General prior authorization requirements

Prior authorization required for many specialty drugs listed below. Providers must submit specific diagnostic tests, prior therapy documentation, and specialty prescriber attestation where noted. Reauthorization often requires documentation of clinical benefit compared to baseline. Do not combine with excluded concomitant therapies (see individual entries).

Amvuttra specific prior auth

Amvuttra: Do not use with TTR-lowering agents (e.g., Onpattro) or TTR stabilizers (e.g., tafamidis). For ATTR-CM require documentation of diagnosis (tissue biopsy, genetic testing, or radionuclide imaging) and cardiac imaging (ECHO/CMR) showing involvement; if radionuclide imaging used, provide Grade 2–3 uptake. Initial and reauth documentation requirements apply.

• Do not combine with TTR stabilizers or TTR-lowering agents
• ATTR-CM: biopsy/genetic or radionuclide imaging; ECHO/CMR required
• If radionuclide imaging used, provide Grade 2 or 3 uptake

Arikayce prior auth

Arikayce (MAC lung disease): For initial review submit sputum culture confirming Mycobacterium avium complex and documentation of failure to achieve negative cultures after ≥6 months of a multidrug background regimen. Prescriber must be or consult infectious disease/pulmonology. Initial approval 6 months; reauthorization 12 months with negative sputum culture within 30 days.

• Sputum culture confirming MAC required for initial review
• Documentation of ≥6 months multidrug therapy and failure to sterilize cultures
• Prescribed by/consult with ID or pulmonologist
• Initial approval: 6 months; Reauth: 12 months (requires negative sputum culture within 30 days)

Briviact prior authorization

Briviact (brivaracetam): Requires documentation of trial and failure of generic levetiracetam and at least one other generic anticonvulsant. Provide records demonstrating inadequate seizure control. Coverage two years; initial prior therapy required.

• Trial/failure with generic levetiracetam and ≥1 other generic anticonvulsant required
• Documentation of inadequate seizure control must be submitted
• Coverage duration: 2 years

Cobenfy prior authorization

Cobenfy: Must have documentation of trial and failure with two generic atypical antipsychotics (≥28 days each). Prescriber must be or consult a specialist. Provide prior therapy documentation and responses.

• Two generic atypical antipsychotics trial/failure (≥28 days each) required
• Prescriber: specialist or consult recommended
• Coverage duration: 2 years

Dihydroergotamine prior authorization

Dihydroergotamine (nasal): Prior authorization requires documentation of trial and failure of one non-oral triptan (e.g., sumatriptan nasal or injection) and trial and failure of Nurtec ODT.

• Trial/failure of one non-oral triptan required
• Trial/failure of Nurtec ODT required
• Coverage duration: 2 years

Dupixent prior authorization

Dupixent: Initial coverage requires indication-specific documentation (e.g., atopic dermatitis: moderate–severe disease and trial/failure of medium+ potency topical steroid or topical calcineurin inhibitor). Chronic urticaria: diagnosis >6 weeks and trial/failure of one H1 antihistamine. Reauthorization requires documentation of clinical benefit compared to baseline.

• AD: confirmation of moderate–severe disease and prior topical steroid/calcineurin inhibitor trial/failure
• Chronic urticaria: urticaria >6 weeks and trial/failure of one H1 antihistamine
• Dupixent reauth: demonstrate clinical benefit vs baseline (exacerbation reduction, symptom improvement, decreased steroid use)

Chronic urticaria prior authorization

Chronic urticaria (general biologics): For agents treating chronic urticaria (e.g., Dupixent, Xolair) initial requests require confirmation of chronic urticaria (>6 weeks) and trial/failure of at least one H1 antihistamine. Reauthorization requires documentation of symptom improvement.

• Chronic urticaria defined as urticaria >6 weeks
• Trial/failure of ≥1 H1 antihistamine required before approval
• Reauthorization: documentation of clinical benefit (improved symptoms)

Eltrombopag prior authorization

Eltrombopag: Initial ITP requests require platelet count <30,000/µL or <50,000/µL with bleeding or bleeding risk, documentation of inadequate response or intolerance to steroids/IVIG, and inadequate response/intolerance to rituximab or splenectomy. Not covered to normalize platelet counts. Reauthorization requires current platelet count <400 x10^9/L and evidence of response.

