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Prior Authorization Criteria for Specialty and Pharmacy Drugs

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This document governs prior authorization criteria for specialty and pharmacy drugs covered by Network Health Insurance Corporation Network Health Cares (PPO D-SNP), including indications, exclusions, medical documentation, age and prescriber restrictions, prerequisite therapy, and authorization durations.

Policy Summary

PayerNetwork Health

PolicyPrior Authorization Criteria for Specialty and Pharmacy Drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the applicable diagnosis, prerequisite treatment history, objective baseline or continuation measures, response to treatment, and documentation that dosing and frequency are within FDA-approved parameters.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Drug criteria sections

6 monthsTyenne initial authorization

LifetimeTyenne continuation authorization

YesTyenne prerequisite therapy

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CurrentNetwork HealthPolicy N/A

Prior Authorization Criteria for Specialty and Pharmacy Drugs

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Policy Summary

PayerNetwork Health

PolicyPrior Authorization Criteria for Specialty and Pharmacy Drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Drug criteria sections

6 monthsTyenne initial authorization

LifetimeTyenne continuation authorization

YesTyenne prerequisite therapy

3 yearsPulmonary hypertension coverage

Coverage Criteria

Tyenne RA initial therapy

Covered when all criteria are met.

RA initial therapy: Confirmed moderate-to-severe active rheumatoid arthritis; baseline objective disease-activity measure documented; FDA-approved dose and frequency; and failure of two of Enbrel, a preferred adalimumab product, Rinvoq, or tofacitinib.Two prerequisite therapies failed

Preferred adalimumab products include Simlandi and Hadlima.

Tyenne RA continuation therapy

Covered when all criteria are met.

RA continuation therapy: Positive response to treatment demonstrated by improvement in an objective disease-activity measurement compared with baseline.Improvement from baseline

Examples include CDAI, DAS28, PAS/PAS-II, RAPID3, and SDAI.

Tyenne pJIA initial therapy

Covered when all criteria are met.

pJIA initial therapy: Polyarticular juvenile idiopathic arthritis with five or more active joints; baseline cJADAS-10 documented; and failure of two of Enbrel, a preferred adalimumab product, Rinvoq, or tofacitinib.At least 5 active joints; 2 prerequisite therapies failed

Minimum age is 2 years.

Tyenne pJIA continuation therapy

Covered when at least one response criterion is met.

pJIA response: Improvement in tender or swollen joint counts, CRP, patient global assessment, or cJADAS-10 score.Improvement from baseline or prior assessment

Tyenne sJIA continuation therapy

Covered when at least one response criterion is met.

sJIA response: Improvement in tender or swollen joint counts, CRP, patient global assessment, or a disease-activity tool such as sJADAS or ACR Pedi 30.Improvement from baseline or prior assessment

Tyenne GCA continuation therapy

Covered when all criteria are met.

GCA continuation therapy: Positive clinical response shown by low disease activity or improvement in symptoms, with improvement from baseline in at least one GCA symptom.Improvement in at least one symptom

Symptoms may include headache, scalp tenderness, constitutional symptoms, jaw or tongue claudication, visual symptoms, polymyalgia rheumatica symptoms, or limb claudication.

Tyenne GCA initial therapy

Covered when the diagnosis and required findings are documented.

GCA initial therapy: GCA or large-vessel arteritis is verified by biopsy or large-vessel imaging, or clinical suspicion remains high because of vascular-abnormality symptoms despite negative temporal artery testing; disease is active; and CRP and ESR are elevated.Elevated CRP and ESR

Imaging may include MRI, PET-CT, or CT angiography.

Tyenne SSc-ILD initial therapy

Covered when all criteria are met.

SSc-ILD initial therapy: Other known causes of ILD are excluded and either qualifying HRCT findings without surgical lung biopsy or qualifying HRCT and surgical lung-biopsy findings demonstrate or probably demonstrate SSc-ILD.Exclusion of other ILD causes plus qualifying imaging or imaging/biopsy findings

Patterns may include NSIP, UIP, or centrilobular fibrosis.

Tyenne SSc-ILD continuation therapy

Covered when all criteria are met.

SSc-ILD continuation therapy: FVC or ppFVC decline has slowed or stabilized compared with pretreatment baseline, and there is no disease progression.No absolute ppFVC decline greater than 10% in any 12-month period

Pulmonary function testing is required.

Adempas authorization criteria

Covered when all criteria are met.

Adempas authorization: Diagnosis is confirmed by right heart catheterization and the history of prerequisite medications is documented.Right-heart-catheterization-confirmed diagnosis

The detailed prerequisite medication list is not included in this window.

Pulmonary arterial hypertension, WHO Group 1

Covered when all criteria are met.

PAH WHO Group 1

Hemodynamic confirmation: Pretreatment right heart catheterization shows mPAP at least 25 mm Hg at rest, left-sided filling pressure no more than 15 mm Hg, and PVR greater than 3 Wood units.mPAP >=25 mm Hg; PCWP/PAWP/left-sided pressure <=15 mm Hg; PVR >3 Wood units
Functional severity: WHO functional class II-IV symptoms.
Endothelin-receptor antagonist requirement: Failure, inadequate response, or intolerance to ambrisentan or bosentan with dates and reason documented; or documented contraindication or expected adverse reaction to both.
PDE-5 inhibitor requirement:

Chronic thromboembolic pulmonary hypertension

Covered when all criteria are met.

CTEPH criteria: Symptomatic chronic thromboembolic pulmonary hypertension that is inoperable or persistent/recurrent after surgical treatment such as pulmonary endarterectomy, with PVR greater than 3 Wood units and mPAP at least 25 mm Hg.PVR >3 Wood units; mPAP >=25 mm Hg

Gaucher disease, Type 1

Covered when either diagnostic pathway is met.

Gaucher disease Type 1 confirmation: Deficient beta-glucocerebrosidase activity is demonstrated in leukocytes or fibroblasts, or molecular genetic testing documents a glucocerebrosidase gene mutation.

Urea cycle disorder initial therapy

Covered for an FDA-approved indication when the diagnosis is confirmed.

Initial urea cycle disorder therapy: Genetic or enzymatic testing confirms a urea cycle disorder.

The requested use must be an FDA-approved indication.

Urea cycle disorder continuation therapy

Covered when treatment benefit is demonstrated.

Continuation therapy: Clinically significant improvement or stabilization in plasma ammonia level is documented.

Aimovig therapy

Covered for an FDA-approved indication when all criteria are met.

Aimovig eligibility: Member is at least 18 years old and has chronic or episodic migraine.Age >=18 years

Alosetron initial therapy

Covered when all criteria are met.

Initial severe diarrhea-predominant IBS: Chronic IBS symptoms for at least 6 months; gastrointestinal anatomic or biochemical abnormalities excluded; failure of one antidiarrheal such as loperamide; and failure of one antispasmodic such as dicyclomine.Symptoms >=6 months

Alosetron continuation therapy

Covered when all criteria are met.

