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CurrentBlue Cross Blue Shield - South CarolinaPolicy N/A

Specialty drug coverage criteria (selected products)

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This document lists coverage criteria, required medical information, prescriber restrictions, coverage durations, and prerequisite therapy rules for multiple specialty pharmacy products relevant to Blue Cross Blue Shield - South Carolina members.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicySpecialty drug coverage criteria (selected products)

Policy CodePolicy N/A

Change TypeNo material changes (routine review)

Effective DateApr 1, 2026

Last ReviewMar 2, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnosis, relevant test results, and documentation of prior therapy trials as specified for the requested product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~20products listed

12 monthscommon coverage duration

specialist often requiredprescriber restrictions

variesprerequisite Part D drug

Coverage Criteria (Initial, Reauthorization, Exclusions)

Covered when ALL of the following criteria for the specific product/indication are met. Each criteria group below consolidates the initial, reauthorization, age, prescriber, coverage duration, prerequisite therapy, and other criteria as listed in the source.

ALL of the following

Non-small cell lung cancer (NSCLC) — Augtyro / related entries: Diagnosis of NSCLC that is locally advanced or metastatic with the specified molecular alteration (e.g., ROS1 rearrangement for Augtyro, RET or other specified fusions/mutations where indicated). Approval requires documentation of the tumor molecular marker by an FDA-approved or CLIA-certified test. Approve for continuation of prior therapy. Coverage duration: 12 months. Prerequisite therapy: where specified by product, prerequisite Part D drug may be required (see product-specific entry).
Augtyro — NTRK fusion tumors and ROS1 NSCLC: Diagnosis of metastatic or unresectable solid tumor with an NTRK gene fusion (e.g., ETV6‑NTRK3, TPM3‑NTRK1) OR NSCLC with ROS1 rearrangement. Disease must be locally advanced, metastatic, or unresectable. Either disease has progressed following prior treatment or there is no satisfactory alternative. Tumor fusion/rearrangement must be confirmed by FDA‑approved or CLIA‑certified testing. Coverage duration: 12 months. Prerequisite therapy: product-specific prerequisite Part D drug required as noted in formulary entry.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicySpecialty drug coverage criteria (selected products)

Policy CodePolicy N/A

Change TypeNo material changes (routine review)

Effective DateApr 1, 2026

Last ReviewMar 2, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required diagnosis, relevant test results, and documentation of prior therapy trials as specified for the requested product.

SourceLink

On This Page

Benlysta — Systemic lupus erythematosus (SLE) initial: Diagnosis of active SLE with autoantibody positivity (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL). Patient must be receiving at least one standard-of-care therapy (e.g., antimalarial, corticosteroid, or immunosuppressant). Age: Benlysta IV/SC for SLE or lupus nephritis is indicated for patients ≥5 years. Prescriber: rheumatologist (SLE) or nephrologist/rheumatologist (lupus nephritis). Coverage duration: 6 months (initial and reauth). Reauth requires demonstration of positive clinical response. Prerequisite therapy: Not required.

Arikayce — Mycobacterium avium complex (MAC) lung disease: Diagnosis of MAC lung disease; used as part of a multidrug antibacterial regimen in patients who do not achieve at least two consecutive negative sputum cultures after ≥6 months of multidrug background therapy. Prescriber: infectious disease specialist or pulmonologist. Coverage duration: 12 months. Prerequisite therapy: Not required.

Cablivi — acquired thrombotic thrombocytopenic purpura (aTTP): Diagnosis of aTTP. First dose administered as bolus IV by a healthcare provider; used with immunosuppressive therapy (e.g., rituximab, glucocorticoids). Either used in combination with plasma exchange OR patient has completed plasma exchange and <59 days have elapsed since last plasma exchange. Prescriber: hematologist/oncologist. Coverage duration: 3 months. Prerequisite therapy: Not required.

Caplyta — schizophrenia, bipolar disorder, MDD adjunctive: Diagnosis of schizophrenia OR bipolar I/II disorder (bipolar depression) OR major depressive disorder (adjunctive). For schizophrenia: trial and failure/intolerance/contraindication to two oral atypical antipsychotics (listed). For bipolar: TF/C/I to quetiapine or olanzapine. For MDD adjunctive: TF/C/I to aripiprazole and quetiapine IR/ER. Coverage duration: 12 months. Prerequisite therapy: Product requires use of a prerequisite Part D drug per formulary entry.

Caprelsa — thyroid cancer (medullary): Diagnosis of metastatic or unresectable locally advanced medullary thyroid cancer with symptomatic or progressive disease. Coverage duration: 12 months. Prerequisite therapy: Not required.

Cayston / Dornase alfa (CF products) — cystic fibrosis: Diagnosis of cystic fibrosis with evidence of Pseudomonas aeruginosa (for Cayston) or diagnosis of CF (for Dornase alfa). Age: Cayston initial ≥7 years. Prescriber: specialist per CF care. Coverage duration: 12 months. Reauth: patient demonstrates benefit (e.g., improved FEV1, fewer exacerbations). Prerequisite therapy: Not required.

Cholbam — bile acid synthesis disorders (BAS) and peroxisomal disorders (PD): BAS due to single enzyme defect confirmed by abnormal urinary bile acid mass spectrometry OR molecular genetic testing. PD confirmed by abnormal urinary bile acid analysis or molecular genetic testing plus clinical features (liver disease, steatorrhea, fat‑soluble vitamin complications). Prescriber: hepatologist, geneticist, gastroenterologist, or metabolic specialist. Initial coverage: 4 months; reauth: 12 months with clinical response (improved liver function). Prerequisite therapy: Not required.

Cinryze — hereditary angioedema (HAE) prophylaxis: (policy entries include Cinryze INJ) — where indicated by product-specific entry; HAE treatment and prophylaxis criteria apply per formulary. Coverage durations and prescriber restrictions as listed in product entry.

Cosentyx / secukinumab — dermatology & rheumatology indications: Indications include plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, hidradenitis suppurativa, enthesitis-related arthritis, and others as specified. Initial therapy requires diagnosis severity criteria (e.g., ≥3% BSA or special site involvement for psoriasis), and trial and failure/intolerance to topical or NSAID or other conventional therapies where specified. Prescriber restrictions: dermatology or rheumatology as appropriate. Coverage duration: initial 6 months, reauth 12 months; reauth requires positive clinical response measures appropriate to indication. Prerequisite therapy: Many Cosentyx entries require prior Part D drug per formulary.

Ctexli — cerebrotendinous xanthomatosis (CTX): Diagnosis confirmed by pathogenic CYP27A1 variant by FDA-approved or CLIA-certified testing. Prescriber: neurologist, geneticist, or metabolic disease specialist. Coverage: initial 12 months; reauth 12 months with positive clinical response. Prerequisite therapy: Not required.

