Prior authorization required (Actimmune, Akeega)

Prior authorization is required for all FDA‑approved indications for Actimmune and Akeega; submit a PA request before dispensing.

Alecensa prior authorization

Alecensa requires prior authorization for all FDA‑approved indications; include documentation confirming ALK‑positive NSCLC when applicable.

Radicava ORS prior authorization

Radicava ORS requires prior authorization for all FDA‑approved indications; provide documentation of ALS per the revised El Escorial criteria.

ALUNBRIG prior authorization and prerequisite

Prior authorization is required for ALUNBRIG for ALK‑positive metastatic NSCLC; the patient must have failed, be intolerant to, or have a contraindication to Alecensa.

Topical testosterone prior authorization & lab/symptom requirements

Prior authorization is required for the specified topical testosterone products for FDA‑approved indications; include two separate serum testosterone measurements and symptom documentation.

• Two separate testosterone levels on different dates showing serum testosterone < 300 ng/dL
• Documentation of at least one symptom (malaise, fatigue, lethargy, muscle loss, depression, or decreased libido)

PA required for listed psychotropic agents

Prior authorization applies to the listed psychotropic medications; provide required prior‑trial documentation as specified elsewhere in the policy.

JUXTAPID prior authorization

JUXTAPID is subject to prior authorization per this segment; submit PA documentation as required.

Authorization duration and reauthorization rules

Initial authorizations are generally time‑limited to 6 months; reauthorization is typically for the Plan Year and NPC indications require fSARA stability or improvement for reauthorization.

• Initial authorization duration: 6 months
• Reauthorization duration: Plan Year
• NPC reauthorization requires fSARA score remained stable or improved

PA required for listed medications (general)

Prior authorization is required for all FDA‑approved indications for the listed medications in this section; obtain PA before therapy initiation.

AUGTYRO prior authorization and required prior therapy documentation

Prior authorization is required for AUGTYRO for all FDA‑approved indications and requires documentation of diagnosis and contraindication/intolerance/failure of Rozlytrek.

• Document diagnosis (ROS1‑positive NSCLC or NTRK fusion‑positive solid tumor)
• Document contraindication, intolerance, or failure of Rozlytrek

AUSTEDO prior authorization and required diagnosis

Prior authorization is required for AUSTEDO (including XR and titration packs) for all FDA‑approved indications; include the documented diagnosis (chorea of Huntington disease or tardive dyskinesia).

• Document diagnosis of chorea associated with Huntington's disease OR tardive dyskinesia

Prior authorization required (both listed medications)

Both of the listed medications in this segment require prior authorization for all FDA‑approved indications; submit PA requests accordingly.

BALVERSA and RUFINAMIDE prior authorization

Prior authorization is required for BALVERSA and RUFINAMIDE for their listed indications; PA applies to all FDA‑approved indications for each drug.

BENLYSTA prior authorization

Prior authorization is required for BENLYSTA for all FDA‑approved indications; obtain PA and document required clinical information per indication.

BESREMI prior authorization and required prior therapy

Prior authorization is required for BESREMI for all FDA‑approved indications; include documentation of diagnosis and prior hydroxyurea intolerance or inadequate response where applicable.

• Document diagnosis of polycythemia vera
• Document inadequate response or intolerance to hydroxyurea

PA required for BESREMI and BOSULIF

Prior authorization is required for BESREMI and BOSULIF for all FDA‑approved indications as listed; follow PA submission requirements for each.

Coverage duration for BESREMI and BOSULIF

Initial authorization durations: BESREMI initial approval is 6 months with reauthorization for the Plan Year; BOSULIF authorization duration is Plan Year.

• BESREMI initial: 6 months; reauthorization: Plan Year
• BOSULIF authorization duration: Plan Year

Prior authorization required (listed medications)

Prior authorization applies for all FDA‑approved indications for the medications listed in this section; submit complete documentation with the PA request.

PA required for listed medications (general)

Prior authorization is required for the listed medications; PA indication is All FDA‑Approved Indications—obtain PA before treatment.

CABLIVI authorization duration limits

CABLIVI approvals are time‑limited: initial coverage is 3 months and a maximum of 58 days following the last day of plasma exchange applies; ensure PA and time‑limit documentation are clear.

