Priority Health Medicare Prior Authorization Criteria — Pharmacy & Specialty Drugs
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Medicare prior authorization criteria for pharmacy and specialty drugs for Priority Health members, organized alphabetically by drug with indication-specific requirements, exclusions, documentation, duration, and utilization controls.
No material clinical or coverage changes in this revision.
Per-Product Coverage Criteria (Alphabetical Index)
ACTHAR — initial and reauthorization requirements
ACTHAR coverage when ALL of the following are met:
Reauthorization requires demonstrated clinical benefit.
Adalimumab and related biologics
Adalimumab-class biologics covered when ALL of the following are met:
Prescriber should be a specialist or have consulted a specialist; documentation of prior therapies and responses required; indication‑specific prior trials required (e.g., RA: trial/failure of traditional non‑biologic immunomodulator; AS: trial/failure of an NSAID; psoriasis: trial/failure of a traditional non‑biologic immunomodulator).
Aimovig — migraine prevention
Aimovig coverage when ALL of the following are met:
Initial approval 1 year; reauthorization 2 years; reauthorization requires documentation of decreased migraine days per month; dosing must align with FDA labeling.
Amvuttra — hATTR-PN and ATTR-CM
Amvuttra coverage differs by indication and requires ALL listed criteria:
Prescriber documentation required; reauthorization requires demonstration of positive clinical response vs baseline; initial and reauth coverage duration one year.
Will not be approved for primary (light‑chain) amyloidosis; reauthorization requires documentation of clinical response; initial and reauth one year.
Arikayce — MAC lung disease
Arikayce coverage when ALL of the following are met:
Must be prescribed by or in consultation with an infectious disease specialist or pulmonologist; initial approval 6 months; reauthorization 12 months and requires a negative sputum culture within the last 30 days.
Benlysta — SLE and lupus nephritis
Benlysta coverage when ALL of the following are met:
Prescriber must be a specialist or have consulted a specialist; initial duration 1 year; reauthorization 2 years with evidence of clinical improvement.
Reauthorization requires evidence of clinical improvement including improved or stable eGFR.
BRAFTOVI initial therapy
BRAFTOVI and brivaracetam initial therapy requirements:
Coverage duration two years; applies to indicated malignancies.
Prerequisite therapy required; coverage duration two years.
Brivaracetam initial therapy
Brivaracetam (oral formulations) coverage when ALL of the following are met:
Coverage duration two years; prerequisite therapy required.
Colistimethate criteria
Colistimethate sodium covered when ALL of the following are met:
Must be prescribed by or in consultation with an infectious disease specialist; coverage duration one year.
CORTROPHIN coverage
CORTROPHIN coverage when ALL of the following are met:
Quantity limited to FDA‑supported dosage; reauthorization requires demonstrated clinical benefit (reauth 1 year).
Cosentyx initial coverage
Cosentyx covered when ALL of the following are met:
Coverage duration two years; dosing per FDA label or compendia.
Dalfampridine safety criteria
Dalfampridine ER safety criteria — covered when ALL of the following are met:
Initial and reauthorization coverage 1 year; reauth requires stability or improvement in walking speed.
Dupixent initial and reauthorization criteria
Dupixent coverage when the applicable indication-specific criteria are met:
Initial approval 1 year; reauth 2 years; reauthorization requires clinical benefit vs baseline.
Reauthorization requires reduced eosinophil count or symptom improvement.
Reauthorization requires documented clinical benefit vs baseline.
Ebglyss AD criteria
Ebglyss (atopic dermatitis) coverage when ALL of the following are met:
Prescriber specialist required; initial limited to 4 doses first month then 2 doses/month thereafter; reauth 2 years with documentation of positive clinical response.
Dupixent (chronic urticaria)
Dupixent — chronic urticaria initial coverage when ALL of the following are met:
Reauthorization requires documentation of clinical benefit vs baseline.
Dupixent (bullous pemphigoid)
Dupixent — bullous pemphigoid initial coverage when ALL of the following are met:
Reauthorization requires documentation of reduction in blister formation and itching.
Eltrombopag (ITP)
Eltrombopag — ITP initial coverage when ALL of the following are met:
Reauthorization: platelet count <400 x10^9/L and documentation of positive response; use to normalize platelet counts is not covered.
Emgality (migraine and cluster headache)
Emgality coverage when indication-specific criteria are met:
Initial approval 1 year; reauth 2 years; reauthorization requires documentation of decreased migraine days per month; must not be used with another CGRP antagonist.
Reauthorization requires documentation of decreased frequency or intensity of cluster headaches.
Enbrel (rheumatologic indications)
Enbrel coverage when the indication-specific criteria are met:
Must not be used with other biologics, Otezla, or JAK inhibitors; prescriber specialist or consult required; coverage duration two years.
Dose must follow FDA labeling.
Fasenra (asthma and EGPA)
Fasenra — severe eosinophilic asthma and EGPA coverage when ALL of the following are met:
Prescriber specialist required; initial 1 year; reauthorization requires clinical benefit documentation.
Reauthorization requires documentation of clinical benefit.
Eohilia (eosinophilic esophagitis)
Eohilia (EoE) coverage when ALL of the following are met:
Age ≥11 years; prescriber specialist required (gastroenterologist or allergist); authorization limited to 12 weeks within a 1‑year authorization.
Endari (sickle cell disease)
Endari coverage when ALL of the following are met:
Prescriber specialist recommended; coverage duration two years.
Growth hormone products (pediatric and adult GHD)
Growth hormone products — pediatric and adult criteria (high‑level):
Prescriber restriction: endocrinologist/gastroenterologist/nephrologist; coverage duration one year.
Prescriber restriction applies; coverage duration one year.
Growth hormone (selected products)
Selected growth hormone product highlights (same content summarized):
Coverage duration one year; specialist prescriber required.