Cyclobenzaprine: Prescriber must acknowledge anticholinergic risks and consider dose changes in older adults. Indications: muscle spasm associated with acute painful musculoskeletal conditions; select off‑label uses (fibromyalgia, acute temporomandibular disorder) with additional criteria. Age: prior authorization applies for patients ≥65. Coverage durations: short courses for muscle spasm/temporomandibular disorder (4 weeks) and longer for fibromyalgia (12 months). Prerequisite therapy: Part D prerequisite required per formulary.

Roflumilast — COPD: Diagnosis of COPD with history of 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. Prerequisite therapy: Requires prerequisite Part D drug.

Pyrimethamine — toxoplasmosis: Use is authorized when pyrimethamine is for active treatment of toxoplasmosis (eg, encephalitis, ocular), secondary prophylaxis, congenital toxoplasmosis, OR for primary prophylaxis only if patient cannot tolerate TMP‑SMX (rechallenge/desensitization attempted or life‑threatening prior reaction). Malaria treatment/prophylaxis with pyrimethamine is excluded (not authorized). Prescriber: infectious disease specialist for toxoplasmosis. Coverage duration: 12 months for toxoplasmosis. Prerequisite therapy: Not required.

Dupixent — indication‑specific coverage criteria: Coverage applies for multiple indications (atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis, etc.) with indication‑specific age limits, severity thresholds (e.g., BSA ≥10% or SCORAD ≥25 for AD), prior topical/systemic therapy trials where applicable, prescriber restrictions (dermatologist, allergist/immunologist, pulmonologist, gastroenterologist), coverage durations (initial generally 6 months; reauth 12 months or 3–12 months for certain indications), and reauth requires documented positive clinical response. Prerequisite therapy: Many Dupixent uses require prior Part D drug per formulary.

Deferasirox — chronic iron overload: Indications include transfusional iron overload and NTDT with defined laboratory thresholds (eg, ferritin, LIC). Age and lab thresholds vary by indication. Coverage durations and reauth criteria include reductions in ferritin or LIC. Prescriber and dosing criteria per product entry.

Emgality — migraine and cluster headache criteria: Episodic migraine: ≥4 migraine days/month and age ≥18; chronic migraine: ≥8 migraine days/month, medication overuse considered; episodic cluster headache: criteria on cluster period history. Product strength‑specific rules (120 mg mL for migraine, 100 mg mL for episodic cluster). Not used in combination with another CGRP inhibitor. Coverage durations: initial 3–6 months; reauth 12 months with positive response. Prerequisite therapy: Not required.

Enbrel — rheumatology and dermatology coverage criteria: Indications include RA, PJIA, PsA, plaque psoriasis, AS, and others; initial therapy requires trials of conventional therapies (e.g., methotrexate) or NSAIDs as applicable. Prescriber: rheumatologist or dermatologist as specified. Coverage duration: initial 6 months, reauth 12 months with positive clinical response. Prerequisite therapy: Enbrel initial uses require use of a prerequisite Part D drug per formulary.

Enbrel initial coverage criteria and Reauthorization / positive response criteria: As above — initial requires diagnosis and prior therapy trials; reauthorization requires evidence of clinical improvement specific to indication (e.g., reduced swollen/tender joint count, decreased BSA).

Fabrazyme — Fabry disease: Diagnosis documented by pathogenic GLA mutation or alpha‑Gal A enzyme deficiency or significant clinical manifestations. Age: ≥2 years. Coverage duration: 12 months; reauth requires positive clinical response. Not used in combination with other Fabry drugs. Prerequisite therapy: Not required.

Fasenra / Nucala / Severe eosinophilic asthma — initial & reauth, EGPA: Biologic anti‑eosinophil therapies: Indications include severe eosinophilic asthma, corticosteroid‑dependent asthma, EGPA, HES, CRSwNP where specified. Eosinophil thresholds, exacerbation history (≥2 exacerbations or prior hospitalization in 12 months), concurrent controller therapy requirements (high‑dose ICS ± controller), age limits, prescriber (pulmonologist/allergist/immunologist), coverage durations (initial 6–12 months, reauth 12 months), and reauth requires positive clinical response. EGPA initial: disease relapsed/refractory to standard therapy; patient on corticosteroids unless contraindicated. Prerequisite therapy: Many entries require Part D prerequisite drug.

Evrysdi — spinal muscular atrophy (SMA): Diagnosis of SMA types I–III with genetic confirmation of SMN1 mutation/deletion and at least 2 copies of SMN2; baseline motor exams for baseline motor ability; not dependent on invasive ventilation/tracheostomy; not to receive concomitant chronic SMN‑modifying therapy (e.g., Spinraza). Initial and reauth: 12 months; reauth requires positive clinical response. Prescriber: neurologist with SMA expertise. Prerequisite therapy: Not required.

Fasenra / Severe eosinophilic asthma and related entries: see Fasenra/Nucala section above.

Gavreto — RET fusion‑positive NSCLC or thyroid cancer: Diagnosis of NSCLC or advanced/metastatic thyroid cancer with RET fusion as detected by FDA‑approved or CLIA test; thyroid cancer age ≥12 for some indications; coverage 12 months; reauth requires positive clinical response. Prerequisite therapy: Not required.

AGHD Initial Therapy and AGHD Reauthorization: Adult growth hormone deficiency diagnostic requirements (stimulation tests or clinical records), baseline IGF‑1 monitoring for reauth within prior 12 months. Prescriber: endocrinologist. Coverage 12 months. Prerequisite therapy: Not required.

Initial Biologic/Targeted Therapy Criteria (selected) and Reauthorization — Evidence of Clinical Response: For many biologic/targeted agents (eg, infliximab, adalimumab, ustekinumab, secukinumab, JAK inhibitors), initial coverage requires diagnosis and prior standard therapy trials per indication; reauthorization requires documented clinical response such as reductions in objective disease measures (BSA, joint counts, lab markers) or symptom improvement. Prescriber restrictions, coverage durations, and prerequisite Part D drug requirements vary by agent and indication per formulary entries.

Ulcerative Colitis Initial: Diagnosis of moderately to severely active UC with objective features (stool frequency, bleeding, ulcers, abnormal labs) or steroid‑dependency/refractoriness. Some therapies require confirmation by gastroenterologist and induction/maintenance coverage durations (eg, UC induction 12 weeks for some agents). Reauth requires clinical response (mucosal healing, lab improvements). Prerequisite therapy: many biologics require prior Part D drugs per formulary.

Itovebi / Mifepristone (Cushing's syndrome): For Cushing's syndrome (endogenous hypercortisolemia) used when surgery is not candidate or not curative; prescriber endocrinologist; coverage 6–12 months depending on product; reauth requires clinical response. Prerequisite therapy: Not required.

