CurrentcareoregonPolicy N/A

Pharmacy & Specialty Drugs — Coverage Criteria (Abilify Mycite and listed specialty drug prior authorization criteria)

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This policy lists prior authorization criteria and coverage requirements for Abilify Mycite (Maintenance and Starter Kits) and multiple specialty pharmacy products; it specifies required documentation, prerequisite therapy, prescriber restrictions, initial and renewal coverage durations, and exclusions for CareOregon members.

Policy Summary

Payercareoregon

PolicyCoverage criteria — Pharmacy & Specialty Drugs (Abilify Mycite and assorted specialty drugs)

Policy CodePolicy N/A

Change TypeAdministrative review — no material changes

Effective DateJul 26, 2026

Last ReviewJul 26, 2026

Next Review DateJul 26, 2026

Key ActionFor members newly starting Abilify Mycite, document medical necessity of tracking compliance with the product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~150+Products in extract (partial)

LifetimeAbilify Mycite coverage duration

6 monthsCommon initial duration

VariesPrerequisite therapy noted

40+Entries shown

Coverage Criteria — Product-specific Authorization Rules

Abilify Mycite — Initial Authorization

Covered when the following is documented for members newly starting the drug

Abilify Mycite initial requirement: Documentation of the medical necessity of tracking compliance with the Abilify Mycite product

Coverage Duration: Lifetime

Other specialty drug PA summaries

Coverage for listed specialty drugs is tied to indication-specific documentation and prerequisite therapy where specified

Acthar / Corticotropin: Medical record documentation of an FDA‑approved indication (examples: infantile spasms, acute MS exacerbation, specified rheumatic, dermatologic, ophthalmic, respiratory, or edematous conditions); contraindications apply (see exclusions)

Coverage/duration vary by indication; see product-specific criteria

Actimmune: Prescribed for an FDA‑approved or medically accepted indication (e.g., supported compendia for T‑cell lymphoma); medical record documentation required

Coverage Duration: Lifetime

Adalimumab products: Prescribed for an FDA‑approved or medically accepted indication; indication‑specific prerequisite and renewal requirements apply (see individual disease entries)

Prescriber specialty and prior therapy requirements vary by indication

Adbry Initial Therapy

Adbry (atopic dermatitis) covered when ALL of the following are met:

Adbry initial criteria: Medical record documentation of body surface area involvement of at least 10% at baselineBSA >= 10%

Prescriber: dermatologist, allergist, or specialist; initial coverage 6 months; renewal requires documentation of positive treatment response

Prerequisite topical therapy: Failure of or contraindication to one very high‑potency topical steroid (e.g., augmented betamethasone, clobetasol) and tacrolimus ointment, or documentation that topical prescription therapies are not appropriate

Required prior therapy per policy

Agamree Initial Therapy

Agamree covered when ALL of the following are met:

Agamree initial criteria: Genetic testing confirming a diagnosis of Duchenne muscular dystrophygenetic test positive

Prescriber: neurologist or DMD/neuromuscular specialist; initial coverage 12 months; requires documentation of failure of prednisone and deflazacort (prerequisite Part D drug)

Required renewal documentation: Medical record documentation of positive treatment response (e.g., improved pulmonary function, muscle strength, or functional measures)

Renewal: 12 months

Aimovig Initial Therapy

Aimovig covered when ALL of the following are met:

Migraine frequency: Episodic migraine: 4–14 headache days per month OR Chronic migraine: >=15 headache days/month with >=8 migraine days for 3 monthsepisodic 4-14; chronic >=15 with >=8 migraine days

Initial coverage 6 months; renewal lifetime; not to be used concurrently with another CGRP preventive agent

Documentation of response at renewal: Medical record documentation of decreased migraine days, reduced abortive medication use, or other clinical benefit

Renewal requires documented benefit

Aldurazyme Initial Therapy

Aldurazyme covered when ALL of the following are met:

Diagnostic confirmation: Medical record documentation of diagnostic confirmation by urinary glycosaminoglycans (GAGs), deficient α‑L‑iduronidase enzyme activity, or genetic testingdiagnostic confirmation present

Initial coverage 6 months; renewal lifetime; dosing consistent with label (0.58 mg/kg IV weekly)

Treatment goals: Provider‑defined, objective, measurable treatment goals documented in the record (e.g., % predicted FVC, 6‑minute walk) for baseline and renewal assessment

Renewal requires documentation of stabilization or improvement

Lotronex Initial Therapy

Lotronex (alosetron) covered when ALL of the following are met:

Symptom duration and severity: Medical record documentation of predominant severe diarrhea lasting at least 6 months with disability or restriction of daily activities>=6 months

Age >=18 years; initial trial duration 8 weeks; renewal lifetime

Prerequisite therapy: Documentation of failure of loperamide and dicyclomine prior to initiation

Coverage excluded for listed contraindications (constipation, intestinal obstruction/stricture, ischemic colitis, severe hepatic impairment, diverticulitis, Crohn's/UC, concomitant apomorphine or fluvoxamine)

Alyftrek Initial Therapy

Alyftrek covered when ALL of the following are met:

Genetic confirmation: Medical record documentation of cystic fibrosis with at least one F508del mutation or another mutation responsive to the drug confirmed by an FDA‑cleared CF mutation testmutation confirmed

Patient age >=6 years; prescriber pulmonologist; initial 6 months, renewal 12 months

Clinical response at renewal: Documentation of treatment response such as improved FEV1 or reduced pulmonary exacerbations

Renewal requires clinical benefit documentation

Ambrisentan Initial Therapy

Ambrisentan covered when ALL of the following are met:

Clinical documentation: Medical record documentation of pulmonary arterial hypertension with WHO functional class II–IVWHO class II-IV

Prescriber: pulmonologist or cardiologist; coverage duration: lifetime; pregnancy is an exclusion

Apomorphine Initial and Renewal Therapy

Apomorphine injection covered when ALL of the following are met:

Prior oral therapy failure: Documentation of failure of maximally tolerated oral levodopa/carbidopa AND failure of one additional listed agent (selegiline, ropinirole, pramipexole, entacapone) or step to Ongentys where applicableprior therapy failure

Prescriber: neurologist; initial coverage 6 months; renewal requires documentation that 'off' time has been reduced

Renewal requirement: Medical record documentation that patient's 'off' time has been reduced with apomorphine

Renewal coverage: lifetime

Aprepitant — Indications and Restrictions

Aprepitant covered when ALL of the following are met:

Indication and co‑therapy: Use consistent with FDA‑approved indications; for PONV confirm prophylactic use and not for established nausea/vomiting; for chemo prophylaxis document concurrent ondansetron, granisetron, or palonosetron use

Coverage durations: PONV 1 month; chemotherapy prophylaxis up to 12 months; exclusion: concomitant use of pimozide

Aqneursa — Initial Therapy

Aqneursa covered when ALL of the following are met:

Diagnostic confirmation: Genetic testing confirming Niemann‑Pick disease type C (NPC) and documentation of neurologic symptomsgenetic confirmation

Prescriber: geneticist or neurologist; coverage duration: lifetime

Aqvesme — Initial and Renewal

Aqvesme covered when ALL of the following are met:

Diagnostic confirmation: Confirmation of alpha or beta thalassemia by genetic testing or hemoglobin analysisdiagnostic confirmation

Age >=18 years; prescriber: hematologist; initial 6 months then renewal 12 months; for transfusion‑dependent beta thalassemia require failure or contraindication to Reblozyl

Renewal requirement: Documentation of clinical benefit such as improvement in anemia or reduction in iron overload

Renewal coverage: 12 months

Aralast NP — Initial and Renewal

Aralast NP covered when ALL of the following are met:

Diagnostic and lab criteria: Documented ZZ or Z/null AAT deficiency AND AAT serum level ≤11 micromoles/L (≈50 mg/dL) AND moderate emphysema and/or FEV1 <80%AAT <=11 micromoles/L or <=50 mg/dL; FEV1 <80%

Prescriber: pulmonologist; provider‑defined measurable treatment goals required; initial 6 months, renewal 12 months

Treatment goals: Provider documents specific measurable goals (e.g., slowing FEV1 decline) and renewal documents meeting goals

Renewal requires evidence of meeting goals

Arcalyst — Indication-Specific Criteria

Arcalyst covered when ALL of the following are met (indication-specific):

Indication meets FDA use: Indication corresponds to an FDA‑approved use (e.g., DIRA, recurrent pericarditis, CAPS) with required diagnostic confirmation

Prescriber specialty varies by indication (immunologist/geneticist for DIRA, cardiologist for recurrent pericarditis); initial 6 months, renewal 12 months; for DIRA require failure of Kineret

Renewal documentation: Medical record documentation of positive clinical response appropriate to the indication (e.g., reduced flares, symptom improvement)

Renewal: 12 months

Arikayce — Initial Therapy

Arikayce covered when ALL of the following are met:

Combination regimen and culture: Documentation that Arikayce will be used as part of a combination antibacterial regimen AND either a positive sputum culture or lack of clinical improvement

Patient ≥18 years; prescribed by specialist/pulmonologist; prior failure of at least 6 months of a multidrug regimen required

Prerequisite therapy: Documentation of prior failure of an adequate multidrug regimen (e.g., ethambutol, rifabutin, clofazimine) prior to initiation>=6 months prior regimen failure

Prerequisite Part D drug required

Aristada — New Start

Aristada covered when ALL of the following are met for new starts:

Switch from oral Abilify: Medical record documentation that the patient is currently taking oral Abilify and the prescriber intends to switch to the long‑acting injectable to improve compliance

Coverage Duration: Lifetime; prerequisite Part D drug (oral Abilify) required for new starts

Aristada Initial Therapy

Aristada (Aristada Initio) coverage conditions

Aristada initial: Member is currently taking oral Abilify AND prescriber wishes to switch to the long‑acting injectable to improve compliance

Coverage duration: Lifetime; prerequisite oral Abilify documented

Armodafinil — Initial and Renewal

Armodafinil covered when ALL of the following are met:

Armodafinil initial: Initial authorization for 6 months with documentation of indication per FDA approval

Prerequisite therapy: not required; renewal requires documentation of reduction in daytime sleepiness or improved functioning (renewal: lifetime)

Astagraf Coverage

Astagraf (tacrolimus ER) coverage conditions

Astagraf Part D transplant consideration: If covered under Part D for transplant patients, document failure of tacrolimus immediate‑release or reason immediate‑release cannot be used

Coverage duration: Lifetime; prerequisite Part D drug required where indicated

Attruby Initial Therapy

Attruby covered when ALL of the following are met:

Attruby initial: Medical record documentation confirming diagnosis of wild‑type or hereditary transthyretin amyloid cardiomyopathy (ATTR)

Prescriber: cardiologist or in consultation with cardiology; coverage duration: lifetime

Austedo Initial and Renewal

Austedo covered when ALL of the following are met:

Austedo Huntington's disease initial: For Huntington's disease: documentation of failure of or contraindication to tetrabenazine prior to initiation

Initial 6 months; renewal 12 months with documentation of clinical response; exclusions include suicidality, hepatic impairment, inadequately treated depression, and certain concomitant drugs

Austedo tardive dyskinesia initial: For tardive dyskinesia: documentation of failure of or contraindication to tetrabenazine AND Ingrezza where noted; age >=18

Initial 6 months; renewal 12 months; prescriber specialty required; prerequisite therapy required

Auvelity Initial Therapy

Auvelity covered when ALL of the following are met:

Auvelity initial: Medical record documentation of trial, intolerance to, or contraindication to bupropion AND an SSRI or SNRI (examples: sertraline, fluoxetine, escitalopram, paroxetine, venlafaxine)

Coverage duration: Lifetime; prerequisite Part D drug required

Nexletol/Nexlizet Initial Therapy

Nexletol / Nexlizet covered when ALL of the following are met:

LDL and statin failure documentation: Medical record documentation of LDL‑C >100 mg/dL without CVD OR >55 mg/dL with CVD AND failure, intolerance, or contraindication to at least one high‑intensity statin for ~12 weeks; prior failure of PCSK9 inhibitors (Repatha or Praluent) where indicatedLDL‑C >100 mg/dL or >55 mg/dL

Patient >=18 years; initial 6 months; renewal lifetime; prescriber: cardiologist/endocrinologist

Benlysta Initial and Renewal

Benlysta covered when ALL of the following are met:

Benlysta SLE initial: Medical record documentation of systemic lupus erythematosus (SLE) AND auto‑antibody positive defined as ANA ≥1:80 OR anti‑dsDNA ≥30 IU/mL AND receipt of standard therapy (NSAIDs, antimalarials, corticosteroids, or immunosuppressants)

Prescriber: rheumatologist or nephrologist; initial coverage 6 months; renewal 12 months with documentation of treatment response

Benlysta lupus nephritis initial: Documentation of active lupus nephritis AND receiving standard therapy (corticosteroids or immunosuppressants)

Initial 6 months; renewal requires stabilization of eGFR or no worsening

Exclusions: Use in severe active CNS lupus or in combination with other biologics or IV cyclophosphamide is excluded

Requests meeting exclusions may be denied

Benznidazole criteria

Benznidazole — Covered when ALL of the following are met:

Diagnostic confirmation: Evidence of Trypanosoma cruzi infection by trypomastigotes on microscopy OR detection of T. cruzi DNA by PCR OR two positive serologic tests using different techniques/antigens showing IgG to T. cruzi

Age restriction: 2 to 12 years; coverage duration: 60 days

Bexsero criteria

Bexsero — Covered when ALL of the following are met:

Age window: Patient age between 10 and 25 years

Coverage duration: 6 months

Bosentan criteria

Bosentan — Covered when ALL of the following are met:

NYHA class documentation: Medical record documentation of NYHA Class II–IV pulmonary arterial hypertensionWHO/NYHA II–IV

Exclusions: concomitant cyclosporine A or glyburide and pregnancy; prerequisite therapy may be required per policy

Botulinum toxin criteria

Botulinum toxins (Botox/Xeomin) — Covered when ALL of the following are met:

Chronic migraine initial: For Botox: at least 15 headache days per month lasting 4 hours or longer prior to initiation>=15 headache days/month

Renewal requires documented clinical response; migraine prophylaxis requires prior failure of propranolol and topiramate

Urinary incontinence initial/renewal: Documentation of prior failure of two oral anticholinergics and, for renewal, documentation of decreased incontinence episodes or frequency

Prescriber specialty and duration per indication

Chronic sialorrhea (Xeomin): Documentation of clinical benefit for renewal (improvement in drooling severity/frequency)

Coverage durations vary by product/indication

Brinsupri criteria

Brinsupri — Covered when ALL of the following are met:

NCFB confirmation: Initial confirmation of non‑cystic fibrosis bronchiectasis by CT scan

Prescriber: pulmonologist; initial 6 months, renewal 12 months

Brivaracetam/Briviact criteria

Brivaracetam / Briviact — Covered when ALL of the following are met:

Tablets formulation: Failure of levetiracetam AND failure of one additional listed antiseizure medication (carbamazepine, phenytoin, topiramate, divalproex, felbamate, tiagabine, lamotrigine, gabapentin, oxcarbazepine, lacosamide, or zonisamide)

Coverage: lifetime; prerequisite Part D drug required

Suspension formulation: Inability to swallow oral solids AND failure of levetiracetam suspension AND failure of one listed suspension/solution antiseizure agent

Suspension requires documentation of inability to swallow and prior therapy failures

Bronchitol - Initial Therapy

Covered when ALL of the following are met for Bronchitol:

Bronchitol initial coverage criteria: Confirmation of a diagnosis of cystic fibrosis; patient is 18 years of age or older; prescribed by or in consultation with a pulmonologist