Biologic agents: combination exclusions and step requirements
Biologic agents: combination exclusions and step therapy rules apply when ALL of the following are met:
Documentation of prior therapies and responses required; prescriber should be a specialist; indication‑specific prior trials required (e.g., RA: fail methotrexate; AS: fail NSAID; PsO: fail methotrexate).
Exceptions for aggressive disease or concurrent initiation with certain DMARDs per product guidance.
HAE products
HAE product requirements — covered when ALL of the following are met:
Prescriber specialist (allergist/immunologist/hematologist) recommended; age limits apply per product; exclusions include concurrent ACE inhibitor use for certain agents.
IVIG
IVIG coverage considerations when ALL of the following are met:
Acute myasthenic crisis with decompensation allowed; chronic routine use for stable MG not covered.
Kalydeco
Kalydeco coverage requirement:
Coverage duration two years.
Kerendia initial criteria
Kerendia initial therapy requirements — covered when ALL of the following are met:
Coverage duration two years.
Coverage duration two years.
Imatinib formulations
Imatinib product‑specific notes — coverage when the following are met:
Coverage duration as specified per product (commonly one to two years).
Krazati — Covered with conditions
Krazati coverage when ALL of the following are met:
Coverage duration two years.
Levetiracetam ODT/soluble — Covered with prior therapy
Levetiracetam ODT/soluble coverage when ALL of the following are met:
Coverage duration two years; prior therapy required; requests may be denied without documentation.
Livtencity — Covered with prior therapy and lab confirmation
Livtencity coverage when ALL of the following are met:
Initial coverage eight weeks; reauthorization requires documented response (e.g., CMV DNA level).
Nexletol / Nexlizet — Step therapy criteria
Nexletol / Nexlizet — step therapy criteria (covered when ONE of the following is met):
Must submit most recent LDL‑C and prior therapy documentation; must not be used with PCSK9 inhibitors or Juxtapid; coverage duration two years.
Nulibry — Genetic confirmation and response for reauth
Nulibry coverage when ALL of the following are met:
Initial 1 year; reauthorization 2 years with documentation of beneficial response in neurological/gross motor/developmental measures.
Pulmonary arterial hypertension agents — diagnostic confirmation required
Pulmonary arterial hypertension (PAH) agents — diagnostic confirmation required:
Coverage duration two years where specified; prescriber specialist involvement recommended.
Marplan — Step therapy requirement
Marplan (antidepressant) step therapy requirement — covered when ALL are met:
Coverage duration two years; prior therapy required.
PAH product criteria
PAH product criteria — covered when documentation and prerequisites are provided:
Coverage duration two years where specified; specialist prescriber recommended.
Oxervate
Oxervate coverage limits — covered when ALL of the following are met:
Dosing must follow FDA label; more than 8 weeks lifetime not covered.
Pirfenidone (IPF)
Pirfenidone (IPF) coverage when ALL of the following are met:
Coverage duration two years; reauthorization requires documentation of improvement.
Radicava
Radicava initial and reauthorization criteria — covered when ALL of the following are met:
Initial limited volumes (70 mL first 28 days; 50 mL every 28 days thereafter); reauthorization requires evidence Radicava is slowing progression.
Redemplo (FCS)
Redemplo (FCS) initial and reauthorization — covered when ALL of the following are met:
Initial one year; reauthorization two years with documentation of benefit vs baseline.
Revcovi
Revcovi monitoring‑based coverage when ALL of the following are met:
Initial and reauthorization one year.
Repatha (PCSK9 inhibitor)
Repatha (PCSK9 inhibitor) prior therapy requirements — covered when ONE of the following is met:
Must submit prior therapy documentation; coverage duration two years.
Biologic/JAKi agents
Biologic/JAKi and other immunomodulator agents — coverage when ALL product‑specific criteria are met:
Step therapy requirements vary by indication (e.g., methotrexate for RA, NSAID for AS); coverage durations commonly one to two years.
General product coverage rule
General product coverage rule — product covered when product‑specific conditions satisfied:
See individual product entries for details.
Tavneos (avacopan) coverage criteria
Tavneos (avacopan) coverage criteria — initial and reauthorization when ALL are met:
Initial 6 months; reauth 12 months.
Sodium oxybate criteria
Sodium oxybate (narcolepsy) criteria — covered when ALL of the following are met:
Coverage duration two years; reauthorization requires documentation of decreased excessive daytime sleepiness or cataplexy episodes.
Rydapt coverage criteria
Rydapt (midostaurin) AML coverage when ALL of the following are met:
Age ≥18; coverage duration one year; mutation testing and combination therapy required.
Secuado coverage criteria
Secuado coverage criteria — covered when ALL of the following are met:
Coverage duration two years.
Tetrabenazine coverage criteria
Tetrabenazine coverage criteria — covered when ALL of the following are met:
Coverage duration two years.
Teriparatide coverage criteria
Teriparatide coverage criteria — covered when ONE of the following is met:
Prescriber must be an endocrinologist; coverage duration two years.
Testosterone coverage criteria
Testosterone (transdermal) coverage when ALL of the following are met:
Coverage duration two years.
Tofacitinib and related products
Tofacitinib and related JAK inhibitor family coverage when ALL of the following are met:
Coverage duration two years; specifics vary by indication.
Products with combination exclusions and CYP2D6/genotype requirements
Products with combination exclusions and CYP2D6/genotype requirements — covered when ALL product‑specific conditions are met:
Applies to specific products as noted in product entries.
Tofacitinib (and similar agents) — rheumatologic requirements
Tofacitinib (and similar agents) — rheumatologic requirements (covered when ALL are met):
Coverage duration two years.
Tolvaptan — indication-specific criteria
Tolvaptan — indication‑specific criteria (covered when relevant criteria are met):
Coverage duration hyponatremia: 30 days.
Coverage duration ADPKD: 2 years; prescriber documentation required.