Itraconazole — strongyloidiasis, onchocerciasis, onychomycosis: Indication‑specific durations and diagnostic confirmation (KOH, culture, histology for onychomycosis) and prior terbinafine failure for toenail; coverage durations per indication (weeks to months). Prerequisite therapy: Not required for systemic parasitic uses; product‑specific rules apply.

Ivermectin: Indication and product‑specific criteria as listed in formulary; follow parasitic infection guidance and age/prescriber rules.

Immune globulin (IVIG/SCIG) criteria: IVIG/SCIG used for primary immunodeficiency, secondary antibody deficiency, selected hematologic autoimmune and neuromuscular disorders (CIDP, GBS, myasthenia gravis exacerbations, etc.). Use minimal effective dosing and appropriate frequency. Prescriber: specialist experienced in IG therapy. Coverage 4–12 months depending on indication; reauth requires objective improvement and intent to maintain minimal effective dose. Subject to Part B vs Part D review; ensure Part B does not apply. Prerequisite therapy: Part D prerequisite required for many uses per formulary.

Jylamvo: Indications include certain hematologic malignancies and autoimmune diseases as listed; prescriber restrictions by indication; coverage 12 months; reauth: continuation of prior therapy. Prerequisite therapy: Not required.

Jynarque (tolvaptan) — ADPKD: Diagnosis of rapidly progressing ADPKD with liver function monitoring requirements (ALT/AST/bilirubin prior to initiation, at 2 and 4 weeks, then monthly for first 18 months, then every 3 months thereafter depending on duration). Prescriber: endocrinology/appropriate. Coverage 12 months; reauth requires monitoring and absence of significant liver injury history. Prerequisite therapy: Not required.

Kalydeco (ivacaftor) — cystic fibrosis: CF diagnosis with at least one CFTR mutation responsive to ivacaftor per FDA‑cleared testing. Age: ≥1 month for some indications. Prescriber: CF specialist or pulmonologist. Coverage 12 months; reauth requires positive clinical response (improved PPFEV1, fewer exacerbations). Prerequisite therapy: Not required.

Kerendia (finerenone): CKD associated with T2D and HF with LVEF ≥40% indications with lab thresholds (UACR, eGFR, serum potassium) and requirement for ACEi/ARB unless contraindicated; prescriber cardiology/renal as indicated; coverage 12 months; reauth requires positive clinical response and continuation on background therapy or documented contraindication. Prerequisite therapy: Part D prerequisite drug may be required.

Kesimpta (ofatumumab) — MS: Diagnosis of relapsing MS; trial and failure/intolerance to at least one disease‑modifying therapy OR continuation of prior therapy. Not used with other DMTs or B‑cell targeted therapies. Prescriber: neurologist. Coverage 12 months; reauth requires positive clinical response. Prerequisite therapy: Requires prerequisite Part D drug.

Kineret (anakinra): Indications include RA (with TF/C/I to listed agents), NOMID (with genetic or clinical confirmation), and other IL‑1 deficiency disorders. Prescriber restrictions and coverage durations per indication (initial 6 months, reauth 12 months). Reauth requires positive clinical response. Prerequisite therapy: Requires prerequisite Part D drug.

Jaypirca; Jakafi; Kisqali; Komzifti; other oncology targeted agents: Indication‑specific requirements include molecular testing where applicable (e.g., NPM1 mutation for Komzifti), prior lines of therapy, combination therapy requirements, prescriber specialty, and coverage duration 12 months. Approve for continuation of prior therapy; prerequisite Part D drug requirements vary by product.

Mifepristone (Cushing's) — see Itovebi/Mifepristone above.

Selected oncology product coverage (examples) and Krazati (KRAS G12C), Livmarli, Lytgobi, Lytgobi intrahepatic cholangiocarcinoma, Mekinist/Mektovi, Modeyso, Mounjaro (T2DM), Neulasta, Sorafenib, Nexletol/Nexlizet, Nilotinib, Ninlaro, Droxidopa, Posaconazole, Nubeqa, etc.: Each product follows the formulary's indication‑specific rules: required diagnostic confirmation (molecular testing where relevant), prior therapy trials, prescriber specialty, coverage duration (commonly 12 months), and reauthorization requiring clinical response measures. Prerequisite therapy: product‑specific per formulary.

Nucala, HES, Severe asthma, Allergic rhinitis, IPF / SSc‑ILD / PPF, RA, PAH initial, RA / PJIA / PsA initial, aGVHD prophylaxis, T2DM initial, MASH initial: See the individual product entries for indication‑specific diagnostic requirements, age limits, prescriber restrictions, requisite prior therapy trials, coverage durations, and reauthorization criteria requiring documented clinical benefit. Many biologic and specialty agents require Part D prerequisite drugs as noted.

Posaconazole prophylaxis/treatment: Prophylaxis of invasive fungal infections in high‑risk patients (HSCT with GVHD or hematologic malignancy with prolonged neutropenia) or secondary prophylaxis; treatment of invasive Aspergillus infections; age minimums and duration vary by indication (prophylaxis: 6 months; treatment: 6 months). Prerequisite therapy: Not required.

Praluent, Repatha (PCSK9 inhibitors): Indications include HeFH, ASCVD, primary hypercholesterolemia, and HoFH with diagnostic/lab thresholds (LDL‑C), requirement for maximally tolerated statin therapy or documented statin intolerance, age limits for pediatric uses. Coverage duration: 12 months; reauth requires LDL‑C reduction or continuation of other lipid‑lowering therapy. Prerequisite therapy: Requires prior Part D drug/trial of statin(s).

Eltrombopag — ITP, SAA, chronic hepatitis C‑associated thrombocytopenia: Diagnosis‑specific baseline thresholds and prior therapy failures required; prescriber hematology/oncology; coverage durations vary by indication; reauth requires platelet response. Prerequisite therapy: Requires prior Part D drug.

Modafinil — OSA, SWD, narcolepsy, MS fatigue, adjunctive depression: Diagnosis confirmed by sleep study or appropriate clinical criteria; reauth requires documented clinical improvement. Prerequisite therapy: Not required.

Dornase alfa (Pulmozyme) — cystic fibrosis: Diagnosis of CF; coverage 12 months; reauth requires benefit (improved FEV1, fewer exacerbations). Subject to Part B vs D review.

Pyrukynd — pyruvate kinase deficiency: Molecular confirmation of PKLR variants per product criteria; hemoglobin ≤10 g/dL and symptomatic anemia or transfusion dependence. Prescriber: hematologist. Coverage initial 6 months; reauth 12 months with clinical response. Prerequisite therapy: Not required.

Qinlock — GIST after prior kinase inhibitors: Advanced GIST with prior treatment with ≥3 kinase inhibitors including imatinib; coverage 12 months. Prerequisite therapy: Requires prior Part D drug.

