TYENNE prior authorization

Prior authorization is required for TYENNE (162 mg/0.9 mL syringe and autoinjector) per the criteria listed in this policy; PA applies to all FDA‑approved indications and initial/continuation requirements (diagnosis, dosing, baseline and follow‑up objective disease activity measures, prescriber/age restrictions) must be documented.

• Documented diagnosis and objective baseline disease activity measure (e.g., CDAI, DAS28) for the indicated rheumatologic condition
• If new to plan, member must have met initial criteria at time therapy was started
• Trials of required biologic/tsDMARDs for RA/pJIA as specified (see policy)

ADEMPAS prior authorization

Prior authorization is required for ADEMPAS and applies to all FDA‑approved indications; diagnosis must be confirmed by pretreatment right heart catheterization and documentation of prior/prerequisite therapies must be provided. Concurrent use with phosphodiesterase inhibitors for pulmonary hypertension or other soluble guanylate cyclase stimulators is excluded.

• Right heart catheterization report showing required hemodynamics must be submitted
• Document dates and reasons for failure/intolerance to preferred agents when applicable

Prior authorization required for listed medications

Prior authorization is required for the listed specialty medications shown under this policy and the PA indication indicator is 'All FDA‑Approved Indications.'

• Submit diagnosis and any required genetic tests or labs as listed in the medication‑specific sections
• Ensure documentation meets the listed required medical information for each product

Phenylbutyrate products - Prior authorization

Prior authorization is required for phenylbutyrate products for urea cycle disorders; initial approval requires genetic or enzymatic confirmation and continuation requires clinically significant improvement or stabilization in plasma ammonia. Concurrent use of more than one phenylbutyrate product is excluded.

• Provide genetic or enzymatic test results confirming a urea cycle disorder
• Do not request concurrent use of more than one phenylbutyrate product

Aimovig autoinjector - Prior authorization

Prior authorization is required for Aimovig autoinjector for FDA‑approved indications; initial approval requires a diagnosis of chronic or episodic migraine and the member must be 18 years or older. Combination use with a prophylactic CGRP antagonist is excluded.

• Provide diagnosis of chronic or episodic migraine
• Confirm patient age ≥ 18 years
• Do not combine with a CGRP antagonist used for prophylaxis

PA required (general statement)

Prior authorization is required for the medications listed in this policy; the PA indicator generally applies to all FDA‑approved indications and medication‑specific required information must be submitted.

• Include diagnosis and any medication‑specific required labs/genetic tests
• Follow the required documentation and prescriber restrictions shown per drug

Prerequisite therapy (alpha‑1 proteinase inhibitors)

For alpha‑1 proteinase inhibitors, prerequisite therapy is required as indicated in the policy; documentation of prior therapies and required baseline tests must be provided.

• Provide required prior therapy documentation as specified
• Include required medical information and labs per the Alpha‑1 section

AAT inhibitor prior authorization

Prior authorization for AAT (alpha‑1 antitrypsin) inhibitor products requires documentation of a baseline (pretreatment) AAT serum concentration below the specified thresholds and that the patient is a current non‑smoker; coverage duration is authorized for 1 year.

• Submit baseline AAT serum concentration with assay type/result (e.g., <11 micromol/L or <80 mg/dL radial immunodiffusion or <57 mg/dL nephelometry)
• Document current non‑smoker status

Ambrisentan prior authorization

Prior authorization is required for ambrisentan for FDA‑approved PAH indications; diagnosis must be confirmed by pretreatment right heart catheterization and prescriber must be a cardiologist or pulmonologist (or in consultation). Coverage duration is lifetime.

• Provide right heart catheterization report showing required hemodynamics (mPAP ≥25 mm Hg; PCWP/PAWP ≤15 mm Hg; PVR >3 Wood units)
• Document WHO functional class II–IV symptoms and prescriber specialty or consultation

PA required for listed anticonvulsant and IV antifungal products

Prior authorization is required for the listed anticonvulsant and IV antifungal products and applies to all FDA‑approved indications; required documentation and prerequisite therapy status vary by section.

• For anticonvulsants, when a non‑preferred product is requested, provide documentation of preferred medication tried, dates, and reason for exception
• For IV antifungals (voriconazole), include the diagnosis in the request

Prerequisite therapy for anticonvulsant PA

Prerequisite therapy is required for anticonvulsant prior authorization: non‑preferred anticonvulsants generally require trial and failure or intolerance of one preferred formulary alternative unless contraindicated or not clinically appropriate.

