OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

DraftBlue Cross Blue Shield - South CarolinaPolicy N/A

Formulary coverage criteria for specialty biologics and therapies (partial document)

Customize your policy alerts

Sign up for all Blue Cross Blue Shield - South Carolina policy alerts

Know when Blue Cross Blue Shield - South Carolina releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Portion of a Blue Cross Blue Shield - South Carolina formulary/policy describing product-specific indications, required documentation, prescriber restrictions, coverage durations, and reauthorization criteria for multiple specialty medications. Affects providers submitting prior authorization for the listed products.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyFormulary coverage criteria for specialty biologics and therapies (partial document)

Policy CodePolicy N/A

Change TypeMinor / no material change

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, required supporting documentation, and specialist prescriber or consultation when specified.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>30products listed in this section

12 monthstypical coverage duration for many products

6 monthsinitial coverage duration for some indications

Requires specialistprescriber restriction common

Coverage Criteria by Product / Indication

Rheumatology and dermatology biologics (examples)

Covered when ALL of the following are met for the indicated condition

Rheumatoid arthritis (RA) initial: Diagnosis of moderately to severely active RA AND minimum 3-month trial and failure, contraindication, or intolerance (TFIC/I) to one of the following conventional therapies at maximally tolerated doses: methotrexate, leflunomide, or sulfasalazine.minimum 3-month TFIC/I

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

Polyarticular juvenile idiopathic arthritis (PJIA) initial: Diagnosis of moderately to severely active PJIA AND minimum 6-week trial and failure, contraindication, or intolerance (TFIC/I) to one of the following conventional therapies at maximally tolerated doses: methotrexate or leflunomide.minimum 6-week TFIC/I

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

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyFormulary coverage criteria for specialty biologics and therapies (partial document)

Policy CodePolicy N/A

Change TypeMinor / no material change

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, required supporting documentation, and specialist prescriber or consultation when specified.

SourceLink

On This Page

Inflammatory bowel disease (examples)

Covered when ALL of the following are met for CD or UC

Crohn's Disease (CD) initial: Diagnosis of moderately to severely active Crohn's disease AND at least one objective severity finding such as frequent diarrhea and abdominal pain, ≥10% weight loss, complications (eg, obstruction, fever, abdominal mass), abnormal labs (eg, elevated CRP), OR Crohn's Disease Activity Index (CDAI) >220.CDAI >220 or listed clinical/lab criteria

Prescribed by or in consultation with a gastroenterologist; reauth requires demonstration of positive clinical response (eg, mucosal healing, improved lab markers).

Ulcerative Colitis (UC) initial: Diagnosis of moderately to severely active ulcerative colitis AND one of the following: >6 stools per day, frequent visible blood in stools, frequent urgency, presence of ulcers, abnormal labs (eg, Hb, ESR, CRP), OR dependence on or refractory to corticosteroids.clinical stool frequency/lab criteria as listed

Prescribed by or in consultation with a gastroenterologist; initial authorization periods (eg, 12 weeks for UC induction) and reauthorization requirements apply; reauth requires evidence of clinical response.

Procrit — anemia across indications

Covered when ALL of the following are met

Anemia with chronic kidney disease (CKD): Diagnosis of anemia associated with CKD with laboratory evidence (hematocrit <30% or hemoglobin <10 g/dL) collected within 30 days of request AND verification of adequate iron stores; prescribed in appropriate dialysis or non-dialysis contexts per policy.Hct <30% OR Hgb <10 g/dL

Prescriber should document labs within specified timeframe; reauth requires demonstration of clinical response.

Chemotherapy-induced anemia: Non-myeloid malignancy receiving myelosuppressive chemotherapy AND lab evidence of anemia (Hgb <10 g/dL or Hct <30%) within 2 weeks of request AND other causes ruled out.Hgb <10 g/dL or Hct <30%

Prescriber must verify iron evaluation prior to use; reauth requires clinical response.

Preoperative anemia (to reduce transfusion): Patient scheduled for elective non-cardiac, non-vascular surgery with Hgb >10 to ≤13 g/dL AND high risk for perioperative transfusion AND patient unwilling or unable to donate autologous blood.Hgb >10 to ≤13 g/dL

Coverage for perioperative use limited and subject to review.

Other specific ESA indications: Anemia associated with HCV on ribavirin therapy, HIV, or MDS per indication-specific lab thresholds and erythropoietin criteria as listed in policy.varies by indication

Off-label uses (except MDS, HCV) will not be approved if Hgb >10 g/dL or Hct >30%.

Pirfenidone — IPF

Covered when ALL of the following are met

Pirfenidone for IPF initial: Diagnosis of idiopathic pulmonary fibrosis (IPF) documented by exclusion of other known causes of interstitial lung disease AND either (1) usual interstitial pneumonia (UIP) pattern on high-resolution CT consistent with IPF in patients not undergoing surgical biopsy OR (2) concordant HRCT and surgical lung biopsy patterns consistent with IPF/probable IPF.

Prescribed by or in consultation with a pulmonologist; initial and reauthorization coverage 12 months; reauth requires demonstration of positive clinical response.

Erivedge — Initial criteria

Covered when ALL of the following are met:

Erivedge initial: 1) Diagnosis of metastatic basal cell carcinoma OR 2) Diagnosis of locally advanced basal cell carcinoma AND (a) disease recurred following surgery OR (b) patient is not a candidate for surgery and radiation.

Prescriber and age restrictions: none specified; prior authorization required; coverage duration 12 months.

Erivedge documentation requirement: Submission of diagnostic documentation confirming metastatic disease OR locally advanced disease with recurrence or inoperability as specified.

Approve for continuation of prior therapy.

Evrysdi SOLR — Initial and reauthorization criteria

Evrysdi SOLR — Covered when ALL of the following are met:

Evrysdi initial: 1) Genetic confirmation of spinal muscular atrophy (SMN1 mutation/deletion) with documentation of SMN2 copy number when applicable; AND 2) Patient is not dependent on both invasive ventilation/tracheostomy and chronic non-invasive ventilation beyond naps/nighttime; AND 3) Baseline motor assessment appropriate for age (HINE-2, HFMSE, RULM, CHOP INTEND, MFM-32, or BSID-III item 22) has been performed; AND 4) Patient is not receiving concomitant chronic SMN-modifying therapy (eg, nusinersen/Spinraza) unless documentation supports inadequate response to prior therapy.

Prescribed by or in consultation with a neurologist experienced in SMA; initial and reauth coverage 12 months; reauth requires evidence of positive clinical response; if prior gene therapy received, submit records documenting inadequate response.

Fasenra — Asthma and EGPA criteria

Fasenra (benralizumab) — Covered when ALL of the following are met:

Asthma initial: Diagnosis of severe eosinophilic asthma with baseline peripheral blood eosinophils ≥150 cells/µL AND history of two or more exacerbations requiring systemic corticosteroids in the past 12 months or prior asthma-related hospitalization in past 12 months; AND appropriate controller therapy at specified intensities (age-specific requirements for ICS +/- other controller agents).>=150 cells/µL

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

EGPA criteria: Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) relapsed or refractory to standard of care (eg, corticosteroids ± immunosuppressive therapy) and patient currently on corticosteroid therapy unless contraindicated.

Prescribed by or in consultation with pulmonologist, rheumatologist, or allergist/immunologist; coverage duration 12 months.

Fabrazyme — Fabry disease criteria

Covered when ALL of the following are met:

Fabrazyme (Fabry disease) initial: Diagnosis of Fabry disease established by one of: pathogenic GLA gene mutation on molecular genetic testing, deficiency of alpha-galactosidase A enzyme activity in plasma/leukocytes/DBS, OR presence of significant clinical manifestations (neuropathic pain, cardiomyopathy, renal insufficiency, angiokeratomas, cornea verticillata).

Will not be used in combination with other Fabry disease drugs; age ≥2 years for initiation; coverage duration 12 months; reauth requires documented positive clinical response.

MS therapies — general criteria

Multiple Sclerosis agents — Covered when ALL of the following are met:

MS disease-modifying therapy initial: Diagnosis of a relapsing form of multiple sclerosis (eg, clinically isolated syndrome, relapsing-remitting MS, or secondary progressive with active disease) AND prescribed by or in consultation with a neurologist; not used in combination with another disease-modifying therapy for MS.

Initial and reauthorization coverage typically 12 months; reauth requires demonstration of positive clinical response (stability in radiologic activity, relapses, or progression).

Imatinib — Indications

Imatinib Mesylate — Covered when ANY of the following diagnoses are present:

Imatinib eligible diagnoses: Ph+ BCR-ABL positive chronic myelogenous leukemia (CML); Ph+ BCR-ABL positive acute lymphoblastic leukemia (ALL); gastrointestinal stromal tumor (GIST); dermatofibrosarcoma protuberans (unresectable, recurrent, or metastatic); hypereosinophilic syndrome or chronic eosinophilic leukemia; myelodysplastic syndrome or myeloproliferative disease; aggressive systemic mastocytosis.

Prescribed per product labeling; coverage duration 12 months; approve continuation of prior therapy.

