Prior authorization required for listed drugs

Many products listed in this document require prior authorization; see individual product entries for indication‑specific PA criteria including required prior trials, prescriber specialty, age limits, exclusions and coverage durations.

Armodafinil (MAC) PA

Prior authorization is required for armodafinil when used for MAC lung disease and must document diagnosis, use as part of a combination antibacterial regimen, failure to achieve at least two negative sputum cultures after a minimum of 6 consecutive months of multidrug background therapy, age ≥18, and that the drug is prescribed by or in consultation with a pulmonologist or infectious disease specialist.

• Diagnosis of MAC lung disease
• Used as part of combination antibacterial regimen
• Persistent positive cultures after ≥6 months of background therapy (no ≥2 negative sputum cultures)
• Member ≥18 years
• Prescribed by/consult pulmonologist or infectious disease specialist

CAYSTON PA

Prior authorization is required for CAYSTON (aztreonam) for cystic fibrosis; the request must document CF diagnosis, evidence of Pseudomonas aeruginosa in the lungs, susceptibility to aztreonam, FEV1 between 25% and 75% predicted, member age ≥7, and that the prescriber is a pulmonologist, infectious disease specialist, or CF care center specialist.

• CF diagnosis with Pseudomonas aeruginosa documented
• Susceptibility showing organism sensitive to aztreonam
• FEV1 25%–75% predicted
• Member ≥7 years
• Prescribed by/consult pulmonologist, ID specialist, or CF center specialist

DOPTELET PA

DOPTELET prior authorization must document indication (CLD procedural support or chronic ITP), baseline platelet thresholds (CLD <50,000/mcL; ITP <30,000/mcL), required prior therapies for ITP, prescriber specialty (hematologist/oncologist), and Part B prerequisite where applicable.

• CLD: baseline platelets <50,000/mcL and scheduled procedure (coverage 1 month)
• ITP: baseline platelets <30,000/mcL plus inadequate response/intolerance to corticosteroids, IVIG, splenectomy, or rituximab (coverage 12 months)
• Prescribed by or in consultation with hematologist/oncologist
• Part B prerequisite: Yes for some uses

Prior authorization required (Dupixent examples)

Prior authorization is required for Dupixent products by indication and must include documentation of diagnosis‑specific criteria, prior therapy failures or intolerances, and appropriate specialist prescriber or consultation.

• Atopic dermatitis: inadequate response/intolerance to topical therapies
• Asthma: eosinophil thresholds and exacerbation history plus controller therapy
• EoE: ≥15 eosinophils/HPF, symptoms of esophageal dysfunction, weight and prior trial documentation
• Prescriber specialty requirements per indication

EMGALITY prior authorization

Emgality (including 300 mg dose) requires prior authorization documenting migraine diagnosis, headache frequency thresholds (episodic 4–14 days/month or chronic ≥15 days/month), and failure or intolerance to two listed prophylactic oral agents.

• Episodic migraine: 4–14 headache days/month and failure/intolerance to two prophylactics
• Chronic migraine: ≥15 headache days/month and failure/intolerance to two prophylactics
• Prescribed by neurologist/headache specialist or certified pain specialist
• Initial coverage typically 6 months

Growth hormone prior authorization

Growth hormone products require prior authorization with documentation meeting indication‑specific diagnostic thresholds (height SDS, growth velocity, bone age, provocative testing), prescriber restriction to an endocrinologist (or consult), and typical approvals of 12 months with annual re‑evaluation for continuation.

• Diagnostic documentation (height SDS, growth velocity, bone age, provocative testing)
• Prescribed by or in consultation with an endocrinologist
• Initial/continuation approvals commonly 12 months; annual re‑evaluation required

High-dose opioid prior authorization

High‑dose opioid therapy (initial and continuation) requires prior authorization; initial high‑dose starts require opioid tolerance and prior evaluation of non‑opioid therapies, and continuation requires recent pain assessment, clinical benefit outweighing safety risks, and that the member is not in substance‑abuse treatment.

• Initial: cancer pain OR chronic non‑cancer pain with opioid tolerance (example dosing thresholds provided) and prior evaluation for non‑opioid pharmacologic treatment
• Continuation: pain assessment within 6 months, clinically meaningful improvement, and no active substance‑abuse treatment
• Coverage duration: remainder of contract year (initial), continuation criteria reference morphine equivalent ≥90 mg/day

CMV — Prior authorization requirements

CMV (Livtencity) prior authorization requires documentation of CMV infection/disease in a transplant recipient, inadequate response or intolerance to at least 2 weeks of listed antivirals (ganciclovir, valganciclovir, foscarnet, cidofovir), member weight ≥35 kg, and specialist prescriber (transplant/ID/oncology).

