Prior Authorization Required — general

Prior Authorization (PA) is required for many specialty, branded, and certain generic products listed on the formulary. Failure to obtain PA when indicated may result in claim denial or delay. For products flagged as "PA for new starts", prescribers must document whether the member is a new start and supply supporting clinical justification.

• Obtain PA for all drugs with the PA flag before dispensing; missing PA is a common denial trigger.
• When a product is marked "PA for new starts", include documentation that the patient is initiating therapy and the medical indication.
• Quantity limits (QL) shown on formulary entries must be respected; requests exceeding QL require prior clinical justification and are subject to denial.

PA and Quantity Limits for Biologics/Targeted Therapies

Prior Authorization and quantity limits apply to many biologic and targeted therapies. Providers must document diagnosis and clinical rationale to meet PA and QL requirements.

• Anti‑TNF, JAK inhibitors, interleukin agents and other biologics often require PA and have explicit QL (for example, ENBREL, RINVOQ, XELJANZ entries).
• Quantity limits for some biologics are diagnosis‑based — include supporting diagnosis documentation when requesting PA.
• Follow the specified QL (e.g., ENBREL: quantity limit based on diagnosis; RINVOQ: 12 mL/day for solution) when submitting requests.

Step Therapy + Prior Authorization — selected products

Step therapy (ST) is required for selected agents and may be coupled with PA. For products with ST, prior trials of preferred alternatives must be documented; failure to meet ST requirements can result in denial even when PA is obtained.

• Combination inhalers such as BREO ELLIPTA, DULERA, and fluticasone‑furoate/vilanterol list ST and PA — document prior therapies and clinical rationale.
• ST applies to multiple classes (e.g., select amphetamine products, some ADHD meds, antidiabetic combos, GLP‑1/GLP‑1‑related injectables).
• When both ST and PA are required, demonstrate that ST criteria were met or provide justification for bypassing ST (e.g., intolerance or contraindication).

Product-specific PA and Quantity Limits (examples)

Specific product groups require PA and have defined quantity limits or level‑based limits. Providers must follow these product‑specific rules when requesting authorization.

• Methylphenidate transdermal patches (Daytrana generics): ST, PA, QL (1 patch/day); PA is required for new starts — document prior therapies and new‑start status.
• Palforzia (peanut allergen immunotherapy) levels: PA required with level‑specific QL (level‑based caps or packets per day as listed).
• Aminoglycosides: ARIKAYCE SUS and tobramycin nebulizer solution require PA; tobramycin nebu soln QL is 10 mL/day.
• Ztalmy: PA and QL (1,100 mL every 30 days).
• Xcopri: PA and QL specified per pack/strength (e.g., 1 tab/day for many packs) — include dosing regimen in request.

PA and QL for Oncology and Selected Specialty Agents

Oncology and other specialty agents frequently list PA plus specific QL per strength or pack. Requests must include regimen details and diagnosis to support medical necessity.

• Many antineoplastic and targeted oral agents require PA and list QL by strength or pack (examples include LENVIMA, VENCLEXTA, ONUREG, FRUZAQLA, XPOVIO).
• TRYVIO and other specialty branded oncology agents require PA and have per‑day QL (e.g., TRYVIO 1 tab/day).
• For oncology agents, include treatment intent, line of therapy, weight or BSA if dosing is weight‑based, and expected duration when requesting PA.

Documentation Expectations and Denial Risk

Documentation must accompany PA requests. Provide diagnosis, prior treatment history, age limits (when applicable), dosing schedule, and justification for exceptions or QL overrides.

• Diagnosis‑required QL (e.g., ENBREL): include supporting diagnosis and relevant clinical notes.
• Document age limits where specified (e.g., phenytoin chewable tablets have a maximum age indication); claims outside age limits may be denied.
• For GLP‑1 agonists and antidiabetic injectables (e.g., MOUNJARO, OZEMPIC, RYBELSUS), include prior therapy trials and indicate if PA is for a new start.
• TRYVIO and other branded agents: supply clinical documentation sufficient to support PA and adherence to the per‑day QL.
• General PA documentation: medication history, rationale for chosen agent, recent labs or imaging if relevant, and notation whether member is a new start.

Quantity and Age Limit Enforcement — denial triggers

Quantity limits and age restrictions are actively enforced. Claims exceeding QL or falling outside age restrictions without adequate documentation are at high risk for denial.

• Review formulary QL entries (examples: OTEZLA 55 tabs/28 days; HUMULIN R U‑500 QL; many oncology agents' tab/cap limits).
• For drugs with explicit daily or per‑28‑day limits, include clinical justification for larger quantities when warranted.
• Age limits (e.g., certain chewable formulations) must be documented; requests for patients outside the age range require medical justification.