Coverage duration: lifetime

Tolerance test exclusion: Failure of bronchitol tolerance test excludes coverage

Requests meeting exclusion may be denied

Cablivi - Initial Therapy

Covered when ALL of the following are met for Cablivi (initial):

aTTP diagnostic support: Medical record support of a diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) and documentation that Cablivi will be used in combination with plasma exchange

Initial coverage duration: 90 days; prescriber: hematologist

Cablivi - Renewal

Renewal coverage criteria for Cablivi:

Cablivi renewal criteria: Documented signs of persistent underlying disease such as suppressed ADAMTS13 activity or ongoing clinical need

Renewal durations vary by plasma exchange status (90 days if receiving plasma exchange; 58 days post plasma exchange)

Camzyos - Initial Therapy

Covered when ALL of the following are met for Camzyos:

Camzyos initial criteria: Medical record documentation of NYHA class II or III obstructive hypertrophic cardiomyopathy AND documentation of left ventricular ejection fraction >=55%LVEF >=55%

Initial coverage 6 months; renewal 12 months with LVEF >50%; prescriber: cardiologist

General Prior Authorization Criteria — oncology drugs (summary)

High-level coverage and authorization conditions for listed oncology drugs

Oncology general prerequisites: Drug must be prescribed for an FDA‑approved indication OR an off‑label use that is a medically accepted indication supported by AHFS, Micromedex, NCCN or other referenced sources; medical record documentation of the diagnosis is required

Prescriber must be appropriate specialist for cancer indications; initial/renewal durations vary

Prerequisite therapy note: For non‑cancer off‑label uses require authoritative compendia support; policy does not require prior use of a Part D drug for the general oncology section

See individual cancer drug criteria for specifics

Caplyta - Initial Therapy

Caplyta covered when ALL of the following are met for members newly starting the drug:

Caplyta initial: Prescribed for an FDA‑approved or medically accepted off‑label indication with required documentation; indication‑specific prerequisite therapy failures documented (e.g., schizophrenia: failure of two listed alternatives)

Coverage Duration: Lifetime; prerequisite therapy required per indication

Carglumic acid - Initial Therapy

Carglumic acid covered when ALL of the following are met:

Carglumic acid initial: For hyperammonemia type III: diagnosis confirmed by DNA testing and objective, measurable treatment goals provided; for other indications diagnostic confirmation documented

Initial coverage 3 months; renewal 12 months

Cayston - Initial Therapy

Cayston covered when ALL of the following are met:

Cayston initial: Documentation that patient has FEV1 between 25% and 90% predicted AND documented Pseudomonas aeruginosa infectionFEV1 25%–90%

Age >=7 years; prescriber pulmonologist or infectious disease; documentation of failure/resistance to tobramycin required; coverage 12 months

Cerdelga / Cerezyme - Initial and Renewal

Cerdelga and Cerezyme covered when ALL of the following are met:

Diagnostic confirmation: Medical record documentation of diagnostic confirmation by enzyme assay or genotyping with signs/symptoms severe enough to warrant therapy and objective measurable treatment goals

Cerdelga and Cerezyme initial 6 months; renewal 12 months; dosing/CYP2D6 considerations apply (Cerdelga dosing limits by metabolizer status); renewal requires documentation of stabilization/improvement

Chenodal - Initial Therapy

Chenodal covered when ALL of the following are met:

Chenodal initial: Medical record documentation that patient is not a candidate for laparoscopic cholecystectomy and failure of ursodiol documented

Coverage duration: 12 months; prerequisite therapy required

Cholbam - Initial and Renewal

Cholbam covered when ALL of the following are met:

Cholbam initial: Medical record documentation of bile acid synthesis disorder or relevant peroxisomal disorder with liver disease manifestations; prescriber hepatologist/gastroenterologist involvement documented

Initial 4 months; renewal 12 months; renewal requires documentation of liver function improvement and absence of complete biliary obstruction

Coverage criteria (summary)

Covered when ALL of the following per-indication requirements are met (summary):

General specialty biologics prerequisites: Product is prescribed for an FDA‑approved indication or a medically accepted off‑label use supported by referenced compendia; medical record documentation of diagnosis and prior therapy failures or contraindications as specified by indication

Initial typically 6 months; renewal commonly 12 months; prescriber specialty required per indication

Step therapy requirement (examples): Initial therapy generally requires failure of or contraindication to two agents from indication‑specific lists (examples provided in policy for AS, nr‑axSpA, CD, PsA, PsO, RA)

See individual disease entries for exact lists

Initial and renewal coverage criteria (per indication, partial)

Covered when the following indication-specific documentation and prerequisite therapy requirements are met:

AS/nr-axSpA/ERA initial: Documentation of diagnosis AND failure of one NSAID (e.g., meloxicam, ibuprofen, naproxen, diclofenac) prior to initiation

Initial 6 months; renewal 12 months; prescriber specialty per indication

Hidradenitis suppurativa initial: Moderate to severe disease with documentation of Hurley Stage II or III and at least 3 abscesses or inflammatory nodulesHurley II or III; >=3 abscesses/nodules

Renewal requires reduction in nodules/abscesses

Plaque psoriasis initial: Involvement of at least 3% body surface area or special site involvement AND failure of specified topical/systemic therapies per policy>=3% BSA

Prescriber: dermatologist; initial 6 months; renewal 12 months

Cysteamine - Initial and Renewal

Cysteamine products covered when ALL of the following are met

Cysteamine initial: Medical record documentation of corneal cysteine crystal deposits

Initial authorization 6 months; renewal 12 months with documentation of reduction in corneal crystal deposits

Dalfampridine - Initial and Renewal

Dalfampridine covered when ALL of the following are met

Dalfampridine initial: Medical record documentation of multiple sclerosis diagnosis AND baseline timed 25‑foot walk prior to initiation

Exclusion: history of seizure or CrCl <= 50 mL/min; initial 6 months; renewal lifetime with documented improvement

Dawnzera - Initial and Renewal

Dawnzera covered when ALL of the following are met

Dawnzera initial: Documentation confirming hereditary angioedema Type I or II by genetic testing or complement studies (Type III by genetic testing with normal complement plus clinical features/family history)

Initial: failure/intolerance/contraindication to Takhzyro required; initial 6 months for long‑term prevention; renewal 12 months with documentation of reduced attack frequency

Daybue - Initial and Renewal

Daybue covered when ALL of the following are met

Daybue initial: Medical record confirmation of a diagnosis of Rett syndrome

Initial 6 months; renewal 12 months with documentation of maintenance or improvement; prescriber: neurologist

Deflazacort - Initial and Renewal

Deflazacort covered when ALL of the following are met

Deflazacort initial: Medical record documentation of genetic testing confirmation of Duchenne muscular dystrophy

Requires failure of or adverse effects to prednisone prior to initiation; coverage duration 12 months; renewal requires documentation of positive treatment response or slowing of disease

Dengvaxia

Dengvaxia covered when ALL of the following are met

Dengvaxia criteria: Laboratory‑confirmed prior dengue infection AND documentation of residence in an endemic area

Age restriction: 9–16 years; coverage duration: 6 months

Diacomit

Diacomit covered when ALL of the following are met

Diacomit initial: Medical record documentation of Dravet syndrome AND documentation that Diacomit will be taken with clobazam

Applies to new starts; prerequisite Part D drug required

Dificid (fidaxomicin)

Dificid covered when ALL of the following are met

Dificid initial: Medical record documentation of an infection caused by Clostridium difficile

Coverage duration: 10 days; for oral powder for suspension document inability to swallow oral solids; prerequisite Part D drug required

Dojolvi - Initial and Renewal

Dojolvi covered when ALL of the following are met

Dojolvi initial: Medical record documentation of diagnosis of long‑chain fatty acid oxidation disorder (LC‑FAOD)

Initial coverage 6 months; renewal 12 months contingent on documented improvement in muscle function, exercise tolerance, or quality of life

Doptelet - Indications and Requirements

Doptelet (and Sprinkle) covered when ALL of the following are met

ITP initial: Medical record documentation of platelet count <30,000 per mm3 AND insufficient response to prior treatment (systemic corticosteroid or IVIG) for chronic ITP<30,000 per mm3

Initial duration: 6 weeks; renewal: documentation of maintenance between 30,000–150,000/mm3 or clinical improvement

Chronic liver disease thrombocytopenia: Platelet count <50,000 per mm3 and documentation of upcoming procedure when indicated<50,000 per mm3

Duration for procedure‑related use: 5 days

Dronabinol - Antiemetic Refractory N/V

Dronabinol covered when ALL of the following are met (for chemotherapy-associated nausea/vomiting)

Antiemetic failure criteria: Documentation of failure of at least one listed antiemetic (dimenhydrinate, meclizine, metoclopramide, promethazine, or prochlorperazine) and ondansetron prior to dronabinol use for chemo‑associated N/V

Coverage duration: 12 months; prerequisite Part D drug required

Droxidopa - Initial and Renewal

Droxidopa covered when ALL of the following are met

Droxidopa initial: Prescribed for an FDA‑approved indication (e.g., symptomatic neurogenic orthostatic hypotension) with documentation of baseline symptoms; renewal requires documentation of decreased lightheadedness/dizziness/falls

Initial 6 months; renewal 12 months; prerequisite Part D drug not required

Dupixent - Indication-specific Initial and Renewal Criteria

Dupixent covered when ALL of the following are met (indication-specific criteria apply)

Atopic dermatitis initial: Body surface area involvement >=10% at baseline AND failure of one very high‑potency topical steroid and tacrolimus ointment OR documentation that topical therapies are inappropriateBSA >= 10%

Initial 6 months; renewal requires documented positive treatment response

Asthma initial: Documentation of eosinophilic phenotype (eosinophils >=150 cells/mcL) OR chronic oral steroid dependence AND trial and failure of an ICS+LABA combinationeosinophils >=150 cells/mcL

Initial 6 months; renewal requires clinical improvement

Eosinophilic COPD initial: Eosinophil count >=300 cells/mcL AND inadequate control on triple therapy (ICS+LAMA+LABA)eosinophils >=300 cells/mcL

Initial 6 months; renewal requires symptom improvement or fewer exacerbations

Eosinophilic esophagitis initial: Biopsy‑confirmed eosinophilic esophagitis with >=15 eosinophils/HPF (or 60 eos/mm2) AND weight >=15 kg>=15 eos/HPF; weight >=15 kg

Initial 6 months; renewal requires clinical or histologic response

Eltrombopag (PA criteria)

Eltrombopag covered when criteria below met

Eltrombopag ITP initial: Medical record documentation of platelet count <30,000/mm3platelets <30,000/mm3

Prescriber: hematologist/oncologist; initial 6 weeks; renewal per policy with platelets 30,000–150,000/mm3

Eltrombopag Hep C initial: Platelets <75,000/mm3 with intent to start interferon‑based therapyplatelets <75,000/mm3

Initial 3 months; renewal 12 months

Eltrombopag AA initial: Platelet counts between 30,000 and 150,000/mm3 or increase from baseline30,000–150,000/mm3

Initial 4 months; renewal 12 months

Emgality (PA criteria)

Emgality covered when criteria below met

Emgality cluster initial: Documentation of diagnosis and >=2 cluster periods (7–365 days) separated by pain‑free intervals >=3 months>=2 cluster periods

Initial 6 months; renewal lifetime; not to be used with another CGRP inhibitor

Emgality migraine initial: Episodic migraine: 4–14 headache days/month OR Chronic migraine: >=15 days/month with >=8 migraine days for 3 monthssee migraine frequency

Initial 6 months; renewal lifetime

Empaveli (PA criteria)

Empaveli covered when criteria below met

Empaveli PNH initial: PNH diagnosis confirmed by high‑sensitivity flow cytometry

Initial 6 months; prescriber: hematologist/oncologist; renewal 12 months with documentation of clinical benefit

Empaveli C3G initial: Biopsy‑confirmed C3G/IC‑MPGN with proteinuria >=1 g/day and spot urine protein/creatinine >=1 g/gproteinuria >=1 g/day; protein/creatinine >=1 g/g

Initial 6 months; renewal 12 months

Enbrel (PA criteria)

Enbrel covered when criteria below met

Enbrel Psoriasis initial: Plaque psoriasis with >=3% BSA involvement or special site involvement AND failure of topical therapy and methotrexate or cyclosporine as specified>=3% BSA

Prescriber: dermatologist; initial 6 months; renewal 12 months

Enbrel arthritis renewal: Medical record documentation of improved functioning and/or tender/swollen joint counts for PsA/RA/JIA on renewal

Prescriber restrictions by indication; renewal 12 months

Enbrel AS initial: Failure of one oral NSAID prior to initiation

Initial 6 months; prescriber: rheumatologist

Edaravone (PA criteria)

Edaravone (Radicava ORS) covered when criteria below met

Edaravone criteria: Prescribed by or in consultation with a neurologist or specialist with documentation per FDA indications

Coverage duration: 12 months

L-glutamine (PA criteria)

L‑glutamine covered when criteria below met

L‑glutamine initial: Medical record documentation of failure of or intolerance to hydroxyurea prior to initiation

Renewal requires documentation that the drug has reduced sickle cell crises; prerequisite Part D drug required

Corticotropin (ACTH) is excluded for members with the following contraindications: patients under age 2 with suspected congenital infections; those with adrenocortical insufficiency or adrenocortical hyperfunction; and patients with conditions where corticotropin should not be used, including scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, active or history of peptic ulcer disease, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins of porcine origin.

Ambrisentan is excluded in pregnancy. Prior authorization requires documentation of WHO functional class II–IV for pulmonary arterial hypertension and prescriber involvement (pulmonologist or cardiologist); pregnancy must be excluded before coverage is approved (pregnancy exclusion).

Lotronex (alosetron) is contraindicated and excluded for patients with certain gastrointestinal or hepatic conditions and for specified drug interactions. Exclusions include constipation, intestinal obstruction/stricture, toxic megacolon, gastrointestinal perforation or adhesions, ischemic colitis or impaired intestinal circulation, severe hepatic impairment, diverticulitis, hypercoagulable state, thrombophlebitis, Crohn’s disease or ulcerative colitis, and concomitant use with apomorphine or fluvoxamine. Coverage requires prior documentation of predominant severe diarrhea for ≥6 months and prior failure of loperamide and dicyclomine.

Aprepitant (including Emend SUSR) lists concomitant use of pimozide as an exclusion. For covered indications, required documentation differs by use (e.g., PONV prophylaxis versus chemotherapy prophylaxis) and aprepitant must be prescribed with the appropriate concurrent antiemetic agents when indicated.

Austedo is excluded in members with certain psychiatric and hepatic risks and with specific concomitant medications. Exclusion criteria include active suicidality or inadequately treated depression, significant hepatic impairment, and concomitant use of MAO inhibitors or reserpine. Initial approval requires documentation of prerequisite therapy (e.g., failure or contraindication to tetrabenazine) and renewals require evidence of clinical response.

Benlysta (belimumab) is excluded for use in patients with severe active central nervous system (CNS) lupus and is not to be used in combination with other biologic agents or with intravenous cyclophosphamide. Initial authorization requires documentation of an SLE diagnosis with auto-antibody positivity and receipt of standard therapy; renewals require evidence of treatment response.

Benlysta exclusions are reiterated: coverage is not appropriate for severe active CNS lupus or when Benlysta would be administered concurrently with other biologic therapies or with IV cyclophosphamide. Prescriber specialty (rheumatologist or nephrologist) and diagnostic antibody thresholds are required for initial approval.

Bosentan coverage excludes use with certain interacting drugs and in pregnancy. Specifically, concomitant administration with cyclosporine A or glyburide is an exclusion and pregnancy is contraindicated; prior authorization requires documentation of NYHA Class II–IV status for the indicated pulmonary vascular disease.

Bronchitol will not be covered when the patient has failed the bronchitol tolerance test. Initial authorization requires confirmation of a cystic fibrosis diagnosis, age ≥18 years, and prescriber involvement by or in consultation with a pulmonologist; a failed tolerance test is an explicit exclusion.