• Diagnosis of CMV infection/disease
• Recipient of HSCT or solid organ transplant
• Inadequate response/intolerance to ≥2 weeks of listed antivirals
• Member weight ≥35 kg
• Prescribed by transplant/ID/oncology specialist; coverage duration 8 weeks

Nucala — Prior authorization requirements

Nucala (mepolizumab) prior authorization requires documentation of indication‑specific eosinophil thresholds (e.g., ≥150 cells/µL at initiation or ≥300 cells/µL within 12 months), exacerbation history or hospitalization, concurrent high‑dose ICS plus controller therapy, and appropriate specialist prescriber involvement.

• Blood eosinophils ≥150 cells/µL at initiation or ≥300 cells/µL within past 12 months
• Exacerbation history (e.g., ≥2 exacerbations requiring systemic steroids or hospitalization) as specified per indication
• Current treatment with high‑dose ICS plus another controller
• Prescribed by pulmonologist or allergy/immunology specialist; initial/reauth coverage details apply

Nurtec — Prior authorization requirements

Nurtec (rimegepant) prior authorization requires documentation of the indication: for acute use, episodic migraine diagnosis with <15 headache days/month and failure of a generic triptan; for preventive use, episodic migraine days and failure of a 4‑week trial of two listed prophylactic agents.

• Acute: migraine diagnosis, <15 headache days/month, failure/intolerance to one generic triptan
• Preventive: episodic migraine (4–18 migraine days/month) and failure/intolerance to two prophylactic agents after 4‑week trials
• Prescriber: neurologist/headache specialist or certified pain specialist; initial 6 months, reauth 12 months

General PA evidence requirements

Approve prior authorization requests when any one of the general evidence standards is met: FDA‑approved indication/regimen requested; NCCN Category 1 or 2A; supportive AHFS‑DI or Clinical Pharmacology narrative; Micromedex Class I/IIa/IIb recommendation; Lexi‑Drugs off‑label evidence level A; or supportive peer‑reviewed literature.

• FDA‑approved indication/regimen
• NCCN Drugs & Biologics Compendium Category 1 or 2A
• Supportive compendia (AHFS, Clinical Pharmacology) or Micromedex Class I/IIa/IIb
• Lexi‑Drugs off‑label evidence level A or peer‑reviewed literature

DMARD prior authorization

DMARD/class biologic prior authorizations require documentation of diagnosis and inadequate response or intolerance to specified conventional DMARDs or prior therapies, with prescriber specialty restrictions applied for many indications.

• Document diagnosis per indication
• Document failure/intolerance to required conventional DMARD(s) or prior biologics per product
• Prescriber: rheumatologist or specialty per indication

CF genotype confirmation

For CFTR modulators and other CF therapies, prior authorization requires genotype confirmation when relevant (e.g., homozygous F508del for ORKAMBI) via an FDA‑cleared test if genotype is unknown, and prescriber should be a pulmonologist or CF care specialist.

• Genotype confirmation (homozygous F508del) via FDA‑cleared test if unknown
• Prescribed by or in consultation with pulmonologist or CF center specialist
• Coverage indefinite where indicated

PROMACTA PA

PROMACTA (eltrombopag) prior authorization requires diagnosis‑specific documentation (e.g., ITP with baseline platelets <30,000/mcL) and documentation of prior therapies; prescriber specialty is typically hematology/oncology.

• ITP: baseline platelet count <30,000/mcL
• Document prior inadequate response or intolerance to corticosteroids, IVIG, splenectomy, or rituximab
• Prescribed by or in consultation with hematologist/oncologist; coverage durations vary

Hyperlipidemia / ASCVD prior authorization

Prior authorization for lipid‑lowering agents (e.g., PCSK9, Nexletol/Nexlizet scenarios) requires documentation of diagnosis and LDL‑C thresholds: LDL‑C ≥70 mg/dL after ≥8 weeks of at least moderate‑intensity statin (or documented statin intolerance) or other specified LDL thresholds depending on indication.

• LDL‑C ≥70 mg/dL after ≥8‑week trial of at least moderate‑intensity statin therapy OR documented statin intolerance
• Nexletol/Nexlizet: often require prior statin and ≥8 weeks of ezetimibe adjunct unless intolerant
• Initial durations commonly 6 months; continuation 12 months

RINVOQ / RINVOQ LQ prior authorization

RINVOQ and RINVOQ LQ prior authorization requires documented diagnosis and prior inadequate response or intolerance to recommended DMARDs and/or TNF inhibitors as specified for each indication; prescriber specialty requirements apply.

