Prior authorization and prerequisite therapy

Prior authorization is required for FDA‑approved indications; prerequisite therapy is required before approval.

PA applies to all FDA‑approved indications

Prior authorization applies to all FDA‑approved indications as indicated by the PA indication indicator.

PA: All FDA‑approved indications (indicator = 1)

The PA indication indicator denotes scope as '1 - All FDA‑Approved Indications' for the listed medication entries.

Actemra prior authorization required (prerequisite therapy = YES)

Prior authorization is required for Actemra; prerequisite therapy is indicated as YES for the Actemra PA entries.

PA for ambrisentan — RHC documentation required

Prior authorization is required for ambrisentan and requests must include documentation of diagnosis confirmed by right heart catheterization showing required hemodynamics.

• Required hemodynamics: mPAP ≥ 25 mm Hg; PCWP/PAWP (or LA pressure/LVEDP) ≤ 15 mm Hg; PVR > 3 Wood units
• Prescribed by or in consultation with a cardiologist or pulmonologist

PA and coverage duration for IV antifungals (voriconazole)

Prior authorization applies to listed IV antifungals (e.g., voriconazole) with PA indication 'All FDA‑Approved Indications' and coverage duration noted.

• Coverage duration for listed IV antifungals: 3 months

PA for listed ESA formulations (indicator = 4)

Prior authorization indicator '4' applies to the listed hematology-related agents (Aranesp formulations), covering all FDA‑approved indications and some medically‑accepted indications.

PA required — all FDA‑approved indications

Prior authorization is required for the listed medications where the PA indicator is 'All FDA‑Approved Indications'.

Arikayce PA — document diagnosis, amikacin MIC, and prior therapy

Arikayce requires prior authorization and documentation must include the diagnosis, the amikacin minimum inhibitory concentration (MIC) for the MAC isolate, and evidence of prior therapy.

• Amikacin MIC must be ≤ 64 µg/mL
• Arikayce to be used with a background multidrug regimen (e.g., macrolide + ethambutol + rifamycin)

Document trials/failures or contraindications for PA

Prior authorization requires documentation of trials and failures or documented contraindications/intolerances to specified preferred alternatives per drug‑specific criteria.

• Document dates of trials and reasons for failure or contraindication as specified in the criteria

PA required for bosentan products (prerequisite therapy required)

Bosentan products require prior authorization and prerequisite therapy is required per the policy.

Prior authorization and standard approval duration (1 year)

Approvals in this section are typically issued for 1 year unless otherwise stated; prior authorization is required.

• Standard approval duration for many listed medications: 1 year

PA required — prerequisite therapy indicated for listed entries

Prior authorization is required for the listed medications in this segment; at least one entry indicates prerequisite therapy is required.

PA required — Chenodal and tadalafil (All FDA‑Approved Indications)

Prior authorization is required for Chenodal and tadalafil; the PA indicator for both is 'All FDA‑Approved Indications'.

Prerequisite therapy required for Chenodal and tadalafil

Prerequisite therapy is required: Chenodal requires trial and failure or contraindication to ursodiol; tadalafil requires trials of two other drug classes with specified minimum durations.

• Chenodal: trial/failure/intolerance or contraindication to ursodiol
• Tadalafil (BPH): trials of alpha‑1 blocker (≥1 month at max tolerated dose) and a 5‑alpha reductase inhibitor (≥4 months at max tolerated dose), or combination per criteria

PA required for COBENFY products (prerequisite therapy required)

Prior authorization is required for COBENFY and COBENFY STARTER PACK; prerequisite therapy is required and coverage is for FDA‑approved indications.

Cosentyx prior authorization (prerequisite therapy = YES)

Prior authorization is required for Cosentyx and prerequisite therapy is required (PREREQUISITE THERAPY REQUIRED = YES).

Crinone PA — includes FDA and some medically‑accepted indications

Crinone Gel has PA indicators that include FDA‑approved and some medically‑accepted indications (indicator = 4).

Step therapy — preferred PAH agents must be tried first

For PAH (WHO Group 1), members must have trial and failure or documented contraindication/intolerance to preferred endothelin receptor antagonists (ambrisentan or bosentan) and to a phosphodiesterase‑5 inhibitor (sildenafil or tadalafil) unless contraindicated.

