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CurrentBlue Cross Blue Shield - South CarolinaPolicy N/A

Biologic and specialty drug coverage criteria (immunology/rheumatology examples)

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Lists products and the payer's coverage criteria, prescriber restrictions, prior‑therapy requirements, coverage durations, and required medical information for multiple specialty medications relevant to immunology and rheumatology affecting prescribers requesting coverage.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyBiologic and specialty drug coverage criteria (immunology/rheumatology examples)

Policy CodePolicy N/A

Change TypeMinor/No material change

Effective DateApr 1, 2026

Last ReviewMar 2, 2026

Next Review Date

Key ActionObtain prior authorization with documented diagnosis, required prior therapy trials or failures, and any specified laboratory or molecular test results.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

26216formulary version

12 mocommon reauth duration

6 motypical initial duration

~20+drugs in excerpt

severalspecialist required

Coverage Criteria by Product / Indication

Initial Therapy — adalimumab-class

Covered when INDICATION-specific criteria are met for diagnosis, prior therapy, prescriber, and reauthorization response measures.

Rheumatoid Arthritis (Initial): Diagnosis of moderately to severely active rheumatoid arthritis AND minimum 3-month trial and failure, contraindication, or intolerance (TF/C/I) to one of: methotrexate, leflunomide, or sulfasalazine at maximally tolerated doses3-month trial

Prescribed by or in consultation with a rheumatologist for initial therapy.

Polyarticular Juvenile Idiopathic Arthritis (PJIA) (Initial): Diagnosis of moderately to severely active PJIA AND minimum 6-week TF/C/I to leflunomide or methotrexate at maximally tolerated doses6-week trial

Prescribed by or in consultation with a rheumatologist for initial therapy.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyBiologic and specialty drug coverage criteria (immunology/rheumatology examples)

Policy CodePolicy N/A

Change TypeMinor/No material change

Effective DateApr 1, 2026

Last ReviewMar 2, 2026

Next Review Date

Key ActionObtain prior authorization with documented diagnosis, required prior therapy trials or failures, and any specified laboratory or molecular test results.

SourceLink

On This Page

Plaque Psoriasis (Initial): Diagnosis of moderate to severe chronic plaque psoriasis AND one of: BSA >= 3%, severe scalp, OR palmoplantar/facial/genital involvement AND trial and failure (minimum 30-day supply; 14 days for topical corticosteroids), contraindication, or intolerance to a topical therapy (medium/high potency corticosteroid, vitamin D analog, tazarotene, or calcineurin inhibitor)30-day topical trial (14 days for topical corticosteroids)

Prescribed by or in consultation with a dermatologist for initial therapy.

Ankylosing Spondylitis (Initial): Diagnosis of active ankylosing spondylitis AND minimum 1-month TF/C/I to an NSAID at maximally tolerated doses1-month NSAID trial

Prescribed by or in consultation with a rheumatologist for initial therapy.

Crohn's Disease (Initial): Diagnosis of moderately to severely active Crohn's disease AND one of: frequent diarrhea and abdominal pain, >=10% weight loss, complications (eg obstruction, fever, abdominal mass), abnormal labs (eg CRP), OR CDAI >220; TF/C/I to listed conventional therapies as requiredCDAI >220 optional

Prescribed by or in consultation with a gastroenterologist for initial therapy.

Reauthorization criteria

Reauthorization covered when evidence of clinical benefit is provided.

Reauth evidence: Patient demonstrates positive clinical response to therapy as evidenced by at least one indication-specific measure (e.g., reduction in swollen/tender joint count, improvement in BSA for psoriasis, reduction in abscess/inflammatory nodule count for HS, mucosal healing or improved lab values for CD/UC)at least one documented improvement

Coverage duration for most reauthorizations: 12 months; UC initial shorter per product guidance.

Initial and continuation — atopic dermatitis

Covered when the patient meets severity and prior topical therapy failure requirements.

Atopic dermatitis (Initial): Diagnosis of moderate to severe atopic dermatitis AND either >=10% BSA involvement or SCORAD >=25 AND trial and failure, contraindication, or intolerance to at least two of: medium+ potency topical corticosteroid, pimecrolimus, tacrolimus, or crisaborole (Eucrisa)>=10% BSA or SCORAD >=25; two prior topical therapies

Age >=12 years and prescribed by or in consultation with a dermatologist or allergist/immunologist; initial coverage 6 months.

Atopic dermatitis (Reauth): Patient demonstrates positive clinical response (reduction in BSA or SCORAD) compared with baselinedocumented improvement from baseline

Reauthorization coverage 12 months.

CGRP inhibitor — migraine

CGRP inhibitor coverage when episodic or chronic migraine diagnostic thresholds and treatment rules are met.

Episodic Migraine (Initial): Diagnosis of episodic migraine AND >=4 migraine days per month AND not used in combination with another CGRP inhibitor for preventive treatment>=4 migraine days/month

Initial coverage 6 months; reauth 12 months; monitor acute medication use.

Chronic Migraine (Initial): Diagnosis of chronic migraine AND medication overuse headache considered/treated AND >=8 migraine days per month>=8 migraine days/month

Initial coverage 6 months; reauth 12 months with monitoring for medication overuse headache.

Benlysta coverage criteria

Benlysta (systemic lupus erythematosus and lupus nephritis) covered when ALL of the following are met:

Benlysta SLE initial: Diagnosis of active systemic lupus erythematosus (SLE) AND autoantibody positive (ANA ≥1:80 OR anti-dsDNA ≥30 IU/mL) AND currently receiving at least one standard-of-care treatment for active SLE (eg antimalarials, corticosteroids, or immunosuppressants)ANA ≥1:80 or anti-dsDNA ≥30 IU/mL

Prescribed by or in consultation with a rheumatologist for SLE initial; patient age ≥5 years for specified formulations; initial and reauth duration 6 months; reauth requires documented positive clinical response.

Arikayce coverage criteria

Arikayce (Mycobacterium avium complex lung disease) covered when ALL of the following are met:

Arikayce MAC lung disease: Diagnosis of Mycobacterium avium complex (MAC) lung disease AND used as part of a combination antibacterial regimen AND patient did not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen (e.g., macrolide, rifamycin, ethambutol)≥6 months background regimen with inadequate sputum culture response

Prescribed by or in consultation with an infectious disease specialist or pulmonologist; coverage duration 12 months.

Augtyro coverage criteria

Augtyro covered when ALL of the following are met:

Augtyro — NSCLC or NTRK fusion tumors: For NSCLC: diagnosis of locally advanced or metastatic NSCLC with ROS1 rearrangement-positive tumor(s) confirmed by FDA‑approved or CLIA‑approved test; For solid tumors: diagnosis with NTRK gene fusion confirmed by FDA‑approved or CLIA‑approved test and disease that is locally advanced, metastatic, or unresectable AND disease progressed following prior treatment or there are no satisfactory alternativesmolecular confirmation of ROS1 or NTRK fusion via FDA-approved or CLIA-compliant test

Prerequisite Part D drug required; coverage duration 12 months; prescribe by appropriate oncology specialist.

Caplyta coverage criteria

Caplyta covered when ALL of the following are met:

Caplyta psychiatric indications: Diagnosis of schizophrenia, bipolar disorder (bipolar depression), or major depressive disorder adjunctive use as specified AND trial and failure, contraindication, or intolerance to required oral generic formulary atypical antipsychotics per indicationfailure/intolerance to listed agents (varies by indication)

Prerequisite Part D drug required; coverage duration 12 months; prescribed by or in consultation with appropriate psychiatric specialist.

Cayston coverage criteria

Cayston covered when ALL of the following are met:

Cayston — Cystic Fibrosis: Diagnosis of cystic fibrosis with evidence of Pseudomonas aeruginosa in respiratory specimens AND age ≥7 years for initial therapy AND documentation of benefit on reauthorization (e.g., improved FEV1 or decreased pulmonary exacerbations)age ≥7 for initial

Coverage duration 12 months; prescribed by or in consultation with a CF specialist or pulmonologist.

Antipsychotic product indications and step therapy

Antipsychotic product coverage follows step therapy and prior-failure rules; example patterns below.

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

Coverage duration 12 months; continuation of prior therapy approved.