Qulipta — episodic and chronic migraine prevention: Episodic migraine ≥4 migraine days/month or chronic migraine ≥8 migraine days/month; not used with another CGRP inhibitor. Age ≥18. Coverage durations: initial 6 months, reauth 12 months with documented reduction in frequency/intensity and decreased acute med use. Prerequisite therapy: Not required.

Infliximab — multiple autoimmune/inflammatory indications: Indication‑specific disease severity criteria and prior conventional therapy trials as listed (e.g., CD, UC, RA, PsO, AS, sarcoidosis). Prescriber: specialty consultation as specified. Coverage initial 6 months; reauth 12 months requiring positive clinical response. Prerequisite therapy: Requires prior Part D drug.

Retacrit (epoetin alfa‑epbx) — anemia indications: Indication‑specific lab thresholds and clinical contexts (CKD, chemotherapy‑induced anemia, preoperative, HIV, HCV, MDS). Iron stores adequacy required (ferritin >100 mcg/L and TSAT >20%). Coverage durations vary by indication (CKD/HIV 6 months initial, reauth 12 months; chemo/HCV 3 months, etc.). Reauth requires hemoglobin/hematocrit response. Prerequisite therapy: Not required.

Laboratory prerequisites: Many products require baseline and ongoing lab monitoring (e.g., LFTs for tolvaptan/Jynarque; SMN2 copy number and motor testing for SMA; ferritin/TSAT for epoetin products; eosinophil counts for eosinophil‑targeting biologics; molecular testing for targeted oncology agents). Ensure documentation of required labs in the medical record prior to approval and for reauthorization.

Rezurock — cGVHD initial: Diagnosis of chronic GVHD with failure of ≥2 systemic therapies. Age ≥12 for initial use. Coverage 12 months; reauth requires lack of progressive disease on therapy. Prerequisite therapy: Requires prior Part D drug.

Molecularly targeted agents (Rozlytrek, Rozlytrek/Rozlytrek entries, Rubraca, Retevmo, Rydapt, Rozlytrek/Rubraca etc.): All require tumor genomic confirmation by FDA‑approved or CLIA‑certified testing for the specified alteration (NTRK, ROS1, RET, BRCA, etc.), disease stage criteria (locally advanced/metastatic or unresectable), prior therapy history (progression or no satisfactory alternatives), prescriber specialty as applicable, coverage duration 12 months, and reauth requires clinical benefit. Prerequisite therapy: product‑specific.

Rinvoq (upadacitinib) — indications and combination restrictions: Indication‑specific requirements include RA, PJIA, PsA, AS, nonradiographic axial spondyloarthritis, CD, UC, AD, GCA with required prior therapy failures and prescriber specialty; not to be used in combination with other JAK inhibitors, biologic immunomodulators, or potent immunosuppressants. Coverage initial 6 months; reauth 12 months with documented positive clinical response. Prerequisite therapy: Requires prior Part D drug.

Rozlytrek (TGCT), Rubraca (ROS1/NTRK), Retevmo, Gavreto, etc.: See molecularly targeted agents above — tumor testing, prior therapy, coverage 12 months, reauth requiring benefit. Prerequisite therapy: product dependent.

Rybelsus — T2DM initial: Documentation of T2DM (medical record or lab: A1c ≥6.5% or FPG ≥126 mg/dL or 2‑hour OGTT ≥200 mg/dL). Coverage 12 months; reauth requires positive clinical response. Prerequisite therapy: Not required.

Hizentra (SCIG) — immune globulin initial therapy: SCIG use for qualifying primary immunodeficiency diagnoses per IVIG criteria; prescriber with IG expertise; coverage 12 months; reauth requires objective improvement and use of minimum effective dose. Subject to Part B vs D review. Prerequisite therapy: Requires Part D drug as noted.

Vigabatrin — indications/prior therapy: For infantile spasms or refractory seizure indications with required prior anticonvulsant failures or age restrictions; prescriber specialty and coverage durations per product entry. Prerequisite therapy: Requires prior Part D drug where specified.

Spravato (esketamine) — MDD: Diagnosis of MDD with inadequate response to ≥2 antidepressants in current episode OR MDD with acute suicidal ideation/behavior used with oral antidepressant. Prescriber: psychiatrist. Coverage 12 months; reauth requires documented response. Prerequisite therapy: Not required.

Stelara (ustekinumab) induction and maintenance criteria: Plaque psoriasis, PsA, Crohn's disease, UC and other indications require diagnosis, prior topical or systemic therapy trials, weight‑based induction IV dosing for CD/UC with specified dosing (260/390/520 mg depending on weight), prescriber specialty, coverage durations (initial 6 months, reauth 12 months), and reauth requires clinical response. Prerequisite therapy: Some uses require prior Part D drug.

Spevigo (GPP) initial therapy: Diagnosis of generalized pustular psoriasis with systemic criteria; patient weight ≥40 kg; prescriber dermatologist; coverage 12 months; reauth requires clinical response. Prerequisite therapy: Not required.

Somavert (pegvisomant) — acromegaly: Failure or intolerance to surgery/radiation/other therapies or not candidate; prescriber endocrinologist; coverage 12 months with reauth requiring biochemical control (IGF‑1). Prerequisite therapy: Requires prior Part D drug.

title":"Coverage Criteria (Initial, Reauthorization, Exclusions)",

type":"criteria_group"}

Medication Identifiers, Formulary IDs and Coding Notes

Products listed (medication identifiers)mixed

Actimmune INJ 100MCG/0.5ML

Product name / NDC not provided in excerpt

Adalimumab productsmixed

Adalimumab-aaty 1-pen Kit	Adalimumab biosimilar product
Adalimumab-adbm	Adalimumab biosimilar product

Atopic dermatitis biologicmixed

Adbry

Tralokinumab (atopic dermatitis)

Pulmonary hypertension agentsmixed

Alyq	Tadalafil TABS 20MG (PAH agent listed)
Adempas	Riociguat (PAH / CTEPH agent listed)

AAT augmentationmixed

Prolastin-c INJ 1000MG/20ML

Alpha-1 antitrypsin augmentation therapy

Formulary Identifiermixed

Formulary ID: 26218

Formulary identifier for entries in this section

Formulary identifiersmixed

Formulary ID: 26218

Formulary identifier repeated on many product entries

Products listed (sample)mixed

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

Formulary metadatamixed

No codes listed

Formulary identifiermixed

Formulary ID: 26218

Formulary identifier and versioned product list

Formulary Identifiermixed

Formulary ID: 26218

Formulary identifier listed for products

Formulary identifiermixed

Formulary ID: 26218

Formulary identifier and version present across entries

Formulary identifiersmixed

No codes listed

No explicit CPT/HCPCS/ICD codes in this sectionmixed

No codes listed

Drugs and formulations listedmixed

No codes listed

Covered CPT Codesmixed

No codes listed

Formulary identifiermixed

Formulary ID: 26218

Formulary identifier for all listed products in these chunks

Atopic dermatitis thresholds (BSA, SCORAD)