Continuation severe diarrhea-predominant IBS: New-to-plan patient met initial criteria when treatment began; dose and frequency are FDA-approved; and positive clinical response is documented.

Alpha 1 proteinase inhibitors

Approve when all criteria are met.

Alpha-1 proteinase inhibitor criteria

Alpha-1 antitrypsin deficiency with emphysema or chronic obstructive pulmonary disease.
Baseline pretreatment AAT is below the applicable threshold.<11 micromol/L; <80 mg/dL by radial immunodiffusion; or <57 mg/dL by nephelometry
Patient is a current nonsmoker.

Ambrisentan initial coverage

Approve when all criteria are met.

Ambrisentan PAH criteria

mPAP >=25 mm Hg at rest; PCWP/PAWP/left-sided filling pressure <=15 mm Hg; and PVR >3 Wood units.mPAP >=25; pressure <=15; PVR >3 Wood units
WHO functional class II-IV symptoms.

FDA-approved indications

Covered for all FDA-approved indications.

FDA-approved indication: Requested therapy is used for an FDA-approved indication.

Anticonvulsant initial therapy

Covered when all applicable requirements are met.

Anticonvulsant requirements

Preferred-product exception
- Failure of or intolerance to one preferred alternative.
- Documented contraindication to one preferred alternative.
- Adverse reaction or expected adverse reaction to one preferred alternative.
- No suitable preferred alternative based on published guidelines or literature.

Intravenous antifungal coverage

Covered for an FDA-approved indication when the diagnosis is documented.

Intravenous voriconazole: Requested intravenous voriconazole is used for an FDA-approved indication and the diagnosis is submitted.

Aranesp initial coverage criteria

Covered when one qualifying indication pathway is met.

Qualifying Aranesp indication

Chronic renal failure anemia: Chronic renal failure, not on dialysis, with symptomatic anemia.Hgb <=10 g/dL
Chemotherapy-induced anemia: Anemia from chemotherapy for a nonmyeloid malignancy; chemotherapy received within 8 weeks and planned for at least 2 months; applicable hemoglobin and iron criteria met.Initiation Hgb <=10 g/dL; ferritin >=100 mcg/L or transferrin saturation >=20% or supplemental iron
MDS anemia: Qualifying refractory MDS anemia, endogenous EPO below 500 mu/mL, and applicable iron-status and prior-response criteria.EPO <500 mu/mL; ferritin >=100 mcg/L or transferrin saturation >=20% or supplemental iron

Arcalyst coverage criteria

Covered for an FDA-approved indication when the diagnosis is documented.

Arcalyst coverage: Diagnosis is documented and requested use is an FDA-approved indication.

For reauthorization, positive clinical response is required.

Initial therapy — CAPS

Covered when all criteria are met.

CAPS initial therapy: FCAS or MWS with classic signs and symptoms; recommended vaccinations completed or planned before therapy; and functional impairment limits activities of daily living.

Continuation therapy — CAPS

Covered when all criteria are met.

CAPS continuation therapy: New-to-plan patient met initial criteria when treatment began and positive clinical response is documented, including low disease activity or improved signs and symptoms.

Initial therapy — DIRA

Covered when all criteria are met.

DIRA initial therapy: Weight is at least 10 kg; genetic testing confirms an IL1RN mutation; clinical benefit was demonstrated with anakinra subcutaneous infusion; and recommended vaccinations are completed or planned before therapy.Weight >=10 kg

Continuation therapy — DIRA

Covered when all criteria are met.

DIRA continuation therapy: New-to-plan patient met initial criteria when treatment began and positive clinical response is documented, including low disease activity or improved signs and symptoms.

Initial therapy — Pericarditis

Covered when all criteria are met.

Pericarditis initial therapy: Recurrent pericarditis; failure of at least two standard therapies such as colchicine, NSAIDs, or corticosteroids; and recommended vaccinations completed or planned before therapy.At least 2 standard therapies failed

Continuation therapy — Pericarditis

Covered when all criteria are met.

Pericarditis continuation therapy: New-to-plan patient met initial criteria when treatment began and positive response is documented, including decreased recurrence or improvement in chest pain, rubs, ECG findings, effusion, or CRP.

Initial therapy — MAC lung disease

Covered when all criteria are met.

MAC initial therapy: Negative MAC sputum cultures have not been achieved since the most recent background multidrug regimen; Arikayce will be used with that regimen; and the isolate is amikacin-susceptible.Amikacin MIC <=64 microgram/mL

Background regimen typically includes a macrolide, ethambutol, and rifamycin.

Continuation therapy — MAC lung disease

Covered when either criterion is met.

MAC continuation therapy

Negative MAC sputum cultures have not been achieved.
Negative MAC sputum cultures have been achieved for less than 12 months.Less than 12 months

Fanapt, Caplyta, and Rexulti

Covered when both requirements are met.

Fanapt, Caplyta, or Rexulti

Qualifying exception: Failure or intolerance, contraindication, adverse reaction or expected adverse reaction to both Lybalvi and Vraylar, or no preferred formulary alternative for the condition.

Other non-preferred atypical antipsychotics

Covered when both requirements are met.

Qualifying exception: Failure or intolerance, contraindication, or adverse reaction to two preferred alternatives, or no preferred formulary alternative for the condition.Two preferred alternatives

Atypical antipsychotic indication exceptions

Preferred-product trials are not required for these indications.

Indication exceptions

Rexulti, quetiapine extended release, or fluoxetine-olanzapine for major depressive disorder.
Fluoxetine-olanzapine or quetiapine extended release for bipolar depression.
Rexulti for agitation associated with dementia due to Alzheimer's disease.

Basaglar, Basaglar Tempo, and Rezvoglar

Covered when at least one exception criterion is met.

Basaglar, Basaglar Tempo, or Rezvoglar exception: Failure, intolerance, documented contraindication, or adverse reaction or expected adverse reaction to Lantus or insulin glargine-YFGN for the requested diagnosis.

Insulin glargine U300 and Tresiba

Covered when at least one exception criterion is met.

Insulin glargine U300 or Tresiba exception: Failure, intolerance, documented contraindication, or adverse reaction or expected adverse reaction to Lantus, insulin glargine-YFGN, or Toujeo for the requested diagnosis.

Benlysta for lupus nephritis

Covered when all indication-specific criteria are met.

Lupus nephritis initial therapy: Autoantibody-positive without SLE drugs; biopsy-proven Class III, IV, or V lupus nephritis; and active renal disease requiring specified standard induction and maintenance therapy.ANA >=1:80 or anti-dsDNA >=30 I/ml

Lupus nephritis continuation: New-to-plan patient met initial criteria at treatment start and prescriber reports improvement.

Benlysta for systemic lupus erythematosus

Covered when all indication-specific criteria are met.