Bipolar disorder (depressive episodes): Diagnosis of bipolar I or II with depressive episodes and used as monotherapy or adjunctive with lithium or valproate AND trial and failure, contraindication, or intolerance to quetiapine (IR or ER) or olanzapinetrial/failure of quetiapine or olanzapine

Prescriber specialty per product guidance.

MDD adjunctive use: Diagnosis of major depressive disorder used as adjunctive therapy with an antidepressant AND trial and failure, contraindication, or intolerance to both aripiprazole and quetiapine IR/ERtrial/failure of two agents

Coverage duration 12 months.

Cinryze (HAE prophylaxis) initial criteria

Cinryze: Covered when ALL of the following are met

HAE diagnostic paths: Either: (1) Low C4 AND C1‑INH antigenic OR functional level below lower limit of normal (Type I/II HAE), OR (2) Normal C4 and C1‑INH with either pathogenic mutation (factor XII, plasminogen, angiopoietin-1, kininogen-1, myoferlin, HS3ST6) detected by FDA‑approved or CLIA test OR confirmed family history of recurrent angioedema (HAE‑nl‑C1INH)

Used for prophylaxis of HAE attacks; not combined with other prophylactic treatments; age ≥6 years for initial; prescribed by or in consultation with immunologist/allergist; coverage duration 12 months.

Prescriber and age: Patient is ≥6 years for prophylaxis initial AND prescribed by or in consultation with an immunologist or allergist

Reauth requires documented positive clinical response.

Ciclopirox Nail Lacquer criteria

Ciclopirox Nail Lacquer: Covered when ALL of the following are met

Diagnosis confirmation: Diagnosis of onychomycosis confirmed by KOH, culture, or histology AND no lunula/matrix involvement

Documentation required prior to approval.

Disease extent and prior therapy: If toenail onychomycosis: mild to moderate disease involving at least 1 target toenail AND trial and failure/contraindication/intolerance to oral terbinafine (minimum 12-week supply); If fingernail: trial and failure/contraindication/intolerance to oral terbinafine (minimum 6-week supply)toenail: 12-week terbinafine; fingernail: 6-week terbinafine

Coverage duration 48 weeks; prescribed by appropriate clinician.

Cosentyx indications and step therapy

Cosentyx (secukinumab) and Cosentyx 125mg: Covered when ALL of the following are met (indication-specific)

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

Initial coverage 6 months; reauth 12 months with demonstration of clinical response; prescriber dermatologist for initial.

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

Prescriber rheumatologist or dermatologist required for initial PsA.

Axial spondyloarthritis initial: Diagnosis of active ankylosing spondylitis (AS) or non‑radiographic axial spondyloarthritis with objective signs of inflammation (eg elevated CRP or sacroiliitis on MRI) AND minimum 1‑month trial and failure/contraindication/intolerance to an NSAID for AS (TF/C/I to two NSAIDs for some nr-axSpA indications)1-month NSAID trial

Prescribed by or in consultation with a rheumatologist.

Chenodal initial criteria

Chenodal: Covered when ALL of the following are met

Chenodal initial diagnostic criteria: Diagnosis of radiolucent gallstones with well‑opacifying gallbladder on oral cholecystography AND non‑calcified stones AND trial and failure/contraindication/intolerance to ursodiol AND patient not a candidate for surgery

Prescribed by or in consultation with a gastroenterologist or provider experienced in gallstone management; reauth requires imaging evidence (cholecystogram or ultrasound).

Roflumilast initial criteria

Roflumilast: Covered when ALL of the following are met

COPD exacerbation history and prior therapy: Diagnosis of COPD with history of exacerbations requiring systemic corticosteroids, antibiotics, or hospitalization AND trial and failure/intolerance/contraindication to two prior COPD therapies (e.g., Combivent, Spiriva)two prior COPD therapies tried

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

Dupixent — Indication-specific initial criteria

Dupixent — Covered when the indication-specific criteria are met

Eosinophilic Asthma (Initial): Diagnosis of moderate to severe asthma with eosinophilic phenotype defined by baseline peripheral blood eosinophils >=150 cells/mcL AND either ≥2 exacerbations requiring systemic corticosteroids in past 12 months OR prior asthma-related hospitalization in past 12 monthseosinophils >=150 cells/mcL

Age‑specific controller therapy requirements apply; prescriber pulmonologist/allergist; coverage durations per indication.

Corticosteroid Dependent Asthma (Initial): Diagnosis of moderate to severe asthma and current dependence on oral corticosteroids; plus age-based concomitant controller therapy requirements as specifiedage and controller therapy specifics

Reauth requires clinical response.

EoE (Eosinophilic Esophagitis) Initial: Diagnosis of EoE with symptoms of esophageal dysfunction, ≥15 intraepithelial eosinophils per high power field, exclusion of other causes, weight ≥15 kg, AND trial and failure/intolerance/contraindication to an 8‑week PPI or topical esophageal corticosteroid>=15 eos/hpf

Prescriber gastroenterologist or allergist/immunologist; reauth requires improvement in symptoms or histology/endoscopy.

COPD with type 2 inflammation (Initial): Diagnosis of COPD with type 2 inflammation (blood eosinophils ≥300 cells/mcL), on maximally tolerated triple therapy (ICS+LAMA+LABA) or LAMA+LABA if ICS contraindicated, AND ≥2 exacerbations requiring systemic corticosteroids or COPD‑related hospitalization in past 12 monthseosinophils >=300 cells/mcL; >=2 exacerbations

Prescribed by pulmonologist; reauth requires continued triple therapy and clinical response.

Pyrimethamine — allowable indications

Pyrimethamine — Covered only for toxoplasmosis indications with specialist involvement where specified

Toxoplasmosis indications: Use for active treatment of toxoplasmosis (eg toxoplasmic encephalitis, ocular toxoplasmosis), secondary prophylaxis, congenital toxoplasmosis OR primary prophylaxis when TMP‑SMX intolerance/contraindication demonstrated (including failed desensitization or life‑threatening prior reaction)documented intolerance or desensitization attempts

Prescribed by or in consultation with an infectious disease specialist; requests for malaria treatment/prophylaxis are not authorized.

Deferasirox — Iron overload criteria

Deferasirox — Covered when specific iron overload thresholds and transfusion history are met

Transfusional iron overload (Initial): Diagnosis of chronic iron overload due to transfusions with baseline ferritin >1000 mcg/L AND history of transfusion of at least 100 mL/kg packed RBCsferritin >1000 mcg/L; transfusion >=100 mL/kg

Age ≥2 years for transfusional indication; reauth requires reduction in ferritin or LIC.

Non-transfusion-dependent thalassemia (NTDT) initial: Diagnosis of NTDT with liver iron concentration (LIC) ≥5 mg Fe/g dw AND serum ferritin >300 mcg/LLIC >=5 mg Fe/g dw; ferritin >300 mcg/L

Age ≥10 years for NTDT; reauth LIC ≥3 mg Fe/g dw.

Doptelet — ITP and procedure-related thrombocytopenia

Doptelet — Covered for thrombocytopenia prior to planned procedure and for ITP when baseline platelet thresholds and prior therapy trials are met

Thrombocytopenia prior to planned procedure (TPPP): Diagnosis of thrombocytopenia in chronic liver disease scheduled for a procedure AND baseline platelet count <50,000/mcLplatelets <50,000/mcL

Coverage duration 1 month.

Immune thrombocytopenia (ITP) initial: Diagnosis of chronic ITP (relapsed/refractory or persistent pediatric) with baseline platelet count <30,000/mcL AND trial and failure/intolerance/contraindication to at least one of corticosteroids, IVIG, or splenectomyplatelets <30,000/mcL

Prescribed by or in consultation with a hematologist/oncologist; coverage duration 12 months; reauth requires increase in platelet count to clinically sufficient level.

Enbrel - Indications and initial criteria (RA, PJIA, PsA, Plaque Psoriasis, AS)

Covered when ALL of the following are met for the specified indication

Rheumatoid Arthritis (Enbrel/Humira class) Initial: Diagnosis of moderately to severely active RA AND minimum 3‑month TF/C/I to one of: methotrexate, leflunomide, or sulfasalazine at maximally tolerated doses3 months trial

Prescribed by or in consultation with a rheumatologist; initial coverage 6 months; reauth 12 months.

