Prior authorization and prerequisite therapy

Prior authorization is required for Actemra and the PA indication indicator covers all FDA‑approved indications; prerequisite therapy is required where noted (e.g., Actemra IBS prerequisite trials).

• PA indicator: All FDA‑Approved Indications (Actemra)
• Prerequisite therapy required per item-specific criteria (see Actemra IBS and others)

PA covers all FDA‑approved indications

The policy’s PA indication indicator applies to all FDA‑approved indications for listed products; providers must submit PA requests for FDA‑labeled uses.

Prior authorization required for FDA indications

Prior authorization is required for the listed agents; submit PA documentation when requesting coverage for any FDA‑approved indication.

Prior authorization and coverage durations

Actemra initial authorization for IBS is granted for 6 months; continuation approvals (and many other products such as alpha‑1 inhibitors) are authorized for 1 year.

• Actemra initial: 6 months
• Continuation/alpha‑1 inhibitors: 1 year

Ambrisentan: RHC confirmation and specialist prescriber required

Ambrisentan requests must include documentation of right heart catheterization confirming PAH and the drug must be prescribed by or in consultation with a cardiologist or pulmonologist.

• Right heart catheterization confirmation required (mPAP, PCWP/PAWP/LVEDP, PVR)
• Prescriber must be or consult a cardiologist or pulmonologist

PA required for listed IV and injectable agents

Prior authorization is required for listed IV antifungal and injectable agents; voriconazole is authorized under the PA indicator for all FDA‑approved indications and ARANESP group has PA level that includes some medically‑accepted indications.

• Voriconazole IV formulations require PA (All FDA‑Approved Indications)
• ARANESP formulations require PA (All FDA‑Approved and some medically‑accepted)

PA applies to listed IV medications (all FDA indications)

Prior authorization applies to the listed IV medications and the PA indicator covers all FDA‑approved indications; follow item‑specific documentation and prerequisite therapy rules.

Prior authorization and prerequisite therapy required (item‑specific)

Prior authorization is required for the listed items and prerequisite therapy is required where indicated in the drug‑specific criteria; submit documentation of prior trials when requested.

• Follow drug‑specific prerequisite therapy rules (Yes where shown)
• Provide dates/reasons for prior therapy failures

Prior authorization and coverage duration for product classes

Some classes have set authorization durations: atypical antipsychotics are authorized up to 3 years and basal insulin products up to 1 year; prerequisite therapy requirements also apply to these classes.

• Atypical antipsychotics coverage duration: 3 years
• Basal insulin coverage duration: 1 year

PA and prescriber restriction — specialist required where noted

Prior authorization is required and for certain products the prescriber must be or consult with an appropriate specialist (e.g., rheumatologist/clinical immunologist/nephrologist for SLE/LN; cardiologist or pulmonologist for PAH/CTEPH).

• Prescriber restriction applies where specified in product criteria
• Include consult notes when applicable

Coverage duration typically 1 year

When authorized, many requests are granted for a coverage duration of 1 year; confirm the product‑specific duration in the criteria.

• General authorization duration commonly 1 year
• Verify initial vs continuation durations for specific products (e.g., Actemra)

PA required for listed medications (FDA indications)

Prior authorization is required for these listed medications; the PA indication indicator notes coverage for FDA‑approved indications and item‑specific prerequisites must be met.

PA required — follow drug‑specific prerequisite therapy

Prior authorization is required for listed indications; providers must follow the specific drug criteria for prerequisite therapy and supply required documentation.

• See drug‑specific sections for prerequisite therapy requirements

COBENFY requires PA and documented prerequisite trials

Prior authorization is required for COBENFY and documentation of trials of specified alternatives is required before approval.

• Document trials and reasons for failure of specified alternatives

Cosentyx prior authorization and prerequisite therapy

Cosentyx requires prior authorization for all FDA‑approved indications and prerequisite therapy (documented trials of preferred antifungals for certain invasive infections) is required when specified.

• PA indicator: All FDA‑Approved Indications
• Prerequisite therapy required for invasive mold infections (document trials of posaconazole/voriconazole)

Crinone prior authorization

Crinone gel requires prior authorization for all FDA‑approved indications and some medically‑accepted indications; include required diagnosis and documentation per criteria.

• PA indicator: All FDA‑Approved Indications and some medically‑accepted indications
• Do not submit for excluded uses (e.g., supplementing/replacing progesterone for infertility)

PAH step therapy — preferred ERA and PDE5 inhibitor trials required

For PAH, providers must document trials and failure or contraindication to preferred endothelin receptor antagonists (ambrisentan or bosentan) and to a PDE5 inhibitor (sildenafil or tadalafil) unless contraindicated.