Tryngolza (Familial Chylomicronemia Syndrome)
Tryngolza (FCS) initial and reauthorization criteria — covered when ALL are met:
Initial one year; reauthorization two years with evidence of benefit vs baseline.
Reauthorization requires documentation of clinical/biochemical benefit.
Verquvo (heart failure)
Verquvo (heart failure) coverage when ALL of the following are met:
Coverage duration two years.
Voydeya (PNH)
Voydeya (PNH) coverage limited to adult PNH patients when ALL are met:
Initial and reauthorization one year; reauth requires improved EVH symptoms and hematologic/transfusion benefit vs baseline.
Reauthorization one year.
Vowst (recurrent C. difficile infection)
Vowst (recurrent C. difficile infection) — single‑course coverage when ALL are met:
Limited to one treatment course; coverage duration one year.
Vyndamax (ATTR-CM)
Vyndamax (tafamidis) — initial coverage when ALL of the following are met:
Will not be approved for primary (light‑chain) amyloidosis; initial coverage one year; reauthorization requires documented clinical response vs baseline.
Vigabatrin/vigadrone (refractory seizures)
Vigabatrin/vigadrone coverage when ALL of the following are met:
Prerequisite therapy required; prescriber documentation required.
Ustekinumab (psoriasis and other indications)
Ustekinumab coverage when ALL of the following are met:
Coverage duration two years.
Vyndamax (ATTR-CM) — Initial Therapy
Vyndamax — Initial Therapy (concise restatement):
Not approved for primary (light‑chain) amyloidosis; initial coverage one year.
Vyndamax — Reauthorization
Vyndamax — Reauthorization when ALL of the following are met:
Reauthorization coverage duration one year.
Documentation, Prescriber, and Prior Authorization Actions
Aimovig: document ≥4 migraine days/month; no concurrent CGRP therapy
Initial Aimovig requests must document at least four migraine days per month and must not be used with another CGRP antagonist; reauthorization requires documentation of a decrease in migraine days per month. Initial approval is 1 year; reauthorization 2 years.
Amvuttra: submit mutation, PND, and indication-specific confirmation
For Amvuttra initial requests provide diagnostic confirmation: TTR mutation, baseline PND ≤ IIIb and clinical signs for hATTR‑PN; for ATTR‑CM document prior failure/intolerance/contraindication to tafamidis, NYHA class I–III, ECHO/CMR showing cardiac involvement, and confirmatory biopsy, genetic testing, or radionuclide imaging (Grade 2–3 uptake if radionuclide used). Initial and reauthorization coverage durations are one year; reauth requires demonstration of clinical response versus baseline.
Arikayce: sputum culture + specialist prescriber required
Arikayce initial requests must include a sputum culture confirming MAC lung disease, documentation of failure to obtain negative cultures after ≥6 months of an appropriate multidrug regimen, and the drug must be prescribed by or in consultation with an infectious disease specialist or pulmonologist. Initial approval is 6 months; reauthorization 12 months and requires a negative sputum culture within the last 30 days and clinical response documentation.
ACTHAR: provide prior-therapy documentation and limit to FDA dosing
ACTHAR requests must include documentation of prior therapies and responses; dosing and quantity are limited to FDA‑supported dosing. Initial coverage duration is 6 weeks; reauthorization requires demonstrated clinical benefit. Note exclusions for acute gouty arthritis, severe psoriasis, and atopic dermatitis.
BRAFTOVI: document BRAF V600 mutation
BRAFTOVI coverage requires submitted documentation of BRAF V600 mutation status prior to approval.
BRUKINSA: provide rationale if substituting for Calquence/Imbruvica
When requesting BRUKINSA for certain hematologic malignancies, the prescriber must provide rationale explaining why alternative agents (Calquence or Imbruvica) cannot be used in place of BRUKINSA.
Colistimethate: ID specialist plus culture/susceptibility required; no nebulization
Prescribe colistimethate IV or IM only and ensure an infectious disease specialist prescribes or is consulted; submit culture and susceptibility data or local epidemiology demonstrating the organism is susceptible. Nebulized/inhalation administration is not covered.
CORTROPHIN: meet FDA duration and submit indication‑specific prior trials
CORTROPHIN initial requests must follow FDA labeling (or max 3 months if unspecified) and include indication‑specific prerequisite trials (e.g., parenteral plus oral glucocorticoid for MS exacerbations); infantile spasms are exempt. Reauthorization requires demonstrated clinical benefit and quantity limited to FDA‑supported dosing.
Cosentyx: no concomitant biologics/JAKi; document indication‑specific prior trials
Cosentyx must not be used in combination with other biologics, Otezla, or JAK inhibitors. Providers must document prior therapy trials specific to the indication (e.g., NSAID for ankylosing spondylitis; traditional immunomodulator for psoriasis) and be a specialist or consult one.
Dalfampridine ER: exclude seizure history, CrCl >50 mL/min, baseline T25FW
Dalfampridine ER requests must confirm no history of seizure, creatinine clearance >50 mL/min, and provide a baseline timed 25‑foot walk demonstrating ambulatory status; reauthorization requires stability or improvement in walking speed. Initial and reauthorization coverage are 1 year.
Duloxetine alternative: document inability to use duloxetine + trial/failure of another generic
For duloxetine alternatives (e.g., Drizalma), submit documentation that the patient is unable to use duloxetine and has trialed and failed one other generic antidepressant.
Ebglyss: failed Rinvoq and Dupixent, specialist prescriber, maintenance dosing limits
Ebglyss initial coverage for atopic dermatitis requires documentation of moderate‑to‑severe disease, trial and failure of Rinvoq and Dupixent, and specialist prescriber involvement; initial dosing limited to 4 doses first month then 2 doses monthly, and reauthorization requires documented positive clinical response versus baseline.