• Document diagnosis per indication (RA, PsA, AD, IBD, etc.)
• Document failure/intolerance to required prior DMARDs and/or TNF inhibitors
• Prescribed by or in consultation with rheumatologist or specialty per indication

VYNDAQEL prior authorization

VYNDAQEL prior authorization requires diagnostic confirmation of ATTR‑CM (TTR mutation, biopsy, or supportive imaging with exclusion of light‑chain amyloidosis), documentation of heart failure history and NYHA class I–III, and cardiology prescriber involvement.

• Confirm ATTR‑CM by TTR mutation, biopsy, or imaging/scintigraphy with exclusion of light‑chain amyloidosis
• Document HF history and NYHA Functional Class I–III
• Prescribed by or in consultation with a cardiologist; initial/reauth 12 months

Bosentan (PAH) prior authorization requirement

Bosentan (Tracleer) prior authorization for PAH initial therapy requires WHO Group I PAH with NYHA Class II–IV, hemodynamic confirmation by catheterization or echocardiography including mean PAP ≥25 mm Hg at rest (or >30 mm Hg with exertion), and prescriber cardiologist or pulmonologist.

• PAH WHO Group I with NYHA FC II–IV
• Diagnostic confirmation by right‑heart catheterization or echocardiography
• Mean pulmonary artery pressure ≥25 mm Hg at rest (or >30 mm Hg with exertion)
• Prescribed by/consult cardiologist or pulmonologist; initial 6 months

Tremfya prior authorization requirement

Tremfya prior authorization requires indication‑specific prior trials: for PsO and PsA inadequate response or intolerance to two specified agents (lists vary), and for UC/CD trials as specified or use as maintenance after IV induction; concurrent biologic therapy is an exclusion.

• Plaque psoriasis/PsA: inadequate response or intolerance to two listed agents (e.g., Cosentyx, Enbrel, Humira, Skyrizi, Ustekinumab, Otezla)
• UC/CD: inadequate response/intolerance to listed agents or used as maintenance after IV induction
• Exclusion: concurrent biologic DMARDs or TNF antagonists; prescriber specialist required

Tymlos prior authorization requirement

Tymlos prior authorization for postmenopausal osteoporosis requires documentation of PMO with high fracture risk (multiple vertebral fractures, BMD T‑score ≤ −2.5, or prior osteoporotic fracture) and inadequate response or intolerance to one listed therapy; cumulative lifetime limits apply.

• Diagnosis of PMO with high fracture risk (multiple vertebral fractures, BMD T‑score ≤ −2.5, or osteoporotic fracture)
• Inadequate response/intolerance to one listed therapy (e.g., bisphosphonates, HRT, SERMs, denosumab)
• Coverage typically remainder of contract year; cumulative lifetime therapy limits noted

Vowst prior authorization requirement

Vowst prior authorization for prevention of recurrent C. difficile infection requires documentation of recurrent CDI (≥2 recurrences in 12 months), positive stool toxin test, completion of at least 10 days of specified antibiotics 2–4 days prior, completion of recommended bowel prep, and prescriber specialty (gastroenterology or infectious disease).

• ≥2 recurrent CDI episodes within 12 months and positive stool test for C. difficile toxin
• Completed ≥10 consecutive days of oral vancomycin or fidaxomicin 2–4 days prior
• Completed recommended bowel prep the day before and ≥8 hours prior to initiation
• Prescribed by/consult gastroenterologist or ID specialist; coverage 14 days

Xolair (OMALIZUMAB) prior authorization

Xolair (omalizumab) prior authorization for IgE‑mediated food allergy requires documentation of diagnosis or severe allergic history, baseline total serum IgE between 30–1850 IU/mL, and dosing per IgE and body weight; initial and reauthorization durations are 12 months.

• Diagnosis or clinical history of IgE‑mediated food allergy or history of severe allergic response/anaphylaxis
• Baseline total IgE ≥30 and ≤1850 IU/mL
• Dosing based on pretreatment IgE and body weight
• Prescribed by appropriate specialist; initial/reauth 12 months

XYREM prior authorization

XYREM prior authorization requires diagnosis confirmation by polysomnography or MSLT for cataplexy or EDSN (or prescriber justification if sleep study not feasible), prescriber specialty (neurologist, psychiatrist, or sleep specialist), and prior therapy failure for EDSN; coverage duration is 12 months.

• Diagnosis confirmed by PSG or MSLT or prescriber justification if not feasible
• EDSN: prior inadequate response or intolerance to modafinil/armodafinil
• Prescribed by neurologist, psychiatrist, or sleep specialist; reauth annually with efficacy documentation
• Exclusion: concurrent sedative hypnotics and alcohol

ZTALMY and ZURZUVAE prior authorization

ZTALMY prior authorization requires genetic confirmation of CDKL5 mutation, documentation of motor seizures, and trial/failure or intolerance to two formulary anticonvulsants with neurologist prescriber; ZURZUVAE requires failure/intolerance to one generic SSRI and one generic SNRI and is limited to 14 days.

