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CurrentBlue Cross Blue Shield - South CarolinaPolicy N/A

Drug-specific coverage criteria for specialty medications (partial list)

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Formulary coverage criteria, required medical information, prescriber restrictions, coverage durations, and reauthorization requirements for multiple specialty drugs for Blue Cross Blue Shield - South Carolina members.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyDrug-specific coverage criteria for specialty medications (partial list)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Last ReviewNov 3, 2025

Next Review DateN/A

Key ActionObtain prior authorization with required diagnostic documentation and proof of trial/failure or intolerance to specified prior therapies where indicated.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥15products with detailed criteria in this extract

12 momost common coverage duration

6 mocommon initial approval length

manyrequire specialist prescribing

Drug-Specific Coverage Criteria

General product coverage criteria (pattern) "Initial/Continuation"

Covered when ALL of the following are met for each listed indication as specified:

Diagnosis: Documented diagnosis consistent with the specified indication (e.g., RA, PJIA, PsA, PsO, AS, CD, UC, uveitis, PAH, SEGA, AAT deficiency, etc.)

See product-specific lines for exact phrasing

Prior therapy or severity requirement: Where required, documentation of trial and failure, contraindication, or intolerance (TF/C/I) to specified conventional therapies or demonstration of disease severity (e.g., BSA for psoriasis, migraine days for CGRP inhibitors)varies by indication (see thresholds)

Examples: RA requires 3-month TF/C/I to methotrexate/leflunomide/sulfasalazine; PsO requires 4-week TF/C/I to topical therapies; Aimovig and other CGRP agents require migraine day thresholds

Prescriber restriction:

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyDrug-specific coverage criteria for specialty medications (partial list)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2025

Last ReviewNov 3, 2025

Next Review DateN/A

Key ActionObtain prior authorization with required diagnostic documentation and proof of trial/failure or intolerance to specified prior therapies where indicated.

SourceLink

On This Page

Initial prescriptions for certain indications must be by or in consultation with the listed specialist (e.g., rheumatologist for RA, dermatologist for PsO, gastroenterologist for IBD)

Prescriber specialty requirements listed per indication

Coverage duration and reauthorization: Initial approvals commonly 6 months (some indications shorter) with reauthorization typically 12 months when patient demonstrates positive clinical responseInitial and reauth durations specified per product/indication

Examples: many biologics initial 6 mo, reauth 12 mo; UC initial 12 wks for some agents

Dalfampridine ER — Initial

Dalfampridine ER — MS (initial): Covered when ALL of the following are met

Dalfampridine ER initial criteria: 1) Diagnosis of multiple sclerosis; 2) Physician confirmation that patient has difficulty walking (e.g., timed 25-foot walk test); 3) One of: EDSS ≤ 7 OR not restricted to using a wheelchair (if EDSS not measured); 4) Prescribed by or in consultation with a neurologist.

Coverage duration: initial 6 months; reauthorization 12 months with documentation of improved walking (physician confirmation).

Benlysta — SLE Initial

Benlysta — Systemic lupus erythematosus (initial): Covered when ALL of the following are met

Benlysta SLE initial: 1) Diagnosis of active systemic lupus erythematosus (SLE); 2) Autoantibody positive defined as ANA ≥ 1:80 OR anti-dsDNA ≥ 30 IU/mL; 3) Currently receiving at least one standard-of-care treatment for active SLE (e.g., antimalarials, corticosteroids, or immunosuppressants); 4) Prescribed by or in consultation with a rheumatologist.

Coverage duration: initial and reauth 6 months; reauth requires demonstration of positive clinical response.

Benlysta — Lupus Nephritis Initial

Benlysta — Lupus nephritis (initial): Covered when ALL of the following are met

Benlysta lupus nephritis initial: 1) Diagnosis of active lupus nephritis; 2) Currently receiving standard-of-care therapy for lupus nephritis (for example corticosteroids with mycophenolate or cyclophosphamide); 3) Prescribed by or in consultation with a nephrologist or rheumatologist.

Coverage duration: initial and reauth 6 months; reauth requires demonstration of positive clinical response.

Arikayce — MAC lung disease

Arikayce — MAC lung disease: Covered when ALL of the following are met

Arikayce criteria: 1) Diagnosis of Mycobacterium avium complex (MAC) lung disease; 2) Used as part of a combination antibacterial regimen; 3) Patient did not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen; 4) Prescribed by or in consultation with an infectious disease specialist or pulmonologist.

Coverage duration: 12 months.

Augtyro — tumor-specific

Augtyro — NSCLC and solid tumors: Covered when ALL of the following are met

Augtyro criteria: NSCLC: diagnosis of locally advanced or metastatic NSCLC with ROS1 rearrangement–positive tumor(s). Solid tumors: unresectable/locally advanced/metastatic solid tumor with NTRK gene fusion and disease progressed after prior treatment or no satisfactory alternatives available.

Prescribed per oncology standards; coverage duration 12 months; continuation of prior therapy may be approved.

Teriflunomide — MS

Teriflunomide — MS: Covered when ALL of the following are met

Teriflunomide criteria: 1) Diagnosis of a relapsing form of multiple sclerosis (clinically isolated syndrome, relapsing‑remitting, or secondary progressive with active disease); 2) Not used in combination with another disease‑modifying therapy for MS; 3) Prescribed by or in consultation with a neurologist.

Coverage duration: initial and reauth 12 months; reauth requires demonstration of positive clinical response.

Bronchitol — CF Initial

Bronchitol — Cystic Fibrosis (initial): Covered when ALL of the following are met

Bronchitol CF initial: 1) Diagnosis of cystic fibrosis; 2) Patient passed the Bronchitol Tolerance Test (BTT); 3) Prescribed by or in consultation with a pulmonologist or CF center specialist; 4) Patient age ≥ 18 years.

Coverage duration: initial 6 months; reauthorization 12 months with evidence of clinical benefit.

Cablivi — aTTP

Cablivi — acquired TTP: Covered when ALL of the following are met

Cablivi aTTP criteria: 1) Diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP); 2) First dose administered by healthcare provider as bolus IV injection; 3) Used in combination with immunosuppressive therapy (e.g., rituximab, glucocorticoids); 4) Either used in combination with plasma exchange OR patient completed plasma exchange and <59 days have elapsed since last plasma exchange; 5) Prescribed by or in consultation with a hematologist or oncologist.

Coverage duration: 3 months.

Antipsychotic product indications (schizophrenia, bipolar)

Covered when ALL of the following are met for schizophrenia or bipolar indications as specified:

Schizophrenia initial: Diagnosis of schizophrenia AND trial and failure, contraindication, or intolerance to two listed oral generic atypical antipsychotics (asenapine, aripiprazole, olanzapine, paliperidone, quetiapine IR/ER, risperidone, ziprasidone)two agents

Coverage duration 12 months; prescribe per psychiatry guidance

Pyrimethamine (toxoplasmosis) coverage

Covered when ALL of the following are met:

Toxoplasmosis indication: Pyrimethamine used for active treatment, secondary prophylaxis, or congenital toxoplasmosis OR for primary prophylaxis when TMP‑SMX intolerance documented with desensitization attempted or life‑threatening prior reaction; prescribed by or in consultation with an infectious disease specialist

Requests for pyrimethamine for malaria treatment or prophylaxis are not authorized; coverage duration 12 months.

Cinryze for HAE prophylaxis

Covered when ALL of the following are met:

HAE prophylaxis initial: Diagnosis of hereditary angioedema (HAE) confirmed by C1‑INH antigenic or functional level below the lower limit of normal; used for prophylaxis against HAE attacks; not used in combination with other approved prophylactic HAE treatments; prescribed by or in consultation with an immunologist or allergistage ≥ 6 years

Coverage duration: initial and reauth 12 months; reauth requires demonstration of positive clinical response.

Cosentyx (secukinumab) indications and reauth criteria

Covered when specified disease‑specific criteria and prior therapy trials are met:

Plaque psoriasis initial: Diagnosis of moderate to severe plaque psoriasis with ≥3% BSA involvement or severe scalp/palmoplantar/facial/genital involvement AND trial and failure, contraindication, or intolerance to a 4‑week topical therapy (corticosteroid, vitamin D analog, tazarotene, or calcineurin inhibitor)BSA ≥3% or specified locations

Prescribed by/with dermatologist; Cosentyx initial coverage 6 months; reauth requires documented clinical response.

Psoriatic arthritis initial: Diagnosis of active PsA with actively inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement AND trial and failure/intolerance/contraindication to specified systemic agents or continuation of prior therapy

Initial coverage 6 months; reauth requires clinical improvement documentation.