• Not covered for use to normalize platelet counts
• ITP initial: platelet count thresholds and prior therapy failures required
• Eltrombopag must not be used with other maintenance thrombopoietin receptor agonists
• Reauthorization: current platelet count <400 x10^9/L and evidence of response

Fasenra prior authorization

Fasenra: Initial coverage for severe eosinophilic asthma requires elevated eosinophils (≥150 cells/µL within 6 weeks or ≥300 cells/µL in past 12 months) and trial/failure of an ICS/LABA. Reauthorization requires documentation of clinical benefit (reduced exacerbations, symptom improvement, reduced oral steroid use). For EGPA and other indications follow specific documentation needs.

• Eosinophil thresholds: ≥150 cells/µL (within 6 weeks) or ≥300 cells/µL (past 12 months)
• Trial/failure of 1 ICS/LABA in past 6 months required
• Reauthorization: documentation of clinical benefit vs baseline
• Initial coverage: 1 year; reauth: 2 years

Enbrel prior authorization

Enbrel: For rheumatoid arthritis and related indications, require trial/failure of one traditional non-biologic immunomodulator (e.g., methotrexate). For JIA, patient may start Enbrel concurrently with methotrexate/sulfasalazine/leflunomide or have aggressive disease per prescriber. Document prior therapies and responses. Do not use in combination with other biologics, Otezla, or JAK inhibitors.

• Trial/failure of traditional non-biologic immunomodulator required for RA
• JIA: concurrent initiation with specified DMARDs allowed or aggressive disease justification
• Do not use in combination with other biologics, Otezla, or JAKis
• Coverage duration: 2 years

Eucrisa prior authorization

Eucrisa: Approve after trial and failure of a prescription-strength topical steroid; if steroid inappropriate, trial and failure of a generic topical calcineurin inhibitor is required. Documentation of prior topical therapy must be submitted.

• Trial/failure of prescription-strength topical steroid required
• If steroid not appropriate, trial/failure of topical calcineurin inhibitor required
• Coverage duration: one year

Growth hormone: prior authorization requirements

Growth hormone therapies: For children submit ≥1 year growth velocity data, GH stimulation test results showing deficiency, bone age, IGF-1/IGFBP3 when required; prescriber must be appropriate specialist. For adults, confirm GHD via stimulation testing or criteria listed (e.g., >=3 pituitary hormone deficiencies). Documentation of diagnostic testing and growth curves required.

• Children: untreated growth velocity curve with ≥1 year data, GH stimulation tests <10 ng/mL or alternative criteria
• Adults: GH-stimulation test or child-onset persistent GHD or documented pituitary disease + ≥3 pituitary hormone deficiencies and low IGF-1
• Prescriber: endocrinologist (or specialist)

Nexletol prior authorization

Nexletol / Nexlizet (bempedoic acid ± ezetimibe): Submit most recent LDL-C and documentation of prior therapies and responses. Patient must have tried high-intensity statin (or maximally tolerated statin) plus ezetimibe as indicated; if statin-intolerant, document intolerance to at least two statins.

• Submit most recent LDL-C level
• Document trial of high-intensity statin ± ezetimibe or maximally tolerated statin
• If statin-intolerant, document trials of ≥2 statins with intolerance

Nuedexta prior authorization

Nuedexta: Coverage requires diagnosis of pseudobulbar affect from an underlying neurologic condition (e.g., ALS, MS, stroke) and that a neurologist prescribes. Provide medical records supporting diagnosis.

• Diagnosis of pseudobulbar affect and documentation of underlying neurologic condition required
• Prescribed by a neurologist
• Coverage duration: 2 years

Tryngolza prior auth

Tryngolza (volanesorsen): Initial requests require dosing per FDA labeling and confirmation of familial chylomicronemia syndrome (fasting TG >880 mg/dL) refractory to standard triglyceride-lowering therapies and history of acute pancreatitis. For reauthorization provide biochemical response or reduction in pancreatitis episodes.