Humira (adalimumab) - multiple indications

Covered when indication-specific criteria are satisfied:

Humira — RA initial: Diagnosis of moderately to severely active RA AND minimum 3-month trial and failure, contraindication, or intolerance to one conventional therapy (methotrexate, leflunomide, or sulfasalazine).minimum 3-month TFIC/I

Prescribed by or in consultation with a rheumatologist; reauth requires positive clinical response; coverage durations vary by indication (eg, UC induction 12 weeks).

Humira — PJIA initial: Diagnosis of moderately to severely active PJIA AND minimum 6-week TFIC/I to leflunomide or methotrexate.minimum 6-week TFIC/I

Prescribed by or in consultation with a rheumatologist; reauth requires positive clinical response.

Humira — Plaque psoriasis initial: Diagnosis of moderate to severe chronic plaque psoriasis AND at least one of: ≥3% BSA involvement, severe scalp, or palmoplantar/facial/genital involvement; AND minimum 4-week trial and failure to topical therapies.>=3% BSA or severe site involvement

Prescribed by or in consultation with a dermatologist; reauth requires documented response.

Humira — Crohn's Disease initial: Diagnosis of moderately to severely active Crohn's disease with objective severity (frequent diarrhea/abdominal pain, ≥10% weight loss, complications, abnormal labs, or CDAI >220).CDAI >220 or listed criteria

Prescribed by or in consultation with a gastroenterologist; reauth requires clinical response.

Humira — Ulcerative Colitis initial: Diagnosis of moderately to severely active UC with criteria such as >6 stools/day, frequent blood in stools, urgency, ulcers, abnormal labs, or steroid dependence/refractory status.clinical stool frequency/lab criteria

Initial UC induction typically 12 weeks; prescriber gastroenterologist; reauth 12 months with clinical response.

Ingrezza (implied example entries near chunk 108)

Examples of product-specific initial criteria (selected entries from this part):

Ingrezza — Tardive dyskinesia (initial): Diagnosis of moderate to severe tardive dyskinesia AND either persistent symptoms despite trial of dose reduction/taper/discontinuation of offending medication OR patient is not a candidate for dose reduction/taper/discontinuation.severity: moderate to severe

Prescribed by or in consultation with a neurologist or psychiatrist; initial coverage duration 3 months; reauth requires positive clinical response.

Ingrezza — Huntington chorea (initial): Diagnosis of chorea associated with Huntington's disease as documented by treating neurologist.

Initial coverage 3 months; reauth 12 months with demonstrated clinical benefit.

Immune globulin (IVIG/SCIG)

Covered when ALL of the following are met based on route and diagnosis:

IVIG indications: IVIG administered at the minimum effective dose for FDA- or guideline-supported diagnoses such as primary immunodeficiency (CVID, congenital agammaglobulinemia, SCID, Wiskott-Aldrich), certain secondary antibody deficiencies, hematologic autoimmune disorders, and neuromuscular autoimmune disorders when prior standard therapies have failed or are contraindicated.IgG below age-normal or diagnosis-specific lab thresholds

Prescribed by or in consultation with specialist experienced in immune globulin therapy; coverage and reauth require objective improvement and use of minimum effective maintenance dosing.

SCIG indications: SCIG used subcutaneously for primary immunodeficiency diagnoses with low IgG and inadequate vaccine response; administered at the minimum effective dose/frequency for maintenance.IgG below normal and inadequate vaccine response

Subject to Part B vs Part D determinations; prescriber specialist required for initiation and reauth.

Kerendia (finerenone)

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

Kerendia — CKD associated with T2D (Initial): Diagnosis of chronic kidney disease associated with type 2 diabetes AND UACR ≥30 mg/g AND eGFR ≥25 mL/min/1.73 m2 AND serum potassium ≤5.0 mEq/L at initiation; AND either trial of a minimum 30-day maximally tolerated ACE inhibitor or ARB (and continuation) OR documented contraindication/intolerance to ACE/ARB; AND either concurrent SGLT2 inhibitor use or documented contraindication/intolerance to SGLT2 inhibitor.UACR >=30 mg/g; eGFR >=25; K+ <=5.0

Prescribed by or in consultation with appropriate specialist; reauth requires continued benefit and ongoing ACE/ARB and SGLT2 use where applicable.

Kerendia — HF with LVEF >=40% (Initial): Diagnosis of heart failure with LVEF ≥40% (NYHA II–IV), eGFR ≥25 mL/min/1.73 m2, serum potassium ≤5.0 mEq/L, on diuretic therapy ≥30 days, and either on SGLT2 inhibitor or has contraindication/intolerance to SGLT2 inhibitor; not receiving concomitant mineralocorticoid receptor antagonists per criteria.LVEF >=40%; eGFR >=25; K+ <=5.0

Prescribed by or in consultation with a cardiologist; reauth requires positive clinical response.

Kesimpta and Kineret examples (neurologic / rheumatologic products)

Coverage criteria and required prior trials for neurologic and rheumatologic products:

Kesimpta (MS) initial: Diagnosis of a relapsing form of multiple sclerosis AND trial and failure, contraindication, or intolerance to at least one disease-modifying therapy for MS OR for continuation of prior therapy. Not used in combination with another DMT or another B-cell targeted therapy.TF/C/I to >=1 DMT

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

Kineret (RA/NOMID) initial: For RA: diagnosis of moderately to severely active RA AND trial and failure/contraindication/intolerance to two specified agents OR attestation that trials are inappropriate. For NOMID: genetic confirmation of NLRP3 mutation OR clinical syndrome with elevated acute phase reactants consistent with NOMID.TF/C/I to 2 agents for RA; genetic or clinical+lab confirmation for NOMID

Prescriber restrictions per indication; initial durations vary (eg, RA/NOMID 6 months), reauth requires positive clinical response.

Mekinist and BRAF-targeted oncology agents

Covered when ALL of the following are met per indication

Mekinist / BRAF-targeted oncology indications: Diagnosis of indicated cancer (eg, unresectable/metastatic melanoma, metastatic NSCLC, anaplastic thyroid cancer, or BRAF-mutant solid tumor) AND tumor is BRAF V600E or V600K mutant as detected by an FDA-approved or CLIA-certified test (eg, THxID-BRAF Kit), and agent is used per indication (often in combination with a BRAF inhibitor such as dabrafenib when required).BRAF V600E or V600K mutation confirmed by approved test

Prescribed per oncology specialty; coverage duration commonly 12 months; continuation of prior therapy allowed when criteria met.

Nucala (mepolizumab) — multiple eosinophilic indications

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

Nucala — Asthma initial: Diagnosis of severe eosinophilic asthma with baseline blood eosinophils ≥150 cells/µL (or historical ≥300 cells/µL where specified) AND history of ≥2 exacerbations requiring systemic corticosteroids in past 12 months or prior hospitalization; AND patient on appropriate controller therapy per age and severity.>=150 cells/µL baseline OR >=300 cells/µL historical

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

Nucala — HES initial: Diagnosis of hypereosinophilic syndrome (HES) for ≥6 months with secondary causes excluded, FIP1L1-PDGFRA negative, uncontrolled disease with ≥2 flares in past 12 months and pre-treatment eosinophils ≥1000 cells/µL; trial and failure/intolerance to corticosteroids or cytotoxic agents required.pre-treatment eosinophils >=1000 cells/µL

Prescribed by allergist/immunologist or hematologist; coverage 12 months.

Neulasta (pegfilgrastim) — febrile neutropenia prophylaxis and treatment

Covered when ANY of the following apply:

Neulasta — Primary prophylaxis: Patient receiving chemotherapy associated with high febrile neutropenia (FN) risk such as dose-dense regimens (eg, NCI INT C9741) or regimens with >20% FN incidence, or regimens with 10–20% FN risk plus additional patient risk factors.

Prescribed by or in consultation with hematologist/oncologist; coverage duration per chemo course (eg, 3 months or duration of treatment).

Neulasta — Secondary prophylaxis: Patient with prior FN or dose-limiting neutropenic event on prior chemotherapy and receiving myelosuppressive regimen that caused prior event.

Coverage 3 months or duration of treatment; prescriber hematologist/oncologist.

Neulasta — Treatment of FN/ARS: Use for treatment of febrile neutropenia or acute radiation syndrome per indication and specialist guidance.

Coverage durations per indication (eg, ARS 1 month); prescriber hematologist/oncologist.

Armodafinil — sleep disorders

Covered when ALL of the following are met:

Armodafinil — OSA initial: Diagnosis of obstructive sleep apnea (OSA) defined by either ≥15 obstructive respiratory events/hour on a sleep study OR ≥5 events/hour with qualifying symptoms (daytime sleepiness, unrefreshing sleep, fatigue, etc.) when sleep study not feasible; patient demonstrates excessive sleepiness impacting function.>=15 events/hour OR >=5 events/hour plus symptoms

Coverage duration initial/reauth 6 months; reauth requires documented positive clinical response.

Armodafinil — Narcolepsy initial: Diagnosis of narcolepsy confirmed by appropriate sleep study testing (unless prescriber documents infeasibility).

Coverage duration initial/reauth 12 months; reauth requires clinical benefit.

