Prior authorization required

Prior authorization is required for the specialty and pharmacy products listed in this policy; an alphabetical index of covered drugs appears after the criteria listings. Providers must submit required clinical documentation per the product-specific criteria to support approval.

Weight management PA duration

Initial and reauthorization approvals for anti‑obesity (weight‑management) GLP‑1 agents are limited to 6 months; renewal requires meeting the documented weight‑loss renewal criteria (e.g., ≥5% weight loss in adults).

Austedo prior authorization

Austedo (deutetrabenazine) requires prior authorization: initial approval for TD or Huntington’s chorea is one year and reauthorization two years; provider must attest symptoms have improved or stabilized for reauthorization and Austedo must not be used with tetrabenazine or Ingrezza.

• Initial duration: 1 year; reauthorization: 2 years
• Provider must attest symptoms improved or stabilized for reauth
• Combination exclusion: do not use with tetrabenazine or Ingrezza

Avmapki Fakzynja prior authorization

Avmapki Fakzynja Co‑Pack requires prior authorization with a one‑year coverage duration; providers must submit documentation of prior therapies and responses and meet any step‑therapy prerequisites.

• Coverage duration: one year
• Document prior therapies and responses
• Step‑therapy prerequisite applies

Benlysta prior authorization

Benlysta (belimumab) requires prior authorization: initial approvals are one year and reauthorization two years; prescriber must be a specialist or consult one and initial requests must meet specified clinical and serologic criteria (SELENA‑SLEDAI ≥6 and antibody criteria or biopsy‑confirmed lupus nephritis).

• Initial: 1 year; reauthorization: 2 years
• Prescriber must be specialist or consulted
• SLE initial: SELENA‑SLEDAI ≥6 AND anti‑dsDNA >30 IU/ml or ANA >1:80
• LN initial: kidney biopsy confirming class 3, 4 and/or 5 disease

Cosentyx prior authorization

Cosentyx requires prior authorization for two years; prescriber must be a specialist or consult one and documentation of prior therapies and responses is required (condition‑specific prior trials such as NSAID for AS or methotrexate for psoriasis).

• Coverage duration: 2 years
• Prescriber specialist or consultation required
• Document prior trials/responses (e.g., NSAID for AS; methotrexate for psoriasis)

Diacomit: Dravet syndrome prior auth

Diacomit (fenfluramine) prior authorization for Dravet syndrome requires documentation that the patient has seizures associated with Dravet syndrome, is not controlled on current therapy (seizures within prior 28 days), and is taking concomitant clobazam; prescriber must be or consult a specialist.

• Diagnosis of seizures associated with Dravet syndrome
• Uncontrolled on current therapy (generalized tonic‑clonic or clonic seizures within past 28 days)
• Concomitant clobazam therapy required
• Prescriber specialist or consultation required

Dupixent prior auth

Dupixent initial and reauthorization requests require disease‑specific documentation (for example, eosinophil counts for eosinophilic asthma or biopsy confirmation for EoE), prior therapy failures, and evidence of clinical benefit for reauthorization; prescriber should be a specialist or have consulted one.

• Provide required diagnostic tests (e.g., eosinophil counts; esophageal biopsy ≥15 eos/HPF for EoE)
• Document prior therapy failures per indication
• Reauthorization requires documentation of clinical benefit

Evrysdi prior authorization

Evrysdi (risdiplam) requires prior authorization: initial and reauthorization durations are 12 months; prescriber must be a neurologist or consult one, submit genetic test confirming SMA diagnosis, and reauthorization must document positive clinical response versus baseline; concurrent Spinraza or prior/planned gene therapy (Zolgensma) precludes concurrent Evrysdi.

• Initial: 12 months; reauth: 12 months
• Submit genetic test confirming SMA
• Prescriber neurologist or consult required
• Cannot be used concurrently with Spinraza or prior/planned Zolgensma
• Reauthorization: document positive clinical response vs baseline

Fasenra prior authorization

Fasenra requires prior authorization with initial coverage of one year and reauthorization of two years; dosing must follow FDA labeling, prescriber should be a specialist or consulted, and initial requests must include required blood eosinophil counts and trial/failure of an ICS/LABA.

• Initial: 1 year; reauth: 2 years
• Eosinophil requirement: ≥150 cells/µL within 6 weeks OR ≥300 cells/µL in prior 12 months
• Document trial and failure of 1 ICS/LABA in past 6 months
• Must not be used with other biologic drugs

Growth hormone prior authorization

Growth hormone therapies (e.g., Norditropin, Omnitrope, Increlex) require prior authorization—typically one‑year approvals—with extensive diagnostic documentation (growth velocity curves, stimulation testing, IGF‑1 levels, open growth plates for pediatrics) and specialist prescribing.

• Provide untreated growth velocity curve (≥1 year) and GH stimulation testing as specified
• Prescriber must be endocrinologist/gastroenterologist/nephrologist
• Coverage duration commonly one year

Biologic prior authorization

Biologic agents (e.g., adalimumab products) require prior authorization: documentation of prior therapies and responses, specialist prescriber or consultation, dosing per FDA label (or compendia for Part D), and common two‑year coverage durations; many biologics also have combination therapy exclusions.

• Document prior therapy trials and responses
• Prescriber specialist or consult required
• Dosing must follow FDA label or supported compendia
• Coverage commonly 2 years
• Combination exclusions with other biologics, Otezla, or JAKis

Product-specific prior authorization

Coverage durations and prior authorization requirements vary by product; providers must follow the product‑specific prior authorization instructions and submit required documentation per the product entry.