• Document the preferred product trial (drug name, dates, and reason for failure/intolerance) or provide documentation of a contraindication/adverse reaction to preferred agents

Prior authorization required (ARANESP, ARCALYST)

Prior authorization is required for listed medications such as ARANESP and ARCALYST per the PA indicators; provide the diagnosis and required labs or documentation as specified for each indication.

• Include diagnosis and indication‑specific labs (e.g., Hgb, ferritin, TSAT, endogenous EPO) for Aranesp requests
• For Arcalyst, document diagnosis and positive clinical response for reauthorization and avoid concurrent biologic/tsDMARD use

Prior authorization required for listed disease‑specific indications (CAPS, DIRA, Pericarditis)

Prior authorization is required for disease‑specific indications (CAPS, DIRA, recurrent pericarditis) and ARIKAYCE for MAC lung disease; submit the disease‑specific documentation and testing required for initial approval and reauthorization.

• For CAPS/DIRA/Pericarditis: provide genetic testing, vaccine status, weight (where required), and documentation of prior standard therapy failures
• For ARIKAYCE: submit diagnosis, background multidrug regimen history, and amikacin MIC ≤ 64 µg/mL

Prior authorization requirement (IV antifungals/Part B note)

Prior authorization is required for IV antifungals; Part B prerequisite is N/A in this section but prerequisite therapy is flagged YES for some related entries — always include the diagnosis and any required trial documentation.

• Provide the diagnosis on the prior authorization request
• Where step or prerequisite therapy is required elsewhere, include dates and reasons for trials

PA applies to all FDA-approved indications (general)

Prior authorization applies to all FDA‑approved indications for many of the listed medications; verify the PA indication indicator and include the required documentation accordingly.

• Confirm the PA indication indicator in the policy for each drug (e.g., '1 - All FDA‑Approved Indications')
• Provide diagnosis and medication‑specific required tests or trials

Prior authorization requirement (bosentan)

Prior authorization is required for bosentan; approval requires right heart catheterization confirmation of PAH or documentation that CTEPH is inoperable/persistent and symptomatic. Prescriber must be or consult with a cardiologist or pulmonologist.

• Submit pretreatment right heart catheterization showing mPAP ≥25 mm Hg, PCWP/PAWP/LVEDP ≤15 mm Hg, and PVR >3 Wood units or documentation of inoperable/persistent CTEPH
• Include WHO functional class and prescriber specialty or consultation

Prior authorization required (carglumic acid)

Prior authorization is required for carglumic acid per the PA indicator; provide the diagnosis and genetic testing where applicable (NAGS deficiency) or plasma ammonia values for acute hyperammonemia cases.

• For NAGS deficiency: include genetic test confirming mutation
• For acute PA/MMA hyperammonemia: provide plasma ammonia ≥ 50 µmol/L and plan for concurrent ammonia‑lowering therapies

Prior authorization requirements (ursodiol failure / gallstone criteria)

Prior authorization for gallstone dissolution therapy (e.g., ursodiol failure/CHENODAL) requires documentation that the patient has tried and failed ursodiol or is not a candidate for cholecystectomy; continuation requires imaging demonstrating ongoing need.

• Document trial and failure or contraindication to ursodiol and that the patient is not a candidate for cholecystectomy
• For continuation, provide oral cholecystograms or ultrasonograms showing need

Prior authorization required (initial approval 6 months then possible lifetime)

Prior authorization is required with initial approval duration of 6 months for certain indicated therapies, with potential lifetime approval if symptoms improve per the policy (e.g., tadalafil for BPH).

• Provide baseline symptom score (AUA‑SI) and documentation of prior therapy trials as specified
• If symptoms improve, request reauthorization for lifetime coverage

Prior authorization required (Basal Insulin and Cosentyx)

Prior authorization is required for Basal Insulin products and Cosentyx; prerequisite therapy is required and documentation of prior therapies and required medical information must be submitted.