SLE initial therapy: Autoantibody-positive without SLE drugs; active SLE score at least 6 while receiving corticosteroid, antimalarial, or immunosuppressant therapy; and Benlysta is used with at least one other standard therapy.SELENA-SLEDAI or comparable score >=6

SLE continuation: New-to-plan patient met initial criteria at treatment start; prescriber reports improvement; and Benlysta continues with at least one standard therapy.

Bosentan initial coverage criteria

Covered when either indication pathway is met.

Bosentan indications

PAH WHO Group 1: PAH confirmed by pretreatment right heart catheterization with mPAP >=25 mm Hg, left-sided filling pressure <=15 mm Hg, PVR >3 Wood units, and WHO functional class II-IV symptoms.
CTEPH is inoperable or persistent/recurrent after surgical treatment and is symptomatic.

Lymphoma preferred-product exceptions

Covered when at least one exception applies.

Lymphoma preferred-product exception: For mantle cell, chronic lymphocytic, or small lymphocytic lymphoma: intolerance, contraindication, adverse reaction or expected adverse reaction to Calquence, or no preferred formulary alternative supported by guidelines or literature.

Carglumic acid diagnosis-specific criteria

Covered when one qualifying pathway is met.

Carglumic acid pathways

NAGS deficiency: Genetic testing confirms a mutation causing N-acetylglutamate synthase deficiency.
Acute PA or MMA: Acute propionic acidemia or methylmalonic acidemia with hyperammonemia; plasma ammonia is at least 50 micromol/L; and therapy is used with other ammonia-lowering therapies.Ammonia >=50 micromol/L

Cystic fibrosis/Pseudomonas criteria

Covered when all criteria are met.

Cystic fibrosis/Pseudomonas: Diagnosis of cystic fibrosis and Pseudomonas aeruginosa colonization in the lungs with recurrence despite prior tobramycin inhalation solution or tobramycin resistance.

Chenodal initial and continuation therapy

Initial and continuation criteria differ.

Initial Chenodal therapy: Radiolucent gallstones in a well-opacifying gallbladder; ursodiol failure, contraindication, or intolerance; and not a candidate for cholecystectomy.

Continuation Chenodal therapy: Provider confirms ongoing treatment is required based on oral cholecystograms or ultrasonograms.

Tadalafil initial therapy

Covered when all criteria are met.

Tadalafil initial therapy: Benign prostatic hyperplasia; tadalafil 2.5 mg or 5 mg once daily; bothersome moderate-or-greater symptoms; and failure, intolerance, or contraindication to two drugs from two different qualifying classes.AUA-SI >=8; 2.5 mg or 5 mg once daily

Classes include alpha-1 blockers, 5-alpha reductase inhibitors, and combination products.

Tadalafil continuation therapy

Covered after the initial authorization when response is demonstrated.

Tadalafil continuation: After the initial six-month authorization, BPH symptoms improve as shown by a decrease in AUA-SI score.AUA-SI decrease

Cobenfy initial therapy

Covered for an FDA-approved indication when all criteria are met and exclusions are absent.

Cobenfy initial therapy: Member is at least 18 years old; request is for an FDA-approved indication; diagnosis, eGFR, medication history, and preferred alternatives are submitted.Age >=18 years

Exclusions include urinary retention, hepatic or gastric retention, untreated narrow-angle glaucoma, hypersensitivity, and eGFR <60 mL/min.

Cosentyx plaque psoriasis initial therapy

Covered when all criteria are met.

Plaque psoriasis initial therapy

PASI >=7; BSA >=3%; or involvement of hands, feet, scalp, face, or genital area.
Failure, intolerance, or contraindication to phototherapy, topical therapy, or a systemic non-biologic DMARD.

Cosentyx plaque psoriasis continuation

Covered when a positive response is documented.

Plaque psoriasis continuation: Clear or minimal disease is achieved or maintained, or PASI decreases from baseline.

Cosentyx psoriatic arthritis initial therapy

Covered when all criteria are met.

Psoriatic arthritis initial therapy: Active psoriatic arthritis with active inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement, and active disease.

Cosentyx psoriatic arthritis continuation

Covered when a positive response is documented.

Psoriatic arthritis continuation: Improvement in swollen joints, tender joints, dactylitis, enthesitis, or axial disease.

Cosentyx ankylosing spondylitis initial therapy

Covered when all criteria are met.

Ankylosing spondylitis initial therapy: Confirmed active ankylosing spondylitis for at least 4 weeks and failure, intolerance, or contraindication to two different NSAIDs at maximum tolerated doses.Active disease >=4 weeks; BASDAI >=4 is an example

Cosentyx ankylosing spondylitis continuation

Covered when at least one objective improvement is documented.

Ankylosing spondylitis continuation: Improvement from baseline in an objective measure such as ASDAS, ASQoL, BASDAI, BASFI, BAS-G, BASMI, DFI, HAQ-S, CRP, or ESR.

Cosentyx nr-axSpA initial therapy

Covered when all criteria are met.

nr-axSpA initial therapy: Objective inflammation shown by elevated CRP or sacroiliitis on MRI, and failure, intolerance, or contraindication to two different NSAIDs at maximum tolerated doses.

Cosentyx nr-axSpA continuation

Covered when a positive response is documented.

nr-axSpA continuation: Improvement from baseline in disease activity, CRP, axial status, or total active swollen and tender joint count.

Cosentyx hidradenitis suppurativa initial therapy

Covered when prior treatment is documented.

Hidradenitis suppurativa initial therapy: Patient has tried at least one other therapy, such as corticosteroids, systemic antibiotics, or isotretinoin.

Cosentyx hidradenitis suppurativa continuation

Covered when objective improvement is documented.

Hidradenitis suppurativa continuation: Improvement from baseline in Hurley staging, Sartorius score, PGA, or HASI.

Cosentyx enthesitis-related arthritis initial therapy

Covered when all criteria are met.

Enthesitis-related arthritis initial therapy: At least three active joints and at least one active enthesitis site at baseline or by history, plus failure, intolerance, or contraindication to an NSAID, sulfasalazine, or methotrexate.>=3 active joints and >=1 active enthesitis site

Cosentyx enthesitis-related arthritis continuation

Covered when improvement from baseline is documented.

Enthesitis-related arthritis continuation: Improvement in flares, joints with active arthritis, joints with limited movement, dactylitis, or enthesitis.

Additional schizophrenia criteria

Covered when all criteria are met.

Schizophrenia criteria

Inadequate response to two of Lybalvi, Vraylar, and Caplyta.
Intolerance, hypersensitivity, or FDA-labeled contraindication to all three specified drugs.

Initial Therapy Criteria

Tyenne initial therapy

Initial therapy requires the applicable indication-specific criteria.

Tyenne initial indications: Applicable diagnosis, age, clinical findings, diagnostic testing, and prerequisite therapy criteria are met for RA, pJIA, sJIA, GCA, or SSc-ILD.

Adempas initial therapy

Covered when diagnosis and prerequisite history are documented.