Armodafinil — Shift Work Disorder (SWD) initial: Diagnosis of shift-work disorder with symptoms ≥3 months associated with work period OR sleep study demonstrating disturbed sleep-wake pattern; exclusion of other causes required.>=3 months symptoms

Coverage duration initial/reauth 6 months; reauth requires clinical response.

Selected pulmonology/oncology/ILD criteria

Covered when ALL of the following are met (examples):

Odomzo — locally advanced basal cell carcinoma: Diagnosis of locally advanced basal cell carcinoma AND disease has recurred following surgery or patient is not a candidate for surgery/radiation.

Coverage duration 12 months; continuation of prior therapy approved.

Ofev (nintedanib) — IPF and progressive fibrosing ILD: Diagnosis of IPF documented by exclusion of other known causes of ILD AND UIP pattern on HRCT consistent with IPF OR concordant HRCT and surgical lung biopsy consistent with IPF; or diagnosis of chronic fibrosing ILD with progressive phenotype supported by HRCT showing ≥10% fibrotic lung involvement and evidence of progression.HRCT >=10% fibrotic features for progressive ILD

Prescribed by or in consultation with a pulmonologist; initial/reauth typically 12 months; reauth requires evidence of benefit.

Pirfenidone — IPF initial: Diagnosis of idiopathic pulmonary fibrosis with exclusion of other causes and HRCT pattern of UIP/probable UIP or concordant HRCT and surgical lung biopsy consistent with IPF.

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

Onpattro — hATTR polyneuropathy

Covered when ALL of the following are met:

Onpattro — hATTR with polyneuropathy initial: Diagnosis of hereditary transthyretin-mediated amyloidosis (hATTR) with polyneuropathy AND presence of a pathogenic TTR mutation AND baseline neuropathy severity meeting specified ranges (PND ≤ IIIb OR FAP stage 1–2 OR NIS 5–130) AND clinical signs/symptoms of neuropathy.PND <= IIIb OR FAP stage 1-2 OR NIS 5-130

Prescribed by or in consultation with a neurologist; coverage duration 12 months; reauth requires demonstrated clinical response; subject to Part B vs D review.

IV induction biologic (one-time) — Crohn's disease / Ulcerative colitis induction dosing

Covered when ALL of the following are met:

IV induction biologic (one-time) — Crohn's/UC induction dosing: Diagnosis of moderately to severely active Crohn's disease or ulcerative colitis meeting listed severity criteria (eg, CDAI >220 for CD; stool frequency/lab criteria for UC) AND induction dosing to be administered per FDA-labeled weight-based schedule (260 mg ≤55 kg; 390 mg >55–85 kg; 520 mg >85 kg).dosing: 260 mg (≤55 kg); 390 mg (>55–85 kg); 520 mg (>85 kg)

One-time IV induction dosing per label; prescriber/gastroenterologist involvement required; documentation of disease severity required for approval.

Tafinlar (with Mekinist) and other oncology targeted uses

Covered when ALL of the following are met (by indication):

Tafinlar + Mekinist — BRAF V600E/Tafinlar combinations: Diagnosis of unresectable or metastatic melanoma, metastatic NSCLC, anaplastic thyroid cancer, or other BRAF V600E/V600K-mutant solid tumor AND confirmation of BRAF V600E or V600K mutation by an FDA-approved or CLIA-certified test (eg, THxID-BRAF Kit); used in combination with MEK inhibitor (trametinib) where indicated.BRAF V600E or V600K mutation detected by approved test

Prescribed by oncology specialist; coverage duration commonly 12 months; continuation allowed when prior therapy meets criteria.

Tavneos (avacopan) — ANCA-associated vasculitis

Initial therapy covered when ALL of the following are met

Tavneos (avacopan) — ANCA-associated vasculitis initial: Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) confirmed by positive PR3-ANCA or MPO-ANCA or tissue biopsy AND patient is receiving concurrent cyclophosphamide or rituximab AND patient is on glucocorticoids or has documented contraindication/intolerance to glucocorticoids.

Prescribed by or in consultation with nephrology, pulmonology, or rheumatology; initial and reauth coverage 12 months; reauth requires no progressive disease while on therapy.

Rolvedon — Febrile neutropenia (FN) prophylaxis

Covered when ALL of the following are met:

Rolvedon — Febrile neutropenia (FN) prophylaxis: Patient will receive prophylaxis for FN due to dose-dense chemotherapy (eg, NCI INT C9741), a regimen with >20% FN risk, or a regimen with 10–20% FN risk plus additional patient risk factors; OR patient has prior FN/dose-limiting event and is receiving myelosuppressive drugs; AND trial and failure or intolerance to one of the specified G-CSF alternatives (Neulasta/Neulasta Onpro OR Udenyca/Udenyca Onbody).

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

Hizentra — Immune globulin subcutaneous (SCIG)

Covered when ALL of the following are met:

Hizentra — SCIG indications: Diagnosis of CIDP or primary immunodeficiency (eg, CVID, congenital agammaglobulinemia, SCID, Wiskott-Aldrich) with IgG below age-normal and inadequate response to protein/polysaccharide antigens AND plan to administer SCIG at the minimum effective dose and frequency for maintenance.IgG below normal and inadequate vaccine response

Prescribed by or in consultation with immunology/hematology/neurology specialist; subject to Part B vs Part D review; reauth requires objective improvement and dose optimization.

Rivfloza — Primary hyperoxaluria type I

Covered when ALL of the following are met:

Rivfloza — Primary hyperoxaluria type I initial: Diagnostic confirmation by elevated urinary oxalate excretion or plasma oxalate or elevated urine oxalate/creatinine ratio for age AND genetic testing demonstrating AGXT mutation OR liver biopsy demonstrating absent/reduced AGT activity; patient has preserved kidney function (eGFR ≥30 mL/min/1.73 m2).eGFR >= 30 mL/min/1.73m^2

Prescribed by or in consultation with hepatology/nephrology/urology/genetics specialist; initial and reauth coverage 12 months; reauth requires positive clinical response.

Skyrizi/Sotyktu/other dermatology agents — Plaque psoriasis, Psoriatic arthritis, CD, UC

Covered when ALL of the following are met (per indication):

Skyrizi/Sotyktu — Plaque psoriasis initial: Diagnosis of moderate-to-severe plaque psoriasis AND ≥3% BSA involvement or special-site severe disease AND minimum 4-week trial and failure, contraindication, or intolerance to topical therapies as specified.>=3% BSA or severe site involvement

Prescribed by or in consultation with a dermatologist; initial coverage 6 months; reauth 12 months with demonstrated clinical response.

Skyrizi — Psoriatic arthritis initial: Diagnosis of active psoriatic arthritis with active joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement per product labeling.

Prescribed by or in consultation with dermatologist or rheumatologist; initial coverage 6 months; reauth requires clinical improvement.

Selected endocrine and osteoporosis criteria

Covered when ONE of the following is met:

Somavert — Acromegaly initial: Failure of surgery, radiation, or other medical therapies OR patient not a candidate for surgery/radiation/dopamine agonist therapy AND inadequate response or contraindication to a somatostatin analog OR clinical rationale for pegvisomant (eg, comorbid diabetes).

Prescribed by or in consultation with an endocrinologist; coverage 12 months; reauth requires biochemical response (IGF-1 decrease/normalization).

Teriparatide — Osteoporosis initial: Postmenopausal or male primary/hypogonadal osteoporosis with BMD T-score ≤ -2.5 and either history of low-trauma hip/spine/proximal humerus/pelvis/distal forearm fracture OR trial and failure/contraindication to alternative osteoporosis therapy; OR moderate BMD with fracture history plus elevated FRAX (≥20% US) or country-specific threshold.BMD T-score <= -2.5 OR FRAX >=20% (per criteria)

Initial coverage 24 months; lifetime parathyroid hormone use must not exceed 24 months without high-risk justification; prescriber specialty as appropriate.

Tibsovo (ivosidenib) — IDH1-mutant hematologic and solid tumors

Covered for listed indications when ALL of the following are met

Tibsovo (ivosidenib) — IDH1-mutant indications: Diagnosis of relapsed/refractory AML OR newly-diagnosed AML in patients ≥75 years or with comorbidities precluding intensive induction chemotherapy; OR locally advanced/metastatic cholangiocarcinoma with IDH1 mutation; patient has IDH1 mutation detected by an FDA-approved or CLIA-certified test.IDH1 mutation confirmed by approved/CLIA test

Coverage duration 12 months; prescriber oncology/hematology specialist involvement; continuation of prior therapy allowed when criteria met.