• Confirm product‑specific initial duration (commonly 1–2 years)
• Submit documentation required in the product entry

IVIG prior authorization

IVIG prior authorization requires submission of current weight, requested dose, supporting medical records for the diagnosis and dosing, and dosing consistent with FDA labeling or accepted standards (with weight‑adjustment rules for BMI ≥30 or actual weight ≥20% over ideal); IVIG for chronic/routine use in stable myasthenia gravis is not covered except for acute myasthenic crisis with decompensation.

• Provide current weight and requested dose
• Dose per FDA label or accepted standards; adjust dosing for BMI ≥30 or actual weight ≥20% over ideal
• Document diagnosis and indication; chronic routine IVIG for stable MG not covered

Nexlizet prior authorization

Nexlizet requires prior authorization with submission of the most recent LDL‑C and documentation of prior therapies and responses; patient must have tried a high‑intensity statin plus ezetimibe (or maximally tolerated statin plus ezetimibe) for at least 4 weeks with LDL‑C ≥70 mg/dL, or ezetimibe ≥4 weeks if statin‑intolerant; concurrent use with PCSK9 inhibitors is excluded. Coverage duration: two years.

• Submit most recent LDL‑C
• Document trial of high‑intensity statin + ezetimibe ≥4 weeks (LDL‑C ≥70 mg/dL) OR ezetimibe ≥4 weeks if statin‑intolerant
• Statin intolerance = tried ≥2 statins with symptoms on both
• Do not use with PCSK9 inhibitors (concurrency exclusion)
• Coverage duration: 2 years

Nurtec prior authorization

Nurtec requires prior authorization for prevention and acute indications; prevention requires 4–14 migraine days/month and reauthorization documents decreased migraine days; combination use with other CGRP antagonists is excluded. Initial and reauth durations are 1 year.

• Prevention: 4–14 migraine days/month
• Acute: trial/failure of one generic triptan unless contraindicated
• Must not be used with other CGRP antagonist therapy
• Initial and reauth: 1 year

Antifibrotic agents prior authorization

Antifibrotic agents (nintedanib, Ofev, pirfenidone) require prior authorization: HRCT confirming diagnosis is required for all indications; dosing must follow FDA labeling; initial and reauthorization durations specified (commonly 1 year initial, 2 years reauth); reauthorization requires documentation of improvement or stability.

• HRCT confirming diagnosis required
• Follow FDA dosing
• Initial typically 1 year; reauth commonly 2 years
• Reauthorization: documentation of improvement or stability

Oxervate prior authorization

Oxervate prior authorization requires documentation confirming Stage 2 or 3 neurotrophic keratitis (e.g., slit lamp exam), prescriber must be or consult an ophthalmologist, dosing per FDA labeling, and total lifetime treatment is limited to 8 weeks.

• Confirm Stage 2 or 3 neurotrophic keratitis with exam
• Prescribed by or in consultation with an ophthalmologist
• Dosing per FDA label
• Lifetime limit: 8 weeks

Promacta (eltrombopag) PA criteria

Promacta (eltrombopag) PA for ITP initial requests requires a platelet count <30,000/mcL OR <50,000/mcL with bleeding or bleeding risk factors, inadequate response/intolerance to steroids/IVIG and to rituximab or splenectomy; reauthorization requires current platelet <400 x10^9/L and documentation of response.

• Platelets <30,000/mcL OR <50,000/mcL with bleeding/risk
• Inadequate response/intolerance to steroids/IVIG AND rituximab or splenectomy
• Reauthorization: current platelet <400 x10^9/L and evidence of response
• Not covered to normalize platelet counts

Biologics: prior therapy & specialist requirement

Many biologic/targeted immunomodulators require prior authorization documenting prior therapy trials and results and must be prescribed by or in consultation with a specialist; for psoriasis specifically, try and fail a traditional non‑biologic immunomodulator before biologic initiation.

• Document prior therapies and responses
• Prescriber specialist or consultation required
• Psoriasis: try and fail one traditional non‑biologic immunomodulator (e.g., methotrexate)

Prior authorization and prescriber requirements

Prior authorization generally requires documentation of prior therapies and responses; many products also require specialist prescribers or specialist consultation as part of the approval process.

• Submit documentation of prior trials, intolerances, or contraindications
• Confirm prescriber is a specialist or includes specialist consultation when required

Tolvaptan prior auth dosing limits

Tolvaptan prior authorization requires documentation confirming hyponatremia type (hypervolemic or euvolemic) with serum sodium <125 mEq/L or symptomatic nonresponsive hyponatremia; dosing limits follow FDA labeling (up to 60 mg/day for hyponatremia; up to 120 mg/day for ADPKD).

• Document hyponatremia type and serum sodium <125 mEq/L for hyponatremia use
• Dose limits: up to 60 mg/day (hyponatremia) or up to 120 mg/day (ADPKD)
• Coverage durations differ by indication (e.g., 30 days hyponatremia; 2 years ADPKD)

Prior authorization required

Prior authorization is required for numerous products in this policy; providers must provide the specific prior‑therapy and diagnostic documentation indicated in each product entry.