Polyarticular Juvenile Idiopathic Arthritis (PJIA) Initial: Diagnosis of moderately to severely active PJIA AND minimum 6‑week TF/C/I to methotrexate or leflunomide at maximally tolerated doses6 weeks trial

Prescribed by or in consultation with a rheumatologist.

Psoriatic Arthritis (PsA) Initial: Diagnosis of active PsA with actively inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement AND TF/C/I to specified systemic agents as requiredindication‑specific

Prescriber rheumatologist or dermatologist required for initial.

Plaque psoriasis initial: Diagnosis of moderate to severe chronic plaque psoriasis with >=3% BSA or severe scalp/palmoplantar/facial/genital involvement AND trial and failure of at least 30‑day supply (14 days for topical corticosteroids) of specified topical therapies30 days (14 days for topical corticosteroids)

Prescribed by or in consultation with a dermatologist.

Ankylosing Spondylitis (AS) initial: Diagnosis of active AS with minimum 1‑month TF/C/I to an NSAID at maximally tolerated doses1 month

Prescribed by or in consultation with a rheumatologist.

Enbrel - Reauthorization criteria

Reauthorization covered when ALL of the following are met by indication

RA/PJIA reauth: Patient demonstrates positive clinical response evidenced by reduction in total active joint count from baseline OR improvement in symptoms (pain, stiffness, inflammation)documented improvement

Reauth interval commonly 12 months.

PsA reauth: Patient demonstrates positive clinical response evidenced by reduction in total active joint count, improvement in symptoms, OR reduction in BSA involvementdocumented improvement

Reauth 12 months.

Plaque psoriasis reauth: Patient demonstrates positive clinical response evidenced by reduction in BSA OR improvement in symptomsdocumented improvement

Reauth 12 months.

AS reauth: Patient demonstrates positive clinical response evidenced by improvement in disease activity, labs (ESR/CRP), function, axial status, OR joint countsdocumented improvement

Reauth 12 months.

L-glutamine (Sickle cell disease)

Covered when ALL of the following are met

L‑glutamine (Sickle cell disease) initial: Diagnosis of sickle cell disease AND history of ≥2 painful sickle cell crises within the past 12 months2 or more crises in 12 months

Prescribed as indicated; coverage duration 12 months; reauth requires demonstration of clinical response.

Ensacove (NSCLC with ALK rearrangement)

Covered when ALL of the following are met

Ensacove (ALK‑rearranged NSCLC) initial: Diagnosis of locally advanced or metastatic NSCLC with ALK rearrangement detected by FDA‑approved or CLIA test AND patient has not previously received an ALK‑inhibitormolecular confirmation of ALK rearrangement

Coverage duration 12 months; continuation of prior therapy approved; prescribed by oncology specialist.

Sofosbuvir/velpatasvir (Chronic hepatitis C)

Covered when ALL of the following are met

Sofosbuvir/velpatasvir (HCV) initial: Diagnosis of chronic hepatitis C and regimen selection consistent with current AASLD/IDSA guidelines AND not used in combination with another HCV direct‑acting antiviral agenttreatment duration per guideline (12–24 weeks)

Prescribed by hepatologist, gastroenterologist, infectious disease or certified HIV specialist; coverage 12–24 weeks per regimen.

Procrit (Erythropoiesis-stimulating agent) - multiple indications

Covered when ALL specific indication criteria are met

Procrit — CKD anemia initial: Diagnosis of CKD with anemia defined by Hct <30% or Hgb <10 g/dL collected within 30 days; additional dialysis status conditions applyHct <30% or Hgb <10 g/dL

Coverage examples: CKD initial 6 months, reauth 12 months; iron stores confirmed (ferritin >100 mcg/L and TSAT >20%).

Procrit — Chemotherapy‑associated anemia initial: Non‑myeloid malignancy receiving chemotherapy AND anemia by labs (Hgb <10 g/dL or Hct <30%) within prior 2 weeks; other causes ruled outHgb <10 g/dL or Hct <30%

Coverage duration typically 3 months for chemo indications; reauth requires documented response.

Procrit — HIV/HCV/MDS specific pathways: Indication‑specific lab thresholds and eligibility criteria apply (see product guidance); adequate iron stores required for many indicationsvaries by indication

Prescriber and monitoring requirements per indication; off‑label uses disallowed when Hgb >10 g/dL or Hct >30% except MDS/HCV.

Pirfenidone (Idiopathic pulmonary fibrosis)

Covered when ALL of the following are met

Pirfenidone (IPF) initial: Diagnosis of idiopathic pulmonary fibrosis documented by exclusion of other known causes of ILD AND either UIP pattern on HRCT (probable/definite) in patients without surgical lung biopsy OR concordant HRCT and surgical lung biopsy patterns consistent with IPFradiographic/biopsy confirmation per guidance

Prescribed by or in consultation with pulmonologist; coverage 12 months; reauth requires positive clinical response.

Evrysdi (risdiplam) for Spinal Muscular Atrophy (SMA)

Covered when ALL of the following are met

Evrysdi (SMA) initial: Diagnosis of spinal muscular atrophy type I, II, or III with genetic confirmation (SMN1 homozygous deletion/mutation or compound heterozygous mutation) AND at least 2 copies of SMN2 AND baseline motor exam with appropriate scale performed AND not dependent on both invasive ventilation/tracheostomy and chronic non‑invasive ventilation beyond naps/nighttimeSMN2 >=2; baseline motor testing

Prescribed by neurologist experienced in SMA; not to receive concomitant chronic SMN‑modifying therapy (e.g., Spinraza); initial and reauth 12 months; reauth requires documented clinical response.

Evrysdi — prior gene therapy: Either no prior gene replacement therapy OR prior gene therapy with submission of medical records documenting inadequate response to gene therapydocumented inadequate response if prior gene therapy

Specialist documentation required.

Fabrazyme (alpha-galactosidase A) for Fabry disease

Covered when ALL of the following are met

Fabrazyme (Initial) diagnostic options: Diagnosis of Fabry disease established by one of: pathogenic GLA gene mutation on molecular genetic testing; deficient α‑galactosidase A enzyme activity in plasma, leukocytes, or dried blood spots (DBS); OR significant clinical manifestations consistent with Fabry disease (e.g., neuropathic pain, cardiomyopathy, renal insufficiency, angiokeratomas, cornea verticillata)patient >=2 years old

Prescribed per product guidance; will not be used in combination with other Fabry drugs; coverage 12 months; reauth requires clinical response.

Fasenra (benralizumab) for severe eosinophilic asthma

Covered when ALL of the following are met

Fasenra — Severe eosinophilic asthma initial: Diagnosis of severe asthma with eosinophilic phenotype defined by baseline peripheral blood eosinophils ≥150 cells/µL AND either ≥2 exacerbations requiring systemic corticosteroids in past 12 months OR prior asthma‑related hospitalization in past 12 months; age‑ and therapy‑dependent controller requirements apply>=150 cells/µL; 2 exacerbations or 1 hospitalization in 12 months

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

Icatibant (HAE attacks) - Initial

Covered when ALL of the following are met:

Icatibant (HAE acute attack) diagnostic options: Either: (1) Low C4 AND C1‑INH antigenic or functional level below lower limit of normal (Type I/II HAE) OR (2) Normal C4 and C1‑INH with pathogenic mutation detected (factor XII, plasminogen, angiopoietin‑1, kininogen‑1, myoferlin, HS3ST6) OR confirmed family history of recurrent angioedema (HAE‑nl‑C1INH)

For acute HAE attacks; not used in combination with other approved acute HAE treatments; initial age ≥18 years; prescribed by immunologist/allergist; coverage 12 months.

Fasenra (asthma and EGPA) - Initial/Reauth

Covered when criteria specific to indication and age are met:

Fasenra — Asthma initial (ages >=6): Diagnosis of severe eosinophilic asthma with baseline peripheral blood eosinophils ≥150 cells/µL AND history of ≥2 exacerbations requiring systemic corticosteroids in past 12 months OR prior asthma‑related hospitalization in past 12 months>=150 cells/µL

Age‑based controller therapy requirements apply; prescriber pulmonologist/allergist; initial 6 months; reauth 12 months with response.