Provider Actions — Prior Authorization, Documentation, Denial Risks

Prior Authorization

Abilify Mycite prior authorization and documentation

Prior authorization is required for Abilify Mycite (Maintenance Kit and Starter Kit); coverage duration: lifetime. For members newly starting the product, include medical record documentation showing the medical necessity of tracking medication compliance.

Coverage duration: Lifetime
Required documentation: medical necessity of tracking compliance for members newly starting the drug

Prior Authorization

General prior authorization requirement for specialty drugs

Prior authorization is required for many specialty drugs listed in this policy; approval and duration are drug- and indication-specific and generally require indication-specific documentation and any prerequisite therapy indicated in the drug entry.

Prescriber specialty requirements often apply (e.g., dermatologist, pulmonologist, neurologist)
Initial and renewal durations commonly specified (e.g., initial 6 months, renewal 12 months)

Prior Authorization

Adbry prior authorization and prescriber restriction

Adbry requires prior authorization with initial approval for 6 months and renewal for 12 months. Prescriber must be a dermatologist, allergist, or similar specialist.

Initial: 6 months; Renewal: 12 months
Prescriber: dermatologist, allergist, or specialist
Required documentation: baseline BSA ≥10% and renewal response measures

Prior Authorization

Agamree PA, documentation, and step therapy

Agamree requires prior authorization with 12-month coverage and prescriber restriction to a neurologist or Duchenne specialist; documentation of genetic testing confirming Duchenne is required and failure of prednisone and deflazacort must be documented.

Coverage duration: 12 months
Required documentation: genetic confirmation of Duchenne; renewal: treatment response
Step therapy: failure of prednisone and deflazacort

Prior Authorization

Aimovig PA and concurrent CGRP prohibition

Aimovig requires prior authorization: initial approval for 6 months with renewal as lifetime coverage. The request must document migraine frequency and confirm it will not be used concurrently with another CGRP preventive agent.

Initial: 6 months; Renewal: Lifetime
Required documentation: episodic (4–14 days/month) or chronic (≥15 headache days/month with ≥8 migraine days for 3 months)
Exclusion: concurrent use with another CGRP preventive agent

Prior Authorization

Aldurazyme PA, dosing, and documentation

Aldurazyme requires prior authorization with initial approval for 6 months and renewal as lifetime; dosing must follow the product label (0.58 mg/kg IV once weekly) and diagnostic confirmation is required.

Initial: 6 months; Renewal: Lifetime
Required documentation: diagnostic confirmation (urinary GAGs, deficient α-L-iduronidase activity, or genetic testing) and objective treatment goals
Dosing per label: 0.58 mg/kg IV weekly

Prior Authorization

Lotronex PA, age limit, prerequisite therapy, and documentation

Lotronex (alosetron) requires prior authorization with an initial 8‑week trial and lifetime renewal; patient must be age ≥18 and have documentation of predominant severe diarrhea for ≥6 months and failure of loperamide and dicyclomine.

Initial trial: 8 weeks; Renewal: Lifetime
Age restriction: ≥18 years
Prerequisite therapy: failure of loperamide and dicyclomine
Required documentation: severe diarrhea ≥6 months impacting activities and 8‑week trial response for renewal

Prior Authorization

Alyftrek PA, prescriber, and documentation

Alyftrek requires prior authorization with initial approval for 6 months and 12‑month renewal; prescriber must be a pulmonologist for pediatric patients (age ≥6 years) and documentation of a responsive CFTR mutation is required.

Initial: 6 months; Renewal: 12 months
Age restriction: ≥6 years
Prescriber: pulmonologist
Required documentation: diagnosis of CF with at least one F508del or responsive mutation confirmed by FDA‑cleared test

Prior Authorization

Ambrisentan PA, exclusions, and prescriber restriction

Ambrisentan requires prior authorization with lifetime coverage; pregnancy is an exclusion and WHO functional class II–IV must be documented; prescriber should be a pulmonologist or cardiologist.

Coverage duration: Lifetime
Required documentation: WHO functional class II–IV
Exclusion: pregnancy
Prescriber: pulmonologist or cardiologist

Prior Authorization

Apomorphine PA, prescriber restriction, step therapy, and renewal documentation

Apomorphine injection requires prior authorization with initial coverage for 6 months and renewal as lifetime; prescriber must be a neurologist (or in consultation with one) and initial requests must document failure of maximally tolerated oral levodopa/carbidopa and one additional listed agent.

Initial: 6 months; Renewal: Lifetime
Prescriber: neurologist or consultation with neurologist
Prerequisite/step therapy: failure of maximally tolerated levodopa/carbidopa and one of selegiline, ropinirole, pramipexole, entacapone or Ongentys
Renewal documentation: evidence that 'off' time has been reduced

Documentation Required

Apomorphine renewal documentation and step requirement

Apomorphine prior authorization also requires renewal documentation demonstrating reduced 'off' time after treatment; initial use must show prior oral therapy failures as specified.

Renewal: document reduction in 'off' time
Initial requirement: prior maximally tolerated levodopa/carbidopa plus another agent
Prescriber specialty: neurologist

Prior Authorization

Aprepitant PA, duration limits and required concurrent antiemetic

Aprepitant (including Emend SUSR) requires prior authorization; PONV coverage is limited to one month and chemotherapy prophylaxis to 12 months; ensure aprepitant will be prescribed with concurrent IV or oral ondansetron, granisetron, or palonosetron when used for chemo prophylaxis.

PONV coverage: 1 month
Chemotherapy prophylaxis: up to 12 months
Required documentation: for PONV confirm prophylactic use; for chemo prophylaxis document concurrent use with ondansetron, granisetron, or palonosetron

Prior Authorization

Aqneursa PA, required diagnostic confirmation and prescriber restriction

Aqneursa requires prior authorization with lifetime coverage for confirmed Niemann‑Pick disease type C (NPC); prescriber must be or consult a geneticist or neurologist and genetic confirmation plus neurologic symptoms must be documented.

Coverage duration: Lifetime
Required documentation: genetic confirmation of NPC and neurologic symptoms
Prescriber: geneticist or neurologist (or consult)

Prior Authorization

Aqvesme PA, documentation, prescriber, and step therapy

Aqvesme requires prior authorization for adults (≥18) with confirmed thalassemia; initial approval is 6 months with 12‑month renewal and prescriber must be or consult a hematologist; for transfusion‑dependent beta thalassemia document failure of or contraindication to Reblozyl.

Initial: 6 months; Renewal: 12 months
Age: ≥18 years
Required documentation: genetic testing or hemoglobin analysis confirming thalassemia; renewal: clinical benefit
Step therapy for transfusion‑dependent beta thalassemia: failure/contraindication to Reblozyl

Prior Authorization

Aralast NP PA and required diagnostic documentation

Aralast NP requires prior authorization with initial approval for 6 months and 12‑month renewal; prescriber should be or consult a pulmonologist and initial requests must document ZZ or Z/null AAT deficiency with AAT serum ≤11 micromoles/L (50 mg/dL), moderate emphysema and/or FEV1 <80%, and measurable treatment goals.

Initial: 6 months; Renewal: 12 months
Required documentation: ZZ or Z/null AAT deficiency, AAT ≤11 micromoles/L (50 mg/dL), moderate emphysema and/or FEV1 <80% and measurable treatment goals
Prescriber: pulmonologist

Prior Authorization

Arcalyst PA, prescriber restrictions, and step therapy for DIRA

Arcalyst requires prior authorization with initial 6‑month approval and 12‑month renewal; prescriber specialty varies by indication (e.g., immunologist/geneticist for DIRA, cardiologist for recurrent pericarditis) and for DIRA documentation of failure of Kineret is required.

Initial: 6 months; Renewal: 12 months
Prescriber restrictions by indication (immunologist/geneticist for DIRA; cardiologist for pericarditis)
Step therapy (DIRA): failure of Kineret required

Prior Authorization

Arikayce PA and prerequisite regimen failure documentation

Arikayce requires prior authorization for adults (≥18) with specialist involvement; requests must document use as part of a combination antibacterial regimen, positive sputum culture or lack of clinical improvement, and prior failure of at least 6 months of a multidrug regimen.

Initial: specialist/pulmonologist involvement
Required documentation: combination regimen use and culture or clinical nonresponse
Prerequisite therapy: failure of ≥6 months multidrug regimen (e.g., ethambutol, rifabutin, clofazimine)

Prior Authorization

Aristada PA and prerequisite oral Abilify documentation

Aristada requires prior authorization with lifetime coverage; for members newly starting the injection, document that the patient is currently taking oral Abilify and the prescriber intends to switch to the long‑acting injectable to improve compliance (prerequisite Part D drug requirement).

Coverage duration: Lifetime
Required documentation for new starts: current use of oral Abilify and intent to switch for compliance
Prerequisite therapy: oral Abilify required

Documentation Required

Aristada required medical information for new starts

Aristada prior authorization must document the patient is on oral Abilify and the prescriber is switching to injectable therapy to improve compliance.

Required medical information for initial authorization: documentation of current oral Abilify use and rationale to switch

Prior Authorization

Armodafinil PA and renewal documentation

Armodafinil requires prior authorization with an initial 6‑month approval and renewal as lifetime; renewal requests must include documentation of reduced daytime sleepiness or improved functioning.

Initial: 6 months; Renewal: Lifetime
Renewal documentation: reduction in daytime sleepiness or improved functioning

Prior Authorization

Astagraf PA and prerequisite immediate‑release tacrolimus

Astagraf (tacrolimus ER) requires prior authorization; for Part D coverage in transplant patients, document failure of tacrolimus immediate‑release or why immediate‑release cannot be used.

Coverage duration: Lifetime
Prerequisite therapy: failure of tacrolimus immediate‑release or documented reason immediate‑release unsuitable for Part D coverage

Prior Authorization

Attruby PA and required diagnostic documentation

Attruby requires prior authorization with medical record documentation confirming wild‑type or hereditary transthyretin amyloid cardiomyopathy and should be prescribed by or in consultation with a cardiologist.

Required documentation: confirmatory diagnostic testing for ATTR
Prescriber: cardiologist or consult

Prior Authorization

Austedo PA, step therapy, renewal documentation, and exclusions

Austedo requires prior authorization; initial durations differ by indication (HD or TD) and prerequisite therapy must be documented (failure or contraindication to tetrabenazine; for TD also failure of Ingrezza). Renewal requires documentation of clinical response.

Initial: 6 months (HD and TD); Renewal: 12 months
Prerequisite therapy: failure/contraindication to tetrabenazine (and Ingrezza for TD)
Required renewal documentation: clinical response (e.g., improved chorea or reduced AIMS score)
Exclusions: suicidality, hepatic impairment, inadequately treated depression, concomitant MAOIs or reserpine

Prior Authorization

Auvelity PA and prerequisite antidepressant trials

Auvelity requires prior authorization and documentation of trial, intolerance, or contraindication to bupropion and an SSRI or SNRI prior to initiation unless intolerant/contraindicated.

Coverage duration: Lifetime
Prerequisite therapy: trial of bupropion and an SSRI or SNRI (or documented intolerance/contraindication)

Prior Authorization

Nexletol/Nexlizet PA, LDL criteria, and prerequisite therapies

Nexletol/Nexlizet require prior authorization with documentation of LDL‑C thresholds and prior high‑intensity statin therapy failure; prior PCSK9 inhibitor failure (Repatha or Praluent) must be documented where indicated.

Initial: 6 months; Renewal: Lifetime
Required documentation: LDL‑C >100 mg/dL (no CVD) or >55 mg/dL (with CVD)
Prerequisite therapy: failure/intolerance to a high‑intensity statin for 12 weeks and failure of PCSK9 inhibitor where applicable

Prior Authorization

Benlysta PA, required antibody documentation, prescriber, and exclusions

Benlysta requires prior authorization with initial and renewal criteria: document SLE diagnosis with auto‑antibody positivity (ANA ≥1:80 or anti‑dsDNA ≥30 IU/ml) and receipt of standard therapy; prescriber should be a rheumatologist or nephrologist. Renewal requires documentation of treatment response.

Initial: 6 months; Renewal: 12 months
Required documentation: ANA ≥1:80 or anti‑dsDNA ≥30 IU/ml and receipt of standard therapy
Prescriber: rheumatologist or nephrologist
Exclusion: severe active CNS lupus or use with other biologics/IV cyclophosphamide

Documentation Required

Benlysta required medical information for PA

Benlysta prior authorization specifically requires documentation of diagnosis, antibody positivity, prior/concurrent standard therapy, and prescriber specialty (rheumatologist or nephrologist).

Ensure ANA or anti‑dsDNA titers and standard therapy documentation are included
Prescriber specialty should be documented

Prior Authorization

Benznidazole PA, age restriction, and diagnostic confirmation

Benznidazole requires prior authorization for pediatric patients aged 2–12 and diagnostic confirmation of T. cruzi infection (microscopy, PCR, or two positive serologies). Requests outside the 2–12 age range may be denied.

Age restriction: 2–12 years
Required documentation: trypomastigotes on microscopy, PCR detection of T. cruzi DNA, or two positive serologic tests using different techniques

Prior Authorization

Botulinum toxin PA, eligibility, and prerequisite therapy

Botulinum toxin (Botox, Xeomin) requires prior authorization with eligibility and renewal response documentation; migraine prophylaxis and urinary incontinence have prerequisite medication failures documented.

Initial and renewal documentation: for chronic migraine, ≥15 headache days/month (initial) and evidence of response at renewal
Prerequisite therapy: failure of propranolol and topiramate for migraine; failure of two oral anticholinergics for urinary incontinence

Prior Authorization

Brivaracetam/Briviact PA and required prior antiseizure therapy

Brivaracetam/Briviact prior authorization requires documentation of prior antiseizure medication failures, including levetiracetam and at least one additional listed antiseizure agent; suspension forms require inability to swallow and specific formulation failure documentation.

Coverage: Lifetime
Required documentation: failure of levetiracetam plus one or more specified antiseizure agents (lists differ for tablets vs suspension)
Suspension: inability to swallow oral dosage forms and failure of levetiracetam suspension

Prior Authorization

Bronchitol PA, age and diagnostic requirements, and exclusion

Bronchitol requires prior authorization with initial confirmation of cystic fibrosis, age ≥18, and prescriber involvement of a pulmonologist; failure of the bronchitol tolerance test is an exclusion.

Initial: confirmation of cystic fibrosis diagnosis
Age: ≥18 years
Prescriber: pulmonologist or consultation
Exclusion: failure of bronchitol tolerance test

Prior Authorization

Buprenorphine PTWK PA and prerequisite therapy note

Buprenorphine PTWK (patch) is listed with prior authorization criteria; the policy notes prerequisite therapy is required and cites prior failure of morphine sulfate ER under other criteria.

Prerequisite therapy: prior failure of morphine sulfate ER noted under 'Other Criteria'
PA required with documentation per product entry

Prior Authorization

Cablivi PA and required aTTP documentation

Cablivi prior authorization requires medical record documentation supporting a diagnosis of acquired TTP and that Cablivi will be used in combination with plasma exchange; renewal requires documentation such as suppressed ADAMTS13 activity.

Initial documentation: diagnosis of aTTP and plan to use with plasma exchange
Initial coverage: 90 days; Renewal durations vary (90 days if receiving plasma exchange; 58 days post plasma exchange)
Prescriber: hematologist

Prior Authorization

Camzyos PA and required cardiac documentation

Camzyos prior authorization requires documentation of NYHA class II or III obstructive hypertrophic cardiomyopathy and LVEF ≥55% initially (renewal >50%); prescriber must be a cardiologist.

Initial: NYHA class II or III and LVEF ≥55%
Initial: 6 months; Renewal: 12 months
Prescriber: cardiologist

Note

Prior authorization not specified in excerpt — verify product entries

This excerpt contains sections where prior authorization is not specified; verify product‑level entries for PA requirements when processing requests.