• Confirm FCS: fasting triglycerides >880 mg/dL and refractory to standard therapy
• Document history of acute pancreatitis or recurrent abdominal pain
• Reauthorization: evidence of benefit (biochemical response, reduced pancreatitis)

VOWST prior auth

VOWST (fecal microbiota product for recurrent C. difficile): Require documentation of at least 2 recurrent CDI episodes (3+ total) after failure of appropriate antibiotics. Limited to one treatment course; patient must be ≥18.

• Documentation of ≥2 recurrent CDI episodes after appropriate antibiotic failure (≥3 total episodes)
• Patient age ≥18 years
• Limit: one treatment course (12 capsules over 3 days)

Vigabatrin prior auth

Vigabatrin: For refractory complex partial seizures require documentation of trial/failure with at least two other generic anticonvulsants. Provide seizure control documentation.

• Trial/failure of ≥2 other generic anticonvulsants required
• Documentation of inadequate seizure control must be submitted
• Coverage duration: 2 years

Vyndaqel (ATTR-CM) prior auth

Vyndaqel / Vyndamax (tafamidis) for ATTR-CM: Initial coverage requires NYHA class 1–3 heart failure with current manifestations or prior HF hospitalization, echocardiogram or CMR showing increased LV wall thickness, and diagnosis confirmation by tissue biopsy, genetic testing, or radionuclide imaging (99mTc-PYP/DPD/HMDP). If radionuclide imaging used, provide Grade 2–3 uptake. Reauthorization requires documentation of positive clinical response versus baseline.

• NYHA class 1–3 and clinical manifestations or prior HF hospitalization
• ECHO or CMR showing cardiac involvement (increased LV wall thickness)
• Diagnosis confirmed by biopsy, genetic testing, or radionuclide imaging
• If radionuclide imaging used, provide Grade 2 or 3 uptake
• Reauthorization: evidence of clinical benefit vs baseline

Winrevair (PAH) prior auth

Winrevair (PAH): Initial requests require right heart catheterization–confirmed PAH (WHO Group 1), WHO functional class II–III, and prior trial/failure of dual therapy with a PDE5 inhibitor and an endothelin receptor antagonist. Must be prescribed by or consult a PAH specialist. Reauthorization requires documentation of beneficial response (improved WHO class, risk status, or 6MWD).

• Right heart cath confirmation of PAH (WHO Group 1) required
• WHO FC II–III required
• Trial/failure of PDE5 inhibitor + endothelin receptor antagonist required prior to add-on
• Prescriber: PAH specialist or consult recommended
• Reauthorization: document improvement in WHO class, risk status, or 6MWD

Combination therapy exclusions

Combination and concurrent-use exclusions to watch for: many biologics and specialty agents are not covered when combined with other biologic drugs, Otezla, JAK inhibitors, PCSK9 inhibitors (for certain agents), ACE inhibitors (with some HAE therapies), TTR-lowering/stabilizing agents, or other named concurrent therapies. Verify drug-specific exclusions before prescribing.

• Do not combine many biologics with other biologics, Otezla, or JAK inhibitors
• Certain drugs exclude PCSK9 inhibitors or specific classes (check product notes)
• HAE agents: concurrent ACE inhibitor or other HAE preventives may be exclusionary

Haegarda exclusion and documentation

Haegarda: Not covered if used with an ACE inhibitor, with other HAE preventative therapies (e.g., Orladeyo, Takhyzro), or for acute attacks. Submit C4, C1-INH protein, and C1-INH function labs to confirm diagnosis. Reauthorization requires documentation of decreased attack frequency.

• Not covered with ACE inhibitors or other preventative HAE therapies
• Not for treatment of acute HAE attacks
• Submit C4, C1-INH protein, and C1-INH function results to confirm diagnosis
• Reauthorization: evidence of decreased frequency of attacks

Livtencity prior authorization and documentation

Livtencity: Baseline CMV DNA required to confirm diagnosis. Must document trial and failure with ganciclovir, valganciclovir, cidofovir or foscarnet prior to approval. Do not coadminister with other CMV antivirals. For reauthorization provide documentation of virologic response (CMV DNA level).