Ankylosing spondylitis / nr‑axSpA initial: Diagnosis of active AS or non‑radiographic axial spondyloarthritis with objective signs of inflammation AND trial and failure of specified NSAIDs (AS) or demonstration of objective MRI/CRP for nr‑axSpA1‑month NSAID trial for AS; objective MRI/CRP for nr‑axSpA

Initial coverage 6 months; reauth requires documented clinical response.

Cayston for cystic fibrosis

Covered when ALL of the following are met:

CF initial/reauth: Diagnosis of cystic fibrosis AND evidence of Pseudomonas aeruginosa in the lungs; prescribed by or in consultation with CF specialistage ≥ 7 years for initial use

Coverage duration 12 months; reauth requires evidence of clinical benefit such as improved FEV1 or fewer exacerbations.

Chenodal for radiolucent gallstones

Covered when ALL of the following are met:

Radiolucent gallstones initial: Diagnosis of radiolucent gallstones with a well‑opacifying gallbladder on oral cholecystography AND trial and failure/intolerance/contraindication to ursodiol AND patient is not a surgical candidate AND stones are not calcified

Prescribed by or in consultation with a gastroenterologist; coverage duration 12 months; reauth requires imaging re‑evaluation.

Cholbam for bile acid synthesis / peroxisomal disorders

Covered when criteria differ by indication:

Bile acid synthesis disorders initial: Diagnosis of bile acid synthesis disorder due to single enzyme defect based on abnormal urinary bile acid analysis by mass spectrometry OR molecular genetic testing consistent with the diagnosis

Initial coverage 4 months; reauth 12 months with evidence of clinical response; prescriber: hepatologist/geneticist/pediatric gastroenterologist or metabolic specialist.

Peroxisomal disorders initial: Diagnosis of peroxisomal disorder by abnormal urinary bile acid analysis OR molecular genetic testing AND presence of clinical features (liver disease, steatorrhea, or fat‑soluble vitamin complications) AND use as adjunctive therapy

Initial 4 months; reauth 12 months with clinical improvement documentation; specialist prescribing required.

Cyclobenzaprine age-related PA and indications

Covered when specified clinical conditions are met and prescriber acknowledges risks:

Muscle spasm: Diagnosis of muscle spasm associated with acute painful musculoskeletal conditionscoverage duration 4 weeks

Prescriber must acknowledge anticholinergic risks; PA applies to patients ≥65 years.

Fibromyalgia off‑label: Diagnosis of fibromyalgia when used for severe sleep disturbancecoverage duration 12 weeks

Off‑label use must be documented; prescriber to consider anticholinergic risk.

Pyrimethamine: Toxoplasmosis

Pyrimethamine — Toxoplasmosis coverage (Initial or prophylaxis): Covered when ALL of the following are met

Pyrimethamine - toxoplasmosis criteria: 1) Patient is using pyrimethamine for active toxoplasmosis treatment, secondary prophylaxis, or congenital toxoplasmosis OR 2) For primary prophylaxis: patient had intolerance to TMP‑SMX and was re‑challenged with desensitization and remains intolerant, or has history of life‑threatening reaction to TMP‑SMX; AND prescribed by or in consultation with an infectious disease specialist; AND coverage duration limited to 12 months.

Deferasirox: Transfusional iron overload

Deferasirox — Chronic iron overload (Initial): Covered when ALL of the following are met

Deferasirox - transfusional iron overload initial: Diagnosis of chronic iron overload due to blood transfusions; baseline ferritin > 1,000 mcg/L; history of transfusion of at least 100 mL/kg packed RBCs; patient age ≥2 years for transfusional indication; prescribed by or in consultation with appropriate specialistferritin >1000 mcg/L; transfusion ≥100 mL/kg

Coverage duration 12 months; reauth requires reduction in ferritin or clinical response.

Diacomit: Dravet syndrome

Diacomit — Dravet syndrome (Initial): Covered when ALL of the following are met

Diacomit - Dravet syndrome: 1) Diagnosis of seizures associated with Dravet syndrome; 2) Used in combination with clobazam; 3) Patient weight ≥ 7 kg; 4) Patient age ≥ 6 months; 5) Prescribed by or in consultation with a neurologist>=7 kg

Coverage duration 12 months; reauth allows continuation of prior therapy.

Enbrel: RA, PJIA, Psoriasis, AS

Enbrel — Rheumatologic and dermatologic indications (Initial): Covered when ALL of the following are met

Enbrel - RA initial: Diagnosis of moderately to severely active rheumatoid arthritis; minimum 3‑month trial and TF/C/I to one conventional DMARD at maximally tolerated dose (methotrexate, leflunomide, sulfasalazine); prescribed by or in consultation with a rheumatologist3 months trial

Initial coverage 6 months; reauth 12 months.

Enbrel - PJIA initial: Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis; minimum 6‑week trial and TF/C/I to methotrexate or leflunomide at maximally tolerated dose; prescribed by or in consultation with a rheumatologist6 weeks trial

Initial coverage 6 months; reauth 12 months.

Enbrel - Plaque psoriasis initial: Diagnosis of moderate to severe chronic plaque psoriasis with ≥3% BSA involvement or severe scalp/palmoplantar/facial/genital disease; minimum 4‑week trial and TF/C/I to topical therapies; prescribed by or in consultation with a dermatologistBSA ≥3% or specified locations; 4 weeks trial

Initial coverage 6 months; reauth requires documented clinical response.

Dupixent: Indication-specific criteria

Dupixent — Multiple indications (Initial): Covered when the listed indication‑specific criteria are met

Dupixent indications: Indications include eosinophilic asthma, corticosteroid‑dependent asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, atopic dermatitis, COPD with type‑2 inflammation, bullous pemphigoid, chronic spontaneous urticaria — each requires diagnosis confirmation, indication‑specific prior therapy trials or biomarker thresholds (e.g., eosinophils), age and prescriber restrictions as specifiedvaries by indication

Coverage durations variable (typically 6–12 months); prescriber specialty and prior therapy trials required per indication.

Emgality: Migraine and cluster headache

Emgality — Headache indications (Initial): Covered when ALL of the following are met

Emgality - migraine/cluster: Episodic migraine: ≥4 migraine days/month (120 mg/mL strength only); Chronic migraine: ≥8 migraine days/month (120 mg/mL strength only) with medication overuse considered and managed; Episodic cluster headache: meets cluster period definitions; medication not used in combination with another injectable CGRP inhibitor; age ≥18 years; prescribed per neurology/headache specialist as indicatedEM ≥4 days/month; CM ≥8 days/month

Initial coverage 3–6 months depending on indication; reauth 12 months with documented response.

Evrysdi coverage criteria

Evrysdi coverage criteria — Covered when ALL of the following are met

Evrysdi Initial: 1) Diagnosis of spinal muscular atrophy (SMA) type I, II, or III with qualifying SMN1 mutation/deletion; 2) At least 2 copies of SMN2; 3) Not dependent on invasive ventilation or NIV beyond naps/nighttime; 4) Baseline motor exam documented using an age‑appropriate validated scale (HINE‑2, HFMSE, RULM, CHOP‑INTEND, MFM‑32, or BSID‑III Item 22); 5) Not receiving concomitant chronic SMN‑modifying gene therapy (e.g., Spinraza); 6) If prior gene therapy received, documentation of inadequate response (sustained decrease in at least one motor test over 6 months)

Prescribed by or in consultation with neurologist experienced in SMA; coverage initial and reauth 12 months; reauth requires documented clinical benefit.

Fasenra asthma and EGPA criteria

Fasenra — Covered when ALL of the following are met (age‑dependent branches)

Age‑based asthma eligibility: Branch A (ages 6–11): baseline blood eosinophils ≥150 cells/µL, ≥2 exacerbations requiring systemic steroids in past 12 months or prior asthma hospitalization, and current treatment with medium‑dose ICS plus additional controller OR medium‑dose combination ICS/LABA; Branch B (≥12 years): baseline eosinophils ≥150 cells/µL, same exacerbation/hospitalization criteria, and current treatment with high‑dose ICS plus additional controller OR maximally‑dosed combination ICS/LABAeosinophils ≥150 cells/µL

Prescribed by or in consultation with pulmonologist or allergist/immunologist; initial coverage 6 months, reauth 12 months.

Icatibant (Sajazir) criteria

Covered when ALL of the following are met:

Icatibant for acute HAE attacks: Diagnosis of hereditary angioedema confirmed by C1‑INH antigenic or functional deficiency (level below lower limit of normal); indicated for treatment of acute HAE attacks only; not used in combination with other approved acute HAE treatments; prescribed by or in consultation with an immunologist or allergistC1‑INH level below LLN; age ≥18 for initial use

Coverage duration 12 months; reauth requires demonstration of clinical benefit.

