Prior authorization required

Submit a prior authorization request for TYENNE (TYENNE 162 mg/0.9 mL syringe or autoinjector) and for ADEMPAS; PA is required for all FDA‑approved indications listed under these entries.

Coverage duration (TYENNE initial 6 months; continuation lifetime)

Initial authorization for TYENNE is granted for 6 months; continuation authorizations are lifetime.

Prior authorization required for listed specialty agents

Obtain prior authorization before dispensing the listed specialty agents (examples include CERDELGA, CEREZYME, ELELYSO, MIGLUSTAT, VPRIV, YARGESA, SODIUM PHENYLBUTYRATE).

PA required for FDA‑approved indications (listed medications)

Requests for the listed medications require prior authorization for all FDA‑approved indications—ensure the PA documents the specific FDA indication being requested.

Medications covered by PA (AIMOVIG AUTOINJECTOR and others)

Include AIMOVIG AUTOINJECTOR on PA requests when applicable; ensure diagnosis documentation accompanies the request.

Alosetron prior authorization

Submit prior authorization for ALOSETRON HCL for its FDA‑approved indications and include required diagnostic documentation and evidence of prior therapies as specified.

Alpha-1 proteinase inhibitor prior authorization

Prior authorization is required for alpha‑1 proteinase inhibitor products; include the diagnosis and required baseline laboratory data.

Prior authorization and coverage duration for Alpha1 therapies

For alpha‑1 therapies and ambrisentan, submit PA with documentation meeting the diagnostic and clinical criteria; approvals for alpha‑1 therapies are typically for 1 year and ambrisentan approvals are lifetime.

PA required for listed anticonvulsant and IV antifungal products

Prior authorization is required for the listed anticonvulsant and IV antifungal products for their FDA‑approved indications; include diagnosis and applicable trial history.

Prerequisite therapy requirement for anticonvulsants/non-preferred products

When requesting non‑preferred anticonvulsant products, provide evidence of prior therapy with preferred formulary alternatives (dates, outcomes) as PA prerequisite therapy.

Prior authorization required; PA indicator notes

Prior authorization is required for entries where the PA indicator is listed; follow the product‑specific documentation and prerequisite therapy instructions in each section.

Prior authorization and prerequisite therapy for IV antifungal/amikacin therapies

PA is required for IV antifungal and amikacin (ARIKAYCE) therapies; include diagnosis and amikacin MIC where applicable and document use with background regimen.

Prerequisite therapy required for IV antifungals and atypical antipsychotics

Prior authorization for IV antifungals and some atypical antipsychotics requires evidence of prerequisite therapy per section notes (PREREQUISITE THERAPY REQUIRED: YES).

PA covers FDA‑approved indications (atypical antipsychotics and basal insulin)

PA for atypical antipsychotics and basal insulin covers FDA‑approved indications; include indication‑specific documentation and prior therapy evidence when required.

Prior authorization requirements (failure/intolerance/contraindication documentation)

Provide documentation that the patient meets product‑specific PA criteria (failure, intolerance, contraindication, or anticipated adverse reaction to preferred products); for Benlysta include required autoantibody and disease activity documentation.

Prior authorization required for basal insulin section medications

Prior authorization is required for listed basal insulin and related entries (bosentan and others) per the section; submit prior therapy and diagnostic evidence as indicated.

Prior authorization required (coverage durations examples)

PA is required for multiple entries; some approvals use a 1‑year coverage duration—ensure the requested duration aligns with section guidance.

Variable coverage durations for NAGS (genetic test affects duration)

For NAGS-related requests, document whether genetic testing is present; coverage duration varies: no genetic test → 3 months, genetic test present → 12 months, other indications per section.

Prior authorization / prerequisite therapy (general)

Submit prior authorization and document prerequisite therapy where indicated—many sections require prior trials before approval.

Prerequisite therapy required (reiteration)

Prerequisite therapy is frequently required across sections—confirm and document the specific prior medications tried and reasons for failure when submitting PA.

Prior authorization required; PA prerequisite flag YES

PA is required for several products with 'PREREQUISITE THERAPY REQUIRED = YES'—ensure prior therapy documentation is included with the request.