• For Basal Insulin, document prior therapy trials and reasons for failure/intolerance as specified
• For Cosentyx, include diagnosis, other medications tried, and dosing within FDA limits; Cosentyx PA indicator = All FDA‑Approved Indications

Prerequisite biologic/tsDMARD trials (TYENNE)

For TYENNE, initial approval for RA and pJIA requires trials of two of the listed biologic/tsDMARDs (Enbrel, a preferred adalimumab product, Rinvoq, or Xeljanz/XR); pJIA and other indications require specified objective baseline disease activity documentation.

• Document trials of two specified biologic/tsDMARDs with dates and reasons for failure/intolerance
• Include baseline objective disease activity measures (e.g., CDAI, cJADAS‑10 for pJIA)

Prerequisite therapy for PAH

For PAH indications across the policy (including agents like ambrisentan and ADEMPAS), prerequisite therapy requires documented failure, intolerance, or contraindication to preferred endothelin receptor antagonists (ambrisentan or bosentan) and preferred PDE‑5 inhibitors (sildenafil or tadalafil) with dates and reasons for trial failure, or documented contraindications to both agents in each class.

• Provide dates and reasons for trials of preferred endothelin receptor antagonists and PDE‑5 inhibitors or documentation of contraindications/adverse reactions to those agents

No prerequisite therapy required (where noted)

Where the policy explicitly states 'N/A' for prerequisite therapy, no prior trial requirement is listed for that medication section; confirm the specific product entry for N/A notation.

• Check the PREREQUISITE THERAPY REQUIRED field in the product section (e.g., 'N/A' indicates no prerequisite therapy)

Alosetron step/therapeutic prerequisites

For alosetron (severe diarrhea‑predominant IBS), initial approval requires failure of one antidiarrheal (e.g., loperamide) and one antispasmodic (e.g., dicyclomine) among other criteria; continuation requires documented positive clinical response and dosing within FDA limits.

• Provide documentation of prior trials (agent name, dates) of an antidiarrheal and an antispasmodic
• Submit evidence of positive clinical response for reauthorization

No prerequisite therapy required (N/A)

For sections marked 'N/A' at the PREREQUISITE THERAPY heading, no prerequisite therapy is required (confirm per product entry).

• Verify the product section for 'N/A' in the prerequisite therapy field before assuming trial requirements

Step therapy for anticonvulsants

Step therapy for non‑preferred anticonvulsants requires trial and failure or intolerance of one preferred formulary alternative unless contraindicated or not clinically appropriate; submit documentation of the preferred trial with dates and reasons.

• Include preferred product name, trial dates, and reason for failure/intolerance or documentation of contraindication

No prerequisite or Part B prerequisite listed (selected items)

For selected medication entries where no prerequisite or Part B prerequisite is listed (PREREQUISITE THERAPY = N/A), no prior trial is required; confirm per product section.

• Check the product's PREREQUISITE THERAPY REQUIRED field for N/A before requesting additional trials

Prerequisite therapy required (pericarditis and MAC lung disease)

For pericarditis and MAC lung disease indications, prerequisite therapy is required: patients must have tried and failed specified standard therapies (pericarditis) or completed and not achieved negative cultures on a background multidrug regimen (MAC) before ARIKAYCE consideration.

• For pericarditis: document trials of at least two standard therapies (e.g., colchicine, NSAIDs, corticosteroids)
• For MAC: provide prior multidrug regimen history and persistent positive cultures

Step therapy for atypical antipsychotics

Step therapy is required for many atypical antipsychotics: trials of preferred formulary alternatives (one or two, depending on the agent) or documentation of contraindication/intolerance/adverse reaction are required before authorization, except for certain specified indications where no trial is needed.

• When requesting a non‑preferred atypical antipsychotic, include preferred medication trial details and reason for exception
• Note specified indications (MDD, bipolar depression, agitation with dementia) where trials may be waived for some agents

Step therapy / preferred product requirement (certain insulin products)

Certain insulin and insulin‑analog products require step therapy or preferred product failure before approval (e.g., Basaglar, Basaglar Tempo, Rezvoglar, insulin glargine U300, Tresiba); document failure/intolerance or contraindication to preferred products.

• Provide documentation of failure, intolerance, contraindication, or adverse reaction to preferred products (e.g., Lantus, insulin glargine‑YFGN, Toujeo)

Prerequisite therapy indicated at heading level (details in source)

Prerequisite therapy is indicated at the heading level for several entries; review the specific product section for the detailed prerequisite therapy requirements and document trials or contraindications accordingly.