Atopic dermatitis eligibilityBSA >= 10% OR SCORAD >= 25

Required prior topical therapyTrial and failure of at least two: medium+ potency topical corticosteroid, pimecrolimus, tacrolimus, or crisaborole (minimum 30-day supply; 14 days for topical corticosteroids)

Age for initial therapyPatient is 12 years of age or older

Migraine frequency thresholds for Aimovig

Aimovig — episodic migraine threshold>= 4 migraine days per month

Aimovig — chronic migraine threshold>= 8 migraine days per month

Combination restrictionNot to be used in combination with another CGRP inhibitor for preventive treatment

RA prior conventional therapy duration

RA prior conventional therapy durationMinimum 3-month trial of one conventional DMARD (methotrexate, leflunomide, or sulfasalazine) with TF/C/I documented

PJIA prior therapy duration (comparison)Minimum 6-week trial of methotrexate or leflunomide

Prescriber requirementPrescribed by or in consultation with a rheumatologist for initial RA therapy

AS NSAID trial duration

AS NSAID trial durationMinimum 1-month trial of an NSAID at maximally tolerated doses (eg, ibuprofen, naproxen) with TF/C/I documented

Prescriber requirementPrescribed by or in consultation with a rheumatologist for AS initial therapy

Related psoriasis/axial indicationsNSAID trial requirement also applied for ankylosing spondylitis entries (Cosentyx/Cosentyx-related criteria)

Benlysta age threshold

Benlysta age thresholdPatient is 5 years of age or older for IV/SC formulations

Autoantibody requirementAutoantibody positive (ANA >=1:80 or anti-dsDNA >=30 IU/mL) required for SLE initial coverage

Prescriber requirementPrescribed by or in consultation with a rheumatologist

Bronchitol age threshold

Bronchitol age thresholdPatient is 18 years of age or older for initial CF use

Required tolerance testPatient must have passed the Bronchitol Tolerance Test (BTT)

Prescriber requirementPrescribed by or in consultation with a pulmonologist or CF center specialist

Cayston age threshold

Cayston age thresholdCF initial: patient is 7 years of age or older

Microbiology requirementEvidence of Pseudomonas aeruginosa in the lungs required

Reauthorization measureReauth requires clinical benefit (improved FEV1 or fewer exacerbations)

Plaque psoriasis BSA involvement

Plaque psoriasis BSA involvementAt least 3% body surface area involvement qualifies as moderate to severe disease

Topical trial requirementMinimum 30-day trial (14 days for topical corticosteroids) of specified topical therapies required prior to biologic therapy

Prescriber requirementPrescribed by or in consultation with a dermatologist

Cinryze age threshold

Cinryze age threshold6 years of age or older for prophylaxis

HAE diagnostic confirmationDiagnosis confirmed by C4 below LLN and C1-INH antigenic or functional deficiency OR normal C4/C1-INH with pathogenic gene mutation or family history

Prescriber requirementPrescribed by or in consultation with an immunologist/allergist

Ferritin

Ferritin threshold for transfusional iron overloadBaseline ferritin > 1,000 mcg/L required for chronic transfusional iron overload initial therapy

Transfusion history requirementHistory of transfusion totaling at least 100 mL/kg packed RBCs required for transfusional indication

Reauthorization evidenceReauth requires reduction from baseline in serum ferritin or liver iron concentration (LIC)

Eosinophils for EoE

EoE eosinophil threshold>= 15 intraepithelial eosinophils per high power field required for EoE diagnosis

Symptom requirementSymptoms of esophageal dysfunction (eg, dysphagia, food impaction) required and other causes excluded

Prior therapy requirementTrial and failure/CI/intolerance to an 8-week PPI or topical esophageal corticosteroid required

Blood eosinophils for Dupixent in eosinophilic asthma

Dupixent blood eosinophils threshold>= 150 cells/mcL baseline peripheral blood eosinophils for eosinophilic asthma indications

Exacerbation history requirementPlus history of >=2 exacerbations requiring systemic corticosteroids in past 12 months or prior asthma-related hospitalization

Controller therapy prerequisitesAge- and therapy-specific inhaled controller regimens required per criteria before biologic use

Migraine frequency for Emgality - episodic

Emgality episodic migraine threshold>= 4 migraine days per month for episodic migraine initial therapy

Age restrictionEM initial: 18 years or older

Combination restrictionNot to be used with another injectable CGRP inhibitor for prevention

Migraine frequency for Emgality - chronic

Emgality chronic migraine threshold>= 8 migraine days per month for chronic migraine initial therapy

Medication overuse considerationMedication overuse headache should be considered and offending medications discontinued prior to initiation

Age restrictionCM initial: 18 years or older

Peripheral blood eosinophil

Peripheral blood eosinophil threshold>= 150 cells per microliter (baseline) used to define eosinophilic asthma phenotype

Alternate historical threshold>= 300 cells/µL within past 12 months acceptable for some severe asthma criteria

Required exacerbation historyDocumented >=2 exacerbations requiring systemic steroids or prior asthma hospitalization in past 12 months typically required

Minimum prior therapy duration (Enbrel - initial)

Enbrel minimum prior therapy duration (initial RA)3 months trial and failure/CI/intolerance to one conventional therapy (methotrexate, leflunomide, or sulfasalazine)

PJIA prior duration6 weeks trial and failure/CI/intolerance to methotrexate or leflunomide

AS prior duration1-month trial and failure/CI/intolerance to an NSAID at maximally tolerated doses

Baseline peripheral blood eosinophil

Baseline peripheral blood eosinophil>= 150 cells per microliter required for severe eosinophilic asthma initial eligibility

Historical criterionOr >=300 cells/µL within past 12 months may be acceptable for some agents/indications

Exacerbation documentationDocumentation of >=2 exacerbations or prior hospitalization commonly required

Growth hormone stimulation peak values (examples)

ITT peak GH thresholdInsulin tolerance test (ITT) peak GH <= 5 mcg/L

Glucagon peak GH thresholdGlucagon stimulation peak GH <= 3 mcg/L

Macimorelin peak thresholdMacimorelin peak GH <= 2.8 ng/mL (measured at 30,45,60,90 minutes)

GH stimulation test peak values

GH stimulation test peak valuesConfirmatory GH stimulation test thresholds: ITT <= 5 mcg/L; glucagon <= 3 mcg/L; macimorelin <= 2.8 ng/mL (measured at 30, 45, 60, and 90 minutes)

Diagnostic contextUsed to confirm adult growth hormone deficiency when clinical records indicate organic hypothalamic-pituitary cause or childhood-onset GHD

Reauthorization monitoringIGF-1/somatomedin-C monitoring within past 12 months required for reauth

Prior Authorization, Documentation, Step Therapy and Denial Risks

Prior Authorization

Prior Authorization Required (general)

Prior authorization (PA) is required for many Part D and specialty products on the formulary. Providers must submit a prior authorization request with the required clinical documentation before claims will be approved. PA timing and duration rules vary by product: initial approvals are typically issued for 6–12 months depending on indication, with reauthorization often for 12 months when clinical response is documented.