Adempas initial therapy: Diagnosis is confirmed by right heart catheterization and history of prerequisite medications is documented.

PAH initial therapy

Covered when all clinical and preferred-product requirements are met.

Continuation Criteria

Tyenne continuation therapy

Continuation requires indication-specific response or stabilization.

Tyenne continuation therapy: RA: objective improvement; pJIA/sJIA: improvement in accepted response measures; GCA: low disease activity or improved symptoms; SSc-ILD: stabilization or slower decline in pulmonary function without progression.

Urea cycle disorder continuation

Covered when treatment benefit is documented.

Urea cycle disorder continuation: Clinically significant improvement or stabilization in plasma ammonia level.

Alosetron continuation

Covered when all criteria are met.

Prior Authorization and Provider Requirements

Prior Authorization

Submit prior authorization for Tyenne

Prior authorization applies to Tyenne for all FDA-approved indications. Document that the requested dose and frequency are within FDA-approved parameters and that the applicable indication-specific criteria are met.

Prior Authorization

Submit prior authorization for Adempas

Prior authorization applies to Adempas for all FDA-approved indications. Submit right-heart-catheterization confirmation of the diagnosis and the patient’s history of prerequisite medications.

Note

Use the required pulmonary hypertension specialist

PAH and CTEPH medications must be prescribed by or in consultation with a cardiologist or pulmonologist.

Preferred Product and Step-Therapy Requirements

Step	Required therapy	Exception or documentation
1	For Tyenne rheumatoid arthritis or polyarticular juvenile idiopathic arthritis initial therapy, try and fail two of: Enbrel, a preferred adalimumab product, Rinvoq, or tofacitinib.	Document failure of two prerequisite therapies.

Category	Preferred products	Requirement
Preferred adalimumab products	Simlandi; Hadlima	Either product may satisfy the preferred adalimumab prerequisite for applicable Tyenne criteria.

Step	Required therapy	Documentation
1	Adempas requires prerequisite medication history.	Document the history of prerequisite medications; the detailed list is not included in this policy window.

Step	Preferred therapy	Exception or documentation
1	Try at least one endothelin-receptor antagonist: ambrisentan or bosentan.	Document failure, inadequate response, or intolerance to one product, including trial dates and reason; alternatively document contraindication or expected adverse reaction to both.
1	Try at least one phosphodiesterase-5 inhibitor: sildenafil or tadalafil.	Document failure, inadequate response, or intolerance to one product, including trial dates and reason; alternatively document contraindication or expected adverse reaction to both.

Step	Prerequisite therapy	Documentation
1	Prerequisite therapy is required for alpha-1 proteinase inhibitors.	The specific prerequisite is not stated in this policy window.

Step	Preferred alternative	Exception or documentation
1	Try a preferred formulary or preferred drug-list anticonvulsant, such as carbamazepine, divalproex, gabapentin, lamotrigine, levetiracetam, phenytoin, topiramate, valproic acid, or zonisamide.	The requested drug must follow accepted dosing guidance, and an exception must be documented: failure or intolerance, contraindication, adverse reaction or expected adverse reaction, or no suitable preferred alternative.

Step	Standard therapies	Requirement
1	Try standard pericarditis therapies, such as colchicine, nonsteroidal anti-inflammatory drugs, or corticosteroids.	At least two agents must have been tried and failed.

Step	Prior therapy	Requirement
1	Anakinra subcutaneous infusion	Demonstrated clinical benefit is required before initial DIRA therapy.

Step	Requested products	Preferred products and exception
1	Fanapt, Caplyta, or Rexulti	Use Lybalvi and Vraylar first. An exception requires failure or intolerance, contraindication, adverse reaction or expected adverse reaction to both, or no preferred alternative for the condition.

Step	Requested products	Preferred products and exception
1	Clozapine ODT, olanzapine/fluoxetine, paliperidone ER, Secuado, Versacloz suspension, asenapine, Perseris ER, or quetiapine ER	Use two preferred alternatives first. An exception requires failure or intolerance, contraindication, adverse reaction or expected adverse reaction to two alternatives, or no preferred alternative for the condition.

Step	Requested products	Preferred product trial
1	Nonpreferred basal insulin	Before approval, try the applicable preferred product and document failure, intolerance, contraindication, or adverse reaction. Preferred products include Lantus or insulin glargine-YFGN; for insulin glargine U300 or Tresiba, Toujeo also applies.

Step	Prerequisite therapy	Documentation
1	Prerequisite therapy before bosentan	Document the required prerequisite therapy before coverage.

Step	Preferred product	Exception or documentation
1	Calquence	For applicable mantle cell, chronic lymphocytic, or small lymphocytic lymphoma criteria, document intolerance, contraindication, adverse reaction or expected adverse reaction, or lack of a preferred alternative supported by guidelines or literature.

Step	Prerequisite product	Exception
1	Ursodiol before initial Chenodal therapy	Try and fail ursodiol, or document contraindication or intolerance.

Therapeutic class	Examples and minimum trial	Requirement
Alpha-1 adrenergic blocker	Terazosin, doxazosin, tamsulosin, alfuzosin, or silodosin; at least 1 month at the maximum tolerated dose	Use one drug from this class and one from another listed class; failure, intolerance, or contraindication is required.
5-alpha reductase inhibitor	Finasteride or dutasteride; at least 4 months at the maximum tolerated dose	Use one drug from this class and one from another listed class; failure, intolerance, or contraindication is required.
Combination alpha-1 adrenergic blocker/5-alpha reductase inhibitor	Dutasteride/tamsulosin; at least 4 months at the maximum tolerated dose	Counts as one therapeutic class; use with a second different class.

Step	Prerequisite therapy	Requirement
1	Phototherapy, topical therapy, or systemic non-biologic DMARDs	At least one option must have failed, been intolerable, or been contraindicated.

Indication	Prerequisite therapy	Requirement
Ankylosing spondylitis	Two different NSAIDs at maximum tolerated doses	Failure, intolerance, or contraindication to both is required.
Non-radiographic axial spondyloarthritis	Two different NSAIDs at maximum tolerated doses	Failure, intolerance, or contraindication to both is required.

Step	Prerequisite therapy	Requirement
1	At least one other therapy, such as intralesional or oral corticosteroids, systemic antibiotics, or isotretinoin	At least one prior therapy must have been tried.

Step	Prerequisite therapy	Requirement
1	An NSAID, sulfasalazine, or methotrexate	Failure, intolerance, or contraindication to the applicable therapy is required.

Step	Preferred products	Exception or documentation
1	Lybalvi, Vraylar, and Caplyta	For schizophrenia, document inadequate response to two of the three products, or intolerance, hypersensitivity, or an FDA-labeled contraindication to all three.