Fabrazyme criteria

Fabrazyme — Covered when ALL of the following are met

Fabrazyme coverage: 1) Diagnosis of Fabry disease documented by pathogenic GLA mutation OR deficient alpha‑galactosidase A enzyme activity OR significant clinical manifestations consistent with Fabry disease (neuropathic pain, cardiomyopathy, renal insufficiency, angiokeratomas, cornea verticillata); 2) Patient age ≥2 years for initial therapy; 3) Not used in combination with other Fabry disease drugsage ≥2 years

Initial and reauth coverage 12 months; reauth requires documented positive clinical response.

Erythropoiesis-stimulating agent (Procrit) criteria

Erythropoiesis‑stimulating agent (Procrit) — Covered when ALL of the following are met depending on indication

Procrit indication branches: Branches include anemia with CKD, anemia with chemotherapy, preoperative reduction of transfusion need, anemia with HCV due to ribavirin, anemia with HIV, MDS — each requires diagnosis, specific lab thresholds (Hct/Hgb) within specified timeframes, and additional condition‑specific requirements (e.g., dialysis status, chemotherapy receipt, serum erythropoietin where required)varies by branch (see lab thresholds)

Coverage durations vary by indication (1–12 months); reauth requires demonstration of clinical response.

Acute hereditary angioedema (HAE) treatment

HAE — acute treatment: Covered when ALL of the following are met

HAE acute treatment criteria: 1) Diagnosis of hereditary angioedema confirmed by C1‑INH antigenic level below LLN OR C1‑INH functional level below LLN; 2) Indication limited to treatment of acute HAE attacks; 3) Not used in combination with other approved treatments for acute HAE attacks; 4) Initial age ≥18 years; 5) Prescribed by or in consultation with an immunologist or allergist; 6) Coverage duration initial and reauth 12 months; 7) Reauth requires demonstration of positive clinical responseage ≥18

Do not combine with other approved acute HAE treatments.

Hereditary angioedema (HAE) prophylaxis

HAE — prophylaxis: Covered when ALL of the following are met

HAE prophylaxis criteria: 1) Diagnosis of hereditary angioedema confirmed by C1‑INH antigenic or functional level below LLN; 2) For prophylaxis against HAE attacks; 3) Not used in combination with other approved prophylactic HAE treatments; 4) Initial age ≥6 years; 5) Prescribed by or in consultation with an immunologist or allergist; 6) Coverage duration initial and reauth 12 months; 7) Reauth requires demonstration of positive clinical responseage ≥6

Do not combine with other approved prophylactic HAE treatments.

Humira (adalimumab) coverage criteria

Humira (adalimumab) — Covered when ALL of the following are met (indication‑specific)

Humira covered indications: Indications include RA, PJIA, PsA, PsO, AS, Crohn's disease, ulcerative colitis, uveitis and others listed; for each indication, additional criteria (diagnosis, prior therapy trials, severity thresholds) apply as specifiedvaries by indication

See individual indication nodes for trials and prescriber requirements.

RA Humira initial criteria: 1) Diagnosis of moderately to severely active RA; 2) Minimum 3‑month trial and TF/C/I to one conventional DMARD at maximally tolerated dose (methotrexate, leflunomide, or sulfasalazine); 3) Prescribed by or in consultation with a rheumatologist; 4) Coverage: initial 6 months, reauth 12 months

Step therapy required: trial of conventional DMARD.

Plaque Psoriasis Humira initial criteria: 1) Diagnosis of moderate to severe plaque psoriasis meeting ≥3% BSA or severe scalp/palmoplantar/facial/genital involvement; 2) Minimum 4‑week trial and TF/C/I to topical therapies; 3) Prescribed by or in consultation with a dermatologist; 4) Coverage: initial 6 months, reauth 12 monthsBSA ≥3%

Topical therapy trial required.

Growth hormone (Genotropin) coverage criteria

Growth hormone (Genotropin) — Covered when ALL of the following per indication are met

Genotropin indications: Indications include pediatric GHD, Prader‑Willi, SGA, Turner/Noonan, SHOX deficiency, congenital renal insufficiency, idiopathic short stature, adult GHD; diagnostic and testing requirements vary by indicationvaries by indication

Refer to specific indication criteria for stimulation test thresholds, bone age, growth charts, and specialist prescribing.

Adult GHD initial criteria: 1) Diagnosis of adult‑onset GHD with clinical records supporting hypothalamic‑pituitary disease OR childhood‑onset GHD; 2) One GH stimulation test confirming peak GH at or below thresholds (ITT ≤5 mcg/L; glucagon ≤3 mcg/L; macimorelin <2.8 ng/mL) OR documentation of deficiency of 3 anterior pituitary hormones plus low IGF‑1; 3) Prescribed by or in consultation with an endocrinologist; 4) Coverage duration 12 months; 5) Reauth requires IGF‑1 monitoring within prior 12 monthsITT ≤5 mcg/L; glucagon ≤3 mcg/L; macimorelin <2.8 ng/mL

Specific stimulation test thresholds required.

Multiple sclerosis disease-modifying therapies

Multiple sclerosis disease‑modifying therapies — Covered when ALL of the following are met

MS therapy initial criteria: 1) Diagnosis of a relapsing form of MS (clinically isolated syndrome, relapsing‑remitting, secondary progressive with active disease); 2) Not used in combination with another disease‑modifying therapy for MS; 3) Prescribed by or in consultation with a neurologist; 4) Coverage duration 12 months; 5) Reauth requires demonstration of positive clinical response (stability in radiologic disease activity, clinical relapses, or disease progression).

Combination use with other DMTs is excluded.

Gattex (teduglutide) for short bowel syndrome

Gattex (teduglutide) for short bowel syndrome — Covered when ALL of the following are met

Gattex SBS initial criteria: 1) Diagnosis of short bowel syndrome; 2) Patient dependent on parenteral nutrition/IV support for at least 12 months with documentation (chart notes, labs); 3) Prescribed by or in consultation with a gastroenterologist; 4) Coverage duration: initial 6 months, reauth 12 months; 5) Reauth requires documentation of reduction in weekly PN/IV support from baseline while on therapy.>=12 months PN dependence

Specialist prescribing recommended.

Gamastan (IM immune globulin)

Gamastan (IM immune globulin) — Covered when ALL of the following are met

Gamastan IM criteria: 1) Immune globulin is being administered intramuscularly at minimum effective dose and appropriate frequency for the diagnosis; 2) Indication is immunization prophylaxis for hepatitis A, measles, rubella, or varicella; 3) Prescribed per immunology/infectious disease guidance

Coverage duration: 14 days.

Rheumatoid Arthritis (Initial)

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

RA initial coverage: Diagnosis of moderately to severely active rheumatoid arthritis; minimum 3‑month trial and TF/C/I to one of: methotrexate, leflunomide, sulfasalazine at maximally tolerated doses; prescribed by or in consultation with a rheumatologist3 months trial

Initial coverage commonly 6 months; reauth 12 months with documented response.

Polyarticular JIA (Initial)

Covered when ALL of the following are met for Polyarticular Juvenile Idiopathic Arthritis (initial):

PJIA initial coverage: Diagnosis of moderately to severely active polyarticular JIA; minimum 6‑week TF/C/I to leflunomide or methotrexate at maximally tolerated doses; prescribed by or in consultation with a rheumatologist6 weeks trial

Initial coverage 6 months; reauth 12 months with documented improvement.

Psoriatic Arthritis (Initial)

Covered when ANY of the following disease manifestations are present for Psoriatic Arthritis (initial):

PsA initial coverage: Diagnosis of active psoriatic arthritis with at least one of: actively inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement; prescribed by or in consultation with a dermatologist or rheumatologist

Initial coverage 6 months; reauth 12 months with evidence of clinical response.

Plaque Psoriasis (Initial)

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

Psoriasis initial coverage: Diagnosis of moderate to severe chronic plaque psoriasis AND one of: ≥3% BSA involvement, severe scalp, or palmoplantar/facial/genital involvement; minimum 4‑week TF/C/I to topical therapies (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors)4 weeks trial; BSA ≥3% or specified locations

Prescribed by or in consultation with a dermatologist; initial coverage 6 months.

Ankylosing Spondylitis (Initial)

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

AS initial coverage: Diagnosis of active ankylosing spondylitis; minimum 1‑month TF/C/I to one NSAID at maximally tolerated dose (e.g., ibuprofen, naproxen); prescribed by or in consultation with a rheumatologist1 month NSAID trial

Initial coverage 6 months; reauth 12 months with documented clinical response.