Fasenra — Asthma controller therapy by age: Ages 6–11: currently treated with medium‑dose ICS plus additional controller OR one medium‑dose combination ICS/LABA unless contraindicated. Ages ≥12: currently treated with high‑dose ICS plus additional controller OR maximally dosed combination ICS/LABA unless contraindicated.

Prescriber and documentation per product guidance.

Fasenra — EGPA initial: Diagnosis of eosinophilic granulomatosis with polyangiitis with relapsed or refractory disease to standard care AND currently receiving corticosteroid therapy unless contraindicated

Prescribed by pulmonologist, rheumatologist, or allergist/immunologist; coverage 12 months.

Fentanyl Citrate Oral Transmucosal — breakthrough cancer pain opioid tolerance criteria

Covered when ALL of the following are met:

Fentanyl oral transmucosal — opioid tolerance: Patient is taking a long‑acting opioid around the clock for cancer pain AND has at least one week history demonstrating opioid tolerance at or above specified equianalgesic doses (e.g., morphine ≥60 mg/day; fentanyl patch ≥25 µg/hr; oxycodone ≥30 mg/day; hydromorphone ≥8 mg/day; oxymorphone ≥25 mg/day; hydrocodone ≥60 mg/day; methadone ≥20 mg/day)specified equianalgesic doses

Prescribed by or in consultation with pain/oncology/hospice/palliative specialists; coverage 12 months.

Multiple Sclerosis agents (fingolimod, glatiramer) - Initial/Reauth

Covered when ALL of the following are met:

MS agents (Initial): Diagnosis of a relapsing form of multiple sclerosis (e.g., clinically isolated syndrome, relapsing‑remitting MS, secondary progressive with active disease) AND not used in combination with another disease‑modifying therapy for MS

Prescribed by or in consultation with a neurologist; coverage duration 12 months; reauth requires positive clinical response (radiologic stability, relapse control).

Oncology and targeted therapies (Fotivda, Gavreto, Imatinib, Fruzaqla)

Covered when indication‑specific diagnostic or prior therapy conditions are met:

Fotivda (advanced RCC): Diagnosis of advanced renal cell carcinoma that is relapsed or refractory AND patient received two or more prior systemic therapies>=2 prior systemic therapies

Coverage 12 months; prerequisite Part D drug may be required.

Gavreto (RET fusion positive tumors): NSCLC or thyroid cancer with metastatic RET gene fusion detected by FDA‑approved or CLIA‑approved test; for thyroid cancer patient ≥12 years and radioactive iodine‑refractory or unsuitablemolecular confirmation of RET alteration

Coverage 12 months.

Imatinib indications: Diagnosis of Ph+ CML, Ph+ ALL, GIST, unresectable/recurrent/metastatic dermatofibrosarcoma protuberans, hypereosinophilic syndrome, MDS/MPD, or aggressive systemic mastocytosis

Coverage 12 months; continue prior therapy.

Use of another calcitonin gene-related peptide (CGRP) inhibitor concurrently with Aimovig for preventive migraine therapy is explicitly excluded. Requests for combination preventive therapy with more than one CGRP‑targeting product will not meet coverage criteria.

Many product entries in this excerpt do not specify additional exclusion criteria; several items list Exclusion Criteria: N/A. Where exclusions are not listed, coverage determinations are governed by the stated indication-specific requirements and required documentation.

For Cinryze used for prophylaxis of hereditary angioedema (HAE), the policy states it is not used in combination with other approved treatments for prophylaxis. Cinryze prophylactic therapy must be prescribed by or in consultation with an immunologist or allergist and meets other diagnostic and age requirements.

Concurrent administration of tadalafil with nitrates is an exclusion. Requests that would result in combined nitrate and tadalafil therapy are not allowed under the formulary criteria.

Requests for coverage of any pyrimethamine product for treatment or prophylaxis of malaria are not authorized and will be denied. Pyrimethamine coverage is limited to specified toxoplasmosis indications with infectious disease specialist involvement.

Therapy with Fabrazyme will not be used in combination with other drugs for Fabry disease. Coverage is contingent on diagnostic confirmation (pathogenic GLA mutation, deficient α‑Gal A activity, or characteristic clinical manifestations) and age restrictions as noted.

For erythropoiesis‑stimulating agents such as Procrit, off‑label uses (except specified indications like MDS or HCV) will not be approved when the patient’s hemoglobin is > 10 g/dL or hematocrit is > 30%. Coverage decisions for labeled indications require the Hgb/Hct thresholds and supporting laboratory documentation described in the policy.

Formulary Identifiers, Product Lists, and Key Numeric Thresholds

Formulary identifiers / product listmixed

Formulary ID: 26216

Formulary identifier listed for products in this extract

Formulary ID entrymixed

No codes listed

Formulary identifiersmixed

Formulary ID: 26216

Formulary identifier repeated across products in this segment

Covered Part D biologic product strengthsmixedCovered

Dupixent INJ 200MG/1.14ML	Dupixent product strength listed in formulary
Dupixent INJ 300MG/2ML	Dupixent product strength listed in formulary
Enbrel INJ 25MG/0.5ML	Enbrel product strength listed in formulary
Enbrel INJ 50MG/ML	Enbrel product strength listed in formulary

Covered products with prerequisitesmixedCovered

Empaveli

Empaveli (pegcetacoplan) — listed with indications

Products Affected - Enbrel formulationsmixed

Enbrel INJ 25MG/0.5ML	Product listed
Enbrel INJ 50MG/ML	Product listed
Enbrel Mini	Product listed
Enbrel Sureclick	Product listed

Products Affected - assorted specialty drugsmixed

Empaveli	Product listed
L-glutamine PACK	Product listed
Ensacove	Product listed
Sofosbuvir/velpatasvir	Product listed
Epidiolex	Product listed
Procrit	Product listed
Pirfenidone	Product listed
Evrysdi SOLR	Product listed
Fabrazyme	Product listed
Fasenra / Fasenra Pen	Product listed

Formulary identifiermixed

26216

Formulary ID referenced for multiple products (Version 11)

Formulary Identifiersmixed

Formulary ID: 26216

Listed formulary identifier for multiple products in this section

No explicit CPT/HCPCS/ICD-10/NDC codes listed in this segmentmixed

No codes listed

Formulary identifiers in this segmentmixed

No codes listed

No explicit CPT/HCPCS/ICD-10/NDC codes listed in this sectionmixed

No codes listed

Formulary identifiermixed

Formulary ID: 26216

Formulary identifier and version for listed products (Version 11, Effective 04/01/2026)

Formulary identifiermixed

Formulary ID: 26216

Formulary identifier and version (Version 11)

No explicit CPT/HCPCS/ICD-10/NDC codes listed in this segmentmixed

No codes listed

Covered drugs listed (by name)mixedCovered

No codes listed

Formulary Identifiermixed

Formulary ID: 26216

Formulary identifier for listed drugs (version 11)

Plaque Psoriasis BSA threshold

Plaque psoriasis BSA threshold>= 3% body surface area

Alternate severity criteriaSevere scalp, palmoplantar, facial, or genital involvement qualifies as moderate-to-severe

Topical therapy prerequisite durationMinimum 30-day trial (14 days for topical corticosteroids) required before biologic

Episodic migraine frequency threshold (>=4 days/mo)

Episodic migraine frequency threshold>= 4 migraine days per month

Age restrictionEM initial: 18 years or older for listed CGRP products

Initial coverage duration6 months (reauth 12 months)

Chronic migraine frequency threshold (>=8 days/mo)

Chronic migraine frequency threshold>= 8 migraine days per month

Medication overuse considerationMedication overuse headache must be considered and offending agents discontinued

Initial coverage duration6 months (reauth 12 months)

ANA titer / anti-dsDNA threshold for SLE

ANA titer thresholdANA >= 1:80

Anti-dsDNA thresholdanti-dsDNA >= 30 IU/mL

Clinical contextRequired as 'autoantibody positive' for Benlysta SLE eligibility

Arikayce sputum culture response window

Arikayce sputum culture response windowUsed when patient does not achieve at least two negative sputum cultures after >=6 consecutive months of multidrug background regimen

Treatment contextUsed as part of combination antibacterial regimen; prescribed by ID specialist or pulmonologist