Quantity Limits

Tadalafil quantity limit

MedicationTadalafil

Quantity limit2.5 mg or 5 mg once daily

Symptom thresholdAUA-SI greater than or equal to 8

Policy Summary

PayerNetwork Health

PolicyPrior Authorization Criteria for Specialty and Pharmacy Drugs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Failure, inadequate response, or intolerance to sildenafil or tadalafil with dates and reason documented; or documented contraindication or expected adverse reaction to both.

PAH initial therapy: PAH diagnosis, required hemodynamic thresholds, WHO functional class II-IV symptoms, and applicable preferred-product experience or contraindication requirements are documented.

Gaucher disease initial therapy

Covered when either diagnostic pathway is met.

Gaucher Type 1 diagnostic evidence: Deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts, or a glucocerebrosidase gene mutation documented by molecular testing.

Urea cycle disorder initial approval

Covered when diagnosis is confirmed.

Urea cycle disorder initial approval: Genetic or enzymatic testing confirms a urea cycle disorder.

Aimovig initial approval

Covered when all criteria are met.

Aimovig initial approval: Member is at least 18 years old and has chronic or episodic migraine.Age >=18 years

Alosetron initial therapy

Covered when all four criteria are met.

Alosetron initial therapy: IBS symptoms for at least 6 months; gastrointestinal abnormalities excluded; one antidiarrheal failed; and one antispasmodic failed.Symptoms >=6 months

Alpha 1 proteinase inhibitors

Covered when all criteria are met.

Alpha-1 proteinase inhibitors: Alpha-1 antitrypsin deficiency with emphysema or COPD; baseline AAT below threshold; and current nonsmoker status.AAT <11 micromol/L; <80 mg/dL by radial immunodiffusion; or <57 mg/dL by nephelometry

Ambrisentan

Covered when all criteria are met.

Ambrisentan: Pretreatment right heart catheterization confirms mPAP >=25 mm Hg, left-sided filling pressure <=15 mm Hg, and PVR >3 Wood units; WHO functional class II-IV symptoms are present.mPAP >=25; pressure <=15; PVR >3 Wood units; WHO II-IV

Anticonvulsant therapy

Covered for an FDA-approved indication.

Anticonvulsant therapy: Requested anticonvulsant is prescribed for an FDA-approved indication.

Anticonvulsant prerequisite therapy

Covered when dosing and a preferred-product exception are documented.

Anticonvulsant prerequisite

Failure or intolerance, contraindication, adverse reaction or expected adverse reaction, or no suitable preferred alternative.

Aranesp initial therapy

Covered when the indication-specific criteria are met.

Aranesp initial therapy: Qualifying indication and applicable hemoglobin, iron-status, disease, treatment-history, and prescriber requirements are met.

Arcalyst initial therapy

Covered when diagnosis and indication are documented.

Arcalyst initial therapy: Diagnosis is documented and requested use is an FDA-approved indication.

Initial — CAPS

Covered when all criteria are met.

CAPS initial therapy: FCAS or MWS with classic signs and symptoms; vaccinations completed or planned; and functional impairment limits activities of daily living.

Initial — DIRA

Covered when all criteria are met.

DIRA initial therapy: Weight >=10 kg; IL1RN mutation confirmed; clinical benefit from anakinra; and vaccinations completed or planned.Weight >=10 kg

Initial — Pericarditis

Covered when all criteria are met.

Pericarditis initial therapy: Recurrent pericarditis; at least two standard therapies failed; and vaccinations completed or planned.At least 2 therapies failed

Initial — Arikayce for MAC

Covered when all criteria are met.

Arikayce for MAC: No negative MAC sputum cultures since the latest background regimen; Arikayce used with a background multidrug regimen; and isolate is amikacin-susceptible.MIC <=64 microgram/mL

Fanapt, Caplyta, and Rexulti

Covered when dosing and an exception are documented.

Fanapt, Caplyta, or Rexulti: Dose is within accepted guidance and failure/intolerance, contraindication, adverse reaction, or lack of a preferred alternative involving Lybalvi and Vraylar is documented.

Other atypical antipsychotics

Covered when dosing and an exception are documented.

Other atypical antipsychotics: Dose is within accepted guidance and failure/intolerance, contraindication, adverse reaction involving two preferred alternatives, or lack of a preferred alternative is documented.

Benlysta initial therapy

Covered when all indication-specific criteria are met.

Lupus nephritis: Autoantibody-positive; biopsy-proven Class III, IV, or V lupus nephritis; and active renal disease requiring specified standard therapy.

SLE: Autoantibody-positive; active SLE score >=6 while on standard therapy; and concurrent standard therapy.SELENA-SLEDAI or comparable score >=6

Bosentan initial therapy

Covered when either pathway is met.

Bosentan pathways

PAH WHO Group 1 confirmed by right heart catheterization with required hemodynamics and WHO II-IV symptoms.
Symptomatic CTEPH that is inoperable or persistent/recurrent after surgery.

Brukinsa initial therapy

Covered for a medically accepted indication.

Brukinsa: Requested use is a medically accepted indication for Brukinsa.

Carglumic acid initial therapy

Covered when one qualifying diagnosis pathway is met.

Carglumic acid

Genetically confirmed NAGS deficiency with hyperammonemia.
Acute PA or MMA with ammonia >=50 micromol/L and concurrent ammonia-lowering therapy.

Chenodal initial therapy

Covered when all criteria are met.

Chenodal initial therapy: Radiolucent gallstones in a well-opacifying gallbladder; ursodiol failure, contraindication, or intolerance; and not a candidate for cholecystectomy.

Tadalafil initial authorization

Covered when all criteria are met.

Tadalafil initial authorization: BPH; tadalafil 2.5 mg or 5 mg once daily; AUA-SI >=8; and failure, intolerance, or contraindication to two drugs from different qualifying classes.AUA-SI >=8

Cobenfy initial authorization

Covered for an FDA-approved indication when criteria are met and exclusions are absent.

Cobenfy initial authorization: Member is at least 18 years old; requested use is FDA-approved; diagnosis, eGFR, medication history, and preferred alternatives are submitted.Age >=18 years

Cosentyx initial therapy

Covered when the applicable indication-specific criteria are met.

Cosentyx initial therapy: Criteria are met for the applicable indication: plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, nr-axSpA, hidradenitis suppurativa, or enthesitis-related arthritis.

Alosetron continuation: New-to-plan patient met initial criteria at treatment start; FDA-approved dose and frequency; and positive clinical response.

Aranesp coverage duration

Authorization duration is indication-specific.

Aranesp duration

Chemotherapy-induced anemia: 6-month authorization.
All other indications: 1-year authorization.

Arcalyst continuation criteria

Reauthorization requires positive clinical response.

Arcalyst continuation: Positive clinical response is documented and the diagnosis remains supported.

Continuation — CAPS, DIRA, and pericarditis

Continuation requires initial eligibility for new-plan patients and response.

CAPS, DIRA, and pericarditis continuation: New-to-plan patient met initial criteria at treatment start and positive clinical response is documented.

For pericarditis, response includes decreased recurrence or improvement in specified symptoms and findings.

