PA required for All FDA‑Approved Indications

Prior authorization is required for medications when the PA Indication Indicator is set to "1 - All FDA-Approved Indications." Submit a prior authorization request for any product flagged with this indicator.

Alecensa: Prior authorization required

Alecensa requires prior authorization for all FDA‑approved indications. Include documentation that the request is for an FDA‑approved use.

Radicava ORS: Prior authorization required

Radicava ORS (and the Radicava ORS Starter Kit) require prior authorization for all FDA‑approved indications; submit PA prior to dispensing.

ALUNBRIG: Prior authorization required

ALUNBRIG (brigatinib) requires prior authorization for all FDA‑approved indications; include indication-specific documentation with the request.

Psychotropic agents: Prerequisite therapy required

Prior authorization for the listed psychotropic agents requires documentation of prerequisite therapy trials before approval.

• Document prior trial(s) as indicated under each medication entry.

Prior authorization (prerequisite therapy required)

Prior authorization is required for the listed medications; many entries indicate prerequisite therapy is required — provide required prior‑therapy documentation when requested.

AQNEURSA and ARCALYST: PA required

AQNEURSA and ARCALYST require prior authorization for all FDA‑approved indications; submit the PA with the required clinical documentation.

PA requirements and AD-specific documentation

Prior authorization is required for the listed medications; for some (Adbry, Cibinqo) include the AD‑specific required medical information with the PA request.

• Include AD-specific documentation (e.g., BSA and prior therapy failures) for Adbry/Cibinqo.

PA applies to All FDA‑Approved Indications

Prior authorization applies to all FDA‑approved indications for the medications flagged with PA Indication Indicator 1; ensure the PA request references the FDA‑approved indication.

Prerequisite therapy: submit prior‑therapy documentation

Prerequisite therapy is required where indicated (PREREQUISITE THERAPY REQUIRED = YES). For AUSTEDO and other entries marked YES, include documentation of the required prior therapy or rationale.

AVMAPKI FAKZYNJA & AYVAKIT: PA required

Prior authorization is required for AVMAPKI FAKZYNJA co-pack and AYVAKIT for their FDA‑approved indications; include indication-specific documentation.

Listed drugs: PA required for FDA‑approved indications

Prior authorization is required for the listed drugs and applies to all FDA‑approved indications; attach the required documentation per the medication section.

Benlysta: PA required

Benlysta requires prior authorization for all FDA‑approved indications; include the PA and supporting clinical documentation.

Medication identifiers: include product identifier

The policy identifies specific medication identifiers (e.g., BENLYSTA 200 MG/ML SOLN A‑INJ, BENLYSTA 200 MG/ML SOLN PRSYR); use these identifiers on PA requests when applicable.

Besremi & Bosulif: PA and prerequisite therapy

Prior authorization is required and prerequisite therapy is required for Besremi and Bosulif; include documentation of prior therapy trials (e.g., hydroxyurea failure for Besremi, imatinib failure for Bosulif).

• Besremi: document inadequate response or intolerance to hydroxyurea.
• Bosulif: document Ph+ CML diagnosis and prior failure/intolerance to imatinib when applicable.

PA required; coverage duration: Plan Year (unless noted)

Prior authorization is required for the listed medications; coverage duration is generally Plan Year unless otherwise specified in the medication section.

PA indication scope: All FDA‑Approved Indications

PA applies to all FDA‑approved indications for products flagged as such; ensure the PA request reflects an FDA‑approved use.

Cablivi: PA requires aTTP diagnosis and inpatient initiation with plasma exchange

Cablivi prior authorization requires documentation of a diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) and documentation that therapy was initiated inpatient in combination with plasma exchange; note coverage duration limits.

• Document inpatient initiation with plasma exchange.
• Coverage duration: 3 months; maximum 58 days following last day of plasma exchange.

Calquence & Caprelsa: PA required (oncology)

Prior authorization is required for listed oral oncology medications (e.g., Calquence 100 mg tablet and Caprelsa) for all FDA‑approved indications; include required oncology documentation.

PA requirement: All FDA‑Approved Indications

Prior authorization applies to products where the PA Indication Indicator is set to cover All FDA‑Approved Indications; include required documentation per medication.

Akeega: Step therapy (Lynparza required)

Akeega requires step therapy: document intolerance, contraindication, or failure of Lynparza (olaparib) before Akeega will be authorized.

• Provide records showing trial of Lynparza and reason for discontinuation (failure, intolerance, or contraindication).

Alecensa: Prerequisite therapy documentation required

Alecensa has a prerequisite therapy requirement; include documentation of the required prior therapy as specified in the full medication section.

• Provide prior‑therapy details per the Alecensa section when requested.