• Refer to the product PREREQUISITE THERAPY REQUIRED field and required medical information in the policy for specifics

Hematologic malignancy alternative therapy criteria (magnitude)

For some hematologic malignancy indications, approval is granted if the patient is intolerant of, contraindicated to, or had an adverse reaction to the preferred product (Calquence) or lacks a listed preferred alternative per guidelines.

• Provide documentation of intolerance, contraindication, or adverse reaction to Calquence if applicable

Prerequisite therapy (ursodiol failure requirement)

For ursodiol/gallstone dissolution indications, prior authorization requires documented trial and failure or contraindication to ursodiol before CHENODAL is considered.

• Document ursodiol trial dates and reason for failure or intolerance
• Confirm patient is not a candidate for cholecystectomy

Step therapy (BPH: failure of other therapies)

For BPH, step therapy requires failure of two other drugs from two different therapeutic classes (alpha‑1 blockers, 5‑alpha reductase inhibitors, or combination therapy) with specified minimum trial durations and documentation of AUA‑SI score ≥8.

• Provide trials with dates and maximum tolerated dose durations for two different classes
• Include baseline AUA‑SI score (≥8) and diagnosis of BPH

Step therapy requirements (Basal Insulin)

Basal Insulin step therapy requires prior trials or documented intolerance/contraindication to specified antipsychotics for schizophrenia‑related criteria when applicable; provide detailed medication history and reasons for exceptions.

• Include documentation showing trials of two specified antipsychotics (Lybalvi, Vraylar, Caplyta) and dates or documented intolerance/contraindication

General documentation requirements (TYENNE)

For TYENNE requests, document diagnosis, dose/frequency consistent with FDA labeling, objective baseline and follow‑up disease activity measures, and prescriber specialty or consultation as required for the indication; reauthorization requires evidence of positive clinical response.

• Provide baseline and follow‑up objective disease activity scores (examples: CDAI, DAS28, RAPID3, SDAI)
• If new to plan, confirm initial criteria were met when therapy was started

SSc-ILD documentation (TYENNE)

For SSc‑ILD indications under TYENNE, include documentation excluding other causes of ILD and HRCT or surgical lung biopsy findings consistent with SSc‑ILD, plus pulmonary function tests and evidence of response for reauthorization.

• Submit HRCT findings consistent with SSc‑ILD (or HRCT plus surgical lung biopsy if available)
• Provide pulmonary function tests and evidence of stabilization or decreased rate of decline in FVC for continuation

ADEMPAS documentation requirements

ADEMPAS documentation must include diagnosis confirmed by right heart catheterization and history of prerequisite medications as described in the policy.

• Attach right heart catheterization report with mPAP, PCWP/PAWP/LVEDP, and PVR values
• Include dates and outcomes of prior medication trials or documented contraindications

Required documentation (diagnosis, genetic tests, labs, RHC)

Required documentation across multiple entries includes diagnosis, genetic tests and lab results; for PAH confirmation provide pretreatment right heart catheterization results and WHO functional class; for genetic disorders provide enzymatic or molecular testing.

• Provide genetic or enzymatic test results where indicated
• Include right heart catheterization data and WHO functional class for PAH/CTEPH requests

Required documentation (urea cycle disorders)

For urea cycle disorders and phenylbutyrate product requests, include diagnosis and confirmatory genetic or enzymatic testing; continuation requires stabilization or improvement in plasma ammonia.

• Submit genetic or enzymatic test results confirming the urea cycle disorder
• Provide plasma ammonia trends showing improvement or stabilization for continuation

Required documentation (Aimovig)

For Aimovig prior authorization, required documentation includes the diagnosis of chronic or episodic migraine and for reauthorization documentation of positive clinical response.

• Provide initial diagnosis and patient age (≥18)
• For reauthorization, include documentation of clinical improvement

Documentation required (reauthorization positive clinical response)

For reauthorization of therapies, documentation of positive clinical response is required as specified in each product section (improvement in objective measures or clinical signs/symptoms).

• Include prescriber statement and objective measures demonstrating improvement compared to baseline

AAT baseline laboratory and smoking status (documentation)

AAT inhibitor requests must include baseline (pretreatment) AAT serum concentration with assay type/result and the patient's smoking status.