• ZTALMY: CDKL5 mutation documented, motor seizures present, failure/intolerance to two formulary anticonvulsants, neurologist prescriber, member ≥2 years, coverage indefinite
• ZURZUVAE: PPD diagnosis, failure/intolerance to one generic SSRI and one generic SNRI, coverage limited to 14 days

Index: prior authorization location references

The index section lists drug names and points to product‑specific policy pages; it does not itself include prior authorization rules—providers must consult the referenced policy pages for PA criteria.

Step therapy referenced

Step therapy is used for some drugs; detailed step therapy rules are contained in the separate 2025 Utilization Management Criteria: Step Therapy document—refer to that document and product entries for specific step requirements.

LYBALVI step requirement

LYBALVI new starts require documented trial of two generic formulary antipsychotics prior to approval.

• Trial of two generic formulary antipsychotics for new starts

Antipsychotic step trials

For certain antipsychotic indications the policy requires trials of two atypical antipsychotics (e.g., aripiprazole, quetiapine, risperidone, olanzapine) as prior step therapy before authorizing listed agents.

• Inadequate response or intolerance to TWO atypical antipsychotics prior to approval

Migraine prophylaxis step requirement (Emgality)

Emgality for migraine prophylaxis requires failure or intolerance to two listed oral prophylactic agents before approval; headache frequency must be documented per episodic or chronic thresholds.

• Failure/intolerance to two listed oral prophylactic medications
• Document episodic (4–14 days/month) or chronic (≥15 days/month) headache frequency

Biologic/rheumatologic step therapy

Certain biologic and rheumatologic agents require inadequate response or intolerance to specified prior therapies (e.g., methotrexate for RA) before approval; prescriber specialty and concurrent biologic exclusions apply per product.

• Document failure/intolerance to specified conventional therapies (e.g., methotrexate)
• Trials of specified biologics/targeted agents as listed per indication
• Prescriber specialty (rheumatologist, dermatologist, gastroenterologist) required

Nexletol/Nexlizet — Step therapy

Nexletol/Nexlizet prior authorization requires prior statin therapy (unless statin intolerant) and in many scenarios at least 8 weeks of ezetimibe as an adjunct before approval.

• LDL‑C documented and prior ≥8‑week trial of statin therapy at maximally tolerated dose or documented statin intolerance
• ≥8 weeks of ezetimibe as adjunct required in many scenarios unless contraindicated/intolerant

GLP-1 agents — Step therapy

For specified GLP‑1 agents, step therapy requires inadequate response or intolerance to two preferred brand GLP‑1 agents (e.g., Ozempic, Trulicity, Rybelsus, Mounjaro, Victoza) with documentation (commonly 90 days each) prior to approval.

• Medical records confirming T2DM diagnosis (A1C/FPG/OGTT) where applicable
• Inadequate response/intolerance to two preferred GLP‑1 brand agents with ~90‑day trials each

Step requirements for branded vs generic

Some products require trial and inadequate response to lower‑cost or generic alternatives before brand approval; documentation of failure or intolerance to the alternative is required.

• Trial and inadequate response/intolerance to generic or lower‑cost alternative (example: generic tadalafil before brand PAH product)

Step therapy for biologics

Many biologic therapies require trials of indicated alternative biologics or targeted therapies (e.g., TNF inhibitors, Cosentyx, Adalimumab) with documentation of inadequate response or intolerance prior to approval.

• Document failure/intolerance to the specified alternative biologics/targeted therapies per indication
• Concurrent biologic therapy is an exclusion across many entries

Tremfya step therapy

Tremfya requires prior inadequate response or intolerance to two listed agents (e.g., Cosentyx, Enbrel, Humira, Skyrizi, Ustekinumab, Otezla) before approval for plaque psoriasis and related indications.

• Document failure/intolerance to two listed prior agents
• Exclusion for concurrent biologic DMARDs

Xifaxan step therapy for IBS-D

Rifaximin (Xifaxan) for IBS‑D requires inadequate response or intolerance to a TCA or SSRI plus dicyclomine (both components) prior to approval and is limited to a maximum of three total courses (42 days) across therapy.

• Failure/intolerance to ONE TCA or ONE SSRI AND dicyclomine
• Member must not exceed three total courses (42 days total)

Uptravi step therapy

Uptravi for PAH initial therapy requires inadequate response or intolerance to two of: an endothelin receptor antagonist, a phosphodiesterase inhibitor, or riociguat, as part of step therapy prior to approval.