Crohn's Disease (Initial)

Covered when ALL of the following are met for Crohn's Disease (initial):

CD initial coverage: Diagnosis of moderately to severely active Crohn's disease AND one of: frequent diarrhea and abdominal pain, ≥10% weight loss, complications (obstruction, fever, abdominal mass), abnormal labs (e.g., CRP), OR CDAI >220; trial and failure/contraindication/intolerance to conventional therapies (e.g., 6‑MP, azathioprine, corticosteroids, methotrexate); prescribed by or in consultation with a gastroenterologistCDAI >220 optional

Initial coverage 6 months; reauth 12 months with documented response.

Ulcerative Colitis (Initial)

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

UC initial coverage: Diagnosis of moderately to severely active ulcerative colitis AND one of: >6 stools/day, frequent blood in stools, urgency, ulcers, abnormal labs (e.g., hemoglobin, ESR, CRP), OR steroid‑dependent/refractory disease; trial and failure/contraindication/intolerance to conventional therapies (corticosteroids, aminosalicylates, azathioprine, 6‑MP); prescribed by or in consultation with a gastroenterologist>6 stools/day option

UC initial coverage 12 weeks for some products; reauth 12 months with documented clinical response.

Hidradenitis Suppurativa (Initial)

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

HS initial coverage: Diagnosis of moderate to severe hidradenitis suppurativa (Hurley Stage II or III); prescribed by or in consultation with a dermatologist

Initial coverage 6 months; reauth 12 months with evidence of clinical response.

Reauthorization / Continuation Criteria

Reauthorization / Continuation Criteria — Reauthorization covered when ANY of the following response criteria are met:

Reauth response criteria: Demonstrated positive clinical response from baseline using disease‑specific measures (examples: reduction in swollen/tender joint count for RA/PJIA; reduction in BSA for psoriasis; mucosal healing or lab improvement for CD/UC; improvement in symptoms or function for AS)

Documentation of response required to justify continued coverage for 12 months.

Prior biologic requirement (where specified)

Additional coverage constraints:

Remicade/Infliximab prior biologic requirement: For certain agents and indications, initial approval may require prior trial and failure or intolerance to Remicade (infliximab) or documented prior biologic as specified

Document prior use and reason for discontinuation when applicable.

Prior Authorization, Documentation & Step Therapy Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for specialty medications listed in this policy; submit documentation of the indicated diagnosis and any required prior therapy trials, confirmatory testing, and prescriber specialty as specified for the product/indication.

Prior Authorization

Dalfampridine ER prior authorization

Dalfampridine ER requires prior authorization for MS initial use; include physician confirmation of walking difficulty (eg, timed 25-foot walk), and documentation that EDSS ≤ 7 or the patient is not restricted to a wheelchair; initial approval is 6 months with reauthorization to 12 months contingent on documented walking improvement.

Prior Authorization

Benlysta prior authorization

Benlysta (SLE and lupus nephritis) requires prior authorization with specialty prescriber involvement (rheumatologist for SLE; nephrologist or rheumatologist for lupus nephritis) and documentation of active disease and required autoantibody or concurrent therapy; coverage duration is 6 months with reauth requiring positive clinical response.

Prior Authorization

Specialty drugs prior authorization

Many oncology, infectious disease, and rare-disease specialty products require prior authorization and submission of supporting diagnostic molecular testing (e.g., ROS1, NTRK, FGFR2, PIK3CA, BRAF) and prior therapy history as specified for the product and indication.

Prior Authorization

Product-level prior authorization requirements

Prior authorization requirements are applied at the product/indication level; provide the specific indication documentation and required prior therapy trials or step-therapy evidence listed for the named product.

Prior Authorization

Pyrimethamine prior authorization

Pyrimethamine requires prior authorization for toxoplasmosis; requests must include documented indication and specialist prescribing (infectious disease); use of pyrimethamine for treatment or prophylaxis of malaria is explicitly not authorized.

Prior Authorization

Pyrimethamine prior authorization

Prior authorization for pyrimethamine for toxoplasmosis must include documentation of the specific toxoplasmosis indication or documented TMP‑SMX intolerance/desensitization failure, and infectious disease specialist involvement; malaria uses are excluded and will not be approved.

Prior Authorization

Prior authorization and duration

Prior authorization approvals have indication-specific durations (commonly initial 6 months and reauthorization 12 months); include required prior therapy trials (eg, NSAID trials for AS) and specialist prescribing/consultation where applicable.

Prior Authorization

Prior authorization requirement

Prior authorization is required with submission of indication-specific documentation including diagnosis, prescriber specialty, age limits, and duration as specified per product and indication.

Prior Authorization

Prior authorization requirement

Prior authorization requires documentation of diagnosis and trial/failure/contraindication/intolerance to specified first-line therapies and prescriber specialty when indicated; initial and reauthorization coverage periods are specified per product.

Prior Authorization

Molecular- or diagnosis-dependent agents require prior authorization

Agents that depend on molecular or diagnostic biomarkers require prior authorization with submission of the specific mutation/rearrangement or receptor status detected by an FDA‑approved or CLIA‑performed test and any required prior endocrine or systemic therapy documentation.

Prior Authorization

IVIG/SCIG prior authorization

IVIG and SCIG require prior authorization with diagnosis-specific criteria, specialist prescribing or consultation, immunologic testing (IgG levels, vaccine response where applicable), and indication‑appropriate documentation of prior therapy trials; coverage durations vary by indication.

Documentation Required

Prior authorization and required clinical data

Prior authorization submissions must include required clinical data such as diagnosis and any required genetic, biomarker or laboratory test results (e.g., PKU blood Phe, AGXT/AGT testing, RET/FGFR/PIK3CA/BRAF results) as specified per product.

Prior Authorization

Prior authorization requirement

Prior authorization requires submission of specified diagnostic tests, prior treatment history, and prescriber specialty per product; include mutation/test reports and prior therapy details where listed.

Prior Authorization

Prior authorization required with indication-specific documentation

For each product, prior authorization must include documentation of the diagnosis and required prior therapeutic trials or confirmatory testing as specified for the indication; reauthorization is contingent on documented positive clinical response.

Prior Authorization

Prior authorization required

Prior authorization requires submission of diagnosis and the specific medical information listed for the product/indication; coverage duration and reauthorization requirements vary by product.

Prior Authorization

PKLR genetic confirmation and hemoglobin threshold required

For pyruvate kinase deficiency therapies, prior authorization requires molecular confirmation of PKLR variants per policy rules and hemoglobin ≤ 10 g/dL with symptomatic or transfusion‑dependent anemia.

Prior Authorization

Infliximab and biosimilars prior auth requirements

Prior authorization for infliximab and biosimilars requires diagnosis documentation and evidence of trial/failure or contraindication to listed conventional therapies, with initial prescribing by or consultation with the specialist noted for each indication.

Prior Authorization

Prior authorization required

Prior authorization is required for the listed products and must include diagnosis-specific documentation and specialist involvement when specified; typical coverage durations are initial 6 months or 12 months based on indication.

Prior Authorization

Prior authorization required

Prior authorization is required with documentation of diagnosis (example: Ph+ CML chronic phase) and is typically approved for 12 months; continuation/reauthorization requires relevant clinical evidence.

Step Therapy

Step therapy / prior treatment trials

Step therapy requirements apply where specified: providers must document trials and failure, contraindication, or intolerance to required conventional agents (eg, methotrexate/leflunomide/sulfasalazine for RA) before biologic or specialty agent approval.

Step Therapy

Caplyta step therapy

Caplyta requires prior trial and failure or documented contraindication/intolerance to specified oral generic atypical antipsychotics before approval.

Step Therapy

Step therapy requirements

Multiple products require documented trial and failure of specific formulary agents (examples include schizophrenia antipsychotics and specified prior biologics or conventional therapies for rheumatologic and dermatologic indications) prior to approval.

Step Therapy

Dupixent step therapy for asthma

Dupixent for asthma requires prior trial and failure, contraindication, or intolerance to Breo Ellipta (fluticasone furoate + vilanterol) before approval; include documentation of response at reauthorization.

Step Therapy

Fasenra step requirements

Fasenra step requirements mandate trials of specified inhaled corticosteroid regimens and additional controller therapies at age‑dependent intensities prior to approval.

Step Therapy

Humira step therapy

Humira (adalimumab) for RA requires documentation of trial and failure, contraindication, or intolerance to at least one conventional DMARD (methotrexate, leflunomide, or sulfasalazine) prior to approval.