When PA not specified in an excerpt, check full product entry for requirements

Prior Authorization

Cancer drug PA requirement and required documentation

Drugs listed in the cancer drugs section require prior authorization with medical record documentation of the diagnosis; prescriber must be an appropriate specialist (oncologist/hematologist) per indication.

Required documentation: medical record confirming diagnosis
Prescriber: oncologist, hematologist, or other specialist per indication

Prior Authorization

Caplyta PA and step therapy for new starts

Caplyta requires prior authorization with lifetime coverage; new starts must document failure of listed alternative agents per indication (step therapy).

Coverage: Lifetime
Prerequisite therapy: depend on indication (e.g., schizophrenia—failure of two listed antipsychotics)

Prior Authorization

Carglumic acid PA and diagnostic confirmation

Carglumic acid requires prior authorization with initial coverage for 3 months and 12‑month renewal; diagnostic confirmation is required for certain indications (e.g., DNA testing for hyperammonemia type III).

Initial: 3 months; Renewal: 12 months
Required documentation: diagnostic confirmation (e.g., DNA testing) and measurable treatment goals for hyperammonemia type III

Prior Authorization

Cayston PA, FEV1 and infection documentation, and step therapy

Cayston requires prior authorization with 12‑month coverage, age ≥7 years, prescriber specialty involvement, documentation of FEV1 between 25%–90% predicted and Pseudomonas aeruginosa infection, and prior failure or resistance to tobramycin.

Coverage: 12 months
Age: ≥7 years
Required documentation: FEV1 25%–90% predicted and Pseudomonas infection
Step therapy: failure/resistance to tobramycin (TOBI)

Prior Authorization

Cerdelga and Cerezyme PA, diagnostic confirmation, and dosing notes

Cerdelga and Cerezyme require prior authorization with initial and renewal durations specified (initial 6 months; renewal 12 months), diagnostic confirmation by enzyme assay or genotyping, and for Cerdelga CYP2D6 metabolizer testing and dosing limits.

Initial: 6 months; Renewal: 12 months
Required documentation: diagnostic confirmation by enzyme assay or genotyping and objective treatment goals
Cerdelga: CYP2D6 metabolizer testing and dose limits

Prior Authorization

Chenodal PA, coverage duration, and step therapy

Chenodal requires prior authorization with 12‑month coverage and documentation that the patient is not a candidate for laparoscopic cholecystectomy; failure of ursodiol must be documented (step therapy).

Coverage: 12 months
Required documentation: not a candidate for laparoscopic cholecystectomy
Step therapy: failure of ursodiol required

Prior Authorization

Cholbam PA, prescriber, and required documentation

Cholbam requires prior authorization with initial coverage for 4 months then 12‑month renewal; prescriber should be or consult a hepatologist/gastroenterologist and initial documentation of bile acid synthesis disorder or peroxisomal disorder is required.

Initial: 4 months; Renewal: 12 months
Prescriber: hepatologist or gastroenterologist
Required documentation: bile acid synthesis defect or peroxisomal disorder with liver disease manifestations

Prior Authorization

Cimzia and biologics — PA and prescriber requirements

Cimzia and other biologics require prior authorization; initial approvals are generally 6 months with 12‑month renewals and prescriptions must come from or in consultation with the required specialist for the indication.

Initial: 6 months; Renewal: 12 months
Prescriber: specialist per indication (dermatologist, rheumatologist, gastroenterologist, etc.)
Prior authorization required with indication‑specific documentation

Prior Authorization

Cosentyx PA, durations, and prerequisite therapy

Cosentyx products require prior authorization with initial approvals generally 6 months and renewals at 12 months; prerequisite Part D drug use is required per the policy.

Initial: 6 months; Renewal: 12 months
Prerequisite therapy: required (Part D drug)
Prescriber: specialist per indication

Prior Authorization

Cysteamine PA and required ophthalmic documentation

Cysteamine products require prior authorization with initial duration commonly 6 months and renewal 12 months; initial documentation must show corneal cystine crystal deposits and renewal requires documentation of reduction.

Initial: 6 months; Renewal: 12 months
Required documentation: corneal cysteine crystal deposits initially; reduction documented for renewal

Prior Authorization

Dalfampridine PA, exclusion, and baseline documentation

Dalfampridine requires prior authorization with initial approval for 6 months and renewal as lifetime; exclude patients with a history of seizure or CrCl ≤50 mL/min and document a timed 25‑foot walk baseline prior to initiation.

Initial: 6 months; Renewal: Lifetime
Exclusion: history of seizure or CrCl ≤50 mL/min
Required documentation: diagnosis of MS and timed 25‑foot walk prior to initiation

Step Therapy

Prerequisite therapy requirements and acceptable support

The policy requires documentation of prerequisite therapies for many products (examples: failure of one NSAID for AS/nr‑axSpA; 8‑week methotrexate trial for JIA; topical/systemic failures for psoriasis); prerequisite therapy must be an FDA‑approved indication or supported references.

Prerequisite therapies must be FDA‑approved or supported by listed references (AHFS, Micromedex)
Common examples: NSAID failure for AS/nr‑axSpA; methotrexate trial for JIA; topical+systemic failure for PsO

Prior Authorization

Daybue PA and required diagnostic documentation

Daybue requires prior authorization with initial 6‑month approval and 12‑month renewal; initial documentation must confirm Rett syndrome.

Initial: 6 months; Renewal: 12 months
Required documentation: medical record confirmation of Rett syndrome

Prior Authorization

Deflazacort PA, diagnostic confirmation, and step therapy

Deflazacort requires prior authorization with 12‑month coverage; initial requests must include genetic testing confirming Duchenne muscular dystrophy and prior failure or adverse effects to prednisone must be documented.

Coverage duration: 12 months
Required documentation: genetic confirmation of Duchenne
Prerequisite therapy: failure or adverse effects to prednisone

Step Therapy

Lotronex step therapy requirement

Lotronex step therapy requires documented failure of loperamide and dicyclomine prior to approval.

Prerequisite therapy: failure of loperamide and dicyclomine must be documented

Prior Authorization

Diacomit PA and required concomitant medication documentation

Diacomit requires prior authorization for members newly starting the drug and must be taken with clobazam; document Dravet syndrome in the medical record.

Required documentation: medical record confirmation of Dravet syndrome and that Diacomit will be taken with clobazam
PA applies to new starts

Prior Authorization

Dificid PA and required infection documentation

Dificid (fidaxomicin) requires prior authorization with coverage duration of 10 days; initial authorization requires documentation of C. difficile infection and, for the oral powder for suspension, documentation of inability to swallow solids.

Coverage duration: 10 days
Required documentation: medical record evidence of C. difficile infection
Oral powder for suspension: document inability to swallow solid oral dosage forms

Denial Risk

Dificid prerequisite therapy and documentation denial risk

Dificid prior authorization also notes prerequisite therapy is required for initial requests and lack of documentation of C. difficile infection may lead to denial.

Prerequisite therapy: required (policy item)
Denial risk: absence of documentation of C. difficile infection

Prior Authorization

Dojolvi PA and renewal documentation

Dojolvi requires prior authorization for LC‑FAOD with initial coverage for 6 months and 12‑month renewal contingent on documented improvement in muscle function, exercise tolerance, or quality of life.

Initial: 6 months; Renewal: 12 months
Required documentation: diagnosis of LC‑FAOD and renewal evidence of clinical improvement

Prior Authorization

Doptelet PA and required platelet documentation

Doptelet (including Sprinkle) requires prior authorization with specific platelet count documentation: for chronic ITP initial platelet count <30,000/mm3 and renewal maintenance between 30,000–150,000/mm3; prescriber should be or consult a hematologist or surgeon.

ITP initial: platelets <30,000/mm3; ITP renewal: 30,000–150,000/mm3
Chronic liver disease thrombocytopenia: platelets <50,000/mm3 for procedure‑related use
Prescriber: hematologist or surgeon

Prior Authorization

Dronabinol PA and prerequisite antiemetic trials

Dronabinol capsules require prior authorization (coverage 12 months) for chemotherapy‑associated nausea/vomiting after failure of specified antiemetics; document prior antiemetic trials.

Coverage: 12 months
Prerequisite therapy: failure of at least one antiemetic (dimenhydrinate, meclizine, metoclopramide, promethazine, prochlorperazine, and ondansetron)

Prior Authorization

Droxidopa PA and renewal documentation

Droxidopa requires prior authorization with initial 6‑month approval and 12‑month renewal; renewal requests must document treatment response (reduced lightheadedness/dizziness/falls).

Initial: 6 months; Renewal: 12 months
Required renewal documentation: clinical response such as decreased lightheadedness, dizziness or falls

Prior Authorization

Dupixent PA and indication‑specific documentation

Dupixent requires prior authorization for all FDA‑approved indications with indication‑specific baseline and renewal documentation; initial coverage is commonly 6 months with 12‑month renewals and prerequisite Part D drug use is required where specified.

Initial: typically 6 months; Renewal: 12 months
Required baseline documentation: e.g., BSA for AD, eosinophil counts for asthma/E‑COPD, biopsy confirmation for EoE
Prerequisite therapy: required for many indications

Prior Authorization

Prior authorization: general summary of durations and documentation expectations

Prior authorization is required across many products with indication‑specific documentation; most entries specify initial and renewal durations (initial commonly 6 months, renewals commonly 12 months) and prescriber specialties.

Initial commonly 6 months; renewals commonly 12 months
Indication‑specific baseline measures and renewal evidence of clinical response required

Prior Authorization

Eltrombopag PA criteria and required platelet documentation

Eltrombopag requires prior authorization with specific platelet thresholds and prior therapy failures for chronic ITP; document platelet counts meeting the ITP, Hep C, or AA thresholds and prior therapy failures where indicated.

ITP initial: platelets <30,000/mm3; ITP renewal: 30,000–150,000/mm3
Hep C thrombocytopenia initial: platelets <75,000/mm3
Chronic ITP requires prior failure of systemic corticosteroids, IVIG, or splenectomy

Denial Risk

Common denial triggers — missing documentation and prerequisite therapies

Lack of required medical information, missing prerequisite therapy documentation, or absence of diagnostic confirmation (e.g., DNA testing, enzyme assays, flow cytometry, biopsy) are common denial triggers; include all indicated baseline measures and prior therapy details with PA submissions.

Denial risks: missing diagnosis documentation, missing prerequisite therapy failures, missing diagnostic confirmation (DNA testing, enzyme assay, flow cytometry, biopsy)
Include baseline measures (BSA, eosinophils, platelet counts, LDL) and prior therapy history

Prior Authorization

Empaveli PA and required diagnostic confirmation

Empaveli requires prior authorization with diagnostic confirmation for PNH (flow cytometry) and for C3G/IC‑MPGN (biopsy plus proteinuria ≥1 g/day and protein/creatinine ≥1 g/g); initial approval is 6 months and renewal 12 months with prescriber specialty restrictions.

Initial: 6 months; Renewal: 12 months
PNH documentation: high‑sensitivity flow cytometry
C3G/IC‑MPGN documentation: biopsy confirmation and proteinuria ≥1 g/day and protein/creatinine ≥1 g/g

Prior Authorization

Enbrel PA criteria and prerequisite therapy

Enbrel requires prior authorization for all FDA‑approved indications with documentation of prior therapy failures where specified; initial approvals are generally 6 months with 12‑month renewals and prescriber specialty varies by indication.

Initial: 6 months; Renewal: 12 months
Required documentation: disease‑specific baseline and renewal measures (e.g., BSA for psoriasis, tender/swollen joint counts)
Prior therapy failures required for certain indications (e.g., NSAID for AS, methotrexate for JIA)

Initial Therapy Criteria (per-product)

Continuation / Renewal Criteria

Step Therapy and Prerequisite Treatments

Requirement	Details
Prerequisite therapy required
Initial therapy for many biologic indications requires documented failure of specified prior agents (examples: AS/nr-axSpA: failure of one NSAID; JIA: 8-week methotrexate trial; PsO: failure of topical agent plus methotrexate or cyclosporine).
Policy expectation
Prerequisite therapies must be documented in the medical record; criteria indicates use of a prerequisite Part D drug where specified.

Requirement	Details
Failure of levodopa/carbidopa and adjunct agent
Initial approval requires documented failure of maximally tolerated oral levodopa/carbidopa AND failure of one additional listed agent (selegiline, ropinirole, pramipexole, entacapone); step therapy to Ongentys referenced.
Prescriber
Must be prescribed by or in consultation with a neurologist; renewal requires documentation that 'off' time has been reduced.

Requirement	Details
Failure of loperamide and dicyclomine
Lotronex (alosetron) initial approval requires prior failure of loperamide and dicyclomine; initial documentation of predominant severe diarrhea for ≥6 months is required.
Age restriction
Age ≥18 years for initial use; contraindications (e.g., constipation, intestinal obstruction, ischemic colitis, severe hepatic impairment) exclude coverage.

Requirement	Details
Failure of prednisone and deflazacort
Agamree initial approval requires documented failure of prednisone and deflazacort; genetic testing confirming Duchenne muscular dystrophy is required.
Prescriber / Coverage
Prescribed by or in consultation with a neurologist or Duchenne specialist; coverage duration: 12 months.

Requirement	Details
Failure of Kineret prior to Arcalyst for DIRA
For Deficiency of Interleukin-1 Receptor Antagonist (DIRA), Arcalyst coverage requires prior failure of Kineret (anakinra) documented in the medical record.
Prescriber
Prescribed by or in consultation with an immunologist or geneticist for DIRA; initial coverage 6 months, renewal 12 months.

Requirement	Details
Failure of or contraindication to Reblozyl
Aqvesme for transfusion-dependent beta thalassemia requires documentation of failure of or contraindication to Reblozyl prior to approval.
Other requirements
Initial confirmation of alpha or beta thalassemia by genetic testing or hemoglobin analysis; patient ≥18 years; prescriber involvement: hematologist; initial 6 months, renewal 12 months.

Requirement	Details
Prerequisite Part D drug required
Members newly starting Aristada must have documentation that the patient is currently taking oral Abilify (aripiprazole) and the prescriber intends to switch to the long-acting injectable to improve compliance.
Coverage duration
Coverage duration: Lifetime.

Requirement	Details
Failure of tetrabenazine (and Ingrezza for TD where noted)
Austedo initial criteria require failure of or contraindication to tetrabenazine; for tardive dyskinesia, failure of Ingrezza is also required where noted.
Prescriber / Duration
Prescribed by or in consultation with a neurologist (HD) or movement disorder specialist/psychiatrist (TD); initial 6 months, renewal 12 months; exclusions apply (suicidality, hepatic impairment, inadequately treated depression).

Requirement	Details
Failure/intolerance to high-intensity statin and PCSK9 agents where indicated
Nexletol/Nexlizet initial approval requires documentation of LDL-C thresholds (LDL-C >100 mg/dL without CVD or >55 mg/dL with CVD), failure/intolerance to a high-intensity statin for 12 weeks, and failure of PCSK9 agents (Repatha or Praluent) where applicable.
Age / Prescriber
Age ≥18 years; prescribed by or in consultation with cardiologist or endocrinologist; initial 6 months, renewal lifetime.

Requirement	Details
Document medication failures per formulation
Brivaracetam/Briviact criteria specify different prior failure requirements for tablets versus suspension (e.g., tablets: failure of levetiracetam plus one additional antiseizure agent from a listed set; suspension: inability to swallow solids plus analogous failure requirements). Document formulation-specific failures in the medical record.

Requirement	Details
Prerequisite therapy must be FDA‑approved or supported by listed references
The policy requires prerequisite therapy to be for an FDA‑approved indication or, if off‑label, supported by AHFS Drug Information or Micromedex DrugDex (cancer off‑label uses require NCCN or other listed references). The policy also clarifies when a prerequisite Part D drug is required or not.