Continuation — Arikayce

Covered when infection persists or has been recently controlled.

Arikayce continuation

Negative MAC sputum cultures have not been achieved.
Negative cultures have been achieved for less than 12 months.Less than 12 months

Benlysta continuation

Continuation requires initial eligibility for new-plan patients and improvement.

Lupus nephritis continuation: New-to-plan patient met initial criteria at treatment start and prescriber reports improvement.

SLE continuation: New-to-plan patient met initial criteria at treatment start; prescriber reports improvement; and Benlysta continues with standard therapy.

Coverage duration

Duration depends on the medication and qualifying pathway.

Applicable medication criterion has a 1-year duration.
NAGS without genetic testing: 3 months.
NAGS with genetic testing: 12 months.
All other carglumic acid cases: 7 days.

Chenodal continuation

Continuation is authorized for 1 year when ongoing treatment is documented.

Chenodal continuation: Provider confirms continued treatment is required based on oral cholecystograms or ultrasonograms.

Tadalafil lifetime continuation

Lifetime continuation may follow the initial six-month authorization.

Tadalafil lifetime continuation: BPH symptoms improve, shown by a decrease in AUA-SI score, after the initial six-month duration.

Cosentyx continuation therapy

Continuation requires indication-specific positive response or objective improvement.

Cosentyx continuation response: Positive response is documented using the applicable measure: psoriasis disease status or PASI; PsA joint, dactylitis, enthesitis, or axial measures; AS objective disease measure; nr-axSpA disease activity, CRP, axial status, or joint count; HS objective measure; or enthesitis-related arthritis flares, joints, dactylitis, or enthesitis.

Note

Note the 3-year authorization duration

Authorization for the pulmonary hypertension criteria has a coverage duration of 3 years.

Note

Use the required Gaucher specialist

Gaucher disease therapies must be prescribed by or in consultation with a geneticist, endocrinologist, hepatologist, metabolic disorder subspecialist, or physician specializing in lysosomal storage disorders.

Note

Note the 1-year authorization duration

Authorization for the Gaucher disease criteria has a coverage duration of 1 year.

Prior Authorization

Obtain specialist review and confirm the urea cycle disorder

For urea cycle disorder treatment, prescribing must be by or in consultation with a metabolic disease specialist. Initial approval requires genetic or enzymatic confirmation; continuation requires clinically significant improvement or stabilization in plasma ammonia.

Prior Authorization

Confirm Aimovig eligibility

Aimovig requires the member to be at least 18 years old and to have chronic migraine or episodic migraine.

Prior Authorization

Submit an alosetron indication review

Alosetron HCl requires prior authorization and is reviewed for all FDA-approved indications.

Prior Authorization

Meet all initial IBS-D criteria

For severe diarrhea-predominant IBS, initial approval requires symptoms for at least 6 months, exclusion of gastrointestinal anatomic or biochemical abnormalities, failure of one antidiarrheal, and failure of one antispasmodic.

Documentation Required

Document response for alosetron continuation

Continuation approval requires applicable initial criteria for new-to-plan members, FDA-approved dose and frequency, and a positive clinical response.

Prior Authorization

Submit an alpha-1 inhibitor indication review

Aralast NP, Glassia, Prolastin C 1,000 mg/20 mL vial, and Zemaira require prior authorization and are reviewed for all FDA-approved indications.

Prior Authorization

Confirm alpha-1 inhibitor criteria

Coverage requires alpha-1 antitrypsin deficiency with emphysema or COPD, a baseline pretreatment AAT concentration below the applicable threshold, and current nonsmoker status.

AAT must be <11 micromol/L; <80 mg/dL by radial immunodiffusion; or <57 mg/dL by nephelometry.
Patient must be a current nonsmoker.

Prior Authorization

Submit ambrisentan authorization

Ambrisentan requires prior authorization for all FDA-approved indications. For PAH, submit pretreatment right-heart-catheterization findings and confirm WHO functional class II-IV symptoms.

Prior Authorization

Submit anticonvulsant authorization

The listed anticonvulsant therapy medications require prior authorization for all FDA-approved indications.

Prior Authorization

Meet anticonvulsant PA requirements

Prior authorization applies to the listed anticonvulsants. Use dosing within manufacturer, accepted compendia, or current literature guidelines and establish the required preferred-product exception.

Prior Authorization

Submit intravenous voriconazole authorization

The listed intravenous voriconazole products require prior authorization for all FDA-approved indications.

Documentation Required

Submit Aranesp clinical documentation

Prior authorization applies to Aranesp for all FDA-approved and some medically accepted indications. Requests must meet the applicable clinical criteria and include the required medical information.

Prior Authorization

Submit Arcalyst authorization and response

Prior authorization applies to Arcalyst for all FDA-approved indications. Reauthorization requires documentation of a positive clinical response.

Step Therapy

Address prerequisite therapy

Prior authorization requires prerequisite therapy. The policy lists the Part B prerequisite as not applicable.

Document the applicable prerequisite therapy requirement for the requested medication.

Note

Use the required specialist prescriber

CAPS therapy must be prescribed by or provided in consultation with a rheumatologist, geneticist, allergist/immunologist, or dermatologist. DIRA and pericarditis have separate specialist requirements.

DIRA: rheumatologist, geneticist, dermatologist, or physician specializing in autoinflammatory disorders.
Pericarditis: rheumatologist or cardiologist.

Note

Use a qualified MAC prescriber

Arikayce for MAC must be prescribed by a pulmonologist, infectious disease physician, or physician specializing in MAC lung infections.

Prior Authorization

Verify indication-specific age

The policy requires age 12 years or older for CAPS and pericarditis, and age 18 years or older for MAC.

Prior Authorization

Submit atypical antipsychotic authorization

Prior authorization applies to the listed atypical antipsychotics for all FDA-approved indications, and prerequisite therapy is required.

Documentation Required

Document basal insulin history

Prior authorization applies to the listed basal insulin products for all FDA-approved indications. Document previous therapies.

Prior Authorization

Submit the required prior authorization

Prior authorization is required for the listed medications. Submit the applicable diagnosis, treatment history, objective measures, response, and FDA-approved dosing information.

Prior Authorization

Review all FDA-approved Benlysta indications

Benlysta prior authorization applies to all FDA-approved indications.

Note

Use the required Benlysta specialist

For systemic lupus erythematosus, Benlysta must be prescribed by or in consultation with a rheumatologist, clinical immunologist, nephrologist, neurologist, or dermatologist. Lupus nephritis requires a nephrologist or rheumatologist.

Prior Authorization

Submit bosentan authorization

Prior authorization applies to bosentan for all FDA-approved and some medically accepted indications, including CTEPH, when applicable criteria are met.

Prior Authorization

Submit Brukinsa authorization

Prior authorization applies to Brukinsa for all medically accepted indications. The listed coverage duration is 1 year.