Formulary Identifiers, Strengths, and Code Details

Formulary Identifiersmixed

Formulary ID: 25384

Formulary identifier repeated for listed products

Formulary identifiermixed

Formulary ID: 25384

Formulary identifier repeated across entries

Product listingsmixed

Humira INJ 20MG/0.2ML, 40MG/0.8ML, 100MG/0.4ML	Humira product presentations listed
Haegarda INJ 2000UNIT	C1-INH prophylaxis product listing

Formulary identifiermixed

Formulary ID: 25384

Formulary identifier and version for products listed

Required diagnostic tests for BRAF-targeted therapiesmixed

THxID-BRAF Kit

FDA-approved BRAF mutation test referenced for BRAF V600E/V600K detection

Formulary identifiermixed

Formulary ID: 25384

Referenced formulary identifier/version for listed products

Formulary identifiermixed

Formulary ID: 25384

Formulary identifier for listed products, Version 17

Products listed with strength/volumemixed

300MG/2ML	Spevigo INJ 150MG/ML, 300MG/2ML
150MG/ML	Spevigo INJ 150MG/ML

Steqeyma product strengthsmixed

45MG/0.5ML	Steqeyma INJ 45MG/0.5ML
90MG/ML	Steqeyma INJ 90MG/ML
130MG/26ML	Steqeyma INJ 130MG/26ML

Spravato dosing optionsmixed

S6mg	Spravato S6mg Dose
84mg	Spravato 84mg Dose

Policy uses drug names and clinical criteria (no explicit billing codes in excerpt)mixed

N/A	No explicit CPT/HCPCS/ICD-10/NDC codes listed in this document section; coverage described by drug and clinical criteria.

Clinical Thresholds and Key Values

inv-146: Psoriasis BSA

Psoriasis BSA threshold>= 3% body surface area involvement

Alternative severe-site criteriaSevere scalp, palmoplantar, facial, or genital involvement may substitute for BSA threshold

Required topical trial before biologicMinimum 4-week trial and failure/contraindication/intolerance to topical therapies (eg, corticosteroids, vitamin D analogs, tazarotene, calcineurin inhibitors)

inv-147: PJIA prior therapy duration

PJIA prior therapy durationMinimum 6-week trial and failure, contraindication, or intolerance (TFIC/I) to leflunomide or methotrexate

PrescriberPrescribed by or in consultation with a rheumatologist

Authorization durationsInitial commonly 6 months; reauthorization 12 months when positive clinical response documented

inv-148: RA prior therapy duration

RA prior therapy durationMinimum 3-month trial and failure, contraindication, or intolerance (TFIC/I) to methotrexate, leflunomide, or sulfasalazine

Combination useSome agents required to be used in combination with methotrexate per product-specific criteria (see individual entries)

PrescriberPrescribed by or in consultation with a rheumatologist

inv-149: Crohn's Disease severity

Crohn's disease severityModerately to severely active CD defined by one of: frequent diarrhea and abdominal pain, >=10% weight loss, complications (eg, obstruction, fever, abdominal mass), abnormal labs (eg, elevated CRP), OR CDAI > 220

Objective signsCRP elevation or other abnormal labs may be used as objective evidence of activity

PrescriberPrescribed by or in consultation with a gastroenterologist

inv-150: Atopic dermatitis BSA/SCORAD

Atopic dermatitis BSA/SCORAD threshold>= 10% body surface area involvement OR SCORAD >= 25

Required topical/systemic trialsTrial and failure of at least two topical therapies (minimum 30 days; 14 days for topical corticosteroids) or systemic therapy as specified

Age and prescriberInitial: patient >=12 years; prescribed by or in consultation with a dermatologist or allergist/immunologist

inv-151: hematologic thresholds for polycythemia vera

Polycythemia vera hemoglobin thresholdsHgb >16.5 g/dL (men) or >16.0 g/dL (women) as part of diagnostic criteria; alternate severe thresholds also specified (eg, Hgb >18.5 men/>16.5 women)

Hematocrit thresholdsHct >49% (men) or >48% (women); alternate severe Hct thresholds noted (eg, >55.5% men/>49.5% women)

Bone marrow and EPOBone marrow panmyelosis and subnormal serum erythropoietin level or JAK2 mutation required for diagnosis confirmation

inv-152: platelet count requirement

Platelet count requirement (mastocytosis) Platelet count >50 x 10^9/L required for certain systemic mastocytosis indications

ContextApplied when approving therapy for advanced or indolent systemic mastocytosis per product entries

PrescriberNo specific age restriction noted; prescriber details per product entry

inv-153: Baseline ferritin for transfusional iron overload

Baseline ferritin for transfusional iron overloadBaseline serum ferritin >1,000 mcg/L

Transfusion historyDocumentation must show at least 100 packed red blood cells transfused for transfusional iron overload eligibility

Age limitsInitial transfusional iron overload criteria apply to patients >=2 years of age

inv-154: Transfused RBC units

Minimum transfused RBC unitsAt least 100 packed red blood cells transfused required for chronic transfusional iron overload eligibility

Associated ferritin criterionBaseline ferritin >1,000 mcg/L typically required in conjunction with transfusion history

Reauthorization evidenceReauth requires reduction from baseline in serum ferritin or LIC as documented

inv-155: LIC for NTDT initial

LIC threshold — NTDT initial>= 5 mg Fe/g dry weight (LIC) for non‑transfusion‑dependent thalassemia initial eligibility

Serum ferritin supportSerum ferritin >300 mcg/L supportive for NTDT initial indication

Age requirementNTDT initial: age >=10 years

inv-156: LIC for NTDT reauth

LIC threshold — NTDT reauthorization>= 3 mg Fe/g dry weight (LIC) required for NTDT reauthorization

Reauth evidenceReauth also requires reduction in serum ferritin or LIC from baseline

Coverage durationInitial NTDT coverage 6 months; reauth 6–12 months per product entry

inv-157: Diacomit weight requirement

Diacomit weight minimum>= 7 kg

Indication contextWeight requirement applies to seizure/epilepsy treatment entries specifying Diacomit; prescriber and age details per product entry

DocumentationConfirm weight in medical record at time of request

inv-158: Platelet count thresholds

Platelet count thresholds — TPPPBaseline platelet count <50,000/mcL for thrombocytopenia prior to planned procedure (TPPP)

Platelet count thresholds — chronic ITPBaseline platelet count <30,000/mcL for chronic ITP initial eligibility

Prior therapy requirementTFIC/I to corticosteroids, IVIG, or splenectomy required for chronic ITP initial

inv-159: Eosinophil thresholds

Eosinophil thresholds — asthmaBaseline peripheral blood eosinophils >=150 cells/µL for eosinophilic asthma eligibility

Historical eosinophil optionHistorical eosinophils >=300 cells/µL within past 12 months may meet criteria for some indications

Associated requirementsExacerbation history or hospitalization and controller therapy trials also required per product-specific criteria

inv-160: Hemoglobin / Hematocrit thresholds for erythropoiesis-stimulating agents

ESA Hgb/Hct thresholds (common)Hct <30% or Hgb <10 g/dL for CKD- or chemotherapy-related anemia initial eligibility

Other context thresholdsSome contexts cite Hct <36% or Hgb <12 g/dL or pediatric-specific thresholds per indication

Lab timingRelevant Hgb/Hct values must be collected within specified timeframes (eg, within 30 days or 2 weeks depending on indication)

inv-161: Peripheral blood eosinophil level

Peripheral blood eosinophil level for biologics>= 150 cells/µL baseline OR >= 300 cells/µL historical (used across asthma/COPD/eosinophilic indications)

DocumentationProvide baseline and/or historical eosinophil counts in medical records for eligibility and reauth

Associated clinical criteriaExacerbation history, hospitalizations, and controller therapy trials typically required in addition to eosinophil counts

inv-162: CDAI

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

Objective evidenceCDAI >220 may be supported by frequent diarrhea/abdominal pain, >=10% weight loss, complications, or abnormal labs (eg, CRP)

Use with IV inductionCDAI threshold referenced for eligibility including maintenance following IV induction dosing where specified

inv-163: Psoriasis BSA

Psoriasis BSA — policy referenceAt least 3% body surface area involvement qualifies as moderate-to-severe plaque psoriasis for biologic eligibility

Severe-site exceptionsSevere scalp, palmoplantar, facial, or genital disease may qualify even if BSA <3%

Required topical trialMinimum 4‑week trial and failure to topical therapies required prior to biologic initiation for plaque psoriasis

inv-164: Blood phenylalanine (Phe)

Blood phenylalanine (Phe) monitoringMeasure blood Phe after 1 week of therapy (new starts) and periodically for up to 2 months to assess response to sapropterin

ReauthorizationReauth requires demonstration of positive clinical response and continued Phe monitoring per PKU criteria

DocumentationSubmit serial blood Phe results in medical record to support ongoing therapy

inv-165: Advanced bone age

Advanced bone age criterionAt least one year advanced bone age compared with chronological age for central precocious puberty diagnosis

Diagnostic testingConfirmatory testing may include GnRHa stimulation or pubertal-range LH values per product-specific criteria

PrescriberPrescribed by or in consultation with an endocrinologist

inv-166: Blood eosinophil count

Blood eosinophil count thresholds>=150 cells/µL baseline OR >=300 cells/µL historical (applies across asthma, COPD and eosinophilic indications)

Indication-specific applicationSome indications (eg, HES, EGPA) require higher absolute counts or additional criteria (eg, >=1000 cells/µL pre-treatment for HES)

DocumentationProvide baseline/historical eosinophil counts and exacerbation/hospitalization history as required

inv-167: Obstructive respiratory events per hour (OSA)

OSA obstructive events/hour>= 15 obstructive respiratory events per hour (AHI/REI) OR >=5 events/hour plus qualifying daytime symptoms