Requirement	Details
Documented trial and failure of listed therapies prior to Dupixent
Dupixent initial approval is indication-specific and requires documentation of prior trials/failures as listed (examples: AD — failure of a very high‑potency topical steroid and tacrolimus or documentation topical therapy inappropriate; asthma — trial and failure of ICS+LABA). Criteria indicates use of a prerequisite Part D drug where specified.

Requirement	Details
Failure or intolerance to hydroxyurea required
L‑glutamine (ENDARI) requires medical record documentation of failure of or intolerance to hydroxyurea prior to approval; renewal requires documentation that the drug has reduced the number of sickle cell crises.

Requirement	Details
Prior failures required for chronic ITP
Eltrombopag for chronic ITP requires documentation that systemic corticosteroids, immunoglobulin replacement, or splenectomy were tried and the disease was refractory; initial platelet count thresholds and prescriber restrictions apply (ITP initial: platelets <30,000/mm3).

Requirement	Details
Prior therapy failures required for certain Enbrel indications
Some Enbrel indications require documented failure of specified prior therapies (examples: AS — failure of one oral NSAID; JIA — failure of methotrexate for ≥8 weeks; PsO — failure of topical plus systemic agents). Documentation of these prior therapy failures is required for initial approval.

Coding — Product Listings and Key Numeric Thresholds

Bronchitol product listingNDC

No codes listed

Buprenorphine PTWK product listingNDC

No codes listed

Cablivi product listingNDC

No codes listed

Camzyos product listingNDC

No codes listed

Cancer drug product listings (partial)mixed

No codes listed

Drug list (no codes provided)NDC | mixed

No codes listed

inv-105: LDL-C thresholds — initial LDL-C thresholds for Nexletol/Nexlizet

Initial LDL-C thresholdsInitial LDL-C >100 mg/dL without cardiovascular disease OR >55 mg/dL with cardiovascular disease

Prerequisite statin therapyFailure, intolerance, or contraindication to one high-intensity statin (eg, atorvastatin 40–80 mg or rosuvastatin 20–40 mg) for 12 weeks

PCSK9 requirementFailure of Repatha or Praluent required prior to initiation where indicated

Age / prescriberAdults (≥18 years); prescribed by or in consultation with cardiologist or endocrinologist

Coverage durationInitial: 6 months; Renewal: lifetime

inv-106: Cayston FEV1 requirement

FEV1 requirementFEV1 between 25% and 90% predicted

Infection requirementDocumented Pseudomonas aeruginosa infection

AgePatient age ≥7 years

Prior therapyDocumentation of failure of or resistance to tobramycin (TOBI)

PrescriberPrescribed by or in consultation with pulmonologist or infectious disease specialist

Coverage duration12 months

inv-107: Cerezyme dosing range

Cerezyme dose range2.5 units/kg IV three times weekly to 60 units/kg IV every 2 weeks; usual dosage is 60 units/kg IV every 2 weeks

Dosing consistencyDosing must be consistent with product label

Initial/renewal durationsInitial: 6 months; Renewal: 12 months

Diagnostic confirmationRequired: glucocerebrosidase assay ≤30% of normal activity or genotyping with 2 pathogenic mutations

inv-108: Cerdelga CYP2D6 dose limits

Cerdelga CYP2D6 dose limitsFor CYP2D6 extensive or intermediate metabolizers: do not exceed 84 mg twice daily; for CYP2D6 poor metabolizers: do not exceed 84 mg daily

Diagnostic confirmationRequired: decreased glucocerebrosidase activity or genotyping revealing 2 pathogenic mutations

Initial/renewal durationsInitial: 6 months; Renewal: 12 months

Severity criteriaSigns/symptoms severe enough to cause anemia, thrombocytopenia, bone disease, or significant hepatosplenomegaly

inv-109: Creatinine clearance threshold (dalfampridine exclusion)

Creatinine clearance thresholdCreatinine clearance ≤ 50 mL/min (CrCl ≤ 50 mL/min) is listed as exclusion for dalfampridine

Seizure historyHistory of seizure is an exclusion for dalfampridine

Required baseline measureTimed 25-foot walk time must be documented prior to initiation

Coverage durationsInitial: 6 months; Renewal: lifetime

inv-110: Dengvaxia age window (9-16 years)

Dengvaxia age windowAge between 9 and 16 years (inclusive)

Prior infection confirmationLaboratory-confirmed previous dengue infection required

Residence requirementDocumentation of residence in an endemic area

Coverage duration6 months

inv-111: ITP platelet threshold (initial) (<30,000/mm3)

ITP platelet threshold (initial)Platelet count <30,000 per mm3 for initial ITP indication

ITP renewal rangeRenewal: maintenance between 30,000 and 150,000 per mm3 or increase from baseline with resolution of bleeding

Prior therapy requirementDocumentation of insufficient response to systemic corticosteroids or immunoglobulin replacement (or splenectomy) for chronic ITP

PrescriberPrescribed by or in consultation with hematologist or oncologist for ITP

inv-112: Chronic liver disease thrombocytopenia threshold (<50,000/mm3)

Chronic liver disease thrombocytopenia thresholdPlatelet count <50,000 per mm3 for chronic liver disease–related thrombocytopenia (procedure-related use)

Duration for procedure useDuration for procedure-related thrombocytopenia: 5 days

PrescriberPrescribed by or in consultation with hematologist, hepatologist, gastroenterologist, infectious disease specialist, or surgeon

inv-113: Eosinophilic COPD eosinophil threshold (>=300 cells/mcL)

Eosinophilic COPD eosinophil thresholdEosinophil count ≥300 cells/mcL required for E-COPD initial approval

Therapy failureInadequate control on triple therapy (ICS + LAMA + LABA) required prior to approval

PrescriberPrescribed by or in consultation with a pulmonologist

inv-114: Asthma eosinophil threshold (>=150 cells/mcL)

Asthma eosinophil thresholdEosinophil count ≥150 cells/mcL for eosinophilic asthma phenotype (or chronic oral steroid dependence)

Prerequisite therapyTrial and failure of an ICS + LABA combination required prior to approval

Renewal evidenceRenewal requires reduction in oral steroid use or improvement in asthma symptoms

inv-115: EoE biopsy eosinophil threshold (>=15 eos/HPF or 60 eos/mm2)

EoE biopsy eosinophil thresholdPeak biopsy showing ≥15 eosinophils per high power field (HPF) OR 60 eosinophils per mm2

Weight requirementPatient weight ≥15 kg for EoE indication

Clinical correlationBiopsy confirmation must be correlated with symptoms of esophageal dysfunction

inv-116: EoE weight threshold (>=15 kg)

EoE weight thresholdPatient weight ≥15 kg (required for eosinophilic esophagitis initial therapy)

Diagnostic requirementBiopsy-confirmed eosinophilic esophagitis plus symptom correlation

Coverage durationInitial: 6 months; Renewal: 12 months

inv-117: Eosinophil counts summary (>=150 for asthma; >=300 for COPD)

Asthma and COPD eosinophil summaryEosinophil thresholds: asthma ≥150 cells/mcL; eosinophilic COPD ≥300 cells/mcL

Indication linkThresholds used to define eosinophilic phenotype for Dupixent and other biologics

Prerequisite therapyDocumented trial and failure of indicated prior controller therapies (eg, ICS+LABA for asthma; triple therapy for COPD)

inv-118: Atopic dermatitis BSA (>=10% baseline)

Atopic dermatitis baseline BSABody surface area involvement ≥10% at baseline required for initial atopic dermatitis therapy

Required documentationMedical record documentation of BSA at baseline and renewal evidence of clinical response (reduced BSA, improved itching/functioning, IGA/EASI)

PrescriberPrescribed by or in consultation with dermatologist, allergist, or immunologist

inv-119: EoE histology requirement (>=15 eos/HPF or 60 eos/mm2)

EoE histology requirementPeak value ≥15 eosinophils per HPF OR 60 eosinophils per mm2 required for EoE diagnosis

Symptom correlationBiopsy must be consistent with symptoms of esophageal dysfunction

Weight thresholdPatient weight ≥15 kg

inv-120: Duvyzat age (>=6 years)

Duvyzat age requirementDuvyzat initial therapy: patient age ≥6 years

Diagnostic confirmationGenetic testing confirming Duchenne muscular dystrophy required for initiation

PrescriberPrescribed by or in consultation with neurologist or DMD specialist

inv-121: EoE weight (>=15 kg)

EoE weight requirementPatient weight ≥15 kg required for eosinophilic esophagitis initial therapy

Biopsy thresholdBiopsy showing ≥15 eos/HPF or 60 eos/mm2 required

Coverage durationsInitial: 6 months; Renewal: 12 months

inv-122: Eltrombopag platelet thresholds (ITP initial <30,000; renewal 30,000–150,000; Hep C <75,000)

Eltrombopag ITP thresholds summaryITP initial: platelets <30,000/mm3 (initial); ITP renewal maintenance: 30,000–150,000/mm3

Hepatitis C thresholdHep C thrombocytopenia initial: platelets <75,000/mm3 to allow interferon-based therapy

Aplastic anemiaAA: platelet counts between 30,000 and 150,000/mm3 or increase from baseline (per product-specific guidance)

Prior therapyChronic ITP: documentation of refractory disease to systemic corticosteroids, IVIG, or splenectomy required

inv-123: Proteinuria threshold for C3G/IC-MPGN (>=1 g/day and spot urine protein-to-creatinine >=1 g/g)

Proteinuria threshold (C3G/IC-MPGN)Proteinuria ≥1 g/day AND spot urine protein-to-creatinine ratio ≥1 g/g required for C3G/IC‑MPGN indication

Diagnostic confirmationBiopsy confirmation of diagnosis required

PrescriberPrescribed by or in consultation with nephrologist, hematologist, or oncologist as indicated

inv-124: Migraine frequency definitions (episodic vs chronic)

Migraine frequency — episodic vs chronicEpisodic migraine: 4–14 headache days per month; Chronic migraine: ≥15 headache days/month with ≥8 migraine days for 3 months

Documentation for renewalRenewal requires documented reduction in migraine days or abortive medication use

Emgality concurrencyNot to be used in combination with another CGRP inhibitor for migraine prevention

inv-125: Cluster headache episode definition

Cluster headache episode definitionAt least 2 cluster periods of 7–365 days separated by pain‑free intervals of ≥3 months

Required documentationMedical record documentation of diagnosis and episode history required for initial approval

Coverage durationInitial: 6 months; Renewal: lifetime

Required Medical Information and Documentation

Note

Background and Scope Notes

This document provides a compiled list of products with prior authorization metadata (coverage durations, required documentation, prerequisite therapy and prescriber specialties) rather than detailed clinical practice guidelines. For each product the policy specifies the information providers must supply to support medical necessity and the exclusions/contraindications that would preclude coverage.

Definitions and Key Terms

inv-307: Products Affected — Abilify Mycite Maintenance Kit / Starter Kit

Products affectedAbilify Mycite Maintenance Kit; Abilify Mycite Starter Kit

Coverage duration (product)Coverage duration listed as Lifetime for Abilify Mycite

Initial documentation requirementFor members newly starting, documentation of medical necessity of tracking compliance with the product is required

inv-308: Diagnostic confirmation for Aldurazyme

Diagnostic confirmation (Aldurazyme)Presence of urinary glycosaminoglycans (GAGs), deficient α-L-iduronidase enzyme activity, OR genetic testing confirming diagnosis

Objective goalsObjective, measurable treatment goals required at initiation

Renewal evidenceRenewal requires documentation of stabilization such as improved % predicted FVC or 6‑minute walk test

inv-309: Episodic vs Chronic Migraine (Aimovig)

Episodic vs chronic migraineEpisodic: 4–14 headache days/month; Chronic: ≥15 headache days/month with ≥8 migraine days for 3 months

Renewal evidenceRenewal requires documentation of treatment response (reduced migraine days or abortive medication use)

ConcurrencyMust not be used concurrently with a second CGRP preventive agent

inv-310: Auto-antibody positive (SLE) — ANA >=1:80 or anti-dsDNA >=30 IU/ml

Auto‑antibody positivity (SLE)Defined as ANA titer ≥1:80 OR anti‑dsDNA ≥30 IU/ml for Benlysta SLE coverage

Required concomitant therapyReceiving standard therapy (NSAIDs, antimalarials, corticosteroids, or immunosuppressants) required

PrescriberPrescribed by or in consultation with a rheumatologist or nephrologist

inv-311: Failure of bronchitol tolerance test (definition)

Failure of Bronchitol tolerance testFailure of the Bronchitol tolerance test is listed as an exclusion for Bronchitol

Initial requirementInitial authorization requires confirmation of cystic fibrosis diagnosis

Age and prescriberAge ≥18 years; prescribed by or in consultation with a pulmonologist

inv-313: Medically-accepted indication / Off-label support — required references for off-label uses

Off‑label support requirementOff‑label non‑cancer uses must be supported by AHFS or Micromedex DrugDex; off‑label cancer uses require NCCN or listed references

Medical record documentationMedical record documentation of the diagnosis is required for all such uses

Prerequisite therapy notePrerequisite therapy must be FDA‑approved or supported by listed references; criteria does not require use of a prerequisite Part D drug generally

inv-314: Prescriber restrictions — specialist prescriber requirements summarized

Specialist prescriber requirementMany drugs must be prescribed by or in consultation with a specialist (eg, oncologist, hematologist, neurologist, hepatologist, pulmonologist) as specified per indication

Cancer prescribersFor cancer drugs, prescriber must be an oncologist, hematologist, endocrinologist or neurologist; transplant specialist for chronic GVHD, allergist for systemic mast cell disease, dermatologist for DFSP

DocumentationMedical record documentation of diagnosis required; missing specialty or documentation may trigger denial

inv-316: Renewal documentation — evidence of improved functioning or disease-specific improvement

Renewal documentation generalRenewal generally requires evidence of improved functioning or disease‑specific clinical improvement (examples vary by indication)

Examples of renewal evidenceReduced 'off' time (apomorphine), improved timed walk (dalfampridine), decreased BSA/itch (AD), increased platelets (eltrombopag)

Coverage durationsInitial commonly 6 months; renewals commonly 12 months unless specified otherwise

inv-317: Hurley staging for hidradenitis suppurativa — Stage II or III

Hurley stagingHurley Stage II or III required for hidradenitis suppurativa initial therapy

Nodule countAt least 3 abscesses or inflammatory nodules required for HS initial approval

PrescriberPrescribed by or in consultation with a dermatologist for HS

inv-318: Moderate or severe renal impairment definition — CrCl <= 50 mL/min

Moderate/severe renal impairmentDefined as creatinine clearance ≤50 mL/min (relevant exclusion for dalfampridine)

Dalfampridine exclusionHistory of seizure or CrCl ≤50 mL/min excludes use

inv-319: LC-FAOD abbreviation

LC-FAOD abbreviationLC-FAOD = long‑chain fatty acid oxidation disorders

Dojolvi indicationDojolvi is indicated for LC-FAOD with required documentation for initiation and renewal

inv-320: Body surface area (BSA) definition

BSA definitionBSA = body surface area (used for atopic dermatitis and psoriasis assessments)

AD baseline requirementInitial therapy requires documentation of BSA involvement (eg, ≥10% for AD)

Quantity Limits and Dose Strengths

inv-402: Lenvima dose strengths listed (4–24 mg daily)

Lenvima dose strengthsAvailable daily strengths listed: 4, 8, 10, 12, 14, 18, 20, 24 mg

SectionListed within cancer drugs section; applies to quantity/strength limits

inv-403: Cerezyme dose range

Cerezyme dose range (repeat)Dose range: 2.5 units/kg IV three times weekly to 60 units/kg IV every 2 weeks; usual 60 units/kg IV every 2 weeks

Usual dosingUsual dosage is 60 units/kg IV every 2 weeks

Note

Policy Summary

Payercareoregon

PolicyCoverage criteria — Pharmacy & Specialty Drugs (Abilify Mycite and assorted specialty drugs)

Policy CodePolicy N/A

Change TypeAdministrative review — no material changes

Effective DateJul 26, 2026

Last ReviewJul 26, 2026

Next Review DateJul 26, 2026

Key ActionFor members newly starting Abilify Mycite, document medical necessity of tracking compliance with the product.

