CurrentBlue Cross Blue Shield - South CarolinaPolicy N/A

Adalimumab and selected specialty drugs — coverage criteria

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This document governs medical benefit coverage criteria, prescriber requirements, prior authorization details, and coverage durations for multiple specialty drugs (including adalimumab products) for Blue Cross Blue Shield - South Carolina members.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyAdalimumab and selected specialty drugs — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes (routine review)

Effective DateJan 1, 2026

Last ReviewSep 22, 2025

Next Review DateN/A

Key ActionObtain prior authorization with required documentation of diagnosis, prerequisite therapy trials or contraindications, and appropriate specialist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Version 8formulary/version referenced

01/01/2026effective date listed

12 monthstypical coverage duration

6–12 monthsauthorization lengths

26218formulary id

Coverage Criteria by Product / Indication

Chronic granulomatous disease (CGD) and severe malignant osteopetrosis (SMO)

Covered when ALL of the following are met

Diagnosis requirements: Diagnosis of one of the following: 1) Chronic granulomatous disease (CGD); or 2) severe malignant osteopetrosis (SMO).

Coverage duration 12 months.

Adalimumab — Rheumatology, Dermatology, Gastroenterology indications (initial)

Covered when ALL of the following are met

Prerequisite therapy: Documented trial and failure, contraindication, or intolerance (TFIC/I) to specified conventional or topical therapies per indication (examples: methotrexate/leflunomide/sulfasalazine for RA; minimum 30-day topical trial [14 days for topical corticosteroids] for plaque psoriasis; 1-month NSAID trial for AS; 6-week trial for PJIA).

TFIC/I durations specified in policy.

Prescriber requirement: Prescribed by or in consultation with the specified specialist for the indication (eg, rheumatologist for RA/AS/PJIA; dermatologist for psoriasis/HS; gastroenterologist for CD/UC; ophthalmologist or rheumatologist for uveitis).

See per‑indication prescriber restrictions.

Reauthorization criteria

Covered when ANY of the following are met (evidence of response)

Clinical response: Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following depending on indication: reduction in active swollen/tender joint count, symptomatic improvement (eg, pain, stiffness), reduction in body surface area (BSA) for psoriasis, reduction in abscess/inflammatory nodules for hidradenitis suppurativa, improvement in laboratory markers (ESR/CRP) or mucosal healing for inflammatory bowel disease.

Reauthorization durations typically 12 months.

Arformoterol — Covered with criteria

Arformoterol Tartrate covered when ALL of the following are met:

Arformoterol coverage: Diagnosis of chronic obstructive pulmonary disease (COPD) for maintenance treatment of bronchoconstriction (including chronic bronchitis and emphysema).

Coverage duration: 12 months; subject to Part B vs Part D review.

Prerequisite therapy: No prerequisite Part D drug required.

Arikayce — Covered with criteria

Arikayce covered when ALL of the following are met:

Arikayce coverage: Diagnosis of Mycobacterium avium complex (MAC) pulmonary disease and use as part of a combination antibacterial regimen in patients who do not achieve at least two consecutive negative sputum cultures after a minimum of 6 months of multidrug background therapy.

Coverage duration: 12 months.

Prescriber: Prescribed by or in consultation with an infectious disease specialist or pulmonologist.

Augtyro — Covered with criteria

Augtyro covered when ALL of the following are met:

Indication: Diagnosis of NSCLC with ROS1 rearrangement OR a solid tumor with an NTRK gene fusion that is locally advanced, unresectable, or metastatic and has progressed after prior therapy or has no satisfactory alternative treatments.

Coverage duration: 12 months; continuation of prior therapy may be approved.

Prerequisite therapy: Criteria requires use of a prerequisite Part D drug as specified in the product entry where applicable.

Benlysta — Covered with criteria

Benlysta covered when ALL of the following are met:

SLE initial: Diagnosis of active systemic lupus erythematosus (SLE) with serologic autoantibody positivity (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL) and currently receiving at least one standard‑of‑care treatment (eg, antimalarial, corticosteroid, or immunosuppressant).

Prescribed by or in consultation with a rheumatologist; coverage duration 6 months.

Lupus nephritis initial: Diagnosis of active lupus nephritis and currently receiving standard‑of‑care therapy (eg, corticosteroids with mycophenolate).

Prescribed by or in consultation with a nephrologist or rheumatologist; coverage duration 6 months.

Reauthorization: Patient demonstrates positive clinical response to therapy.

Reauthorization coverage duration 6 months.

Cablivi — Covered with criteria

Cablivi covered when ALL of the following are met:

Diagnosis of acquired thrombotic thrombocytopenic purpura (aTTP).

First dose must be administered by a healthcare provider as a bolus IV injection.

Adjunct treatments: Used in combination with immunosuppressive therapy AND either used in combination with plasma exchange OR patient completed plasma exchange with less than 59 days elapsed since last plasma exchange.

Prescribed by or in consultation with a hematologist/oncologist; coverage duration 3 months.

Cholbam — Covered with criteria

Cholbam covered when ALL of the following are met:

BAS initial: Diagnosis of a bile acid synthesis disorder due to a single enzyme defect confirmed by abnormal urinary bile acid analysis by mass spectrometry OR molecular genetic testing consistent with the diagnosis.

Coverage initial 4 months; reauthorization 12 months.

Peroxisomal disorder initial: Diagnosis of a peroxisomal disorder confirmed by abnormal urinary bile acid analysis or molecular genetic testing AND patient exhibits liver disease (eg, jaundice, elevated transaminases), steatorrhea, or complications from decreased fat‑soluble vitamin absorption AND therapy will be used as adjunctive treatment.

Prescribed by a hepatologist, medical geneticist, gastroenterologist or specialist treating inborn errors of metabolism; coverage initial 4 months, reauth 12 months.

Tadalafil — Covered with criteria

Tadalafil tablets covered when ALL of the following are met:

BPH coverage: Diagnosis of benign prostatic hyperplasia (BPH) with trial and failure, contraindication, or intolerance to an alpha‑blocker or a 5‑alpha reductase inhibitor.

Exclusion: concurrent use of nitrates; coverage duration 12 months.

Bile acid synthesis disorders (BAS) and Peroxisomal disorders (PD)

Covered when ALL of the following are met

BAS (initial): Diagnosis of a bile acid synthesis disorder due to a single enzyme defect based on abnormal urinary bile acid analysis by mass spectrometry OR molecular genetic testing consistent with diagnosis.

Coverage duration 4 months initial, 12 months reauth.

Peroxisomal disorders (initial): Diagnosis based on abnormal urinary bile acid analysis or molecular genetic testing; patient has liver disease, steatorrhea, or complications from decreased fat‑soluble vitamin absorption; and will be used as adjunctive treatment.

Coverage duration 4 months initial, 12 months reauth.

Hereditary angioedema (Cinryze) prophylaxis

Covered when ALL of the following are met

HAE prophylaxis (initial): Diagnosis of hereditary angioedema (HAE) confirmed by low C4 and C1‑INH deficiency or dysfunction (antigenic or functional level below lower limit of normal).

Patient age ≥6 years; prescribed by or in consultation with an immunologist/allergist; not used with other approved prophylactic treatments; coverage initial/reauth 12 months.

Plaque psoriasis, Psoriatic arthritis, Ankylosing spondylitis, nr-axSpA, ERA, HS (Cosentyx and related agents)

Covered when specified disease-specific criteria and prior therapy requirements are met

Plaque psoriasis (initial): Diagnosis of moderate to severe plaque psoriasis with ≥3% BSA or severe scalp/palmoplantar/facial/genital involvement; trial and failure/contraindication/intolerance to at least one topical therapy (minimum 30 days; 14 days for topical corticosteroids).BSA >= 3%

Initial coverage 6 months; reauth 12 months; prescriber dermatologist or consult.

Psoriatic arthritis (initial): Diagnosis of active PsA with inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement; trial and failure/contraindication/intolerance to required conventional/biologic agents per product or continuation of prior therapy.

Initial coverage 6 months; reauth 12 months; prescriber rheumatologist or dermatologist.

Ankylosing spondylitis / nr-axSpA / ERA (initial): Diagnosis of active disease; minimum 1‑month trial and failure/contraindication/intolerance to one NSAID (AS) or two NSAIDs (nr‑axSpA/ERA) at maximally tolerated doses; objective inflammation required for nr‑axSpA (eg, elevated CRP or MRI sacroiliitis).

Prescriber rheumatologist; initial 6 months; reauth 12 months.

Hidradenitis suppurativa (initial): Diagnosis of moderate to severe hidradenitis suppurativa (eg, Hurley stage II or III).

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

Onychomycosis (Ciclopirox nail lacquer / Ciclodan)

Covered when ALL of the following are met

Onychomycosis (initial): No lunula (matrix) involvement; diagnosis of toenail or fingernail onychomycosis confirmed by KOH, culture, or histology; if toenail disease, mild–moderate involvement of at least one target toenail; trial and failure/contraindication/intolerance to oral terbinafine (minimum 6 weeks fingernail, 12 weeks toenail) as applicable.

Coverage duration 48 weeks.

