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CurrentBlue Cross Blue Shield - South CarolinaPolicy N/A

Medical benefit drug coverage criteria (selected immunology/rheumatology agents)

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Governs coverage criteria, required medical information, prescriber restrictions, coverage durations, and prerequisite therapy requirements for specified specialty medications (examples include adalimumab products, Actimmune, Adbry, Aimovig) for Blue Cross Blue Shield - South Carolina members.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyMedical benefit drug coverage criteria (selected immunology/rheumatology agents)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2026

Last ReviewFeb 2, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with indication-specific diagnostic documentation and required prior-therapy trials per Formulary ID 26216.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Formulary ID 26216formulary identifier and version

12 monthscommon reauthorization duration

6 monthsinitial coverage duration (many)

>=20drugs listed in excerpt

Coverage Criteria and Medical Necessity

Adalimumab — Initial RA

Adalimumab products — Initial therapy covered when ALL of the following are met

Adalimumab initial RA criteria: Diagnosis of moderately to severely active rheumatoid arthritis; minimum 3-month trial and failure, contraindication, or intolerance (TF/C/I) to one of: methotrexate, leflunomide, or sulfasalazine at maximally tolerated doses3-month TF/C/I

Prescribed by or in consultation with a rheumatologist for RA

Plaque Psoriasis — Initial

Plaque psoriasis (PsO) initial criteria — covered when ALL of the following are met

PsO initial criteria: Diagnosis of moderate to severe chronic plaque psoriasis AND one of: at least 3% body surface area (BSA) involvement OR severe scalp psoriasis OR palmoplantar/facial/genital involvement; AND trial and failure, contraindication, or intolerance to at least one topical therapy (minimum 30-day supply; 14 days for topical corticosteroids)

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyMedical benefit drug coverage criteria (selected immunology/rheumatology agents)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateMar 1, 2026

Last ReviewFeb 2, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with indication-specific diagnostic documentation and required prior-therapy trials per Formulary ID 26216.

SourceLink

On This Page

30-day topical trial (14-day for topical corticosteroids)

Prescribed by or in consultation with a dermatologist for PsO

Reauthorization — Positive clinical response

Reauthorization general requirement

Positive clinical response at reauth: 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 symptoms, reduction in BSA, reduction in abscess/inflammatory nodule count, mucosal healing)clinical improvement measures

Required for reauthorization across RA, PJIA, PsA, PsO, HS, AS, CD, UC and other listed indications; typical reauth duration 12 months

Adbry — Initial

Adbry (atopic dermatitis) initial criteria

Adbry initial: Diagnosis of moderate to severe atopic dermatitis AND involvement of >=10% BSA OR SCORAD >=25; trial and failure, contraindication, or intolerance to at least two topical agents: medium-or higher-potency topical corticosteroid, pimecrolimus, tacrolimus, or crisaborole (Eucrisa)>=10% BSA or SCORAD >=25; two topical therapy trials

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

Aimovig — Initial

Aimovig (migraine) initial criteria

Aimovig initial: Diagnosis of episodic or chronic migraine AND for episodic migraine (EM): >=4 migraine days per month; for chronic migraine (CM): >=8 migraine days per month AND medication overuse headache considered and offending meds discontinued>=4 (EM) or >=8 (CM) migraine days/month

Medication will not be used in combination with another CGRP inhibitor for migraine prevention; initial coverage 6 months

Arikayce — initial

Arikayce coverage (Mycobacterium avium complex lung disease)

Arikayce initial approval: Diagnosis of Mycobacterium avium complex (MAC) lung disease; used as part of a combination antibacterial regimen; patient has not achieved at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen>=6 months failed multidrug regimen with persistent positive cultures

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

Benlysta — initial and reauthorization

Benlysta coverage (Systemic lupus erythematosus and Lupus Nephritis)

Benlysta initial SLE: Diagnosis of active systemic lupus erythematosus (SLE); autoantibody positive defined as ANA >=1:80 OR anti-dsDNA >=30 IU/mL; patient is currently receiving at least one standard-of-care therapy (e.g., antimalarial, corticosteroid, or immunosuppressant)ANA >=1:80 or anti-dsDNA >=30 IU/mL

Prescribed by or in consultation with a rheumatologist; initial coverage 6 months; reauth requires positive clinical response

Benlysta Lupus Nephritis initial: Diagnosis of active lupus nephritis; patient currently receiving standard-of-care treatment for lupus nephritis (e.g., corticosteroids with mycophenolate); age >=5 years for IV/SC formulationsage >=5 years

Prescribed by or in consultation with nephrologist or rheumatologist; initial coverage 6 months; reauth requires positive clinical response

Augtyro — product-specific criteria (ROS1/NTRK molecular requirements)

Augtyro coverage (ROS1/NTRK molecular requirements)

Augtyro indications: NSCLC with ROS1 rearrangement OR solid tumors with NTRK gene fusion that are locally advanced, metastatic, or unresectable; disease progressed following prior treatment or no satisfactory alternative treatments

Document tumor ROS1 rearrangement or NTRK gene fusion by FDA-approved or CLIA-approved test; approve continuation of prior therapy; coverage 12 months

Caplyta step/coverage

Caplyta coverage (psychiatric indications) — step therapy and prerequisite trials

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

12 months coverage; approve continuation of prior therapy; prerequisite Part D drug required

Caplyta bipolar disorder: Diagnosis of bipolar I or II with depressive episodes AND trial and failure, contraindication, or intolerance to quetiapine (IR or ER)

Used as monotherapy or adjunctive; 12 months coverage

Caplyta MDD adjunctive: Diagnosis of major depressive disorder (MDD) used as adjunctive therapy with an antidepressant AND trial and failure, contraindication, or intolerance to aripiprazole and quetiapine IR/ER

12 months coverage

Antipsychotic prerequisite criteria

Antipsychotic prerequisite criteria (context for Caprelsa and antipsychotic-related approvals)

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

Required prior trials documented; coverage duration 12 months; continuation allowed

Thyroid cancer and CF product criteria

Thyroid cancer and cystic fibrosis product criteria — examples

Caprelsa (thyroid cancer): Diagnosis of metastatic medullary thyroid cancer (MTC) or unresectable locally advanced MTC AND symptomatic or progressive disease

Coverage duration 12 months; continuation of prior therapy allowed

Cayston (CF): Diagnosis of cystic fibrosis AND evidence of Pseudomonas aeruginosa in the lungsage >=7 for initial therapy

Prescribed by or in consultation with CF specialist; reauth requires clinical benefit (improved FEV1 or fewer exacerbations); coverage 12 months

Cerdelga — product criteria

Cerdelga (Gaucher disease) criteria

Cerdelga (Gaucher): Diagnosis of Gaucher disease type 1 AND patient is an extensive, intermediate, or poor CYP2D6 metabolizer as detected by an FDA-cleared testage >=18

Coverage 12 months

Bile acid and gallstone products — Chenodal and Cholbam criteria

Chenodal (radiolucent gallstones): Diagnosis of radiolucent gallstones; well-opacifying gallbladder on oral cholecystography; trial and failure, contraindication, or intolerance to ursodiol; patient is not a candidate for surgery; stones are not calcified or radiolucent bile pigment stones

Prescribed by gastroenterologist or specialist; initial and reauth coverage 12 months; prerequisite Part D drug required

Cholbam (bile acid synthesis disorders): For bile acid synthesis disorders due to single enzyme defects: abnormal urinary bile acid analysis by mass spectrometry OR molecular genetic testing consistent with diagnosis; for peroxisomal disorders: abnormal urinary bile acid analysis or molecular testing AND at least one clinical manifestation (liver disease, steatorrhea, or fat-soluble vitamin complications)

Prescribed by hepatologist/geneticist/metabolic specialist; initial coverage 4 months, reauth 12 months

Onychomycosis topical criteria

Onychomycosis topical criteria — ciclopirox nail lacquer

Ciclopirox (nail lacquer): No lunula (matrix) involvement; confirmed onychomycosis by KOH, culture, or histology; for toenails mild-to-moderate disease involving at least 1 target toenail (toenail trial 12 weeks) or fingernail disease (fingernail trial 6 weeks); trial and failure, contraindication, or intolerance to oral terbinafine (6 weeks fingernail, 12 weeks toenail)6-week fingernail; 12-week toenail trial

Coverage duration 48 weeks; prerequisite Part D drug required

HAE prophylaxis criteria

HAE prophylaxis criteria — Cinryze

Cinryze diagnostic options: Either: (1) C4 below LLN AND C1-INH deficiency or dysfunction documented by antigenic or functional level below LLN; OR (2) normal C4 and C1-INH AND either detection of specified gene mutation by FDA-approved/CLIA test OR confirmed family history of recurrent angioedema

Age >=6 for prophylaxis; prescribed by or in consultation with immunologist/allergist; not used in combination with other prophylactic treatments; reauth requires positive clinical response; coverage 12 months

Cosentyx multi-indication criteria

Cosentyx multi-indication criteria (multiple formulations and indications)

Cosentyx — Plaque psoriasis initial: Diagnosis of moderate-to-severe plaque psoriasis AND at least 3% BSA OR severe scalp/palmoplantar/facial/genital involvement; minimum 4-week trial and failure, contraindication, or intolerance to one topical therapy (steroid, vitamin D analog, tazarotene, or calcineurin inhibitor)>=3% BSA or defined locations

Prescribed by or in consultation with a dermatologist; initial 6 months; reauth 12 months; prerequisite Part D drug required