• Document failure/intolerance to two of the listed drug classes prior to Uptravi
• Prescribed by/consult cardiologist or pulmonologist

Step therapy / prior trials (examples)

Several products require documentation of prior trial(s) and reasons for failure or intolerance before approval (e.g., XYREM requires prior modafinil/armodafinil for EDSN; ZTALMY requires two formulary anticonvulsants), per product‑specific step therapy rules.

• Document prior trial(s) and reason for failure/intolerance
• Follow product‑specific step trial requirements as listed

XTAMPZA ER required documentation

Providers must obtain and retain documentation specific to each PA: for XTAMPZA ER either prior use of two generic opioids or documentation of both a history/potential for drug abuse and a current patient‑prescriber opioid treatment agreement.

• Either prior use of TWO generic opioids OR both: (a) history or potential for drug abuse in individual/household AND (b) current patient‑prescriber opioid treatment agreement

Acthar required documentation

Acthar (H.P. Acthar Gel) PA documentation must include indication‑specific evidence (e.g., dosing per FDA for infantile spasms, diagnosis confirmation, prior trials of systemic steroids or DMARDs as applicable, and relevant lab thresholds such as proteinuria >3.5 g/24h for nephrotic syndrome).

• Infantile spasms: dosing per FDA labeling (≤150 U/m2 daily) and neurologist/neonatologist prescriber
• Nephrotic syndrome: proteinuria >3.5 g/24h and serum albumin <3 mg/dL where applicable
• Prior inadequate response/intolerance to required systemic therapies per indication

MAC lung disease documentation

For MAC lung disease (Arikayce/Armodafinil context), documentation must include diagnosis of MAC lung disease, that the medication is part of a combination antibacterial regimen, and evidence that the patient has not achieved at least two negative sputum cultures after a minimum of 6 consecutive months of multidrug background therapy.

• Diagnosis of MAC lung disease
• Use as part of a combination antibacterial regimen
• Persistent positive sputum cultures after ≥6 months of background therapy (no ≥2 negative cultures)

EoE documentation

EoE documentation for Dupixent and related agents must include diagnosis with symptoms of esophageal dysfunction, biopsy showing at least 15 intraepithelial eosinophils per high‑power field, exclusion of other causes, member weight ≥15 kg, and prior inadequate response or intolerance to an 8‑week trial of specified therapies.

• Symptoms of esophageal dysfunction (dysphagia, food impaction, etc.)
• ≥15 intraepithelial eosinophils per HPF on biopsy
• Exclusion of other causes and member weight ≥15 kg
• Prior inadequate response/intolerance to an 8‑week trial of PPI or topical esophageal corticosteroids

Baseline platelet count and prior therapies for CLD/ITP

For DOPTELET uses in CLD/ITP, providers must document baseline platelet counts meeting the thresholds for the requested indication and prior therapies/intolerances (e.g., corticosteroids, IVIG, splenectomy, rituximab) for ITP.

• CLD procedure support: baseline platelets <50,000/mcL and scheduled procedure
• ITP initial: baseline platelets <30,000/mcL and failure/intolerance to listed prior therapies
• Prescriber: hematologist/oncologist

Diagnosis documentation and prior trials for atopic dermatitis, asthma, CRSwNP, EoE, bullous pemphigoid

For atopic dermatitis, asthma, CRSwNP, EoE and bullous pemphigoid, prior authorization documentation must include objective diagnostic measures and prior trials as specified (e.g., eosinophil counts, biopsy for BP, weight and biopsy/histology for EoE); specialist prescriber or consultation is required.

• AD: inadequate response to topical therapies; prescriber dermatologist/allergist/immunologist
• Asthma: eosinophil thresholds and exacerbation history; prescriber pulmonologist/allergist
• CRSwNP: diagnosis plus intranasal corticosteroid use; prescriber ENT/allergist
• BP: biopsy confirmation; prescriber dermatologist

Headache frequency documentation and prophylactic trial requirements

For migraine PA (e.g., Emgality, Nurtec), providers must document headache frequency consistent with episodic (4–14 days/month) or chronic (≥15 days/month) definitions and trials of required prophylactic medications (two agents) or contraindications.

• Document episodic vs chronic headache day frequency per thresholds
• Document failure or intolerance to two prophylactic medications (4‑week trials) or contraindications
• Prescriber: neurologist or headache specialist

Epidiolex baseline testing documentation

Epidiolex initiation requires baseline CBC, liver transaminases and total bilirubin prior to starting therapy for Dravet, LGS, or TSC indications and specialist (neurologist) prescriber involvement.

• Baseline CBC, AST/ALT and total bilirubin prior to initiation
• Prescribed by or in consultation with a neurologist
• Concurrent use with additional antiepileptics as specified

Growth failure required documentation

Growth failure documentation must include height measurements relative to midparental height or population mean, growth velocity, bone age, and results of provocative GH testing when applicable; prescriber is an endocrinologist and approvals are commonly 12 months.