• Provide assay method and numerical AAT level (micromol/L or mg/dL)
• Document current non‑smoker status

Right heart catheterization and WHO functional class documentation

For PAH requests, include the pretreatment right heart catheterization report showing mPAP, PCWP/PAWP (or LA pressure/LVEDP), and PVR, plus documentation of WHO functional class.

• Attach the RHC report with hemodynamic values and a statement of WHO functional class II–IV

Required documentation for non-preferred anticonvulsants

When requesting a non‑preferred anticonvulsant, provide documentation of the preferred medication tried, dates of the trial, and the specific reason for the exception (failure, contraindication, adverse reaction, or lack of preferred alternative).

• List preferred agent(s) tried with start/stop dates and reason for discontinuation/failure
• Include clinician rationale if exception is requested

Required documentation for IV antifungals

For IV antifungal prior authorization, include the diagnosis and any required supporting information; absence of a diagnosis may trigger denial.

• Provide the specific fungal diagnosis and relevant clinical details
• If prerequisite therapy is required elsewhere, include trial dates and reasons

Required medical information and reauthorization documentation (Aranesp/MDS)

For ARANESP (and similar agents), include diagnosis and required labs for the indication (Hgb, ferritin or TSAT, endogenous EPO for MDS) and documentation of positive clinical response for reauthorization.

• Submit Hgb, ferritin, TSAT, and endogenous EPO where applicable
• For reauthorization, document clinical response to therapy

Prescriber restriction (MDS anemia)

For MDS anemia, prescriptions should be by or in consultation with a hematologist or oncologist; include prescriber specialty documentation.

• Document that the prescriber is a hematologist/oncologist or that consultation occurred

Required documentation for ARIKAYCE (diagnosis, amikacin MIC)

For ARIKAYCE (MAC), include diagnosis and amikacin MIC results; reauthorization requires documentation of clinical response or continued need.

• Provide amikacin MIC (≤ 64 µg/mL) and documentation of background multidrug regimen
• For continuation, include culture results and clinical response

Required medical information for non-preferred atypical antipsychotics

When requesting a non‑preferred atypical antipsychotic, include documentation of preferred medication trials, dates, and reason for exception (failure, contraindication, adverse reaction, or lack of alternatives).

• List preferred agents tried with dates and reasons for failure/intolerance
• Provide clinical rationale if requesting exception

Required clinical documentation for SLE and lupus nephritis

For SLE and lupus nephritis requests, include diagnosis and disease‑specific objective measures (e.g., ANA or anti‑dsDNA levels, SELENA‑SLEDAI score) and biopsy proof for lupus nephritis.

• Provide ANA titer or anti‑dsDNA and SELENA‑SLEDAI score (≥6 for active SLE)
• For lupus nephritis, submit biopsy‑proven diagnosis

Required medical information for PAH (RHC)

For PAH requests, required medical information includes pretreatment right heart catheterization results (mPAP, PCWP/PAWP/LVEDP, PVR) and WHO functional class II–IV; for CTEPH include documentation that disease is inoperable or persistent/recurrent after pulmonary endarterectomy.

• Attach pretreatment RHC report and documentation of operability status for CTEPH
• Document WHO functional class

Prescriber restriction (bosentan must be by/with cardiologist or pulmonologist)

Bosentan requests must be prescribed by or in consultation with a cardiologist or pulmonologist; include prescriber documentation of specialty or consultation.

• Include prescriber specialty or documentation of consultation with cardiology/pulmonology

Required medical information (diagnosis and genetic test)

For certain metabolic or genetic disorder therapies, required medical information includes diagnosis and confirmatory genetic testing.

• Attach genetic test results confirming the diagnosis
• Confirm prescriber is a metabolic disease specialist or consulted with one when required

Prescriber restriction (metabolic disease specialist required)

Prescriptions for metabolic disease treatments must be by, or in consultation with, a metabolic disease specialist or clinician who focuses on metabolic diseases; document specialist involvement.

• Provide evidence of specialist prescribing or consultation

Required imaging documentation (radiolucent gallstones)

For gallstone dissolution therapy, required imaging documentation must show radiolucent gallstones in a well‑opacifying gallbladder on oral cholecystography.