Coverage duration12 months

Bronchitol tolerance requirement (BTT passed)

Bronchitol tolerance requirementPatient must have passed a Bronchitol Tolerance Test (BTT) prior to initiation

Age requirementInitial CF use: patient is 18 years of age or older

Prescriber restrictionPrescribed by or in consultation with pulmonologist or CF care center specialist

Age thresholds examples across products

Age threshold examplesExamples in policy: Briviact >=1 month; Bronchitol initial >=18 years; Cayston initial >=7 years; Benlysta formulations >=5 years

Prescriber specialty notesMany age-restricted products require specialist prescriber or consultation as noted per product

Coverage duration examplesInitial coverage commonly 6 months; reauth commonly 12 months

Psoriasis BSA threshold (>=3% BSA)

Psoriasis BSA threshold>= 3% body surface area

Severe-site alternativeSevere scalp or palmoplantar/facial/genital involvement also qualifies

Required topical trialMinimum 30-day topical trial (14 days for topical corticosteroids) before biologic approval

Onychomycosis terbinafine trial durations (toenail/fingernail)

Toenail terbinafine trial durationMinimum 12-week supply trial of oral terbinafine required before topical lacquer for toenail onychomycosis

Fingernail terbinafine trial durationMinimum 6-week supply trial required for fingernail onychomycosis

Diagnostic confirmationOnychomycosis must be confirmed by KOH, culture, or histology

Ferritin baseline for deferasirox and LIC thresholds

Ferritin baseline for deferasiroxBaseline ferritin > 1,000 mcg/L required for transfusional iron overload initial therapy

LIC thresholdsNTDT initial: LIC >= 5 mg Fe/g dw; NTDT reauth: LIC >= 3 mg Fe/g dw

Transfusion history requirementTransfusional indication: transfusion of at least 100 mL/kg packed RBCs documented

LIC thresholds for iron overload initial/reauth

LIC for NTDT initialLIC >= 5 mg Fe/g dw required for NTDT initial approval

LIC for NTDT reauthorizationReauthorization requires LIC >= 3 mg Fe/g dw and reduction in ferritin/LIC from baseline

Serum ferritinNTDT initial also requires serum ferritin >300 mcg/L

Dupixent eosinophil thresholds (>=150 or >=300 cells/mcL depending on indication)

Dupixent eosinophil thresholds>= 150 cells/mcL for eosinophilic asthma; >=300 cells/mcL for COPD with type 2 inflammation

Indication-specific requirementsEosinophil thresholds are paired with exacerbation history or hospitalization criteria per indication

Age-dependent controller therapyDenoted controller regimens differ for ages 6–11 vs >=12 years for asthma indications

Eosinophil count thresholds (Dupixent examples)

Eosinophil count examples (Dupixent)>=150 cells/mcL baseline for eosinophilic asthma lead-in; >=300 cells/mcL threshold used for COPD type 2 inflammation

Associated clinical criteriaThresholds are linked to exacerbation frequency or hospitalizations as specified

Reauth expectationsReauthorization requires continued controller therapy and evidence of clinical response

Migraine frequency for Emgality (>=4 EM, >=8 CM)

Emgality migraine frequency thresholdsEpisodic migraine (EM): >=4 migraine days/month; Chronic migraine (CM): >=8 migraine days/month

Combination therapy exclusionMedication will not be used in combination with another injectable CGRP inhibitor for prevention

Age restrictionEM/CM initial: 18 years or older for Emgality per formulary entry

Peripheral blood eosinophils threshold (>=150 cells/µL) used across several asthma agents

Peripheral blood eosinophils threshold>= 150 cells/µL baseline used across multiple asthma biologics as eosinophilic phenotype definition

Clinical pairingOften paired with history of >=2 exacerbations requiring systemic steroids or prior hospitalization in past 12 months

Use across productsThreshold cited for Fasenra, Dupixent, Nucala and others as phenotype criterion

Hemoglobin/Hematocrit thresholds for Procrit and ESA therapy

Hemoglobin/Hematocrit thresholds for ESA therapyExamples: Hgb <10 g/dL or Hct <30% for many indications; off-label uses not approved if Hgb >10 g/dL or Hct >30%

Indication-specific timingLabs must be current within specified timeframes (e.g., within 2 weeks for chemotherapy-induced anemia)

Iron stores requirement linkageESA use requires adequate iron stores (see ferritin/TSAT thresholds) prior to initiation

SMA genetic criteria for Evrysdi

SMA genetic criteria for EvrysdiSMN1 homozygous deletion or compound heterozygous mutation AND at least 2 copies of SMN2

Baseline assessmentsBaseline motor function testing (HINE-2, HFMSE, RULM, CHOP-INTEND, MFM-32 or BSID-III Item 22) required

Ventilation exclusionPatient not dependent on both invasive ventilation/tracheostomy and chronic non-invasive ventilation beyond naps/nighttime

Iron stores required for ESA therapy (Ferritin >100 mcg/L and TSAT >20%)

Iron stores required for ESA therapyFerritin >100 mcg/L and TSAT >20% required to confirm adequate iron stores prior to ESA initiation

Application across indicationsRequired for CKD, chemo, preop, MDS and other ESA indications per formulary

Lab timingFerritin and TSAT must be documented in the required pre-treatment timeframe

Prior Authorization, Documentation & Step-Therapy Actions

Prior Authorization

Prior authorization — initial therapy requirements (diagnosis, prior trials, documentation)

Submit a prior authorization that includes the documented diagnosis and evidence of required prior therapy trials or failures (e.g., 3-month TF/C/I to methotrexate, leflunomide, or sulfasalazine for RA; 30-day topical therapy trial [14 days for topical corticosteroids] for plaque psoriasis). Prescriber specialty must be included where required for initial therapy.

For RA initial: documentation of moderately to severely active RA and a minimum 3-month TF/C/I to methotrexate, leflunomide, or sulfasalazine.
For PJIA initial: diagnosis and minimum 6-week TF/C/I to leflunomide or methotrexate.
For plaque psoriasis initial: ≥3% BSA or severe site involvement and trial/failure of topical therapy (min 30 days; 14 days for topical corticosteroids).
Include required prescriber specialty or consultation note for indications that require it (rheumatologist, dermatologist, gastroenterologist, etc.).

Prior Authorization

Prior authorization required — providers must supply diagnosis and molecular testing where specified

Prior authorization is required for many formulary entries; the provider must supply the diagnosis and any required molecular or laboratory test results, plus specialty prescriber information when the product specifies it.

When molecular or mutation testing is required by the product, include FDA‑approved or CLIA lab test results.
If the product requires a specialist prescriber, include documentation of that specialty or consultation.

Prior Authorization

Prior authorization requirement — documentation of diagnosis, prior therapy trials/failures, coverage duration

Most specialty products require prior authorization with documentation of the diagnosis, prior therapy trials/failures, and stated coverage duration (commonly 12 months). Ensure submission includes those items per product-specific criteria.

Include indication-specific objective measures and prior TF/C/I documentation.
Note coverage duration listed in the product entry (e.g., 6 months initial for many; 12 months reauth).

Prior Authorization

Prior authorization required for listed Part D drugs

Prior authorization applies to multiple Part D drugs listed; for some entries (e.g., anticholinergic risk note) PA applies to patients age 65 and older — include age and PA reasons in the submission.

If the product entry notes PA applies to patients ≥65 (or other age groups), include patient age in documentation.
Include any required prescriber attestation (e.g., anticholinergic risk acknowledgement) when requested.

Prior Authorization

Dupixent — PA with disease-specific criteria (eosinophils, prior therapy trials)

For Dupixent requests include disease‑specific objective data (e.g., baseline peripheral blood eosinophils per indication) and documentation of prior therapy trials or failures as required by the indication.

Eosinophilic asthma: baseline eosinophils ≥150 cells/mcL plus history of exacerbations or hospitalization as specified.
COPD/type 2 inflammation: eosinophils threshold (e.g., ≥300 cells/mcL) and trials of maximized inhaled therapies per product details.

Prior Authorization

Prior authorization required — specified initial and reauth criteria including specialist prescriber where required

Submit PA documentation that meets the product's initial and reauthorization criteria, including minimum trial durations, prescriber specialty and evidence of clinical response for reauthorization where applicable.