Prior Authorization

Identify the qualifying indication

Prior authorization applies to all FDA-approved indications and some medically accepted indications for the listed medication. Submit the indication supporting the request.

Note

Use a metabolic disease specialist

Prescribing must be by, or in consultation with, a metabolic disease specialist or a specialist who focuses on metabolic disease treatment.

Step Therapy

Complete prerequisite therapy

Prerequisite therapy is required for the cystic fibrosis-related medication criteria.

Prior Authorization

Submit Chenodal authorization

Chenodal requires prior authorization and prerequisite therapy. Initial therapy requires ursodiol failure, contraindication, or intolerance, together with ineligibility for cholecystectomy.

Prior Authorization

Submit PA and prerequisite history

Prior authorization applies to tadalafil 2.5 mg and 5 mg tablets and to Cobenfy and Cobenfy Starter Pack. Prerequisite therapy is required for both medication groups.

Documentation Required

Submit complete authorization information

Prior authorization is required. Submit the applicable diagnosis, prerequisite treatment history, objective baseline or continuation measures, treatment response, and documentation that dosing and frequency are within FDA-approved parameters.

Note

Use the required Cosentyx specialist

For psoriasis and hidradenitis suppurativa, Cosentyx must be prescribed by or in consultation with a dermatologist. For ankylosing spondylitis, nr-axSpA, and enthesitis-related arthritis, use a rheumatologist; psoriatic arthritis requires a rheumatologist or dermatologist.

Prior Authorization

Verify Cosentyx age requirements

Cosentyx age requirements vary by indication: psoriasis 6 years or older; psoriatic arthritis 2 years or older; enthesitis-related arthritis 4 years or older; nr-axSpA 18 years or older; and ankylosing spondylitis or hidradenitis suppurativa 12 years or older.

Step Therapy

Document Tyenne prerequisite therapy

For RA and pJIA initial approval, Tyenne requires failure of two of Enbrel, a preferred adalimumab product, Rinvoq, or tofacitinib. Preferred adalimumab products include Simlandi and Hadlima.

Documentation Required

Document Adempas medication history

Adempas requires a documented history of prerequisite medications. The detailed prerequisite medication list is referenced but is not included in this policy window.

Step Therapy

Complete PAH preferred-product trials

For PAH, establish failure, inadequate response, or intolerance to at least one preferred endothelin-receptor antagonist—ambrisentan or bosentan—and at least one preferred PDE-5 inhibitor—sildenafil or tadalafil. A documented contraindication or expected adverse reaction to both products in a class is an alternative.

Step Therapy

Address alpha-1 inhibitor prerequisites

Prerequisite therapy is required for the alpha-1 proteinase inhibitor category.

Step Therapy

Try a preferred anticonvulsant

Try a preferred formulary or preferred drug-list anticonvulsant before the requested non-preferred product unless a listed exception applies.

Exceptions include failure or intolerance, contraindication, adverse reaction or expected adverse reaction, or no suitable preferred alternative.

Step Therapy

Document pericarditis treatment failure

For pericarditis, the patient must have tried and failed at least two standard therapies, such as colchicine, nonsteroidal anti-inflammatory drugs, or corticosteroids.

Step Therapy

Document prior anakinra response

For DIRA, the patient must have demonstrated clinical benefit with anakinra subcutaneous infusion before initial approval.

Step Therapy

Complete intravenous antifungal prerequisite therapy

Prerequisite therapy is required for intravenous antifungals.

Step Therapy

Complete atypical antipsychotic prerequisites

Prerequisite therapy is required for atypical antipsychotics. Depending on the product, document failure or intolerance of preferred alternatives, contraindications, adverse reactions, or a qualifying condition without a preferred alternative.

Step Therapy

Complete preferred basal insulin trial

Prerequisite therapy is required for nonpreferred basal insulin through failure, intolerance, contraindication, or adverse-reaction criteria involving the specified preferred insulin products.

Step Therapy

Complete bosentan prerequisite therapy

Prerequisite therapy is required before bosentan coverage.

Step Therapy

Address the preferred Calquence requirement

For applicable lymphoma criteria, use preferred Calquence unless the patient demonstrates intolerance, contraindication, adverse reaction or expected adverse reaction, or has a condition without a preferred formulary alternative supported by guidelines or literature.

Step Therapy

Try ursodiol before Chenodal

Before initial Chenodal therapy, the patient must have tried and failed ursodiol or have a contraindication or intolerance to ursodiol.

Step Therapy

Complete tadalafil prerequisite therapy

For tadalafil, document failure, intolerance, or contraindication to two drugs from any two different therapeutic classes: alpha-1 adrenergic blockers, 5-alpha reductase inhibitors, or combination products.

Step Therapy

Complete psoriasis prerequisite therapy

For plaque psoriasis, document failure, intolerance, or contraindication to at least one of phototherapy, topical therapy, or systemic non-biologic DMARDs.

Step Therapy

Document the ankylosing spondylitis NSAID trial

For ankylosing spondylitis, document failure, intolerance, or contraindication to two different NSAIDs at maximum tolerated doses.

Step Therapy

Document the nr-axSpA NSAID trial

For non-radiographic axial spondyloarthritis, document failure, intolerance, or contraindication to two different NSAIDs at maximum tolerated doses.

Step Therapy

Document prior hidradenitis therapy

For hidradenitis suppurativa, the patient must have tried at least one other therapy, such as intralesional or oral corticosteroids, systemic antibiotics, or isotretinoin.

Step Therapy

Complete enthesitis-related arthritis prerequisites

For enthesitis-related arthritis, document failure, intolerance, or contraindication to an NSAID, sulfasalazine, or methotrexate.

Step Therapy

Complete schizophrenia prerequisite therapy

For the additional schizophrenia criteria, document an inadequate response to two of Lybalvi, Vraylar, and/or Caplyta, or intolerance, hypersensitivity, or an FDA-labeled contraindication to all three.

Denial Risk

Avoid concurrent DMARD use with Tyenne

Tyenne is excluded when used concurrently with a biologic DMARD or targeted synthetic DMARD.

Denial Risk

Avoid contraindicated Adempas combinations

Adempas is excluded with phosphodiesterase inhibitors used for pulmonary hypertension or with other soluble guanylate cyclase stimulators.

Denial Risk

Meet Tyenne initial criteria

Tyenne initial approval may be denied when the applicable indication-specific criteria or required prerequisite therapy are not met.

Denial Risk

Document Tyenne continuation response

Tyenne continuation approval may be denied without documented positive clinical response. For SSc-ILD, document stabilization or reduced decline in FVC or ppFVC and no disease progression.

Denial Risk

Support PAH diagnostic and preferred-therapy criteria

PAH requests may be denied without the required pretreatment right-heart-catheterization findings, WHO functional class II-IV symptoms, and preferred-product failure, inadequate response, intolerance, contraindication, or adverse-reaction documentation.