• Documentation must include dates of trials and reasons for failure

No prerequisite therapy required (N/A entries)

No prerequisite or step therapy is required for certain listed medication entries where the policy documents 'N/A'.

Actemra entries with no prerequisite therapy documented

Some Actemra entries document 'N/A' for prerequisite therapy; no prerequisite therapy is required in those Actemra entries.

Actemra for severe diarrhea‑predominant IBS — step therapy required

Actemra for severe diarrhea‑predominant IBS requires prior trials and failures of one antidiarrheal agent (e.g., loperamide) and one antispasmodic agent (e.g., dicyclomine) before authorization.

• Initial criteria require chronic IBS symptoms ≥ 6 months and exclusion of anatomic/biochemical GI abnormalities

Step therapy not required (N/A)

For entries documented as 'N/A', no prerequisite therapy is required.

Part B prerequisite — none specified (N/A) for some IV listings

Part B prerequisite is not specified for several IV listings; some entries explicitly state 'N/A' for Part B prerequisite and prerequisite therapy.

Prerequisite therapy required (YES)

The policy documents that prerequisite therapy is required (PREREQUISITE THERAPY REQUIRED = YES) for specific entries.

Arikayce prerequisite — background multidrug regimen required

Arikayce must be used in conjunction with a background multidrug regimen (typical regimen includes a macrolide, ethambutol, and a rifamycin); prerequisite background therapy is required.

• Background regimen typically: azithromycin or clarithromycin + ethambutol + rifampin or rifabutin

Step therapy required for many atypical antipsychotics and basal insulin

Step therapy is required for many atypical antipsychotics and basal insulin products: members must have failed or be intolerant to specified preferred alternatives unless exception criteria are met.

• Document prior failures, intolerances, contraindications, or adverse reactions to preferred products as specified

Documentation required for SLE/lupus nephritis concurrent standard therapy

For SLE and lupus nephritis, documentation must include concurrent use of at least one standard SLE therapy and specified clinical data (autoantibody levels, SELENA‑SLEDAI score, and biopsy for lupus nephritis).

• SLE: ANA or anti‑dsDNA and SELENA‑SLEDAI ≥ 6 required
• Lupus nephritis: biopsy‑proven Class III, IV and/or V required

PAH/CTEPH entries — no step therapy specified in parts (N/A)

No prerequisite or step therapy is specified for the PAH/CTEPH criteria in parts of the policy (documented as N/A or unspecified).

CAYSTON prerequisite — prior tobramycin inhalation or resistance required

For CAYSTON, prior use of tobramycin inhalation solution or documentation of tobramycin resistance is required as part of the prerequisite therapy.

• Member must have Pseudomonas aeruginosa colonization with recurrence despite prior tobramycin inhalation solution or demonstrated tobramycin resistance

Chenodal and tadalafil — prerequisite trials required

Chenodal requires a trial and failure or documented intolerance/contraindication to ursodiol before authorization; tadalafil requires trials of two other drug classes per criteria.

• Chenodal: try ursodiol first (or document contraindication/intolerance)
• Tadalafil: trial of alpha‑1 blocker (≥1 month) and 5‑alpha reductase inhibitor (≥4 months) or combination per policy

Step therapy — two‑class trial and failure requirement

Where required, the patient must have tried and failed or be intolerant/contraindicated to two other drugs from two different therapeutic classes with specified minimum trial durations.

• Alpha‑1 blockers: minimum 1 month at max tolerated dose
• 5‑alpha reductase inhibitors: minimum 4 months at max tolerated dose

Antifungal step therapy — document trials/failures of preferred agents

For invasive aspergillosis or mucormycosis indications, document trial and failure/intolerance of preferred antifungal agents (posaconazole and/or voriconazole) or documented contraindication/adverse reaction to preferred agents.

• Provide dates of trials and reasons for failure or contraindication

Required clinical documentation — RHC and prior therapy details

Provide diagnosis confirmed by right heart catheterization and documentation of prerequisite medication trials (including dates and reasons for failure or contraindications) when requesting PAH/CTEPH therapies.

• Include pretreatment RHC hemodynamics (mPAP, PCWP/PAWP/LVEDP, PVR) and WHO functional class
• Include dates and reasons for prior medication trials

Provide genetic/enzymatic/lab test results when required

Provide diagnosis and supporting genetic, enzymatic, or laboratory test results where applicable; some indications require molecular genetic testing or enzyme demonstration.

