Actimmune — Prior authorization required

Prior authorization is required for Actimmune; coverage is limited to all FDA‑approved indications and authorization is granted for a plan year.

Alecensa — Prior authorization

Prior authorization is required for Alecensa; the PA indicator applies to all FDA‑approved indications.

Radicava ORS — Prior authorization

Prior authorization is required for Radicava ORS and the Radicava ORS Starter Kit; the PA indicator applies to all FDA‑approved indications.

Listed medications — Prior authorization required

Prior authorization is required for the listed drugs in this section; ALUNBRIG is included with PA scope of all FDA‑approved indications.

Antipsychotic products — PA required

Prior authorization is required for the listed antipsychotic products and prerequisite therapy is required as specified in the policy.

JUXTAPID — Prior authorization

Prior authorization is required for JUXTAPID products; prerequisite therapy is required and specific clinical thresholds must be met.

AQNEURSA / ARCALYST — PA required

Prior authorization is required for AQNEURSA and ARCALYST per the listed criteria in the policy.

PA applies to FDA‑approved indications

Prior authorization applies to the listed medications for all FDA‑approved indications when the PA indicator is marked.

Adbry, Cibinqo, Augtyro — PA required

Prior authorization is required for Adbry, Cibinqo, and Augtyro as listed in this section.

PA required for FDA‑approved indications

Prior authorization applies to the listed medication(s) for all FDA‑approved indications when so indicated in the policy.

AVMAPKI FAKZYNJA — PA required

Prior authorization is required for AVMAPKI FAKZYNJA for all FDA‑approved indications.

AYVAKIT — PA required

Prior authorization is required for AYVAKIT for all FDA‑approved indications.

Listed medications — PA required for FDA indications

Prior authorization is required for the listed medications in this segment and applies to all FDA‑approved indications as noted.

Benlysta — Prior authorization required

Prior authorization is required for Benlysta products listed; PA covers all FDA‑approved indications and is granted for a plan year.

Besremi / Bosulif (Part B) — PA required

Prior authorization is required for Besremi and Bosulif under Part B; prerequisite therapy is required for both agents per policy.

Listed medications — Prior authorization required

Prior authorization is required for the listed medications and applies to all FDA‑approved indications noted for each drug.

Listed medications — PA for FDA indications

Prior authorization is required for the listed medications for all FDA‑approved indications as indicated in the policy.

PA required — All FDA‑Approved Indications

Prior authorization is required for the listed medications for all FDA‑approved indications (PA indicator = All FDA‑Approved Indications).

PA required for FDA‑approved indications (general)

Prior authorization applies for all FDA‑approved indications for the listed medications in this section when indicated.

Prerequisite therapy — Not required (N/A)

No prerequisite therapy is required for the entries where 'N/A' is specified.

Alecensa — Prerequisite therapy required

Alecensa requires prerequisite therapy (PREREQUISITE THERAPY REQUIRED = YES) and documentation of prior therapy must be provided.

Prerequisite therapy required — General

Prerequisite therapy is required for the medication blocks where the policy indicates 'YES' for prerequisite therapy.

Antipsychotic step therapy — Prior trial required

For antipsychotic products, a trial of at least one listed antipsychotic is required prior to approval.

• Previous trial must be on at least one of: aripiprazole, clozapine, fluoxetine‑olanzapine, haloperidol, olanzapine, quetiapine, risperidone, or ziprasidone.
• For MDD or schizophrenia, a prior trial of Rexulti is required.

JUXTAPID — Step therapy requirements

For JUXTAPID, prior trial or intolerance to statin therapy plus a prior trial of a PCSK9 inhibitor (Repatha or Praluent) is required before approval.

• Fasting LDL > 500 mg/dL AND triglycerides < 300 mg/dL must be documented.
• Documented trial of at least one statin (atorvastatin, rosuvastatin, simvastatin) or documented statin intolerance.
• Prior trial of Repatha OR Praluent is required.

AQNEURSA — Step therapy (miglustat required)

For AQNEURSA, the patient must have tried and failed at least 3 months of miglustat therapy prior to approval.

• Provide evidence of lack of improvement after >=3 months of miglustat (examples: horizontal saccadic eye movements, SARA scale).
• Use in combination with Miplyffa is excluded.