Follow the product-specific initial duration and reauth intervals (examples: initial 6 months, reauth 12 months).
Include specialist consultation notes when required.

Prior Authorization

Prior authorization requirement — submission of diagnosis-specific documentation (genetic/enzyme tests, C4/C1-INH)

When a product requires submission of diagnosis‑specific testing, include the exact laboratory or genetic/enzyme test results (e.g., Fabry: GLA mutation or α‑Gal A enzyme results; HAE: C4 and C1‑INH antigenic/function levels).

Attach actual lab or genetic test reports (FDA‑approved or CLIA‑certified where specified).
For HAE include C4 and C1‑INH antigenic or functional assay results or mutation/family history documentation for HAE‑nl‑C1INH.

Prior Authorization

Specialist-prescribed prior authorization — many indications require specialist prescribing/consultation

Many indications require the prescriber to be a specialist or to document consultation with a specialist (e.g., endocrinologist for growth disorders; rheumatologist for RA); include specialist credentials or consultation notes in the PA.

If the policy lists a prescriber restriction, include the specialist's note confirming diagnosis and treatment plan.
For initial therapy, confirm the specialist involvement per product entry.

Prior Authorization

Prior authorization requirement — documentation of diagnosis, specialist involvement, prerequisite therapy trials

Include diagnosis documentation, evidence of specialist involvement when required, and prior therapy trial/failure or TF/C/I documentation as part of the PA submission for products that specify these prerequisites.

Document TF/C/I to required agents and include dates/durations of trials.
Attach baseline disease activity measures used for later reauthorization comparisons.

Documentation Required

Jynarque - monitoring and authorization requirements (lab monitoring schedule)

For Jynarque (tolvaptan) include the ADPKD diagnosis and follow the specified liver‑function monitoring schedule: measure ALT, AST, and bilirubin prior to initiation, at 2 and 4 weeks after start, then monthly for the first 18 months (or at least every 3 months if treated >18 months).

Document absence of significant preexisting liver impairment (excluding uncomplicated polycystic liver disease).
Include monitoring schedule results with PA and reauthorization requests.

Prior Authorization

Kesimpta - specialist-prescribed prior auth (neurology requirement for MS)

Kesimpta requests must show diagnosis of a relapsing form of MS and either a trial/failure or continuation rationale; prescriber must be a neurologist — include neurologist documentation and do not combine with another DMT.

Provide trial/failure or intolerance to prior DMTs (minimum 4‑week supply) or documentation supporting continuation.
Confirm Kesimpta will not be used with another disease‑modifying or B‑cell targeted therapy.

Prior Authorization

Kineret - RA prior auth requiring prior biologic/JAK trials or continuation criteria

For Kineret (anakinra) in RA, include documentation of trial and failure/contraindication/intolerance to two specified biologic/JAK agents or documentation demonstrating continuation of prior therapy; reauthorization requires evidence of clinical response.

List the two prior agents tried (e.g., Enbrel, formulary adalimumab, Orencia, Rinvoq, Xeljanz) with dates and outcomes.
Provide objective measures of response for reauth (reduced swollen/tender joint count or symptom improvement).

Prior Authorization

Prior authorization requirement — Part D drugs require mutation/lab testing documentation where applicable

For Part D drugs where molecular/mutation or lab testing is applicable, include the specified test results (e.g., KRAS, BRAF, FGFR2, RET) and prior therapy history as required by the product entry.

Attach FDA‑approved or CLIA‑certified assay reports for required mutations.
Include prior systemic therapy details when mandated by the indication.

Prior Authorization

Prior authorization required per product — document diagnosis, labs, prior therapy trials

Many Part D drugs require PA with documentation of diagnosis, required lab values or prior therapy trials as described per product; include those objective data and trial histories in the PA submission.

Examples: LDL‑C within 120 days for Nexletol/Nexlizet; prior triptan trial for acute migraine agents; fibrosis staging for MASH agents.
Attach the supporting lab/test reports and prior medication trial records.

Prior Authorization

Prior authorization and prescriber restriction — many agents require specialist prescriber

Many products include prescriber restrictions (pulmonologist, rheumatologist, dermatologist, gastroenterologist); include the required prescriber specialty or documentation of consult in the PA.

If the product entry requires specialist involvement, include consultation notes or the specialist's attestation.
PA may be denied without required prescriber specialty documentation.

Prior Authorization

Prior authorization required — documentation of indication, diagnostics, prescriber specialty, prerequisite therapies

Include the specific indication, supporting diagnostic evidence (labs, imaging, genetic tests), prescriber specialty when specified, and evidence of prerequisite therapies or trial‑and‑failure in the PA submission.

Ensure objective criteria (e.g., CDAI >220, eosinophil counts, LDL‑C thresholds) are documented with test dates.
Attach prior medication trials with dosages and durations.

Prior Authorization

Prior authorization required — document diagnosis, objective criteria, prescriber specialty, and reauth response measures

PA submissions must include diagnosis, required objective criteria, prescriber specialty restrictions where specified, and evidence of clinical response for reauthorization.

For reauthorization, provide at least one indication‑specific measure of improvement (e.g., decreased BSA, improved joint counts, mucosal healing).
Document that prerequisite therapy trials were completed unless contraindicated.

Documentation Required

Prior authorization required — molecular testing documentation and common 12-month coverage durations noted

PA for products that require molecular testing must include the diagnostic molecular test report (FDA‑approved or CLIA‑certified) and typical coverage durations are noted (commonly 12 months).

Attach the molecular diagnostic report (e.g., IDH1, RET, KRAS G12C, FGFR2) and prior therapy history if required.
Note the coverage duration indicated in the product entry.

Step Therapy

step therapy requirements — TF/C/I prerequisites for biologic initiation

Providers must document trials of conventional therapies before specialty biologic approval in many indications (e.g., RA requires TF/C/I to one conventional DMARD; psoriasis requires topical therapy trials).

Document duration and outcome of conventional therapy trials and include dates and reasons for failure/intolerance/contraindication.
For RA: minimum 3 months; for PJIA: minimum 6 weeks; for plaque psoriasis: topical trial durations as specified.

Step Therapy

Caplyta step therapy — trial/failure to listed atypical antipsychotics

Caplyta requires trial and failure, contraindication, or intolerance to specified oral generic atypical antipsychotics prior to approval; include documentation of those trials in the PA.

List the antipsychotics tried and duration/outcome.
Attach chart notes showing inadequate response or intolerance.

Step Therapy

Step therapy requirements — documented TF/C/I to specified agents

Several products require documented trial and failure (or contraindication/intolerance) to specified formulary agents (examples include antipsychotics for schizophrenia, topical therapies for psoriasis, two prior COPD therapies for roflumilast). Provide trial documentation in the PA.

Roflumilast: document TF/C/I to two prior COPD therapies (e.g., Combivent, Spiriva).
Psoriasis and psychiatric agents: document required prior medication trials per product.

Step Therapy

Roflumilast — prerequisite therapy (two prior COPD therapies required)

Roflumilast requires prior trial and failure/intolerance/contraindication to two prior COPD therapies (for example, Combivent and Spiriva); include those trial records in the PA.

Provide dates and reasons for discontinuation or failure of each prior COPD therapy.
Include exacerbation history that supports need for roflumilast.

Step Therapy

PROVIDER ACTIONS — conventional therapy trial prerequisites for biologic/specialty agents

Many biologic and immunomodulatory agents require documented trial and failure or intolerance to conventional therapies (e.g., methotrexate, leflunomide, sulfasalazine for RA) before approval; include these TF/C/I details in the PA.

List conventional agents attempted, duration of trials, and objective measures of lack of efficacy or intolerance.
For reauthorization, provide evidence of clinical improvement compared to baseline.

Step Therapy

Asthma controller therapy prerequisites — document prior inhaled/controller regimens

For asthma biologics and other asthma agents, document prior controller therapy regimens (e.g., inhaled corticosteroid dosing and additional controller use) per age group before approval.

For ages 6–11 include medium‑dose ICS plus additional controller or medium‑dose combo ICS/LABA documentation; for ≥12 include high‑dose ICS plus additional controller or maximally dosed combo ICS/LABA.
Attach medication lists and dosing.