Prior authorization required per-product and per formulary entries — see product-specific criteria (examples below).
PA timing and duration: Initial approvals commonly 6 months (some oncology, PAH, and specialty agents) or 12 months; reauthorization commonly 12 months when response is documented.
Part D prior authorization applies to prescription drug benefit covered products; some agents may be subject to Part B vs Part D review (e.g., some SC/IV immune globulins, oncology infusions).

Documentation Required

Required documentation, diagnosis, prior therapy and denial risks

Many products require documentation of diagnosis, prior therapies (trial and failure/intolerance/contraindication), specialist prescriber or consultation, and supporting labs/genetic testing where applicable. Missing or incomplete documentation is a frequent reason for denial.

Submit diagnosis and prior therapy records with the PA request (clinic notes, medication trials, lab results).
Requests may be denied if documentation is missing, incomplete, or fails to confirm required diagnosis or prior therapy.
Failure to document a required diagnosis (example: Actimmune — must document CGD or severe malignant osteopetrosis) may trigger denial.

Step Therapy

Step therapy / prerequisite therapy documentation

For many biologics and specialty products there are specific prerequisite therapy or step therapy requirements. Providers must document trials of required agents at maximally tolerated doses and reasons for failure/intolerance when applicable.

For adalimumab-class products and Humira/Humira biosimilars: document diagnosis and required trials (e.g., methotrexate for RA) and specialist consultation when indicated.
Adbry (atopic dermatitis): document prior topical therapies and systemic/phototherapy trials per product-specific criteria.
Prerequisite therapy examples: Enbrel and other rheumatologic agents require documentation of prior conventional therapy trials (methotrexate, leflunomide, sulfasalazine) where specified.
Dupixent (asthma) — document blood eosinophil counts and exacerbation history and prior inhaled controller regimens.

Documentation Required

Product-specific required documentation and monitoring

Selected product- and indication-specific notes providers must include with PA requests to avoid denials: lab thresholds, genetic/molecular testing, monitoring, and safety-related documentation.

PAH agents (e.g., Adempas, Alyq): documentation of symptomatic PAH and confirmation by right heart catheterization OR evidence patient is currently on PAH therapy; prescriber should be pulmonologist or cardiologist.
Targeted oncology agents (e.g., ROS1/NTRK/RET/FGFR/RET inhibitors, Retevmo, Rozlytrek, Rozlytrek, Lytgobi, Retevmo): submit required molecular testing (ROS1, NTRK, RET, FGFR2, KRAS, etc.) performed by FDA-approved or CLIA-certified lab and prior systemic therapy history when required.
TGCT agents (e.g., Rivfloza): document symptomatic TGCT and rationale that surgical resection would cause severe morbidity or worsen function.
Retacrit: submit recent Hgb/Hct within specified windows (Hgb <10 g/dL or Hct thresholds) and confirm adequate iron stores (ferritin >100 mcg/L and TSAT >20%) where applicable; include dialysis status and indication (CKD, chemo, preop, HCV).
Pyrimethamine: malaria treatment or prophylaxis is not authorized — requests for malaria will be denied.
Pyrukynd, Jynarque and other products with genetic or lab monitoring: include genetic confirmation and specified liver or other lab monitoring per product criteria (e.g., Jynarque ALT/AST/bilirubin monitoring schedule).
HES (hematopoietic growth factors) and Retacrit: include laboratory documentation and transfusion history as required.
Cinryze, Cholbam and similar: include diagnostic documentation that supports labeled indication (e.g., C1 esterase inhibitor deficiency, documented bile acid/liver disease).
Modafinil/armodafinil: submit diagnostic documentation for narcolepsy/OSA/SWD as specified.

Prior Authorization

PA timing, duration, common denial triggers and Part D notes

Examples of administrative and operational PA rules and denial risks to watch for: prior trial durations, specialist prescriber requirements, Part D exclusions, and conditions that routinely prompt denials when not met.

Part D prior authorization required for many outpatient prescription products; some therapies are subject to Part B vs Part D determination (document site of care and intent).
Nurtec (migraine): document acute migraine therapy trials — trial and failure or intolerance to a triptan is required for acute treatment in many CGRP-related criteria.
PCSK9 inhibitors (Praluent, Repatha): document diagnosis (HeFH, HoFH, ASCVD, primary HLD), highest tolerable statin use or statin intolerance (document trial of at least two statins or contraindication), and concurrent lipid-lowering therapy.
Required timing and duration rules: many PA initial approvals are for 6 months for certain indications (e.g., PAH, some biologic initiations) and 12 months for chronic maintenance; reauth typically requires evidence of clinical response.
Requests lacking required prior trials, specialist consultation, lab data, or molecular testing may be denied.
Potential denial triggers: missing genetic confirmation for ALGS/PFIC (Mavyret/Pyrukynd examples), missing right heart catheterization for PAH agents when required, missing lab monitoring for Jynarque, and missing transfusion history or iron studies for erythropoietic agents.

Prior Authorization

Operational checklist — what to include with the PA request

When submitting PAs include concise, targeted supporting items to speed review: diagnosis with date, prior medication trials with dates and reasons for failure/intolerance, recent labs and imaging, specialist consultation notes, and any genetic/molecular test reports.

Required: diagnosis documentation, prior therapy history, and relevant labs/imaging.
Include specialist prescriber attestation or consultation if the product requires it (e.g., rheumatology for RA biologics, gastroenterology for IBD, pulmonology/cardiology for PAH).
If product requires genetic/molecular testing (e.g., ROS1, NTRK, RET, FGFR2, KRAS), attach the report from an FDA-approved or CLIA-certified lab.
For abuse/coverage exclusions (e.g., pyrimethamine for malaria), note that such uses are not authorized and will be denied.
Retacrit and other agents: include recent lab values and transfusion history; note adequacy of iron stores where required.
Documentation gaps (e.g., missing diagnosis confirmation, missing labs, lack of prior trial details) are a leading cause of denials — provide complete records at initial submission to avoid delays.

Denial Risk

Denial risks and common failure points

Denial risk highlights — submit required clinical details up front to reduce risk of denial.