Metyrosine — preoperative preparation and treatment of pheochromocytoma

Covered when ALL of the following are met

Preoperative preparation: Diagnosis of pheochromocytoma confirmed biochemically (plasma free metanephrines OR urinary fractionated metanephrines) AND medication used for preoperative preparation after trial and failure/contraindication/intolerance to both an alpha‑adrenergic blocker AND a beta‑adrenergic blocker.

Coverage 4 weeks for preoperative preparation.

Treatment of pheochromocytoma (initial): Biochemical confirmation of hormonally active pheochromocytoma AND patient is not a candidate for surgery OR requires chronic treatment for malignant disease, AND trial and failure/contraindication/intolerance to both an alpha‑adrenergic blocker AND a beta‑adrenergic blocker is documented.

Initial 6 months; reauth 12 months; prescriber endocrinologist or specialist in pheochromocytoma.

Deferasirox — iron overload indications

Covered when ALL of the following are met

Transfusional chronic iron overload (initial): Diagnosis of chronic iron overload due to transfusions with baseline ferritin >1,000 mcg/L AND history of at least 100 packed RBC transfusions.

Age ≥2 years for transfusional iron overload; coverage 12 months.

Myelodysplastic syndrome (MDS): Diagnosis of MDS with low or intermediate‑1 disease or transplant candidate AND >20 RBC transfusions documented.

Coverage 12 months.

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

Age ≥10 years; reauth requires reduction in ferritin or LIC.

Metyrosine (preoperative and treatment of pheochromocytoma)

Covered when ALL of the following are met

Diagnostic confirmation: Diagnosis of pheochromocytoma confirmed by plasma free metanephrines or urinary fractionated metanephrines.

Indication-specific: For preoperative preparation: used for preoperative prep after required alpha/beta blocker trials; for treatment: hormonally active pheochromocytoma and patient is not a surgical candidate or has malignant disease and has not achieved normotension after selective alpha and beta blockade or is intolerant to those agents.

Therapy prerequisites: Documented trial and failure, contraindication, or intolerance to both an alpha‑adrenergic blocker AND a beta‑adrenergic blocker must be provided.

Prescriber restriction: Prescribed by or in consultation with an endocrinologist, endocrine surgeon, or provider experienced in pheochromocytoma management.

Doptelet (thrombocytopenia indications)

Covered when ALL of the following are met

Indication-specific platelet thresholds: TPPP (procedure): chronic liver disease with planned procedure AND baseline platelet <50,000/mcL; ITP: chronic or relapsed/refractory ITP with baseline platelet <30,000/mcL.

Prior therapy for ITP: Trial and failure, contraindication, or intolerance to at least one of corticosteroids, IVIG, or splenectomy for ITP initial therapy.

Prescriber restriction for ITP: Prescribed by or in consultation with a hematologist/oncologist for ITP initial.

Enbrel and biosimilars (RA, PJIA, PsA, plaque psoriasis, AS)

Covered when ALL of the following are met

Diagnosis appropriate to the indication (eg, moderately to severely active RA, PJIA, active PsA, moderate to severe plaque psoriasis, active AS).

Prerequisite conventional therapy: Minimum trial and failure, contraindication, or intolerance to specified conventional therapies at maximally tolerated doses (eg, methotrexate, leflunomide, sulfasalazine for RA) or topical therapies for plaque psoriasis with durations specified per indication (eg, 3 months for RA; 6 weeks for PJIA).

Durations specified per indication.

Prescriber restriction: Prescribed by or in consultation with a rheumatologist (or dermatologist for plaque psoriasis) as specified per indication.

Reauthorization: Patient demonstrates positive clinical response to therapy with measures specified per indication (eg, reduction in swollen/tender joint count; improvement in BSA for psoriasis).

Procrit (erythropoiesis-stimulating agent)

Covered when ALL of the following are met (indication-specific)

Indication-specific lab criteria: Anemia confirmed by lab values with hematocrit and hemoglobin thresholds per indication (eg, Hct <30% or Hgb <10 g/dL for CKD and chemotherapy‑related anemia).

Labs must be recent as specified (eg, within 2 weeks or 30 days).

Iron stores: Adequate iron stores confirmed where required (eg, ferritin >100 mcg/L AND TSAT >20%).ferritin>100 mcg/L; TSAT>20%

Other indication criteria: Additional indication‑specific requirements (eg, patient receiving chemotherapy for chemo indication; dialysis status for CKD).

Evrysdi (risdiplam) for spinal muscular atrophy

Covered when ALL of the following are met

Genetic confirmation: Diagnosis of spinal muscular atrophy (SMA) type I, II, or III with SMN1 homozygous deletion or compound heterozygous mutation AND at least 2 copies of SMN2.

Respiratory status: Patient is not dependent on both invasive ventilation/tracheostomy AND chronic non‑invasive ventilation beyond naps/nighttime.

Baseline motor assessment: At least one age‑appropriate baseline motor exam performed (HINE‑2, HFMSE, RULM, CHOP‑INTEND, MFM‑32, or BSID‑III item 22).

Prior SMN therapy: Patient is not to receive concomitant chronic SMN‑modifying therapy (eg, nusinersen); prior gene therapy (Zolgensma) allowed only if inadequate response documented with medical records.

Documentation of inadequate response to prior gene therapy required if applicable; coverage duration 12 months.

Evrysdi - Spinal Muscular Atrophy (Initial and Reauthorization)

Covered when ALL of the following are met

Evrysdi initial criteria: 1) Diagnosis of SMA type I, II, or III with SMN1 mutation/deletion and ≥2 copies of SMN2; 2) Not dependent on both invasive ventilation/tracheostomy and chronic non‑invasive ventilation beyond naps/nighttime; 3) Baseline motor exam performed using age‑appropriate scale; 4) Not receiving concomitant chronic SMN‑modifying therapy (eg, Spinraza); 5) Prescribed by or in consultation with a neurologist experienced in SMA; 6) Either no prior gene replacement therapy OR prior gene therapy with documented inadequate response (eg, sustained decrease in motor test score over 6 months).coverage duration 12 months

Reauthorization requires demonstration of positive clinical response; initial and reauth criteria mirror each other.

Fabrazyme - Fabry Disease

Covered when ALL of the following are met

Fabrazyme initial criteria: Diagnosis of Fabry disease confirmed by pathogenic GLA mutation OR deficient alpha‑galactosidase A activity in plasma/leukocytes/DBS OR significant clinical manifestations consistent with Fabry disease; not used in combination with other Fabry drugs; patient age ≥2 years.age >= 2 years

Coverage duration 12 months; reauthorization requires positive clinical response.

Icatibant - Hereditary Angioedema (Acute Attacks)

Covered when ALL of the following are met

Icatibant initial criteria: Diagnosis of hereditary angioedema (HAE) confirmed by low C4 and C1‑INH deficiency/dysfunction (antigenic or functional) AND use for treatment of acute HAE attacks only; not used in combination with other approved acute HAE therapies; initial age ≥18 years; prescribed by or in consultation with an immunologist or allergist.

Coverage duration 12 months; reauthorization requires positive clinical response.

Humira and formulations - Multiple Indications

Covered for specified indications when ALL relevant indication-specific criteria are met

RA initial criteria: Diagnosis of moderately to severely active rheumatoid arthritis and minimum 3‑month TFIC/I to one conventional DMARD (methotrexate, leflunomide, or sulfasalazine); prescribed by/consult rheumatologist; initial approvals commonly 6 months (reauth 12 months).

Reauthorization requires demonstration of positive clinical response (eg, reduced swollen/tender joint count).

Plaque psoriasis initial criteria: Diagnosis of moderate to severe plaque psoriasis with ≥3% BSA or severe scalp/palmoplantar/facial/genital involvement; trial and failure/contraindication/intolerance to topical therapies (minimum 30 days; 14 days for topical corticosteroids); prescriber dermatologist; reauth requires clinical response (BSA reduction or symptom improvement).BSA >= 3%

Psoriatic arthritis initial criteria: Diagnosis of active PsA with inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail disease; prescriber rheumatologist or dermatologist; reauth requires improvement in joint counts, symptoms, or BSA.

Ankylosing spondylitis initial criteria: Diagnosis of active AS with minimum 1‑month TFIC/I to one NSAID at maximally tolerated doses; prescriber rheumatologist; reauth requires clinical or lab improvement.1-month NSAID trial

Product-specific initial coverage criteria (general template)

Covered when ALL of the following are met for the specific product:

Diagnosis: Documented diagnosis matching the product‑specific indication (eg, AML with IDH2 mutation for Idhifa; myelofibrosis for Jakafi).

See product entry for exact diagnostic subtypes and required tests.

Testing/Pertinent results: When required, documentation of specific molecular testing or disease stratification (eg, IDH2 mutation, KRAS G12C, EGFR, RET, NTRK) using FDA‑approved or CLIA‑certified tests.

Prior therapy or trial requirement: If specified, documented trial and failure, contraindication, or intolerance to indicated prior therapies (requirements vary by product).

Some products require >1 prior therapy or specific classes tried.

Prescriber restriction: When indicated, initial prescribing or consultation by a relevant specialist must be documented (eg, neurologist, oncologist, hepatologist).

Applies to select products.