• Height SDS and deviation thresholds, growth velocity data, bone age documentation
• Abnormal provocative testing results where applicable
• Prescribed by/consult endocrinologist; initial/continuation typically 12 months

Kalydeco mutation documentation

Kalydeco (ivacaftor) requests require documentation of a CFTR mutation responsive to ivacaftor by an FDA‑cleared mutation test, with verification by bi‑directional sequencing when recommended.

• Document CFTR mutation responsive to ivacaftor via FDA‑cleared test
• Bi‑directional sequencing verification when recommended
• Prescribed by/consult pulmonologist or CF center specialist

DM2 documentation for GLP-1 agents

For GLP‑1 and related agents for type 2 diabetes, medical records must confirm diagnosis (e.g., A1C ≥6.5% or FPG ≥126 mg/dL or 2‑hr OGTT ≥200 mg/dL) and document inadequate response or intolerance to a minimum 90‑day supply of two preferred brand GLP‑1 agents.

• Confirm diagnosis of type 2 diabetes via labs or chart documentation
• Document failure/intolerance to two preferred brand GLP‑1 agents (≥90 days each)

Posaconazole documentation

Posaconazole prior authorization must include documentation of the invasive aspergillosis or Candida diagnosis and prior inadequate response or intolerance to voriconazole when seeking prophylaxis; prescriber should be an infectious disease, transplant, hematology/oncology specialist, or part of chemo prophylaxis.

• Diagnosis of invasive aspergillosis or need for prophylaxis
• Prior inadequate response/intolerance to voriconazole when prophylaxis sought
• Prescribed by infectious disease/transplant/oncology specialist or as part of chemo protocol

Nuplazid documentation

Nuplazid prior authorization requires documentation of inadequate response or intolerance to quetiapine or clozapine for Parkinson disease psychosis prior to approval.

• Document failure/intolerance to quetiapine or clozapine
• Prescriber neurologist or psychiatrist per product guidance

PAH required documentation

PAH medication requests must include diagnostic confirmation (WHO Group I PAH), NYHA functional class, and hemodynamic confirmation (right‑heart catheterization or echocardiography) including mean pulmonary artery pressure meeting policy thresholds.

• Diagnosis of PAH WHO Group I with NYHA FC II–IV
• Diagnostic confirmation by catheterization or echocardiography
• Document mean PAP ≥25 mm Hg at rest (or >30 mm Hg with exertion)

Lipid therapy documentation

For lipid‑lowering agents (PCSK9 and similar), documentation must include LDL‑C values measured after an ≥8‑week trial of at least moderate‑intensity statin therapy or evidence of statin intolerance with supporting labs or clinical notes.

• LDL‑C ≥70 mg/dL after ≥8 weeks of moderate‑intensity statin (or documented statin intolerance)
• Supporting documentation of statin intolerance (CK, AST/ALT, clinical notes)

Diagnostic confirmation and response documentation (ATTR-CM, BVAS)

For diagnoses requiring diagnostic confirmation (e.g., ATTR‑CM, ANCA‑vasculitis), PA and reauthorization must include the appropriate diagnostic test results (biopsy, imaging, genetic test) and evidence of positive clinical response for continuation when specified.

• ATTR‑CM: TTR mutation, biopsy, or supportive imaging + scintigraphy and exclusion of light‑chain amyloidosis
• TAVNEOS reauth: documentation of sustained remission assessed by BVAS
• Reauthorization often requires evidence of positive clinical response

Testosterone initial diagnostic documentation

Initial testosterone therapy requires attestation that hypogonadism diagnosis was confirmed by two early‑morning total testosterone levels <300 ng/dL on separate occasions, a normal prolactin level, and appropriate symptoms, with prostate/breast cancer screening considerations documented.

• Two early‑morning total testosterone measurements <300 ng/dL on separate occasions
• Normal prolactin level and documentation of symptoms of testosterone deficiency
• Document prostate/breast cancer history or risk–benefit assessment as required

Vowst required documentation

Vowst authorization requires documentation of ≥2 recurrent CDI episodes within 12 months, positive stool toxin test, completion of at least 10 days of specified antibiotics 2–4 days prior to initiation, and completion of recommended bowel prep prior to dosing.

• ≥2 recurrent CDI episodes in 12 months with positive stool toxin test
• Completed ≥10 days of oral vancomycin or fidaxomicin 2–4 days prior
• Completed recommended bowel prep day before and ≥8 hours prior to initiation

Xolair IgE and dosing documentation

Xolair for IgE‑mediated food allergy requires baseline total IgE between 30–1850 IU/mL and dosing per IgE and weight; documentation must include diagnosis or clinical history and history of severe allergic response where applicable.