SourceLink

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CurrentcareoregonPolicy N/A

Pharmacy & Specialty Drugs — Coverage Criteria (Abilify Mycite and listed specialty drug prior authorization criteria)

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Policy Summary

Payercareoregon

PolicyCoverage criteria — Pharmacy & Specialty Drugs (Abilify Mycite and assorted specialty drugs)

Policy CodePolicy N/A

Change TypeAdministrative review — no material changes

Effective DateJul 26, 2026

Last ReviewJul 26, 2026

Next Review DateJul 26, 2026

Key ActionFor members newly starting Abilify Mycite, document medical necessity of tracking compliance with the product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~150+Products in extract (partial)

LifetimeAbilify Mycite coverage duration

6 monthsCommon initial duration

VariesPrerequisite therapy noted

40+Entries shown

Coverage Criteria — Product-specific Authorization Rules

Abilify Mycite — Initial Authorization

Covered when the following is documented for members newly starting the drug

Abilify Mycite initial requirement: Documentation of the medical necessity of tracking compliance with the Abilify Mycite product

Coverage Duration: Lifetime

Other specialty drug PA summaries

Coverage for listed specialty drugs is tied to indication-specific documentation and prerequisite therapy where specified

Coverage/duration vary by indication; see product-specific criteria

Actimmune: Prescribed for an FDA‑approved or medically accepted indication (e.g., supported compendia for T‑cell lymphoma); medical record documentation required

Coverage Duration: Lifetime

Adalimumab products: Prescribed for an FDA‑approved or medically accepted indication; indication‑specific prerequisite and renewal requirements apply (see individual disease entries)

Prescriber specialty and prior therapy requirements vary by indication

Adbry Initial Therapy

Adbry (atopic dermatitis) covered when ALL of the following are met:

Adbry initial criteria: Medical record documentation of body surface area involvement of at least 10% at baselineBSA >= 10%

Prescriber: dermatologist, allergist, or specialist; initial coverage 6 months; renewal requires documentation of positive treatment response

Required prior therapy per policy

Agamree Initial Therapy

Agamree covered when ALL of the following are met:

Agamree initial criteria: Genetic testing confirming a diagnosis of Duchenne muscular dystrophygenetic test positive

Prescriber: neurologist or DMD/neuromuscular specialist; initial coverage 12 months; requires documentation of failure of prednisone and deflazacort (prerequisite Part D drug)

Required renewal documentation: Medical record documentation of positive treatment response (e.g., improved pulmonary function, muscle strength, or functional measures)

Renewal: 12 months

Aimovig Initial Therapy

Aimovig covered when ALL of the following are met:

Initial coverage 6 months; renewal lifetime; not to be used concurrently with another CGRP preventive agent

Documentation of response at renewal: Medical record documentation of decreased migraine days, reduced abortive medication use, or other clinical benefit

Renewal requires documented benefit

Aldurazyme Initial Therapy

Aldurazyme covered when ALL of the following are met:

Initial coverage 6 months; renewal lifetime; dosing consistent with label (0.58 mg/kg IV weekly)

Treatment goals: Provider‑defined, objective, measurable treatment goals documented in the record (e.g., % predicted FVC, 6‑minute walk) for baseline and renewal assessment

Renewal requires documentation of stabilization or improvement

Lotronex Initial Therapy

Lotronex (alosetron) covered when ALL of the following are met:

Symptom duration and severity: Medical record documentation of predominant severe diarrhea lasting at least 6 months with disability or restriction of daily activities>=6 months

Age >=18 years; initial trial duration 8 weeks; renewal lifetime

Prerequisite therapy: Documentation of failure of loperamide and dicyclomine prior to initiation

Alyftrek Initial Therapy

Alyftrek covered when ALL of the following are met:

Patient age >=6 years; prescriber pulmonologist; initial 6 months, renewal 12 months

Clinical response at renewal: Documentation of treatment response such as improved FEV1 or reduced pulmonary exacerbations

Renewal requires clinical benefit documentation

Ambrisentan Initial Therapy

Ambrisentan covered when ALL of the following are met:

Clinical documentation: Medical record documentation of pulmonary arterial hypertension with WHO functional class II–IVWHO class II-IV

Prescriber: pulmonologist or cardiologist; coverage duration: lifetime; pregnancy is an exclusion

Apomorphine Initial and Renewal Therapy

Apomorphine injection covered when ALL of the following are met:

Prescriber: neurologist; initial coverage 6 months; renewal requires documentation that 'off' time has been reduced

Renewal requirement: Medical record documentation that patient's 'off' time has been reduced with apomorphine

Renewal coverage: lifetime

Aprepitant — Indications and Restrictions

Aprepitant covered when ALL of the following are met:

Coverage durations: PONV 1 month; chemotherapy prophylaxis up to 12 months; exclusion: concomitant use of pimozide

Aqneursa — Initial Therapy

Aqneursa covered when ALL of the following are met:

Diagnostic confirmation: Genetic testing confirming Niemann‑Pick disease type C (NPC) and documentation of neurologic symptomsgenetic confirmation

Prescriber: geneticist or neurologist; coverage duration: lifetime

Aqvesme — Initial and Renewal

Aqvesme covered when ALL of the following are met:

Diagnostic confirmation: Confirmation of alpha or beta thalassemia by genetic testing or hemoglobin analysisdiagnostic confirmation

Age >=18 years; prescriber: hematologist; initial 6 months then renewal 12 months; for transfusion‑dependent beta thalassemia require failure or contraindication to Reblozyl

Renewal requirement: Documentation of clinical benefit such as improvement in anemia or reduction in iron overload

Renewal coverage: 12 months

Aralast NP — Initial and Renewal

Aralast NP covered when ALL of the following are met:

Prescriber: pulmonologist; provider‑defined measurable treatment goals required; initial 6 months, renewal 12 months

Treatment goals: Provider documents specific measurable goals (e.g., slowing FEV1 decline) and renewal documents meeting goals

Renewal requires evidence of meeting goals

Arcalyst — Indication-Specific Criteria

Arcalyst covered when ALL of the following are met (indication-specific):

Indication meets FDA use: Indication corresponds to an FDA‑approved use (e.g., DIRA, recurrent pericarditis, CAPS) with required diagnostic confirmation

Prescriber specialty varies by indication (immunologist/geneticist for DIRA, cardiologist for recurrent pericarditis); initial 6 months, renewal 12 months; for DIRA require failure of Kineret

Renewal documentation: Medical record documentation of positive clinical response appropriate to the indication (e.g., reduced flares, symptom improvement)

Renewal: 12 months

Arikayce — Initial Therapy

Arikayce covered when ALL of the following are met:

Combination regimen and culture: Documentation that Arikayce will be used as part of a combination antibacterial regimen AND either a positive sputum culture or lack of clinical improvement

Patient ≥18 years; prescribed by specialist/pulmonologist; prior failure of at least 6 months of a multidrug regimen required

Prerequisite therapy: Documentation of prior failure of an adequate multidrug regimen (e.g., ethambutol, rifabutin, clofazimine) prior to initiation>=6 months prior regimen failure

Prerequisite Part D drug required

Aristada — New Start

Aristada covered when ALL of the following are met for new starts:

Switch from oral Abilify: Medical record documentation that the patient is currently taking oral Abilify and the prescriber intends to switch to the long‑acting injectable to improve compliance

Coverage Duration: Lifetime; prerequisite Part D drug (oral Abilify) required for new starts

Aristada Initial Therapy

Aristada (Aristada Initio) coverage conditions

Aristada initial: Member is currently taking oral Abilify AND prescriber wishes to switch to the long‑acting injectable to improve compliance

Coverage duration: Lifetime; prerequisite oral Abilify documented

Armodafinil — Initial and Renewal

Armodafinil covered when ALL of the following are met:

Armodafinil initial: Initial authorization for 6 months with documentation of indication per FDA approval

Prerequisite therapy: not required; renewal requires documentation of reduction in daytime sleepiness or improved functioning (renewal: lifetime)

Astagraf Coverage

Astagraf (tacrolimus ER) coverage conditions

Astagraf Part D transplant consideration: If covered under Part D for transplant patients, document failure of tacrolimus immediate‑release or reason immediate‑release cannot be used

Coverage duration: Lifetime; prerequisite Part D drug required where indicated

Attruby Initial Therapy

Attruby covered when ALL of the following are met:

Attruby initial: Medical record documentation confirming diagnosis of wild‑type or hereditary transthyretin amyloid cardiomyopathy (ATTR)

Prescriber: cardiologist or in consultation with cardiology; coverage duration: lifetime

Austedo Initial and Renewal

Austedo covered when ALL of the following are met:

Austedo Huntington's disease initial: For Huntington's disease: documentation of failure of or contraindication to tetrabenazine prior to initiation

Initial 6 months; renewal 12 months with documentation of clinical response; exclusions include suicidality, hepatic impairment, inadequately treated depression, and certain concomitant drugs

Austedo tardive dyskinesia initial: For tardive dyskinesia: documentation of failure of or contraindication to tetrabenazine AND Ingrezza where noted; age >=18

Initial 6 months; renewal 12 months; prescriber specialty required; prerequisite therapy required

Auvelity Initial Therapy

Auvelity covered when ALL of the following are met:

Auvelity initial: Medical record documentation of trial, intolerance to, or contraindication to bupropion AND an SSRI or SNRI (examples: sertraline, fluoxetine, escitalopram, paroxetine, venlafaxine)

Coverage duration: Lifetime; prerequisite Part D drug required

Nexletol/Nexlizet Initial Therapy

Nexletol / Nexlizet covered when ALL of the following are met:

Patient >=18 years; initial 6 months; renewal lifetime; prescriber: cardiologist/endocrinologist

Benlysta Initial and Renewal

Benlysta covered when ALL of the following are met:

Prescriber: rheumatologist or nephrologist; initial coverage 6 months; renewal 12 months with documentation of treatment response

Benlysta lupus nephritis initial: Documentation of active lupus nephritis AND receiving standard therapy (corticosteroids or immunosuppressants)

Initial 6 months; renewal requires stabilization of eGFR or no worsening

Exclusions: Use in severe active CNS lupus or in combination with other biologics or IV cyclophosphamide is excluded

Requests meeting exclusions may be denied

Benznidazole criteria

Benznidazole — Covered when ALL of the following are met:

Age restriction: 2 to 12 years; coverage duration: 60 days

Bexsero criteria

Bexsero — Covered when ALL of the following are met:

Age window: Patient age between 10 and 25 years

Coverage duration: 6 months

Bosentan criteria

Bosentan — Covered when ALL of the following are met:

NYHA class documentation: Medical record documentation of NYHA Class II–IV pulmonary arterial hypertensionWHO/NYHA II–IV

Exclusions: concomitant cyclosporine A or glyburide and pregnancy; prerequisite therapy may be required per policy

Botulinum toxin criteria

Botulinum toxins (Botox/Xeomin) — Covered when ALL of the following are met:

Chronic migraine initial: For Botox: at least 15 headache days per month lasting 4 hours or longer prior to initiation>=15 headache days/month

Renewal requires documented clinical response; migraine prophylaxis requires prior failure of propranolol and topiramate

Urinary incontinence initial/renewal: Documentation of prior failure of two oral anticholinergics and, for renewal, documentation of decreased incontinence episodes or frequency

Prescriber specialty and duration per indication

Chronic sialorrhea (Xeomin): Documentation of clinical benefit for renewal (improvement in drooling severity/frequency)

Coverage durations vary by product/indication

Brinsupri criteria

Brinsupri — Covered when ALL of the following are met:

NCFB confirmation: Initial confirmation of non‑cystic fibrosis bronchiectasis by CT scan

Prescriber: pulmonologist; initial 6 months, renewal 12 months

Brivaracetam/Briviact criteria

Brivaracetam / Briviact — Covered when ALL of the following are met:

Coverage: lifetime; prerequisite Part D drug required

Suspension formulation: Inability to swallow oral solids AND failure of levetiracetam suspension AND failure of one listed suspension/solution antiseizure agent

Suspension requires documentation of inability to swallow and prior therapy failures

Bronchitol - Initial Therapy

Covered when ALL of the following are met for Bronchitol:

Bronchitol initial coverage criteria: Confirmation of a diagnosis of cystic fibrosis; patient is 18 years of age or older; prescribed by or in consultation with a pulmonologist

Coverage duration: lifetime

Tolerance test exclusion: Failure of bronchitol tolerance test excludes coverage

Requests meeting exclusion may be denied

Cablivi - Initial Therapy

Covered when ALL of the following are met for Cablivi (initial):

aTTP diagnostic support: Medical record support of a diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP) and documentation that Cablivi will be used in combination with plasma exchange

Initial coverage duration: 90 days; prescriber: hematologist

Cablivi - Renewal

Renewal coverage criteria for Cablivi:

Cablivi renewal criteria: Documented signs of persistent underlying disease such as suppressed ADAMTS13 activity or ongoing clinical need

Renewal durations vary by plasma exchange status (90 days if receiving plasma exchange; 58 days post plasma exchange)

Camzyos - Initial Therapy

Covered when ALL of the following are met for Camzyos:

Camzyos initial criteria: Medical record documentation of NYHA class II or III obstructive hypertrophic cardiomyopathy AND documentation of left ventricular ejection fraction >=55%LVEF >=55%

Initial coverage 6 months; renewal 12 months with LVEF >50%; prescriber: cardiologist

General Prior Authorization Criteria — oncology drugs (summary)

High-level coverage and authorization conditions for listed oncology drugs

Prescriber must be appropriate specialist for cancer indications; initial/renewal durations vary

Prerequisite therapy note: For non‑cancer off‑label uses require authoritative compendia support; policy does not require prior use of a Part D drug for the general oncology section

See individual cancer drug criteria for specifics

Caplyta - Initial Therapy

Caplyta covered when ALL of the following are met for members newly starting the drug:

Coverage Duration: Lifetime; prerequisite therapy required per indication

Carglumic acid - Initial Therapy

Carglumic acid covered when ALL of the following are met:

Carglumic acid initial: For hyperammonemia type III: diagnosis confirmed by DNA testing and objective, measurable treatment goals provided; for other indications diagnostic confirmation documented

Initial coverage 3 months; renewal 12 months

Cayston - Initial Therapy

Cayston covered when ALL of the following are met:

Cayston initial: Documentation that patient has FEV1 between 25% and 90% predicted AND documented Pseudomonas aeruginosa infectionFEV1 25%–90%

Age >=7 years; prescriber pulmonologist or infectious disease; documentation of failure/resistance to tobramycin required; coverage 12 months

Cerdelga / Cerezyme - Initial and Renewal

Cerdelga and Cerezyme covered when ALL of the following are met:

Chenodal - Initial Therapy

Chenodal covered when ALL of the following are met:

Chenodal initial: Medical record documentation that patient is not a candidate for laparoscopic cholecystectomy and failure of ursodiol documented

Coverage duration: 12 months; prerequisite therapy required

Cholbam - Initial and Renewal

Cholbam covered when ALL of the following are met:

Initial 4 months; renewal 12 months; renewal requires documentation of liver function improvement and absence of complete biliary obstruction

Coverage criteria (summary)

Covered when ALL of the following per-indication requirements are met (summary):

Initial typically 6 months; renewal commonly 12 months; prescriber specialty required per indication