Coverage duration and response: Most products state a coverage duration (commonly 12 months); reauthorization often requires objective clinical response or continued benefit.Duration: commonly 12 months

IVIG and some specialty products have specific reauth requirements.

Selected product criteria (examples)

Coverage criteria are product‑specific; examples below capture exact criteria as stated for selected products in this segment.

Jaypirca - Indications: Diagnosis of primary myelofibrosis, post‑polycythemia vera myelofibrosis, or post‑essential thrombocythemia myelofibrosis; for polycythemia vera, TFIC/I to hydroxyurea required; other hematologic indications per product entry.

Coverage duration 12 months; approve continuation of prior therapy.

Jylamvo criteria

Jylamvo - Mantle Cell Lymphoma: Diagnosis of relapsed or refractory mantle cell lymphoma AND patient received at least two prior therapies for MCL, one of which is a BTK inhibitor.

Coverage duration 12 months; continuation approvals allowed.

Jylamvo - CLL/SLL: Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma AND prior treatment with both a BTK inhibitor and a BCL‑2 inhibitor.

Coverage duration 12 months.

Jynarque criteria

Jynarque - Initial ADPKD: Diagnosis of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) AND monitoring plan for liver tests: if on therapy ≤18 months then ALT/AST/bilirubin measured at baseline, 2 and 4 weeks then monthly for first 18 months; if >18 months then measured at least every 3 months; patient without significant liver impairment.

Coverage duration 12 months; reauth requires positive clinical response.

Kalydeco criteria

Kalydeco (CF) - Initial: Diagnosis of cystic fibrosis AND at least one CFTR mutation responsive to ivacaftor as determined by an FDA‑cleared or CLIA‑approved test; meets age requirement per label; prescribed by or in consultation with CF specialist or pulmonologist.

Coverage duration 12 months; reauth requires evidence of benefit (eg, improved ppFEV1 or fewer exacerbations).

Kesimpta criteria

Kesimpta - Multiple Sclerosis: Diagnosis of a relapsing form of multiple sclerosis AND trial and failure, contraindication, or intolerance to one disease‑modifying therapy (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.

Kineret criteria

Kineret - RA initial: Diagnosis of moderately to severely active rheumatoid arthritis AND trial and failure/contraindication/intolerance to two listed agents (eg, etanercept, one formulary adalimumab product, abatacept, upadacitinib, tofacitinib) OR attestation that trials are inappropriate.

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

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

Initial coverage 6 months; reauth 12 months.

Selected oncology product criteria

Selected oncology indications: Diagnosis consistent with the indicated cancer type and biomarker status where specified (eg, EGFR mutations, IDH2, RET, FLT3); product‑specific testing and prior therapy requirements apply.

Coverage duration generally 12 months; approve continuation of prior therapy.

Lumakras (sotorasib) — Covered with criteria

Covered when ALL of the following are met

Lumakras coverage criteria: Diagnosis of locally advanced or metastatic non‑small cell lung cancer (NSCLC) or metastatic colorectal cancer (mCRC) with documented KRAS G12C mutation by FDA‑approved or CLIA‑certified test AND prior systemic therapy as specified for the tumor type (eg, at least one prior systemic therapy for NSCLC; prior fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy for mCRC).

Coverage duration 12 months; criteria may require prerequisite Part D drug.

Lynparza (olaparib) — Covered with criteria

Covered when ALL of the following are met

Lynparza coverage criteria: Diagnosis of an indicated malignancy (eg, epithelial ovarian/fallopian tube/primary peritoneal cancer, pancreatic adenocarcinoma, certain breast or prostate cancer indications) per product labeling with required biomarker or prior therapy documentation where applicable.

Coverage duration 12 months; approve continuation of prior therapy.

Neulasta (pegfilgrastim) — Covered with criteria

Covered when one of the following indication‑specific criteria are met

Neulasta indications: FN prophylaxis for dose‑dense regimens (eg, INT C9741), regimens with >20% FN risk, or 10–20% risk with additional patient risk factors; secondary prophylaxis for prior FN or dose‑limiting neutropenia; ARS after myelosuppressive radiation exposure; treatment of FN in high‑risk patients; prescribed by or in consultation with hematology/oncology.

Coverage durations: ARS 1 month; FN prophylaxis/treatment commonly 3 months or duration of treatment.

MS disease-modifying therapies (Rebif, Avonex, Betaseron) — Covered with criteria

Covered when ALL of the following are met

MS DMT criteria: Diagnosis of a relapsing form of multiple sclerosis (including active secondary progressive disease) AND trial and failure/contraindication/intolerance to one interferon (Avonex or Betaseron) for initial therapy unless continuation of prior therapy; prescribed by or in consultation with a neurologist.

Coverage duration 12 months; reauth requires positive clinical response. Not used in combination with another DMT.

Dihydroergotamine — Covered with criteria (acute migraine)

Covered when ALL of the following are met

Dihydroergotamine criteria: Diagnosis of migraine (with or without aura) for acute treatment AND trial and failure or intolerance to one triptan OR contraindication to triptans.

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

Mounjaro (tirzepatide) — Covered with criteria

Covered when ALL of the following are met

Mounjaro criteria: Diagnosis of type 2 diabetes mellitus (T2DM) with supporting documentation (medical records) OR laboratory evidence (A1c ≥6.5% OR fasting plasma glucose ≥126 mg/dL OR 2‑hour OGTT ≥200 mg/dL).

Coverage duration 12 months; reauth requires documented positive clinical response.

Posaconazole suspension — Covered with criteria (SFI prophylaxis, OPC)

Covered when ALL of the following are met

Posaconazole indications: Prophylaxis of invasive fungal infections in high‑risk patients (eg, HSCT with GVHD or hematologic malignancy with prolonged neutropenia); secondary prophylaxis for prior fungal infection; or oropharyngeal candidiasis with trial/failure or resistance to fluconazole.

Age ≥13 years for prophylaxis/OPC; coverage: prophylaxis 6 months, OPC 1 month.

Droxidopa — Covered with criteria (neurogenic orthostatic hypotension)

Covered when ALL of the following are met

Droxidopa criteria: Diagnosis of symptomatic neurogenic orthostatic hypotension due to primary autonomic failure, dopamine beta‑hydroxylase deficiency, or non‑diabetic autonomic neuropathy AND trial and failure/contraindication/intolerance to fludrocortisone acetate or midodrine.

Prescribed by or in consultation with cardiology, neurology, or nephrology; initial coverage 1 month, reauth 12 months with positive clinical response.

Pseudobulbar affect (PBA) — Initial

Covered when ALL of the following are met

PBA initial coverage: Diagnosis of pseudobulbar affect (PBA) AND absence of listed contraindications (eg, concomitant quinidine/quinine/mefloquine, history of drug‑induced thrombocytopenia/hepatitis/bone marrow depression, hypersensitivity to dextromethorphan, current or recent MAOI use within 14 days, prolonged QT or high torsades risk, use of drugs that both prolong QT and are metabolized by CYP2D6, complete AV block without pacemaker).

Prescribed by or in consultation with neurologist or psychiatrist; coverage duration 12 months.

Armodafinil — OSA, SWD, Narcolepsy

Covered when listed diagnostic criteria are met

OSA initial: Diagnosis of obstructive sleep apnea (OSA) defined by either ≥15 obstructive events/hour on sleep study OR ≥5 events/hour plus associated symptoms (eg, daytime sleepiness); sleep study confirmation required unless not feasible.OSA thresholds per sleep study

Initial/reauth coverage: OSA and SWD 6 months; narcolepsy 12 months.

SWD initial: Diagnosis of shift‑work disorder (SWD) with excessive sleepiness or insomnia ≥3 months associated with work period or sleep study demonstrating circadian disturbance; exclude other causes.

Narcolepsy initial: Diagnosis of narcolepsy confirmed by appropriate study unless not feasible.

Odactra — House dust mite allergic rhinitis

Covered when ALL of the following are met

HDM allergic rhinitis initial: Diagnosis of house dust mite‑induced allergic rhinitis with positive in‑vitro or skin testing AND trial and failure/contraindication/intolerance to an intranasal corticosteroid AND an antihistamine.Age 5–65 years for initial therapy

Prescribed by or in consultation with an allergist/immunologist; coverage 12 months; reauth requires symptom improvement or decreased medication use.

Pulmonary arterial hypertension (PAH) — Opsumit/Orenitram/Orenitram titration kits

Covered when ALL of the following are met

PAH diagnostic confirmation: Diagnosis of symptomatic pulmonary arterial hypertension (PAH) confirmed by right heart catheterization OR patient currently on any therapy for PAH.

Initial coverage commonly 6 months; reauth 12 months; prescriber should be or consult pulmonologist or cardiologist.

Orencia (all formulations) — Rheumatoid arthritis, PJIA, Psoriatic arthritis, aGVHD prophylaxis

Covered when ALL of the following are met

RA initial: Diagnosis of moderately to severely active RA AND minimum 3‑month TFIC/I to one conventional therapy at maximally tolerated dose (eg, methotrexate, leflunomide, sulfasalazine).

Initial coverage 6 months; reauth 12 months; prescriber rheumatologist.

PJIA initial: Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis AND minimum 6‑week TFIC/I to methotrexate or leflunomide.