Dupixent: provide diagnosis confirmation and prior‑therapy documentation
Submit indication‑specific documentation for Dupixent (diagnosis confirmation and required prior therapy trials). For chronic urticaria initial requests, document urticaria >6 weeks and trial/failure of one H1 antihistamine; reauthorization requires clinical benefit versus baseline.
Eltrombopag: platelet thresholds plus prior therapy trials and no concurrent TPO‑R agents
Eltrombopag prior authorization requires current platelet count meeting thresholds (<30,000/mcL or <50,000/mcL with bleeding/risk), documentation of inadequate response or intolerance to steroids/IVIG and to rituximab or splenectomy, and it must not be combined with other maintenance thrombopoietic agents; reauth requires platelet <400 x10^9/L and evidence of response.
Emgality: ≥4 migraine days/month (migraine) or verapamil trial (cluster); no concurrent CGRP therapy
Emgality for migraine prevention requires at least four migraine days per month; for cluster headache, document trial of verapamil with intolerance or failure. Emgality must not be used with another CGRP antagonist. Reauthorization requires documentation of decreased frequency/intensity.
Enbrel: document required prior non‑biologic trials; no concomitant biologics/JAKi
Enbrel prior authorization requires documentation of prior therapies and trial/failure of specified non‑biologic agents per indication (e.g., methotrexate for RA; NSAID for ankylosing spondylitis). Enbrel must not be used with other biologics, Otezla, or JAK inhibitors; prescriber should be a specialist or consult one.
Fasenra: submit eosinophil counts and failed ICS/LABA; specialist involvement required
Fasenra requests must include blood eosinophil counts (≥150 cells/µL within 6 weeks or ≥300 cells/µL in prior 12 months), documentation of trial and failure of an ICS/LABA in the past 6 months, and specialist involvement; reauthorization requires documentation of clinical benefit.
Many specialty drugs: prior authorization per product‑specific criteria
The listed specialty products require prior authorization per their product‑specific criteria; providers must supply the specified documentation, prescriber specialty (when required), and meet the stated coverage durations.
Kalydeco: genetic test confirming ivacaftor‑responsive CFTR mutation required
Kalydeco coverage requires laboratory confirmation of an ivacaftor‑responsive CFTR mutation prior to approval.
Krazati: submit records showing NCCN‑aligned use
Krazati prior authorization requires medical records demonstrating use follows current NCCN recommendations; coverage duration is two years.
Levetiracetam ODT/soluble: document inability to use generic tablet + trial/failure
Levetiracetam ODT/soluble requests must include documentation of inability to use generic levetiracetam tablet and trial/failure with one other generic anticonvulsant; absence of this documentation may result in denial.
Livtencity: baseline CMV DNA and prior antiviral trial/failure required; no concomitant CMV antivirals
Livtencity prior authorization requires baseline CMV DNA confirming diagnosis, documentation of trial and failure with ganciclovir/valganciclovir/cidofovir or foscarnet, and it must not be used concomitantly with other CMV antivirals; reauthorization requires evidence of response (e.g., CMV DNA level).
Nexletol/Nexlizet: recent LDL‑C and statin/ezetimibe step documentation; no PCSK9/Juxtapid
Nexletol and Nexlizet require submission of the most recent LDL‑C and documentation of prior statin/ezetimibe therapy and response: either high‑intensity statin plus ezetimibe ≥4 weeks with LDL‑C ≥70 mg/dL, or ezetimibe ≥4 weeks with statin intolerance (≥2 statin trials with symptoms). Do not use concomitantly with PCSK9 inhibitors or Juxtapid.
Orgovyx: document trial/failure with Firmagon (degarelix)
Orgovyx prior authorization requires documentation of trial and failure with Firmagon (degarelix) before coverage; prerequisite therapy must be documented.
Prior authorization required for listed specialty drugs
Prior authorization is required for many listed specialty drugs; providers must submit indication‑specific documentation, prior therapy trials, prescriber specialty evidence (when required), and meet product durations (commonly two years unless noted).
Radicava: baseline ALS criteria (%FVC, ALSFRS‑R) and reauth evidence of slowed progression
Radicava prior authorization requires ALS diagnosis per revised El Escorial/Arlie House criteria (definite or probable), diagnosis ≤2 years, baseline ALSFRS‑R item scores ≥2 (total ≥24), %FVC ≥80%, and dosing within specified volume limits; reauthorization requires documentation that Radicava is slowing progression.
Per‑product prior authorization: follow each product's documented requirements
All products in the list require prior authorization per their specific entries; providers must follow the product‑level criteria for documentation, prescriber specialty, and coverage duration as specified.
Tofacitinib: prior auth and indication‑specific prior therapy documentation required
Tofacitinib entries require prior authorization and documentation of prerequisite therapies per indication (e.g., RA: trial and failure of one traditional non‑biologic immunomodulator; AS: trial and failure of one NSAID; JIA: specified prerequisites). Providers should document specialist involvement.
Vowst: document recurrent CDI after antibiotic failures; one 12‑capsule course only
Vowst prior authorization requires documentation of at least two recurrent CDI episodes (three or more total) after failure of appropriate antibiotics; limited to one treatment course (12 capsules over 3 days); initial coverage duration one year.
Tolvaptan: submit indication‑specific labs and limit dosing to FDA‑labeled maxima
Tolvaptan prior authorization requires indication‑specific documentation: for hyponatremia confirm hypervolemic/euvolemic hyponatremia with serum sodium <125 mEq/L or symptomatic nonresponse to fluid restriction (dosing up to 60 mg/day); for ADPKD document risk of rapid progression (dosing up to 120 mg/day). Coverage durations vary by indication.
Voydeya: PNH confirmation, active complement inhibitor therapy, and EVH criteria required
Voydeya prior authorization requires PNH diagnosis by flow cytometry, active treatment with ravulizumab or eculizumab, and evidence of symptomatic extravascular hemolysis (fatigue or dyspnea plus Hgb <9.5 g/dL or ARC >120 x10^9/L). Initial and reauthorization coverage are one year.