Cosentyx — Psoriatic arthritis initial: Diagnosis of active PsA with inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement AND TF/C/I to specified systemic agents (e.g., listed biologics or continuation of prior therapy)

Prescribed by rheumatologist or dermatologist; initial 6 months; reauth 12 months; reauth requires evidence of clinical response

Cosentyx — AS/nr-axSpA/ERA: Diagnosis of active ankylosing spondylitis, non-radiographic axSpA, or enthesitis-related arthritis; prior TF/C/I to one or two NSAIDs as specified or TF/C/I to specified biologics where indicated

Prescribed by or in consultation with a rheumatologist; initial 6 months; reauth 12 months; reauth requires clinical improvement

Cosentyx — Hidradenitis suppurativa: Diagnosis of moderate-to-severe hidradenitis suppurativa; initial use per product criteria with dermatologist consultation; reauth requires reduction in abscess/inflammatory nodule count or fewer new sinus tracts/scarring

Initial 6 months; reauth 12 months

Cotellic — product criteria

Cotellic (combination melanoma) criteria

Cotellic (melanoma): Diagnosis of unresectable or metastatic melanoma with BRAF V600E or V600K mutation detected by FDA-approved or CLIA test; used in combination with vemurafenib

Coverage 12 months; continuation allowed

Cresemba (isavuconazole)

Cresemba (isavuconazole) product criteria

Cresemba (invasive fungal infection): Diagnosis of invasive aspergillosis or invasive mucormycosis

Coverage duration 6 months

Ctexli — product criteria

Ctexli (cerebrotendinous xanthomatosis) criteria

Ctexli initial: Diagnosis of cerebrotendinous xanthomatosis confirmed by pathogenic CYP27A1 variant detected by FDA-approved or CLIA test

Prescribed by neurologist, geneticist, or metabolic specialist; initial and reauth 12 months; reauth requires positive clinical response

Cyclobenzaprine — product criteria

Cyclobenzaprine product criteria — muscle spasm and anticholinergic-risk considerations

Cyclobenzaprine indications: Muscle spasm associated with acute painful musculoskeletal conditions OR off-label uses such as fibromyalgia (sleep-related symptoms) or acute temporomandibular disorder when used with an NSAID and specific exam findings

Prescriber must acknowledge anticholinergic risks; PA applies to patients >=65 years; coverage durations vary by indication (4 weeks for muscle spasm/TMD; 12 weeks for fibromyalgia)

Roflumilast — product criteria (COPD context)

Roflumilast (COPD) criteria

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

Coverage initial and reauth 12 months; reauth requires positive clinical response; prerequisite Part D drug required

Muscle spasm / anticholinergic-risk criteria (Roflumilast entry context)

Muscle spasm / anticholinergic-risk criteria (example — cyclobenzaprine context)

Muscle spasm indication (example): Diagnosis of muscle spasm associated with acute, painful musculoskeletal conditions

Prescriber must acknowledge anticholinergic risks and consider deprescribing other anticholinergic medications; PA applies to patients 65 years or older; coverage 4 weeks

COPD (initial and reauth)

COPD (initial and reauthorization) — Roflumilast/Danziten context

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

Coverage duration 12 months; reauth requires positive clinical response

Pyrimethamine (toxoplasmosis) coverage

Pyrimethamine coverage (toxoplasmosis) — exclusions for malaria

Toxoplasmosis uses: Patient using pyrimethamine for active treatment of toxoplasmosis, secondary prophylaxis, or congenital toxoplasmosis OR for primary prophylaxis when TMP-SMX intolerance proven after desensitization or life-threatening reaction to TMP-SMX

Prescribed by or in consultation with infectious disease specialist; coverage 12 months

Malaria exclusion: Requests for pyrimethamine for treatment and/or prophylaxis of malaria are not authorized and will not be approved

Use for malaria not recommended by CDC; excluded

Deferasirox indications and monitoring

Transfusional iron overload (initial): Diagnosis of chronic iron overload due to blood transfusions; baseline ferritin >1,000 mcg/L; transfusion of at least 100 mL/kg packed RBCsbaseline ferritin >1,000 mcg/L; transfusion >=100 mL/kg

Coverage 12 months; reauth requires reduction in serum ferritin or LIC

NTDT initial: Diagnosis of chronic iron overload due to non-transfusion dependent thalassemia (NTDT) with LIC >=5 mg Fe/g dw and serum ferritin >300 mcg/LLIC >=5 mg Fe/g dw; ferritin >300 mcg/L

Initial age >=10 years; reauth criteria include LIC >=3 mg Fe/g dw or reduction in ferritin

Metyrosine (pheochromocytoma) criteria

Preoperative preparation: Biochemical confirmation of pheochromocytoma by plasma free or urinary fractionated metanephrines; used for preoperative preparation with trial and failure/intolerance to alpha- and beta-adrenergic blockers

Prescribed by or in consultation with endocrinologist or endocrine surgeon; coverage 4 weeks for preop prep

Treatment of pheochromocytoma: Biochemically confirmed hormonally active pheochromocytoma in patient who is not a surgical candidate or requires chronic treatment for malignant disease; has not achieved normotension after selective alpha-1 blocker plus beta blocker

Prescribed by endocrinologist or specialist; initial coverage 6 months, reauth 12 months

Doptelet coverage (avatrombopag)

Doptelet (avatrombopag) coverage

TPPP (pre-procedure): Thrombocytopenia in chronic liver disease scheduled for procedure with baseline platelet <50,000/mcLplatelet <50,000/mcL

Coverage duration 1 month

ITP initial: Diagnosis of chronic/relapsed/refractory ITP or pediatric persistent ITP with baseline platelet <30,000/mcL; trial and failure/intolerance/contraindication to at least one of corticosteroids, IVIG, or splenectomyplatelet <30,000/mcL

Prescribed by or in consultation with hematologist/oncologist; coverage 12 months; reauth requires platelet response

Dupixent multi-indication criteria

Eosinophilic asthma (initial): Moderate-to-severe asthma with eosinophilic phenotype (baseline eosinophils >=150 cells/mcL) AND either >=2 exacerbations requiring systemic steroids in past 12 months OR prior asthma-related hospitalization in past 12 months>=150 cells/mcL and exacerbation history

Age and prior therapy requirements vary by age; coverage durations differ by indication; prescriber restrictions apply

Corticosteroid-dependent asthma (initial): Moderate-to-severe asthma dependent on oral corticosteroids; requires prior inhaled controller therapies unless contraindicated

Coverage durations vary by indication

CRSwNP (initial): Diagnosis of chronic rhinosinusitis with nasal polyps with inadequate response to 2 months intranasal corticosteroids unless contraindicated; used in combination with another agent for CRSwNP2-month intranasal steroid trial

Coverage 12 months

EoE (initial): Diagnosis of eosinophilic esophagitis with symptoms of esophageal dysfunction, >=15 eos/HPF, exclusion of other causes, weight >=15 kg, and trial and failure/intolerance/contraindication to 8-week PPI or topical esophageal corticosteroid>=15 eos/HPF

Coverage 12 months; prescriber specialty varies

Emgality (galcanezumab) criteria

Episodic migraine (EM): Diagnosis of episodic migraine with >=4 migraine days/month; 120 mg/mL strength specified; not used with another CGRP inhibitor>=4 migraine days/month

Initial coverage 6 months; reauth requires positive response

Chronic migraine (CM): Diagnosis of chronic migraine with >=8 migraine days/month; medication overuse considered/treated; not used with another CGRP inhibitor>=8 migraine days/month

Initial coverage 6 months; reauth 12 months

Episodic cluster headache (ECH): Diagnosis of episodic cluster headache with at least 2 cluster periods lasting 7–365 days separated by >=3 months pain-free; 100 mg/mL strength specified; not used with another injectable CGRP inhibitor

Initial coverage 3 months; reauth 12 months

Empaveli coverage

Empaveli (pegcetacoplan) coverage

PNH initial: Diagnosis of paroxysmal nocturnal hemoglobinuria (PNH)

Prescribed by or in consultation with hematologist/oncologist; coverage 12 months; reauth requires positive clinical response

C3G / primary IC-MPGN initial: Diagnosis of C3G or primary immune-complex MPGN; for primary IC-MPGN patient has not had a kidney transplant and has been on maximally tolerated ACEi/ARB or SGLT2 inhibitor for at least 12 weeks to reduce proteinuria

Age >=12 years for these indications; coverage 12 months

Enbrel - Initial and Reauthorization Criteria

Enbrel — Initial and Reauthorization Criteria (selected indications)

RA Initial: Diagnosis of moderately to severely active rheumatoid arthritis; minimum 3-month trial and TF/C/I to one of methotrexate, leflunomide, or sulfasalazine at maximally tolerated doses3-month trial

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

PJIA Initial: Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis; minimum 6-week TF/C/I to methotrexate or leflunomide at maximally tolerated doses6-week trial

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

Plaque Psoriasis Initial: Diagnosis of moderate to severe chronic plaque psoriasis with >=3% BSA or special-site involvement; trial and failure of minimum 30-day supply (14 days for topical corticosteroids) of topical therapies30-day topical (14-day for topical steroids)

Prescribed by/with dermatologist; initial 6 months; reauth 12 months

AS Initial: Diagnosis of active ankylosing spondylitis; minimum 1-month TF/C/I to one NSAID at maximally tolerated doses1-month trial

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

Reauthorization: Patient demonstrates positive clinical response to therapy evidenced by at least one specified clinical improvement measure (e.g., reduced swollen/tender joint count, improved symptoms, reduced BSA, improved labs or mucosal healing)