Step Therapy

Required conventional therapy trials — document durations and outcomes

Required conventional therapy trials must be documented with durations as specified per indication (examples: methotrexate 3 months for RA; topical therapy 4 weeks for plaque psoriasis) prior to biologic approval.

Include start and stop dates, doses, and reason for failure/intolerance/contraindication.
Attach relevant lab or objective measures used to evaluate response.

Step Therapy

Step therapy and prerequisite trials — TF/C/I to specified agents often required

Many indications require prior TF/C/I to specified agents (for example, TF/C/I to Remicade/Infliximab or specified biologics) — include documentation of those prerequisite trials in the PA.

For biosimilars like Renflexis, document TF/C/I to Remicade or Infliximab if required.
List prior biologics tried with dates and outcomes.

Step Therapy

Kerendia - ACE/ARB prerequisite (30‑day trial unless contraindicated)

Kerendia for CKD with T2D requires documentation of a minimum 30‑day trial of a maximally tolerated generic ACE inhibitor or ARB unless contraindicated; include trial documentation or documented intolerance in the PA.

Provide ACE/ARB name, dose, duration (minimum 30 days), and intolerances/contraindications if applicable.
Attach UACR, eGFR, and serum potassium values as required.

Step Therapy

Step therapy / prerequisite drugs — prior Part D drug trials required for some products

Many products require trial and failure of specified prerequisite Part D drugs (e.g., loperamide for IBS; a triptan for acute migraine); include those prior medication trials in the PA.

For acute migraine agents, document trial/failure or contraindication to one triptan.
For IBS agents, document trial/failure of antidiarrheal agent (e.g., loperamide).

Step Therapy

Step therapy / prior trials — document required prior therapies before approval

Some agents require a documented trial and failure of specified therapies prior to approval (examples: Nurtec acute requires trial/failure of one triptan; Nexletol/Nexlizet require adjunct to statin or documented statin intolerance). Include such trial evidence in submissions.

Attach records of triptan therapy and intolerance/inefficacy for acute migraine approvals.
For lipid agents, include LDL‑C result and statin trial/intolerance documentation.

Step Therapy

Required trial of conventional therapies — document TF/C/I to listed conventional agents

Certain agents require prior TF/C/I to specified conventional therapies before authorization (e.g., Orencia requires methotrexate/leflunomide/sulfasalazine for RA; Otezla requires a 4‑week topical therapy trial for plaque psoriasis). Provide trial documentation accordingly.

Include medication names, durations, and reasons for discontinuation.
For topical trials, include dates and agent potency where relevant.

Step Therapy

Trial-and-failure requirements — TF/C/I to conventional therapies required before many specialty agents

Many biologic or specialty agents require documented trial and failure, contraindication, or intolerance to specified conventional therapies before approval; include clear evidence of those trials in the PA.

Provide timeline and objective measures supporting lack of response or intolerance.
For biosimilars, document any Remicade/Infliximab step requirements when specified.

Note

Documentation Required

Reauthorization clinical response — provide objective evidence of benefit

For reauthorization, include documentation of positive clinical response to therapy, such as reductions in swollen/tender joint counts, improvement in BSA for psoriasis, mucosal healing for IBD, or other indication‑specific objective measures.

Attach baseline and follow‑up measures to demonstrate clinical benefit.
Specify which reauth metric is being used per indication.

Documentation Required

Benlysta required clinical documentation — active SLE and autoantibody confirmation

Benlysta PA must include documentation of active SLE, positive autoantibody (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL), and that the patient is receiving standard‑of‑care treatment.

Attach ANA or anti‑dsDNA laboratory reports with dates.
Include current standard‑of‑care medication list (antimalarials, corticosteroids, immunosuppressants).

Documentation Required

Augtyro diagnostic testing requirements — ROS1/NTRK testing and advanced disease documentation

Augtyro requests must include molecular testing confirming ROS1 rearrangement for NSCLC or NTRK gene fusion for solid tumors and documentation that disease is locally advanced, metastatic, or unresectable and progressed on prior therapy or lacks satisfactory alternatives.

Attach FDA‑approved or CLIA test reports for ROS1 or NTRK.
Include prior therapy history and rationale for Augtyro use.

Documentation Required

Schizophrenia documentation — two oral atypical antipsychotic trials required

For schizophrenia medications requiring PA, document diagnosis and trial and failure (or intolerance/contraindication) to two listed oral atypical antipsychotics with dates and outcomes.

List the two oral atypical antipsychotics tried (e.g., aripiprazole, quetiapine) with duration and reason for failure/intolerance.
Attach clinic notes supporting inadequate response.

Documentation Required

Chenodal documentation — radiographic confirmation and prior ursodiol trial

Chenodal PA must include diagnosis of radiolucent non‑calcified gallstones, oral cholecystography showing a well‑opacifying gallbladder, trial/failure to ursodiol, and documentation that the patient is not a surgical candidate; reauthorization requires imaging evidence of ongoing need.

Attach oral cholecystogram or ultrasound reports and prior ursodiol trial details.
Provide documentation that surgery is contraindicated or not appropriate.

Documentation Required

Cosentyx documentation — BSA and location‑specific severe involvement and prior therapy

Cosentyx requests must include disease‑specific objective findings (e.g., BSA ≥3% or severe scalp/palmoplantar/facial/genital involvement for plaque psoriasis) and documentation of prior topical or systemic therapy trials as required by the indication.

Provide BSA calculations, lesion location details, and prior topical/systemic therapy trial records.
Include prescriber specialty/consultation note when required (dermatologist or rheumatologist).

Documentation Required

Anticholinergic risk acknowledgment — prescriber must acknowledge and document plan

Prescribers must acknowledge anticholinergic risks where noted and include that acknowledgment in the PA when the product entry requests it.

Document prescriber acknowledgement and any plan to lower or discontinue other anticholinergic medications.
Include patient age if PA applies to patients ≥65 years.

Documentation Required

Metyrosine — required biochemical confirmation for pheochromocytoma

Preoperative use of metyrosine requires biochemical confirmation of pheochromocytoma (plasma free metanephrines OR urinary fractionated metanephrines); include those test results in the PA.

Attach plasma free metanephrine or urinary fractionated metanephrines report.
Include documentation of alpha‑ and beta‑blocker trials as required if applicable.

Documentation Required

Evrysdi documentation — baseline genetic confirmation and motor function testing

For Evrysdi, include baseline genetic confirmation of SMA (SMN1 mutation/deletion and SMN2 copy number) and baseline motor function testing results (HINE‑2, HFMSE, RULM, CHOP‑INTEND, MFM‑32 or BSID‑III Item 22) with PA.

Attach genetic testing showing SMN1 deletion/mutation and SMN2 copy number.
Include baseline motor exam scores appropriate to patient age.

Documentation Required

Procrit required lab documentation — recent Hct/Hgb and iron stores verification

For Procrit and related ESAs, include recent hemoglobin/hematocrit values and evidence of adequate iron stores (ferritin >100 mcg/L and TSAT >20%) within specified timeframes in the PA.

Provide Hct/Hgb lab dates and values and ferritin/TSAT reports.
For off‑label uses, do not submit requests when Hgb >10 g/dL or Hct >30% (except MDS/HCV exceptions).

Documentation Required

HAE diagnostic documentation — low C4 and C1‑INH deficiency confirmation required

Confirmatory laboratory testing for HAE must be included: low C4 and documented C1‑INH antigenic or functional deficiency, or genetic testing/family history for HAE‑nl‑C1INH.

Attach C4 and C1‑INH antigenic/function assay results with lab reference ranges.
If HAE‑nl‑C1INH, include mutation testing or documented family history.

Documentation Required

Fabry disease diagnostic documentation — genetic or enzyme confirmation required

Fabry disease PA must include molecular genetic testing showing a pathogenic GLA mutation OR α‑Gal A enzyme deficiency in plasma/leukocytes/DBS OR documentation of characteristic clinical manifestations consistent with Fabry disease.

Attach genetic or enzyme assay reports and list relevant clinical findings (neuropathic pain, cardiomyopathy, renal insufficiency, angiokeratomas, cornea verticillata).
Confirm patient age meets the product's minimum (e.g., ≥2 years for Fabrazyme).