Atopic dermatitis — Required prior therapy failures

Coverage for atopic dermatitis agents requires prior failure of two specified therapies before approval.

• Failure of two of: topical corticosteroid; topical calcineurin inhibitor; phototherapy; oral immunomodulator (azathioprine, cyclosporine, mycophenolate); topical PDE‑4 (Eucrisa).

Entrectinib — Prerequisite therapy required

Entrectinib requests must include contraindication, intolerance, or failure of Rozlytrek (prerequisite therapy required).

AVMAPKI FAKZYNJA — Step therapy note

AVMAPKI FAKZYNJA notes no general prerequisite but requires documentation of prior platinum‑based therapy and prior Mekinist treatment or rationale per the policy.

• Reauthorization requires documentation showing no disease progression per RECIST v1.1.

Rufinamide — Prerequisite therapy required

Rufinamide requires prerequisite therapy as indicated by the policy prior to authorization.

SLE / Lupus Nephritis — Prerequisite and concomitant therapy

For SLE/lupus nephritis, the patient must have prior treatment with at least two specified agents and continue concomitant standard therapy with at least one of those classes.

• Prior treatments must include at least two of: corticosteroids, antimalarials, immunosuppressives.
• Concomitant continuation of at least one of those classes is required.

Besremi — Step therapy prerequisites

Besremi reauthorization and initial use require documentation showing inadequate response or intolerance to hydroxyurea (step therapy prerequisite).

• Diagnosis of polycythemia vera and documentation of inadequate response or intolerance to hydroxyurea are required.

BRAFTOVI / MEKTOVI — Prerequisite therapy

BRAFTOVI/MEKTOVI group requires prerequisite therapy as specified in the policy.

CABOMETYX — Prerequisite/step therapy

For some CABOMETYX indications, prior specific therapies are required (e.g., prior sorafenib for HCC; prior VEGFR‑targeted therapy for DTC; failed everolimus or sunitinib for pNET).

Prerequisite therapy — General requirement

Prerequisite therapy is required where the policy indicates 'YES' for prerequisite therapy.

No prerequisite therapy required

No prerequisite or step therapy is required for the medications where the policy explicitly lists 'N/A' for prerequisite therapy.

Actimmune — Required diagnosis documentation

Documentation must include a diagnosis of chronic granulomatous disease OR severe malignant osteopetrosis for Actimmune requests.

Alecensa — Required documentation (ALK‑positive NSCLC)

Alecensa requests must include documentation of NSCLC that is ALK‑positive (tumors are ALK‑positive).

Radicava ORS — Required documentation (ALS)

Radicava ORS requests must include documentation of amyotrophic lateral sclerosis (ALS) as defined by the revised El Escorial criteria.

ALS — Documentation per revised El Escorial criteria

Required medical information for ALS must include documentation that the diagnosis meets the revised El Escorial criteria.

ALK+ NSCLC — Required documentation

For ALK‑positive NSCLC, documentation must show metastatic NSCLC with ALK‑positive tumors and that the patient has failed, is intolerant of, or has a contraindication to Alecensa where applicable.

Antipsychotic group — Prior trial documentation

Documentation of prior psychotropic medication trials must specify agents tried and the indication; for MDD or schizophrenia include evidence of a prior trial of Rexulti.

JUXTAPID — Required medical information

For JUXTAPID, required documentation includes fasting LDL > 500 mg/dL and triglycerides < 300 mg/dL, genetic testing or family history/xanthoma documentation as listed, documentation of statin trial or intolerance, and prior trial of Repatha or Praluent.

AQNEURSA — Required documentation

AQNEURSA documentation must show trial and failure of at least 3 months of miglustat with evidence of lack of improvement in disease progression.

• Include neurologic symptom documentation, ambulatory status, weight (>=15 kg), SARA and functional test scores where applicable.
• Provide genetic confirmation per policy or alternative biochemical evidence if one allele mutated.

AQNEURSA — Genetic confirmation required

AQNEURSA requests must include genetic confirmation by DNA sequence analysis showing mutations in both alleles of NPC1 or NPC2, or if only one allele mutated provide positive filipin staining or elevated cholestane triol/oxysterols (>2x ULN).