• Initial coverage duration: 3 months
• Maximum of 58 days following last day of plasma exchange

Prior authorization indicated (listed drugs)

Prior authorization is indicated for the listed medications and the PA indicator denotes coverage for all FDA‑approved indications; submit PA per policy.

PA required for CHOLBAM and COMETRIQ

Prior authorization is required for CHOLBAM and COMETRIQ and both list the PA indication as 'All FDA‑Approved Indications'; include required documentation with the PA.

Akeega step therapy requirement (Lynparza)

For Akeega, document contraindication, intolerance, or failure of Lynparza before requesting coverage; include evidence of the prior Lynparza trial or contraindication.

• Provide documentation of contraindication, intolerance, or treatment failure with Lynparza

Step therapy: no other requirements specified

No additional step therapy criteria are specified in this section beyond those explicitly listed for individual drugs.

ALUNBRIG step therapy: Alecensa trial required

Before ALUNBRIG will be authorized, document failure, intolerance, or contraindication to Alecensa; include supporting clinical notes or prior therapy records.

• Document attempt with Alecensa and reason for discontinuation (failure, intolerance, or contraindication)

Prior trial requirement for listed psychiatric agents

For the listed psychiatric medications, provide documentation of a prior trial on at least one specified antipsychotic; for MDD or schizophrenia, a prior trial on Rexulti is required when indicated.

• Prior trial on at least one of: aripiprazole, clozapine, fluoxetine‑olanzapine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone
• For MDD or Schizophrenia, prior trial on Rexulti

Prior lipid‑lowering therapy required

For severe hypercholesterolemia indications, document prior trial of at least one high/moderate‑intensity statin (atorvastatin, rosuvastatin, or simvastatin) and prior trial of Repatha or Praluent as specified.

• Prior trial of atorvastatin, rosuvastatin, or simvastatin OR documented statin intolerance
• Prior trial of Repatha OR Praluent

Prior therapy requirement for atopic dermatitis agents

For ADBRY/CIBINQO, document failure of two prior therapies (topical corticosteroid, topical calcineurin inhibitor, phototherapy, oral immunomodulator, or topical PDE‑4) before authorization.

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

NPC prior therapy and eligibility requirements

For the NPC indication after miglustat failure, document prior miglustat therapy of at least 3 months and other required genetic, weight, neurologic, ambulatory, and functional score criteria.

• ≥3 months of miglustat therapy with documented failure
• Weight ≥ 15 kg; genetic confirmation or alternative testing; neurologic symptoms and ambulatory status; SARA and HPT‑D criteria

Avmapki Fakzynja step requirement: Mekinist

For the Avmapki Fakzynja co‑pack, prior treatment with Mekinist is required or provide a documented medical rationale explaining why Mekinist is inappropriate.

• Document prior Mekinist treatment OR provide rationale why Mekinist is inappropriate

Prior systemic therapy required (urothelial carcinoma)

For urothelial carcinoma indications, document progression on or after at least one line of prior systemic therapy before coverage is granted.

Provider must document prior adequate trials

Providers must document prior adequate trials: for seizure indications at least one anti‑epileptic drug trial; for lupus nephritis/SLE at least two prior agents and plan to continue concomitant therapy.

• Seizure: documentation of inadequate control despite ≥1 AED
• Lupus nephritis/SLE: prior treatment with ≥2 agents and plan to continue concomitant therapy with ≥1 agent

Required prior therapy for BESREMI and BOSULIF

For BESREMI, document prior intolerance or inadequate response to hydroxyurea; for BOSULIF, document prior failure or intolerance to imatinib for CML in chronic phase.

• BESREMI: prior hydroxyurea intolerance or inadequate response
• BOSULIF: prior imatinib failure or intolerance (chronic phase CML)

Step/prior therapy requirements for Brukinsa

For Brukinsa, document prior lines or types of therapy required by indication (e.g., ≥1 prior therapy for MCL; prior anti‑CD20 regimen for MZL; ≥2 prior lines for FL).

• MCL: ≥1 prior therapy
• MZL: prior anti‑CD20–based regimen
• FL: ≥2 prior lines and will be used with obinutuzumab

Prescriber restriction: none specified

No prescriber restrictions are specified in these sections; prescriptions may be written by any appropriate provider meeting clinical standards.