Initial 6 months; reauth requires demonstrated clinical benefit.

aGVHD prophylaxis: Used for prophylaxis of acute graft‑versus‑host disease in HSCT recipients from matched or 1‑allele mismatched unrelated donors with recommended antiviral prophylaxis continued per guidance.Age ≥2 years

Coverage duration for aGVHD: 2 months.

Onpattro — hATTR amyloidosis with polyneuropathy

Covered when ALL of the following are met

hATTR initial: Diagnosis of hereditary transthyretin‑mediated amyloidosis (hATTR) with polyneuropathy with pathogenic TTR mutation detected by FDA‑approved or CLIA‑approved test AND baseline PND ≤ IIIb or FAP stage 1–2 or NIS 5–130 AND clinical signs of neuropathy; not used in combination with a TTR silencer or stabilizer.PND ≤ IIIb; NIS 5–130

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

Orkambi — Cystic fibrosis (CF)

Covered when ALL of the following are met

CF initial: Diagnosis of cystic fibrosis with homozygous F508del CFTR mutation detected by FDA‑cleared or CLIA‑approved test; patient age ≥6 years; prescribed by or in consultation with CF care center specialist or pulmonologist.Age ≥ 6 years

Coverage 12 months; reauth requires evidence of benefit (improved FEV1, fewer exacerbations).

Orserdu — Advanced/metastatic ER-positive breast cancer with HER mutation

Covered when ALL of the following are met

Orserdu initial: Diagnosis of advanced/metastatic ER‑positive breast cancer with an appropriate HER mutation detected by FDA‑approved or CLIA‑approved test AND disease progressed after at least one line of endocrine therapy.

Coverage duration 12 months; continuation approvals possible.

Osphena — Dyspareunia or vaginal dryness due to VVA

Covered when ALL of the following are met

Osphena indications: Diagnosis of moderate to severe dyspareunia or vaginal dryness due to vulvar and vaginal atrophy associated with menopause.

Coverage 12 months; reauth requires demonstrated positive clinical response.

Otezla — Psoriatic arthritis, plaque psoriasis, Behcet's oral ulcers

Covered when ALL of the following are met

PsA initial: Diagnosis of active psoriatic arthritis (signs such as inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement).

Initial coverage 6 months; reauth 12 months; reauth requires demonstration of clinical response (reduced swollen/tender joint count, symptom improvement, or reduced BSA).

Plaque psoriasis initial: Diagnosis of plaque psoriasis with minimum 4‑week TFIC/I to topical therapies (corticosteroids, vitamin D analogs, tazarotene, or calcineurin inhibitors); patient weight ≥20 kg.Weight ≥20 kg

Initial coverage 6 months; reauth 12 months; reauth requires clinical response.

Psoriatic arthritis / Plaque psoriasis — Initial Therapy (example from other products)

Covered when ALL of the following are met

PsA/Plaque psoriasis initial criteria: Diagnosis of active psoriatic arthritis OR plaque psoriasis with minimum 4‑week TFIC/I to topical therapies (corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors) AND meet age/weight thresholds where specified and prescribed by/consult with dermatologist or rheumatologist.4-week topical trial for plaque psoriasis

Initial coverage 6 months; reauth 12 months.

Eltrombopag — ITP / SAA / Chronic hepatitis C-associated thrombocytopenia

Covered when ALL of the following are met for each indication

ITP initial criteria: Diagnosis of relapsed/refractory, persistent, or chronic ITP with baseline platelet count <30,000/mcL AND TFIC/I to corticosteroids, IVIG, or splenectomy AND prescribed by or in consultation with a hematologist/oncologist.platelets <30,000/mcL

Reauth requires clinical response (increase in platelet count sufficient to avoid clinically important bleeding).

SAA first-line criteria: Diagnosis of severe aplastic anemia used in combination with standard immunosuppressive therapy and meeting hematologic thresholds (eg, ANC <500/mcL, platelets <20,000/mcL, ARC <60,000/mcL).see text

Initial coverage 6 months; reauth 12 months.

Type 2 Diabetes Mellitus (GLP-1 example) — Initial

Covered when ALL of the following are met

T2DM diagnostic options: Documentation of type 2 diabetes mellitus by medical records OR laboratory evidence: A1c ≥6.5% OR fasting plasma glucose ≥126 mg/dL OR 2‑hour OGTT ≥200 mg/dL.see text

Prescriber documentation required for ongoing treatment.

Pyruvate kinase deficiency — Initial

Covered when ALL of the following are met

Pyruvate kinase deficiency diagnostic criteria: Chronic hemolysis documented AND molecular testing confirming PKLR variants with ≥2 variant alleles (≥1 missense), not homozygous for c.1436G>A (p.R479H), and not having two non‑missense variants without another missense variant; hemoglobin ≤10 g/dL AND symptomatic anemia or transfusion dependence; exclusion of other causes of hemolytic anemia.hemoglobin <=10 g/dL

Prescribed by or in consultation with a hematologist; initial 6 months, reauth 12 months.

Infliximab: Initial and Reauthorization Criteria

Covered when criteria specific to each indication are met

Plaque psoriasis (initial): Active plaque psoriasis including scalp, palmoplantar, facial, or genital involvement AND minimum 4‑week TFIC/I to a topical therapy as specified.4-week trial

Ankylosing spondylitis (initial): Diagnosis of active AS AND minimum 1‑month TFIC/I to an NSAID at maximally tolerated doses.1-month NSAID trial

Prescriber: rheumatologist.

Sarcoidosis (initial): Diagnosis of sarcoidosis AND TFIC/I to both an immunosuppressant (eg, methotrexate, cyclophosphamide, azathioprine) AND a corticosteroid.TFIC/I to immunosuppressant + corticosteroid

Prescriber: pulmonologist, dermatologist, or ophthalmologist.

Reauthorization (general): Patient demonstrates positive clinical response to therapy as evidenced by indication‑specific objective or symptomatic improvement (eg, reduced BSA, reduced swollen/tender joint counts, improved labs, mucosal healing).demonstrated clinical response from baseline

Reauth duration typically 12 months.

Other specialty products: summary criteria

Other covered specialty drugs have indication‑specific criteria summarized below

Retacrit - CKD/Anemia indications: Diagnosis and laboratory thresholds required (eg, Hct <30% or Hgb <10 g/dL) with adequate iron stores confirmed (ferritin >100 mcg/L and TSAT >20%) and indication‑specific timing of labs; reauth requires demonstrated response.Hgb/Hct cutoffs and iron indices

Coverage durations vary by indication.

Retevmo - RET fusion-positive tumors: Diagnosis of NSCLC, MTC, or other solid tumor with RET fusion/mutation detected by FDA‑approved or CLIA test; disease locally advanced or metastatic and progressed or not a candidate for systemic therapy.molecular testing positive for RET

Coverage duration 12 months.

Rinvoq LQ - PJIA and PsA: Diagnosis of active PJIA or PsA with inadequate response or intolerance to conventional therapies; not used concomitantly with other JAK inhibitors/biologic DMARDs.prior conventional therapy failure

Initial 6 months, reauth 12 months.

Hizentra (SCIG) initial and reauthorization

Covered when ALL of the following are met

Initial SCIG criteria: Immune globulin administered subcutaneously at the minimum effective dose and frequency for an indicated diagnosis (eg, CVID, congenital agammaglobulinemia, SCID, Wiskott‑Aldrich, or other primary immunodeficiency with IgG below normal and inadequate vaccine response).

Prescriber requirement: Prescribed by or in consultation with a clinician experienced in SCIG therapy (eg, immunologist, hematologist, neurologist).

Reauthorization: Patient has objective improvement on therapy and dosing will be at the minimum effective dose for maintenance.

Stelara IV induction for Crohn's disease / Ulcerative colitis

Covered when ALL of the following are met

Dosing support: Will be administered as IV induction dose per FDA‑labeled weight‑based dosing (260 mg ≤55 kg; 390 mg >55–85 kg; 520 mg >85 kg).

Skyrizi / Skyrizi 600 mg and Steqeyma / other psoriasis and IBD biologics

Covered when specified product‑specific initial criteria are met

Plaque psoriasis initial criteria: Diagnosis of moderate to severe plaque psoriasis with ≥3% BSA or severe involvement and TFIC/I to topical therapies (minimum 30 days; 14 days for topical corticosteroids).

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

Rydapt (midazolam?) and T2DM agents diagnostic requirement

Covered when diagnostic evidence provided

T2DM documentation: Submit medical records confirming diagnosis OR laboratory evidence meeting diabetes thresholds (A1c ≥6.5%, FPG ≥126 mg/dL, or 2‑hr OGTT ≥200 mg/dL).

Spevigo for generalized pustular psoriasis (GPP)

Covered when ALL of the following are met

Diagnosis of generalized pustular psoriasis (GPP) defined by primary sterile macroscopic pustules (excluding pustulation restricted to psoriatic plaques).

Administration restriction: Subcutaneous formulation will not be used to treat GPP flare.

Weight and age: Patient weighs at least 40 kg and is ≥12 years of age.

Prescriber: Prescribed by or in consultation with a dermatologist.