Required medical information and reauthorization evidence

Required documentation includes the diagnosis; for reauthorization of certain agents (e.g., Alosetron) provide evidence of a positive clinical response.

• Alosetron reauthorization: documentation of positive clinical response

Actemra (IBS‑D) documentation — chronic symptoms and exclusions

For Actemra in severe diarrhea‑predominant IBS, document chronic symptoms ≥ 6 months and exclusion of anatomic/biochemical GI abnormalities as part of the PA requirements.

• Document prior trials and failures of one antidiarrheal and one antispasmodic agent

Alpha‑1 inhibitors — baseline AAT concentration and smoking status required

For alpha‑1 proteinase inhibitors, document the diagnosis and a baseline (pretreatment) AAT serum concentration below the specified laboratory thresholds and current non‑smoker status.

• Baseline AAT thresholds: < 11 micromol/L (or <80 mg/dL RID or <57 mg/dL nephelometry)

RHC hemodynamics and WHO class required for PAH authorization

Provide pretreatment right heart catheterization hemodynamics (mPAP, PCWP/PAWP or equivalent, and PVR) and documentation of WHO functional class II–IV when requesting PAH therapies.

• Required hemodynamics: mPAP ≥ 25 mm Hg; PCWP/PAWP (or LA pressure/LVEDP) ≤ 15 mm Hg; PVR > 3 Wood units

Arikayce — supply diagnosis and amikacin MIC

Provide diagnosis and amikacin minimum inhibitory concentration (MIC) for the MAC isolate when requesting Arikayce.

• Amikacin MIC threshold: ≤ 64 µg/mL

Documentation for initial and reauthorization — show positive clinical response

For reauthorization and continuation requests, document diagnosis and evidence of positive clinical response or ongoing benefit per the specific drug criteria.

• Continuation typically requires documentation of clinical improvement or sustained need

Arikayce — background multidrug therapy required and documented

Arikayce requires background multidrug therapy alongside its use; documentation must show Arikayce will be used with a multidrug regimen.

• Background regimen typically: macrolide + ethambutol + rifamycin

Document prior therapies for basal insulin requests

Previous therapies must be documented when requesting basal insulin agents.

SLE/lupus nephritis — required lab and biopsy documentation

For SLE include ANA or anti‑dsDNA level and SELENA‑SLEDAI score; for lupus nephritis include biopsy‑proven pathology as part of required documentation.

• SLE: ANA ≥ 1:80 or anti‑dsDNA ≥ 30 IU/mL and SELENA‑SLEDAI ≥ 6
• Lupus nephritis: biopsy‑proven Class III/IV/V

PAH/CTEPH — RHC hemodynamics, WHO class, and CTEPH operability documentation required

Provide pretreatment RHC hemodynamics, WHO functional class, and for CTEPH document that disease is inoperable or persistent/recurrent after pulmonary endarterectomy and symptomatic.

CAYSTON — document CF, Pseudomonas colonization, and prior tobramycin use/resistance

Provide diagnosis documentation (including genetic testing when applicable) and for CAYSTON include cystic fibrosis diagnosis and Pseudomonas aeruginosa colonization evidence with prior tobramycin failure/resistance.

• CAYSTON: document CF diagnosis and Pseudomonas colonization with recurrence despite tobramycin or tobramycin resistance

Chenodal — document radiolucent gallstones via oral cholecystography

For Chenodal, document radiolucent gallstones in a well‑opacifying gallbladder as shown by oral cholecystography.

Tadalafil — document AUA‑SI ≥ 8 and prior therapy trials

For tadalafil requests, document an AUA‑SI score ≥ 8 and prior trials of required therapies per the prerequisite therapy section.

• Include medication history and trial durations at maximum tolerated doses

Provide diagnosis, eGFR, and medication history with preferred alternatives

Provide diagnosis, eGFR, and medication history including preferred formulary alternatives when required by the policy.

Document prior medications and FDA‑approved dosing/frequency

Provide diagnosis, prior medications tried, and confirmation that dose and frequency are within FDA‑approved dosing and frequency when requested.

Antifungal prerequisite documentation — trials/failures or contraindications to preferred agents

For invasive aspergillosis or mucormycosis, document trial and failure/intolerance dates and reasons for posaconazole or voriconazole, or document contraindications/adverse reactions to the preferred agents.