Reauth typically 12 months

Evrysdi - Initial and Reauthorization Criteria

Evrysdi — Initial and Reauthorization Criteria (SMA)

SMA Diagnostic Criteria: Diagnosis of SMA type I, II, or III with qualifying 5q SMN1 mutation/deletion AND at least 2 copies of SMN2

Baseline motor exam with an approved scale required; prescriber neurologist with SMA expertise; initial and reauth coverage 12 months

Baseline and respiratory status: Patient is not dependent on both invasive ventilation/tracheostomy and chronic non-invasive ventilation beyond naps/nighttime; document baseline motor ability

Concomitant chronic SMN-modifying therapy not permitted; prior gene therapy history documented if applicable

Prior gene therapy: Either no prior gene replacement therapy OR prior gene therapy with medical records documenting inadequate response (e.g., sustained decrease in motor test score over 6 months)

If prior gene therapy inadequate, may approve; reauth requires positive clinical response

Procrit - Indication-specific Criteria

Procrit (epoetin alfa) — indication-specific criteria

CKD anemia initial: Diagnosis of CKD with anemia by lab (Hct <30% or Hgb <10 g/dL) collected within 30 days; meet dialysis/ESRD-related conditions as specifiedHct <30% or Hgb <10 g/dL

Coverage durations vary by indication; reauth requires positive clinical response

Chemotherapy-associated anemia initial: Non-myeloid cancer patient receiving chemotherapy with Hct <30% or Hgb <10 g/dL within prior 2 weeks; other causes ruled outHct <30% or Hgb <10 g/dL

Coverage durations per indication; adequate iron stores required

Reauthorization: Patient demonstrates positive clinical response from pre-treatment level; reauth durations vary by indication

Some off-label uses not approved if Hgb >10 g/dL or Hct >30%

Fasenra - Initial Criteria

Fasenra — Initial and reauthorization criteria (severe eosinophilic asthma and EGPA)

Fasenra asthma initial: Diagnosis of severe eosinophilic asthma with baseline peripheral blood eosinophils >=150 cells/µL AND history of >=2 exacerbations requiring systemic corticosteroids in prior 12 months OR prior asthma-related hospitalization; patient must be on specified inhaled corticosteroid/controller regimen per age unless contraindicated>=150 cells/µL; exacerbation history

Prescriber pulmonologist or allergist/immunologist; initial 6 months; reauth 12 months requiring documented positive clinical response

Fasenra EGPA initial: Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) relapsed or refractory to standard care and patient currently receiving corticosteroid therapy unless contraindicated

Prescriber pulmonologist, rheumatologist, or allergist/immunologist; coverage 12 months; reauth requires positive response

Fabrazyme (Fabry Disease) Initial

Fabrazyme (agalsidase beta) — Fabry disease initial criteria

Fabrazyme initial criteria: Diagnosis of Fabry disease confirmed by pathogenic GLA mutation OR deficient alpha-galactosidase A enzyme activity in plasma, leukocytes, or dried blood spots OR significant clinical manifestations (e.g., neuropathic pain, cardiomyopathy, renal insufficiency, angiokeratomas, cornea verticillata)age >=2 years

Will not be used in combination with other Fabry disease drugs; coverage 12 months; prescriber restrictions as specified

Fentanyl Citrate Oral Transmucosal (Breakthrough Cancer Pain)

Fentanyl citrate oral transmucosal — breakthrough cancer pain

Fentanyl OTM criteria: Patient has breakthrough cancer pain AND is currently taking a long-acting opioid around the clock for cancer pain AND has at least one week history demonstrating opioid tolerance at specified equianalgesic doses (e.g., morphine >=60 mg/day, fentanyl patch >=25 µg/hr, oxycodone >=30 mg/day, etc.)specified opioid tolerance doses

Prescribed by or in consultation with pain specialist, oncologist, hematologist, hospice/palliative care; coverage 12 months

Icatibant (HAE attacks) — treatment criteria

Icatibant (HAE acute attacks) — treatment criteria

Icatibant acute HAE: Diagnosis of hereditary angioedema confirmed by either (1) low C4 and C1-INH antigenic or functional level OR (2) normal C4 and C1-INH with confirmatory pathogenic mutation or family history; initial age >=18

Not used in combination with other approved acute HAE treatments; prescriber immunologist/allergist; coverage 12 months; reauth requires positive clinical response

Fingolimod / Glatiramer Acetate (Multiple Sclerosis)

Fingolimod / Glatiramer Acetate (Multiple Sclerosis) — coverage criteria

MS DMT general: Diagnosis of a relapsing form of multiple sclerosis (e.g., clinically isolated syndrome, relapsing-remitting, secondary progressive with active disease); prescribed by or in consultation with a neurologist

Not used in combination with another disease-modifying therapy for MS; coverage 12 months; reauth requires evidence of positive clinical response

Oncology (Fotivda, Fruzaqla, Gavreto, Gilotrif, Imatinib)

Oncology targeted products — indication- and prior-therapy-specific criteria (examples)

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

Coverage 12 months; prerequisite Part D drug may be required

Fruzaqla (mCRC): Diagnosis of metastatic colorectal cancer with prior fluoropyrimidine-oxaliplatin-irinotecan chemotherapy and anti-VEGF therapy; additional prior therapies depending on RAS status

Coverage 12 months; continuation allowed

Gavreto indications: RET fusion-positive NSCLC OR thyroid cancer with RET fusion (advanced/metastatic and RAI-refractory or RAI not appropriate)

Coverage 12 months; age and prescriber criteria vary

Genotropin (Growth hormone) Coverage

Genotropin (growth hormone) and growth-related criteria — examples by indication

Genotropin indications summary: Multiple pediatric growth indications (PGHD, PWS, GFSGA, TS, NS, SHOX deficiency, GFCRI, ISS) with specific diagnostic thresholds (height SDS, growth velocity, bone age limits) and documented testing requirementsage/bone age limits apply per indication

Prescribed by or in consultation with an endocrinologist; reauth requires evidence of clinical response and expected adult height not attained

Inflammatory disease biologic coverage criteria

Inflammatory disease biologic coverage criteria — examples by indication

RA initial (biologics): Diagnosis of moderately to severely active rheumatoid arthritis AND minimum 3-month TF/C/I to one conventional therapy (methotrexate, leflunomide, sulfasalazine)3 months

Prescribed by/with rheumatologist; initial 6 months; reauth 12 months

Plaque psoriasis initial (biologics): Diagnosis of moderate to severe chronic plaque psoriasis with >=3% BSA or special-site involvement AND trial and failure to topical therapies (minimum 30-day; 14 days for topical steroids)30-day topical trial

Prescribed by dermatologist; initial 6 months; reauth 12 months

Crohn's disease initial (biologics): Diagnosis of moderately to severely active Crohn's disease with clinical features or CDAI >220 AND TF/C/I to conventional therapies (e.g., 6-MP, azathioprine, corticosteroids, methotrexate)CDAI>220 or clinical features

Prescribed by gastroenterologist; initial 6 months; reauth requires positive response

Inflectra coverage criteria

Inflectra coverage criteria — infliximab biosimilar sequencing example

Inflectra CD/Fistulizing CD initial: Diagnosis of moderately to severely active Crohn's disease or fistulizing Crohn's disease with clinical features (frequent diarrhea/abdominal pain, >=10% weight loss, complications, abnormal labs or CDAI >220) AND TF/C/I to conventional therapies (6-MP, azathioprine, corticosteroids, methotrexate)clinical features/CDAI

Prescribed by gastroenterologist; initial coverage 6 months; prerequisite Part D drug required

Inflectra plaque psoriasis initial: Diagnosis of chronic severe plaque psoriasis with >=3% BSA or special-site involvement AND minimum 4-week trial and failure to topical therapies4-week topical trial

Prescribed by dermatologist; initial 6 months; reauth 12 months

Examples — Initial therapy requirements (AS)

Examples — Initial therapy requirements (ankylosing spondylitis example)

AS initial example: Diagnosis of active ankylosing spondylitis AND minimum one-month TF/C/I to one NSAID at maximally tolerated dosesone-month NSAID trial

Initial coverage commonly 6 months; reauth 12 months

Reauthorization response criteria

Reauthorization response criteria — general top-level node

Reauthorization general: Patient demonstrates positive clinical response to therapy evidenced by at least one indication-specific improvement (e.g., reduced BSA for psoriasis, reduced swollen/tender joint count for RA/PsA, mucosal healing for IBD)at least one objective improvement measure from baseline

Reauth durations typically 12 months

IVIG initial coverage criteria

IVIG initial coverage criteria — primary immunodeficiency and hematologic/autoimmune indications

IVIG initial — primary immunodeficiency: IVIG administered IV or SC at minimum effective dose AND diagnosis of qualifying primary immunodeficiency (e.g., CVID, congenital agammaglobulinemia, SCID, Wiskott-Aldrich, or other PI with IgG below age-normal and inadequate vaccine response)IgG below normal for age and inadequate vaccine response

Prescriber with specialized expertise; coverage 12 months (4 months for some transplant cases)

IVIG hematologic/autoimmune indications: Specific hematologic autoimmune disorders qualify when criteria met (e.g., PRCA with TF/C/I to corticosteroid and immunosuppressant; ITP with TF/C/I or platelet <30,000/mcL)platelet <30,000/mcL for ITP where listed

Refer to IVIG section for full list; coverage durations vary

Jynarque (tolvaptan) criteria

Jynarque (tolvaptan) — ADPKD initial and reauthorization criteria

Jynarque initial: Diagnosis of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) AND adherence to liver monitoring schedule: if on therapy <=18 months, ALT/AST/bilirubin measured prior to initiation, at 2 and 4 weeks, then monthly for first 18 months; if on therapy >18 months, liver tests at least every 3 monthsliver test monitoring schedule as specified