AQNEURSA — Clinical measures to document

AQNEURSA clinical measures documentation must include neurologic symptoms, ambulatory status, weight (>=15 kg), SARA score, and specified functional test results (e.g., HPT‑D).

• SARA score must be >=7 and <=34.
• HPT‑D time must be >=20 and <=150 seconds.

ARCALYST — Required documentation

ARCALYST documentation must support one of the covered diagnoses: cryopyrin‑associated periodic syndrome, recurrent pericarditis, or deficiency of IL‑1 receptor antagonist (DIRA).

Atopic dermatitis — Required documentation

Atopic dermatitis documentation must show diagnosis of moderate to severe disease with >=10% body surface area and failure of two specified prior therapies; for Adbry reauthorization, patients <100 kg who achieved clear or almost clear skin must have tried every‑4‑week dosing.

AUGTYRO — Prerequisite therapy documentation

AUGTYRO requests require prerequisite therapy (policy indicates 'YES'); details must be provided in the clinical documentation.

Entrectinib — Required documentation

Entrectinib requests must include diagnosis of locally advanced or metastatic ROS1‑positive NSCLC or NTRK gene fusion‑positive solid tumors and documentation of contraindication, intolerance, or failure of Rozlytrek.

AUSTEDO — Required documentation

AUSTEDO documentation must include diagnosis of chorea associated with Huntington's disease or diagnosis of tardive dyskinesia.

AVMAPKI FAKZYNJA — Required documentation

AVMAPKI FAKZYNJA documentation 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 documentation of no progression per RECIST v1.1.

• RECIST v1.1 progression is defined as >=20% increase in sum of diameters of target lesions.

AYVAKIT — Required documentation

AYVAKIT documentation must include one of the covered diagnoses (PDGFRA exon 18 mutation–positive GIST including D842V, Advanced Systemic Mastocytosis subtypes, or Indolent Systemic Mastocytosis).

Balversa — Required documentation

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

Rufinamide — Required documentation

Rufinamide documentation must include evidence of prerequisite therapy as indicated by the policy for the seizure indication.

SLE / Lupus Nephritis — Clinical documentation required

For SLE/lupus nephritis, required clinical documentation must include diagnosis, current active disease status, prior treatments, and planned concomitant standard therapy.

• Document prior treatments and plan to continue at least one concomitant standard therapy (corticosteroid, antimalarial, or immunosuppressive).

Besremi — Required documentation

Besremi initial requests must include diagnosis of polycythemia vera and documentation of inadequate response or intolerance to hydroxyurea.

BRAF mutation — Diagnostic documentation required

Documentation of a BRAF V600E or V600K mutation is required for encorafenib/binimetinib combinations and related indications.

Caplacizumab — Required documentation

Caplacizumab requests must document diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) and that therapy was started inpatient in combination with plasma exchange.

CABOMETYX — Required documentation

CABOMETYX documentation must include the specific diagnosis corresponding to the listed indications and supporting prior therapy history where specified.

Calquence — Required documentation

Calquence documentation must include diagnosis (mantle cell lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma) and HSCT eligibility/prior treatment details when applicable.

Caprelsa — Required diagnostic documentation

Caprelsa requests must document symptomatic or progressive medullary thyroid cancer that is unresectable locally advanced or metastatic.

Carglumic acid / Sapropterin — Required documentation

For carglumic acid and sapropterin, documentation must confirm the specific metabolic diagnoses (NAGS deficiency for carglumic acid; BH4‑responsive PKU for sapropterin).

Actimmune — Hypersensitivity exclusion (denial risk)

A documented hypersensitivity to Actimmune or E. coli‑derived products is an explicit exclusion and will trigger denial of coverage.

Missing required diagnosis — Denial risk

Requests that lack the required diagnosis (for example, ALK‑positive NSCLC for Alecensa or ALS per revised El Escorial criteria for Radicava ORS) may be denied.

Alecensa — Prerequisite therapy not documented (denial risk)

Failure to document prerequisite therapy where required for Alecensa may result in denial.