• Follow product‑specific documentation and prior therapy instructions
• Use the alphabetical index to locate the product entry and requirements

Vowst: prior authorization & limits

Vowst prior authorization: initial coverage limited to one treatment course (12 capsules over 3 days) for patients ≥18 with at least two recurrent CDI episodes (three or more total) after failure of appropriate antibiotics; coverage limited to a single course.

• Document ≥2 recurrent CDI episodes (≥3 total) after failed appropriate antibiotics
• Patient age ≥18
• Limit: one treatment course (12 capsules over 3 days)

Xolair prior authorization

Xolair requires prior authorization with submission of required diagnostic tests and clinical history: baseline IgE, current weight, and indication‑specific documentation (e.g., skin or in vitro reactivity for asthma or food allergy); intranasal steroid continuation required for nasal polyps and H1 antihistamine trial required for chronic urticaria.

• Baseline IgE ≥30 IU/mL for relevant indications
• Provide baseline positive skin or in vitro reactivity for asthma and food allergy
• Provide current weight and age (food allergy ≥1 year)
• Document trial/failure of ICS/LABA (asthma), intranasal steroid (nasal polyps), or H1 antihistamine (chronic urticaria)

Prior authorization references

This section indexes covered drugs and page references; specific prior authorization requirements are presented in the individual product entries rather than this index portion.

Biologic prerequisite therapy

For many biologic/immunomodulator indications (RA, psoriasis, AS, JIA, etc.), providers must document a trial and failure of a conventional non‑biologic immunomodulator or other condition‑specific first‑line therapy prior to biologic initiation.

• Examples: methotrexate for RA/psoriasis, NSAID for ankylosing spondylitis
• Failure defined as intolerance or inability to improve symptoms

Auvelity step therapy

Auvelity requires prior trial and failure of an SSRI or SNRI and one atypical antidepressant (e.g., bupropion or mirtazapine) prior to approval; failure is defined as inability to improve depressive symptoms after at least 4 weeks of treatment.

• Trial/failure of SSRI or SNRI AND one atypical antidepressant
• Failure = lack of improvement after ≥4 weeks

Avmapki Fakzynja step therapy

Avmapki Fakzynja Co‑Pack requires step‑therapy prerequisites per its product entry; providers must document prior therapy trials as specified.

• Step therapy = yes; document prior therapies and responses

Various step therapy requirements

Multiple products require step therapy: providers must document trials and failures of specified generic or alternative therapies (examples include Balversa, calcipotriene‑betamethasone combinations, clobazam, Cosentyx) before the requested product will be approved.

• Document each required prior trial and inadequate response or intolerance
• Follow product‑specific durations and definitions of failure

Eltrombopag step requirements

Eltrombopag (Promacta) for ITP requires prior failure or intolerance to steroids/IVIG and to rituximab or splenectomy before approval; eltrombopag must not be used with other maintenance ITP drugs including other TPO‑RAs.

• Prior failure/intolerance to steroids or IVIG
• Prior failure/intolerance to rituximab or splenectomy
• Do not use in combination with other maintenance ITP drugs

Exxua step therapy

Exxua (for MDD) requires trial and failure of two generic antidepressants from different classes, one of which must be bupropion or mirtazapine, documented prior to approval.

• Two antidepressant trials from different classes required
• One trial must be bupropion or mirtazapine

Fanapt step therapy

Fanapt requires documentation of trial and failure with two listed generic antipsychotics, each used for at least 28 days, before approval.

• Two generic antipsychotic trials required (each ≥28 days)
• Document inadequate response or intolerance

Conventional therapy step requirements

Many immunomodulator/biologic approvals require prior failure of one traditional non‑biologic immunomodulator or NSAID depending on indication (e.g., RA, AS, psoriasis, HS, uveitis); providers must document these trials and outcomes.

• Document trial/failure of specified conventional therapy per indication
• Failure defined as intolerance or inability to improve

Inrebic step therapy

Inrebic requires documentation of trial and failure of Jakafi (ruxolitinib) prior to approval; failure is defined as intolerance or inability to improve the condition.

• Document prior Jakafi trial and inadequate response or intolerance

Inrebic step

Inrebic coverage requires prior Jakafi trial and failure (intolerance or inability to improve) documented in the request.

Kerendia step/requirements

Kerendia initial therapy for CKD with T2DM requires trial of an SGLT2 inhibitor or GLP‑1 RA and that the patient be on a maximally tolerated ACEI or ARB; for certain HF indications, Kerendia must be prescribed by or in consultation with a cardiologist and the patient be on standard HF meds.

• Trial of SGLT2i or GLP‑1 RA required for CKD/T2DM
• On maximally tolerated ACEI/ARB
• Cardiologist prescribing/consult required for HF indication

Lybalvi step therapy

Lybalvi requires prior trial and failure of olanzapine and another generic atypical antipsychotic (e.g., aripiprazole or lurasidone) with failure defined as clinically significant weight gain (≥7%) despite clinical response.

• Trial of olanzapine and another generic atypical antipsychotic required
• Failure defined as clinical response with ≥7% weight gain

Livtencity step

Livtencity requires prior trial and failure of other CMV antivirals (ganciclovir, valganciclovir, cidofovir or foscarnet) and submission of a baseline CMV DNA level confirming diagnosis before approval.

• Document baseline CMV DNA level
• Document trial and failure of ganciclovir/valganciclovir/cidofovir/foscarnet

Jylamvo prerequisite

Jylamvo requires documentation supporting inability to use generic methotrexate prior to approval.