Patient must not have history of significant liver impairment (excluding uncomplicated polycystic liver disease); coverage 12 months

Jynarque reauthorization: Patient demonstrates positive clinical response to therapy AND no signs/symptoms of hepatic injury (or only uncomplicated polycystic liver disease) with ongoing liver monitoring per schedule

Coverage 12 months

Kalydeco (ivacaftor) criteria

Kalydeco (ivacaftor) for cystic fibrosis — mutation-specific criteria

Kalydeco initial: Diagnosis of cystic fibrosis AND at least one CFTR mutation responsive to ivacaftor by FDA-cleared or CLIA-approved testingage >=1 month for initial therapy

Prescribed by or in consultation with CF care center specialist or pulmonologist; coverage 12 months; reauth requires positive clinical response (improved ppFEV1 or fewer exacerbations)

Kerendia - CKD with T2D and HF

Kerendia (finerenone) — CKD with T2D and heart failure (LVEF >=40%) criteria

CKD with T2D initial: Diagnosis of CKD associated with T2D AND UACR >=30 mg/g AND eGFR >=25 mL/min/1.73 m2 AND serum potassium <=5.0 mEq/L prior to initiation; trial of maximally tolerated ACE inhibitor or ARB for minimum 30 days unless contraindicatedUACR >=30 mg/g; eGFR >=25; K+ <=5.0

Prescribed by or in consultation with a nephrologist; coverage 12 months

HF with LVEF >=40% initial: Diagnosis of heart failure with LVEF >=40% and NYHA II–IV symptoms AND eGFR >=25 AND serum potassium <=5.0 prior to initiation AND on diuretic for at least 30 days and not receiving mineralocorticoid receptor antagonist; one of: patient on SGLT2 inhibitor or meets other specified criteriaLVEF >=40%; eGFR >=25; K+ <=5.0

Prescribed by or in consultation with cardiologist; coverage 12 months

Kesimpta - Initial and Reauth

Kesimpta (ofatumumab) — Multiple Sclerosis initial and reauth criteria

Kesimpta initial: Diagnosis of a relapsing form of multiple sclerosis AND trial and failure, contraindication, or intolerance to one disease-modifying therapy for MS (minimum 4-week supply) OR continuation of prior therapy; not used in combination with another DMT or B-cell targeted therapy

Prescribed by or in consultation with a neurologist; coverage 12 months

Kesimpta reauth: Patient demonstrates positive clinical response to therapy AND continues avoidance of combination with other DMTs or B-cell targeted therapies

Coverage 12 months

Kineret - RA, NOMID, DIRA

Kineret (anakinra) — RA, NOMID, DIRA criteria

Kineret RA initial: Diagnosis of moderately to severely active rheumatoid arthritis AND trial and failure, contraindication, or intolerance to two specified therapies (e.g., Enbrel, adalimumab, Orencia, Rinvoq, Xeljanz) OR continuation of prior therapy

Prescribed by or in consultation with a rheumatologist; initial 6 months; reauth 12 months; reauth requires objective improvement

Kineret NOMID initial: Diagnosis of neonatal-onset multisystem inflammatory disease (NOMID) confirmed by NLRP3 mutation OR by clinical criteria with elevated acute phase reactants

Prescribed by allergist/immunologist, rheumatologist or pediatrician; initial 6 months; reauth 12 months; reauth requires positive clinical response

Koselugo - NF1

Koselugo (selumetinib) — NF1 criteria

Koselugo initial: Diagnosis of neurofibromatosis type 1 AND presence of inoperable plexiform neurofibromas causing significant morbidity (disfigurement, motor dysfunction, pain, airway/visual impairment)

Prescribed by specialist; coverage 12 months; continuation allowed

Krazati - NSCLC and CRC

Krazati (adagrasib) — KRAS G12C NSCLC and CRC criteria

Krazati NSCLC initial: Diagnosis of locally advanced or metastatic NSCLC with KRAS G12C mutation detected by FDA-approved or CLIA test AND prior systemic therapy (at least one)

Coverage 12 months; prerequisite Part D drug may be required

Krazati CRC initial: Diagnosis of locally advanced or metastatic colorectal cancer with KRAS G12C mutation detected by FDA-approved or CLIA test AND used in combination with cetuximab and prior fluoropyrimidine- and oxaliplatin-based therapy

Coverage 12 months; prerequisite Part D drug required

Sapropterin - PKU

Sapropterin (Zelvysia) — PKU criteria

Sapropterin initial: Diagnosis of phenylketonuria (PKU); blood phenylalanine measured after 1 week of therapy (new starts) and periodically up to 2 months to assess response

Initial coverage 2 months; reauth 12 months with documented positive clinical response

Lazcluze - EGFR-mutant NSCLC

Lazcluze — EGFR-mutant NSCLC criteria (example)

Lazcluze initial: Diagnosis of locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution detected by FDA-approved or CLIA test AND used as first-line treatment in combination with amivantamab where specified

Coverage 12 months; continuation allowed

Lenvima - Multiple oncologic indications

Lenvima (lenvatinib) — multiple oncologic indications

Lenvima indications: Indications include differentiated thyroid cancer, renal cell carcinoma, hepatocellular carcinoma, and advanced endometrial carcinoma with specific combination and prior therapy requirements (e.g., combination with pembrolizumab or everolimus as specified)

Coverage 12 months; prerequisite Part D drug may be required

Ambrisentan - PAH

Ambrisentan — pulmonary arterial hypertension (PAH) criteria

Ambrisentan initial: Diagnosis of symptomatic pulmonary arterial hypertension confirmed by right heart catheterization OR patient currently on therapy for PAH

Prescribed by or in consultation with pulmonologist or cardiologist; initial coverage 6 months; reauth 12 months requiring positive clinical response

Lidocaine topical products

Topical lidocaine products — post-herpetic neuralgia criteria

Topical lidocaine (PHN): Diagnosis of post-herpetic neuralgia

Coverage duration 12 months where specified

Livmarli - ALGS and PFIC

Livmarli (maralixibat) — ALGS and PFIC pediatric cholestatic liver disease criteria

ALGS initial: Diagnosis of Alagille syndrome with JAG1 or NOTCH2 mutation by molecular genetic testing AND cholestatic pruritus AND inadequate response to one prior antipruritic therapy (e.g., rifampin)

Age >=3 months; prescribed by hepatologist/gastroenterologist; initial and reauth 12 months; reauth requires positive clinical response

PFIC initial: Diagnosis of progressive familial intrahepatic cholestasis with confirmed mutation in specified genes AND cholestatic pruritus AND inadequate response to one prior antipruritic therapy

Age >=12 months; initial 6 months; reauth 12 months; prerequisite Part D drug required

Lonsurf - GI cancers

Lonsurf (trifluridine/tipiracil) — colorectal and gastric cancer criteria

mCRC initial: Diagnosis of metastatic colorectal cancer used as single agent or with bevacizumab after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy; additional molecular/treatment history criteria may apply

Coverage 12 months; prerequisite Part D drug required

Gastric/GEJ initial: Diagnosis of metastatic gastric or gastroesophageal junction adenocarcinoma after at least two prior lines including fluoropyrimidine, platinum, and taxane or irinotecan-based chemotherapy

Coverage 12 months

Lorbrena - NSCLC

Lorbrena (lorlatinib) — NSCLC criteria

Lorbrena metastatic NSCLC: Diagnosis of metastatic non-small cell lung cancer documented; used per product-specific indications

Coverage 12 months; continuation allowed

Alosetron - Severe D-IBS in women

Alosetron — Severe diarrhea‑predominant IBS in women (initial)

Alosetron initial: Diagnosis of severe diarrhea‑predominant IBS in women with symptoms for at least 6 months AND trial and failure, contraindication, or intolerance to an antidiarrheal agent (e.g., loperamide)symptoms >=6 months

Initial age >=18; initial coverage 12 weeks; reauth 6 months with persistent symptoms and positive clinical response

Lumakras - KRAS G12C NSCLC and mCRC

Lumakras (sotorasib) — KRAS G12C NSCLC and mCRC criteria

Lumakras NSCLC initial: Locally advanced or metastatic NSCLC with KRAS G12C mutation detected by FDA-approved or CLIA test AND at least one prior systemic therapy

Coverage 12 months; prerequisite Part D drug required for some uses

Lumakras mCRC initial: Metastatic colorectal cancer with KRAS G12C mutation detected by FDA-approved or CLIA test AND prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; used in combination with panitumumab as specified

Coverage 12 months

Leuprolide/Lupron depot — prostate, endometriosis, uterine leiomyomata, CPP

Leuprolide/Lupron depot — indication-specific coverage

Prostate cancer: Diagnosis of advanced or metastatic prostate cancer

Coverage 12 months; continuation allowed

Endometriosis initial: Diagnosis of endometriosis with prior surgical ablation to prevent recurrence OR trial and failure/contraindication/intolerance to one NSAID and one oral contraceptive

Coverage 6 months

Uterine leiomyomata preop/ anemia: Use prior to surgery to reduce fibroid size or treatment of anemia due to fibroids

Coverage durations vary (3–4 months) per use

Central precocious puberty (CPP): Diagnosis of CPP with early secondary sexual characteristics and advanced bone age >=1 year AND confirmatory testing with peak LH above prepubertal range or random pubertal-range LH