Denial Risk

Meet CTEPH clinical criteria

CTEPH requests may be denied when disease is not inoperable or persistent/recurrent after pulmonary endarterectomy, is not symptomatic, or does not meet PVR and mPAP thresholds.

Denial Risk

Confirm Gaucher disease Type 1

Gaucher disease therapy may be denied unless Type 1 disease is supported by deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts or molecular genetic evidence of a glucocerebrosidase gene mutation.

Denial Risk

Use only one phenylbutyrate product concurrently

Concurrent use with more than one phenylbutyrate product is excluded.

Denial Risk

Avoid prophylactic CGRP antagonist combination

Aimovig is excluded when combined with a CGRP antagonist being used for prophylaxis.

Denial Risk

Meet Aimovig age and diagnosis requirements

Aimovig requires the member to be at least 18 years old and to have chronic or episodic migraine.

Denial Risk

Screen for the alosetron exclusion

Alosetron coverage is excluded if the patient is biologically male.

Denial Risk

Meet the alosetron age requirement

Alosetron requests require the patient to be 18 years or older.

Denial Risk

Meet initial IBS-D criteria

Initial severe diarrhea-predominant IBS coverage requires symptoms for at least 6 months, exclusion of gastrointestinal abnormalities, failure of one antidiarrheal, and failure of one antispasmodic.

Denial Risk

Meet alosetron continuation criteria

Continuation coverage requires applicable initial criteria for new-to-plan members, FDA-approved dose and frequency, and a positive clinical response.

Denial Risk

Meet the alpha-1 inhibitor age requirement

Alpha-1 proteinase inhibitor requests require the patient to be 18 years or older.

Denial Risk

Meet alpha-1 inhibitor clinical criteria

Alpha-1 proteinase inhibitor coverage requires both a baseline pretreatment AAT concentration below the applicable threshold and current nonsmoker status.

Denial Risk

Meet ambrisentan PAH criteria

Ambrisentan coverage requires pretreatment right-heart catheterization confirming the specified hemodynamic criteria and WHO functional class II-IV symptoms.

Denial Risk

Meet anticonvulsant dosing and exception requirements

An anticonvulsant request may be denied when dosing is outside manufacturer, accepted compendia, or current literature guidelines, or when no preferred-product exception is established.

Denial Risk

Screen for Aranesp exclusions

Aranesp coverage may be denied for uncontrolled hypertension, excluded anemia causes, certain concurrent therapies, immediate anemia correction, emergency transfusion substitution, or prophylactic use.

Denial Risk

Avoid concurrent Arcalyst biologic therapy

Coverage may be denied when Arcalyst is used concurrently with a biologic drug or targeted synthetic drug.

Denial Risk

Review concurrent biologic or targeted therapy

Concurrent use of a biologic drug or targeted synthetic drug may preclude coverage.

Denial Risk

Meet initial clinical criteria

Initial CAPS, DIRA, or pericarditis therapy requires all applicable diagnosis-specific clinical criteria, including vaccination requirements and the required disease or treatment history.

Denial Risk

Meet MAC treatment criteria

Arikayce coverage requires persistent or recurrent positive MAC sputum cultures, use with a background multidrug regimen, and an amikacin-susceptible isolate with MIC no greater than 64 microgram/mL.

Denial Risk

Document the atypical antipsychotic exception

Non-preferred atypical antipsychotic requests may be denied without the required preferred-product trials, contraindication or adverse-reaction documentation, or qualifying clinical exception.

Denial Risk

Use an accepted atypical antipsychotic dose

Coverage may be denied when the requested atypical antipsychotic dose is outside manufacturer, accepted compendia, or current literature dosing guidelines.

Documentation Required

Document previous basal insulin therapy

Basal insulin requests require documentation of previous therapies.

Denial Risk

Document the preferred-product exception

Basaglar, Basaglar Tempo, and Rezvoglar may be denied without failure, intolerance, contraindication, or adverse-reaction documentation for Lantus or insulin glargine-YFGN.

Denial Risk

Document the U300 or Tresiba exception

Insulin glargine U300 and Tresiba may be denied without failure, intolerance, contraindication, or adverse-reaction documentation for Lantus, insulin glargine-YFGN, or Toujeo.

Denial Risk

Screen for excluded Benlysta use

Benlysta coverage excludes concurrent use with other biologics, Lupkynis, or Saphnelo, and patients with active central nervous system lupus.

Denial Risk

Meet bosentan clinical criteria

Bosentan coverage may be denied without confirmation of PAH WHO Group 1 or qualifying symptomatic CTEPH and the applicable clinical and hemodynamic criteria.

Denial Risk

Meet the Calquence exception requirement

For mantle cell, chronic lymphocytic, or small lymphocytic lymphoma, approval may be denied without intolerance, contraindication, adverse-reaction documentation, or a qualifying lack of a preferred Calquence alternative.

Denial Risk

Submit diagnosis-specific carglumic acid evidence

For NAGS deficiency with hyperammonemia, approval requires genetic confirmation of the causative mutation. For acute PA or MMA with hyperammonemia, plasma ammonia must be at least 50 micromol/L and therapy must be combined with other ammonia-lowering treatments.

Denial Risk

Meet the metabolic specialist requirement

The medication must be prescribed by, or in consultation with, a metabolic disease specialist or another specialist focused on treating metabolic diseases.

Denial Risk

Meet cystic fibrosis and Pseudomonas criteria

Coverage may be denied without cystic fibrosis and Pseudomonas aeruginosa lung colonization with recurrence despite prior tobramycin inhalation solution use or tobramycin resistance.

Denial Risk

Screen for calcified stones

Chenodal is excluded for patients with calcified (radiopaque) stones.

Denial Risk

Meet Chenodal eligibility criteria

Chenodal coverage requires radiolucent gallstones in a well-opacifying gallbladder and, initially, ursodiol failure, contraindication, or intolerance plus inability to undergo cholecystectomy.

Denial Risk

Screen for tadalafil exclusions

Tadalafil coverage is excluded for erectile dysfunction and concomitant nitrate use.

Denial Risk

Screen for Cobenfy exclusions

Cobenfy coverage is excluded for urinary retention, hepatic or gastric retention, untreated narrow-angle glaucoma, hypersensitivity to Cobenfy or trospium, or eGFR below 60 mL/min.

Denial Risk

Meet tadalafil clinical criteria

Tadalafil requests may be denied without benign prostatic hyperplasia, bothersome moderate-or-greater symptoms with an AUA-SI score of at least 8, and trials of two qualifying therapies from different classes.

Denial Risk

Avoid concurrent biologic or targeted synthetic DMARD use

Coverage is excluded when the patient is concurrently using other biologics or targeted synthetic DMARDs.

Denial Risk

Meet schizophrenia prerequisite criteria

The additional schizophrenia criteria require inadequate response to two specified drugs or intolerance, hypersensitivity, or an FDA-labeled contraindication to all three specified drugs.

Specified drugs are Lybalvi, Vraylar, and Caplyta.