Tryngolza: FCS confirmation (TG>880 mg/dL) and prior Redemplo trial required
Tryngolza prior authorization requires confirmation of familial chylomicronemia syndrome (fasting triglycerides >880 mg/dL and exclusion of secondary causes with genetic testing or clinical diagnosis) and documentation of prior Redemplo trial with inadequate response or intolerance; initial coverage one year, reauthorization two years with evidence of benefit.
Vyndamax: multi‑modality ATTR‑CM confirmation; exclude primary (light‑chain) amyloidosis
Vyndamax (tafamidis) initial and reauthorization require NYHA class I–III, ECHO or CMR demonstrating cardiac involvement, and diagnosis confirmation by biopsy, genetic testing, or radionuclide imaging (Grade 2–3 uptake if radionuclide used); Vyndamax will not be approved for primary (light‑chain) amyloidosis. Reauthorization requires documentation of positive clinical response versus baseline.
Xolair: indication‑specific documentation (IgE, allergen testing, weight) for PA
Xolair prior authorization is required for asthma, food allergy, chronic urticaria, and nasal polyps; submit indication‑specific documentation (e.g., baseline IgE ≥30 IU/mL and positive perennial aeroallergen test for asthma, current weight, trial/failure of an ICS/LABA within 6 months) and evidence of benefit on reauthorization.
Xifaxan: follow indication limits (IBS‑D ≤3 courses; TD ≤3 days); SIBO not covered
Xifaxan prior authorization requires adherence to indication‑specific limits and prerequisites: IBS‑D limited to no more than three 14‑day courses; traveler’s diarrhea limited to three days with prior azithromycin trial/failure; SIBO coverage is not provided.
Biologics: do not combine with other biologics, Otezla, or JAK inhibitors
Use of other biologic drugs, Otezla, or JAK inhibitors in combination with specified biologics will trigger exclusion/denial; providers must not request combination biologic/JAKi therapy for these products.
Depression agents: SSRI/SNRI + one atypical antidepressant trial required
For certain depression agents (e.g., AUVELITY) try and fail an SSRI or SNRI and one atypical antidepressant (e.g., bupropion or mirtazapine) before approval; document trials and outcomes.
Asenapine/Secuado: two generic antipsychotic trials (≥28 days each) required
Asenapine (Secuado) requires documented trial and failure with two specified generic antipsychotics for at least 28 days each prior to coverage.
Brivaracetam: prior levetiracetam + another generic anticonvulsant trial required
Brivaracetam (oral) requires documentation of trial and failure with generic levetiracetam plus at least one other generic anticonvulsant (failure defined as inadequate seizure control) before approval.
Calcipotriene‑betamethasone (scalp): trial of generic steroid + calcipotriene required
For calcipotriene‑betamethasone suspension (scalp), document trial and failure of a generic topical steroid (e.g., fluocinonide or clobetasol solution) plus generic calcipotriene solution prior to approval.
Caplyta: document required prior antipsychotic trials per indication
Caplyta requests must include documentation of prior therapies and required indication‑specific antipsychotic trial/failure patterns (e.g., two generic atypical antipsychotics for schizophrenia).
Cosentyx: indication‑specific non‑biologic trials required before biologic
Cosentyx requires prior non‑biologic therapy trials per indication (e.g., NSAID for ankylosing spondylitis; traditional immunomodulator for psoriasis) before biologic initiation; providers must document trials and responses.
Ebglyss: must have failed Rinvoq and Dupixent
Ebglyss initial therapy requires prior failure of Rinvoq and Dupixent for atopic dermatitis before approval.
Enbrel: trial/failure of traditional non‑biologic therapy (e.g., methotrexate) required
Enbrel (and Enbrel Mini) requires trial and failure of one traditional non‑biologic immunomodulator (e.g., methotrexate) for RA and psoriasis prior to approval; for ankylosing spondylitis a trial and failure of one NSAID is required.
Endari: trial and failure of hydroxyurea required
Endari prior authorization requires documentation that the patient tried and failed hydroxyurea (continued pain episodes despite appropriate dosing or intolerance) before approval.
Biologics/JAKi: document trial/failure of conventional therapies per indication
Many biologic/JAKi indications require trial and failure of one or more specified conventional therapies (examples include methotrexate, NSAIDs, cyclosporine); providers must document prior trials unless exceptions apply.
Nexletol/Nexlizet: statin+ezetimibe or ezetimibe with statin‑intolerance evidence required
Nexletol/Nexlizet step requirement: patient must have tried a high‑intensity statin (or maximally‑tolerated statin) plus ezetimibe for ≥4 weeks with LDL‑C ≥70 mg/dL OR ezetimibe ≥4 weeks with statin intolerance (trial of ≥2 statins with symptoms); submit recent LDL‑C and prior therapy documentation.
Antidepressant step: two generic antidepressant trials required
For certain antidepressant approvals (e.g., Marplan) providers must document trial and failure with two generic antidepressants (SNRIs, SSRIs, mirtazapine, or bupropion).
Livtencity: prior CMV antiviral trial + baseline CMV DNA required
Livtencity requires trial and failure with ganciclovir, valganciclovir, cidofovir, or foscarnet prior to approval; baseline CMV DNA must be submitted and reauthorization requires documented response.
Psoriasis: try and fail one traditional non‑biologic immunomodulator before biologic
For moderate to severe psoriasis agents (examples Yesintek, ustekinumab), providers must document trial and failure of one traditional non‑biologic immunomodulator (e.g., methotrexate, cyclosporine, acitretin) before biologic/JAKi coverage.