Prescribed by or in consultation with endocrinologist; coverage 12 months

Severe diarrhea‑predominant IBS in women (initial)

Severe diarrhea‑predominant IBS in women (initial) — criteria summary

IBS-d initial: Diagnosis of severe diarrhea-predominant IBS in women; symptoms >=6 months; trial and failure, contraindication, or intolerance to an antidiarrheal agent (e.g., loperamide)symptoms >=6 months

Initial coverage 12 weeks; reauth 6 months with persistent symptoms and documented positive clinical response

Modeyso (diffuse midline glioma)

Modeyso (diffuse midline glioma) — criteria

Modeyso initial: Diagnosis of diffuse midline glioma confirmed by H3 K27M mutation detected by FDA-approved or CLIA test AND disease progression following prior therapy

Coverage 12 months; continuation of prior therapy may be approved

Neulasta (febrile neutropenia prophylaxis and treatment)

Neulasta (pegfilgrastim) — febrile neutropenia prophylaxis and treatment scenarios

FN prophylaxis/treatment scenarios: One of listed prophylaxis/treatment scenarios present: dose-dense NCI protocol, regimens with >20% FN incidence, regimens 10–20% FN with additional patient risk factors, secondary prophylaxis after prior FN/dose-limiting event, acute radiation syndrome; or treatment of FN when high infection risk

Prescribed by or in consultation with hematologist/oncologist; coverage durations vary by use

Nucala indication-specific coverage

Nucala (mepolizumab) — indication-specific coverage (asthma, HES, EGPA, CRSwNP, COPD)

Nucala — Asthma initial: Diagnosis of severe eosinophilic asthma with baseline eosinophils >=150 cells/µL or historical >=300 cells/µL within 12 months AND history of >=2 exacerbations requiring systemic corticosteroids or prior asthma-related hospitalization in past 12 months; age- and controller-therapy requirements apply>=150 cells/µL or historical >=300 cells/µL

Prescribed by pulmonologist or allergist/immunologist; initial 6 months; reauth 12 months

Nucala — HES initial: Diagnosis of hypereosinophilic syndrome for >=6 months with other causes ruled out and FIP1L1-PDGFRA-negative; uncontrolled HES defined by >=2 flares in past 12 months and pre-treatment eosinophils >=1000 cells/µL; TF/C/I to corticosteroid or cytotoxic/immunosuppressive therapy required>=1000 cells/µL

Prescribed by allergist/immunologist or hematologist; coverage 12 months; reauth requires positive response

Nucala — COPD initial: Diagnosis of COPD with Type 2 inflammation evidenced by baseline eosinophils >=150 cells/µL or historical >=300 cells/µL, patient on triple therapy or LAMA+LABA if ICS contraindicated, post-bronchodilator FEV1/FVC <0.70, and history of >=2 exacerbations or hospitalization in past 12 months>=150 cells/µL or historical >=300 cells/µL

Prescribed by pulmonologist; reauth requires positive clinical response

Ofev coverage criteria

Ofev (nintedanib) — ILD (IPF, SSc-ILD, chronic fibrosing ILD with progressive phenotype) coverage

IPF initial: Diagnosis of idiopathic pulmonary fibrosis with exclusion of other causes of ILD AND either UIP pattern on HRCT revealing IPF/probable IPF (if no biopsy) OR concordant HRCT and surgical lung biopsy patterns revealing IPF/probable IPF

Prescribed by or in consultation with pulmonologist; initial and reauth 12 months

SSc-ILD initial: Diagnosis of systemic sclerosis-associated ILD with exclusion of other causes AND HRCT or biopsy patterns consistent with SSc-ILD

Prescribed by or in consultation with pulmonologist/rheumatologist; coverage 12 months

Chronic fibrosing ILD with progressive phenotype initial: Diagnosis of chronic fibrosing ILD AND HRCT showing >=10% lung volume with fibrotic features AND evidence of progression (decline in FVC, worsening symptoms, or increased fibrosis on imaging)HRCT >=10% fibrotic features

Coverage 12 months; reauth requires positive clinical response

Odactra coverage

Odactra (house dust mite allergen immunotherapy) coverage

Odactra initial: Diagnosis of house dust mite-induced allergic rhinitis confirmed by positive specific IgE or skin test AND trial and failure, contraindication, or intolerance to an intranasal corticosteroid AND an antihistamine

Age 5–65 years; prescribed by or in consultation with allergist/immunologist; coverage 12 months

Onpattro (patisiran) Initial Coverage

Onpattro (patisiran) — hATTR amyloidosis initial coverage

Onpattro initial hATTR: Diagnosis of hereditary transthyretin-mediated amyloidosis with polyneuropathy AND presence of TTR mutation detected by FDA-approved or CLIA test; baseline neuropathy severity PND <= IIIb OR FAP stage 1–2 OR NIS between 5 and 130; clinical signs of polyneuropathy presentPND <= IIIb OR FAP stage 1–2 OR NIS 5-130

Requested drug not used in combination with TTR silencer or stabilizer; prescribed by neurologist; coverage 12 months; reauth requires positive clinical response

Orencia (abatacept) Initial Coverage

Orencia (abatacept) — indication-specific initial coverage

Orencia RA initial: Diagnosis of moderately to severely active rheumatoid arthritis AND minimum 3-month TF/C/I to one conventional therapy at maximally tolerated dose (methotrexate, leflunomide, sulfasalazine)3-month trial

Prescribed by or in consultation with rheumatologist; initial 6 months; reauth 12 months requiring positive clinical response

Orencia PJIA initial: Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis AND minimum 6-week TF/C/I to methotrexate or leflunomide at maximally tolerated doses6-week trial

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

Orencia PsA initial: Diagnosis of active psoriatic arthritis with clinically inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail disease

Prescribed by or in consultation with rheumatologist or dermatologist; initial 6 months; reauth requires documented positive clinical response

Ozempic (semaglutide) Initial Coverage

Ozempic (semaglutide) — diabetes and MASH initial criteria

Diabetes (T2DM) initial: Documentation confirming diagnosis of type 2 diabetes mellitus via medical records OR lab evidence: A1c >=6.5% OR fasting plasma glucose >=126 mg/dL OR 2-hour OGTT >=200 mg/dLA1c >=6.5% OR FPG >=126 mg/dL OR 2-hr OGTT >=200 mg/dL

Coverage 12 months; reauth requires positive clinical response

MASH initial: Diagnosis of metabolic dysfunction-associated steatohepatitis (MASH) without cirrhosis AND fibrosis stage F2 or F3 confirmed by FibroScan, FIB-4, MAST, MEFIB, or liver biopsy within past 12 months; presence of at least one metabolic risk factorfibrosis stage F2 or F3

Prescribed by or in consultation with gastroenterologist, endocrinologist, or hepatologist; coverage 12 months; reauth requires positive response

Otezla (apremilast) Initial Coverage

Otezla (apremilast) — initial coverage (psoriasis, PsA, Behcet's)

Psoriatic arthritis initial: Diagnosis of active psoriatic arthritis with clinically inflamed joints, dactylitis, enthesitis, axial disease, or skin/nail involvement

Prescribed by or in consultation with dermatologist or rheumatologist; initial 6 months; reauth 12 months

Plaque psoriasis initial: Diagnosis of plaque psoriasis AND minimum 4-week trial and failure, contraindication, or intolerance to one topical therapy (steroids, vitamin D analog, tazarotene, calcineurin inhibitor) AND patient weight >=20 kg4-week topical trial; weight >=20 kg

Initial 6 months; reauth 12 months

Behcet's oral ulcers initial: Diagnosis of Behcet's disease with active oral ulcers

Initial 6 months; reauth requires positive clinical response

The formulary entries in this section frequently indicate Age Restrictions = N/A where specified, meaning no age limit is applied in those product listings. Examples include Actimmune and several other specialty products where the policy explicitly lists age restrictions as N/A in the criteria details. Providers should assume that, unless an age minimum or maximum is stated for a product entry, no age-based exclusion applies.

Several product entries explicitly report Off-Label Uses = N/A or list Exclusion Criteria = N/A, indicating that the document does not define off‑label exclusions for those products in this excerpt. For example, some oncology and neurologic product listings show Off‑Label Uses as N/A, and reauthorization language expects documentation of clinical benefit rather than enumerating off‑label exclusions.

Concurrent use restrictions are specified for some agents. For example, the tadalafil listing identifies concurrent use of nitrates as an exclusion in the criteria details; requests that include concurrent nitrates would not meet the formulary criteria.

Pyrimethamine is permitted for toxoplasmosis indications when criteria are met, but the policy explicitly states that requests for pyrimethamine for treatment and/or prophylaxis of malaria are not authorized and will not be approved. The rationale notes CDC guidance against its use for malaria in the document.

Some products are prohibited from being used in combination with other disease‑specific therapies. For instance, the Fabrazyme entry states it will not be used in combination with other drugs used for Fabry disease. Similarly, the Evrysdi criteria prohibit concomitant chronic SMN‑modifying therapy for patients receiving Evrysdi, and reauthorization requires absence of such combination therapy.

The policy includes multiple combination‑therapy exclusions across therapeutic areas. Examples include Icatibant — which is not to be used in combination with other approved acute HAE treatments — and multiple sclerosis agents (e.g., fingolimod, glatiramer) that are specified not to be used in combination with another disease‑modifying therapy for MS. Other entries similarly prohibit concurrent use of agents targeting the same disease process.