Required medical information: Actimmune and Akeega

Required documentation for Actimmune includes diagnosis of chronic granulomatous disease or severe malignant osteopetrosis; for Akeega include diagnosis of BRCAm mCRPC and documentation of Lynparza contraindication/intolerance/failure.

• Actimmune: document diagnosis of chronic granulomatous disease OR severe malignant osteopetrosis
• Akeega: document deleterious or suspected deleterious BRCA‑mutated mCRPC and prior Lynparza contraindication/intolerance/failure

Alecensa required documentation (ALK positivity)

For Alecensa, include documentation confirming ALK‑positive NSCLC (e.g., ALK test results) with the PA submission.

• Provide test results confirming ALK positivity

Radicava ORS required diagnostic documentation

For Radicava ORS, provide documentation that the patient meets the ALS diagnosis per the revised El Escorial criteria when requesting PA.

• Document ALS diagnosis as defined by the revised El Escorial criteria

ALUNBRIG required medical information

For ALUNBRIG, document metastatic ALK‑positive NSCLC and the patient’s failure, intolerance, or contraindication to Alecensa when submitting PA.

• Document metastatic NSCLC with ALK‑positive tumor
• Document failure/intolerance/contraindication to Alecensa

Testosterone lab and symptom documentation required

For testosterone‑related therapy, provide two separate serum testosterone measurements on different dates showing <300 ng/dL and documentation of at least one clinical symptom.

• Two separate serum testosterone levels on different dates < 300 ng/dL
• Documentation of at least one symptom (malaise, fatigue, lethargy, muscle loss, depression, decreased libido)

Documentation required for listed psychiatric medications

For the listed psychiatric medications, provide documentation of prior trial(s) on at least one of the specified antipsychotic agents; for MDD or schizophrenia, document a prior trial on Rexulti where applicable.

• Document prior trial on one of: aripiprazole, clozapine, fluoxetine‑olanzapine, haloperidol, olanzapine, quetiapine, risperidone, ziprasidone
• For MDD or Schizophrenia, document prior trial on Rexulti

Required medical information for severe hypercholesterolemia

Provide documentation of untreated fasting LDL >500 mg/dL with triglycerides <300 mg/dL and supporting genetic/family/xanthoma evidence, plus prior trials of statin therapy and Repatha or Praluent where required.

• Untreated fasting LDL > 500 mg/dL and TG < 300 mg/dL
• Genetic or family history evidence for homozygous familial hypercholesterolemia or xanthomas before age 10
• Prior trial of atorvastatin, rosuvastatin, or simvastatin OR documented statin intolerance
• Prior trial of Repatha OR Praluent

Required diagnostic information for ARCALYST and similar agents

Provide diagnosis documentation supporting one of the listed indications (for example, cryopyrin‑associated periodic syndrome, recurrent pericarditis, or DIRA for ARCALYST) when requesting PA.

• Document diagnosis consistent with the requested indication

AUGTYRO required documentation

For AUGTYRO, include documented diagnosis (ROS1‑positive NSCLC or NTRK fusion‑positive solid tumor) and evidence of contraindication, intolerance, or failure of Rozlytrek with the PA.

• Diagnosis documentation
• Rozlytrek contraindication/intolerance/failure documentation

Avmapki Fakzynja required documentation and reauthorization evidence

For Avmapki Fakzynja co‑pack, provide diagnosis, prior platinum‑based therapy, ECOG 0–1 performance status, prior Mekinist treatment (or rationale), and reauthorization evidence of no disease progression per RECIST v1.1 when applicable.

• Diagnosis of recurrent KRAS‑mutated, recurrent low‑grade serous ovarian cancer
• Prior platinum‑based therapy
• ECOG performance status 0 or 1
• Prior Mekinist treatment or documented rationale why inappropriate
• Reauthorization: documentation showing no disease progression (RECIST v1.1 ≥20% increase = progression)

Ayvakit required diagnosis documentation

For Ayvakit, include documentation of the specific diagnosed indication (PDGFRA exon 18 mutation–positive GIST including D842V, Advanced Systemic Mastocytosis, or Indolent Systemic Mastocytosis).

