7‑day supply) — prescribing above the new‑start limit may require PA and additional documentation.

Documentation Required for Prior Authorization, Step Therapy, and Quantity Limit Exceptions

Documentation requirements for PA, SP, QL, and ST: When submitting a prior authorization or requests to override QL or ST, provide clear clinical rationale and supporting medical records. For specialty drugs, include details on specialty enrollment, site of care if relevant, and dosing schedule. Document dosing and package/ML calculations when QL or SP settings are present.

• Include diagnosis, prior therapy and response, contraindications/intolerance to preferred therapies (for ST exceptions), and proposed dosing with duration.
• For antineoplastic agents, specify the exact drug, dose, regimen, and indication on the PA request.
• Specialty drug (SP) requests should include specialty pharmacy information and any enrollment/dispensing site requirements.
• When requesting overrides of QL, document why the clinical need exceeds the published quantity limit (include calculation of total dose, frequency, and intended duration).
• Maintain copies of all submitted PA forms and supporting clinical records; denials for missing documentation will cite the missing information.

Provider Actions — How to Submit and What to Expect

Operational steps for providers: verify formulary flags (PA, SP, QL, ST) before prescribing; complete and submit the PA form with supporting documentation; track PA response timelines; and ensure specialty enrollment or site‑of‑care approvals as required.

• Check the formulary entry for PA and QL flags at the time of prescribing — many formulary items require PA.
• If PA is required, complete the payer’s PA form and submit all requested clinical documentation to avoid delays or denials.
• Allow for urgent (24‑hour) and non‑urgent (72‑hour) PA response windows; follow up if the decision is not communicated within these timeframes.
• If a product is SP flagged, coordinate with the specialty pharmacy and confirm any kit/refill restrictions (examples: TYVASO kits, starter/refill kit requirements).
• For non‑FDA or off‑label diagnostic uses, obtain PA before performing or dispensing.

Preventing Denials — Practical Documentation Tips

When PA is indicated on the formulary, include explicit notes about QL, SP, and ST settings to prevent denials. Failure to document QL calculations, specialty handling, or step‑therapy rationale is a common reason for disapproval.

• Document specific quantity calculations (e.g., mL per 28 days, units per day) when QLs are listed.
• If a drug is both SP and PA, confirm specialty pharmacy enrollment and include that documentation with the PA form.
• For ST entries that are not fully specified in the formulary, include documentation of prior therapies tried and outcomes to support exceptions.
• Be aware that some agents list PA with package‑ or fill‑based limits (for example packages per 180 days); include dispensing plan to align with those limits.