• Attach oral cholecystogram demonstrating radiolucent stones in a well‑opacifying gallbladder

Required diagnosis (cystic fibrosis)

For indications that require cystic fibrosis diagnosis (e.g., certain inhaled therapies), include documentation of cystic fibrosis in the medical record.

• Provide documentation confirming diagnosis of cystic fibrosis

Required medical information for BPH and Cobenfy (labs, med history)

For BPH and Cobenfy requests, include diagnosis, relevant labs (eGFR for Cobenfy), and medication history including trials of preferred formulary alternatives per policy.

• Provide eGFR value and medication trial history with dates and reasons for failure/intolerance
• Confirm age ≥18 years where required

Required medical information (general meds)

Required medical information for many requests includes diagnosis, medication history, and dosing consistent with FDA‑approved dosing; include these details in PA submissions.

• Document diagnosis, prior medications tried, and prescribed dose/frequency within FDA limits

Antifungal trial documentation requirements

For antifungal trial documentation (e.g., Cosentyx for invasive fungal infections), include dates of trials and reasons for failure or detailed contraindication/adverse reaction documentation to preferred antifungal agents.

• Provide trial dates, reasons for failure/intolerance, or documented contraindications to preferred antifungals such as posaconazole or voriconazole

Concurrent therapy exclusion (TYENNE)

TYENNE concurrent therapy exclusion: do not combine TYENNE with a Biologic DMARD or Targeted Synthetic DMARD; such concurrent use is an exclusion and may trigger denial.

• Verify current medication list to ensure no concurrent biologic DMARD or targeted synthetic DMARD is being used with TYENNE

Concurrent therapy exclusion (ADEMPAS)

ADEMPAS concurrent therapy exclusion: concurrent use with phosphodiesterase inhibitors for pulmonary hypertension or other soluble guanylate cyclase stimulators is excluded and may lead to denial.

• Confirm patient is not receiving PDE‑5 inhibitors or other sGC stimulators for pulmonary hypertension at time of request

PAH/CTEPH documentation (denial risk)

For PAH/CTEPH requests, lack of documentation of right heart catheterization meeting hemodynamic criteria (mPAP ≥25 mm Hg; PCWP/PAWP/LVEDP ≤15 mm Hg; PVR >3 Wood units) or lack of WHO functional class documentation may trigger denial.

• Ensure pretreatment RHC values and WHO functional class II–IV are included in the submission to avoid denial

Gaucher disease documentation missing (denial risk)

For Gaucher disease Type 1, absence of documented deficient beta‑glucocerebrosidase activity or molecular genetic testing may trigger denial.

• Provide enzyme activity results or molecular genetic test documenting glucocerebrosidase gene mutation

Concurrent phenylbutyrate product exclusion (denial risk)

Concurrent use of more than one phenylbutyrate product is excluded and will trigger denial; do not request overlapping phenylbutyrate products.

• Verify medication list to avoid requests for more than one phenylbutyrate agent concurrently

Combination Aimovig + CGRP prophylaxis exclusion (denial risk)

Combination use of Aimovig with a CGRP antagonist used for prophylaxis is excluded and may result in denial.

• Confirm the patient is not receiving another CGRP antagonist for prophylaxis when requesting Aimovig

Explicit exclusion: biologically male (where specified)

Where the policy lists 'Exclude if patient is biologically male,' requests for those products should be denied if the patient is biologically male.

• Verify sex assigned at birth when the exclusion is specified for the product

AAT deficiency criteria not met (denial risk)

AAT inhibitor denial risk: requests lacking a baseline AAT serum concentration below the specified thresholds or documenting current smoking status may be denied.

• Include numerical pretreatment AAT level and assay method to demonstrate eligibility
• Document non‑smoking status

PAH confirmation missing or inadequate (denial risk)

Denial risk for PAH agents (including bosentan/ambrisentan): requests missing pretreatment right heart catheterization confirmation per hemodynamic criteria may be denied.

• Submit complete RHC data (mPAP, PCWP/PAWP/LVEDP, PVR) and WHO functional class to avoid denial

Documentation required for non-preferred anticonvulsants (denial risk)

Requests for non‑preferred anticonvulsants lacking documentation of preferred medication trials, dates, and reasons (failure, contraindication, adverse reaction) may be denied.