• Provide rationale and records demonstrating inability to use generic methotrexate

Levetiracetam step

Levetiracetam oral disintegrating/soluble formulation requires documentation of inability to use generic levetiracetam tablet and trial/failure with one other generic anticonvulsant prior to approval.

• Document inability to use generic levetiracetam tablet
• Document trial and failure with one other generic anticonvulsant

Mekinist formulation requirement

Mekinist oral solution coverage requires documentation the patient is unable to swallow the tablet formulation.

• Provide clinical documentation of inability to swallow tablets

Mektovi biomarker requirement

Mektovi requires documentation of BRAF V600 mutation status prior to approval.

• Submit BRAF V600 mutation test results

Nexletol/Nexlizet required prior therapy

Nexletol/Nexlizet require prior trial of a high‑intensity statin plus ezetimibe (or statin intolerance with trial of two statins) with documentation of LDL‑C thresholds; providers must submit recent LDL‑C and prior therapy documentation.

• Trial high‑intensity statin + ezetimibe ≥4 weeks OR ezetimibe ≥4 weeks if statin‑intolerant
• Statin intolerance = tried ≥2 statins with symptoms on both
• Submit most recent LDL‑C

Nexlizet step therapy

Nexlizet step therapy: patient must have tried one high‑intensity statin plus ezetimibe for at least 4 weeks (or maximally tolerated statin plus ezetimibe) with LDL‑C ≥70 mg/dL, or ezetimibe for 4 weeks with LDL‑C ≥70 mg/dL if statin‑intolerant; document LDL‑C and prior therapies.

• Trial duration ≥4 weeks
• LDL‑C threshold: ≥70 mg/dL
• Document prior therapy and LDL‑C

Otezla step therapy

Otezla for moderate‑to‑severe psoriasis requires trial and failure of one traditional non‑biologic immunomodulator (e.g., methotrexate, cyclosporine, acitretin) before approval; document prior therapies and responses.

• Trial and failure of one traditional non‑biologic immunomodulator required
• Step not required for mild psoriasis

Allergic ophthalmic agents step requirement

For allergic ophthalmic agents (Zaditor class), non‑preferred coverage requires trial and failure of a preferred product (azelastine or OTC ketotifen) for one month unless contraindicated.

• Trial of preferred agent for one month required prior to non‑preferred

Relistor: lactulose trial required

Relistor requires a trial and failure of lactulose prior to coverage and exclusion if the patient has mechanical gastrointestinal obstruction.

• Trial and failure of lactulose required
• Do not approve if mechanical GI obstruction present

Sodium oxybate: step therapy

Sodium oxybate requires prior trials with stimulant and wake‑promoting agents (amphetamine/dextroamphetamine/methylphenidate AND modafinil or armodafinil) before approval for narcolepsy, plus diagnostic confirmation with polysomnography and MSLT and prescriber specialty.

• Trial/failure of stimulant (amphetamine/dextroamphetamine/methylphenidate) AND modafinil or armodafinil
• Provide MSLT and polysomnography confirming narcolepsy
• Prescriber: sleep specialist or neurologist

Psoriasis step requirement

For psoriasis indications across biologic products, providers must document trial and failure of one traditional non‑biologic immunomodulator (e.g., methotrexate, cyclosporine, acitretin) before some biologics will be approved.

• Document prior trial and inadequate response to specified conventional agent

Tyenne step requirement

Tyenne (for RA and JIA) requires trials and failure of two specified agents (a preferred adalimumab product, Rinvoq, Xeljanz/XR, or Enbrel) prior to approval; document prior therapies and responses.

• Trial and failure of two specified agents required
• Document prior therapies and responses

Narcolepsy step requirement

Sodium oxybate for narcolepsy requires prior trial and failure of stimulant therapy (amphetamine salts/dextroamphetamine/methylphenidate) AND either modafinil or armodafinil before approval; provide diagnostic polysomnography/MSLT documentation.

• Document stimulant + modafinil/armodafinil trial and failure
• Submit MSLT and polysomnography confirming narcolepsy

Step therapy requirements

Many agents require documented prior trial and failure of specified conventional therapies (e.g., methotrexate for psoriasis/RA; NSAID for ankylosing spondylitis); providers must submit records demonstrating these trials and outcomes.

• Provide dates, doses, durations, and reason for discontinuation/intolerance or inadequate response

Xolair step therapy requirements

Xolair step therapy: for chronic urticaria, document trial and failure of at least one H1 antihistamine prior to Xolair; for nasal polyps, document trial and failure of an intranasal steroid (and intranasal steroid must be continued with Xolair).

• Chronic urticaria: trial/failure of one H1 antihistamine
• Nasal polyps: trial/failure of intranasal steroid and continuation required

index chunk — no step therapy rules

This index portion contains drug names and page references only; step therapy rules are detailed in each individual product entry rather than the index chunks.

General documentation

Supporting documentation is required for all prior drug trials to demonstrate inadequate response, intolerance, or FDA‑labeled contraindication; providers must submit clinical notes, dates, doses, and objective measures where applicable.

• Document trial dates, durations, doses, and clinical outcome
• Include laboratory, imaging, or functional testing as required by product-specific criteria

Adempas diagnostic documentation

Adempas (riociguat) prior authorization requires diagnostic documentation: for PAH provide right heart catheterization confirming WHO Group 1; for CTEPH document inoperable disease or persistent/recurrent disease after pulmonary endarterectomy.