• Baseline CMV DNA level required
• Trial/failure with other CMV antivirals required prior to approval
• Do not use concomitantly with ganciclovir/valganciclovir/cidofovir/foscarnet
• Reauthorization: provide CMV DNA response documentation

Repatha LDL-C and prior therapy documentation

Repatha (PCSK9 inhibitor): Submit most recent LDL-C and document prior statin history. Patient must have tried a high-intensity statin (or maximally tolerated statin) and ezetimibe as appropriate; if statin-intolerant, document intolerance to ≥2 statins. Do not combine with Nexlizet/Nexletol per product restrictions.

• Submit most recent LDL-C level
• Document trial of high-intensity statin ± ezetimibe or maximally tolerated statin
• If statin-intolerant, document trials of ≥2 statins with intolerance
• Do not coadminister with Nexl zet/Nexletol where restricted

Denial triggers for specific products

Denial triggers and high-risk denial conditions: missing required diagnostic tests (e.g., right heart cath for PAH, biopsy/radionuclide imaging for ATTR-CM), absent prior therapy trials where required, lack of documented clinical benefit on reauthorization, excluded concurrent therapies, or failure to submit required labs (e.g., C4/C1-INH for HAE, CMV DNA for Livtencity).

• Missing confirmatory diagnostics (right heart cath, biopsy, HRCT, ECHO/CMR, mutation testing) often triggers denial
• Absent prior therapy trials or documentation of failure is a common denial reason
• Reauth denials often occur without documented clinical benefit vs baseline
• Use/exclusion conflicts (concurrent prohibited agents) can cause denials

No explicit authorization or denial rule

No explicit authorization/denial rule: Some index entries indicate no additional prior authorization beyond standard documentation. Always verify product-specific rows for explicit prerequisites, as absence of a rule in the index does not guarantee coverage without standard prior therapy or diagnostic documentation.

• If no explicit PA rule is listed, standard prior therapy and diagnostic documentation expectations still apply
• Check product-level criteria for required labs, prescriber specialty, or prior therapy

Tumor/mutation diagnostic documentation requirements

Required mutation and diagnostic documentation (examples): BRAFTOVI and Mekinist/MEKTOVI/related agents require BRAF V600 mutation documentation; IDHIFA requires IDH2 mutation documentation; FLT3 mutation required for certain AML agents. Provide genetic or test reports when indicated.

• BRAF V600 mutation documentation for BRAFTOVI and related BRAF-targeted agents
• IDH2 mutation documentation for IDHIFA
• FLT3 mutation confirmation for FLT3-targeted AML agents

Cosentyx and biosimilar documentation expectations

Cosentyx and other biologics: Provide prior therapy documentation and responses (e.g., methotrexate, NSAIDs, topical or systemic agents) per indication-specific step requirements. For biosimilar substitution denials, document inability to use preferred biosimilars where required (e.g., Stelara biosimilars).

• Cosentyx: prior therapy trials vary by indication (e.g., NSAID for ankylosing spondylitis; methotrexate for psoriasis)
• If policy requires inability to use biosimilars, document rationale and trials of preferred biosimilars

Dupixent documentation requirements

Dupixent documentation (additional): For reauthorization across indications provide objective evidence of benefit compared to baseline (e.g., reduction in lesion count, fewer exacerbations, decreased steroid use). For eosinophilic esophagitis, provide biopsy results (≥15 eosinophils/HPF) and prior PPI/topical steroid trial documentation.

• Reauth: objective measures of improvement vs baseline required
• EoE: esophageal biopsy with ≥15 eosinophils/HPF and prior PPI/topical steroid trials

Ebglyss documentation requirements

Ebglyss documentation: Initial atopic dermatitis coverage requires confirmation of moderate–severe disease and trials of Rinvoq and Dupixent. Reauthorization requires positive clinical response and documentation if using an every-2-week maintenance schedule due to inadequate response to every-4-week dosing.

• Initial: trial/failure of Rinvoq and Dupixent required for AD
• Reauth: document clinical response and dosing frequency rationale

Reauthorization: demonstrate clinical benefit

Reauthorization clinical benefit: Many agents require demonstration of clinical benefit at reauthorization (examples: Dupixent, Fasenra, Livtencity, Winrevair, Vyndaqel/Vyndamax, Haegarda, Radicava). Providers should submit objective measures (labs, imaging, symptom scales, exacerbation counts) comparing on-treatment to baseline.