Step Therapy

Required step therapy trials

Required step therapy trials include documented trial and failure of conventional agents specific to the indication (examples: azathioprine/6‑MP/methotrexate for Crohn's/UC; topical therapy trials for plaque psoriasis).

Step Therapy

Antifungal step requirement

Itraconazole for onychomycosis requires prior trial and failure, contraindication, or intolerance to oral terbinafine (minimum 6 weeks fingernail, 12 weeks toenail) before itraconazole coverage.

Step Therapy

Specified prior therapy requirements

Several products require prior trials or failure of specific prior therapies (examples include requirements for prior chemotherapy regimens or anti‑VEGF therapy for oncology agents).

Step Therapy

Step therapy / trials required

Many agents require trial and failure, intolerance, or contraindication to specified first‑line therapies (eg, triptan trial for dihydroergotamine; corticosteroids/immunosuppressants for HES) prior to coverage.

Step Therapy

Required trial of alternatives

Several products require trial and failure (or intolerance/contraindication) of specified alternative therapies before approval (examples: Orencia requiring prior conventional DMARD trial(s); Otezla requiring prior topical therapy trial for plaque psoriasis).

Step Therapy

Concomitant/step therapy conditions

Some oncology or antiviral agents require prior or concomitant therapy conditions (eg, Pegasys combinations or requirement to continue other antivirals) as a condition of coverage.

Step Therapy

Required trial and failure, contraindication, or intolerance to specified conventional therapies

Providers must document trial and failure, contraindication, or intolerance to specified conventional therapies (immunosuppressants, corticosteroids, topical agents, NSAIDs) prior to approval for several inflammatory indications.

Step Therapy

Repatha maximally tolerated statin requirement

Repatha (PCSK9) coverage requires the patient be on maximally tolerated statin therapy (or have documented statin intolerance) and meet LDL‑C thresholds or percent‑reduction criteria documented within the last 120 days prior to authorization.

Step Therapy

Step therapy / trials required

Some agents require prior trial and failure of specified alternatives (for example, Rolvedon FN prophylaxis requires trial/failure or intolerance to Neulasta/Udenyca prior to approval).

Step Therapy

Topical therapy trial requirement

For certain dermatologic biologics, a minimum 4‑week trial and failure (or contraindication/intolerance) to at least one topical therapy is required prior to biologic initiation.

Documentation Required

Required diagnostic and prior therapy documentation

Prior authorization requests must include diagnosis consistent with the listed indication and evidence of specified prior therapy trials and durations where listed (eg, RA, PGHD, CGD).

Documentation Required

AAT deficiency diagnostic documentation

For alpha‑1 antitrypsin deficiency, submit documentation of qualifying protein phenotype (eg, PiZZ) or other genotype and pre‑treatment serum AAT level < 11 µM/L (or equivalent lab units) as required for authorization.

Documentation Required

Dalfampridine ER required documentation

Dalfampridine ER prior authorization must include physician confirmation that the MS patient has difficulty walking (eg, timed 25‑foot walk) and documentation that EDSS ≤ 7 or the patient is not wheelchair‑restricted if EDSS not measured.

Documentation Required

Benlysta required documentation

Benlysta prior authorization requires documentation of active SLE with autoantibody positivity (ANA ≥ 1:80 or anti‑dsDNA ≥ 30 IU/mL) and current use of at least one standard‑of‑care treatment; for lupus nephritis include documentation of concurrent standard‑of‑care therapy.

Documentation Required

Arikayce required documentation

Arikayce prior authorization must include documentation of MAC lung disease and failure to achieve at least two negative sputum cultures after ≥ 6 months of an appropriate multidrug background regimen; prescriber should be or consult infectious disease or pulmonology.

Documentation Required

Confirmatory laboratory documentation

Submit confirmatory laboratory documentation of C1‑INH antigenic or functional level below the lower limit of normal to support HAE prophylaxis or acute treatment authorization.

Documentation Required

Disease severity and prior therapy documentation

Document disease severity measures and prior therapy trials for products like Cosentyx (eg, %BSA for psoriasis, active joint findings for PsA, MRI/CRP for nr‑axSpA) as required for authorization and reauthorization.

Documentation Required

Deferasirox baseline labs and transfusion history

For deferasirox initial use in transfusional iron overload, include baseline ferritin > 1,000 mcg/L and documentation of transfusion of ≥ 100 mL/kg packed RBCs.

Documentation Required

Enbrel conventional therapy trial documentation

For Enbrel (RA) initial authorization, document at least a 3‑month trial and failure, contraindication, or intolerance to one conventional DMARD (methotrexate, leflunomide, or sulfasalazine) at maximally tolerated doses.

Documentation Required

Evrysdi required baseline assessments

Evrysdi initial authorization requires baseline motor function testing (age‑appropriate validated scales such as HINE‑2, HFMSE, RULM, CHOP‑INTEND, MFM‑32, or BSID‑III Item 22) and genetic testing/SMN2 copy number documentation.

Documentation Required

HAE diagnostic confirmation

For HAE acute treatment (icatibant) authorization, document C1‑INH antigenic or functional level below the lower limit of normal to confirm diagnosis.

Documentation Required

Lab and prior therapy documentation for erythropoiesis-stimulating agents

Provide recent laboratory values and evidence of prior therapies (eg, Hgb/Hct, serum erythropoietin, transfusion history) when requesting erythropoiesis‑stimulating agents to meet indication‑specific authorization criteria.

Documentation Required

HAE diagnostic documentation

For HAE acute treatment authorization, include documentation of C1‑INH antigenic or functional level below the lower limit of normal to confirm diagnosis.

Documentation Required

HAE prophylaxis documentation

For HAE prophylaxis authorization, include documentation of C1‑INH antigenic or functional level below the lower limit of normal to confirm diagnosis; do not combine with other approved prophylactic HAE treatments.

Documentation Required

Growth hormone documentation

Growth hormone authorization requires growth charts, bone age, genetic testing or stimulation test results, and documentation of prior response/expected adult height as specified by indication.

Documentation Required

Humira indication documentation

Humira requests must include indication‑specific documentation (eg, CDAI for Crohn's) and evidence of required prior trials (topical for psoriasis, NSAID for AS, conventional DMARDs for RA) per the indication.

Documentation Required

Required clinical documentation

Document diagnosis, duration, and results of specified trials (eg, 3 months for RA conventional DMARDs; 4 weeks topical for psoriasis; 1 month NSAID for AS) and evidence of trial and failure/contraindication/intolerance (TF/C/I) to listed therapies.

Documentation Required

Reauthorization response documentation

For reauthorization, submit documentation demonstrating positive clinical response using the specified disease‑specific measures (eg, reduced swollen/tender joint count, BSA reduction, mucosal healing or lab improvement).

Documentation Required

Breast cancer — mutation and prior therapy documentation

Breast cancer targeted therapy prior authorization requires documentation of molecular test results (eg, FDA‑ or CLIA‑approved PIK3CA test) and prior therapy history such as progression after adjuvant endocrine therapy.

Documentation Required

Immune globulin — required medical information

Immune globulin (IVIG/SCIG) prior authorization requires specification of diagnosis, immunologic testing (IgG levels, vaccine response when applicable), prior therapy trials or contraindications, dosing intent (minimum effective dose), and specialist involvement or consultation.

Documentation Required

Required diagnostic and genetic test documentation

Submit required diagnostic and genetic testing results where specified (eg, JAG1/NOTCH2 for Livmarli; AGXT genetic testing or liver biopsy for Rivfloza) as part of prior authorization.

Documentation Required

Required clinical documentation

Provide medical records confirming diagnosis, mutation/test results (FDA‑approved or CLIA lab), prior therapy trials or intolerances, and documentation of clinical response for reauthorization when required.

Denial Risk

Missing prior therapy documentation

For missing prior therapy documentation: failure to document trial and failure, contraindication, or intolerance to required conventional therapies (eg, methotrexate, leflunomide, sulfasalazine for RA) may trigger denial.

Denial Risk

Missing diagnostic/genotype or lab proof

For alpha‑1 antitrypsin deficiency, lack of genotype/phenotype documentation (eg, PiZZ) or absence of pre‑treatment serum AAT level < 11 µM/L may result in denial.

Denial Risk

Dalfampridine ER denial risk

Dalfampridine ER denials may occur if physician confirmation of walking difficulty is not provided (eg, timed 25‑foot walk) or if EDSS > 7 or patient is wheelchair‑restricted without documentation meeting criteria.

Denial Risk

Augtyro denial risk

Augtyro (tumor‑specific agents) may be denied if documentation of required molecular alterations (eg, ROS1 rearrangement or NTRK gene fusion) is missing.