• Submit right heart catheterization confirming PAH (WHO Group 1) for PAH indication
• For CTEPH, document inoperability or persistent/recurrent disease after endarterectomy

Arikayce microbiology documentation

Arikayce prior authorization requires sputum culture supporting MAC diagnosis and documentation of failure to obtain negative sputum cultures after ≥6 months of multidrug background regimen; reauthorization requires a negative sputum culture within 30 days and prescriber specialty involvement.

• Submit sputum culture demonstrating MAC infection
• Document ≥6 months multidrug background regimen without negative cultures
• Reauth: negative sputum culture within 30 days

Amvuttra reauthorization

Amvuttra reauthorization requires documentation demonstrating a positive clinical response compared to baseline (e.g., improved neuropathy symptoms, motor function, quality of life, or reduced cardiovascular events for ATTR‑CM).

• Provide objective measures of clinical benefit versus baseline for reauthorization

Prior therapy documentation

Avmapki Fakzynja Co‑Pack initial requests require documentation of prior therapies and responses to treatment to support the prior authorization.

• Submit prior therapy history and response details

Benlysta diagnostic documentation

Benlysta diagnostic documentation: for SLE initial requests submit SELENA‑SLEDAI ≥6 and serologic criteria (anti‑dsDNA >30 IU/mL or ANA >1:80) and proof of concomitant baseline therapy; for lupus nephritis submit kidney biopsy confirming class 3, 4 and/or 5 and documentation of standard LN therapy.

• SLE: SELENA‑SLEDAI ≥6 AND anti‑dsDNA >30 IU/mL OR ANA >1:80
• LN: kidney biopsy confirming class 3, 4, and/or 5
• Document concomitant baseline agents and prior therapy

Colistimethate microbiology documentation

Colistimethate prior authorization requires culture and susceptibility information or local epidemiology/susceptibility patterns to support IV/IM use (nebulized/inhalation not covered); prescriber should be or consult an infectious disease specialist.

• Provide culture and susceptibility or local epidemiology data
• IV/IM administration only; nebulization not covered
• Prescriber: infectious disease specialist or consult

Asthma documentation

For asthma biologic initial coverage, document oral corticosteroid dependence OR eosinophilic phenotype (blood eosinophils ≥150 cells/µL at initiation or ≥300 cells/µL in past 12 months) AND trial/failure of one ICS/LABA in past 6 months; reauthorization requires documentation of clinical benefit compared to baseline.

• Eosinophils: ≥150 cells/µL at initiation OR ≥300 cells/µL in prior 12 months
• Document trial and failure of 1 ICS/LABA in past 6 months
• Reauth: show clinical benefit vs baseline

Hepatitis C documentation

Epclusa (sofosbuvir/velpatasvir) requests require documentation of chronic hepatitis C infection and that use is consistent with current AASLD/IDSA guidance; pellets have age limits (3–21 years for pellets).

• Provide documentation of chronic HCV infection
• Ensure use aligns with AASLD/IDSA guidance
• Pellets: age 3–21 years

Evrysdi documentation

Evrysdi requires submission of genetic testing confirming SMA diagnosis and prescriber neurologist involvement; reauthorization requires documentation demonstrating positive clinical response compared to baseline.

• Submit genetic test confirming SMA
• Prescriber: neurologist or consult
• Reauth: documentation of positive clinical response vs baseline

Prior therapy documentation

Products such as Exxua require documentation of prior therapies and responses to support approval; include dates, doses, durations, and reason for discontinuation.

• Provide prior therapy history with outcomes and dates

Fasenra lab and benefit documentation

Fasenra requires blood eosinophil counts within the specified windows and documentation of a trial/failure of an ICS/LABA; reauthorization requires documentation of clinical benefit compared to baseline.

• Submit eosinophil counts per timeframe (≥150 within 6 weeks or ≥300 within 12 months)
• Document trial/failure of ICS/LABA
• Reauth: demonstrate clinical benefit

Growth hormone documentation

Growth hormone products require extensive testing documentation (growth velocity curves, GH‑stimulation tests, IGF‑1/IGFBP‑3 levels), open growth plates for children, and specialist prescribing (endocrinologist); provide reauthorization attestations as specified.

• Submit growth velocity data and GH stimulation testing per pediatric/adult criteria
• Prescriber must be endocrinologist/gastroenterologist/nephrologist

HAE documentation

Hereditary angioedema therapies (Haegarda, icatibant) require submission of C4, C1‑INH protein, and C1‑INH function lab results confirming diagnosis; Haegarda is not covered concurrently with ACE inhibitors or other preventative HAE therapies and reauthorization requires decreased attack frequency.

• Submit C4, C1‑INH protein, and C1‑INH function tests
• Do not use Haegarda with ACE inhibitors or other preventative HAE therapies
• Reauth: document decreased frequency of attacks

Shortened-interval dosing documentation

For shortened‑interval dosing approvals with biologics in Crohn’s/UC, providers must submit at least two among symptoms, imaging showing active disease, fecal calprotectin >120, or CRP ≥300, plus inadequate trough levels and initial response to therapy.

• Provide two of: symptoms, imaging of active disease, fecal calprotectin >120, CRP ≥300
• Include drug trough levels and evidence of initial response

IVIG documentation

IVIG requests must include current weight and requested dose, documentation supporting the diagnosis and dose, and administration information to determine Medicare Part B versus Part D benefit when applicable.