Failure to document required diagnosis may result in denial (Actimmune example: must document CGD or severe malignant osteopetrosis).
Missing required prior trials or specialist consultation can trigger denial for rheumatologic/dermatologic/immune indications (e.g., adalimumab class, Enbrel, Rinvoq).
Pyrimethamine for malaria is not authorized and will be denied.
Missing genetic confirmation (e.g., ALGS/PFIC for cholestatic agents, ROS1/NTRK/RET/FGFR testing for targeted oncology agents) is a common denial reason.
Requests for many specialty products (oncology, gene-targeted, immunoglobulins) require specific molecular testing, lab monitoring, and documentation of prior systemic therapy — absence of these will likely lead to denial.

Background and Scope Notes

This excerpt summarizes coverage criteria across multiple specialty medications spanning immunology, rheumatology, infectious disease, and oncology. Coverage decisions are indication-driven and typically require documentation of diagnosis, relevant laboratory or molecular testing when applicable, and evidence of prior therapy trials or failures where specified. Many approvals are processed via prior authorization with common coverage durations of 12 months; some indications (for example certain initial induction periods) have shorter initial durations. Exclusion language is product-specific in the source: some entries explicitly state exclusions (for example pyrimethamine is not authorized for malaria), while other products list exclusion fields as N/A or omit separate exclusion statements in the provided excerpt.

Definitions and Diagnostic Thresholds

TF/C/I definition

TF/C/I definition (trial and failure/contraindication/intolerance)Documented inadequate response, contraindication, or intolerance to a prior therapy after the specified minimum trial duration (eg, 3 months for RA; 6 weeks for PJIA)

Documentation requirementProvider must document reason prior therapy was ineffective or not tolerated (chart notes, labs, or specialist attestation)

Usage across policiesApplied broadly as prerequisite to biologic/targeted therapy approvals in rheumatology and dermatology entries

SCORAD definition

SCORAD definitionSCORing Atopic Dermatitis (SCORAD) index used; threshold >=25 qualifies for moderate-severe AD eligibility

Context of useSCORAD criterion appears as alternative to BSA >=10% for Adbry/AD eligibility

DocumentationReduction in SCORAD used as a reauth measure of positive clinical response

Autoantibody positive (SLE)

Autoantibody positive (SLE)Defined as ANA titer >= 1:80 OR anti-dsDNA >= 30 IU/mL required for SLE initial coverage

Concurrent therapy requirementPatient must be receiving at least one standard-of-care treatment for active SLE (eg, hydroxychloroquine, corticosteroids, immunosuppressants)

PrescriberPrescribed by or in consultation with a rheumatologist

ROS1 rearrangement positive

ROS1 rearrangement positiveTumor testing demonstrating ROS1 rearrangement required for NSCLC ROS1-targeted therapy coverage

Testing standardTesting must be by FDA-approved or CLIA-certified laboratory test where specified

Coverage durationCoverage duration for ROS1/NTRK indications typically 12 months

HAE diagnostic criteria

HAE diagnostic criteriaDiagnosis confirmed by low C4 and either low C1-INH antigenic OR low C1-INH functional level (Type I/II) OR normal C4/C1-INH with pathogenic gene mutation or family history

Age for acute treatmentInitial treatment entries specify age 18+ for acute HAE attacks (per chunk 95)

Prophylaxis noteProphylaxis entries (Cinryze) require age >=6 years for prophylaxis and similar diagnostic confirmation

Bile acid synthesis disorder confirmation

Bile acid synthesis disorder confirmationDiagnosis based on abnormal urinary bile acid analysis by mass spectrometry OR molecular genetic testing consistent with the disorder

PrescriberPrescribed by hepatologist, medical geneticist, gastroenterologist, or specialist in inborn errors of metabolism

Coverage durationsInitial coverage commonly 4 months with reauth 12 months for Cholbam indications

EoE definition

EoE definitionDiagnosis requires symptoms of esophageal dysfunction AND >=15 intraepithelial eosinophils per high power field after exclusion of other causes

Prior therapy requirementTrial and failure/CI/intolerance to an 8-week PPI or topical esophageal corticosteroid required

Weight/age constraintsPatient weight >=15 kg specified for some EoE criteria

RA initial therapy requirement

RA initial therapy requirement (restate)Moderately to severely active RA requires minimum 3-month TF/C/I to one conventional therapy (methotrexate, leflunomide, sulfasalazine) at maximally tolerated doses

SpecialistPrescribed by or in consultation with a rheumatologist for initial therapy

Reauth expectationReauthorization requires demonstration of positive clinical response (reduced joint counts or symptom improvement)

Eosinophilic phenotype (asthma)

Eosinophilic phenotype (asthma)Defined as baseline peripheral blood eosinophil >=150 cells/µL for eligibility for eosinophil-targeted biologics

Additional criteriaPlus history of >=2 exacerbations in past 12 months or prior asthma-related hospitalization often required

Age/controller therapyAge- and controller-specific inhaled regimen prerequisites apply per criteria

SMA genetic criteria (Evrysdi)

SMA genetic criteria (Evrysdi)Mutation or deletion of genes in chromosome 5q (eg, homozygous deletion of exon 7 of SMN1) with at least 2 copies of SMN2 and not dependent on chronic invasive ventilation

Baseline motor assessmentBaseline motor function assessment (HINE-2, HFMSE, CHOP-INTEND, RULM, MFM-32) required

Concomitant therapy restrictionNot to receive concomitant chronic SMN-modifying therapy (eg, Spinraza) unless criteria documented

Eosinophilic asthma

Eosinophilic asthma definitionAsthma phenotype defined by baseline peripheral blood eosinophil >=150 cells/µL with exacerbation history or asthma-related hospitalization

Treatment contextUsed to guide eligibility for agents like Nucala, Fasenra, Dupixent

DocumentationRequires documentation of exacerbations and current controller therapy

HAE diagnostic confirmation

HAE diagnostic confirmationEither low C4 with low C1-INH antigenic or functional deficiency (Type I/II) OR normal C4/C1-INH with pathogenic mutation detected or family history (HAE-nl-C1INH)

Testing standardGenetic testing when required should be by FDA-approved or CLIA-certified test

PrescriberPrescribed by or in consultation with immunologist/allergist for HAE management

Adult Growth Hormone Deficiency (AGHD)

Adult Growth Hormone Deficiency (AGHD)Diagnosis requires clinical records of childhood-onset GHD or adult-onset GHD due to organic causes plus GH stimulation testing or deficiency of three anterior pituitary hormones with low IGF-1/somatomedin-C

GH stimulation thresholdsConfirmatory GH stimulation thresholds: ITT <=5 mcg/L; glucagon <=3 mcg/L; macimorelin <=2.8 ng/mL

ReauthorizationMonitoring IGF-1/somatomedin-C within past 12 months required for reauth

Trial and failure/contraindication/intolerance (TF/C/I)

TF/C/I (definition)Documented inadequate response, contraindication, or intolerance to a prior therapy after the specified minimum trial duration (eg, 3 months for RA; 6 weeks for PJIA)