• Provide trial documentation for preferred anticonvulsant alternatives to support the exception request

Documentation required for IV antifungals (denial risk)

IV antifungal requests (e.g., voriconazole) missing a documented diagnosis may be denied; include the specific diagnosis in the request.

• Include the fungal diagnosis and any relevant culture or susceptibility data

Aranesp exclusion/usage limitations (denial risk)

Aranesp denial triggers: use in uncontrolled hypertension or for inappropriate indications (e.g., immediate anemia correction or prophylactic prevention of chemotherapy‑induced anemia) may lead to denial.

• Ensure indication matches policy criteria and required labs (Hgb, ferritin/TSAT) are provided
• Avoid requests for immediate transfusion replacement or prophylactic uses listed as excluded

Arcalyst concurrent biologic exclusion (denial risk)

Arcalyst concurrent biologic exclusion: concurrent use with a biologic or targeted synthetic drug is an exclusion and may trigger denial.

• Verify no concurrent biologic or targeted synthetic drug is being prescribed with Arcalyst

Concurrent therapy exclusion (general)

Concurrent therapy exclusions are listed throughout the policy; verify current medications to avoid denied requests due to excluded combinations.

• Review medication list for concurrent biologics, targeted synthetics, PDE‑5 inhibitors, or other excluded combinations before submitting PA

Documentation requirement for non-preferred atypical antipsychotics (denial risk)

Failure to provide documentation when requesting a non‑preferred atypical antipsychotic (including preferred medications tried, dates, and reason for exception) may trigger denial.

• Include preferred agent trial dates and reasons for failure/intolerance when requesting non‑preferred atypical antipsychotics

Exclusion triggers (concurrent biologics, Lupkynis/Saphnelo, CNS lupus)

Exclusion triggers noted include concurrent biologics, Lupkynis/Saphnelo, and use in active CNS lupus; such concurrent/excluded uses may lead to denial.

• Confirm patient is not on excluded therapies (e.g., Lupkynis, Saphnelo) and does not have active CNS lupus when applicable

Denial triggers for bosentan (lack of RHC or CTEPH operability documentation)

Bosentan denial triggers: lack of documented RHC confirmation of PAH or lack of documentation that CTEPH is inoperable/persistent after surgery may result in denial.

• Provide RHC data and documentation of CTEPH operability status as applicable

PA/MMA hyperammonemia acute treatment criteria (plasma ammonia threshold)

For PA/MMA acute hyperammonemia treatment, approval requires plasma ammonia ≥ 50 µmol/L and that the requested medication will be used with other ammonia‑lowering therapies.

• Provide plasma ammonia value (≥50 µmol/L) and treatment plan including concurrent ammonia‑lowering therapies

Exclusion: calcified (radiopaque) stones (denial risk)

Exclusion that would trigger denial for gallstone dissolution: presence of calcified (radiopaque) stones—do not request therapy for calcified stones.

• Provide imaging demonstrating stone composition; calcified/radiopaque stones are excluded

Exclusion triggers (tadalafil ED/nitrate use)

Tadalafil exclusion triggers: use for erectile dysfunction or concomitant use of nitrates is excluded and may cause denial for BPH indication.

• Ensure indication is BPH and verify no concomitant nitrate therapy before requesting tadalafil for BPH

Cobenfy exclusion triggers (multiple contraindications)

Cobenfy exclusion triggers: use with urinary retention, significant hepatic impairment, gastric retention, untreated narrow‑angle glaucoma, hypersensitivity to Cobenfy/trospium, or eGFR <60 ml/min is excluded.

• Provide eGFR and screen for listed contraindications prior to PA submission

Basal Insulin denial trigger (lack of required documentation)

Basal Insulin denial trigger: lack of documentation showing required prior trials (or documented intolerance/contraindication) to the specified antipsychotics for schizophrenia may lead to denial.

• Include documentation of trials of two specified antipsychotics (Lybalvi, Vraylar, Caplyta) with dates and outcomes or documented contraindications

Cosentyx denial trigger (lack of antifungal trial documentation)

Cosentyx denial trigger for invasive fungal indications: absence of documentation of failure/intolerance to or contraindication for preferred antifungal(s) (posaconazole or voriconazole) may result in denial.

• Provide documentation of trials or contraindications to preferred antifungals with dates and reasons