• Document dates and reasons for failure or contraindication for preferred ERAs (ambrisentan/bosentan)
• Document dates and reasons for failure or contraindication for PDE5 inhibitors (sildenafil/tadalafil)

No prerequisite therapy when policy lists N/A

Some entries specify no prerequisite therapy (listed as N/A); follow each product’s item‑specific prerequisite field rather than assuming a universal requirement.

• If PREREQUISITE THERAPY REQUIRED = N/A, no trial is required
• Follow product‑specific fields in the policy

Prerequisite therapy listed as N/A — confirm per product

Where the policy lists 'N/A' for prerequisite therapy, no prerequisite trial is required; confirm for each product before requesting PA.

Actemra (IBS) prerequisite therapy — document antidiarrheal and antispasmodic trials

Actemra for severe diarrhea‑predominant IBS requires prior trials and failures of one antidiarrheal (e.g., loperamide) and one antispasmodic (e.g., dicyclomine); document trials and failures in the PA submission.

• Chronic IBS symptoms ≥6 months must be documented
• Trial/failure of one antidiarrheal (e.g., loperamide) and one antispasmodic (e.g., dicyclomine) must be documented

Formulary step therapy for anticonvulsants — document preferred trial

Non‑preferred anticonvulsant requests require documentation of trial and failure of at least one preferred formulary alternative or documentation of contraindication/adverse reaction.

• Provide preferred medication name(s), dates of trial, and reason for failure/intolerance/adverse reaction

Prerequisite therapy varies by agent — follow item‑specific rules

Prerequisite therapy requirements vary by agent; review each drug’s PREREQUISITE THERAPY REQUIRED field and provide trial documentation when 'YES' is indicated.

• Follow item‑specific prerequisite instructions (YES vs N/A)
• Provide dates and reasons for prior therapy failures when required

Prerequisite therapy — document trials/failures of standard agents where specified

For some indications (e.g., pericarditis) the policy requires documented trials and failures of at least two standard agents (colchicine, NSAIDs, corticosteroids); include dates and reasons when submitting PA.

• Document trials and failures of two standard agents with dates and reasons

Arikayce prerequisite background multidrug therapy and susceptibility requirement

Arikayce (amikacin liposome inhalation) requires background multidrug therapy before or with initiation and documentation that the MAC isolate is susceptible to amikacin (MIC ≤ 64 µg/mL).

• Provide amikacin MIC (≤ 64 µg/mL)
• Confirm Arikayce will be used with background multidrug regimen (macrolide + ethambutol + rifamycin)

Step therapy for atypical antipsychotics and basal insulins — document preferred trials

Many atypical antipsychotics and basal insulins require trials of preferred formulary alternatives prior to approval unless contraindicated; document prior trials, dates, and reasons for failure.

• Document failure/intolerance/contraindication to specified preferred alternatives
• Provide dates and clinical rationale for exception requests

Prerequisite therapy for lupus nephritis/SLE — document standard therapies and response

For lupus nephritis and SLE indications, prerequisite therapy with standard regimens (e.g., corticosteroids with mycophenolate or cyclophosphamide→azathioprine; antimalarials/systemic corticosteroid/other immunosuppressants) must be used per criteria; document concurrent use and response.

• Document standard induction/maintenance regimens and prescriber‑reported improvement for continuation

Step therapy notes — follow PAH/CTEPH criteria for preferred agent trials

Preferred alternatives are referenced across the policy; where no specific PAH/CTEPH step therapy is listed, follow the PAH criteria that require failure or contraindication to preferred ERAs and PDE5 inhibitors.

CAYSTON prerequisite — document prior tobramycin failure/resistance and Pseudomonas colonization

CAYSTON requests require evidence of Pseudomonas aeruginosa lung colonization with recurrence despite prior tobramycin inhalation solution use (or tobramycin resistance); prerequisite therapy is required.

• Document prior tobramycin inhalation solution use and recurrence or resistance
• Provide diagnosis of cystic fibrosis

Chenodal and tadalafil prerequisite/step therapy requirements

Chenodal initial therapy requires prior trial and failure or contraindication/intolerance to ursodiol; tadalafil for BPH requires prior trials of two drugs from different classes with specified minimum durations.