See individual disease entries for exact lists

Initial and renewal coverage criteria (per indication, partial)

Covered when the following indication-specific documentation and prerequisite therapy requirements are met:

AS/nr-axSpA/ERA initial: Documentation of diagnosis AND failure of one NSAID (e.g., meloxicam, ibuprofen, naproxen, diclofenac) prior to initiation

Initial 6 months; renewal 12 months; prescriber specialty per indication

Hidradenitis suppurativa initial: Moderate to severe disease with documentation of Hurley Stage II or III and at least 3 abscesses or inflammatory nodulesHurley II or III; >=3 abscesses/nodules

Renewal requires reduction in nodules/abscesses

Plaque psoriasis initial: Involvement of at least 3% body surface area or special site involvement AND failure of specified topical/systemic therapies per policy>=3% BSA

Prescriber: dermatologist; initial 6 months; renewal 12 months

Cysteamine - Initial and Renewal

Cysteamine products covered when ALL of the following are met

Cysteamine initial: Medical record documentation of corneal cysteine crystal deposits

Initial authorization 6 months; renewal 12 months with documentation of reduction in corneal crystal deposits

Dalfampridine - Initial and Renewal

Dalfampridine covered when ALL of the following are met

Dalfampridine initial: Medical record documentation of multiple sclerosis diagnosis AND baseline timed 25‑foot walk prior to initiation

Exclusion: history of seizure or CrCl <= 50 mL/min; initial 6 months; renewal lifetime with documented improvement

Dawnzera - Initial and Renewal

Dawnzera covered when ALL of the following are met

Initial: failure/intolerance/contraindication to Takhzyro required; initial 6 months for long‑term prevention; renewal 12 months with documentation of reduced attack frequency

Daybue - Initial and Renewal

Daybue covered when ALL of the following are met

Daybue initial: Medical record confirmation of a diagnosis of Rett syndrome

Initial 6 months; renewal 12 months with documentation of maintenance or improvement; prescriber: neurologist

Deflazacort - Initial and Renewal

Deflazacort covered when ALL of the following are met

Deflazacort initial: Medical record documentation of genetic testing confirmation of Duchenne muscular dystrophy

Requires failure of or adverse effects to prednisone prior to initiation; coverage duration 12 months; renewal requires documentation of positive treatment response or slowing of disease

Dengvaxia

Dengvaxia covered when ALL of the following are met

Dengvaxia criteria: Laboratory‑confirmed prior dengue infection AND documentation of residence in an endemic area

Age restriction: 9–16 years; coverage duration: 6 months

Diacomit

Diacomit covered when ALL of the following are met

Diacomit initial: Medical record documentation of Dravet syndrome AND documentation that Diacomit will be taken with clobazam

Applies to new starts; prerequisite Part D drug required

Dificid (fidaxomicin)

Dificid covered when ALL of the following are met

Dificid initial: Medical record documentation of an infection caused by Clostridium difficile

Coverage duration: 10 days; for oral powder for suspension document inability to swallow oral solids; prerequisite Part D drug required

Dojolvi - Initial and Renewal

Dojolvi covered when ALL of the following are met

Dojolvi initial: Medical record documentation of diagnosis of long‑chain fatty acid oxidation disorder (LC‑FAOD)

Initial coverage 6 months; renewal 12 months contingent on documented improvement in muscle function, exercise tolerance, or quality of life

Doptelet - Indications and Requirements

Doptelet (and Sprinkle) covered when ALL of the following are met

ITP initial: Medical record documentation of platelet count <30,000 per mm3 AND insufficient response to prior treatment (systemic corticosteroid or IVIG) for chronic ITP<30,000 per mm3

Initial duration: 6 weeks; renewal: documentation of maintenance between 30,000–150,000/mm3 or clinical improvement

Chronic liver disease thrombocytopenia: Platelet count <50,000 per mm3 and documentation of upcoming procedure when indicated<50,000 per mm3

Duration for procedure‑related use: 5 days

Dronabinol - Antiemetic Refractory N/V

Dronabinol covered when ALL of the following are met (for chemotherapy-associated nausea/vomiting)

Coverage duration: 12 months; prerequisite Part D drug required

Droxidopa - Initial and Renewal

Droxidopa covered when ALL of the following are met

Initial 6 months; renewal 12 months; prerequisite Part D drug not required

Dupixent - Indication-specific Initial and Renewal Criteria

Dupixent covered when ALL of the following are met (indication-specific criteria apply)

Initial 6 months; renewal requires documented positive treatment response

Asthma initial: Documentation of eosinophilic phenotype (eosinophils >=150 cells/mcL) OR chronic oral steroid dependence AND trial and failure of an ICS+LABA combinationeosinophils >=150 cells/mcL

Initial 6 months; renewal requires clinical improvement

Eosinophilic COPD initial: Eosinophil count >=300 cells/mcL AND inadequate control on triple therapy (ICS+LAMA+LABA)eosinophils >=300 cells/mcL

Initial 6 months; renewal requires symptom improvement or fewer exacerbations

Eosinophilic esophagitis initial: Biopsy‑confirmed eosinophilic esophagitis with >=15 eosinophils/HPF (or 60 eos/mm2) AND weight >=15 kg>=15 eos/HPF; weight >=15 kg

Initial 6 months; renewal requires clinical or histologic response

Eltrombopag (PA criteria)

Eltrombopag covered when criteria below met

Eltrombopag ITP initial: Medical record documentation of platelet count <30,000/mm3platelets <30,000/mm3

Prescriber: hematologist/oncologist; initial 6 weeks; renewal per policy with platelets 30,000–150,000/mm3

Eltrombopag Hep C initial: Platelets <75,000/mm3 with intent to start interferon‑based therapyplatelets <75,000/mm3

Initial 3 months; renewal 12 months

Eltrombopag AA initial: Platelet counts between 30,000 and 150,000/mm3 or increase from baseline30,000–150,000/mm3

Initial 4 months; renewal 12 months

Emgality (PA criteria)

Emgality covered when criteria below met

Emgality cluster initial: Documentation of diagnosis and >=2 cluster periods (7–365 days) separated by pain‑free intervals >=3 months>=2 cluster periods

Initial 6 months; renewal lifetime; not to be used with another CGRP inhibitor

Emgality migraine initial: Episodic migraine: 4–14 headache days/month OR Chronic migraine: >=15 days/month with >=8 migraine days for 3 monthssee migraine frequency

Initial 6 months; renewal lifetime

Empaveli (PA criteria)

Empaveli covered when criteria below met

Empaveli PNH initial: PNH diagnosis confirmed by high‑sensitivity flow cytometry

Initial 6 months; prescriber: hematologist/oncologist; renewal 12 months with documentation of clinical benefit

Empaveli C3G initial: Biopsy‑confirmed C3G/IC‑MPGN with proteinuria >=1 g/day and spot urine protein/creatinine >=1 g/gproteinuria >=1 g/day; protein/creatinine >=1 g/g

Initial 6 months; renewal 12 months

Enbrel (PA criteria)

Enbrel covered when criteria below met

Enbrel Psoriasis initial: Plaque psoriasis with >=3% BSA involvement or special site involvement AND failure of topical therapy and methotrexate or cyclosporine as specified>=3% BSA

Prescriber: dermatologist; initial 6 months; renewal 12 months

Enbrel arthritis renewal: Medical record documentation of improved functioning and/or tender/swollen joint counts for PsA/RA/JIA on renewal

Prescriber restrictions by indication; renewal 12 months

Enbrel AS initial: Failure of one oral NSAID prior to initiation

Initial 6 months; prescriber: rheumatologist

Edaravone (PA criteria)

Edaravone (Radicava ORS) covered when criteria below met

Edaravone criteria: Prescribed by or in consultation with a neurologist or specialist with documentation per FDA indications

Coverage duration: 12 months

L-glutamine (PA criteria)

L‑glutamine covered when criteria below met

L‑glutamine initial: Medical record documentation of failure of or intolerance to hydroxyurea prior to initiation

Renewal requires documentation that the drug has reduced sickle cell crises; prerequisite Part D drug required

Provider Actions — Prior Authorization, Documentation, Denial Risks

Prior Authorization

Abilify Mycite prior authorization and documentation

Coverage duration: Lifetime
Required documentation: medical necessity of tracking compliance for members newly starting the drug

Prior Authorization

General prior authorization requirement for specialty drugs

Prescriber specialty requirements often apply (e.g., dermatologist, pulmonologist, neurologist)
Initial and renewal durations commonly specified (e.g., initial 6 months, renewal 12 months)

Prior Authorization

Adbry prior authorization and prescriber restriction

Adbry requires prior authorization with initial approval for 6 months and renewal for 12 months. Prescriber must be a dermatologist, allergist, or similar specialist.

Initial: 6 months; Renewal: 12 months
Prescriber: dermatologist, allergist, or specialist
Required documentation: baseline BSA ≥10% and renewal response measures

Prior Authorization

Agamree PA, documentation, and step therapy

Coverage duration: 12 months
Required documentation: genetic confirmation of Duchenne; renewal: treatment response
Step therapy: failure of prednisone and deflazacort

Prior Authorization

Aimovig PA and concurrent CGRP prohibition

Initial: 6 months; Renewal: Lifetime
Required documentation: episodic (4–14 days/month) or chronic (≥15 headache days/month with ≥8 migraine days for 3 months)
Exclusion: concurrent use with another CGRP preventive agent

Prior Authorization

Aldurazyme PA, dosing, and documentation

Initial: 6 months; Renewal: Lifetime
Required documentation: diagnostic confirmation (urinary GAGs, deficient α-L-iduronidase activity, or genetic testing) and objective treatment goals
Dosing per label: 0.58 mg/kg IV weekly

Prior Authorization

Lotronex PA, age limit, prerequisite therapy, and documentation

Initial trial: 8 weeks; Renewal: Lifetime
Age restriction: ≥18 years
Prerequisite therapy: failure of loperamide and dicyclomine
Required documentation: severe diarrhea ≥6 months impacting activities and 8‑week trial response for renewal

Prior Authorization

Alyftrek PA, prescriber, and documentation

Initial: 6 months; Renewal: 12 months
Age restriction: ≥6 years
Prescriber: pulmonologist
Required documentation: diagnosis of CF with at least one F508del or responsive mutation confirmed by FDA‑cleared test

Prior Authorization

Ambrisentan PA, exclusions, and prescriber restriction

Ambrisentan requires prior authorization with lifetime coverage; pregnancy is an exclusion and WHO functional class II–IV must be documented; prescriber should be a pulmonologist or cardiologist.

Coverage duration: Lifetime
Required documentation: WHO functional class II–IV
Exclusion: pregnancy
Prescriber: pulmonologist or cardiologist

Prior Authorization

Apomorphine PA, prescriber restriction, step therapy, and renewal documentation

Initial: 6 months; Renewal: Lifetime
Prescriber: neurologist or consultation with neurologist
Prerequisite/step therapy: failure of maximally tolerated levodopa/carbidopa and one of selegiline, ropinirole, pramipexole, entacapone or Ongentys
Renewal documentation: evidence that 'off' time has been reduced

Documentation Required

Apomorphine renewal documentation and step requirement

Apomorphine prior authorization also requires renewal documentation demonstrating reduced 'off' time after treatment; initial use must show prior oral therapy failures as specified.

Renewal: document reduction in 'off' time
Initial requirement: prior maximally tolerated levodopa/carbidopa plus another agent
Prescriber specialty: neurologist

Prior Authorization

Aprepitant PA, duration limits and required concurrent antiemetic

PONV coverage: 1 month
Chemotherapy prophylaxis: up to 12 months
Required documentation: for PONV confirm prophylactic use; for chemo prophylaxis document concurrent use with ondansetron, granisetron, or palonosetron

Prior Authorization

Aqneursa PA, required diagnostic confirmation and prescriber restriction

Coverage duration: Lifetime
Required documentation: genetic confirmation of NPC and neurologic symptoms
Prescriber: geneticist or neurologist (or consult)

Prior Authorization

Aqvesme PA, documentation, prescriber, and step therapy

Initial: 6 months; Renewal: 12 months
Age: ≥18 years
Required documentation: genetic testing or hemoglobin analysis confirming thalassemia; renewal: clinical benefit
Step therapy for transfusion‑dependent beta thalassemia: failure/contraindication to Reblozyl

Prior Authorization

Aralast NP PA and required diagnostic documentation

Initial: 6 months; Renewal: 12 months
Required documentation: ZZ or Z/null AAT deficiency, AAT ≤11 micromoles/L (50 mg/dL), moderate emphysema and/or FEV1 <80% and measurable treatment goals
Prescriber: pulmonologist

Prior Authorization

Arcalyst PA, prescriber restrictions, and step therapy for DIRA

Initial: 6 months; Renewal: 12 months
Prescriber restrictions by indication (immunologist/geneticist for DIRA; cardiologist for pericarditis)
Step therapy (DIRA): failure of Kineret required

Prior Authorization

Arikayce PA and prerequisite regimen failure documentation

Initial: specialist/pulmonologist involvement
Required documentation: combination regimen use and culture or clinical nonresponse
Prerequisite therapy: failure of ≥6 months multidrug regimen (e.g., ethambutol, rifabutin, clofazimine)

Prior Authorization

Aristada PA and prerequisite oral Abilify documentation

Coverage duration: Lifetime
Required documentation for new starts: current use of oral Abilify and intent to switch for compliance
Prerequisite therapy: oral Abilify required

Documentation Required

Aristada required medical information for new starts

Aristada prior authorization must document the patient is on oral Abilify and the prescriber is switching to injectable therapy to improve compliance.

Required medical information for initial authorization: documentation of current oral Abilify use and rationale to switch

Prior Authorization

Armodafinil PA and renewal documentation

Armodafinil requires prior authorization with an initial 6‑month approval and renewal as lifetime; renewal requests must include documentation of reduced daytime sleepiness or improved functioning.

Initial: 6 months; Renewal: Lifetime
Renewal documentation: reduction in daytime sleepiness or improved functioning

Prior Authorization

Astagraf PA and prerequisite immediate‑release tacrolimus

Astagraf (tacrolimus ER) requires prior authorization; for Part D coverage in transplant patients, document failure of tacrolimus immediate‑release or why immediate‑release cannot be used.

Coverage duration: Lifetime
Prerequisite therapy: failure of tacrolimus immediate‑release or documented reason immediate‑release unsuitable for Part D coverage

Prior Authorization

Attruby PA and required diagnostic documentation

Required documentation: confirmatory diagnostic testing for ATTR
Prescriber: cardiologist or consult

Prior Authorization

Austedo PA, step therapy, renewal documentation, and exclusions

Initial: 6 months (HD and TD); Renewal: 12 months
Prerequisite therapy: failure/contraindication to tetrabenazine (and Ingrezza for TD)
Required renewal documentation: clinical response (e.g., improved chorea or reduced AIMS score)
Exclusions: suicidality, hepatic impairment, inadequately treated depression, concomitant MAOIs or reserpine

Prior Authorization

Auvelity PA and prerequisite antidepressant trials

Auvelity requires prior authorization and documentation of trial, intolerance, or contraindication to bupropion and an SSRI or SNRI prior to initiation unless intolerant/contraindicated.

Coverage duration: Lifetime
Prerequisite therapy: trial of bupropion and an SSRI or SNRI (or documented intolerance/contraindication)

Prior Authorization

Nexletol/Nexlizet PA, LDL criteria, and prerequisite therapies

Initial: 6 months; Renewal: Lifetime
Required documentation: LDL‑C >100 mg/dL (no CVD) or >55 mg/dL (with CVD)
Prerequisite therapy: failure/intolerance to a high‑intensity statin for 12 weeks and failure of PCSK9 inhibitor where applicable

Prior Authorization

Benlysta PA, required antibody documentation, prescriber, and exclusions

Initial: 6 months; Renewal: 12 months
Required documentation: ANA ≥1:80 or anti‑dsDNA ≥30 IU/ml and receipt of standard therapy
Prescriber: rheumatologist or nephrologist
Exclusion: severe active CNS lupus or use with other biologics/IV cyclophosphamide

Documentation Required

Benlysta required medical information for PA

Benlysta prior authorization specifically requires documentation of diagnosis, antibody positivity, prior/concurrent standard therapy, and prescriber specialty (rheumatologist or nephrologist).