RA/axial spondyloarthritis: document required prior non‑biologic trials (e.g., methotrexate, NSAID)
Rheumatoid arthritis and axial spondyloarthritis prior authorization/step requirements: providers must document trial and failure of one traditional non‑biologic immunomodulator (e.g., methotrexate) for RA and one NSAID for axial spondyloarthritis before coverage of specified agents.
Prior therapy documentation: submit records showing trial/failure or intolerance
For many products, providers must submit supporting documentation of prior drug trials and responses demonstrating inadequate response, intolerance, or FDA‑labeled contraindication; missing prior‑therapy documentation can trigger denial.
Amvuttra: submit mutation test, baseline PND, and confirmatory diagnostics
For Amvuttra provide mutation testing, baseline PND score, clinical signs, and confirmatory diagnostics (biopsy, genetic testing, or radionuclide imaging); for ATTR‑CM include NYHA class and imaging showing cardiac involvement.
Arikayce: provide initial and reauth sputum culture documentation
Arikayce initial review requires submission of a sputum culture confirming MAC and documentation of failure to obtain negative cultures after ≥6 months of a multidrug background regimen; reauthorization requires a negative sputum culture within 30 days and clinical response documentation.
Nexletol/Nexlizet: submit recent LDL‑C and prior therapy records or risk denial
Nexletol/Nexlizet documentation must include the most recent LDL‑C and records of prior statin/ezetimibe therapy and response; lack of recent LDL‑C or prior‑therapy documentation may result in denial.
Redemplo: fasting TG >880 mg/dL + genetic or clinical confirmation required
Redemplo initial requests must include fasting triglyceride >880 mg/dL (10 mmol/L) and genetic testing or clinical diagnosis per guidance; dosing must align with FDA labeling and prescriber should be a specialist.
Vowst: document ≥2 recurrences after antibiotics; one 12‑capsule course only
For Vowst, submit documentation of at least two recurrent CDI episodes (three or more total) after failure of appropriate antibiotics; limited to one treatment course (12 capsules over 3 days).
Vyndamax: submit NYHA, imaging, and diagnostic confirmation; exclude primary amyloidosis
Vyndamax initial documentation requires NYHA class I–III, ECHO or CMR showing cardiac involvement, and diagnosis confirmation by biopsy, genetic testing, or radionuclide imaging (Grade 2–3 uptake if radionuclide used); Vyndamax will not be approved for primary (light‑chain) amyloidosis.
Xifaxan: follow course limits (IBS‑D ≤3×14 days; TD ≤3 days); SIBO not covered
Xifaxan for IBS‑D is limited to up to three 14‑day courses; traveler’s diarrhea limited to three days (requires azithromycin trial/failure); coverage for SIBO is not provided.
Combination biologic/JAKi exclusion: do not request concurrent biologic/JAKi therapy
Biologic products must not be used in combination with other biologic drugs, Otezla, or JAK inhibitors for the same condition; requests that propose such combinations will be denied.
CGRP agents: no concurrent CGRP antagonist therapy; meet indication thresholds
CGRP antagonists (Aimovig, Emgality) must not be combined with another CGRP antagonist; providers must document single‑agent use and meet migraine frequency or other indication‑specific prerequisites.
Colistimethate: inhalation not supported — IV/IM only with culture/susceptibility
Colistimethate requests for inhalation/nebulization will not be supported; IV or IM administration only and must include culture/susceptibility or local epidemiology showing likely susceptibility to justify use.
PAH agents: right heart cath confirmation required or risk denial
When requesting PAH agents providers must submit documentation confirming pulmonary arterial hypertension (WHO Group 1) by right heart catheterization; absence of right heart catheterization documentation may lead to denial.
Oxervate: lifetime limit 8 weeks and ophthalmologist prescriber required
Oxervate requests exceeding an 8‑week lifetime treatment will not be covered; initial approval requires documentation of Stage 2 or 3 neurotrophic keratitis and ophthalmologist prescriber or consultation.
Sodium oxybate: MSLT/PSG required; no sedative hypnotics or SSADH deficiency
For sodium oxybate, do not prescribe with concurrent sedative hypnotics or in patients with succinic semialdehyde dehydrogenase deficiency; provide MSLT and polysomnography documentation confirming narcolepsy.
Vyndamax denial risk: exclude primary (light‑chain) amyloidosis
Vyndamax will not be approved if the patient has primary (light‑chain) amyloidosis; providers must confirm ATTR‑CM diagnostic pathway and exclude primary amyloidosis.
Index: follow referenced product entry for exact prior‑auth rules
Index entries point to the main policy locations for detailed prior authorization rules; use the referenced product entry in the policy for exact documentation and prior‑therapy requirements.
HAE: submit C4 and C1‑INH labs; ACEI co‑use not covered for icatibant/SAJAZIR
HAE treatments require submission of C4, C1‑INH protein, and C1‑INH function lab results confirming diagnosis; concurrent ACE inhibitor use is not covered for icatibant/SAJAZIR.
IVIG: submit weight, dose rationale, and records; adjust dose if BMI≥30 or weight ≥20% over ideal
IVIG requests must include current weight and requested dose, documentation that dosing follows FDA labeling or accepted practice, and weight‑adjusted dosing if BMI ≥30 or actual weight ≥20% above ideal; provide supporting medical records for diagnosis and dose.
Nulibry: genetic confirmation of MoCD Type A required
Nulibry requests require confirmed genetic testing demonstrating MoCD Type A; lack of genetic confirmation may result in denial and reauthorization requires evidence of neurologic/functional benefit.
PAH/Winrevair: specialist prescriber + right heart cath and prior therapy documentation
For PAH, specialty agents and Winrevair must be prescribed by or in consultation with a specialist and include right heart catheterization documentation and prior therapy history (e.g., failure of dual PDE inhibitor + endothelin receptor antagonist where required).