Symptom examplesQualifying symptoms include excessive daytime sleepiness, unrefreshing sleep, fatigue, witnessed apneas, loud snoring, choking/gasping

DocumentationSleep study report required unless prescriber justifies infeasibility; include event rate and symptom documentation

inv-168: OSA diagnostic event rate

OSA diagnostic event rate>=15 events/hour OR >=5 events/hour plus daytime symptoms consistent with OSA

Study requirementDiagnostic sleep study (polysomnography or home study) report required unless documented justification provided

Authorization durationInitial and reauth durations vary by indication (eg, OSA initial/reauth commonly 6 months)

inv-169: HRCT fibrotic lung involvement for progressive ILD

HRCT fibrotic lung involvement>= 10% of lung volume with fibrotic features on HRCT for progressive fibrosing ILD eligibility

Progression evidenceRequire clinical/radiographic/physiologic evidence of progression (eg, decline in FVC) in addition to HRCT fibrosis

PrescriberPrescribed by or in consultation with a pulmonologist

inv-170: Baseline platelet count for ITP

Baseline platelet count for ITP< 30,000/mcL for chronic ITP initial eligibility

Prior therapy requirementTFIC/I to corticosteroids, IVIG, or splenectomy required before thrombopoietin receptor agonists for chronic ITP

Reauth evidenceReauth requires documented platelet response sufficient to avoid clinically important bleeding

inv-171: OSA diagnostic threshold

OSA diagnostic threshold (summary)>=15 obstructive events/hr OR >=5 events/hr with daytime symptoms

Required documentationSleep study report with event/hour rate and symptom correlation; justification if study not feasible

Typical coverage durationInitial and reauth commonly 6 months for OSA/SWD per policy entries

inv-172: Diabetes diagnostic thresholds

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

DocumentationSubmit medical records/chart notes or lab results confirming diagnostic thresholds for T2DM initial requests

PrescriberPrescribed by or in consultation with relevant specialist per indication (eg, endocrinologist for MASH)

inv-173: LDL-C thresholds for PCSK9 therapy

LDL-C thresholds for PCSK9 therapyExamples: LDL >=55 mg/dL with ASCVD OR LDL >=70 mg/dL without ASCVD; or requirement that >=25% LDL-C reduction needed to reach goal

Prior therapy requirementMaximally tolerated statin therapy required or documented statin intolerance (unable to tolerate >=2 statins) before PCSK9 initiation

HoFH specificsHoFH may require genetic confirmation or specified untreated/treated LDL thresholds and clinical features

inv-174: Hemoglobin / Hematocrit thresholds

Hemoglobin / Hematocrit thresholds (summary)Hct <30% or Hgb <10 g/dL commonly used for CKD- and chemo-related anemia initial eligibility

Context-specific thresholdsOther indications may use Hct <36% or Hgb <12 g/dL or pediatric thresholds per product criteria

Lab timing and iron evaluationLab values must be recent (eg, within 30 days or 2 weeks) and iron stores verified prior to ESA initiation

inv-175: eGFR

eGFR requirement>= 30 mL/min/1.73 m^2 for certain therapies (eg, Rivfloza initial eligibility requires preserved kidney function >=30 mL/min/1.73m^2)

ContexteGFR thresholds are applied to ensure preserved renal function for hepatically/renally cleared specialty agents

DocumentationProvide recent serum creatinine/eGFR in medical record when requested

inv-176: Atopic dermatitis BSA

Atopic dermatitis BSA>= 10% body surface area involvement qualifies for initial systemic/biologic therapy

SCORAD alternativeSCORAD index >=25 may be used as alternative severity measure

Required topical/systemic trialMinimum 30-day topical trial (14 days for TCS) and/or systemic therapy trials as specified prior to biologic initiation

inv-177: SCORAD index

SCORAD index threshold>= 25 (SCORAD >=25 meets severity criterion for moderate-to-severe atopic dermatitis)

Use with BSASCORAD may be used alongside BSA (>=10%) to establish disease severity for eligibility

Reauth evidenceReauth requires documented reduction in SCORAD or BSA from baseline demonstrating positive clinical response

inv-178: Crohn's Disease Activity Index (CDAI)

CDAI for Crohn's Disease> 220 defines moderately to severely active Crohn's disease for infliximab and other biologic eligibility

Supporting criteriaCDAI >220 may be accompanied by symptoms (frequent diarrhea, abdominal pain), weight loss >=10%, complications, or abnormal labs (eg, CRP)

Induction dosing contextCDAI used to support IV induction dosing and subsequent maintenance eligibility where specified

inv-179: BNP requirement for Friedreich's ataxia

BNP requirement — Friedreich's ataxiaB-type natriuretic peptide (BNP) <= 200 pg/mL required for Skyclarys initial eligibility

Genetic confirmationDiagnosis must be confirmed by genetic testing demonstrating FXN gene mutation

Age requirementInitial: patient >=16 years for Friedreich's ataxia entry

inv-180: Treatment duration for parathyroid hormones

Parathyroid hormone treatment duration limitTotal lifetime use of parathyroid hormones (eg, teriparatide) must not exceed 24 months

ExceptionContinuation beyond 24 months only if patient remains at high fracture risk and meets criteria per policy

ReauthReauthorization limited; document BMD, fracture history, FRAX, and prior osteoporosis therapy trials

inv-181: FRAX 10-year probability

FRAX 10-year probability thresholdMajor osteoporotic fracture probability >= 20% (U.S.) or country-specific threshold used as eligibility criterion

Use with BMDFRAX is applied along with BMD T-scores and fracture history to determine teriparatide eligibility

DocumentationProvide FRAX calculation and supporting BMD/fracture history in medical record for prior authorization

Prior Authorization, Documentation, Step Therapy and Denial Risks

Prior Authorization

Prior authorization and prescriber specialty

Prior authorization is required for many specialty products and prescriber specialty or consultation must be documented when specified (examples: rheumatologist for RA/PJIA/AS; dermatologist for PsO/HS; gastroenterologist for CD/UC; neurologist for MS or SMA).

Document prescriber specialty or consultation when the product entry requires it (e.g., neurologist for MS, pulmonologist for IPF).

Prior Authorization

Prior authorization requirement

Submit a prior authorization request including the diagnosis and the supporting clinical information listed in the product-specific criteria; typical authorization durations are stated (commonly 12 months; some initial approvals shorter).

Include indication-specific documentation and any required prior therapy or test results per the drug entry.
Expect common approval durations of 12 months unless a different initial period is specified.

Prior Authorization

Prior authorization required (product-specific)

Prior authorization is required for each listed product; approval depends on meeting the product’s clinical criteria (diagnosis, age, testing, prescriber).

Follow the drug-specific criteria in the formulary entry for approval conditions.

Prior Authorization

Pheochromocytoma — prior authorization

Preoperative use of metyrosine for pheochromocytoma requires prior authorization with biochemical confirmation and documented trial of both alpha- and beta-adrenergic blockade.

Provide plasma free or urinary fractionated metanephrines confirming pheochromocytoma.
Document trial and failure, contraindication, or intolerance to both an alpha-adrenergic blocker and a beta-adrenergic blocker.
Preoperative coverage duration: 4 weeks; chronic initial coverage: 6 months with reauth 12 months when indicated.

Prior Authorization

Thrombopoietin receptor agonist — prior authorization

Doptelet (thrombopoietin receptor agonist) requires prior authorization with diagnosis-specific platelet thresholds and prior therapy history.

TPPP: baseline platelet count <50,000/mcL required.
Chronic ITP initial: baseline platelet count <30,000/mcL and trial/failure, contraindication, or intolerance to at least one of corticosteroids, IVIG, or splenectomy.
Prescriber: hematologist/oncologist for ITP per entry.

Prior Authorization

Dupixent — prior authorization

Dupixent requires prior authorization with indication-specific criteria including eosinophil thresholds, exacerbation history, prior therapy trials, and appropriate specialist prescriber or consultation.

Eosinophilic asthma: baseline blood eosinophils ≥150 cells/mcL and exacerbation history or hospitalization as specified.
Atopic dermatitis: ≥10% BSA or SCORAD ≥25 and trials of topical/systemic therapies.
Document prescriber specialty (pulmonologist, allergist/immunologist, dermatologist, or gastroenterologist) as required.

Prior Authorization

Enbrel — prior authorization

Enbrel requires prior authorization for rheumatologic and dermatologic indications with documentation of prior conventional therapy trials and appropriate specialist prescribing/consultation.

RA: minimum 3-month TFIC/I to methotrexate, leflunomide, or sulfasalazine.
PJIA: minimum 6-week TFIC/I to methotrexate or leflunomide.
AS: minimum 1-month TFIC/I to an NSAID at maximally tolerated doses.
Prescriber: rheumatologist or relevant specialist.

Prior Authorization

Erivedge prior authorization

Erivedge (vismodegib) prior authorization requires documentation that disease meets criteria for metastatic or locally advanced basal cell carcinoma (recurrent or not a candidate for surgery/radiation).

Provide documentation of metastatic BCC OR locally advanced BCC with recurrence after surgery or inoperable for surgery and radiation.
Coverage duration typically 12 months.