• Prepare objective baseline and on-treatment data for reauth (labs, imaging, functional scores)
• Examples: CMV DNA decline, decreased HAE attack frequency, improved 6MWD or WHO class for PAH, reduced exacerbations for asthma agents

Fasenra initial coverage documentation

Fasenra initial coverage documentation: submit eosinophil counts and prior ICS/LABA failure; for EGPA provide non-severe classification documentation. Ensure dosing and prescriber specialty are documented for benefit determination (Part B vs Part D as applicable).

• Eosinophil counts (current or within specified window) required
• Trial/failure of ICS/LABA documented
• Reauth: clinical benefit vs baseline required

Epclusa documentation expectations

Epclusa: Provide documentation consistent with AASLD/IDSA guidance for hepatitis C; confirm chronic HCV infection and follow recommended duration of therapy. For pediatric pellets verify age limits.

• Documentation must align with current AASLD/IDSA guidance
• Confirm chronic HCV infection prior to approval
• Pediatric pellet age restrictions apply (3–21 years for pellets)

Evrysdi documentation

Evrysdi: For spinal muscular atrophy submit genetic confirmation of diagnosis; prescriber should be a neurologist; reauthorization requires objective clinical response showing slowing of progression or functional benefit.

• Genetic testing confirming SMA required
• Prescriber: neurologist or consultation with neurologist required
• Reauthorization: documentation of clinical benefit vs baseline

Biologic prior therapy and shortened-interval documentation

Biologic prior therapy and shortened-interval documentation: When shortened-interval biologic dosing is requested (e.g., adalimumab products), submit evidence such as two of: symptoms, active imaging, fecal calprotectin >120, CRP ≥300, inadequate trough levels, and initial response to therapy. Specialist prescriber documentation is required.

• For shortened-interval dosing, provide objective evidence (≥2 of listed items)
• Inadequate trough levels and initial response documentation required
• Prescriber: specialist or documented specialist consultation

IDH2 mutation documentation

IDH2 mutation documentation: For IDHIFA provide molecular testing confirming IDH2 mutation prior to approval.

• Submit molecular testing confirming IDH2 mutation

Krazati – NCCN documentation

Krazati: Provide documentation that use follows current NCCN recommendations where required.

• Medical records supporting adherence to NCCN guidance must be provided

Livtencity – baseline and response documentation

Livtencity response documentation: For reauthorization submit CMV DNA level demonstrating virologic response compared to baseline.

• Provide on-treatment CMV DNA level showing response for reauthorization

Mektovi oral suspension – swallow inability documentation

Mektovi oral suspension: Coverage requires inability to swallow tablet formulation; submit documentation supporting swallowing impairment.

• Document inability to swallow tablet formulation to justify oral suspension

Nuedexta – diagnosis and prescriber documentation

Nuedexta: In addition to diagnosis, document prescriber specialty (neurologist) and records supporting pseudobulbar affect due to an underlying neurologic disorder.

• Diagnosis of PBA and underlying neurologic condition required
• Prescriber: neurologist

Opipza: inability to use generics

Opipza: Provide documentation that the patient cannot use generic aripiprazole ODT or oral solution in place of Opipza before approval.

• Document inability to use generic aripiprazole ODT and oral solution

Orgovyx prior therapy requirement

Orgovyx: Prior trial and failure with degarelix (Firmagon) is required; submit documentation of prior therapy attempt.

• Document trial/failure of degarelix (Firmagon) prior to Orgovyx approval

Pirfenidone diagnostic imaging and reauth

Pirfenidone: For IPF require HRCT or surgical lung biopsy confirmation (UIP pattern) and prescriber to rule out other causes. Reauthorization requires documentation of improvement or benefit compared to baseline.

• HRCT demonstrating UIP pattern or surgical lung biopsy required for IPF
• Prescriber must rule out other causes of interstitial lung disease
• Reauth: document clinical improvement vs baseline

Radicava: ALS documentation

Radicava (edaravone): Initial ALS requests require diagnosis per revised El Escorial/Arlie House criteria, duration ≤2 years, preserved activities of daily living (ALSFRS-R baseline), and %FVC ≥80%. Reauthorization requires documentation that progression is slowed or stable compared to baseline.