Denial Risk

Explicit non-coverage for malaria indication

Requests for pyrimethamine for the treatment or prophylaxis of malaria are not authorized and will be denied.

Denial Risk

Pyrimethamine - malaria exclusion

Coverage requests for pyrimethamine products for malaria treatment or prophylaxis will not be approved; pyrimethamine is authorized only for toxoplasmosis per policy criteria.

Denial Risk

Diacomit use requirements

Diacomit must be used in combination with clobazam and the patient must weigh ≥ 7 kg; lack of these requirements documented in the request may lead to denial.

Denial Risk

Reauthorization response documentation

Failure to document positive clinical response at reauthorization (eg, reduction in active joint counts, symptom improvement, or BSA reduction) may trigger denial of continued coverage.

Denial Risk

Combination therapy exclusion for Fabrazyme

Use of Fabrazyme in combination with other Fabry disease drugs will not be approved; document absence of combination therapy to avoid denial.

Denial Risk

HAE acute treatment denial triggers

HAE acute treatment requests must include confirmation of diagnosis by low C1‑INH antigenic or functional level; omission or use in combination with other approved acute HAE treatments may trigger denial.

Denial Risk

HAE prophylaxis denial triggers

HAE prophylaxis requests must confirm diagnosis by low C1‑INH antigenic or functional level and not be used in combination with other approved prophylactic HAE treatments; failure to show this may prompt denial.

Denial Risk

RA Humira denial triggers

Humira RA initial approvals require documentation of diagnosis and a minimum 3‑month trial and failure/contraindication/intolerance to at least one conventional therapy; absence of this documentation can lead to denial.

Denial Risk

Missing required prior therapy trials

Failure to document required prior therapy trials (agent and duration per indication) may trigger denial (eg, methotrexate/leflunomide/sulfasalazine for RA; topical trial for psoriasis).

Denial Risk

Prior therapy or biologic failure not documented

For some biologics, lack of documented trial and failure/intolerance to specified conventional therapies or prior biologics (eg, Remicade/Infliximab) may result in non‑approval.

Denial Risk

Missing diagnostic or prior-therapy documentation

Requests missing required diagnosis‑specific information (eg, PIK3CA mutation and HR+/HER2‑ status for specified breast cancer therapy) or lacking prior therapy history risk denial.

Denial Risk

Insufficient clinical justification for IVIG

IVIG requests lacking documentation that the diagnosis meets listed immunologic, hematologic, neurologic or other specified indications, or lacking trial/failure/contraindication to required prior therapies, may be denied.

Denial Risk

Missing required diagnostic or monitoring information

Failure to provide required diagnostic or monitoring information (eg, PKU blood Phe monitoring, genetic confirmation where required) may trigger denial.

Denial Risk

Missing required diagnostic or prior-therapy documentation

Requests lacking required diagnostic confirmation (eg, BRAF V600E mutation for Mektovi/Braftovi, H3 K27M for Modeyso, or required eosinophil thresholds/prior therapy for Nucala/HES) or lacking prior therapy failure documentation risk denial.

Denial Risk

OSA documentation requirement

For obstructive sleep apnea, lack of documentation of a sleep study confirming required obstructive respiratory events (≥15 events/hour or ≥5 events/hour plus daytime symptoms) or prescriber's justification may trigger denial.

Denial Risk

Pemazyre diagnostic requirement

Pemazyre requires documentation of FGFR2 fusion or rearrangement detected by an FDA‑approved or CLIA‑approved test and prior treatment; absence of these will trigger denial.

Documentation Required

Eltrombopag baseline & prior therapy

Eltrombopag (Promacta) for ITP initial requests require baseline platelet count < 30,000/mcL and documentation of trial and failure/intolerance/contraindication to corticosteroids, IVIG, or splenectomy; missing these will risk denial.

Denial Risk

Failure to document diagnostic confirmation may trigger denial

Failure to document diagnostic confirmation (eg, hemolytic anemia labs, PKLR molecular testing with specified variant rules) may trigger denial for pyruvate kinase deficiency therapies.

Denial Risk

Lack of trial-and-failure documentation may trigger denial

Lack of documented trial‑and‑failure (or contraindication/intolerance) to listed conventional therapies (eg, immunomodulators, corticosteroids, azathioprine, methotrexate, topical agents, or prior infliximab) may result in denial.

Denial Risk

Missing diagnostic confirmation

Requests lacking required diagnostic testing documentation (eg, RET gene fusion by FDA‑approved or CLIA test) or disease status (eg, metastatic/advanced disease) may be denied.

Denial Risk

Insufficient diagnostic evidence or kidney function

For Rivfloza (PH1), lack of confirmatory urinary/plasma oxalate testing, AGXT genetic testing or liver biopsy proof, or not meeting eGFR threshold (≥ 30 mL/min/1.73m2) may trigger denial.

Billing Rule

Induction dosing requirement

For weight‑based IV induction dosing (eg, Skyrizi IV for CD/UC), the induction dose must match FDA‑approved weight‑based dosing (260 mg ≤55 kg; 390 mg >55–85 kg; 520 mg >85 kg); deviation could trigger denial.

Note

Formulary Identifiers, Key Clinical Thresholds, and Code Tables

Formulary identifiersmixed

Formulary ID: 25383

Formulary identifier listed on multiple product entries

Formulary identifiermixed

No codes listed

Formulary products listed (partial)mixed

No codes listed

Formulary identifiers and product entriesmixed

Formulary ID: 25383

Formulary identifier present on all listed product entries

Formulary Identifiermixed

Formulary ID: 25383

Formulary identifier associated with listed products

Listed products (examples)mixed

Humira INJ 10MG/0.1ML,20MG/0.2ML,40MG/0.4ML,40MG/0.8ML

Adalimumab formulations listed

Formulary identifiermixed

Formulary ID: 25383

Formulary identifier referenced for the listed products

Molecular/diagnostic tests referenced (no codes provided)mixed

No codes listed

IVIG/SCIG — indications referenced (no billing codes listed)mixed

No codes listed

Formulary identifiersmixed

Formulary ID: 25383

Formulary identifier listed across products in this part

Product list (no billing codes given in this segment)mixed

No codes listed

Formulary Identifiermixed

Formulary ID: 25383

Formulary identifier for listed products

Products referencedmixed

Repatha (product names listed)

Repatha, Repatha Pushtronex System, Repatha Sureclick

Formulary identifiermixed

Formulary ID: 25383

Formulary identifier for listed products in this excerpt

Listed products without explicit codesmixed

N/A in this segment

No explicit CPT/HCPCS/ICD-10/NDC codes provided in these chunks

Formulary identifiersmixed

Formulary ID: 25383

Formulary identifier listed with multiple products

Migraine days per month — EM/CM thresholds

Episodic migraine (EM)≥4 migraine days per month required for initial coverage

Chronic migraine (CM)≥8 migraine days per month required for initial coverage

Age requirementPatient must be ≥18 years of age for EM/CM indications

Plaque psoriasis involvement (BSA)

BSA threshold>= 3% body surface area involvement

Alternate severity criteriaSevere scalp OR palmoplantar OR facial OR genital involvement qualifies regardless of BSA

Topical trial requirementMinimum 4‑week trial and failure/contraindication/intolerance to at least one topical therapy

Pre-treatment serum AAT level

Pre-treatment serum AAT level< 11 µM/L (corresponds to <80 mg/dL by radial immunodiffusion or <57 mg/dL by nephelometry)

Genotype/phenotype requirementDocument PiZZ, PiZ(null), Pi(null)(null) or other qualifying genotypes associated with low AAT

Indication contextRequired for diagnosis of congenital AAT deficiency with emphysema prior to therapy

Psoriasis BSA threshold

Psoriasis BSA threshold>= 3% body surface area

Qualifying locationsSevere scalp, palmoplantar, facial, or genital involvement meet severity criteria

Prior topical therapyMinimum 4‑week trial and failure/contraindication/intolerance to a topical agent required

Cinryze age threshold

Age for Cinryze prophylaxis>= 6 years of age for HAE prophylaxis

Diagnostic confirmationC1-INH antigenic or functional level below the lower limit of normal required

PrescriberPrescribed by or in consultation with an immunologist or allergist

Ferritin threshold

Ferritin threshold> 1000 mcg/L baseline ferritin for transfusional iron overload indication

Transfusion historyHistory of transfusion of at least 100 mL/kg packed RBCs supports diagnosis

Age for transfusional indicationAge >=2 years for transfusional iron overload initial therapy

Packed RBC transfusion volume

Packed RBC transfusion volume>= 100 mL/kg history of packed RBC transfusion required for transfusional iron overload criteria