Step therapy requirement: document prior trials

Entries marked "PREREQUISITE THERAPY REQUIRED" require documentation of trials of specified alternative agents before authorization will be granted.

• Attach prior‑therapy notes, dates, durations, and outcomes.

Step therapy / prerequisite trials: document required trials

Step therapy requires documentation of trials of specified alternative agents (for example, antipsychotic alternatives for the antipsychotic group, and statin and PCSK9 inhibitor trials for JUXTAPID).

• Antipsychotic group: document trial of at least one listed antipsychotic (or Rexulti for MDD/schizophrenia where indicated).
• JUXTAPID: document statin therapy trial/intolerance and prior Repatha or Praluent trial.

AQNEURSA & ARCALYST: Prerequisite therapy documentation required

For AQNEURSA, the patient must have tried and failed at least 3 months of miglustat therapy; for ARCALYST, prerequisite therapy is indicated — include documentation of these prior therapies.

• AQNEURSA: provide evidence of ≥3 months miglustat trial and lack of improvement.
• ARCALYST: include prior‑therapy documentation per the ARCALYST entry.

Adbry: Prerequisite/step therapy and reauthorization documentation

Atopic dermatitis agents (Adbry) require failure of two specified prior therapies before approval; include documented prior treatments and, for reauthorization, dosing‑trial history when applicable.

• Document failure of two listed therapies (topical corticosteroid, topical calcineurin inhibitor, phototherapy, oral immunomodulator, topical PDE‑4).
• Reauthorization: document every‑4‑week dosing trial for responders <100 kg when applicable.

Step therapy noted: include prior therapy details

Where step therapy is noted (PREREQUISITE THERAPY REQUIRED = YES), provide documentation of the required prior therapies; the specific prior agents are listed in each medication's required medical information.

Avapritinib: Mekinist step therapy requirement

Avapritinib requires prior treatment with Mekinist or a documented medical rationale explaining why Mekinist is inappropriate; include that documentation with the PA.

• Provide Mekinist treatment history or clinician rationale for avoiding Mekinist.

Rufinamide: Prerequisite therapy documentation required

Rufinamide requires documentation that prerequisite therapy was received; include prior treatment records showing the required trial(s).

Prerequisite therapy: provide required medical information

Prerequisite therapy requirements are documented under each medication's "Required medical information"; include the specified prior therapies when submitting a PA.

Besremi & Bosulif: Step therapy requirements

Besremi requires documented inadequate response or intolerance to hydroxyurea prior to authorization; Bosulif requires prior failure/intolerance to imatinib where applicable — include those records.

• Besremi: document hydroxyurea trial and outcome.
• Bosulif: document imatinib failure/intolerance for indicated CML phases.

CML: Imatinib prerequisite required

For CML in chronic, accelerated, or blast phase, document prior failure or intolerance to imatinib before seeking authorization for alternative agents.

No prerequisite therapy required (where indicated)

Some medication sections do not require prerequisite therapy; confirm the specific medication entry — if no prerequisite is listed, a prior‑therapy trial is not required.

Prerequisite therapy: follow medication‑specific instructions

When prerequisite therapy is indicated as YES, the required prior therapies and acceptable documentation are described under the medication's required medical information — provide those records with the PA.

Actimmune: Required diagnosis documentation

For Actimmune, provide documentation of a diagnosis of chronic granulomatous disease OR severe malignant osteopetrosis as part of the PA request.

Akeega: Required diagnosis and prior‑therapy documentation

For Akeega, include documentation of deleterious or suspected deleterious BRCA‑mutated metastatic castration‑resistant prostate cancer and evidence of intolerance, contraindication, or failure of Lynparza.

• Provide pathologic/genetic confirmation of BRCAm mCRPC and Lynparza treatment history with reasons for discontinuation if applicable.

Alecensa: Document ALK‑positive NSCLC

Alecensa requests must include documentation of NSCLC that is ALK‑positive; indicate tumor ALK‑positive status in the medical record.

• Provide pathology/genetic test results confirming ALK‑positive tumor status.

Radicava ORS: ALS diagnosis documentation required

For Radicava ORS, include documentation that the patient meets diagnostic criteria for ALS as defined by the revised El Escorial criteria.

• Attach clinical documentation confirming ALS per the revised El Escorial criteria.

ALUNBRIG/Alecensa: Document diagnosis and prior therapy

For ALUNBRIG and Alecensa indications, include the documented diagnosis matching the required medical information (ALS per El Escorial for ALS indications; ALK‑positive metastatic NSCLC with prior Alecensa failure where required).

• Provide diagnostic confirmation and prior‑therapy history as specified.