Across the excerpted chunks there is generally no explicit “Not Medically Necessary” (NMN) statement listed for most products; instead, the document defines coverage by meeting the specified diagnostic, prior‑therapy, and monitoring criteria. Where combination use or other practices are disallowed (for example Kesimpta), the policy frames them as exclusionary coverage criteria rather than standalone NMN clauses.

Within this segment several product listings mark Off‑Label Uses: N/A, indicating the policy does not provide an off‑label use list for those products in the excerpt and relies on the stated indication‑specific criteria to determine coverage.

Kesimpta (ofatumumab) criteria explicitly state that it is not used in combination with another disease‑modifying therapy for MS or another B‑cell targeted therapy. Providers should ensure requests document avoidance of concomitant DMTs or B‑cell agents to meet the Kesimpta coverage requirements.

Formulary Identifiers, Codes and Key Thresholds

Formulary identifiermixed

Formulary ID: 26216

Formulary identifier associated with listed products

Formulary Identifiers (product list)mixed

Formulary ID: 26216

Formulary identifier for listed products

Formulary identifiers and product listingsmixed

Formulary ID: 26216

Formulary identifier repeated for products listed

Formulary identifiers / product listmixed

Formulary ID: 26216

Formulary identifier referenced for multiple products in this segment

Formulary identifier (single)mixed

Formulary ID: 26216

Fabrazyme listed under this formulary ID and version

Formulary identifier (repeated across many entries)mixed

Formulary ID: 26216

Applies to listed products in these chunks

Formulary identifiers (group)mixed

Formulary ID: 26216

Formulary identifier applied to listed products

No explicit billing/diagnosis codes listed in this segmentmixed

No codes listed

Formulary identifiers (single)mixed

Formulary ID: 26216

Jynarque and other listed products (identifier used throughout this section)

Formulary identifiers (segment)mixed

Formulary ID: 26216

Formulary identifier for listed products

Formulary Identifiersmixed

Formulary ID: 26216

Identifier for the formulary entries in this section

Formulary Identifiers (group of entries)mixed

Formulary ID: 26216

Formulary identifier for listed products

Formulary Identifiermixed

Formulary ID: 26216

Formulary identifier for listed products and criteria (version 10)

Covered products listed in this sectionmixedCovered

No codes listed

Formulary identifiers (group)mixed

Formulary ID: 26216

Referenced formulary identification for listed products

Atopic dermatitis — key thresholds

Atopic dermatitis severity threshold>= 10% body surface area (BSA) involvement or SCORAD >=25

Minimum topical therapy trialsTrial and failure/intolerance/contraindication to at least two topical agents (30-day supply; 14 days for topical corticosteroids)

Age requirement (initial)Patient age >= 12 years

Episodic migraine — enrollment threshold

Episodic migraine frequency>= 4 migraine days per month

Age requirement18 years of age or older for EM/CM initial

Combination therapy restrictionNot to be used with another CGRP inhibitor for migraine prevention

Chronic migraine — enrollment threshold

Chronic migraine frequency>= 8 migraine days per month

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

Reauthorization evidencePatient has experienced positive response (reduced frequency/intensity) for reauth

Benlysta — autoantibody thresholds

Benlysta autoantibody criteriaPositive autoantibody: ANA titer >= 1:80 OR anti-dsDNA >= 30 IU/mL

Required background therapyPatient currently receiving at least one standard-of-care treatment for active SLE (eg, antimalarials, corticosteroids, or immunosuppressants)

PrescriberPrescribed by or in consultation with a rheumatologist

Arikayce — MAC nonresponse definition

Definition of MAC nonresponsePatient did not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen

Therapy contextUsed as part of a combination antibacterial regimen for MAC lung disease

Prescriber recommendationPrescribed by or in consultation with infectious disease specialist or pulmonologist

AdvSM — platelet example threshold

AdvSM platelet threshold (Ayvakit)Platelet count > 50 x 10^9/L

PrescriberPrescribed by or in consultation with hematologist/oncologist as indicated

ContextApplies to advanced systemic mastocytosis (example taken from Ayvakit criteria)

Plaque psoriasis — BSA and site criteria

Plaque psoriasis BSA threshold>= 3% body surface area OR severe scalp/palmoplantar/facial/genital involvement

Topical therapy trialMinimum 30-day trial (14 days for topical corticosteroids) of topical therapies required prior to biologic/systemic therapy

PrescriberPrescribed by or in consultation with a dermatologist

Onychomycosis — trial durations

Fingernail oral terbinafine trialMinimum 6-week trial of oral terbinafine (failure/CI/intolerance) required

Toenail oral terbinafine trialMinimum 12-week trial of oral terbinafine (failure/CI/intolerance) required

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

Deferasirox — ferritin and transfusion thresholds

Baseline ferritin thresholdBaseline serum ferritin > 1,000 mcg/L for transfusional iron overload (initial)

Transfusion volume requirementHistory of transfusion of at least 100 mL/kg packed red blood cells

NTDT LIC initial thresholdLiver iron concentration (LIC) >= 5 mg Fe/g dry weight for NTDT initial approval

Prior Authorization, Documentation & Step Therapy Requirements

Prior Authorization

Prior authorization per formulary

Prior authorization is required per Formulary ID 26216; approvals are granted only when indication-specific criteria (diagnosis, required prior therapy trials or TF/C/I, prescriber specialty, and required diagnostic tests) are submitted as specified in each product entry.

Prior Authorization

PA: include diagnosis, tests, prior therapy history

Submit a prior authorization request with the patient’s diagnosis, relevant biomarkers or test results (e.g., mutation or protein testing), and documentation of prior therapies or trial-and-failure/contraindication/intolerance (TF/C/I) when required by the product-specific criteria.

Prior Authorization

Product-specific prior authorization

Follow product-specific PA pathways — many drugs list distinct required trials, specialist prescriber restrictions, and reauthorization conditions that must be met for approval.

Prior Authorization

PA requirement for Part D products

Prior authorization applies to listed Part D drugs; some entries include age-specific PA notes (for example, PA applies for certain agents in patients ≥65 years).

Prior Authorization

Product-level prior authorization with diagnostic criteria

Certain product entries (e.g., roflumilast, Danziten) require PA tied to specific diagnostic criteria (COPD or Ph+ CML) and submission of the indication-specific medical information.

Prior Authorization

Enbrel PA and reauthorization requirements

Enbrel products require prior authorization for initial and reauthorization; initial approvals require documentation of the indication-specific minimum prior-conservative therapy duration (e.g., RA: 3‑month TF/C/I; PJIA: 6 weeks) and reauth requires evidence of positive clinical response.

Initial durations vary by indication (see Enbrel entry).
Reauthorization requires documented clinical improvement.

Prior Authorization

Evrysdi prior authorization and reauth evidence

Evrysdi requires prior authorization for initial and reauthorization requests; reauthorization requires documentation of a positive clinical response and patients must not receive concomitant chronic SMN‑modifying therapy.

Initial and reauth coverage duration typically 12 months.
Provide baseline motor exam using an approved scale and SMN genetic testing.

Prior Authorization

Fabrazyme PA, age limit, and combination exclusion

Fabrazyme requires prior authorization with diagnostic documentation of Fabry disease (pathogenic GLA mutation or deficient α‑Gal A activity) and is limited to patients aged ≥2 years with 12‑month coverage durations; combination use with other Fabry drugs is not permitted.

Will not be used in combination with other Fabry disease drugs.

Prior Authorization

Fasenra PA: diagnostic and therapy documentation

Fasenra prior authorization is required for initial and reauthorization; submit documentation of severe eosinophilic asthma per the entry (baseline blood eosinophils ≥150 cells/µL, exacerbation history) and age‑ and controller‑therapy requirements; initial and reauth durations are specified (initial 6 months; reauth commonly 12 months for asthma).

Provide baseline eosinophil count and exacerbation/hospitalization history.
Prescriber restriction: pulmonologist or allergist/immunologist where specified.

Prior Authorization

Icatibant PA and prescriber restriction

Icatibant requires prior authorization for treatment of acute hereditary angioedema attacks; initial use restricted to adults (≥18) and prescribing is limited to immunologists or allergists; do not combine with other approved acute HAE treatments.

Coverage duration: 12 months.
Submit confirmatory C4 and C1‑INH antigenic or functional testing or genetic/family history for HAE‑nl‑C1INH.

Documentation Required

PA: submit diagnostic and treatment history

Prior authorization requires submission of indication‑specific diagnostic and treatment history, including prior therapy trials, specialist consults when required, and relevant laboratory or imaging results to meet the product criteria.

Prior Authorization

PA required — Formulary ID 26216; specialist documentation

Prior authorization is required per Formulary ID 26216 for many entries; most require specialist prescriber restriction and documentation of diagnosis, prior therapies, and response for both initial approval and reauthorization.

Formulary ID: 26216 applies across product entries.
Specialist involvement (e.g., rheumatologist, dermatologist, pulmonologist) is commonly required.

Documentation Required

PA must include baseline labs and prescriber specialty

Many agents require PA with submission of diagnosis, baseline labs, prescriber specialty (when specified), and adherence to monitoring schedules (examples include liver tests for Jynarque and mutation testing for Kalydeco).

Include baseline and scheduled monitoring labs per product instructions (e.g., ALT/AST/bilirubin for Jynarque).

Prior Authorization

IBS‑D (female) — PA requires symptom duration and prior antidiarrheal trial

For severe diarrhea‑predominant IBS in women, prior authorization requires documentation of the diagnosis, symptom duration of at least 6 months, female sex, and trial and failure/contraindication/intolerance to an antidiarrheal agent (e.g., loperamide).

Initial coverage duration: 12 weeks; reauthorization 6 months with persistent symptoms and response.