• Definite/probable ALS per El Escorial criteria and diagnosis ≤2 years
• Baseline ALSFRS-R demonstrating retained ADLs and %FVC ≥80%
• Reauthorization: evidence Radicava is slowing progression vs baseline

FLT3 mutation documentation

FLT3 mutation documentation: For FLT3-targeted agents (e.g., Rydapt combinations) submit FDA-approved test results confirming FLT3-positive AML where required.

• Submit FLT3 mutation testing results (FDA-approved test) when indicated

Tolvaptan indication documentation

Tolvaptan: Indication-specific documentation required. For hyponatremia submit serum sodium and confirm hypervolemic/euvolemic etiology; for ADPKD document risk of rapid progression. Adhere to FDA dosing limits and duration guidance.

• Hyponatremia: document serum sodium and etiology; follow FDA dosing (≤60 mg/day)
• ADPKD: document risk of rapid progression and follow ADPKD dosing (≤120 mg/day)

Voydeya documentation requirements

Voydeya: Initial PNH requests require flow cytometry confirmation, active treatment with ravulizumab or eculizumab, and symptomatic extravascular hemolysis (fatigue or dyspnea with Hgb <9.5 g/dL or ARC >120×10^9/L). Reauthorization requires ongoing treatment with complement inhibitor and improvement in EVH symptoms and hemoglobin.

• Flow cytometry confirmation of PNH required
• Active treatment with ravulizumab or eculizumab prior to Voydeya
• Symptomatic EVH criteria required (fatigue/dyspnea + Hgb <9.5 g/dL or ARC >120×10^9/L)

Vyndamax/Vyndaqel documentation (ATTR-CM)

Vyndamax/Vyndaqel documentation: See ATTR-CM requirements above (diagnostic imaging/biopsy/genetic confirmation, NYHA class, and reauth clinical benefit). Do not use with TTR-lowering agents.

• ATTR-CM: ECHO/CMR, biopsy/genetic or radionuclide imaging (Grade 2–3 uptake if radionuclide)
• NYHA class 1–3 required
• Do not combine with TTR-lowering agents

Winrevair (PAH) documentation

Winrevair (PAH) documentation: Ensure right heart catheterization, WHO group/class documentation, prior dual therapy trial, specialist prescriber, and objective response measures for reauthorization (WHO class, risk status, 6MWD).

• Right heart cath confirmation required
• Document prior PDE5 + ERA therapy failure
• Specialist prescriber required
• Reauth: objective measures (WHO class, risk status, 6MWD)

Xolair documentation

Xolair: For asthma and food allergy indications submit baseline IgE (≥30 IU/mL), evidence of sensitization (skin test or in vitro), patient's weight, and trial/failure of required inhaled therapies. Reauthorization requires clinical benefit documentation and current weight and baseline IgE.

• Baseline IgE ≥30 IU/mL and allergen sensitization required for asthma and food allergy indications
• Provide patient's current weight
• Trial/failure of ICS/LABA (asthma) or intranasal steroid (nasal polyps) as indicated
• Reauth: clinical benefit documentation and updated weight/IgE

Yorvipath documentation

Yorvipath: Initial hypoparathyroidism coverage requires confirmation of chronic hypoparathyroidism (≥6 months) with labs drawn together (PTH, calcium, magnesium, phosphate) and provider attestation that calcium + vitamin D therapy is inadequate. Reauth requires documented improved serum calcium.

• Confirm chronic hypoparathyroidism ≥6 months with concurrent labs (PTH, calcium, magnesium, phosphate)
• Attest that calcium/vitamin D therapy is inadequate
• Reauth: documented improved serum calcium

Disease-specific step therapy and utilization limits

Disease-specific step therapy highlights: Many agents require failure of preferred/step agents before biologic/specialty initiation — examples include AUVELITY, Caplyta, Otezla, RINVOQ, Trelstar, Xeljanz, Xifaxan limits for IBS-D and SIBO, and others. Providers must document prior trials (drugs, durations, and responses) per product specifics.

• AUVELITY, Caplyta, and other CNS agents: required prior antidepressant/antipsychotic trials documented
• Otezla/RINVOQ/Xeljanz: required step and combination restrictions; do not combine with biologics/JAKis where indicated
• Xifaxan: utilization limits (IBS-D three 14-day courses) and SIBO not covered