• Provide current weight and requested dose
• Include diagnosis support and treatment records
• Specify administration setting for benefit determination

Livtencity documentation

Livtencity requires baseline CMV DNA level confirming diagnosis and medical records showing trial and failure with ganciclovir/valganciclovir/cidofovir/foscarnet; reauthorization requires documentation of response (e.g., CMV DNA level).

• Submit baseline CMV DNA
• Document prior CMV antiviral trials and failures
• Reauth: provide objective response measures

LDL-C documentation

For Nexletol/Nexlizet prior authorization, submit the most recent LDL‑C and documentation of prior therapies and responses to support approval per the LDL‑C thresholds.

• Provide most recent LDL‑C
• Include prior statin/ezetimibe therapy documentation and outcomes

Kalydeco genetic testing

Kalydeco requires laboratory confirmation of an ivacaftor‑responsive CFTR mutation (genetic testing) prior to approval.

• Submit genetic test confirming ivacaftor‑responsive CFTR mutation

Nexlizet — required labs and prior therapy documentation

Nexlizet prior authorization and documentation must include the most recent LDL‑C and prior therapy records (statin/ezetimibe trials) to demonstrate eligibility under the LDL‑C threshold and step‑therapy rules.

• Submit LDL‑C result and prior therapy history
• Confirm statin + ezetimibe trial duration and outcomes

HRCT and diagnostic documentation — nintedanib / Ofev

For nintedanib and Ofev, HRCT confirming the diagnosis is required for all indications; for IPF rule out other causes and document UIP pattern if no biopsy; for progressive fibrosing ILD provide FVC decline data per criteria.

• Submit HRCT confirming diagnosis (include HRCT report/images)
• For IPF: document UIP pattern or surgical biopsy if applicable
• For progressive phenotype: provide FVC decline data (≥10% or ≥5% plus worsening symptoms/imaging)

Nulibry — genetic testing confirmation

Nulibry prior authorization requires confirmed MoCD Type A diagnosis by genetic testing with submission of genetic test results.

• Provide genetic test results confirming MoCD Type A

Nuedexta — diagnostic medical records

Nuedexta requests must include medical records supporting the diagnosis of pseudobulbar affect caused by an underlying neurologic condition; prescriber should be a neurologist.

• Submit medical records documenting underlying neurologic condition and PBA diagnosis
• Prescriber: neurologist

PAH agents — right heart catheterization confirmation

PAH agents (Opsumit, Opsynvi, Orenitram) require documentation that pulmonary arterial hypertension (WHO Group 1) is confirmed by right heart catheterization prior to approval.

• Provide right heart catheterization report confirming WHO Group 1 PAH

Pulmonary function and AAT levels

Prolastin‑C prior authorization requires HRCT confirmation for some indications and documentation of pulmonary function (FEV1) and serum AAT level per specified thresholds (serum AAT <11 micromoles/L or equivalent).

• Provide HRCT where required
• Submit FEV1 and serum AAT level results

Radicava: diagnostic and functional metrics

Radicava initial prior authorization requires ALS diagnosis per revised El Escorial criteria, diagnosis ≤2 years, baseline ALSFRS‑R total ≥24 (≥2 points on each item), and %FVC ≥80%; reauthorization requires documentation that Radicava is slowing progression versus baseline.

• Provide El Escorial/Arlie House diagnostic documentation and date of diagnosis (≤2 years)
• Baseline ALSFRS‑R with minimum total 24; %FVC ≥80%
• Reauth: evidence of slowed progression or stable/improved ALSFRS‑R

Sodium oxybate: sleep study and prior trials

Sodium oxybate prior authorization requires MSLT and polysomnography confirming narcolepsy and documentation of prior trials of stimulant and wake‑promoting agents; prescriber must be a sleep specialist or neurologist.

• Submit polysomnography and MSLT confirming narcolepsy
• Document prior stimulant and modafinil/armodafinil trials and outcomes
• Prescriber: sleep specialist or neurologist

Prior therapy documentation

Providers must supply documentation of prior therapies and responses for multiple products across the policy to meet prior authorization requirements; absence of this documentation may lead to denial.

• Include dates, doses, durations, outcomes, and rationale for stopping prior therapies

Narcolepsy diagnostic documentation

Narcolepsy diagnostic documentation: sodium oxybate requests must include MSLT and polysomnography confirming the diagnosis before approval.

• Submit polysomnography and MSLT reports

Tavneos documentation

Tavneos prior authorization requires documentation to support the diagnosis, that the agent is used as an add‑on to standard therapy (cyclophosphamide, rituximab, steroids), and for reauthorization provide BVAS reduction and steroid dose documentation.

• Provide diagnostic documentation and confirm add‑on use with standard therapy
• Reauth: submit BVAS reduction and steroid dose information

Osteoporosis prior therapy documentation

Teriparatide/Tymlos prior authorization for osteoporosis requires documentation of prior bisphosphonate use or demonstration of very high fracture risk per T‑score or fracture history, and specialist prescribing.

• Document prior bisphosphonate trial or T‑score ≤‑3.0 (or ≤‑2.5 with fragility fracture)
• Prescriber: endocrinologist (as specified)

Prior therapy and diagnostic documentation

For certain heart‑failure or cardiology products, prior therapy and diagnostic documentation must include prior medications, response, and recent assessments (e.g., EF <45% measured within prior 12 months) to support approval.