Prior Authorization

KRAS G12C therapy — molecular test and prior therapy required

KRAS G12C targeted therapies require PA with documentation of NSCLC or mCRC and a KRAS G12C mutation detected by an FDA‑approved or CLIA‑approved test and evidence of required prior systemic therapy (use may require combination with other agents for mCRC).

Submit molecular testing reports from an FDA‑cleared or CLIA‑certified assay.

Prior Authorization

PA approvals and coverage duration (typically 12 months)

Prior authorization approvals specify coverage durations (commonly 12 months); initial durations may be shorter (e.g., many initial approvals 6 months) and reauthorization generally requires evidence of clinical benefit.

Verify the product-specific initial and reauth duration on the formulary entry.

Documentation Required

PA: include product-specific medical info and specialist consults

Submit the product‑specific required medical information and specialist consultation documentation when indicated; many initial approvals are 6–12 months with reauthorization contingent on documented clinical response.

Documentation Required

PA: provide diagnostic confirmation and TF/C/I documentation

Prior authorization requires diagnostic confirmation and documentation of prerequisite therapy trials or contraindications/intolerances (TF/C/I) where specified; include objective test results and treatment history as requested.

Examples: mutation testing for oncology agents, prior TNF inhibitor trials for some JAK/biologic switches, or documented TF/C/I to conventional DMARDs for RA.

Documentation Required

PA must document TF/C/I and prescriber consultation

Prior authorization requires documentation of diagnosis, prerequisite therapy trials (TF/C/I), prescriber specialty consultation when specified, and initial/reauthorization duration limits as stated in the product entry.

Prior Authorization

PA required — submit specified diagnostic confirmation

Prior authorization is required per Formulary ID 26216 for multiple products; ensure required diagnostic confirmation, specialist prescriber restriction, and therapy prerequisites are met for initial approval and reauthorization.

Step Therapy

Required step‑therapy trials before biologics

Many biologics require step‑therapy: document trial and failure, contraindication, or intolerance (TF/C/I) to specified conventional or topical therapies before requesting PA for biologic agents.

Examples: methotrexate/leflunomide/sulfasalazine for RA; topical therapy trial for plaque psoriasis.

Step Therapy

Caplyta step therapy — antipsychotic trials required

Caplyta requires prior trial and failure/contraindication/intolerance to specified oral generic atypical antipsychotics (lists depend on indication) before coverage is approved.

Step Therapy

Cosentyx step therapy — topical and biologic sequencing

Cosentyx requires step therapy for plaque psoriasis (minimum 4‑week topical trial) and, for PsA/AS/nr‑axSpA, trials or failures of specified systemic or biologic agents as listed in the product criteria.

Provide documentation of topical therapy trial and any required biologic/DMARD sequencing where applicable.

Step Therapy

Dupixent step therapy — prior controller/regimen required

Dupixent requires prior trials of specified inhaled corticosteroid regimens or maximally dosed combination controller therapy before biologic approval for asthma and related indications; include baseline eosinophil counts when indicated.

Baseline peripheral blood eosinophils ≥150 cells/µL for eosinophilic asthma indications.

Step Therapy

Enbrel step/prerequisite therapy required

Enbrel requires documented trial and failure (or contraindication/intolerance) to specified conventional systemic or topical therapies before approval; duration requirements vary by indication (see Enbrel entry).

Examples: RA requires 3‑month TF/C/I to a conventional DMARD; PJIA requires 6‑week trial.

Step Therapy

Fasenra step‑therapy: current controller regimen required

Fasenra requires that patients be currently treated with specified inhaled corticosteroid/controller regimens per age group unless contraindicated — this functions as a step requirement prior to biologic initiation.

Step Therapy

Oncology prior therapy requirements (Fotivda, Fruzaqla)

Fotivda and Fruzaqla (oncology agents) mandate prior systemic therapy trials: Fotivda requires two or more prior systemic therapies for advanced RCC; Fruzaqla requires prior fluoropyrimidine‑oxaliplatin‑irinotecan and anti‑VEGF therapy where specified.

Step Therapy

Step therapy / prerequisite therapy documentation required

Many indications require TF/C/I to specified conventional therapies (e.g., methotrexate for RA, topical trials for psoriasis, immunomodulators for IBD) before biologic or specialty drug approval; provide documented trial durations and reasons if TF/C/I is claimed.

Step Therapy

Step therapy / TF/C/I: include dates, doses, durations

Several indications explicitly require documented TF/C/I to specified therapies (e.g., IVIG indications, ankylosing spondylitis NSAID trial) — include dates, doses, duration, and reason for failure/intolerance in PA submission.

Step Therapy

Kesimpta step requirement and concomitant therapy restriction

Kesimpta initial coverage requires trial and failure (minimum 4‑week supply), contraindication, or intolerance to one disease‑modifying therapy (DMT) for MS unless used for continuation of prior therapy; Kesimpta must not be used combined with another DMT or B‑cell targeted therapy.

Prescriber restriction: neurologist; provide documentation of prior DMT trial or rationale for continuation.

Step Therapy

Step therapy examples — document prior agent and outcome

Many entries require trial and failure of at least one specified prior agent (examples: antidiarrheal for IBS‑D, 5‑HT3 antagonists for CINV); document the agent, dose, duration, and outcome of prior therapy.

Step Therapy

Odactra prerequisite therapy: intranasal steroid + antihistamine

Odactra requires prior trial and failure or intolerance to both an intranasal corticosteroid and an antihistamine before approval; include documentation of those trials in the PA request.

Step Therapy

Step therapy examples — TF/C/I to conventional therapies

Some therapies (e.g., Orencia, Otezla, others) require prior trial and failure/intolerance/contraindication to specified conventional therapies (e.g., methotrexate for RA; topical therapy for plaque psoriasis); include TF/C/I documentation.

Step Therapy

Step therapy / trial requirement — TF/C/I documentation needed

Many indications require TF/C/I to specified conventional therapies (e.g., immunomodulators for Crohn's/UC, topical agents for plaque psoriasis, maximally tolerated statins for lipid indications); absence of documented TF/C/I may result in denial.

Step Therapy

Biosimilar sequencing — trial of reference product required

For biosimilar sequencing (e.g., Renflexis), initial approval requires documented trial and failure or intolerance to reference infliximab (Remicade/infliximab); include prior infliximab treatment details.

Step Therapy

Step therapy / prior trials — provide medical records

Several products require documented failure, contraindication, or intolerance to one or more specified prior therapies (examples include TNF inhibitors before some JAK inhibitors or trials of conventional systemic therapies before biologics); provide supporting medical records.

Documentation Required

RA initial documentation: 3‑month TF/C/I required

Initial RA documentation must include diagnosis of moderately to severely active RA and documentation of a minimum 3‑month TF/C/I to an indicated conventional therapy (methotrexate, leflunomide, or sulfasalazine) at maximally tolerated doses.

Documentation Required

AD documentation: BSA/SCORAD and topical therapy trials required

For atopic dermatitis initial coverage (e.g., Adbry), document moderate to severe disease (≥10% BSA or SCORAD ≥25) and trials/failures/intolerance to at least two specified topical agents with dates and durations.

Documentation Required

Benlysta documentation: active SLE and autoantibody positivity

Benlysta initial requests for SLE require documentation of active SLE, qualifying autoantibody positivity (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL), and evidence the patient is on at least one standard‑of‑care therapy.

Policy Background and Scope

This policy provides indication‑specific medical necessity criteria for specialty medications used in immunology and rheumatology. It outlines required diagnostic confirmation, prerequisite therapy trials (TF/C/I), prescriber specialty and monitoring requirements, and coverage durations (commonly initial approvals vary by product with frequent reauthorization durations of 12 months). Prior authorization is required per the listed formulary identifier and approvals depend on meeting the product‑specific criteria described.

Key Definitions and Abbreviations

TF/C/I — definition and implication

TF/C/I abbreviationTrial and failure, contraindication, or intolerance (abbreviated TF/C/I)

Role in criteriaUsed throughout criteria as prerequisite step requirement before specialty therapies

Denial riskFailure to document TF/C/I may trigger denial of coverage

BSA — body surface area (psoriasis)

BSA definition (psoriasis)Body surface area (BSA) — used to quantify extent of plaque psoriasis (eg, >=3% BSA qualifies)

Special-site involvementSevere involvement of scalp, palms/soles, face, or genital area also meets criteria

Topical trial requirementMinimum topical therapy trial (30 days; 14 days for topical corticosteroids) applies when assessing BSA-based eligibility

Autoantibody positive — SLE definition

Autoantibody positive (SLE) definitionANA titer >= 1:80 OR anti-dsDNA >= 30 IU/mL

ApplicationRequired for Benlysta initial SLE eligibility alongside active disease and standard-of-care therapy

PrescriberPrescribed by or in consultation with a rheumatologist

MAC nonresponse — Arikayce definition

MAC nonresponse definitionFailure to achieve at least two negative sputum cultures after >= 6 consecutive months of a multidrug background regimen

Treatment contextUsed as part of a combination antibacterial regimen for MAC lung disease

PrescriberPrescribed by or in consultation with infectious disease specialist or pulmonologist

nr-axSpA — definition

nr-axSpA definitionNon-radiographic axial spondyloarthritis with objective signs of inflammation (eg, elevated CRP or MRI sacroiliitis) without definitive radiographic sacroiliac structural damage

Use in criteriaUsed to define eligibility for biologic therapies for axial disease when radiographs are non-diagnostic