ApplicationUsed as prerequisite logic across many initial biologic/targeted therapy criteria

DocumentationProviders must supply medical records/chart notes showing trials and reasons for failure or intolerance

TF/C/I (restate)

TF/C/I (restate)Trial and failure, contraindication, or intolerance to specified prior therapies required and must be documented (eg, methotrexate for RA)

Minimum durationsExamples: RA 3 months, PJIA 6 weeks, AS 1 month, plaque psoriasis topical 30 days (14 days for topical corticosteroids)

Specialist involvementMany criteria require specialist prescriber or consultation for initial approvals

Reauth objective response

Reauth objective responseReauthorization requires documentation of positive clinical response (eg, reduced joint counts, decreased BSA, symptom improvement) as evidence of ongoing benefit

Examples of measuresRA: reduced swollen/tender joint count; Psoriasis: reduction in BSA; IBD: clinical/lab improvement

Typical reauth durationReauth periods commonly 12 months after initial approval

FDA-approved test or CLIA facility test

FDA-approved or CLIA facility testBiomarker/mutation testing must be performed by an FDA-approved test or at a CLIA-certified laboratory when specified

ApplicabilityRequired for targeted oncology agents (eg, ROS1, NTRK, BRAF, RET, KRAS) per product-specific criteria

DocumentationProvide test results as part of prior authorization submission

Molecular genetic testing

Molecular genetic testingGenetic testing confirming pathogenic mutations (eg, JAG1/NOTCH2 for ALGS; ATP8B1/ABCB11 etc. for PFIC) required for enrollment in some indications

Testing standardTesting should be by FDA-approved assay or CLIA-certified laboratory when specified

PrescriberOften required to be prescribed by or in consultation with relevant specialist (eg, hepatologist) when genetic testing is necessary

BRAF V600E/V600K mutation testing

BRAF V600E/V600K testingBRAF V600E or V600K mutation must be detected by an FDA-approved test (THxID-BRAF Kit) or a CLIA-approved laboratory test

Use caseRequired for Mekinist/Mektovi indications in melanoma, NSCLC, ATC, and certain solid tumors when combined with dabrafenib or encorafenib

Coverage durationCoverage typically 12 months with continuation approvals allowed

Triptan trial prerequisite

Triptan trial prerequisiteTrial and failure or intolerance to one triptan is required prior to use of dihydroergotamine solution for acute migraine

Migraine acute therapy contextDemonstration of triptan TF/C/I must be documented in prior authorization request

Reauth measurePositive clinical response required for reauthorization

Uncontrolled HES

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

Treatment prerequisitesTrial and failure/CI/intolerance to corticosteroid or cytotoxic/immunosuppressive therapy required prior to specialty therapy

Diagnostic exclusionSecondary non-hematologic causes must be excluded (eg, parasites, drug hypersensitivity, HIV, non-hematologic malignancy)

Progressive phenotype (PPF/ILD)

Progressive phenotype (PPF/ILD)Progressive phenotype defined by HRCT fibrotic features plus objective progression (FVC decline, worsening symptoms, or increased fibrosis on imaging)

Diagnostic requirementExclusion of other known causes of ILD and supportive HRCT or biopsy patterns required

PrescriberPrescribed by or in consultation with pulmonologist or rheumatologist

Pulmonary arterial hypertension (PAH) definition

PAH definitionPulmonary arterial hypertension (PAH) is symptomatic and requires either right heart catheterization confirmation OR current PAH therapy to meet coverage documentation

PrescriberPrescribed by or in consultation with a pulmonologist or cardiologist

Coverage durationsInitial 6 months; reauth 12 months typical

RA initial therapy requirement (restate)

RA initial therapy requirement (restate)Moderately to severely active RA requires minimum 3-month TF/C/I to one conventional DMARD at maximally tolerated doses prior to biologic/targeted therapy

DocumentationProvider must submit evidence of prior therapy duration and reason for failure/CI/intolerance

PrescriberRheumatologist involvement recommended for initial approvals

Prophylaxis of systemic fungal infections

Prophylaxis of systemic fungal infectionsUse as prophylaxis of invasive fungal infections caused by Aspergillus or Candida for patients at high risk (eg, HSCT with GVHD, prolonged neutropenia)

Treatment age thresholdTreatment of invasive fungal infections: age >=13 years; prophylaxis: age >=2 years

Coverage durationTypical authorization duration: 6 months

Statin intolerance definition

Statin intolerance definitionInability to tolerate at least two statins, with at least one started at the lowest starting daily dose, due to intolerable symptoms or clinically significant biomarker changes

ApplicationUsed to document eligibility for PCSK9 inhibitors when patients cannot tolerate maximal statin therapy

Documentation requiredProvider must document attempts and adverse effects leading to intolerance

Anemia criteria

Anemia criteria (examples)Hemoglobin and hematocrit thresholds vary by indication; commonly Hgb <10 g/dL or Hct <30% for initial CKD/chemo indications; other thresholds specified for preoperative, HCV/HIV, and pediatric uses

Iron stores prerequisiteAdequate iron stores required: ferritin >100 mcg/L AND TSAT >20% for many Retacrit indications

Reauth measuresReauth requires demonstration of positive clinical response and meeting Hgb/Hct thresholds over monitoring period

Molecular testing requirement

Molecular testing requirementPresence of specified gene fusions or mutations must be detected by an FDA-approved test or a CLIA-certified laboratory test for targeted agents

ExamplesRET, ROS1, NTRK, FGFR2, KRAS G12C, BRAF V600E examples appear in product-specific criteria

DocumentationSubmit test results with prior authorization; lack of required testing may trigger denial

NTRK gene fusion

NTRK gene fusionPresence of NTRK gene fusions (eg, ETV6-NTRK3, TPM3-NTRK1) detected by FDA-approved or CLIA test required for tumor-agnostic NTRK-targeted therapy coverage

Disease statusDisease must be metastatic or unresectable and progressed after prior treatment or lack satisfactory alternatives

Coverage durationTypically 12 months; continuation for prior therapy often approved

ROS1 rearrangement

ROS1 rearrangementROS1 rearrangement positive tumors in metastatic NSCLC identified by appropriate testing are required for ROS1-targeted therapy coverage

Testing standardTesting should be by FDA-approved test or CLIA-certified laboratory when specified

CoverageCoverage duration commonly 12 months; continuation approvals allowed

Revision History

04/01/2026formulary_effective

Formulary effective date set to 04/01/2026 (Formulary ID: 26218, Version 11).

03/02/2026last_updatedLatest

Document last updated on 03/02/2026 (last updated / version information recorded).

Spravato, Stelara (SC), Hizentra, Nucala, Mavyret, Mounjaro and others: include the product-specific clinical documentation listed in the formulary criteria (e.g., prior therapy trials, lab tests, specialist prescriber notes).