Drug/Product Index and Clinical Thresholds
| EBGLYSS | EBGLYSS |
| eltrombopag Olamine oral packet 12.5 mg, 25 mg | eltrombopag olamine oral packet 12.5 mg, 25 mg |
| eltrombopag Olamine oral tablet 12.5 mg, 25 mg, 50 mg, 75 mg | eltrombopag olamine oral tablet 12.5 mg, 25 mg, 50 mg, 75 mg |
| OPSYNVI | OPSYNVI |
| ORENITRAM | ORENITRAM |
| ORGOVYX | ORGOVYX |
| ORKAMBI ORAL PACKET | ORKAMBI ORAL PACKET |
| ORKAMBI ORAL TABLET | ORKAMBI ORAL TABLET |
| XALKORI ORAL CAPSULE | XALKORI ORAL CAPSULE |
| VYNDAMAX | VYNDAMAX |
| No codes listed |
| No codes listed |
| ALUNBRIG ORAL TABLET 180 MG | ALUNBRIG ORAL TABLET 180 MG |
| BETASERON SUBCUTANEOUS KIT | BETASERON SUBCUTANEOUS KIT |
| XALKORI ORAL CAPSULE | XALKORI ORAL CAPSULE |
| XELJANZ ORAL TABLET | XELJANZ ORAL TABLET |
Initial Therapy: Medication-Specific Prerequisites
Reauthorization and Continuation Requirements
Step Therapy Requirements and Tables
| Step | Required prior trials / condition |
|---|---|
| AUVELITY (depression) | |
| Must document trial and inadequate response after ≥4 weeks each of: one SSRI or SNRI AND one atypical antidepressant (e.g., bupropion, mirtazapine) |
| Step | Required prior trials / condition |
|---|---|
| Asenapine (Secuado / transdermal) | |
| Documentation of trial and inadequate response after at least 28 days each with two of the following generics: aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, or lurasidone |
| Step | Required prior trials / condition |
|---|---|
| Brivaracetam (oral) | |
| Must document trial and inadequate seizure control with generic levetiracetam AND at least one other generic anticonvulsant |
| Step | Required prior trials / condition |
|---|---|
| Cosentyx (secukinumab) | |
| Indication-specific: must document trial and inadequate response with required non-biologic therapies (e.g., NSAID for ankylosing spondylitis; one traditional non-biologic immunomodulator such as methotrexate, cyclosporine, or acitretin for psoriasis) before biologic approval |
| Step | Required prior trials / condition |
|---|---|
| Ebglyss (atopic dermatitis) | |
| Initial coverage requires documentation of trial and failure (inadequate response) with Rinvoq (upadacitinib) AND Dupixent (dupilumab) prior to approval |
| Step | Required prior trials / condition |
|---|---|
| Enbrel (etanercept; includes Enbrel Mini) | |
| For rheumatologic indications must document trial and failure (intolerance or inadequate response) of one traditional non-biologic immunomodulator (e.g., methotrexate); for ankylosing spondylitis must trial and fail one NSAID |
| Step | Required prior trials / condition |
|---|---|
| Endari (L-glutamine for sickle cell disease) | |
| Must document trial and failure or intolerance to hydroxyurea (continued pain episodes despite appropriate dosing or intolerance) before approval |
| Step | Required prior trials / condition |
|---|---|
| Conventional therapy try/fail (general immunologic biologics) | |
| For many biologic/JAK/ immunologic indications (RA, psoriasis, ankylosing spondylitis, HS, uveitis, JIA, etc.) must document trial and inadequate response or intolerance to one or more specified conventional non‑biologic therapies (examples: methotrexate, cyclosporine, acitretin, NSAID) prior to biologic or JAK initiation |
| Step | Required prior trials / condition |
|---|---|
| Imatinib (non-tablet formulations / imkeldi) step requirement | |
| Coverage of non-tablet imatinib formulation requires documentation patient is unable to swallow or appropriately use the generic imatinib tablet formulation |
| Step | Required prior trials / condition |
|---|---|
| Nexletol / Nexlizet (lipid-lowering agents) | |
| Patient must have tried a high-intensity statin (or maximally tolerated statin if high-intensity not tolerated) plus ezetimibe ≥4 weeks with LDL‑C ≥70 mg/dL OR tried ezetimibe ≥4 weeks and be statin‑intolerant (trial of ≥2 statins with symptoms); submit recent LDL‑C and prior therapy documentation |
| Step | Required prior trials / condition |
|---|---|
| Marplan (antidepressant) step requirement | |
| Documentation of trial and inadequate improvement with two generic antidepressants (from SNRIs, SSRIs, mirtazapine, or bupropion) required prior to coverage |
| Step | Required prior trials / condition |
|---|---|
| Psoriasis — step therapy (biologic/JAKi) | |
| For moderate‑to‑severe psoriasis must document trial and failure of one traditional non‑biologic immunomodulator (e.g., methotrexate, cyclosporine, acitretin) prior to biologic/JAKi; step not required for mild disease |
| Step | Required prior trials / condition |
|---|---|
| Rheumatoid arthritis — step therapy | |
| Must document trial and failure of one traditional non‑biologic immunomodulator (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) before coverage of specified agents (biologic or JAK) |
| Step | Required prior trials / condition |
|---|---|
| Perampanel (oral) | |
| Must have documentation of trial and inadequate seizure control with at least two generic anticonvulsants prior to approval |
| Step | Required prior trials / condition |
|---|---|
| Multi‑indication RA / AS / JIA step rules (e.g., tofacitinib / Xeljanz family) | |
| RA: trial and failure of one traditional non‑biologic immunomodulator (e.g., methotrexate). AS: trial and failure of one NSAID. JIA: trial and failure of one other drug (e.g., methotrexate/sulfasalazine) or concurrent start with methotrexate/sulfasalazine/leflunomide or evidence of aggressive disease. |
| Step | Required prior trials / condition |
|---|---|
| Secuado (asenapine transdermal) antipsychotic trial requirement | |
| Requires documentation of trial and inadequate response with two listed generic antipsychotics (aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, or lurasidone) used at least 28 days each prior to approval |
| Step | Required prior trials / condition |
|---|---|
| Tofacitinib (and similar JAK inhibitors) — multi‑indication step therapy | |
| Prior to JAK initiation: must document trial and failure of specified conventional therapies per indication (RA: methotrexate; AS: NSAID; JIA: other drug or concurrent DMARD) and not used in combination with other biologics, Otezla, or other JAK inhibitors |