Antipsychotic group: Prior‑trial documentation required

For antipsychotic group requests, document prior trial(s) on at least one listed antipsychotic. If treating MDD or schizophrenia, document a prior trial of Rexulti when required.

• List medication name(s), dates, doses, duration, and reason for discontinuation for prior trials.

JUXTAPID: Required laboratory and prior‑therapy documentation

JUXTAPID requests must include fasting LDL (>500 mg/dL) and triglyceride (<300 mg/dL) values, documentation supporting genetic/family/xanthoma criteria, evidence of prior statin trial or intolerance, and prior trial of Repatha or Praluent.

• Include fasting lipid panel values and documentation of genetic/family history or xanthoma evidence.
• Document statin trial(s) and Repatha/Praluent trial history.

AQNEURSA: Complete required medical information

AQNEURSA authorizations must include documentation the patient tried and failed ≥3 months of miglustat, weight ≥15 kg, genetically confirmed NPC diagnosis (per DNA analysis or filipin/elevated oxysterols), presence of ≥1 neurological symptom, ambulatory status, and SARA/HPT‑D performance measures.

• Provide miglustat treatment records, genetic testing results, neurologic exam findings, weight, SARA score and HPT‑D or gait subtest data.

ARCALYST: Required diagnosis documentation

For ARCALYST, include documentation of the covered indication (CAPS, recurrent pericarditis, or DIRA) and any required prior‑therapy information.

• Attach diagnostic evidence supporting the ARCALYST indication requested.

Adbry: Required clinical documentation (BSA and prior failures)

Provide clinical documentation for atopic dermatitis requests showing moderate to severe AD (≥10% BSA) and failure of two specified prior therapies; for Adbry reauthorization include dosing‑trial history when applicable.

• Document BSA involvement, prior therapy details, and reauthorization dosing trials if applicable.

Rozlytrek: Diagnosis and prior‑therapy documentation required

Rozlytrek authorization requires documentation of ROS1‑positive metastatic or locally advanced NSCLC OR NTRK fusion‑positive solid tumor diagnosis and evidence of contraindication, intolerance, or failure of Rozlytrek where applicable.

• Provide molecular testing reports confirming ROS1 or NTRK fusion and prior‑therapy history.

AUSTEDO: Diagnosis and product documentation required

AUSTEDO requests must include documentation of a diagnosis of chorea associated with Huntington's disease or of tardive dyskinesia and the formulation requested.

• Specify diagnosis and product formulation (AUSTEDO, AUSTEDO XR, or titration pack).

Avapritinib: Required clinical documentation

Avapritinib requests must include diagnosis of recurrent KRAS‑mutated low‑grade serous ovarian cancer, prior platinum‑based therapy, ECOG 0–1, prior Mekinist treatment or documented rationale, and for reauthorization evidence of no progression per RECIST v1.1.

• Include genetic testing, prior chemotherapy history, ECOG status, Mekinist treatment history or rationale, and imaging/RECIST data for reauthorization.

Ayvakit: Required diagnostic documentation

Ayvakit requests must document one of the listed indications (e.g., unresectable/metastatic GIST with PDGFRA exon 18 mutation, advanced systemic mastocytosis, or indolent systemic mastocytosis) and supporting mutation/diagnostic evidence.

• Attach mutation testing or pathology reports supporting the selected indication.

Balversa: FGFR3 and prior‑therapy documentation required

Balversa authorizations must include diagnosis of locally advanced or metastatic urothelial carcinoma, confirmation of FGFR3 genetic alteration, and documentation of progression on or after at least one prior systemic therapy.

• Provide FGFR3 testing results, prior systemic therapy history, and evidence of disease progression.

Rufinamide: Prerequisite therapy must be documented

Rufinamide requests must include documentation that the prerequisite therapy was received; attach prior‑therapy records showing the required trial(s).

Seizure indications: Document inadequate control and prior AEDs

For seizure‑related indications, document inadequate seizure control despite treatment with at least one anti‑epileptic drug when submitting a PA.

• Provide seizure history, medications tried, durations, and documented lack of control.

Lupus indications: Document active disease and prior treatments

For lupus/SLE/lupus nephritis indications, document diagnosis, current active disease, prior treatment with at least two therapy classes (corticosteroids, antimalarials, immunosuppressives), and plan for continued concomitant therapy.

• Include treatment history showing ≥2 prior therapy classes and plan for ongoing concomitant treatment.

Missing required medical information may trigger denial

If required medical information is missing (e.g., diagnosis, prior therapy trials, lab values, mutation testing), the request may be denied — ensure all listed required items for the medication are included.

Actimmune: Hypersensitivity exclusion

Actimmune exclusion: document absence of hypersensitivity to Actimmune or E. coli‑derived products. Presence of hypersensitivity is an exclusion and may lead to denial.