Documentation Required

Opioid tolerance documentation — chronic around‑the‑clock opioid use and equianalgesic dosing required

For opioid‑tolerance–required products (e.g., fentanyl oral transmucosal), document chronic around‑the‑clock long‑acting opioid use and at least one week of opioid dosing at or above specified equianalgesic doses.

Provide medication names, doses, and a one‑week opioid use history demonstrating tolerance (examples listed in policy).
Include prescriber specialty or consultation as required (pain, oncology, hospice, palliative care).

Documentation Required

Growth-related documentation — height SDS, growth velocity, bone age and specialist note required

Growth‑related PAs must include documented growth metrics per indication (height SDS thresholds, growth velocity, bone age) and specialist documentation (endocrinologist) as specified.

Attach height, growth velocity, bone age, IGF‑1, and GH stimulation test results when applicable.
Include endocrinologist consultation note confirming diagnosis and treatment plan.

Documentation Required

Inflectra documentation — baseline disease activity and prior therapy trials required

For Inflectra and similar infliximab‑class agents, include baseline disease activity metrics (e.g., CDAI >220 for Crohn's), documentation of prior conventional therapy trials, and objective measures used for reauthorization.

Provide CDAI scores, stool frequency, lab markers (CRP, ESR), or BSA for psoriasis as applicable.
Attach records of prior TF/C/I to conventional agents with durations.

Background and Scope

This formulary segment covers specialty biologic and small‑molecule agents commonly used in immunology and rheumatology. It defines indication‑specific entry requirements including diagnostic confirmation, minimum trials of conventional therapies or specified prerequisite Part D drugs, prescriber specialty restrictions, and objective measures required for reauthorization. Typical initial coverage durations range from 6 months for some agents to 12 months for many reauthorizations; prior authorization and documentation of positive clinical response are required per product.

Definitions and Abbreviations Used

TF/C/I — Trial and failure, contraindication, or intolerance

TF/C/I definitionTrial and failure, contraindication, or intolerance to a listed prior therapy

Use in prior therapy requirementsApplied across rheumatology, dermatology, GI, and many biologic approval pathways

Documentation noteProviders must document duration and agents tried per indication (e.g., 3-month methotrexate for RA)

BSA — Body surface area (psoriasis severity metric)

BSA definitionBody surface area (BSA) used as a metric for psoriasis severity (eg, >=3% BSA defines moderate-to-severe)

Severity applicationBSA thresholds used for initial eligibility and reauthorization measures

Topical trial linkageBSA threshold is coupled with required topical therapy trials per product entries

Autoantibody positive — ANA ≥1:80 or anti-dsDNA ≥30 IU/mL for SLE

Autoantibody positive definitionANA >=1:80 or anti-dsDNA >=30 IU/mL required to define 'autoantibody positive' for SLE eligibility

Context of useRequired for Benlysta initial eligibility along with active SLE and standard-of-care therapy

Age noteBenlysta IV/SC formulations have age-specific minimums (>=5 years for listed formulations)

MAC lung disease response — Arikayce eligibility definition

MAC lung disease response definitionArikayce indicated for patients who do not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen

Specialist prescriberPrescribed by or in consultation with an infectious disease specialist or pulmonologist

Coverage duration12 months

HAE diagnostic criteria — low C4 and C1-INH deficiency definitions

HAE diagnostic criteriaDiagnosis confirmed by low C4 AND C1‑INH antigenic or functional deficiency (Type I/II) OR normal C4/C1‑INH with specified pathogenic mutation OR confirmed family history

Age for prophylaxisCinryze prophylaxis initial: patient >=6 years

Combination use exclusionNot used in combination with other approved prophylactic HAE treatments

Moderate to severe plaque psoriasis definition (>=3% BSA or severe site involvement)

Moderate to severe plaque psoriasis definition>=3% BSA involvement OR severe scalp/palmoplantar/facial/genital involvement; after topical therapy trial

Topical trial requirementMinimum 4-week topical trial required for some products (Cosentyx) or 30-day for others per entry

Prescriber restrictionInitial therapy usually requires dermatologist involvement or consultation

Eosinophilic asthma / type 2 inflammation definitions (eosinophil thresholds)

Eosinophilic asthma / type 2 inflammationDefined by baseline peripheral blood eosinophils >=150 cells/mcL (or >=300 cells/mcL in COPD) with exacerbation history criteria

Clinical pairingThresholds tied to >=2 exacerbations requiring systemic steroids or prior hospitalization in 12 months

Prescriber involvementMany indications require pulmonologist or allergist/immunologist consultation

Fabry disease diagnostic criteria (GLA mutation or enzyme deficiency)

Fabry diagnostic criteriaDiagnosis by pathogenic GLA mutation OR deficient α‑Gal A enzyme activity in plasma/leukocytes/DBS OR characteristic clinical manifestations

Age restrictionFabrazyme initial: patient >=2 years of age

Combination exclusionWill not be used in combination with other drugs for Fabry disease

Eosinophilic phenotype for severe asthma (baseline >=150 cells/µL plus history)

Eosinophilic phenotype for severe asthmaBaseline peripheral blood eosinophils >=150 cells/µL plus history of exacerbations or hospitalization

Use in approvalsApplied to Fasenra and other severe asthma biologic approvals

Reauth expectationsReauth requires demonstration of clinical response (reduced exacerbations, improved control)

HAE-nl-C1INH definition — HAE with normal C1‑INH

HAE-nl-C1INH definitionHereditary angioedema with normal C1‑INH requiring detection of pathogenic mutation or confirmed family history

Diagnostic testingMutation presence detected by FDA-approved or CLIA lab test qualifies for diagnosis

PrescriberInitial therapy prescribed by immunologist or allergist

PGHD — pediatric growth hormone deficiency-related documentation criteria

PGHD documentation criteriaPediatric GH deficiency diagnoses require height >2.0 SD below midparental or >2.25 SD below population mean, or growth velocity >2 SD below mean, or delayed skeletal maturation >2 SD

PrescriberInitial prescriptions by or in consultation with an endocrinologist

Reauth evidenceReauth requires positive clinical response (eg, expected adult height not yet attained) and documented gains

IGF-1 deficiency definition for growth indications

IGF-1 deficiency definitionSevere primary IGF-1 deficiency: height SDS <= -3.0 and basal IGF-1 SDS <= -3.0 with normal or elevated GH

PrescriberInitial: endocrinologist involvement required

Coverage durationInitial and reauth: 12 months

TF/C/I definition repeated (trial and failure, contraindication, or intolerance)

TF/C/I reiterated'TF/C/I' stands for trial and failure, contraindication, or intolerance to a listed prior therapy

Common useUsed throughout the policy to denote prerequisite therapy status before specialty agent approval

Documentation requirementProviders must document duration and agents tried per indication as specified

Rapidly progressing ADPKD definition for Jynarque

Rapidly progressing ADPKD (Jynarque)Diagnosis of rapidly progressing ADPKD with specified liver test monitoring schedule (ALT/AST/bilirubin pre-init, 2 and 4 weeks, then monthly for first 18 months) required

Monitoring frequency after 18 monthsIf treated >18 months, ALT/AST/bilirubin measured at least every 3 months

ExclusionPatients with significant liver impairment (excluding uncomplicated polycystic liver disease) are not eligible

CFTR responsive mutation definition for ivacaftor

CFTR responsive mutation definitionCFTR mutation responsive to ivacaftor must be detected by FDA-cleared or CLIA-approved test

Age thresholdKalydeco initial: patient >=1 month for specified indications

PrescriberPrescribed by or in consultation with CF specialist or pulmonologist

FDA- or CLIA-approved test definition for molecular diagnostics

FDA- or CLIA-approved test definitionMolecular diagnostic testing must be performed via FDA-approved companion diagnostic or at a CLIA-certified laboratory when required for targeted therapies

ApplicationsUsed for KRAS G12C, IDH1, RET, FGFR2, BRAF and other mutation-directed agent eligibility

DocumentationProviders must submit test results demonstrating the actionable mutation per product entry

Policy Revision History

2026-04-01effective_dateLatest

Formulary and coverage criteria became effective for Formulary ID 26216 (Version 11).

2026-03-02last_review

Policy document last updated/reviewed (Last Updated: 03/02/2026).