• Documented diagnosis of one of the covered indications (PDGFRA exon 18 mutation‑positive GIST including D842V; AdvSM; Indolent SM)

Required molecular confirmation and prior therapy documentation

Document diagnosis and molecular confirmation where specified (e.g., PDGFRA exon 18 mutation for GIST; FGFR3 alteration for urothelial carcinoma) and prior treatment history showing progression after at least one systemic therapy when required.

• Provide molecular confirmation where required
• Document prior therapy history and progression as specified

Seizure documentation requirement

Document that the patient has inadequate seizure control despite treatment with at least one anti‑epileptic drug when requesting coverage for seizure indications.

• Evidence of inadequate seizure control despite ≥1 AED trial

Lupus nephritis / SLE documentation requirements

For lupus nephritis/SLE indications, document diagnosis, evidence of active disease, prior treatment with at least two listed agents, and plan to continue concomitant standard treatment with at least one agent.

• Diagnosis of lupus nephritis or SLE with current active disease
• Prior treatment with ≥2 of corticosteroids, antimalarials, immunosuppressives
• Plan to continue concomitant standard treatment with ≥1 agent

BESREMI and BOSULIF documentation requirements

For BESREMI, document diagnosis of polycythemia vera and evidence of inadequate response or intolerance to hydroxyurea; for BOSULIF, document Ph+ CML diagnosis and prior imatinib failure/intolerance where applicable.

CABLIVI documentation and inpatient start requirement

For CABLIVI initial authorization, document diagnosis of acquired TTP and that CABLIVI was started inpatient in combination with plasma exchange; include reauthorization evidence of persistent disease and clinical response.

• Initial: diagnosis of aTTP and inpatient start with plasma exchange
• Reauth: evidence of persistent disease (e.g., suppressed ADAMTS13) and clinical response (increased platelets, reduced neurologic symptoms, improved organ markers)

CABOMETYX required clinical documentation

For CABOMETYX and other oncology agents, include documentation of the specific FDA‑approved carcinoma diagnosis and prior therapies as applicable (e.g., prior sorafenib for HCC).

• Document specific carcinoma diagnosis
• Provide prior therapy history as required (e.g., prior sorafenib for HCC)

CHOLBAM documentation requirements

For CHOLBAM initial authorization provide abnormal urinary bile acids analysis by FAB‑MS and neurologic exam; for reauthorization provide evidence of improvement in liver tests and/or weight.

• Initial: abnormal urinary bile acids by FAB‑MS and neurologic exam findings
• Reauth: improvement in ALT/AST, bilirubin, and/or weight

Actimmune hypersensitivity exclusion (denial risk)

Coverage will be excluded for members with hypersensitivity to Actimmune or E. coli‑derived products; do not submit PA for such members.

Alecensa denial risk: missing ALK documentation

Lack of documentation confirming ALK‑positive NSCLC may trigger denial for Alecensa; include ALK test results with the PA.

Radicava ORS denial risk: missing ALS documentation

Lack of documentation confirming ALS diagnosis per the revised El Escorial criteria may trigger denial for Radicava ORS; include the diagnostic criteria evidence.

ALUNBRIG denial risk: missing diagnosis or Alecensa trial

Coverage may be denied for ALUNBRIG if the diagnosis is not metastatic ALK‑positive NSCLC or if failure/intolerance/contraindication to Alecensa is not documented.

Testosterone documentation denial risk

Coverage may be denied for testosterone therapy if two separate testosterone measurements on different dates showing serum testosterone <300 ng/dL and required signs or symptoms are not provided.

• Two separate testosterone levels on different dates < 300 ng/dL are required
• At least one qualifying symptom must be documented

Testosterone lab requirement — denial risk

Failure to provide two separate testosterone levels on different dates with serum testosterone below 300 ng/dL may trigger denial for testosterone‑related indications.

Prior trial documentation denial risk (psychiatric agents)

Lack of documented prior trial on at least one of the listed antipsychotics may trigger denial for the indicated psychiatric medications; ensure prior‑trial records are included.

• Document prior trial on an appropriate antipsychotic (listed in policy)

Exclusion criteria and combination exclusion (denial risk)

Requests will be excluded if the patient has significant hepatic disease or alcohol abuse; use of AQNEURSA in combination with Miplyffa is excluded—verify exclusions before submitting PA.