Prior authorization and prerequisite therapy (basal insulin and related)

Prior authorization is required and prerequisite therapy is often required; for basal insulin entries include schizophrenia‑related prior therapy documentation as described.

Prerequisite therapy for TYENNE (RA: trial/failure of two specified agents)

For RA (TYENNE): initial approval requires trial and failure of two of Enbrel, a preferred adalimumab product, Rinvoq, or Xeljanz/XR; document trials and dates.

General prerequisite therapy requirement (documented YES)

Prerequisite therapy is required (document YES) across multiple sections—confirm and include prior therapy evidence on PA requests.

Step therapy / prerequisite trials for PAH

For PAH, document trial and failure/intolerance/contraindication to preferred endothelin receptor antagonists (ambrisentan or bosentan) AND to preferred PDE5 inhibitors (sildenafil or tadalafil) unless contraindicated.

Prerequisite therapy explicitly not required (N/A) in some sections

Some sections indicate no prerequisite therapy (N/A); review the specific entry to confirm before submitting PA.

Prerequisite and step therapy requirements for Alosetron (severe IBS‑D)

For severe diarrhea‑predominant IBS (Alosetron), initial approval requires prior failure of one antidiarrheal (e.g., loperamide) and one antispasmodic (e.g., dicyclomine); document trials.

Prerequisite therapy not required for Alpha1/ambrisentan sections (N/A)

Alpha‑1 and ambrisentan sections list 'N/A' for prerequisite therapy; confirm section specifics before assuming prior trials are required.

Step therapy / preferred product trial for anticonvulsants

When requesting non‑preferred anticonvulsants, document failure/intolerance/contraindication to at least one preferred formulary anticonvulsant (dates and reasons) as required for PA.

No prerequisite therapy required (N/A) in some entries

Some entries explicitly list no prerequisite therapy (N/A); verify the entry-specific header prior to submission.

Pericarditis prerequisite/step therapy (try and fail two standard agents)

For pericarditis, prior to approval document trials and failures of at least two standard agents (e.g., colchicine, NSAIDs, corticosteroids).

Step therapy / failure requirements for certain atypical antipsychotics

For certain atypical antipsychotics (Fanapt, Caplyta, Rexulti) document failure/intolerance to Lybalvi and Vraylar (or contraindication/adverse reaction) per PA step requirements.

Step therapy / product substitution for biosimilars (basal insulin)

When approving biosimilars or alternate basal insulins, document trial and failure/intolerance/contraindication to specified preferred insulin products per the section.

Prerequisite therapy header note (YES indicated)

The PA header may indicate 'Prerequisite therapy required = YES' even where specifics are not listed—include prior therapy documentation when in doubt.

Requirement relative to preferred product (Calquence) for certain lymphoid malignancies

For mantle cell lymphoma, CLL, or SLL, document intolerance, contraindication, or adverse reaction to preferred product Calquence (or absence of a listed preferred alternative) to support approval.

Chenodal step/therapeutic prerequisites (try ursodiol first)

For Chenodal initial therapy document trial/failure or contraindication to ursodiol and that the patient is not a candidate for cholecystectomy; include imaging to support continuation.

Step therapy requirements for tadalafil (BPH) — try specified drug classes first

For tadalafil used for BPH, document trials of one alpha‑1 adrenergic blocker (≥1 month at max tolerated dose) and one 5‑alpha reductase inhibitor (≥4 months at max tolerated dose) or combination therapy prior to PA approval.

Required step therapy trials (basal insulin and antipsychotic prerequisites)

Basal insulin entries require documentation of trials of two specified antipsychotics (Lybalvi, Vraylar, Caplyta) or documented intolerance/contraindication per the section's step therapy rules.

Required medical information (TYENNE) — dose/frequency and objective disease activity measures

For TYENNE PA requests include documented dose and frequency within FDA‑approved dosing and objective disease activity measures at baseline and for continuation (examples: CDAI, DAS28 with ESR/CRP, PAS/PAS‑II, RAPID3, SDAI).