Prior Authorization

Pirfenidone prior authorization

Pirfenidone prior authorization required for IPF: submit diagnostic documentation excluding other causes of ILD and HRCT or biopsy demonstrating UIP/probable UIP; approvals are for 12 months with reauth requiring clinical response.

Document exclusion of other known causes of ILD and either UIP pattern on HRCT or concordant HRCT and surgical lung biopsy.
Prescriber: pulmonologist or consultation with pulmonology.
Initial and reauthorization coverage: 12 months; reauth requires positive clinical response.

Prior Authorization

Evrysdi SOLR prior authorization

Evrysdi SOLR requires prior authorization with genetic confirmation of SMA (SMN1 mutation/deletion and SMN2 copy number), baseline motor assessments, neurologist prescribing or consultation, and reauthorization evidence of clinical benefit.

Provide genetic confirmation (SMN1 mutation/deletion and SMN2 copy number).
Submit baseline motor exam scores (HINE-2, HFMSE, RULM, CHOP INTEND, MFM‑32, or BSID‑III item 22).
Prescribed by or in consultation with a neurologist experienced in SMA; reauth requires demonstrated positive clinical response.

Prior Authorization

Prior authorization and duration

Prior authorization requests must include the diagnosis and the supporting documentation listed for each product entry; most approvals are for 12 months though some initial approvals are shorter.

Review the formulary entry’s required medical information and supply those records with the PA request.
Expect typical approval durations of 12 months unless a different initial duration is specified in the product entry.

Prior Authorization

Humira PA durations

Humira authorizations have indication-specific initial durations (examples: ulcerative colitis initial 12 weeks; many other indications have 6‑month initial approvals) and reauthorizations are generally 12 months.

Provide the indication-specific documentation and prior therapy trial evidence per the Humira entry.
Note the differing initial durations by indication (e.g., UC initial 12 weeks).

Prior Authorization

Prior authorization required for listed products

Many listed specialty products require prior authorization with documentation of diagnosis, prior therapy trials or contraindications, prescriber specialty when specified, and stated coverage duration (commonly 12 months).

Follow each product’s required diagnostic tests, prior therapy trials, and prescriber restrictions.
Be prepared to submit prior therapy history (TFIC/I) and lab or imaging results where specified.

Prior Authorization

Prior authorization required

Submit diagnosis and supporting clinical information per the drug-specific criteria; coverage durations and reauthorization requirements vary by indication (commonly 6–12 months).

Include required biomarker or mutation test results when specified (FDA‑approved or CLIA‑performed tests).
Check the product entry for the initial approval period and reauthorization expectations.

Prior Authorization

Prior authorization required

Prior authorization is required for many specialty products; requests must include diagnosis, prior treatment trials or contraindications when specified, and prescriber specialty consultations where required.

Ensure documentation of TFIC/I durations (eg, 3 months for RA, 6 weeks for PJIA, 4 weeks for topical PsO).
Supply specialist consultation notes when the entry requires a specialist prescriber.

Prior Authorization

Orencia PA requirement

Orencia requires prior authorization with documentation of diagnosis, prior medication trials, and specialist involvement; initial approvals often 6 months with reauthorization for 12 months.

RA: minimum 3‑month TFIC/I to methotrexate, leflunomide, or sulfasalazine.
PJIA: minimum 6‑week TFIC/I to methotrexate or leflunomide.
Prescriber: rheumatologist involvement or consultation required.

Prior Authorization

PAH agents PA requirement

Pulmonary arterial hypertension agents require prior authorization with confirmation of PAH by right heart catheterization or evidence of current PAH therapy and specialist prescribing/consultation.

Provide right heart catheterization documentation or evidence that patient is currently on PAH therapy.
Prescriber: pulmonologist or cardiologist.

Prior Authorization

Prior authorization required with diagnosis and prior therapy/biomarker evidence

Prior authorization requires documentation of diagnosis and specified prior therapy failures or biomarker confirmation for many agents; coverage durations are typically 12 months.

Include mutation or biomarker test results when required (FDA‑approved or CLIA‑performed assays).
Document prior therapy trials and failures per the agent-specific criteria.

Prior Authorization

Modafinil — prior authorization requirements

Modafinil initial authorization for idiopathic hypersomnia requires diagnosis confirmation by a sleep study unless the prescriber documents the study is not feasible; coverage durations vary by indication.

Provide sleep study documentation for idiopathic hypersomnia unless infeasible and justified by prescriber.
Note: narcolepsy initial/reauthorization 12 months; other indications often initial 6 months.

Prior Authorization

Infliximab — prior authorization requirements

Infliximab prior authorization requires indication-specific diagnostic criteria and documentation of trial and failure/contraindication/intolerance to conventional therapies; prescriber specialty restrictions apply (eg, gastroenterologist for CD/UC).

For CD/UC: document objective disease features or CDAI >220 and prior TF/C/I to immunomodulators or corticosteroids.
For RA and dermatologic indications: show combination with methotrexate or required topical/systemic prior trials and specialist prescribing.

Prior Authorization

Repatha — prior authorization requirements

Repatha prior authorization requires prior maximally tolerated statin therapy (or documented statin intolerance) and recent LDL values or prior PCSK9 therapy; HoFH requires genetic confirmation or specific LDL thresholds.

Document attempts at maximally tolerated statin therapy or documented intolerance to ≥2 statins.
Provide recent LDL‑C values and show LDL thresholds per indication (examples: LDL ≥55 mg/dL with ASCVD or ≥70 mg/dL without ASCVD).

Prior Authorization

Prior authorization required

Use the formulary criteria (Formulary ID 25384, Version 17) when submitting prior authorization requests; approvals commonly are 12 months and continuation of prior therapy is allowed per criteria.

Cite Formulary ID 25384, Version 17 on PA submissions when applicable.
Expect typical approval durations of 12 months and criteria for continuation of prior therapy.

Prior Authorization

Rinvoq prior auth

Rinvoq requires prior authorization with indication-specific documentation, prior trial/failure of required therapies, and prescriber specialty consultation for some indications; combinations with other JAK inhibitors or biologic DMARDs are prohibited.

Document TFIC/I to conventional therapies (eg, methotrexate, leflunomide) before initiation where required.
Do not combine Rinvoq with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants per formulary rules.

Prior Authorization

Prior authorization and specialist involvement required

Certain products require prior authorization with specialist involvement documented (e.g., Signifor requires endocrinologist involvement and documentation of pituitary surgery status).

When specialist prescribing/consultation is required, include that specialist’s notes in the PA submission.
For Cushing's disease, document pituitary surgery status or unsuitability for surgery.

Prior Authorization

Specialist prescribing and prior therapy documentation

Agent use for plaque psoriasis, PsA, Crohn's disease, or UC requires documentation of diagnosis and prior topical/systemic therapy trials and appropriate specialist prescribing or consultation.

For plaque psoriasis initial coverage, document a minimum 4‑week TFIC/I to topical therapies.
For IBD and PsA, include disease severity measures (eg, CDAI >220, stool frequency, BSA) and prior therapy history.

Prior Authorization

Prior authorization requirement

Prior authorization is required with documentation of diagnosis, relevant biomarker or mutation test results when specified, and evidence of prior therapy or intolerance as listed per agent.

Include FDA‑approved or CLIA‑performed mutation/biomarker test reports when the drug entry requires them (eg, BRAF, PIK3CA, IDH1).
Provide prior therapy history showing TFIC/I where step therapy is required.

Prior Authorization

Prior authorization — Teriparatide

Teriparatide prior authorization requires documentation of BMD T‑scores, fracture history or FRAX, and prior bisphosphonate or other osteoporosis therapy failure or intolerance; lifetime parathyroid hormone use must not exceed 24 months unless high risk persists.

Submit BMD results and fracture history; include FRAX 10‑year probability when applicable.
Document trial and failure or intolerance to at least one bisphosphonate (eg, alendronate).
Total lifetime parathyroid hormone use must not exceed 24 months except in persistent high‑risk patients.

Step Therapy

Required prior conventional therapy

Many indications require trial and failure, contraindication, or intolerance (TFIC/I) to specified conventional therapies before biologic or specialty agents will be approved; document TFIC/I durations as listed in product entries.

RA: minimum 3‑month TFIC/I to methotrexate, leflunomide, or sulfasalazine.
PsO: minimum 4‑week TFIC/I to topical therapies.
Caplyta and other psychiatric agents: document TFIC/I to listed oral antipsychotics.

Step Therapy

Step therapy for Caplyta

Caplyta for schizophrenia requires prior trial and failure, contraindication, or intolerance to two listed oral generic atypical antipsychotics; bipolar depression indication requires trial and failure to quetiapine or olanzapine.

Document trials and failures (or contraindication/intolerance) to two listed generic atypical antipsychotics for schizophrenia.
For bipolar depressive episodes, document TFIC/I to quetiapine (IR or ER) or olanzapine.

Step Therapy

Many biologic and specialty drug entries require trial and failure (TF/CI)

Many biologic and specialty drug entries require documented trial and failure (TF/CI) of specified prior therapies (examples include topical agents for plaque psoriasis, NSAIDs for AS, or prior biologics/small molecules for PsA) before authorization.