• History of significant hepatic disease or alcohol abuse excludes coverage
• AQNEURSA used in combination with Miplyffa is excluded

Combination therapy exclusions (denial risk)

Coverage is excluded when ARCALYST is used in combination with a TNF‑inhibitor, and ADBRY/CIBINQO are excluded when used with another biologic; document concurrent therapies.

• ARCALYST + TNF‑inhibitor: excluded
• ADBRY/CIBINQO + another biologic (e.g., Dupixent, Xolair): excluded

Documentation deficiencies may trigger denial (Avmapki Fakzynja)

Lack of required documentation such as prior platinum‑based therapy, ECOG 0–1 status, or evidence regarding Mekinist may trigger denial for Avmapki Fakzynja; include these items when applicable.

• Document prior platinum‑based therapy and ECOG performance status
• Document prior Mekinist treatment or rationale if not used

Missing indication or molecular documentation (denial risk)

For Ayvakit and similar agents, absence of documentation of the specific diagnosed indication or requisite molecular criteria may lead to denial; include mutation confirmation when required.

• Provide PDGFRA exon 18 mutation confirmation for GIST where required
• Document diagnosis of AdvSM or Indolent SM as applicable

Genetic alteration and prior therapy denial risk (urothelial carcinoma)

Absence of confirmed FGFR3 genetic alteration or lack of progression after prior systemic therapy may trigger denial for the urothelial carcinoma indication—include genetic and prior‑therapy evidence.

• Confirm FGFR3 genetic alteration
• Document progression after ≥1 line of systemic therapy

Seizure indication denial risk: missing AED trial documentation

Lack of documentation showing inadequate seizure control despite treatment with at least one anti‑epileptic drug may trigger denial for seizure indications.

Lupus nephritis / SLE denial risk: missing prior/concomitant therapy

For lupus nephritis/SLE indications, failure to document prior treatment with at least two agents or lack of documentation of continued concomitant therapy may trigger denial.

• Document prior treatment with ≥2 listed agent classes
• Document plan to continue concomitant standard treatment with ≥1 agent

Missing clinical justification (denial risk)

Lack of required medical information (e.g., no documented diagnosis of polycythemia vera or no documentation of inadequate response/intolerance to hydroxyurea) may trigger denial for BESREMI or BOSULIF requests.

Documentation and prior therapy gaps (denial risk)

Lack of diagnostic confirmation (e.g., no BRAF V600E/V600K documentation) or absence of required prior therapies may cause denial for oncology agents; include mutation and prior‑therapy evidence.

CABLIVI initial authorization denial risk

For CABLIVI, lack of documented diagnosis of aTTP or absence of documentation that therapy was started inpatient with plasma exchange may trigger denial for initial authorization.

CABOMETYX authorization denial risk

For CABOMETYX, missing documentation of the specific FDA‑approved oncology diagnosis or prior therapy history (e.g., prior sorafenib for HCC) may trigger denial; include required prior‑therapy records.

Missing required prior therapies or diagnoses (denial risk)

Lack of required diagnosis or prior therapy (for example, no prior sorafenib for hepatocellular carcinoma or no prior VEGFR‑targeted therapy for DTC) may trigger denial; verify and document prior therapies.

Medullary thyroid cancer documentation denial risk

Absence of documented symptomatic or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease may trigger denial for related requests.

Missing required diagnosis (metabolic therapies) — denial risk

Requests lacking documentation that carglumic acid is for hyperammonemia due to N‑acetylglutamate synthase deficiency or that sapropterin is for BH4‑responsive phenylketonuria may be denied.

CHOLBAM lab/clinical documentation denial risk

For CHOLBAM initial requests, absence of abnormal urinary bile acids by FAB‑MS and neurologic exam findings may trigger denial; for reauthorization, lack of improvement in ALT/AST, bilirubin, or weight may trigger denial.

CABlivi site‑of‑care requirement

Initial CABLIVI therapy must be started inpatient in combination with plasma exchange; ensure site‑of‑care and inpatient initiation are documented.

• CABLIVI must be started inpatient and used with plasma exchange for initial authorization