Stivarga (regorafenib) oncology indications

Covered when diagnosis matches labeled oncology indications

On-label oncology uses: Diagnosis of metastatic colorectal cancer, locally advanced unresectable or metastatic GIST, hepatocellular carcinoma, or other labeled tumors per product labeling.

Coverage duration 12 months; approve continuation of prior therapy.

Oncology products (examples: Stivarga, Sucraid entries)

Covered when ALL of the following are met

Oncology product criteria: Diagnosis consistent with the labeled oncology indication and required diagnostic testing; coverage duration commonly 12 months.

Tavneos (avacopan) — ANCA-associated vasculitis

Covered when ALL of the following are met

Tavneos initial: Diagnosis of severe active ANCA‑associated vasculitis (granulomatosis with polyangiitis or microscopic polyangiitis) confirmed by positive PR3 or MPO ANCA or tissue biopsy; patient receiving concurrent immunosuppressant therapy with cyclophosphamide or rituximab and on glucocorticoids or has intolerance to glucocorticoids; prescribed by or in consultation with nephrologist, pulmonologist, or rheumatologist.

Coverage duration 12 months; reauth requires no evidence of progressive disease while on therapy.

Teriparatide and parathyroid hormone therapies (osteoporosis)

Covered when ALL of the following are met

Initial eligible populations: Postmenopausal osteoporosis/osteopenia or men with primary/hypogonadal osteoporosis/osteopenia or glucocorticoid‑induced osteoporosis meeting BMD and fracture history/FRAX thresholds: Set I (BMD T‑score ≤‑2.5 plus fracture history or TFIC/I to one osteoporosis therapy) OR Set II (BMD T‑score between ‑1.0 and ‑2.5 plus fracture history or TFIC/I plus FRAX meeting thresholds).see BMD and fracture/FRAX thresholds

Treatment duration limits apply (eg, initial 24 months for parathyroid hormone therapies).

Testosterone replacement therapy

Covered when ALL of the following are met

Hypogonadism initial: Diagnosis of hypogonadism in a male patient at birth AND one of: (1) two pre‑treatment total testosterone <300 ng/dL; OR (2) condition altering SHBG with pre‑treatment calculated free or bioavailable T <5 ng/dL; OR (3) history of bilateral orchiectomy/panhypopituitarism/genetic cause; OR (4) patient continuing testosterone therapy with appropriate recent follow‑up labs.testosterone <300 ng/dL

Age restrictions vary by formulation; reauth requires follow‑up testosterone levels per policy.

Hypogonadism (Initial and Reauthorization)

Covered when criteria for hypogonadism are met

Hypogonadism (Initial): Diagnosis of hypogonadism AND male patient at birth AND one of: (1) two pre‑treatment total testosterone <300 ng/dL; OR (2) condition causing altered SHBG with pre‑treatment calculated free/bioavailable T <5 ng/dL; OR (3) history of bilateral orchiectomy/panhypopituitarism/genetic disorder causing hypogonadism; OR (4) continuation of testosterone therapy with follow‑up labs within past 12 months.see thresholds

Age restriction commonly ≥18 years for most formulations; initial and reauth durations specified per product.

Other testosterone indications

Other testosterone uses with specific criteria

Delayed puberty: Diagnosis of delayed puberty in a male patient at birth.age criteria per product

Coverage duration example: 6 months for delayed puberty.

Breast cancer (palliative): Diagnosis of inoperable breast cancer used for palliative treatment in female patients at birth.

Coverage duration example: 12 months.

Gender dysphoria (off‑label): Diagnosis of gender dysphoria/gender incongruence where applicable per product guidance.

Coverage durations specified per product (eg, 12 months).

Tevimbra oncology indications

Covered when specified prior therapy and disease characteristics are met

Esophageal squamous cell carcinoma: Diagnosis of unresectable or metastatic esophageal squamous cell carcinoma AND prior systemic chemotherapy with no prior PD‑(L)1 inhibitor OR used in combination with platinum chemotherapy per product labeling.

Coverage duration 12 months.

Gastric/GJ adenocarcinoma: Diagnosis of unresectable/metastatic gastric or gastroesophageal junction adenocarcinoma that is HER2‑negative AND tumor expresses PD‑L1 by FDA‑approved or CLIA‑approved test AND used with platinum+fluoropyrimidine chemotherapy.

Coverage duration 12 months.

Rheumatology indications (initial and reauth)

Covered when diagnosis and prior therapy or specialist prescriber requirements are met

Rheumatoid arthritis (initial): Diagnosis of moderately to severely active rheumatoid arthritis AND TFIC/I to two specified agents (eg, etanercept, adalimumab, abatacept, or specified JAK inhibitors) OR attestation that trials are inappropriate; prescribed by or in consultation with a rheumatologist.

Initial 6 months; reauth 12 months.

Giant cell arteritis (initial): Diagnosis of giant cell arteritis AND TFIC/I to glucocorticoid therapy where specified; prescribed by or in consultation with rheumatologist.

Coverage durations per product.

Systemic juvenile idiopathic arthritis (initial): Diagnosis of active SJIA AND TFIC/I to one conventional therapy at maximally tolerated doses (eg, NSAID 1 month or systemic glucocorticoid 2 weeks).

Prescriber rheumatologist; initial 6 months; reauth 12 months.

Polyarticular juvenile idiopathic arthritis (initial): Diagnosis of active PJIA AND TFIC/I to two specified agents OR attestation trials are inappropriate.

Prescriber rheumatologist; coverage durations as listed.

SSc‑ILD (initial): Diagnosis of systemic sclerosis‑associated interstitial lung disease with exclusion of other ILD causes AND HRCT pattern consistent with SSc‑ILD or supportive biopsy when performed.

Prescriber pulmonologist or rheumatologist.

Udenyca indications (prophylaxis and treatment of FN)

Covered when chemotherapy regimen and febrile neutropenia (FN) risk satisfy listed scenarios

FN prophylaxis - high risk regimens: Patient receiving dose‑dense chemotherapy (eg, NCI INT C9741), regimens with >20% FN incidence, or regimens with 10–20% FN incidence AND one or more patient risk factors; or secondary prophylaxis for prior FN/dose‑limiting events.

Prescribed by or in consultation with hematologist/oncologist; coverage duration 3 months or per regimen.

Treatment of FN: Diagnosis of febrile neutropenia and high risk for infection‑related complications while receiving myelosuppressive chemotherapy.

Prescribed by hematologist/oncologist; coverage duration 3 months or duration of treatment.

Tymlos (abaloparatide) coverage criteria

Covered when osteoporosis/osteopenia diagnostic thresholds and prior therapy requirements are met

Osteoporosis (Set I): BMD T‑score ≤‑2.5 AND either history of low‑trauma fracture of hip/spine/proximal humerus/pelvis/distal forearm OR TFIC/I to one osteoporosis treatment (eg, bisphosphonate, denosumab).BMD T-score <= -2.5

Coverage duration max 24 months lifetime for parathyroid hormone therapies.

Osteopenia (Set II): BMD T‑score between ‑1.0 and ‑2.5 AND either history of low‑trauma fracture OR TFIC/I to one therapy PLUS elevated FRAX meeting thresholds (major osteoporotic fracture ≥20% or hip ≥3%).FRAX thresholds apply

Udenyca Onbody — Covered with criteria

Udenyca Onbody — febrile neutropenia (FN) prophylaxis/treatment covered when any one of the following is met:

Udenyca FN prophylaxis criteria: 1) Patient receiving NCI INT C9741 dose‑dense chemotherapy for primary breast cancer; OR 2) receiving a dose‑dense chemotherapy regimen with unknown FN incidence; OR 3) receiving chemotherapy regimens associated with >20% FN incidence; OR 4) receiving regimens with 10–20% FN incidence AND patient has ≥1 risk factor for FN/neutropenia; OR 5) receiving myelosuppressive anticancer therapy AND history of FN or dose‑limiting event during prior chemotherapy (secondary prophylaxis).N/A

Prescribed by or in consultation with a hematologist/oncologist; coverage duration: 3 months or duration of treatment.

FLT3-targeted AML therapy — Covered with criteria

FLT3‑targeted therapy covered when ALL of the following are met:

FLT3‑ITD AML therapy: Diagnosis of acute myeloid leukemia (AML) with FLT3‑ITD mutation detected by FDA‑approved or CLIA‑approved test AND use in combination with standard induction/consolidation (cytarabine+anthracycline) and/or as maintenance monotherapy following consolidation as specified.N/A

Coverage duration 12 months; continuation approvals allowed.

Ventavis — Covered with criteria

Ventavis (iloprost) for pulmonary arterial hypertension (PAH) covered when ALL are met:

Ventavis PAH criteria: Diagnosis of symptomatic PAH AND either (A) diagnosis confirmed by right heart catheterization OR (B) patient is currently on any therapy for PAH.N/A

Prescribed by or in consultation with a pulmonologist or cardiologist. Initial coverage 6 months; reauthorization 12 months with positive clinical response.

Vitrakvi — Covered with criteria

Vitrakvi (larotrectinib) covered when ALL of the following are met:

Vitrakvi NTRK fusion criteria: Presence of a solid tumor with NTRK gene fusion detected by FDA‑approved or CLIA‑approved test (eg, secretory breast cancer, MASC, infantile fibrosarcoma) AND disease is metastatic or unresectable (or surgical resection would cause severe morbidity).N/A

Disease may have progressed on prior treatments; coverage duration 12 months.