• Chenodal: document trial/failure or contraindication to ursodiol
• Tadalafil (BPH): document trials of alpha‑1 blocker (≥1 month) and 5‑alpha reductase inhibitor (≥4 months) or combo for ≥4 months

Step therapy — document two‑class trial failures with durations

For step therapy requiring two other drugs from different classes (e.g., BPH), document trials/failures or intolerance/contraindication with specified minimum durations and dosages.

• Provide drugs tried, trial durations, doses, and reasons for failure or intolerance

Antifungal step therapy — document trials of preferred antifungals

For invasive aspergillosis or mucormycosis indications, document trials and failure or intolerance to preferred antifungals (posaconazole and/or voriconazole) or provide documented contraindications/adverse reactions.

• Include medication names, dates of trial, and reasons for failure/intolerance or contraindication

Required clinical documentation — RHC, prior trials, genetics/labs

Provide diagnosis confirmed by pretreatment right heart catheterization with hemodynamic values (mPAP, PCWP/PAWP/LVEDP, PVR), documentation of prerequisite medication trials with dates/reasons for failure, and relevant genetic tests or lab results where specified.

• Attach RHC report with mPAP, PCWP/PAWP/LVEDP, and calculated PVR
• Provide documentation of dates and reasons for prior therapy trials
• Include genetic/enzymatic test results when required

Provide diagnosis and genetic/enzymatic test results when required

Include diagnosis and relevant genetic or enzymatic test results where indicated (e.g., Gaucher disease, urea cycle disorders, NAGS); attach test reports to the PA submission.

• Provide genetic/enzymatic test reports and interpretations
• Document how test results meet the policy’s diagnostic thresholds

Required documentation for reauthorization — positive clinical response required

For reauthorization requests (e.g., alosetron), include documentation of positive clinical response; for initial requests include required diagnosis information.

• For reauth: prescriber statement of positive clinical response
• For initial: complete diagnostic documentation per product criteria

Actemra (IBS) required documentation — symptoms, exclusions, prior trials

Actemra (IBS) PA submissions must document chronicity of IBS symptoms (≥6 months), exclusion of anatomic/biochemical GI abnormalities, and prior trials/failures of one antidiarrheal and one antispasmodic.

• Document IBS duration ≥6 months and exclusion testing
• Provide dates and outcomes for antidiarrheal and antispasmodic trials

Alpha‑1 inhibitor required documentation — AAT level and smoking status

Alpha‑1 proteinase inhibitor requests must include diagnosis and baseline (pretreatment) AAT serum concentration with the test method reported (radial immunodiffusion or nephelometry) and documentation that the patient is a current non‑smoker.

• Report baseline AAT concentration and assay method
• Provide documentation of current non‑smoking status

Required documentation — RHC for ambrisentan; prior trials for non‑preferred anticonvulsants

For ambrisentan and other PAH therapies, include RHC documentation confirming hemodynamic thresholds; for non‑preferred anticonvulsants include prior preferred drug trial dates and reasons for exception.

• Attach pretreatment RHC with mPAP ≥25 mm Hg, PCWP/PAWP ≤15 mm Hg, PVR >3 Wood units
• For anticonvulsants: list preferred agent trials, dates, and reasons for failure or contraindication

Required medical information and lab criteria for specific agents

Certain agents (e.g., Aranesp) require hematologic labs and thresholds (Hgb, ferritin/TSAT, endogenous EPO where applicable); include these labs and prior response data when applicable.

• Include Hgb values and iron studies (ferritin, TSAT)
• For MDS include endogenous EPO if required and disease‑specific findings

Reauthorization documentation — evidence of positive clinical response required

For reauthorization across indications, provide documentation of positive clinical response (e.g., low disease activity, objective improvement) and confirm initial criteria were met for patients new to the plan.

• Prescriber statement of clinical improvement for continuation
• Confirm initial criteria met at medication start for new‑to‑plan patients

Arikayce required documentation — amikacin MIC and sputum culture history

Arikayce PA submissions must include the MAC isolate’s amikacin MIC and, for initial requests, documentation that the patient has not achieved negative MAC sputum cultures since completion of the most recent background regimen.

• Provide amikacin MIC result (≤ 64 µg/mL)
• Document sputum culture history and background regimen details

Arikayce initial therapy documentation — culture failure and background regimen

For initial therapy PA requests, document failure to achieve negative MAC sputum cultures after most recent background regimen and confirm Arikayce will be used with a background multidrug regimen.