| Step | Required prior trials / condition |
|---|---|
| Ustekinumab (psoriasis and other indications) | |
| Must document trial and failure of one traditional non‑biologic immunomodulator (e.g., methotrexate, cyclosporine, acitretin) prior to ustekinumab; must not be used with other biologics, Otezla, or JAK inhibitors |
| Step | Required prior trials / condition |
|---|---|
| Vraylar (cariprazine) antipsychotic trials | |
| Requires trial and inadequate response with two generic antipsychotics chosen from aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, or lurasidone (each used ≥28 days) prior to approval |
| Step | Required prior trials / condition |
|---|---|
| Required prior trials before biologic / JAK initiation (general) | |
| Documentation of trial and inadequate response to specified conventional therapies per indication (examples: methotrexate for RA; NSAID for ankylosing spondylitis) is required before initiating many biologic or JAK agents; prescriber should be specialist or have consulted specialist |
| Step | Required prior trials / condition |
|---|---|
| Required prior trials (misc) — lipid and antidepressant examples | |
| Lipid agents (Nexletol/Nexlizet): high-intensity statin + ezetimibe ≥4 weeks or ezetimibe ≥4 weeks with documented statin intolerance; Antidepressants (Marplan/AUVELITY contexts): trial and failure with two generics prior to coverage as specified |
Quantity Limits and Dosing Restrictions
Prescriber and Site-of-Care Requirements
Arikayce: specialist prescriber or consult required
Arikayce must be prescribed by or in consultation with an infectious disease specialist or pulmonologist (site‑of‑care requirement).
Colistimethate: IV/IM only, ID specialist consult and infection documentation required
Colistimethate is covered only for IV or IM administration; nebulization/inhalation is not covered and an infectious disease specialist must prescribe or be consulted; provide culture/susceptibility or local epidemiology to support use.
Part B vs Part D: submit diagnosis and administration info to determine benefit
Providers must review whether administration qualifies as a Part B or Part D benefit by submitting diagnosis and administration information where indicated.
Livtencity: no concomitant CMV antivirals; baseline CMV DNA and prior antiviral trial required
Livtencity must not be used concomitantly with other CMV antivirals (e.g., ganciclovir, valganciclovir); baseline CMV DNA must be provided and prior antiviral trial/failure documented.
Oxervate: ophthalmologist prescriber/consult and stage documentation required
Oxervate must be prescribed by or in consultation with an ophthalmologist; documentation of Stage 2 or 3 neurotrophic keratitis is required for coverage.
Pirfenidone: pulmonologist prescriber/consult and HRCT or biopsy required
Pirfenidone requests must be prescribed by or in consultation with a pulmonologist and include HRCT confirming diagnosis (surgical lung biopsy or UIP pattern where IPF is suspected); provide reauthorization evidence of improvement.
Redemplo: specialist prescriber and FCS confirmation required
Redemplo must be prescribed by or in conjunction with a specialist (specialty clinic) and include FCS confirmation (fasting TG >880 mg/dL and genetic testing or clinical diagnosis).
General site‑of‑care: office acceptable unless specialist prescriber required
When no specific site‑of‑care restriction is listed, office administration is acceptable unless a specialist prescriber is required; always verify product entry for exceptions.
Verquvo: cardiologist prescriber/consult and EF <45% documentation required
Verquvo must be prescribed by or in consultation with a cardiologist; providers must submit EF <45% within 12 months and documentation of prior guideline‑directed therapies and symptomatic worsening.
Tryngolza: specialist prescriber/consult and FCS + prior Redemplo documentation required
Tryngolza must be prescribed by or in consultation with a cardiologist, endocrinologist, or other specialist; initial requests must include FCS confirmation and prior Redemplo trial documentation.
Winrevair: specialist prescriber + right heart cath and prior therapy evidence required
Winrevair for PAH must be prescribed by or in consultation with a specialist for pulmonary arterial hypertension and include right heart catheterization confirmation and prior dual‑therapy failure where applicable.
Xolair: submit diagnosis/administration details to determine Part B vs Part D benefit
Xolair administration coverage may be Part B or Part D depending on diagnosis and administration details; submit diagnosis and administration information to determine benefit.
Policy Purpose and Scope
This document sets Priority Health’s Medicare prior authorization requirements for pharmacy and specialty drugs. It is intended to guide clinical and billing staff on the coverage conditions that must be met before authorization is issued, including required diagnostic confirmation, specified prior therapy trials or failures, prescriber specialty or consultation, dosing/quantity limits aligned with FDA labeling, and reauthorization evidence of clinical benefit.
Coverage rules are drug- and indication-specific and are organized alphabetically by product. Typical controls include step-therapy requirements (trial and failure of one or more conventional therapies), combination exclusions (e.g., no concomitant use of other biologics, Otezla, or JAK inhibitors where stated), laboratory or genetic test confirmation when required, and site-of-care or prescriber specialist requirements for selected agents.
Authorization durations and utilization limits vary by product; common patterns are initial approvals of 1 year with reauthorizations of 2 years for many specialty drugs, shorter initial courses when clinically appropriate (examples: 6 months for Arikayce; Oxervate limited to 8 weeks lifetime), and quantity limits that follow FDA labeling or product-specific caps. Supporting medical records must document prior therapies, responses, and the specific clinical data called for in each drug’s criteria.
Clinical Definitions and Diagnostic Criteria
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.