Voquezna family — Covered with criteria

Voquezna/Voquezna Dual/Triple Pak coverage depends on indication:

H. pylori Voquezna criteria: Diagnosis of H. pylori infection AND trial and failure/contraindication/intolerance to bismuth quadruple therapy for Dual/Triple Pak, OR use in recommended combination regimens per product labeling.N/A

Coverage duration for H. pylori: 1 month.

HRH/MHRH/NERD Voquezna criteria: For healing/relief of heartburn associated with erosive esophagitis (HRH) or maintenance (MHRH) or NERD: trial and inadequate response, contraindication, or intolerance to TWO specified generic PPIs; symptom duration criteria for NERD apply.N/A

Coverage durations: HRH 2 months, MHRH 6 months, NERD 1 month.

Vowst — Covered with criteria

Vowst coverage criteria:

Vowst recurrent CDI criteria: Diagnosis of recurrent Clostridioides difficile infection per stool frequency and positive toxin/toxigenic test; history of ≥2 recurrent CDI episodes within 12 months; completion of at least 10 consecutive days of appropriate antibiotic therapy (eg, oral vancomycin or fidaxomicin) prior to Vowst; completion of magnesium citrate bowel prep the day before dosing; previous episode under control (<3 unformed stools/day for 2 consecutive days) prior to administration.Patient ≥18 years

Prescribed by or in consultation with gastroenterologist or infectious disease specialist; coverage duration 14 days.

Vumerity — Covered with criteria

Vumerity for multiple sclerosis covered when ONE of the following is met:

Vumerity MS criteria: Diagnosis of relapsing forms of multiple sclerosis AND either intolerance to two listed disease‑modifying therapies (teriflunomide, fingolimod, dimethyl fumarate) OR continuation of prior Vumerity therapy.N/A

Prescribed by or in consultation with a neurologist; coverage duration 12 months; not to be used in combination with another DMT for MS.

Vyjuvek — Covered with criteria

Vyjuvek for dystrophic epidermolysis bullosa (DEB) covered when ALL are met:

Vyjuvek DEB criteria: Diagnosis of dystrophic epidermolysis bullosa with COL7A1 mutation; medication used for wounds that require healing and applied by a healthcare professional; wounds meet criteria (adequate granulation tissue, excellent vascularization, no active infection, no evidence/history of squamous cell carcinoma); not used concurrently with other FDA‑approved EB therapies.Patient ≥6 months

Prescribed by or in consultation with wound care specialist; initial coverage 6 months, reauth 12 months with positive clinical response.

The policy excerpt frequently records Off‑Label Uses as N/A or leaves related fields blank. Where the document marks Off‑Label Uses as N/A or omits exclusion language, no additional off‑label coverage should be assumed without an explicit, product‑specific criterion. Providers must rely on the stated product indications, required diagnostic evidence, and prerequisite therapy rules in each product section rather than inferring permissive off‑label coverage from absent entries.

For tadalafil products the policy includes an explicit drug–drug exclusion: concurrent use of nitrates is not permitted. Requests documenting concomitant nitrate therapy should be denied per the exclusion and will not meet coverage criteria.

The document flags specific interaction and product exclusions. For example, tadalafil entries list concurrent nitrates as an exclusion. Separately, pyrimethamine products are explicitly not authorized for malaria treatment or prophylaxis and will be denied for those uses; pyrimethamine coverage is limited to approved, documented indications (e.g., toxoplasmosis) with specialist involvement as specified.

Multiple product entries in this extract are labeled Pending CMS Review. Where an item is listed as Pending CMS Review the policy provides no finalized exclusion, age, prescriber, or coverage duration criteria in the excerpt; such products should be treated as awaiting CMS determination and not assumed approved until the CMS review is completed and explicit criteria are published.

The policy specifies that certain products must not be used in combination with specified disease‑modifying therapies. Examples include Evrysdi (risdiplam), which should not be given concomitantly with chronic SMN‑modifying therapies (e.g., nusinersen/Spinraza), and Fabrazyme, which will not be used in combination with other Fabry disease drugs. When combination therapy is disallowed, requests documenting such concurrent therapy do not meet coverage criteria.

Across numerous product entries the Off‑Label Uses field is either blank or annotated as Pending CMS Review / NIA. These placeholders indicate incomplete criteria in this excerpt; the absence of explicit off‑label allowances means such requests require separate review and cannot be approved based on absence of an off‑label entry. Do not infer coverage for off‑label indications when the policy shows blank or pending fields.

Formulary Identifiers, Codes, and Key Numeric Thresholds

Products listed (sample group)mixed

Adalimumab-aaty 1-pen Kit	Listed product
Adalimumab-aaty Cdluc/hs Starter	Listed product
Adalimumab-aaty 2-pen Kit	Listed product
Adalimumab-aaty 2-syringe Kit	Listed product
Adalimumab-adbm	Listed product
Adalimumab-adbm Crohns/uc/hs Starter	Listed product
Adalimumab-adbm Psoriasis/uveitis Starter	Listed product
Adalimumab-adbm Starter Package	Listed product
Adbry	Listed product

Other specialty productsmixed

Alyq	Listed product
Everolimus TBSO	Listed product
Prolastin-c INJ 1000MG/20ML	Listed product

Covered/Referenced drugs (listed by product name in document)mixed

No codes listed

Formulary identifiersmixed

Formulary ID: 26218

Formulary identifier repeated for listed products

Formulary identifiersmixed

Formulary ID: 26218

Formulary identifier shown with Evrysdi and other products

Listed drug entries (no codes provided in this section)mixed

No codes listed

Products listed (no billing codes provided in this section)mixed

No codes listed

Formulary identifiersmixed

Formulary ID: 26218

Formulary identifier for listed products

Formulary identifiersmixed

Formulary ID: 26218

Formulary identifier referenced throughout document

Document versioningmixed

Version: 8

Document version

Affected/placeholder codesmixed

affected codes

placeholder — specific CPT/HCPCS codes not present in this excerpt

Formulary identifiermixed

Formulary ID: 26218

Formulary identifier for listed products

Formulary identifiers / product listingsmixed

Formulary ID: 26218

Formulary identifier repeated for listed products

Products listed (no billing codes given in segment)mixed

No codes listed

Plaque Psoriasis BSA — numeric threshold

Plaque psoriasis BSA threshold>= 3% body surface area

Alternate severe involvementSevere scalp, palmoplantar, facial, or genital involvement qualifies regardless of %BSA

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

RA conventional therapy duration

Minimum durationMinimum 3-month trial of conventional therapy (methotrexate, leflunomide, or sulfasalazine)

Required conditionDiagnosis of moderately to severely active rheumatoid arthritis

TFIC/ITrial and failure, contraindication, or intolerance (TFIC/I) must be documented

PJIA conventional therapy duration

Minimum durationMinimum 6-week trial of conventional therapy (methotrexate or leflunomide)

Required conditionDiagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA)

TFIC/ITrial and failure, contraindication, or intolerance must be documented

Benlysta autoantibody threshold

Autoantibody positivityANA titer >= 1:80 OR anti-dsDNA >= 30 IU/mL

IndicationActive systemic lupus erythematosus (SLE) or lupus nephritis

PrescriberPrescribed by or in consultation with a rheumatologist (SLE) or nephrologist/rheumatologist (lupus nephritis)

Polycythemia vera hemoglobin/hematocrit thresholds

Hemoglobin thresholdsHemoglobin >16.5 g/dL (men) or >16.0 g/dL (women)

Hematocrit thresholdsHematocrit >49% (men) or >48% (women)

Alternate sustained erythrocytosisHigher cutoffs (eg, Hgb >18.5 men) and JAK2 mutation/biopsy criteria apply for sustained erythrocytosis pathways

Ferritin or transfusion thresholds for deferasirox

Transfusional iron overload ferritinBaseline serum ferritin > 1,000 mcg/L

Transfusion requirementHistory of at least 100 packed RBC transfusions for transfusional iron overload

NTDT thresholdFor non‑transfusion‑dependent thalassemia (NTDT): LIC >= 5 mg Fe/g dw AND serum ferritin >300 mcg/L

HAE age threshold

Age thresholdPatient is 6 years of age or older for HAE prophylaxis

Diagnostic confirmationHAE diagnosis confirmed by low C4 and low C1‑INH antigenic or functional level

PrescriberPrescribed by or in consultation with an immunologist or allergist

Platelet counts for Doptelet

ITP baseline platelet thresholdBaseline platelet count <30,000/mcL for ITP indication

TPPP thresholdBaseline platelet count <50,000/mcL for thrombocytopenia prior to planned procedure (TPPP)

Prior therapy requirementTFIC/I to at least one of corticosteroids, IVIG, or splenectomy for ITP

Hemoglobin / Hematocrit thresholds for Procrit

Common Hgb/Hct thresholdHematocrit <30% OR hemoglobin <10 g/dL for many Procrit indications

Timing of labsLab values must be recent within specified timeframes per indication (eg, within 2 weeks or 30 days)