• Document timeline of background regimen and culture results
• Confirm planned concurrent background multidrug regimen

Document prior therapy failures/intolerances/contraindications

Provide documentation of previous therapies, failures, intolerances, contraindications, or adverse reactions to preferred formulary alternatives when requested; include dates and clinical rationale.

• List previous medications, trial dates, and reasons for failure/intolerance
• Attach supporting clinical notes if available

Required documentation for SLE/LN — autoantibodies, disease activity, biopsy

For SLE and lupus nephritis, include ANA or anti‑dsDNA, SELENA‑SLEDAI score for SLE, and biopsy‑proven lupus nephritis class when applicable; include prescriber statements of improvement for continuation.

• Provide ANA or anti‑dsDNA levels and SELENA‑SLEDAI score
• Attach renal biopsy report showing class III/IV/V if for LN

Required diagnostic documentation — pretreatment RHC and WHO functional class

Attach the pretreatment right heart catheterization report documenting mPAP, PCWP/PAWP/LVEDP, and calculated PVR and include WHO functional class documentation for PAH/CTEPH PA requests.

• Include numeric RHC hemodynamics and calculated PVR
• Document WHO functional class (II–IV)

Provide diagnosis and genetic test results; CAYSTON: CF + prior tobramycin documentation

Provide diagnosis and genetic test results where indicated (e.g., NAGS deficiency confirmation); for CAYSTON include diagnosis of cystic fibrosis and evidence of Pseudomonas recurrence despite prior tobramycin use.

• Attach genetic test confirming NAGS mutation when applicable
• For CAYSTON: provide CF diagnosis and prior tobramycin use/recurrence documentation

Chenodal required documentation — imaging and ursodiol trial

Chenodal documentation must show radiolucent gallstones in a well‑opacifying gallbladder on oral cholecystography and prior trial/failure or contraindication to ursodiol; include imaging reports.

• Attach oral cholecystography or ultrasound showing radiolucent stones in an opacifying gallbladder
• Document ursodiol trial/failure or contraindication

Required documentation for tadalafil (BPH) — AUA‑SI, prior trials, eGFR and dosing

For BPH/tadalafil requests include diagnosis, eGFR, AUA‑SI score (>=8), documentation of prior trials of preferred alternatives with durations, and confirmation that daily dose is 2.5 mg or 5 mg once daily.

• Provide AUA‑SI score ≥8
• Document prior alpha‑1 blocker (≥1 month) and 5‑alpha reductase inhibitor (≥4 months) trials or combination trial

Document medications tried and dosing within FDA guidelines

Provide diagnosis, other medications tried, and confirm dose/frequency align with FDA‑approved dosing when requested for product‑specific criteria.

Antifungal prerequisite documentation — posaconazole/voriconazole trials required

For invasive mold indications, document trials and failure or intolerance to preferred antifungals (posaconazole and/or voriconazole) including dates and reasons, or document contraindications/adverse reactions.

• Include names, dates, and reasons for antifungal trials/failures or contraindications

Documentation‑based denial risks — missing RHC, hemodynamics, or prior trials

Providers must document diagnosis and attach supporting tests; failure to document RHC hemodynamics, WHO functional class, or requisite prior trials may result in denial for PAH/PAH‑related agents (e.g., ambrisentan).

• Lack of RHC or missing hemodynamics may trigger denial
• Missing documentation of prior preferred agent trials may trigger denial

Exclusion for concurrent pulmonary vasodilators — may trigger denial

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

Concurrent product exclusion — multiple phenylbutyrate products not allowed

Concurrent use of more than one phenylbutyrate product is excluded and may result in denial; confirm only one phenylbutyrate product is used.

Explicit exclusions — CGRP prophylaxis combination and biologically male (alosetron)

Use in combination with a CGRP antagonist when the CGRP antagonist is being used for prophylaxis, or use in biologically male patients for alosetron, are explicit exclusions and may cause denial.

Actemra (IBS) denial risk — missing chronicity, exclusion testing, or prior trials

Actemra requests for IBS may be denied if the provider does not document chronic symptoms ≥6 months, exclusion of anatomic/biochemical GI causes, or prior trials/failures of one antidiarrheal and one antispasmodic.

• Ensure documentation of IBS chronicity (≥6 months)
• Attach records proving exclusion of structural/biochemical GI disease and prior drug trials

Alpha‑1 inhibitor denial risk — missing AAT level or smoking status

Alpha‑1 proteinase inhibitor requests may be denied if a baseline AAT serum concentration below the policy thresholds is not provided or if the patient is not documented as a current non‑smoker.