PrescriberPrescribed by or in consultation with a rheumatologist

HAE — diagnostic criteria

HAE diagnostic criteriaDiagnosis confirmed by low C4 and C1-INH deficiency/dysfunction (Type I/II) OR normal C4/C1-INH with confirmatory pathogenic mutation or family history (HAE-nl-C1INH)

Treatment restrictionsProphylaxis/treatment agents not used in combination with other approved therapies for same indication

PrescriberPrescribed by or in consultation with an immunologist or allergist where specified

Eosinophilic phenotype — asthma threshold

Eosinophilic asthma thresholdBaseline peripheral blood eosinophils >= 150 cells/mcL

Higher thresholds for COPDHigher eosinophil thresholds specified for COPD indications (eg, >=300 cells/mcL in some contexts)

RoleSupports eligibility for biologic therapies for severe asthma phenotype

EoE — diagnostic histology threshold

EoE histologic threshold>= 15 intraepithelial eosinophils per high power field (eos/HPF)

Diagnostic exclusionsOther causes of esophageal eosinophilia must be excluded before diagnosis

Weight requirementPatient weighs at least 15 kg for biologic consideration in EoE

SMA — baseline motor assessments

Baseline motor assessments (SMA)Validated scales examples: HINE-2, HFMSE, RULM, CHOP-INTEND, MFM-32, BSID-III Item 22

PurposeDocument baseline motor ability prior to Evrysdi initiation and for reauthorization comparisons

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

Adequate iron stores — ESA precondition

Adequate iron stores for ESAsFerritin >100 mcg/L AND transferrin saturation (TSAT) >20%

ApplicationRequired before Procrit (epoetin) approval for listed anemia indications

DocumentationRecent labs confirming iron indices must be submitted

HAE‑nl‑C1INH — definition

HAE-nl-C1INH definitionHereditary angioedema with normal C1 inhibitor levels; diagnosis requires normal C4/C1-INH and confirmatory pathogenic mutation or family history

TestingGenetic testing (eg, factor XII, plasminogen mutations) by FDA-cleared or CLIA lab may confirm diagnosis

Clinical useUsed to qualify for some prophylactic or acute HAE therapies when Type I/II testing is normal

α‑Gal A deficiency — Fabry confirmatory testing

α‑Gal A deficiency testingDeficient alpha‑galactosidase A enzyme activity in plasma, leukocytes, or dried blood spot confirms Fabry disease

Alternative confirmationPathogenic GLA gene mutation detection by molecular genetic testing also confirms diagnosis

Combination therapy exclusionFabrazyme will not be used in combination with other Fabry disease drugs

Growth hormone deficiency — testing thresholds

GH stimulation test cutoffs (examples)ITT ≤ 5 mcg/L; glucagon ≤ 3 mcg/L; macimorelin ≤ 2.8 ng/mL

Growth metricsHeight SDS or percentiles, growth velocity, and bone age used per indication

PrescriberEndocrinologist involvement recommended for growth-related indications

Moderately to severely active Crohn's — activity description

Moderately to severely active Crohn's DiseaseDescribed by frequent diarrhea/abdominal pain, >=10% weight loss, complications (eg, obstruction, fever), abnormal labs (eg, elevated CRP), or CDAI >220

Prior therapy requirementTrial and failure/contraindication/intolerance to conventional immunomodulators (eg, azathioprine, 6-MP, corticosteroids, methotrexate)

PrescriberPrescribed by or in consultation with a gastroenterologist

TF/C/I — shorthand and usage

TF/C/I expanded definitionTrial and failure, contraindication, or intolerance to a specified prior therapy (abbreviated TF/C/I)

Use across policyUsed as prerequisite step requirement for many biologic and specialty therapies

Denial riskLack of documented TF/C/I may result in denial

Jynarque — liver monitoring schedule

Jynarque monitoring scheduleALT/AST/bilirubin measured prior to initiation, at 2 and 4 weeks after initiation, then monthly for first 18 months; thereafter at least every 3 months

IndicationRapidly progressing ADPKD — diagnosis required for Jynarque eligibility

ReauthorizationReauth requires positive clinical response and adherence to liver monitoring schedule

Rapidly progressing ADPKD — Jynarque eligibility

Rapidly progressing ADPKD requirementDiagnosis of rapidly progressing ADPKD required for Jynarque initial approval

Monitoring linkAccompanied by specific liver monitoring (ALT/AST/bilirubin) schedule as stated in policy

PrescriberPrescribed by or in consultation with nephrologist where indicated

CFTR mutation — ivacaftor testing requirement

CFTR mutation requirement for ivacaftorAt least one CFTR mutation demonstrably responsive to ivacaftor by FDA-cleared or CLIA-approved test

PrescriberPrescribed by or in consultation with a CF care center specialist or pulmonologist for initial requests

Age thresholdPatient age >= 1 month for initial Kalydeco therapy

FDA‑approved or CLIA‑approved test — definition

FDA‑approved or CLIA‑approved test definitionMolecular diagnostic assay either cleared by the FDA or performed in a CLIA-certified facility

ApplicationRequired for tumor genomic alterations (eg, KRAS G12C, ROS1, NTRK) to qualify for targeted therapies

DocumentationSubmit test results as part of prior authorization

LDL‑C threshold — definition and timing

LDL‑C timing and thresholdsLDL‑C value within the last 120 days used; thresholds: >=55 mg/dL with ASCVD OR >=70 mg/dL without ASCVD

ContextApplies to eligibility for lipid‑lowering therapy (eg, PCSK9 inhibitors) per policy

ReauthorizationReauth requires demonstration of LDL‑C reduction/clinical response

Uncontrolled HES — definition

Uncontrolled HES definitionHistory of >=2 flares within the past 12 months AND pre‑treatment blood eosinophil count >= 1000 cells/µL

Prior therapyTrial and failure/contraindication/intolerance to corticosteroids or cytotoxic/immunosuppressive therapy required

SpecialistPrescribed by or in consultation with hematology where indicated

Progressive phenotype — chronic fibrosing ILD definition

Progressive phenotype (chronic fibrosing ILD)Disease progression evidenced by decline in FVC, worsening respiratory symptoms, or increased extent of fibrosis on imaging; HRCT showing >=10% lung volume with fibrotic features

HRCT threshold>= 10% of lung volume with fibrotic features

PrescriberPrescribed by or in consultation with a pulmonologist or rheumatologist

Usual interstitial pneumonia (UIP) — pattern definition

UIP pattern definitionUsual interstitial pneumonia (UIP) pattern on HRCT used to diagnose IPF or probable IPF when surgical lung biopsy not performed

ApplicationUsed as part of ILD diagnostic criteria for antifibrotic therapy eligibility

RequirementExclusion of other known causes of ILD required

PND, FAP, NIS — neuropathy scoring definitions

PND/FAP/NIS ranges for hATTRBaseline PND <= IIIb OR FAP stage 1–2 OR NIS between 5 and 130

ApplicationRequired baseline neuropathy scores to qualify for Onpattro and similar agents

TestingTTR mutation detection by FDA‑approved or CLIA‑approved test required

T2DM diagnostic criteria — thresholds

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

DocumentationSubmit medical records or laboratory evidence confirming diagnosis for DM indications

UseApplies to diabetes product eligibility (eg, Ozempic, Rybelsus) in policy

MASH — staging and cirrhosis exclusion

MASH fibrosis stagingDisease must be fibrosis stage F2 or F3 as confirmed by FibroScan, FIB‑4, MAST, FAST, MEFIB, or liver biopsy; cirrhosis excluded

Documentation timingBiopsy within past 12 months or equivalent noninvasive testing required for initial approval

PrescriberPrescribed by or in consultation with gastroenterologist, endocrinologist, or hepatologist

TF/C/I — reiteration for Crohn's/IBD contexts

Moderately to severely active Crohn's TF/C/ITrial and failure, contraindication, or intolerance to specified conventional therapies required prior to biologic approval

Examples of conventional therapies6‑mercaptopurine, azathioprine, corticosteroids, methotrexate

PrescriberPrescribed by or in consultation with a gastroenterologist

BSA — definition (psoriasis) reiteration

BSA definition (psoriasis) — reiterationBody surface area (BSA) used to quantify plaque psoriasis extent; >=3% BSA typically meets moderate‑to‑severe threshold

Special‑site considerationSevere involvement of scalp, palms/soles, face, or genitals qualifies regardless of BSA

Topical trialMinimum topical therapy trial durations apply prior to systemic/biologic therapy

MASH — definition and staging

MASH definitionMetabolic dysfunction‑associated steatohepatitis (MASH), formerly NASH; diagnosis requires absence of cirrhosis and fibrosis stage F2 or F3

Confirmatory testsFibroScan, FIB‑4, MAST, FAST, MEFIB, or liver biopsy acceptable for staging

PrescriberPrescribed by or in consultation with gastroenterologist, endocrinologist, or hepatologist

NTRK gene fusion / ROS1 rearrangement — testing requirement

NTRK/ROS1 testing requirementTumor genomic alterations (NTRK gene fusion or ROS1 rearrangement) must be detected by an FDA‑approved or CLIA‑approved test

ApplicationRequired for targeted therapy eligibility (eg, Rozlytrek, Augtyro) in metastatic or unresectable disease

DocumentationSubmit molecular testing results with prior authorization request

Policy Revision History

03/01/2026effective_date

Policy effective date set for Formulary ID 26216

02/02/2026last_review

Policy last updated/reviewed (Last Updated: 02/02/2026) for multiple product entries

No material changes were identified in the pipeline summary; the changes array for this document is empty per the inventory, indicating no documented policy revisions in the provided excerpt.