Supporting labBaseline ferritin >1,000 mcg/L also required

Indication notesApplies to deferasirox initial coverage for transfusional iron overload

Diacomit patient weight

Minimum patient weight>= 7 kg required for Diacomit use in Dravet syndrome

Concomitant therapyMust be used in combination with clobazam

Age thresholdPatient age >=6 months noted for indication

Emgality episodic migraine frequency

Emgality — episodic migraine>= 4 migraine days per month required for initial EM coverage

Formulation note120 mg/mL strength specified for EM/CM preventive indications

Age requirementPatient must be ≥18 years of age for EM indication

Emgality chronic migraine frequency

Emgality — chronic migraine>= 8 migraine days per month required for initial CM coverage

Medication overuseConsideration and discontinuation of offending medications required prior to initiation

Age requirementPatient must be ≥18 years of age for CM indication

Eosinophil threshold for COPD/EA

Eosinophil threshold — asthma>= 150 cells/µL baseline peripheral blood eosinophils (some asthma criteria) — or historical >=300 cells/µL for severe eosinophilic phenotype

Eosinophil threshold — COPD>= 300 cells/mcL for COPD with type 2 inflammation

HES threshold>= 1000 cells/µL pre-treatment for uncontrolled HES (with other criteria)

Peripheral blood eosinophil level

Peripheral blood eosinophil level>= 150 cells/µL considered baseline threshold for eosinophilic asthma eligibility

Historical value allowanceHistorical eosinophil >=300 cells/µL may be used where specified

Use contextThreshold applied to biologic therapy eligibility (e.g., Fasenra, Nucala)

Hemoglobin / Hematocrit thresholds

Hemoglobin threshold (example)Hgb < 10 g/dL commonly used threshold for many anemia/ESA chemotherapy indications

Hematocrit threshold (example)Hct < 30% commonly used threshold for many indications; pediatric thresholds vary

Timing of labsHgb/Hct must be recent within specified timeframes (eg, within 2–30 days) depending on indication

Plaque Psoriasis lesion involvement

Plaque psoriasis lesion involvement>= 3% BSA involvement qualifies as moderate-to-severe disease

Alternate qualifying sitesSevere scalp or palmoplantar/facial/genital involvement also qualifies

Prior topical trialMinimum 4‑week topical therapy trial required prior to biologic initiation

Crohn's Disease Activity Index (CDAI)

CDAI threshold> 220 indicates moderately to severely active Crohn's disease (CDAI >220)

Clinical correlatesFrequent diarrhea/abdominal pain, ≥10% weight loss, complications or abnormal labs may be used alternatively

PrescriberDocumentation required from a gastroenterologist for CD indications

Minimum trial durations for prior therapies

RA prior therapy minimum duration3 months trial and failure/contraindication/intolerance to one conventional DMARD (methotrexate, leflunomide, sulfasalazine)

PJIA prior therapy minimum duration6 weeks trial and failure/contraindication/intolerance to methotrexate or leflunomide

Psoriasis topical trial durationMinimum 4‑week trial of topical therapy required before biologic

Plaque psoriasis severity thresholds

Plaque psoriasis severityAt least 3% BSA involvement OR severe scalp OR palmoplantar/facial/genital involvement

Topical therapy requirementMinimum 4‑week trial and failure/contraindication/intolerance to a topical agent required

PrescriberInitial prescriptions generally by or in consultation with a dermatologist

UACR threshold

UACR threshold>= 30 mg/g required for CKD associated with T2D eligibility for finerenone

eGFR contextUsed alongside eGFR and serum potassium thresholds for CKD criteria

PrescriberPrescribed or in consultation with appropriate specialist (nephrologist/cardiologist per indication)

eGFR threshold

eGFR threshold (Kerendia)>= 25 mL/min/1.73 m2 required for CKD/T2D and HF indications

Rivfloza eGFR>= 30 mL/min/1.73 m2 required for Rivfloza (PH1) initial therapy

ContexteGFR thresholds are required prior to initiation and documented in prior authorization

Serum potassium threshold

Serum potassium threshold<= 5.0 mEq/L required prior to initiating finerenone

MonitoringSerum potassium must be documented prior to initiation

Clinical contextApplies to CKD/T2D and HF indications for finerenone

PKU blood phenylalanine monitoring

PKU blood Phe monitoringBlood phenylalanine measured after 1 week of therapy for new starts and periodically for up to 2 months to determine response; ongoing periodic monitoring during therapy

Coverage durationsInitial PKU coverage 2 months; reauth 12 months with demonstrated response

PrescriberMonitoring and documentation required as part of prior authorization

Eosinophil thresholds

Eosinophil thresholds summaryBaseline pre-treatment eosinophils ≥150 cells/µL (some asthma criteria) or historical ≥300 cells/µL; HES requires ≥1000 cells/µL

ApplicationUsed to determine eligibility for biologics (e.g., Nucala, Fasenra) and HES therapies

Diagnostic exclusionSecondary causes must be ruled out before applying thresholds for HES

OSA diagnostic threshold

OSA diagnostic threshold>= 15 obstructive respiratory events/hour on sleep study OR >=5 events/hour plus daytime symptoms

Alternative documentationPrescriber justification accepted if sleep study not feasible

Coverage durationOSA initial/reauth durations commonly 6 months (narcolepsy 12 months)

LDL-C thresholds for Nexletol/Nexlizet

LDL-C threshold — with ASCVDLDL-C ≥55 mg/dL within last 120 days for patients with ASCVD

LDL-C threshold — without ASCVDLDL-C ≥70 mg/dL within last 120 days for patients without ASCVD

Statin requirementPatient must be on maximally tolerated statin therapy or have documented statin intolerance

HRCT fibrotic extent

HRCT fibrotic extent>= 10% of lung volume with fibrotic features required for chronic fibrosing ILD with progressive phenotype

Progression evidenceProgression shown by FVC decline, worsening symptoms, or increased fibrosis on imaging

PrescriberPrescribed by or in consultation with a pulmonologist

OSA respiratory events

OSA respiratory events (restated)>= 15 obstructive events/hour OR >=5 events/hour plus qualifying daytime symptoms (e.g., excessive sleepiness)

Study requirementConfirmed by sleep study unless prescriber documents infeasibility

Coverage noteDocumentation required for prior authorization; reauth requires clinical response

Baseline platelet count for ITP

Baseline platelet count for ITPBaseline platelet count < 30,000/mcL required for initial eltrombopag (ITP) coverage

Prior therapy requirementTrial and failure/intolerance/contraindication to corticosteroids, IVIG, or splenectomy required

PrescriberPrescribed by or in consultation with a hematologist/oncologist

Diabetes diagnostic lab thresholds

Diabetes diagnostic lab thresholdsA1c >= 6.5% OR fasting plasma glucose >= 126 mg/dL OR 2‑hour OGTT >= 200 mg/dL required to document T2DM

DocumentationSubmit medical records or labs to support diagnosis for Ozempic prior authorization

Coverage durationTypical coverage duration 12 months with reauth based on clinical response

Hemoglobin threshold for Pyrukynd

Hemoglobin threshold for PyrukyndHemoglobin <= 10 g/dL required for initial Pyrukynd (pyruvate kinase deficiency) coverage

Molecular confirmationPKLR molecular testing confirming ≥2 variant alleles with specified variant constraints required

Clinical contextPatient must have symptomatic anemia or transfusion dependence

Hemoglobin threshold for PK deficiency therapy

Hemoglobin threshold — PK deficiency therapyHemoglobin ≤10 g/dL required for initiation of PK deficiency therapies (e.g., Qinlock/Pyrukynd)

Genotyping requirementMolecular PKLR testing with at least 2 variant alleles (≥1 missense), exclusion of certain genotypes required

PrescriberPrescribed by or in consultation with a hematologist

LDL thresholds for PCSK9 therapy

LDL thresholds for PCSK9 therapy≥55 mg/dL with ASCVD or ≥70 mg/dL without ASCVD OR need for ≥25% LDL‑C reduction to reach goal; LDL must be within 120 days

Statin requirementPatient must be on maximally tolerated statin therapy or have documented statin intolerance

AgeAge >=10 years for HeFH/HoFH indications where specified

Erythropoiesis-stimulating agent lab thresholds

ESA lab thresholdsHct <30% or Hgb <10 g/dL commonly used thresholds for erythropoiesis-stimulating agent eligibility (varies by indication)

TimingLabs must be recent within indication-specific timeframes (eg, within 30 days or 2 weeks)

Pediatric considerationsSpecific pediatric thresholds and timing apply depending on indication