ALS — Diagnosis documentation missing (denial risk)

Lack of documentation confirming ALS per the revised El Escorial criteria may trigger denial for Radicava ORS or related ALS entries.

ALK+ NSCLC — Missing prior therapy or diagnosis (denial risk)

Failure to document metastatic ALK‑positive NSCLC or failure/intolerance/contraindication to Alecensa may trigger denial.

Antipsychotic trials — Missing documentation (denial risk)

Failure to document required prior antipsychotic trials (including agents listed or Rexulti for MDD/schizophrenia) may result in denial.

JUXTAPID — Prerequisite failures (denial risk)

For JUXTAPID, not meeting LDL/triglyceride thresholds, lacking genetic/family/xanthoma documentation, or lacking documented trials/intolerance to statins and PCSK9 inhibitor may trigger denial.

• Required thresholds: untreated fasting LDL > 500 mg/dL AND triglycerides < 300 mg/dL.

AQNEURSA — Combination with Miplyffa excluded

Use of AQNEURSA in combination with Miplyffa is an exclusion and may trigger denial.

ARCALYST — TNF‑inhibitor combination excluded

Combination use of ARCALYST with a TNF‑inhibitor is excluded and may result in denial.

Combination biologic use — Exclusion (denial risk)

Use of specified medications in combination with another biologic (examples listed) is excluded and may trigger denial.

• Examples: Dupixent, Xolair, Humira, Entyvio, Otezla.

Entrectinib — Missing diagnosis/prior therapy (denial risk)

Lack of required diagnosis or prior therapy documentation for Entrectinib (ROS1‑positive NSCLC or NTRK fusion tumors and Rozlytrek failure/intolerance) may trigger denial.

AUSTEDO — Missing diagnosis (denial risk)

Absence of a documented diagnosis of chorea due to Huntington's disease or tardive dyskinesia may trigger denial for AUSTEDO.

AVMAPKI FAKZYNJA — Documentation triggers (denial risk)

Lack of required documentation for AVMAPKI FAKZYNJA (diagnosis, prior platinum therapy, ECOG 0–1, Mekinist treatment/rationale, reauthorization RECIST evidence) may trigger denial.

AYVAKIT — Missing required documentation (denial risk)

Lack of required documentation for AYVAKIT (one of the specified diagnoses) may trigger denial.

Balversa — FGFR3 confirmation required (denial risk)

Absence of documented FGFR3 genetic alteration or lack of progression after prior systemic therapy may trigger denial for Balversa.

Rufinamide — Missing prerequisite therapy (denial risk)

If prerequisite therapy is not documented for Rufinamide, authorization may be denied.

Seizure indication — Inadequate documentation (denial risk)

For seizure indications, lack of documentation that the patient has inadequate seizure control despite at least one anti‑epileptic drug may trigger denial.

Besremi / Bosulif — Missing clinical rationale (denial risk)

Missing required clinical rationale (e.g., Besremi: polycythemia vera and inadequate response/intolerance to hydroxyurea; Bosulif: Ph+ CML and imatinib failure/intolerance) may trigger denial.

BRAF mutation documentation missing (denial risk)

Lack of documented BRAF V600E or V600K mutation for intended encorafenib/binimetinib or related uses may trigger denial.

Caplacizumab — Missing prerequisite documentation (denial risk)

Caplacizumab requests lacking documentation of aTTP diagnosis and inpatient initiation with plasma exchange may be denied.

CABOMETYX — Missing prerequisite documentation (denial risk)

For CABOMETYX, lack of required disease‑specific documentation (e.g., prior sorafenib for HCC; prior VEGFR therapy for DTC; failed everolimus/sunitinib for pNET) may trigger denial.

Calquence — Insufficient history (denial risk)

Insufficient diagnostic or treatment history for Calquence (e.g., mantle cell lymphoma prior therapy or HSCT eligibility) may trigger denial.

Caprelsa — Insufficient diagnostic documentation (denial risk)

Lack of required documentation demonstrating symptomatic or progressive medullary thyroid cancer that is unresectable locally advanced or metastatic may trigger denial for Caprelsa.

Missing required medical information — General denial risk

Requests missing required clinical information per the diagnosis‑specific required medical information sections may be denied.