• Baseline total serum IgE ≥30 and ≤1850 IU/mL
• Dosing per pretreatment IgE and body weight
• Document diagnosis/clinical history and history of severe allergic response/anaphylaxis

Xolair required documentation (severe allergic history)

Xolair authorization must include documentation of diagnosis or clinical history and history of severe allergic response (including anaphylaxis) when used for IgE‑mediated food allergy; dosing must follow IgE and weight guidance.

• Clinical history or diagnosis supporting IgE‑mediated food allergy
• History of severe allergic response/anaphylaxis where applicable
• Dosing based on pretreatment IgE level and body weight

XYREM required documentation

XYREM documentation must confirm diagnosis by polysomnography (PSG) or MSLT for cataplexy or EDSN, or include prescriber justification if sleep study is not feasible; for EDSN, document prior inadequate response or intolerance to modafinil/armodafinil.

• PSG or MSLT confirmation or prescriber justification if study not feasible
• For EDSN: prior inadequate response/intolerance to modafinil or armodafinil
• Prescriber specialty: neurologist, psychiatrist, or sleep specialist

ZTALMY and ZURZUVAE required documentation

ZTALMY authorization requires documentation of CDKL5 mutation, presence of motor seizures, and trial/failure or intolerance of two formulary anticonvulsants; ZURZUVAE requires documentation of failure/intolerance to one generic SSRI and one generic SNRI and is limited to 14 days.

• ZTALMY: CDKL5 mutation documented, motor seizures specified, failure/intolerance to two anticonvulsants, neurologist prescriber
• ZURZUVAE: PPD diagnosis and failure/intolerance to one SSRI and one SNRI; therapy limited to 14 days

Prior authorization required — failure to obtain may result in non-coverage

Failure to obtain required prior authorization may result in the plan not covering the drug.

CAYSTON denial triggers

CAYSTON may be denied if FEV1 is not between 25% and 75% predicted, if Pseudomonas aeruginosa is not demonstrated in the lungs, or if susceptibility to aztreonam is not documented.

• FEV1 outside 25%–75% predicted
• No evidence of Pseudomonas aeruginosa in lungs
• No susceptibility showing P. aeruginosa sensitive to aztreonam

CORLANOR denial triggers

Corlanor (ivabradine) may be denied if left ventricular ejection fraction is >35%, resting heart rate <70 bpm, or if the patient is not clinically stable on an optimized regimen for at least 4 weeks as required.

• LVEF >35%
• Resting heart rate <70 bpm
• Not clinically stable on optimized regimen for ≥4 weeks

Deferasirox renal/platelet exclusion

Deferasirox requests may be denied if the member's GFR is <40 mL/min/1.73m2 or platelet counts <50,000/mcL for NTDT or CIO‑BT indications per exclusion criteria.

• GFR <40 mL/min/1.73 m2
• Platelet count <50,000/mcL for NTDT/CIO‑BT

Baseline platelet and other denial triggers for CLD/ITP

Requests lacking required baseline platelet counts or prior therapy documentation for CLD procedural support or ITP (e.g., platelets not meeting <50,000/mcL for CLD or <30,000/mcL for ITP) may be denied.

• Missing baseline platelet counts meeting thresholds
• Lack of documented prior therapies or intolerances where required

Migraine therapy denial triggers

For migraine therapies, requests may be denied for insufficient documentation of required prophylactic medication trials or if documented headache frequency does not meet episodic or chronic thresholds required by the policy.

• Insufficient documentation of two prophylactic medication trials
• Headache frequency not documented as episodic (4–14 days/month) or chronic (≥15 days/month)

Concurrent biologic therapy exclusion denial risk

Concurrent therapy with another biologic (including other biologic DMARDs or injectable CGRP inhibitors) is an exclusion in many biologic and allergy/asthma entries and may trigger denial if documented.

• Concurrent biologic therapy for same indication is excluded
• Examples: concurrent biologics for asthma/allergic conditions, CGRP inhibitors

Growth hormone documentation denial triggers

Growth hormone requests lacking required diagnostic documentation (height/velocity measures, bone age, abnormal provocative testing) risk denial.

• Missing height SDS or growth velocity documentation
• No bone age or provocative testing results when applicable

High-dose opioid prerequisites denial triggers

High‑dose opioid therapy requests without documentation of opioid tolerance (per example thresholds) and prior evaluation of non‑opioid pharmacologic treatment may be denied.

• No documentation of opioid tolerance (e.g., ≥1 week at specified opioid dosing thresholds)
• No evidence of prior evaluation for non‑opioid pharmacologic treatment

CMV — triggers for denial

CMV requests may be denied if inadequate response or intolerance to listed prior antivirals is not documented, or if transplant recipient status or member weight ≥35 kg is not documented per PA requirements.