• Provide baseline AAT <11 micromol/L (or equivalent assay thresholds) and assay method
• Document current non‑smoking status

Denial risk — missing documentation of prior therapy failures or presence of exclusions

Requests may be denied if required prior therapy failures/intolerances/contraindications to preferred formulary alternatives are not documented or if exclusion criteria (e.g., concurrent biologics) apply.

• Document prior therapy failures/intolerance with dates and reasons
• Confirm absence of exclusionary concurrent biologic use when applicable

Exclusion conditions that can trigger denial — clinical condition exclusions

Claims can be excluded for conditions such as uncontrolled hypertension, anemia from other causes, use as substitute for emergency transfusion, or prophylactic use to prevent chemotherapy‑induced anemia; verify exclusions before submitting PA.

Exclusion — concurrent biologic/targeted synthetic use may trigger denial

Concurrent use of a biologic drug or targeted synthetic drug is an exclusion and may trigger denial for several indications; verify concurrent medications prior to PA submission.

• List current biologic or targeted synthetic therapies on the PA form
• If concurrent use is present, note whether the policy permits or excludes it

Arikayce denial triggers — susceptibility, background regimen, and culture status

Arikayce requests may be denied if the MAC isolate is not susceptible to amikacin at MIC ≤ 64 µg/mL, if Arikayce will not be used with a background multidrug regimen, or if the patient has maintained negative MAC cultures for ≥12 months.

• Provide amikacin MIC result and susceptibility documentation
• Confirm concurrent use with standard background regimen and sputum culture timeline

Denial risk — missing documentation of prior therapy failures/intolerances/contraindications

Denials may occur if required prior therapy failures/intolerances/contraindications to preferred formulary alternatives are not documented; include clear clinical rationale and dates.

• Attach clinical notes showing treatment failure or intolerance to preferred alternatives
• Include dates and objective findings when available

Denial risk — previous therapy and exclusion checks must be documented

Requests may be denied if required previous therapies or exclusion conditions (for example concurrent biologics) are present but not documented or justified; review exclusion lists and previous therapy history carefully.

Exclusion triggers — concurrent excluded biologics or active CNS lupus may cause denial

Use concurrent with excluded biologics (e.g., Lupkynis or Saphnelo) or in patients with active CNS lupus may trigger denial for lupus indications; check for these exclusions prior to PA submission.

• Confirm patient is not receiving excluded biologics
• Document CNS lupus status if relevant

PAH diagnostic confirmation required — missing RHC/hemodynamics or WHO class may cause denial

Pretreatment right heart catheterization confirming mPAP ≥25 mm Hg, PCWP/PAWP/LVEDP ≤15 mm Hg, and PVR >3 Wood units, plus documentation of WHO functional class II–IV, are required for PAH; lack of these will trigger denial.

• Attach RHC report with numeric mPAP, PCWP/PAWP/LVEDP, and PVR
• Document WHO functional class II–IV

CTEPH operability and symptom requirement — lack of inoperable/symptomatic status may trigger denial

For CTEPH, approval requires disease to be inoperable or persistent/recurrent post‑endarterectomy and symptomatic; operable or asymptomatic patients may not meet criteria and requests can be denied.

• Document operability status and symptomatic status
• If post‑endarterectomy, provide details of persistent or recurrent disease

Genetic testing denial risk — NAGS mutation confirmation required where specified

If genetic testing does not confirm a mutation for NAGS deficiency when invoked for hyperammonemia scenarios, the request may be denied; provide genetic test reports when applicable.

• Attach genetic test confirming NAGS mutation when required
• For acute hyperammonemia, include plasma ammonia values and concurrent ammonia‑lowering therapy plan

Explicit exclusions — Chenodal calcified stones and tadalafil ED/nitrates

Explicit exclusions noted in the policy include patients with calcified (radiopaque) gallstones for Chenodal and use of tadalafil for erectile dysfunction or with concomitant nitrates; these will be denied.

• Do not request Chenodal for calcified (radiopaque) stones
• Do not request tadalafil for ED or with nitrates

Exclusion‑related denial risks — Cobenfy and related product exclusions

Exclusion‑related denials can occur if the patient has urinary retention, hepatic impairment, gastric retention, untreated narrow‑angle glaucoma, hypersensitivity to Cobenfy/trospium, or eGFR <60 mL/min; verify exclusions before PA submission.

• Provide eGFR and confirm absence of exclusionary conditions
• Document any hypersensitivity history to Cobenfy/trospium