Follow the product-specific required prior therapy sequence and provide documentation of duration and outcome of each trial.
If continuing prior therapy, include records supporting continuation.

Step Therapy

Therapeutic step requirements (asthma/COPD/Dupixent)

Asthma, COPD and Dupixent/Nucala/Fasenra entries require prior controller therapy trials and documented eosinophil thresholds or phenotype criteria before authorization.

Provide baseline eosinophil counts (eg, ≥150 cells/µL baseline or ≥300 historical where specified).
Document trials of controller inhaled therapies (ICS/LABA, medium/high‑dose ICS) and exacerbation history.

Step Therapy

Fasenra step therapy expectations

Fasenra step therapy expects patients to have an eosinophilic phenotype (≥150 cells/µL) and prior controller therapy trials at specified intensities before approval; prescriber must be a pulmonologist or allergist/immunologist.

Document baseline eosinophils ≥150 cells/µL (or historical ≥300 cells/µL if applicable).
Show prior controller therapy trials (medium/high‑dose ICS plus additional controller or maximally dosed combination ICS/LABA).

Step Therapy

Humira RA step therapy

Humira for RA requires a minimum 3‑month TFIC/I to one conventional therapy (methotrexate, leflunomide, or sulfasalazine) prior to biologic initiation.

Document duration and outcome of the 3‑month trial with one conventional DMARD at maximally tolerated doses.

Step Therapy

Humira PJIA step therapy

Humira for PJIA requires a minimum 6‑week TFIC/I to leflunomide or methotrexate before authorization.

Provide evidence of a 6‑week trial and failure, contraindication, or intolerance to leflunomide or methotrexate.

Step Therapy

Inbrija step therapy

Inbrija for Parkinson’s OFF episodes requires prior trial and failure, contraindication, or intolerance to two classes (MAO‑B inhibitor, dopamine agonist, or COMT inhibitor) while on carbidopa/levodopa.

Document trials and outcomes for two of the specified classes and confirm concomitant carbidopa/levodopa therapy.

Step Therapy

Step therapy / required prior trials

Some products require documented trial and failure or intolerance to specific prior therapies (examples: Kesimpta requires TF/C/I to one disease‑modifying MS therapy; Kineret for RA requires TF/C/I to two listed therapies).

Provide documentation of prior DMTs tried and reasons for failure/intolerance when required by the product entry.

Step Therapy

Some indications require trial and failure of specified prior therapies

Certain indications require trials of specified prior therapies (e.g., alosetron requires trial/failure or intolerance to an antidiarrheal agent; Rebif requires a minimum 4‑week trial of Avonex or Betaseron where listed).

Document prior trial durations (minimum 4 weeks for interferons when required) and outcomes per the product criteria.

Step Therapy

Step therapy / prior trials

Some products require prior trial and failure of specified alternative agents (examples include Rebif, Nucala); include evidence of those prior trials in the PA submission.

For Rebif, document a minimum 4‑week trial and failure/contraindication to Avonex or Betaseron when required.
For Nucala/Nucala‑like biologics, include prior controller therapy trials and eosinophil counts.

Step Therapy

Parkinson's step therapy

Osmolex ER for Parkinson's disease requires trial and failure or intolerance to amantadine IR and one other class agent (carbidopa‑levodopa, MAO‑B inhibitor, or dopamine agonist) before approval.

Document trials of amantadine IR and one additional class agent with outcomes and reasons for failure/intolerance.

Step Therapy

Antipsychotic step requirements

Many antipsychotic product entries (eg, Opipza, Caplyta) require documented trials and failures/contraindications/intolerances to listed antipsychotics before approval.

Provide records of prior antipsychotic trials, durations, and reasons for failure or intolerance per the product criteria.

Step Therapy

Many agents require trials and failure or intolerance to specified therapies first

Generally, many agents require documented trials and failure or intolerance to specified therapies prior to initiation; include trial details and supporting clinical notes.

Include dates, medications, doses, duration, and clinical rationale for discontinuation or failure for each prior therapy trial.

Step Therapy

Infliximab: ankylosing spondylitis requirement

For ankylosing spondylitis, infliximab requires a minimum one‑month TFIC/I to one NSAID at maximally tolerated doses prior to approval.

Document the one‑month NSAID trial at maximally tolerated dose and clinical response.

Documentation Required

Pyruvate kinase deficiency agent (Pyrukynd): molecular testing requirement

Pyrukynd (pyruvate kinase deficiency) requires molecular confirmation of PKLR mutations meeting the policy’s specified variant criteria, evidence of chronic hemolysis, symptomatic anemia (Hgb ≤10 g/dL) or transfusion dependence, and hematology specialist involvement.

Provide molecular testing results showing required PKLR variant alleles per the entry.
Document evidence of chronic hemolysis (indirect bilirubin, LDH, low haptoglobin, reticulocytosis) and symptomatic anemia or transfusion dependence.
Prescriber: hematologist involvement or consultation required.

Step Therapy

Rinvoq step therapy

Rinvoq requires prior trial and failure, contraindication, or intolerance to specified conventional therapies (eg, methotrexate, leflunomide) before initiation for several indications.

Document TFIC/I to conventional therapies and any prior biologic use per the indication-specific requirements.

Step Therapy

Rolvedon step therapy

Rolvedon for febrile neutropenia (FN) prophylaxis requires prior trial and failure or intolerance to a specified G‑CSF agent (Neulasta/Onpro or Udenyca/Onbody) and documentation of the chemotherapy regimen qualifying for FN prophylaxis.

Document the chemotherapy regimen meeting FN prophylaxis criteria (dose‑dense regimen, >20% FN risk, or prior FN history).
Show trial and failure/intolerance to one of the specified G‑CSF agents.

Step Therapy

For plaque psoriasis initial coverage, required topical/systemic therapy trial

For plaque psoriasis initial coverage, document a minimum 4‑week trial and failure, contraindication, or intolerance to specified topical therapies before systemic or biologic therapy will be authorized.

Provide documentation of a 4‑week topical trial (steroids, vitamin D analog, tazarotene, or calcineurin inhibitor) and outcome.

Step Therapy

Step therapy: teriparatide requires prior bisphosphonate trial

Teriparatide requires prior trial and failure or contraindication/intolerance to at least one bisphosphonate (eg, alendronate) or other specified osteoporosis therapies prior to authorization; lifetime parathyroid hormone use must not exceed 24 months unless patient remains high risk.

Submit BMD, fracture history, prior osteoporosis therapy trials and documentation of bisphosphonate failure or intolerance.
Confirm total lifetime parathyroid hormone exposure has not exceeded 24 months unless high risk persists.

Documentation Required

Required clinical documentation

Provide required clinical documentation with PA submissions: diagnosis consistent with the listed indication, evidence of prior therapy trials/failures or contraindications/intolerance with specified durations, and objective disease severity measures when listed.

Include objective disease measures when required (eg, CDAI >220 for Crohn's; BSA or SCORAD for psoriasis/AD).
Attach records of prior treatments with dates, doses, durations, and rationale for discontinuation.

Documentation Required

PAH/CTEPH documentation

For PAH/CTEPH agents, submit confirmation of diagnosis (right heart catheterization) or documentation that patient is currently on therapy for PAH/CTEPH and include specialist (pulmonologist or cardiologist) involvement.

Attach right heart catheterization report when available or documentation of current PAH therapy.
Include specialist consult notes per the product entry.

Documentation Required

Benlysta required documentation

Benlysta requests must include documentation of active SLE with positive autoantibody (ANA ≥1:80 or anti‑dsDNA ≥30 IU/mL), current standard‑of‑care treatment, and rheumatology prescribing or consultation.

Provide ANA and/or anti‑dsDNA results meeting thresholds and notes showing current SOC treatment (eg, hydroxychloroquine, corticosteroid, immunosuppressant).
Include rheumatologist documentation.

Documentation Required

Bronchitol required documentation

For Bronchitol prior authorization, include a cystic fibrosis diagnosis and a passed Bronchitol Tolerance Test (BTT); initial authorization is for patients ≥18 years and typically 6 months.

Attach CF diagnosis documentation and BTT results.
Prescriber: pulmonologist or CF center specialist; initial coverage 6 months, reauth 12 months with evidence of benefit.

Documentation Required

Required documentation examples: diagnosis confirmation, organism detection

Examples of required documentation include diagnosis confirmation, organism detection (eg, Pseudomonas for CF), and evidence of benefit for reauthorization (eg, improved FEV1 or fewer pulmonary exacerbations).

For CF products, include microbiology confirming Pseudomonas aeruginosa where required.
For reauth, supply objective measures showing clinical benefit.

Documentation Required

Ferritin and LIC documentation for deferasirox

For deferasirox, document baseline ferritin, number of packed RBC transfusions, or liver iron concentration (LIC) per the indication (transfusional, NTDT, MDS) to support authorization and reauthorization.

Transfusional iron overload: baseline ferritin >1,000 µg/L and ≥100 packed RBC units transfused.
NTDT initial: LIC ≥5 mg Fe/g dw and ferritin >300 µg/L; reauth requires LIC ≥3 mg Fe/g dw and reduction from baseline.