• No documentation of transplant recipient status
• No documentation of prior inadequate response/intolerance to required antivirals
• Member weight <35 kg (when threshold not met)

Nucala — concurrent biologic exclusion

Nucala requests that document concurrent use of other biologics for asthma/allergic conditions will be excluded and may be denied.

• Concurrent biologic therapy (e.g., benralizumab, dupilumab, omalizumab, reslizumab) is an exclusion

Tavaborole diagnostic and prior therapy requirement

Tavaborole will be denied if confirmatory diagnostic testing (KOH, culture, or histology) is missing or if there is no documentation of inadequate response/intolerance to both oral terbinafine and either oral itraconazole or topical ciclopirox.

• Missing KOH, culture, or histology confirmation of dermatophyte
• No documentation of failure/intolerance to oral terbinafine and either oral itraconazole or topical ciclopirox

Evidence-based indication required — denial risk if unsupported

Requests may be denied if the indication or regimen is not FDA‑approved and is not supported by recognized compendia or peer‑reviewed literature per the general PA evidence standards.

• Indication/regimen not FDA‑approved and not supported by NCCN, AHFS/Clinical Pharmacology, Micromedex, Lexi, or peer‑reviewed literature

PAH diagnostic confirmation required — denial risk

For PAH medications, lack of diagnostic confirmation by right‑heart catheterization or echocardiography and absence of documented mean pulmonary artery pressure ≥25 mm Hg at rest (or >30 mm Hg with exertion) can trigger denial.

• No right‑heart catheterization or echocardiography confirmation
• Mean PAP not documented to meet ≥25 mm Hg at rest (or >30 mm Hg with exertion)

Missing required prior therapy documentation — denial risk

Requests lacking documentation of required diagnosis or failure/intolerance to specified prior therapies (e.g., statin trial for lipid agents, TNF inhibitor trials for rheumatologic agents) may be denied.

• Missing documentation of required prior therapy trials
• Missing diagnosis documentation as specified by product criteria

Concurrent biologic therapy exclusion — denial risk

Concurrent therapy with biological DMARDs or other TNF antagonists for indications such as PsO, PsA, UC, CD is an exclusion and will trigger denial.

• Concurrent biologic DMARD or TNF antagonist therapy documented

Course limit for Rifaximin (IBS-D) — denial risk

For rifaximin in IBS‑D, requests exceeding three total courses (42 days total) will be denied per the policy course‑limit rule.

• Exceeding three total courses (42 days total) of rifaximin for IBS‑D

XYREM exclusion — denial risk

Concurrent use of sedative hypnotics and alcohol is an exclusion for XYREM and may trigger denial.

• Concurrent sedative hypnotic use and alcohol documented

Index: section note — no auth rules present in index

The index section does not contain authorization rules itself; it only lists drug names and points to the detailed policy pages where PA/step/documentation rules are defined. Providers must consult the referenced pages for actionable requirements.

Infusion center — Part B vs Part D considerations

For infusion or physician‑administered products, note that benefit review may determine Part B vs Part D responsibility which can affect site‑of‑care billing and payment; consult the product entry and payer guidance.

Infusion center — IV induction before SC maintenance (Entyvio example)

Some medications (e.g., Entyvio) may require IV induction administration prior to approval of subcutaneous maintenance dosing; providers should document IV induction where applicable and coordinate site‑of‑care accordingly.

• Document IV induction when required (Entyvio IV before SC maintenance)
• Prescriber: gastroenterologist or specialist as indicated

Infusion center — pulmonologist/ID/CF specialist prescribing

Certain inhaled or specialized therapies for pulmonary infections should be prescribed by or in consultation with a pulmonologist, infectious disease specialist, or CF center specialist; site‑of‑care (infusion center/clinic) and specialist involvement are required for authorization.

• Prescribed by/consult pulmonologist, infectious disease, or CF care center specialist
• Site‑of‑care and specialist documentation required for PA

Hospital outpatient — transplant/ID/oncology prescribing

For transplant‑related antivirals and some oncology agents, prior authorization requires prescriber involvement from transplant, infectious disease, or oncology specialists and may point to hospital outpatient or infusion site for administration.

• Prescribed by/consult transplant, infectious disease, or oncology specialist
• Coverage durations and administration site may align with hospital outpatient or infusion center

Infusion center | hospital outpatient | office — antifungal prophylaxis/site notes

Some antifungal prophylaxis or treatment (e.g., posaconazole) requires specialist prescribing and may be delivered in infusion center, hospital outpatient, or office settings as part of chemotherapy prophylaxis protocols.

• Prescribed by infectious disease/transplant/hematology‑oncology specialist or as part of chemo prophylaxis
• Site‑of‑care may be infusion center, hospital outpatient, or office depending on regimen