• Provide recent EF and prior medication history per product requirements

Voydeya initial documentation

Voydeya initial prior authorization requires flow cytometry‑confirmed PNH diagnosis, active treatment with ravulizumab or eculizumab, and evidence of symptomatic extravascular hemolysis (fatigue/dyspnea plus Hgb <9.5 g/dL or ARC >120 x10^9/L); reauthorization requires documentation of improvement in EVH symptoms and hemoglobin.

• Submit flow cytometry confirming PNH
• Document active complement inhibitor therapy (ravulizumab/eculizumab)
• Provide Hgb and ARC data and symptom documentation
• Reauth: demonstrate improved EVH symptoms and hemoglobin/hemolysis markers

Xolair baseline documentation

Xolair baseline documentation for asthma requires baseline IgE ≥30 IU/mL, positive skin or in‑vitro reactivity to a perennial aeroallergen, current weight, and trial/failure of an ICS/LABA in the past 6 months; reauthorization requires documentation of clinical benefit and current weight.

• Baseline IgE ≥30 IU/mL (pre‑IgE‑lowering therapy)
• Positive skin or in‑vitro reactivity to perennial aeroallergen
• Document current weight and ICS/LABA trial/failure
• Reauth: show clinical benefit and current weight

Xolair — required documentation

For Xolair food allergy initial requests, submit positive in‑vitro IgE and positive skin prick testing to specified foods, clinical history of significant allergic reaction, baseline IgE ≥30 IU/mL, current weight, and patient age ≥1 year; reauthorization requires continued avoidance diet, current weight and baseline IgE, and documentation of clinical benefit.

• Positive in‑vitro IgE AND positive skin prick to specified foods
• Clinical history of significant allergic reaction
• Baseline IgE ≥30 IU/mL; current weight; age ≥1 year
• Reauth: document clinical benefit and provide current weight and baseline IgE

Yorvipath — required documentation

Yorvipath initial authorization for chronic hypoparathyroidism requires labs drawn together (PTH, calcium, magnesium, phosphate), provider attestation that condition is not adequately controlled on calcium and vitamin D, endocrinologist prescribing/consult, and reauthorization must document improved serum calcium.

• Provide PTH, calcium, magnesium, phosphate drawn together
• Provider attestation of inadequate control on calcium and vitamin D
• Prescriber: endocrinologist or consult required
• Reauth: document improved serum calcium

Acthar exclusions and limits

Acthar is not covered for acute gouty arthritis, severe psoriasis, and atopic dermatitis; quantity is limited to FDA‑supported dosage and reauthorization requires demonstrated clinical benefit.

• Not covered for acute gouty arthritis, severe psoriasis, atopic dermatitis
• Quantity limited to FDA‑supported dosage
• Reauthorization requires demonstrated clinical benefit

GLP-1 weight loss exclusions/attestations

Weight‑loss GLP‑1 agents require prescriber attestations (no concurrent GLP‑1 use, optimization for eating disorders, ruling out metabolic causes, contraindications such as pregnancy/lactation or MTC/MEN2), and confirmation that therapy is part of an overall weight‑management plan; absence of required attestations or contraindications may trigger denial.

• Prescriber attest single‑agent class use and absence of contraindications
• Confirm diet/exercise plan and prior failure of other interventions
• Attest optimized treatment for eating disorder if present

Amvuttra initial coverage risks

Amvuttra initial coverage carries denial risk if required diagnostic confirmation is missing (TTR mutation, baseline PND score ≤IIIb, clinical signs for HATTR‑PN) or ATTR‑CM imaging/diagnostic criteria are incomplete; reauthorization requires documentation of positive clinical response versus baseline.

• Submit TTR mutation and baseline PND score for HATTR‑PN
• For ATTR‑CM, provide tafamidis trial history, NYHA class, cardiac imaging and confirmatory testing
• Reauth: document clinical benefit

Colistimethate administration restriction

Colistimethate administration via nebulization/inhalation is not covered; only IV or IM administration is allowed and requires microbiologic documentation of susceptible bacteria or local epidemiology—lack of microbiology support will risk denial.

• Nebulized/inhalation administration not covered
• Provide culture/susceptibility or local epidemiology to support IV/IM use

Austedo combination exclusion

Austedo must not be used in combination with tetrabenazine or Ingrezza; requests documenting prohibited combinations will be denied.

• Do not combine Austedo with tetrabenazine or Ingrezza

Cosentyx combination exclusion

Cosentyx must not be used in combination with other biologic drugs, Otezla, or JAK inhibitors; requests indicating combination therapy will be excluded.

• Combination with other biologics, Otezla, or JAKis is not allowed

Benlysta combination exclusion

Benlysta must not be used concomitantly with another biologic drug or Lupkynis; documentation of prohibited combination use will trigger denial.

• Do not use Benlysta with other biologic drugs or Lupkynis

Dalfampridine safety and documentation

Dalfampridine carries denial risk if the patient has a history of seizure or creatinine clearance ≤50 mL/min; baseline timed 25‑foot walk and ambulatory status must be documented.

• No history of seizure
• Creatinine clearance >50 mL/min
• Provide baseline timed 25‑foot walk and ambulatory status

Dihydroergotamine mesylate nasal denial risk

Dihydroergotamine mesylate nasal prior authorization may be denied if documentation of trial and failure of one non‑oral triptan and Nurtec ODT is not provided.