Akeega: Missing diagnosis or Lynparza trial may trigger denial

For Akeega, failure to document the required BRCA‑mutated mCRPC diagnosis or lack of a documented Lynparza intolerance/contraindication/failure may result in denial.

Alecensa: Missing ALK‑positive diagnosis/prior therapy risks denial

Alecensa: absence of documented ALK‑positive NSCLC or missing prior‑therapy documentation where required may trigger denial.

Radicava ORS: ALS diagnostic confirmation required

Radicava ORS: lack of documentation confirming ALS per the revised El Escorial criteria may result in denial.

Alecensa: Prior‑therapy failure/intolerance documentation required

Failure to document prior therapy failure, intolerance, or contraindication to Alecensa (where required for ALK‑positive metastatic NSCLC) may trigger denial.

Antipsychotic group: Missing prior trial documentation risks denial

Lack of documentation of prior trials on the specified antipsychotics (or Rexulti where indicated for MDD/schizophrenia) may lead to denial for the antipsychotic group.

• Ensure records show medication name, dose, duration, and outcome for prior trials.

JUXTAPID: Incomplete prerequisite documentation risks denial

Incomplete JUXTAPID documentation (missing LDL >500 mg/dL with TG <300 mg/dL, genetic/family/xanthoma criteria, statin/PCSK9 trial evidence) may result in denial.

• Provide fasting lipid results, genetic/family history or xanthoma evidence, statin trial history, and Repatha/Praluent trial documentation.

Combination therapy exclusions: AQNEURSA & ARCALYST

Use of AQNEURSA in combination with Miplyffa, or ARCALYST in combination with a TNF‑inhibitor, are explicit exclusions and may result in denial if combination therapy is documented.

Combination biologic exclusion for AD agents

Use in combination with another biologic (e.g., Dupixent, Xolair, Humira, Entyvio, Otezla) is an exclusion for certain AD agents and may trigger denial.

Rozlytrek: Missing ROS1/NTRK documentation risks denial

Rozlytrek: lack of documentation confirming ROS1‑positive NSCLC or NTRK fusion‑positive tumor, or missing evidence of contraindication/intolerance/failure of Rozlytrek where required, may result in denial.

AUSTEDO: Diagnosis documentation required

AUSTEDO: absence of documentation for chorea associated with Huntington's disease or for tardive dyskinesia may lead to denial.

Avapritinib: Documentation‑based denial risks

Lack of required documentation for Avapritinib (diagnosis, prior platinum therapy, ECOG 0–1, Mekinist trial/rationale, and reauthorization RECIST data) may lead to denial.

Balversa: Missing FGFR3/diagnosis/prior‑therapy risks denial

Balversa: missing FGFR3 genetic alteration confirmation, absence of documented locally advanced/metastatic urothelial carcinoma, or lack of prior systemic therapy/progression documentation may result in denial.

Seizure control: Document inadequate control on prior AED(s)

Failure to document inadequate seizure control despite treatment with ≥1 anti‑epileptic may trigger denial for seizure‑related indications.

Lupus: Prior‑treatment documentation required

For lupus/lupus nephritis indications, failure to document prior treatment with at least two of corticosteroids, antimalarials, or immunosuppressives may result in denial.

Missing required medical information: risk of denial

When required medical information is missing for products like Besremi or Bosulif (e.g., diagnosis or prior therapy evidence), the PA may be denied — provide the listed documentation.

Imatinib prerequisite absent: denial risk

Absence of documented prior failure or intolerance to imatinib for indicated CML phases may trigger denial when prerequisite therapy is required.

Missing mutation testing (BRAF) risks denial

Missing mutation testing (e.g., BRAF V600E or V600K) for indicated tumor types may lead to denial; include molecular testing reports with the PA.

Cablivi: Inpatient initiation and plasma exchange documentation required

For Cablivi, failure to document that therapy was started inpatient with plasma exchange may result in denial; include inpatient and plasma exchange documentation.

• Submit records showing inpatient initiation and plasma‑exchange dates.

Insufficient diagnosis/prior‑therapy documentation risks denial

Insufficient diagnosis documentation (e.g., mantle cell lymphoma for Calquence or symptomatic/progressive medullary thyroid cancer for Caprelsa) may trigger denial; include the specific diagnostic and prior‑therapy details requested.

Missing required diagnosis: denial risk

Absence of a required diagnosis (e.g., symptomatic/progressive medullary thyroid cancer, hyperammonemia due to N‑acetylglutamate synthase deficiency, or BH4-responsive PKU) may lead to denial; include the specific diagnostic evidence requested.