ALS functional and pulmonary thresholds

ALS functional and pulmonary thresholdsALSFRS-R scores ≥2 in all items and %FVC ≥80% at treatment start required for ALS therapy eligibility

Diagnostic criteriaDiagnosis must meet revised El Escorial criteria with supporting records

PrescriberPrescribed by or in consultation with a neurologist

eGFR threshold (Rivfloza)

eGFR threshold (Rivfloza)>= 30 mL/min/1.73 m2 required for Rivfloza (PH1) initial therapy

Diagnostic confirmationPH1 confirmed by elevated urinary or plasma oxalate AND AGXT genetic testing or liver biopsy showing reduced/absent AGT activity

AgePatient age >=2 years for initial Rivfloza therapy

Atopic dermatitis involvement

Atopic dermatitis involvement>= 10% BSA involvement OR SCORAD >= 25 required for moderate-to-severe AD initial coverage

Topical/systemic trialTrial and failure of topical therapies and other specified systemic treatments required prior to biologic use

AgeInitial: patient typically ≥12 years for many AD biologic indications

Body Surface Area (BSA) for psoriasis

BSA for psoriasis (general)>= 3% BSA for moderate-to-severe plaque psoriasis (policy standard)

Alternate qualifiersSevere scalp or palmoplantar/facial/genital involvement also meets criteria

Topical trialMinimum 4‑week topical therapy trial required prior to biologic initiation

Crohn's Disease Activity Index (CDAI) repeat

CDAI repeat threshold> 220 (used to indicate moderately to severely active Crohn's disease)

Induction dosing noteIV induction dosing for some agents uses weight-based dosing per FDA label (260 mg ≤55 kg; 390 mg >55–85 kg; 520 mg >85 kg)

PrescriberDocumentation required from gastroenterologist for CD indications

Weight for Spevigo in GPP

Minimum weight for Spevigo in GPP>= 40 kg required for Spevigo initial use in generalized pustular psoriasis

Age requirementPatient must be >=12 years of age for Spevigo initial coverage

Formulation limitationSubcutaneous formulation not to be used to treat GPP flares

Weight for Steqeyma dosing example

Steqeyma dosing example weight> 100 kg (220 lbs) noted for some Steqeyma dosing considerations

Indication contextWeight-based dosing influences product formulation selection and dosing strength

Prescriber noteDocument weight in medical record for dosing justification

Policy Background and Scope

This document provides formulary coverage criteria for multiple specialty medications administered to Blue Cross Blue Shield – South Carolina members. It lists indication-specific requirements that must be met for approval, including diagnosis confirmation, required prior therapy trials or evidence of intolerance/contraindication, prescriber specialty or consultation when specified, and baseline diagnostic or laboratory data when applicable (for example, genetic or biomarker test results for targeted oncology agents). [[chunk 283]][[chunk 188]][[chunk 126]]

Most listed products require prior authorization with submission of the indicated medical information and supporting records. Typical PA elements are: documentation of the diagnosis that matches the policy indication; records of prior conventional therapy trials with specified minimum durations (e.g., RA 3 months; PJIA 6 weeks); timing and values for required labs or imaging; and specialist prescribing or consultation when the criteria specify a rheumatologist, neurologist, pulmonologist, gastroenterologist, oncologist, or other specialist. Failure to provide these items is a common denial risk. [[chunk 188]][[chunk 1]][[chunk 129]]

Coverage durations are stated per product and indication. For many biologic and specialty therapies the pattern in this extract is initial approval often 6 months (some initial approvals are shorter, e.g., 3 months for certain acute or induction uses) and reauthorization commonly 12 months conditional on documentation of positive clinical response using the disease-specific measures listed in the product criteria (examples: reduction in swollen/tender joint count for RA; decreased BSA for psoriasis; improved functional or pulmonary measures for ILD). [[chunk 3]][[chunk 4]][[chunk 283]]

The formulary emphasizes safety and exclusion rules where relevant. Examples include restrictions against combining certain disease-modifying therapies for MS, explicit non-coverage of pyrimethamine for malaria, and prohibitions on combining listed HAE therapies with other approved HAE treatments for the same indication. These exclusions and combination rules are enforced through the prior authorization process and are documented in the product-specific lines. [[chunk 20]][[chunk 54]][[chunk 91]]

Providers should use the document to verify the exact indication-specific thresholds and required documentation (e.g., autoantibody levels for Benlysta in SLE, EDSS walking impairment confirmation for dalfampridine ER, LDL thresholds and statin optimization for PCSK9 agents, or molecular test results for targeted oncologics) before submitting a PA request to minimize risk of denial and speed authorization decisions. [[chunk 26]][[chunk 18]][[chunk 229]]

Key Definitions and Diagnostic Criteria

Episodic Migraine (EM)

Episodic Migraine (EM) definitionDiagnosis of EM with ≥4 migraine days/month required for certain CGRP inhibitors (e.g., Aimovig/Emgality)

Chronic Migraine (CM) definitionDiagnosis of CM with ≥8 migraine days/month; assess for medication overuse prior to initiation

AgeAdult patients (typically ≥18 years) for EM/CM biologic preventive therapies

Chronic Migraine (CM)

Chronic Migraine (CM) definitionDiagnosis of CM: ≥8 migraine days/month and consideration of medication overuse prior to initiation

Medication overuse considerationPotential offending medications should be discontinued before initiating preventive biologics

AgeTypically applies to adults (≥18 years)

EDSS definition

EDSS definitionExpanded Disability Status Scale (EDSS) used to quantify disability in MS; EDSS ≤7 or notation patient not wheelchair-restricted required for dalfampridine

Use casePhysician confirmation of walking difficulty (e.g., timed 25-foot walk) required for dalfampridine prior authorization

PrescriberPrescribed by or in consultation with a neurologist for dalfampridine

FDA-approved molecular test

FDA-approved molecular testMolecular biomarkers must be detected by an FDA-approved test or a CLIA-certified laboratory test for targeted therapy eligibility

ExamplesTests referenced include PIK3CA, KRAS G12C, FGFR3, BRAF V600E/K, RET fusions as specified per agent

DocumentationSubmit test results with prior authorization request

Body Surface Area (BSA)

BSA definitionBody surface area (BSA) used to quantify extent of psoriasis involvement; policy uses >=3% BSA as threshold for moderate-to-severe plaque psoriasis

Alternate qualifiersSevere scalp or palmoplantar/facial/genital involvement may qualify regardless of BSA

Measurement contextBSA documented in medical record as part of prior authorization

C1-INH deficiency

C1-INH deficiency confirmationC1‑INH antigenic level below LLN or C1‑INH functional level below LLN required to confirm HAE Type I/II

ApplicationRequired for prophylaxis (Cinryze/Haegarda) and for acute HAE treatments (icatibant) prior authorization

Age thresholdsProphylaxis: ≥6 years; Acute treatment initial: ≥18 years (per product-specific criteria)

Eosinophilic phenotype (asthma)

Eosinophilic phenotype (asthma)Baseline peripheral blood eosinophils ≥150 cells/µL defines eosinophilic asthma eligibility for certain biologics

Higher thresholdsHistorical eosinophils ≥300 cells/µL may be acceptable where specified

Clinical contextAlso require exacerbation history and controller therapy trials per indication

Transfusional iron overload

Transfusional iron overload definitionBaseline ferritin >1000 mcg/L plus history of transfusion >=100 mL/kg packed RBCs supports diagnosis

AgeInitial transfusional indication: age >=2 years

Reauth evidenceReauth requires reduction in ferritin or LIC from baseline

HAE Type I/II confirmation

HAE Type I/II confirmationC1-INH antigenic or functional level below the lower limit of normal required to confirm HAE Type I/II

Not combinableHAE therapies should not be used in combination with other approved treatments for same HAE indication

PrescriberPrescribed by or in consultation with immunologist/allergist for initial therapy

Hereditary angioedema (HAE)

Hereditary angioedema (HAE)Inherited disorder caused by C1‑INH deficiency/dysfunction; diagnosis requires low antigenic or functional C1‑INH level; required for acute treatment and prophylaxis

Age thresholdsAcute treatment initial: ≥18 years; prophylaxis initial: ≥6 years

Combination therapy exclusionDo not combine with other approved HAE acute or prophylactic treatments

Drug-specific coverage criteria for specialty medications (partial list)

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Drug-Specific Coverage Criteria

Prior Authorization, Documentation & Step Therapy Requirements

Formulary Identifiers, Key Clinical Thresholds, and Code Tables

Policy Background and Scope

Key Definitions and Diagnostic Criteria

Policy Revision History