Exclusion — concurrent PDE inhibitor or sGC stimulator use

Concurrent use with phosphodiesterase inhibitors for pulmonary hypertension or other soluble guanylate cyclase stimulators is an exclusion and may trigger denial.

Exclusion — multiple phenylbutyrate products

Concurrent use with more than one phenylbutyrate product triggers exclusion/denial.

Exclusion — Actemra with prophylactic CGRP antagonist

Actemra combined with a CGRP antagonist used for prophylaxis is an exclusion and may trigger denial.

Alosetron sex‑based exclusion

Alosetron is excluded if the patient is biologically male.

Denial risk — missing IBS prior‑trial documentation for Actemra

Lack of documentation of prior trial and failure of one antidiarrheal and one antispasmodic agent for severe diarrhea‑predominant IBS may trigger denial for Actemra.

Denial risk — missing baseline AAT or smoking status for alpha‑1 inhibitors

For alpha‑1 proteinase inhibitors, failure to document baseline AAT serum concentration below the specified thresholds or current non‑smoker status may lead to denial.

Denial risk — missing right heart catheterization confirmation

Absence of diagnosis confirmed by right heart catheterization may trigger denial for PAH/CTEPH therapy requests.

Denial risk — specified exclusion criteria (e.g., uncontrolled hypertension)

Coverage is excluded for patients with uncontrolled hypertension and for specified anemia‑related exclusions per the ESA/antifungal section.

• Includes exclusions for prophylactic use to prevent chemotherapy‑induced anemia and for immediate substitution for emergency transfusion

Exclusion — concurrent biologic or targeted synthetic therapy

Concurrent use with a biologic drug or targeted synthetic drug is an exclusion and can trigger denial.

Arikayce denial triggers — MIC > 64 µg/mL or no background regimen

Requests for Arikayce may be denied if the MAC isolate is not susceptible to amikacin (MIC > 64 µg/mL) or if Arikayce is not being used with a background multidrug regimen.

Denial risk — missing documentation of trials of preferred formulary alternatives

Failure to document trials of required preferred formulary alternatives or lack of documented contraindication/intolerance/adverse reaction may trigger denial.

Denial risk — missing prior basal insulin trials

Failure to demonstrate prior failure, intolerance, contraindication, or adverse reaction to preferred basal insulin products may trigger denial.

Denial risk — concurrent biologics or active CNS lupus

Concurrent use with other biologics, Lupkynis or Saphnelo, or active central nervous system lupus will result in exclusion/denial for certain autoimmune indications.

Denial risk — unmet PAH hemodynamic or WHO class thresholds

Requests lacking right heart catheterization confirmation of PAH (mPAP ≥25 mm Hg, PCWP/PAWP/LVEDP ≤15 mm Hg, and PVR >3 Wood units) or lacking documented WHO functional class II–IV symptoms may be denied.

Denial risk — CTEPH operability or symptom documentation missing

CTEPH therapy requests may be denied if the diagnosis is not documented as inoperable or persistent/recurrent after pulmonary endarterectomy or if CTEPH is asymptomatic.

Denial risk — unmet genetic or plasma ammonia thresholds

Requests that do not meet documented genetic confirmation for NAGS deficiency with hyperammonemia or do not meet plasma ammonia ≥ 50 µmol/L (when required) may be at risk for denial.

Denial risk — calcified (radiopaque) stones exclude Chenodal

Chenodal requests may be denied if the patient has calcified (radiopaque) stones.

Denial risk — tadalafil excluded with nitrates or for ED

Tadalafil is excluded for erectile dysfunction and for patients using nitrates; such requests will be denied.

Denial triggers — exclusion conditions (renal, hepatic, urinary, hypersensitivity)

Presence of urinary retention, hepatic impairment, gastric retention, untreated narrow‑angle glaucoma, hypersensitivity to Cobenfy/trospium, or eGFR < 60 ml/min may trigger denial for those medications.

• Moderate or severe renal impairment defined as eGFR < 60 mL/min

Denial triggers — CYP3A4 interactions and familial short QT syndrome

Concurrent use with strong CYP3A4 inhibitors or inducers, or use in patients with familial short QT syndrome, are exclusion criteria that may trigger denial for Cosentyx/related entries.