Required medical information (ADEMPAS) — right heart catheterization and medication history

For ADEMPAS PA requests include diagnosis confirmed by right heart catheterization and a history of prerequisite medications as described in the PAH/CTEPH sections.

Required clinical documentation — diagnosis, genetic tests, labs, and RHC data for PAH/CTEPH

Provide diagnosis, genetic test results, laboratory values, and pretreatment right heart catheterization data (mPAP, PCWP/PAWP/LVEDP, PVR) with dates and reasons for prior therapy failures or contraindications when applicable.

Required medical information — phenylbutyrate product (genetic/enzymatic test results)

For phenylbutyrate product PA requests include diagnosis and results of genetic or enzymatic testing confirming the urea cycle disorder.

Required medical information — Aimovig (diagnosis)

For Aimovig (erenumab) PA requests include the diagnosis of chronic or episodic migraine (age ≥18) and note that combination use with prophylactic CGRP antagonists is excluded.

Required documentation — reauthorization requires positive clinical response

For reauthorization requests, document a positive clinical response to therapy; include objective measures or prescriber‑reported improvement as applicable.

Alpha1 baseline lab and smoking status required

For alpha‑1 inhibitor PA requests include baseline (pretreatment) AAT serum concentration with measurement method and value (e.g., <11 micromol/L or specified mg/dL equivalents) and document smoking status.

Ambrisentan diagnostic documentation (RHC report and WHO functional class)

For ambrisentan PA include the right heart catheterization report documenting mPAP, PCWP/PAWP/LVEDP and PVR, and document the patient's WHO functional class.

Required documentation for non-preferred anticonvulsants

When a non‑preferred anticonvulsant is requested, include documentation of preferred medication tried, trial dates, and the specific reason for exception (failure, contraindication, adverse reaction, or clinical rationale).

Required documentation for IV antifungals and ARIKAYCE (diagnosis and MIC)

For IV antifungal PA include the diagnosis; for ARIKAYCE include the MAC isolate amikacin MIC and evidence the drug will be used with a background multidrug regimen.

Required documentation and prior therapy requirements (general reauth and labs)

Provide diagnosis and, for reauthorization, documentation of a positive clinical response. Include specific labs/details required by the indication (e.g., Hgb, ferritin, TSAT for anemia indications).

Laboratory and diagnostic criteria required (examples: anemia/ESA use)

Follow the laboratory and diagnostic thresholds per indication (e.g., chronic renal failure Hgb ≤10 g/dL; chemo‑induced anemia Hgb ≤10 g/dL plus ferritin ≥100 mcg/L or TSAT ≥20%; MDS endogenous EPO <500 mu/ml).

Required documentation for ARIKAYCE (diagnosis and amikacin MIC)

For ARIKAYCE include diagnosis and amikacin MIC ≤64 µg/mL; for continuation document ongoing clinical response and culture status.

Documentation required for non-preferred atypical antipsychotics

When requesting non‑preferred atypical antipsychotics provide documentation of preferred medication trial(s) with dates and reasons for exception (failure, contraindication, adverse reaction, or clinical rationale).

Exclusion-based denial triggers (multiple concurrent therapy and explicit exclusions)

Exclusions that trigger denials include: concurrent use of a biologic DMARD or targeted synthetic DMARD; concurrent sGC/PDE inhibitors for ADEMPAS; concurrent use of more than one phenylbutyrate product; CGRP prophylactic combination with Aimovig; biologically male for Alosetron; and concurrent biologic/targeted synthetic therapy in multiple sections—verify and document that none apply.

• Confirm patient is not on a biologic DMARD or targeted synthetic DMARD when required.
• Confirm no concurrent PDE5 or sGC stimulators when requesting ADEMPAS.
• Do not combine more than one phenylbutyrate product.
• Do not combine Aimovig with a prophylactic CGRP antagonist.
• Do not approve Alosetron for biologically male patients.

Denial risk for missing clinical criteria (PAH/CTEPH hemodynamics and WHO FC)

Do not approve requests that lack required diagnostic confirmation for PAH or CTEPH — include pretreatment RHC hemodynamics (mPAP ≥25 mm Hg; PCWP/PAWP/LVEDP ≤15 mm Hg; PVR >3 Wood units) and document WHO FC II‑IV when applicable.