Iron storesAdequate iron stores often required (eg, ferritin >100 mcg/L and TSAT >20%)

SMN2 copies

SMN2 copy number requirementAt least 2 copies of SMN2

Genetic confirmationSMN1 homozygous deletion or compound heterozygous mutation required for SMA diagnosis

Baseline motor examAge‑appropriate baseline motor exam (HINE‑2, HFMSE, RULM, CHOP‑INTEND, MFM‑32, or BSID‑III item 22) required

Psoriasis BSA

Psoriasis BSA thresholdAt least 3% body surface area involvement

Severe site criteriaSevere scalp, palmoplantar, facial, or genital involvement qualifies regardless of %BSA

Topical therapy trialMinimum 30-day topical trial (14 days for topical corticosteroids) required prior to biologic initiation

Height standard deviation score

Height SDS thresholdHeight standard deviation score of -3.0 or less

Basal IGF‑1 SDSBasal IGF-1 standard deviation score of -3.0 or less

PrescriberPrescribed by or in consultation with an endocrinologist

Basal IGF-1 standard deviation score

Basal IGF-1 SDS thresholdBasal IGF-1 standard deviation score of -3.0 or less

Height SDSHeight standard deviation score of -3.0 or less typically required in IGF‑1 deficiency

SpecialistPrescribed by or in consultation with an endocrinologist

Platelet count threshold for ITP IVIG

ITP IVIG platelet thresholdPlatelet count < 30,000 cells/mm3

IVIG administrationIVIG to be administered at minimum effective dose and appropriate frequency for diagnosis

Specialist requirementPrescribed by or in consultation with specialist experienced in immune globulin therapy

IgG level thresholds for certain secondary immunodeficiencies

IgG thresholds examplesIgG <500 mg/dL for CLL; IgG <400 mg/dL for HIV cited as examples

Primary immunodeficiency criteriaIgG below normal for age plus inadequate response to protein/polysaccharide antigens required for primary immunodeficiency IVIG

AdministrationIVIG given at minimum effective dose and appropriate frequency

Jynarque liver monitoring schedule

Liver monitoring (<=18 months)If on Jynarque <=18 months: ALT/AST/bilirubin at baseline, 2 weeks, 4 weeks, then monthly for first 18 months

Liver monitoring (>18 months)If on Jynarque >18 months: ALT/AST/bilirubin at least every 3 months

Contraindication checkPatient must not have history of significant liver impairment beyond uncomplicated polycystic liver disease

Glycated hemoglobin (A1c)

A1c diagnostic threshold>= 6.5%

ContextAcceptable to confirm type 2 diabetes mellitus when paired with clinical documentation

UsageRequired for initial coverage of certain antidiabetic agents per policy

Fasting plasma glucose (FPG)

Fasting plasma glucose threshold>= 126 mg/dL

Diagnostic roleAcceptable laboratory criterion to confirm T2DM when documented in medical records

Policy useUsed as evidence for initiating T2DM therapies per coverage criteria

2-hour OGTT plasma glucose

2-hour OGTT plasma glucose>= 200 mg/dL

Diagnostic roleAcceptable lab criterion (OGTT) to confirm T2DM when documented

Policy useUsed alongside A1c and FPG for diabetes diagnostic documentation

Prior Authorization, Documentation, Step Therapy, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required for multiple products and indications; verify PA submission and required documentation to avoid denial.

Submit all requested clinical records with initial and reauthorization requests.
Ensure product-specific criteria are met before submission (diagnostics, prior therapies, prescriber restrictions).

Denial Risk

Concurrent Nitrates Exclusion (Tadalafil)

Concurrent use of nitrates is an exclusion for tadalafil products; do NOT approve or dispense when nitrates are being used.

Tadalafil (BPH indication): exclusion — concurrent use of nitrates is not allowed.
Confirm medication reconciliation and document absence of short-acting and long-acting nitrates.

Documentation Required

Evrysdi — Inadequate Response Documentation and Reauth Requirements

Evrysdi: when prior gene therapy was given, submit documentation showing inadequate response (e.g., sustained decrease in motor test scores over ~6 months). For reauthorization, provide objective evidence of clinical benefit.

Baseline motor function assessments required (HINE-2, HFMSE, RULM, CHOP INTEND, MFM-32, or BSID-III) as applicable.
If prior gene replacement therapy (e.g., Zolgensma) was given, include chart notes documenting inadequate response (decline in motor scores).
Reauthorization: submit evidence of positive clinical response per policy (motor score improvement or stabilization).

Documentation Required

Reauthorization — Clinical Response Documentation Required

For biologics and immunomodulators requiring reauthorization (eg, IBD, RA, PsA, HS), submit disease-specific documentation showing clinical response from baseline for continuation approvals.

Infliximab, Stelara, Humira, and similar agents: provide objective measures (e.g., reduced swollen/tender joint count, mucosal healing, CRP/ESR improvements, reduced BSA for psoriasis).
For IBD (CD/UC): include endoscopy/pathology reports or objective inflammatory markers and symptom improvement notes.
Document duration of prior response and dosing history to support reauthorization (policy examples: initial 6 months; reauth 12 months).

Denial Risk

Missing Disease-Specific Documentation — Denial Risk (IBD example)

Missing or incomplete disease-specific documentation (especially for IBD indications) is a common denial trigger — include labs, imaging/endoscopy reports, and symptom assessments.

Crohn's Disease/Ulcerative Colitis: submit CDAI, endoscopy reports (mucosal healing), CRP/ESR, fecal calprotectin when available.
Rheumatology: baseline and follow-up swollen/tender joint counts, functional assessments, and medication trials documented.
Absence of these items may result in denial or request for additional information.

Documentation Required

Metyrosine — Required Medical Information and Denial Triggers

Metyrosine prior authorization requires specific biochemical confirmation and evidence of prior trials with alpha- and beta-blockers; missing these items risks denial.

Preoperative prep: confirm pheochromocytoma diagnosis with plasma free or urinary fractionated metanephrines and that medication is for preoperative use.
Treatment: document biochemical confirmation, surgical candidacy status or malignancy, and trial/failure or intolerance to both an alpha-adrenergic blocker (eg, phenoxybenzamine, doxazosin, terazosin) AND a beta-adrenergic blocker (eg, propranolol, metoprolol).
Prescriber restriction: endocrinologist or endocrine surgeon consultation/authorization notes for preop and treatment indications.

Denial Risk

Indication and Testing — Denial Risk

Indication-based denials occur when requested use does not match documented diagnosis, required molecular testing, or prior therapy trials — confirm indication alignment before submission.

Oncology targeted therapies (eg, Lumakras, Rydapt, Iclusig): include FDA‑approved or CLIA‑validated mutation test reports.
Step/previous therapy requirements: document prior systemic therapies, trial durations, and reasons for failure/intolerance where required.
When Part B vs Part D ambiguity exists, document site of care and intent to help payer route the request appropriately.

Policy Scope and Background

This coverage criteria document addresses a broad range of specialty drugs across immunology, rheumatology, dermatology, gastroenterology and related specialties. It sets indication‑specific medical necessity rules, prerequisite therapy (trial/failure/contraindication/intolerance) requirements, specialist prescriber or consultation expectations, objective disease measures (for example BSA ≥ 3% for plaque psoriasis), and typical coverage durations (commonly 6–12 months). Prior authorization with supporting documentation is required for the products summarized in the policy.

Key Definitions and Abbreviations

TFIC/I definition (trial and failure / contraindication / intolerance)

DefinitionTrial and failure, contraindication, or intolerance to listed conventional therapies required prior to biologic initiation

AbbreviationTFIC/I or TF/C/I used throughout policy to indicate prior therapy requirement

DocumentationProviders must document duration and reason (failure/contraindication/intolerance) for prerequisite trials

BSA definition

DefinitionBody surface area (BSA) used to quantify psoriasis severity; threshold example >=3% BSA for plaque psoriasis

UseBSA reduction used as reauthorization objective response measure

Alternate criteriaSevere involvement of scalp/palmar/plantar/facial/genital areas may qualify despite lower BSA

COPD maintenance therapy (arformoterol)

IndicationMaintenance treatment of bronchoconstriction in COPD (chronic bronchitis and emphysema)

Part B vs DSubject to Part B vs. Part D review for coverage determination

Prerequisite therapyNo prerequisite Part D drug required

Autoantibody positive SLE (Benlysta)

Autoantibody positive SLE definitionANA titer >=1:80 OR anti-dsDNA >=30 IU/mL required to define autoantibody positive SLE for Benlysta

PrescriberPrescribed by or in consultation with a rheumatologist for SLE initial

Coverage durationInitial and reauthorization coverage: 6 months

HAE diagnostic confirmation

Diagnostic confirmationHAE diagnosis confirmed by low C4 AND C1-INH antigenic OR functional level below lower limit of normal

Treatment vs prophylaxisDifferent age thresholds: prophylaxis age >=6 years; acute treatment initial age >=18 years

Not combinedNot to be used in combination with other approved prophylactic or acute HAE therapies as specified

Pheochromocytoma biochemical confirmation

Biochemical confirmationPheochromocytoma confirmed by plasma free metanephrines OR urinary fractionated metanephrines