• Document trial/failure of one non‑oral triptan
• Document trial/failure of Nurtec ODT

Epclusa denial risk

Epclusa requests may be denied if documentation confirming chronic hepatitis C infection and alignment with AASLD/IDSA guidance is not provided.

• Provide documentation of chronic HCV infection and guideline‑consistent use

Haegarda excluded combinations/uses

Haegarda is not covered if used with an ACE inhibitor, other preventative HAE therapies (Orladeyo, Takhyzro), or for acute attacks; missing C4/C1‑INH lab documentation will also risk denial.

• Do not use Haegarda with ACE inhibitors or other preventative HAE therapies
• Submit C4, C1‑INH protein, and C1‑INH function labs to confirm diagnosis

Fasenra excluded combinations

Fasenra must not be used in combination with other biologic drugs; documentation indicating combination use will be excluded.

• Combination with other biologics is not permitted

Biologic combination exclusions

Many biologic products (e.g., Humira/Hadlima) are subject to combination therapy exclusions — concurrent use with other biologics, Otezla, or JAK inhibitors is not allowed and will result in denial.

• Confirm no concurrent biologic, Otezla, or JAK inhibitor therapy

Icatibant excluded combination

Icatibant acetate concurrent use with an ACE inhibitor is not covered; providers must confirm ACE inhibitor is not being used.

• Do not approve if patient is on an ACE inhibitor

IVIG for myasthenia gravis

IVIG for chronic or routine use in stable myasthenia gravis is not covered; approval is limited to acute myasthenic crisis with decompensation and requests must include current weight, requested dose, and supporting medical records.

• Chronic/routine IVIG for stable MG is not covered
• Provide weight, requested dose, and medical records for acute indications

IVIG dosing documentation

IVIG requests risk denial if current weight, requested dose, dosing rationale, and supporting medical records are not provided; dosing must follow FDA labeling or accepted standards including weight adjustments for BMI ≥30 or actual weight ≥20% over ideal.

• Include current weight and requested dosing details
• Provide diagnosis support and dosing calculation (weight‑adjusted if applicable)

Concurrency exclusion — Nexlizet

Nexlizet will be denied if used concomitantly with PCSK9 inhibitors (e.g., Repatha) — concurrent use is an exclusion.

• Do not approve if PCSK9 inhibitor therapy is concurrent

Concurrency exclusion — Nurtec

Nurtec must not be used in combination with other CGRP antagonist therapy; combination use is excluded and will lead to denial.

• Ensure no concurrent CGRP antagonist therapy

Lifetime duration limit — Oxervate

Oxervate has a lifetime treatment limit of 8 weeks; requests exceeding this limit will be denied or considered not covered.

• Lifetime total treatment limited to 8 weeks

Diagnostic documentation required

Requests may be denied if diagnostic documentation required by the product entry is missing (for example, FEV1 <80% predicted and low serum AAT for Prolastin‑C); providers must include all required diagnostic tests.

• Include all required diagnostic tests (labs, imaging, functional studies) per product

Prior therapy / prescriber requirements

Denial risk exists when prior therapy requirements or specialist prescriber requirements are not documented; providers must include evidence of specified trials, failures/intolerances, and specialist involvement when required.

• Document prior trials, durations, outcomes, and specialist consultations as required

Combination therapy exclusions

Combination therapy exclusions apply to many products; use in combination with other biologic drugs, Otezla, or JAK inhibitors where prohibited will be excluded from coverage.

• Verify no prohibited combination therapies are present

Sodium oxybate exclusions

Sodium oxybate exclusions: patients receiving sedative hypnotics or with succinic semialdehyde dehydrogenase deficiency are excluded and such combinations or contraindications will preclude coverage.

• Do not approve if sedative hypnotics are being taken concurrently
• Do not approve if succinic semialdehyde dehydrogenase deficiency present

Combination exclusion

Voydeya is not covered in combination with Fabhalta or Empaveli; requests indicating prohibited combinations will be denied.

• Do not combine Voydeya with Fabhalta or Empaveli

Exclusion by diagnosis

Vyndamax will be denied for patients with primary (light‑chain) amyloidosis; ensure diagnosis is transthyretin ATTR‑CM and not light‑chain amyloidosis.

• Confirm ATTR‑CM diagnosis and exclude primary (light‑chain) amyloidosis

Indication restrictions

Xifaxan coverage limits: coverage for SIBO is not provided and IBS‑D is limited to no more than three 14‑day treatment courses; for travelers’ diarrhea and hepatic encephalopathy, document required prior trials (e.g., azithromycin or lactulose).

• IBS‑D: up to three 14‑day courses
• SIBO: coverage not provided
• TD: document trial/failure of azithromycin; HE: trial/failure of lactulose

Documentation-dependent denials

Requests lacking documentation of required diagnostic testing, clinical history, baseline IgE, current weight, or failure/response documentation (as specified per indication) may be denied; providers must include all specified elements from the product entry.

• Ensure all indication‑specific documentation (labs, tests, prior therapy history) is submitted

Combination therapy exclusion

Certain products are excluded from combination use with other biologic drugs, Otezla, or JAK inhibitors; document that the requested agent is not being used concurrently with excluded agents to avoid denial.

• Verify no concurrent excluded biologics, Otezla, or JAKis

This index section provides an alphabetical listing of covered drugs and page references; it does not itself state authorization or denial rules — refer to each drug’s criteria entry for actionable requirements.