Exclusion for phenylbutyrate products (no concurrent phenylbutyrate products)

Do not approve concurrent use of more than one phenylbutyrate product; such concurrent use is an exclusion and may trigger denial.

Exclusion for Aimovig combination therapy (CGRP prophylaxis)

Do not authorize Aimovig in combination with another CGRP antagonist when that CGRP agent is being used for prophylaxis; this combination is excluded.

Exclusion that triggers denial (Alosetron and biologically male)

Do not approve Alosetron for biologically male patients — this exclusion will trigger denial.

Alpha1 baseline lab and smoking status required (denial risk if missing)

For alpha‑1 inhibitor PA requests, failure to document baseline AAT serum concentration below 11 micromol/L (or specified mg/dL equivalents) or to document the patient is a non‑smoker may lead to denial.

PAH hemodynamic confirmation required (denial risk if absent)

For ambrisentan, absence of pretreatment right heart catheterization data confirming mPAP ≥25 mm Hg, PCWP/PAWP/LVEDP ≤15 mm Hg, and PVR >3 Wood units, or lack of WHO functional class II‑IV documentation, may result in denial.

Documentation and prior therapy requirements for non-preferred anticonvulsants (denial risk if missing)

Requests for non‑preferred anticonvulsants must include documentation of prior preferred medication trials (dates and reasons); missing this documentation may result in denial.

Exclusion-based denial triggers (e.g., uncontrolled hypertension, excluded anemia causes)

Denials may result if exclusionary conditions exist: uncontrolled hypertension, anemia from excluded causes, use for immediate anemia correction or as transfusion substitute, prophylactic chemotherapy use, or concurrent hormonal/biologic/radiotherapy without concomitant myelosuppressive chemotherapy.

Concurrent therapy exclusion (biologic/targeted synthetic)

Concurrent use of a biologic drug or targeted synthetic drug where listed as an exclusion may trigger denial—confirm no concurrent biologic/tsDMARD therapy when applicable.

Concurrent biologic/targeted synthetic therapy (denial risk)

Concurrent use of biologic or targeted synthetic therapy listed as an exclusion in several sections may trigger denial—verify current medications and include rationale if concurrent therapy is necessary.

MAC susceptibility and regimen requirements (denial risk if missing)

For ARIKAYCE, failure to document MAC isolate susceptibility (amikacin MIC ≤64 µg/mL) or failure to use ARIKAYCE with a background multidrug regimen may cause denial.

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

When a non‑preferred atypical antipsychotic is requested, missing documentation of preferred medication trials, dates, or reasons for exception may result in denial.

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

Concurrent use with other biologics (including Lupkynis or Saphnelo) or use in patients with active central nervous system lupus are exclusions and may lead to denial for relevant entries.

Potential denial triggers (missing RHC, prescriber specialty)

Potential denial triggers include missing RHC documentation for PAH/CTEPH, absence of required prescriber specialty (cardiologist/pulmonologist), or incomplete diagnostic evidence—confirm prescriber specialty and attach RHC results.

Ammonia threshold for acute PA/MMA (approval requirement)

For PA or MMA with acute hyperammonemia, approval requires plasma ammonia ≥50 micromol/L and use with other ammonia‑lowering therapies—document ammonia level and concomitant therapies.

Exclusion that may trigger denial (radiopaque/calcified stones for Chenodal)

Do not approve Chenodal for patients with calcified (radiopaque) stones—this exclusion will trigger denial.

Exclusion-based denials (tadalafil ED use; Cobenfy exclusions)

Exclusion‑based denials: do not approve tadalafil for erectile dysfunction or with concomitant nitrates; do not approve Cobenfy with listed exclusion conditions (urinary retention, hepatic impairment, gastric retention, untreated narrow‑angle glaucoma, hypersensitivity, eGFR <60 mL/min).

Cosentyx exclusion triggers (CYP3A4 interactions, familial short QT)

Do not approve Cosentyx in patients taking strong CYP3A4 inhibitors or inducers or in patients with familial short QT syndrome; document concomitant medications.