Ensure ANA or anti‑dsDNA titers and standard therapy documentation are included
Prescriber specialty should be documented

Prior Authorization

Benznidazole PA, age restriction, and diagnostic confirmation

Age restriction: 2–12 years
Required documentation: trypomastigotes on microscopy, PCR detection of T. cruzi DNA, or two positive serologic tests using different techniques

Prior Authorization

Botulinum toxin PA, eligibility, and prerequisite therapy

Initial and renewal documentation: for chronic migraine, ≥15 headache days/month (initial) and evidence of response at renewal
Prerequisite therapy: failure of propranolol and topiramate for migraine; failure of two oral anticholinergics for urinary incontinence

Prior Authorization

Brivaracetam/Briviact PA and required prior antiseizure therapy

Coverage: Lifetime
Required documentation: failure of levetiracetam plus one or more specified antiseizure agents (lists differ for tablets vs suspension)
Suspension: inability to swallow oral dosage forms and failure of levetiracetam suspension

Prior Authorization

Bronchitol PA, age and diagnostic requirements, and exclusion

Initial: confirmation of cystic fibrosis diagnosis
Age: ≥18 years
Prescriber: pulmonologist or consultation
Exclusion: failure of bronchitol tolerance test

Prior Authorization

Buprenorphine PTWK PA and prerequisite therapy note

Buprenorphine PTWK (patch) is listed with prior authorization criteria; the policy notes prerequisite therapy is required and cites prior failure of morphine sulfate ER under other criteria.

Prerequisite therapy: prior failure of morphine sulfate ER noted under 'Other Criteria'
PA required with documentation per product entry

Prior Authorization

Cablivi PA and required aTTP documentation

Initial documentation: diagnosis of aTTP and plan to use with plasma exchange
Initial coverage: 90 days; Renewal durations vary (90 days if receiving plasma exchange; 58 days post plasma exchange)
Prescriber: hematologist

Prior Authorization

Camzyos PA and required cardiac documentation

Camzyos prior authorization requires documentation of NYHA class II or III obstructive hypertrophic cardiomyopathy and LVEF ≥55% initially (renewal >50%); prescriber must be a cardiologist.

Initial: NYHA class II or III and LVEF ≥55%
Initial: 6 months; Renewal: 12 months
Prescriber: cardiologist

Note

Prior authorization not specified in excerpt — verify product entries

This excerpt contains sections where prior authorization is not specified; verify product‑level entries for PA requirements when processing requests.

When PA not specified in an excerpt, check full product entry for requirements

Prior Authorization

Cancer drug PA requirement and required documentation

Required documentation: medical record confirming diagnosis
Prescriber: oncologist, hematologist, or other specialist per indication

Prior Authorization

Caplyta PA and step therapy for new starts

Caplyta requires prior authorization with lifetime coverage; new starts must document failure of listed alternative agents per indication (step therapy).

Coverage: Lifetime
Prerequisite therapy: depend on indication (e.g., schizophrenia—failure of two listed antipsychotics)

Prior Authorization

Carglumic acid PA and diagnostic confirmation

Initial: 3 months; Renewal: 12 months
Required documentation: diagnostic confirmation (e.g., DNA testing) and measurable treatment goals for hyperammonemia type III

Prior Authorization

Cayston PA, FEV1 and infection documentation, and step therapy

Coverage: 12 months
Age: ≥7 years
Required documentation: FEV1 25%–90% predicted and Pseudomonas infection
Step therapy: failure/resistance to tobramycin (TOBI)

Prior Authorization

Cerdelga and Cerezyme PA, diagnostic confirmation, and dosing notes

Initial: 6 months; Renewal: 12 months
Required documentation: diagnostic confirmation by enzyme assay or genotyping and objective treatment goals
Cerdelga: CYP2D6 metabolizer testing and dose limits

Prior Authorization

Chenodal PA, coverage duration, and step therapy

Coverage: 12 months
Required documentation: not a candidate for laparoscopic cholecystectomy
Step therapy: failure of ursodiol required

Prior Authorization

Cholbam PA, prescriber, and required documentation

Initial: 4 months; Renewal: 12 months
Prescriber: hepatologist or gastroenterologist
Required documentation: bile acid synthesis defect or peroxisomal disorder with liver disease manifestations

Prior Authorization

Cimzia and biologics — PA and prescriber requirements

Initial: 6 months; Renewal: 12 months
Prescriber: specialist per indication (dermatologist, rheumatologist, gastroenterologist, etc.)
Prior authorization required with indication‑specific documentation

Prior Authorization

Cosentyx PA, durations, and prerequisite therapy

Cosentyx products require prior authorization with initial approvals generally 6 months and renewals at 12 months; prerequisite Part D drug use is required per the policy.

Initial: 6 months; Renewal: 12 months
Prerequisite therapy: required (Part D drug)
Prescriber: specialist per indication

Prior Authorization

Cysteamine PA and required ophthalmic documentation

Initial: 6 months; Renewal: 12 months
Required documentation: corneal cysteine crystal deposits initially; reduction documented for renewal

Prior Authorization

Dalfampridine PA, exclusion, and baseline documentation

Initial: 6 months; Renewal: Lifetime
Exclusion: history of seizure or CrCl ≤50 mL/min
Required documentation: diagnosis of MS and timed 25‑foot walk prior to initiation

Step Therapy

Prerequisite therapy requirements and acceptable support

Prerequisite therapies must be FDA‑approved or supported by listed references (AHFS, Micromedex)
Common examples: NSAID failure for AS/nr‑axSpA; methotrexate trial for JIA; topical+systemic failure for PsO

Prior Authorization

Daybue PA and required diagnostic documentation

Daybue requires prior authorization with initial 6‑month approval and 12‑month renewal; initial documentation must confirm Rett syndrome.

Initial: 6 months; Renewal: 12 months
Required documentation: medical record confirmation of Rett syndrome

Prior Authorization

Deflazacort PA, diagnostic confirmation, and step therapy

Coverage duration: 12 months
Required documentation: genetic confirmation of Duchenne
Prerequisite therapy: failure or adverse effects to prednisone

Step Therapy

Lotronex step therapy requirement

Lotronex step therapy requires documented failure of loperamide and dicyclomine prior to approval.

Prerequisite therapy: failure of loperamide and dicyclomine must be documented

Prior Authorization

Diacomit PA and required concomitant medication documentation

Diacomit requires prior authorization for members newly starting the drug and must be taken with clobazam; document Dravet syndrome in the medical record.

Required documentation: medical record confirmation of Dravet syndrome and that Diacomit will be taken with clobazam
PA applies to new starts

Prior Authorization

Dificid PA and required infection documentation

Coverage duration: 10 days
Required documentation: medical record evidence of C. difficile infection
Oral powder for suspension: document inability to swallow solid oral dosage forms

Denial Risk

Dificid prerequisite therapy and documentation denial risk

Dificid prior authorization also notes prerequisite therapy is required for initial requests and lack of documentation of C. difficile infection may lead to denial.

Prerequisite therapy: required (policy item)
Denial risk: absence of documentation of C. difficile infection

Prior Authorization

Dojolvi PA and renewal documentation

Initial: 6 months; Renewal: 12 months
Required documentation: diagnosis of LC‑FAOD and renewal evidence of clinical improvement

Prior Authorization

Doptelet PA and required platelet documentation

ITP initial: platelets <30,000/mm3; ITP renewal: 30,000–150,000/mm3
Chronic liver disease thrombocytopenia: platelets <50,000/mm3 for procedure‑related use
Prescriber: hematologist or surgeon

Prior Authorization

Dronabinol PA and prerequisite antiemetic trials

Dronabinol capsules require prior authorization (coverage 12 months) for chemotherapy‑associated nausea/vomiting after failure of specified antiemetics; document prior antiemetic trials.

Coverage: 12 months
Prerequisite therapy: failure of at least one antiemetic (dimenhydrinate, meclizine, metoclopramide, promethazine, prochlorperazine, and ondansetron)

Prior Authorization

Droxidopa PA and renewal documentation

Droxidopa requires prior authorization with initial 6‑month approval and 12‑month renewal; renewal requests must document treatment response (reduced lightheadedness/dizziness/falls).

Initial: 6 months; Renewal: 12 months
Required renewal documentation: clinical response such as decreased lightheadedness, dizziness or falls

Prior Authorization

Dupixent PA and indication‑specific documentation

Initial: typically 6 months; Renewal: 12 months
Required baseline documentation: e.g., BSA for AD, eosinophil counts for asthma/E‑COPD, biopsy confirmation for EoE
Prerequisite therapy: required for many indications

Prior Authorization

Prior authorization: general summary of durations and documentation expectations

Initial commonly 6 months; renewals commonly 12 months
Indication‑specific baseline measures and renewal evidence of clinical response required

Prior Authorization

Eltrombopag PA criteria and required platelet documentation

ITP initial: platelets <30,000/mm3; ITP renewal: 30,000–150,000/mm3
Hep C thrombocytopenia initial: platelets <75,000/mm3
Chronic ITP requires prior failure of systemic corticosteroids, IVIG, or splenectomy

Denial Risk

Common denial triggers — missing documentation and prerequisite therapies

Denial risks: missing diagnosis documentation, missing prerequisite therapy failures, missing diagnostic confirmation (DNA testing, enzyme assay, flow cytometry, biopsy)
Include baseline measures (BSA, eosinophils, platelet counts, LDL) and prior therapy history

Prior Authorization

Empaveli PA and required diagnostic confirmation

Initial: 6 months; Renewal: 12 months
PNH documentation: high‑sensitivity flow cytometry
C3G/IC‑MPGN documentation: biopsy confirmation and proteinuria ≥1 g/day and protein/creatinine ≥1 g/g

Prior Authorization

Enbrel PA criteria and prerequisite therapy

Initial: 6 months; Renewal: 12 months
Required documentation: disease‑specific baseline and renewal measures (e.g., BSA for psoriasis, tender/swollen joint counts)
Prior therapy failures required for certain indications (e.g., NSAID for AS, methotrexate for JIA)

Initial Therapy Criteria (per-product)

Continuation / Renewal Criteria

Step Therapy and Prerequisite Treatments

Requirement	Details
Prerequisite therapy required
Initial therapy for many biologic indications requires documented failure of specified prior agents (examples: AS/nr-axSpA: failure of one NSAID; JIA: 8-week methotrexate trial; PsO: failure of topical agent plus methotrexate or cyclosporine).
Policy expectation
Prerequisite therapies must be documented in the medical record; criteria indicates use of a prerequisite Part D drug where specified.

Requirement	Details
Failure of levodopa/carbidopa and adjunct agent
Initial approval requires documented failure of maximally tolerated oral levodopa/carbidopa AND failure of one additional listed agent (selegiline, ropinirole, pramipexole, entacapone); step therapy to Ongentys referenced.
Prescriber
Must be prescribed by or in consultation with a neurologist; renewal requires documentation that 'off' time has been reduced.

Requirement	Details
Failure of loperamide and dicyclomine
Lotronex (alosetron) initial approval requires prior failure of loperamide and dicyclomine; initial documentation of predominant severe diarrhea for ≥6 months is required.
Age restriction
Age ≥18 years for initial use; contraindications (e.g., constipation, intestinal obstruction, ischemic colitis, severe hepatic impairment) exclude coverage.

Requirement	Details
Failure of prednisone and deflazacort
Agamree initial approval requires documented failure of prednisone and deflazacort; genetic testing confirming Duchenne muscular dystrophy is required.
Prescriber / Coverage
Prescribed by or in consultation with a neurologist or Duchenne specialist; coverage duration: 12 months.

Requirement	Details
Failure of Kineret prior to Arcalyst for DIRA
For Deficiency of Interleukin-1 Receptor Antagonist (DIRA), Arcalyst coverage requires prior failure of Kineret (anakinra) documented in the medical record.
Prescriber
Prescribed by or in consultation with an immunologist or geneticist for DIRA; initial coverage 6 months, renewal 12 months.

Requirement	Details
Failure of or contraindication to Reblozyl
Aqvesme for transfusion-dependent beta thalassemia requires documentation of failure of or contraindication to Reblozyl prior to approval.
Other requirements
Initial confirmation of alpha or beta thalassemia by genetic testing or hemoglobin analysis; patient ≥18 years; prescriber involvement: hematologist; initial 6 months, renewal 12 months.

Requirement	Details
Prerequisite Part D drug required
Members newly starting Aristada must have documentation that the patient is currently taking oral Abilify (aripiprazole) and the prescriber intends to switch to the long-acting injectable to improve compliance.
Coverage duration
Coverage duration: Lifetime.

Requirement	Details
Failure of tetrabenazine (and Ingrezza for TD where noted)
Austedo initial criteria require failure of or contraindication to tetrabenazine; for tardive dyskinesia, failure of Ingrezza is also required where noted.
Prescriber / Duration
Prescribed by or in consultation with a neurologist (HD) or movement disorder specialist/psychiatrist (TD); initial 6 months, renewal 12 months; exclusions apply (suicidality, hepatic impairment, inadequately treated depression).

Requirement	Details
Failure/intolerance to high-intensity statin and PCSK9 agents where indicated
Nexletol/Nexlizet initial approval requires documentation of LDL-C thresholds (LDL-C >100 mg/dL without CVD or >55 mg/dL with CVD), failure/intolerance to a high-intensity statin for 12 weeks, and failure of PCSK9 agents (Repatha or Praluent) where applicable.
Age / Prescriber
Age ≥18 years; prescribed by or in consultation with cardiologist or endocrinologist; initial 6 months, renewal lifetime.

Requirement	Details
Document medication failures per formulation
Brivaracetam/Briviact criteria specify different prior failure requirements for tablets versus suspension (e.g., tablets: failure of levetiracetam plus one additional antiseizure agent from a listed set; suspension: inability to swallow solids plus analogous failure requirements). Document formulation-specific failures in the medical record.

Requirement	Details
Prerequisite therapy must be FDA‑approved or supported by listed references
The policy requires prerequisite therapy to be for an FDA‑approved indication or, if off‑label, supported by AHFS Drug Information or Micromedex DrugDex (cancer off‑label uses require NCCN or other listed references). The policy also clarifies when a prerequisite Part D drug is required or not.

Requirement	Details
Documented trial and failure of listed therapies prior to Dupixent
Dupixent initial approval is indication-specific and requires documentation of prior trials/failures as listed (examples: AD — failure of a very high‑potency topical steroid and tacrolimus or documentation topical therapy inappropriate; asthma — trial and failure of ICS+LABA). Criteria indicates use of a prerequisite Part D drug where specified.

Requirement	Details
Failure or intolerance to hydroxyurea required
L‑glutamine (ENDARI) requires medical record documentation of failure of or intolerance to hydroxyurea prior to approval; renewal requires documentation that the drug has reduced the number of sickle cell crises.

Requirement	Details
Prior failures required for chronic ITP
Eltrombopag for chronic ITP requires documentation that systemic corticosteroids, immunoglobulin replacement, or splenectomy were tried and the disease was refractory; initial platelet count thresholds and prescriber restrictions apply (ITP initial: platelets <30,000/mm3).

Requirement	Details
Prior therapy failures required for certain Enbrel indications
Some Enbrel indications require documented failure of specified prior therapies (examples: AS — failure of one oral NSAID; JIA — failure of methotrexate for ≥8 weeks; PsO — failure of topical plus systemic agents). Documentation of these prior therapy failures is required for initial approval.