Preoperative requirementUsed for preoperative preparation when biochemical diagnosis confirmed and alpha- and beta-blocker trials attempted or contraindicated

Treatment prerequisitesFor treatment: hormonally active pheochromocytoma and not a surgical candidate OR chronic malignant disease

Preoperative preparation (pheochromocytoma)

Preoperative useMetyrosine used for preoperative preparation when biochemical diagnosis confirmed

Required trialsDocument trial and failure/contraindication/intolerance to BOTH an alpha‑adrenergic blocker AND a beta‑adrenergic blocker

PrescriberPreop: prescribed by or in consultation with endocrinologist or endocrine surgeon

SMN genetic criteria (SMA)

SMN genetic criteriaSMN1 homozygous deletion or compound heterozygous mutation PLUS at least 2 copies of SMN2

Baseline motor assessmentAge‑appropriate motor exam (HINE‑2, HFMSE, RULM, CHOP‑INTEND, MFM‑32, or BSID‑III item 22) required

Concomitant therapy exclusionNot to receive concomitant chronic SMN‑modifying therapy (eg, nusinersen) unless documented inadequate response to prior gene therapy

SMA genetic confirmation

Genetic confirmationDiagnosis of SMA requires mutation or deletion in SMN1 (eg, homozygous deletion of exon 7 or compound heterozygous mutation) and documentation of SMN2 copy number

DocumentationSubmit medical records/chart notes confirming SMN1/SMN2 status and baseline motor exam

SpecialistPrescribed by or in consultation with a neurologist experienced in SMA

HAE diagnostic criteria (C4, C1-INH)

HAE diagnostic criteriaLow C4 plus either low C1‑INH antigenic level OR low C1‑INH functional level consistent with Type I or II HAE

Laboratory evidenceC1‑INH antigenic or functional level below lower limit of normal required

PrescriberPrescribed by or in consultation with immunologist/allergist

IDH2 mutation testing requirement

IDH2 testing requirementIDH2 mutation must be detected by an FDA‑approved test OR a CLIA‑approved laboratory test

IndicationUsed to confirm eligibility for IDH2‑targeted AML therapy

DocumentationMedical records with test results required for prior authorization

TFIC/I definition (repeated)

DefinitionTrial and failure, contraindication, or intolerance to listed therapies (TFIC/I) — prerequisite prior therapy pathway

Documentation expectationProviders must document duration and reason for TFIC/I as specified per indication

AbbreviationsTFIC/I and TF/C/I used interchangeably in policy to denote prior therapy requirement

TF/C/I abbreviation

AbbreviationTF/C/I = trial and failure, contraindication, or intolerance

ContextUsed in rheumatology coverage sections to indicate prerequisite therapy requirements

DocumentationAttestation accepted when trials are inappropriate per product criteria

CLIA definition

CLIA definitionCLIA = Clinical Laboratory Improvement Amendments (facility standard for laboratory testing)

UsePolicy requires FDA‑approved or CLIA‑approved tests for molecular/mutation confirmation in multiple criteria

ExamplesUsed for IDH2, KRAS G12C, CFTR, FLT3‑ITD, TTR mutation testing references

KRAS G12C mutation definition

KRAS G12C definitionSpecific KRAS point mutation (G12C) required and must be detected by FDA‑approved or CLIA‑approved test

IndicationRequired for Lumakras eligibility in NSCLC and mCRC per policy

DocumentationSubmit molecular testing results with prior authorization request

Prophylaxis of systemic fungal infections (posaconazole)

SFI prophylaxis definitionUse of posaconazole for prophylaxis of invasive fungal infections in high‑risk patients (eg, HSCT with GVHD or hematologic malignancy with prolonged neutropenia)

OPC useAlso indicated for oropharyngeal candidiasis after trial/failure or resistance to fluconazole

Age thresholdPatient age >=13 years for prophylaxis and OPC per policy

Obstructive sleep apnea definition

OSA diagnostic definitionOSA defined as >=15 obstructive events/hour on sleep study OR >=5 events/hour plus associated symptoms

Study requirementSleep study confirmation required unless prescriber documents infeasibility

Coverage durationsOSA initial/reauth 6 months; narcolepsy initial/reauth 12 months

hATTR amyloidosis with polyneuropathy

hATTR with polyneuropathy definitionPresence of pathogenic TTR mutation by FDA‑approved or CLIA test with clinical signs of peripheral/autonomic neuropathy and baseline PND <= IIIb

StagingBaseline PND score <= IIIb, FAP stage 1–2, or NIS 5–130 used for eligibility and monitoring

Therapy exclusionNot to be used concomitantly with a TTR silencer or stabilizer per policy

Positive clinical response (reauth)

Positive clinical response (reauth)Provider‑documented improvement appropriate to the indication (eg, reduced swollen/tender joint count, reduced BSA, improved labs or mucosal healing)

Reauth requirementReauthorization typically requires objective evidence of response as specified per product

ExamplesExamples include BSA reduction for psoriasis, CDAI improvement for Crohn's, platelet increase for ITP

Molecular confirmation for pyruvate kinase deficiency

Molecular confirmation for PK deficiencyDetection of at least two variant alleles in PKLR with >=1 missense variant; not homozygous for p.R479H; not two non‑missense variants without another missense variant

Hemoglobin thresholdHemoglobin <= 10 g/dL required along with chronic hemolysis evidence

SpecialistPrescribed by or in consultation with a hematologist

TFICM abbreviation

TFICM definitionTrial and failure, contraindication, or intolerance to medication (used for prior topical/systemic therapies)

ContextApplied to prerequisite topical/systemic therapy requirements (eg, psoriasis topicals, NSAID for AS)

DocumentationProviders must document trials and reasons for failure/intolerance

IV induction dosing (Stelara)

Stelara IV induction dosing260 mg for <=55 kg; 390 mg for >55–85 kg; 520 mg for >85 kg (FDA‑labeled)

IndicationUsed as IV induction for Crohn's disease and ulcerative colitis per labeled dosing

AdministrationAdministered as a one‑time IV induction dose per policy; coverage duration: one time for induction

T2DM diagnostic thresholds

T2DM diagnostic thresholdsA1c >= 6.5%; FPG >= 126 mg/dL; 2‑hr OGTT >= 200 mg/dL

DocumentationMedical records or chart notes confirming diagnosis or lab evidence required for coverage of T2DM therapies

Policy useUsed to establish eligibility for GLP‑1 and other diabetes agents per policy

ANCA-associated vasculitis (Tavneos)

ANCA-associated vasculitis definitionSevere active ANCA‑associated vasculitis includes GPA or MPA confirmed by PR3 or MPO ANCA test or tissue biopsy

Concurrent therapyPatient must be receiving concurrent cyclophosphamide OR rituximab plus glucocorticoids (or have intolerance to glucocorticoids)

PrescriberPrescribed by or in consultation with nephrologist, pulmonologist, or rheumatologist

Hypogonadism (testosterone therapy)

Hypogonadism lab requirementTwo pre‑treatment total serum testosterone measurements <300 ng/dL OR alternate low calculated free/bioavailable testosterone criteria

Patient criteriaMale at birth required for HG initial criteria; alternative pathways include history of bilateral orchiectomy or other causes

DocumentationFollow‑up testosterone measurements required for reauthorization per product guidance

Hypogonadism (HG) initial criteria

Initial HG criteria summaryMale patient at birth PLUS two pre‑treatment total T <300 ng/dL (10.4 nmol/L) OR pre‑treatment calculated free/bioavailable T <5 ng/dL when SHBG altered

Alternate criteriaHistory of bilateral orchiectomy, panhypopituitarism, or genetic disorder known to cause HG qualifies

Age restrictionMost testosterone products: initial HG age >=18 years (testosterone cypionate: >=12 years for certain uses)

SSc-ILD diagnostic requirements

SSc-ILD diagnostic requirementHRCT pattern consistent with SSc‑ILD or supportive surgical lung biopsy with exclusion of other ILD causes

PrescriberPrescribed by or in consultation with pulmonologist or rheumatologist

UseRequired for coverage of therapies for SSc‑ILD per policy

FLT3-ITD mutation

FLT3‑ITD definitionFLT3‑ITD internal tandem duplication detected by FDA‑approved or CLIA‑approved test

IndicationRequired for FLT3‑targeted AML therapy eligibility

DocumentationSubmit molecular testing results with prior authorization request

Recurrent C. difficile infection (CDI)

Recurrent CDI definitionDiarrhea (>=3 loose stools/24h for 2 consecutive days) PLUS positive stool test for C. difficile toxin or toxigenic C. difficile AND history of >=2 recurrences within 12 months

Pre-treatment requirementCompletion of at least one course (e.g., oral vancomycin or fidaxomicin) and recommended bowel prep before Vowst

Age & prescriberPatient >=18 years; prescribed by or in consultation with gastroenterologist or infectious disease specialist

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyAdalimumab and selected specialty drugs — coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes (routine review)

Effective DateJan 1, 2026

Last ReviewSep 22, 2025

Next Review DateN/A

Key ActionObtain prior authorization with required documentation of diagnosis, prerequisite therapy trials or contraindications, and appropriate specialist involvement.

SourceLink

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