Documentation Required

Pheochromocytoma — required diagnostic and trial history

Preoperative pheochromocytoma PA requires biochemical confirmation (plasma free or urinary fractionated metanephrines) and documentation of trial/failure or contraindication/intolerance to both alpha‑ and beta‑blockers.

Attach biochemical test results confirming pheochromocytoma.
Document trials of alpha‑adrenergic blocker and beta‑adrenergic blocker with outcomes.

Documentation Required

Hepatitis C — guideline-consistent documentation

Hepatitis C antiviral therapy requests must follow current AASLD/IDSA guideline‑consistent documentation and exclude decompensated liver disease (Child‑Pugh B or C); do not combine with another HCV DAA.

Provide documentation consistent with AASLD/IDSA guidance and show absence of decompensated liver disease.
Do not submit concurrent DAA combination therapies.

Note

Policy Background and Scope

This section compiles product-specific coverage criteria and the administrative requirements that providers must meet when requesting prior authorization for specialty medications listed in the formulary. It covers agents across immunology, rheumatology, dermatology, gastroenterology, pulmonology, hematology, and oncology and describes the clinical thresholds, required prior therapy trials, required diagnostic testing or biomarker confirmation, prescriber specialty expectations, and typical authorization durations that determine coverage.

Providers should note that prior authorization is required for these products and that approvals are contingent on submission of the diagnosis and supporting documentation specified for each agent (for example: trial-and-failure documentation, relevant labs or imaging, mutation or biomarker test reports, or specialist consultation notes). Many entries require demonstration of a positive clinical response for reauthorization (e.g., improvement in objective disease measures such as reduced swollen/tender joint counts, improved FEV1 for cystic fibrosis, reduced ferritin or LIC for iron overload, or decreased exacerbations for asthma).

The formulary applies step therapy and minimum trial-duration requirements in multiple settings (examples include a minimum 3-month trial for RA conventional DMARDs, a 6-week trial for PJIA, and a 4-week topical trial for plaque psoriasis). For many oncology and targeted agents, an FDA-approved or CLIA-certified diagnostic test is required to document actionable mutations or fusions (for example, BRAF, EGFR, PIK3CA, RET, IDH1/2), and coverage decisions hinge on those results.

Typical authorization lengths are stated in the formulary entries (commonly 12 months for maintenance and reauthorization; some initial approvals are shorter — e.g., 3, 4, or 6 months where indicated). Requests lacking required documentation — such as confirmation of diagnosis, trial-and-failure evidence, prescriber specialty involvement, or required laboratory/biomarker results — are at high risk for denial.

Use this section as the administrative and clinical background when preparing prior authorization submissions: include the specific indication, the required prior therapies and their durations, the numeric thresholds or test results cited for the indication, and documentation of specialist involvement when required. Accurate, contemporaneous clinical records mapped to the formulary criteria improve the likelihood of timely approval.

Key Definitions and Terms

inv-296: TFIC/I

TFIC/I definitionTrial and failure, contraindication, or intolerance to specified conventional therapy

ApplicationRequired prior-conventional therapy trials are required before many biologic/specialty agents (eg, RA, PsO, IBD)

Documentation riskFailure to document TFIC/I may lead to denial of coverage

inv-297: Reauth positive clinical response

Reauth — demonstration of positive clinical responseDocumented improvement from baseline in disease‑specific measures (eg, reduced swollen/tender joint count; reduced BSA or SCORAD; improved labs or mucosal healing) is required for reauthorization

Examples of measuresRA/PsA: joint counts; PsO/AD: BSA or SCORAD reduction; IBD: mucosal healing or improved CRP/CDAI

TimingReauth periods commonly 12 months; initial shorter in some indications (eg, 6 months) per product entries

inv-298: biomarker/mutation requirement

Biomarker/mutation testing requirementTumor mutation or biomarker status must be confirmed by an FDA‑approved or CLIA‑certified test when specified (eg, EGFR exon19/21, BRAF V600E/K, IDH1, PIK3CA)

Examples of testsExamples include THxID‑BRAF Kit, therascreen PIK3CA RGQ PCR Kit, Abbott RealTime IDH1 assay

DocumentationSubmit test report from FDA‑approved kit or CLIA lab with prior authorization request

inv-299: Reauthorization evidence of benefit

Reauthorization evidence of benefit — examplesDocumented clinical improvement such as improved FEV1 or reduced pulmonary exacerbations (CF), reduced joint counts (RA/PsA), or mucosal healing (IBD)

Required documentationProvide objective measures and chart notes showing improvement from baseline for reauth consideration

Common reauth intervalReauthorizations commonly granted for 12 months when benefit demonstrated

inv-300: LIC

LIC definitionLiver iron concentration measured in mg Fe per g dry weight (mg Fe/g dw); used to determine eligibility and reauthorization for deferasirox

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

DocumentationProvide LIC measurement method and value in prior authorization request

inv-301: Eosinophilic phenotype asthma

Eosinophilic phenotype asthma definitionAsthma with baseline peripheral blood eosinophils >=150 cells/µL (or historical >=300 cells/µL) and exacerbation history as specified

Associated requirementsRequires controller therapy trials and exacerbation/hospitalization history per biologic-specific criteria

PrescriberPrescribed by or in consultation with pulmonologist or allergist/immunologist

inv-302: Eosinophilic esophagitis (EoE)

EoE diagnostic requirementSymptomatic esophageal dysfunction plus >=15 intraepithelial eosinophils per high power field and exclusion of other causes

Prior therapyTrial and failure, contraindication, or intolerance to a PPI or topical esophageal steroid required unless contraindicated

Weight requirementPatient must weigh at least 15 kg for EoE eligibility

inv-303: UIP

UIP definitionUsual interstitial pneumonia pattern on HRCT consistent with idiopathic pulmonary fibrosis (UIP/probable UIP)

Role in eligibilityPresence of UIP on HRCT (or concordant HRCT + biopsy) required for IPF-specific therapies like pirfenidone

SpecialistPrescribed by or in consultation with a pulmonologist

inv-304: SMN1 / SMN2

SMN1/SMN2 testing for SMAGenetic confirmation of SMN1 mutation/deletion and documentation of SMN2 copy number required for SMA therapy eligibility

Baseline motor assessmentsProvide age-appropriate baseline motor exams (HINE-2, HFMSE, RULM, CHOP INTEND, MFM-32, or BSID-III item 22)

Concomitant therapy restrictionNot receiving concomitant chronic SMN‑modifying therapy (eg, Spinraza) unless documented inadequate response to prior gene therapy

inv-305: TFIC/I (alternate)

Alternate TFIC/I abbreviationTFIC/I (trial and failure, contraindication, or intolerance) used interchangeably with TF/C/I in the policy

ApplicationApplied across indications to denote required prior therapy trials before specialty agents

Denial riskFailure to document TFIC/I may result in denial

inv-306: C1-INH

C1‑INH criterion for HAE prophylaxisC1‑INH antigenic OR functional level below the lower limit of normal required for HAE prophylaxis eligibility

Age requirementPatient must be >=6 years of age for prophylactic C1‑INH use

Combination exclusionNot used in combination with other approved prophylactic HAE treatments

inv-307: TF/C/I

TF/C/I definitionTrial and failure, contraindication, or intolerance — abbreviation TF/C/I used to document prior therapy requirements

Use in policiesRequired for initial eligibility in multiple indications (eg, Kesimpta, Kineret, various biologics)

Documentation expectationMedical records should document duration and outcome of prior therapy attempts

inv-308: FDA/CLIA-approved test

FDA/CLIA‑approved test requirementWhen specified, biomarker/mutation testing must be performed by an FDA‑approved kit or CLIA‑certified laboratory for eligibility (eg, EGFR, BRAF, IDH1)

ExamplesTHxID‑BRAF Kit, therascreen PIK3CA RGQ PCR Kit, Abbott RealTime IDH1 assay cited as examples

DocumentationAttach lab/test report from FDA‑approved kit or CLIA lab with prior authorization request

inv-309: Oncology mutation testing requirement examples

Oncology mutation testing examplesExamples include detection of BRAF V600E/K, KRAS G12C, EGFR exon 19/21, FGFR2/FGFR3 alterations via FDA‑approved or CLIA tests

Combination therapy notesSome targeted agents require use in combination (eg, BRAF/MEK combinations) when indicated by tumor type and mutation

ContinuationContinuation of prior therapy allowed when prior response documented and mutation testing verified

inv-310: Phenylalanine (Phe) monitoring

Phe monitoring for PKU (sapropterin)Blood phenylalanine (Phe) must be measured after 1 week of therapy for new starts and periodically up to 2 months to assess response

Reauth monitoringContinued periodic Phe monitoring required during therapy and to support reauthorization

DocumentationProvide serial Phe lab results in medical record

inv-311: BRAF V600E / V600K mutant

BRAF V600E / V600K mutant requirementTumor must be BRAF V600E or V600K mutant as detected by an FDA‑approved test (eg, THxID‑BRAF Kit) or CLIA lab for BRAF‑targeted therapy eligibility

Indication examplesMelanoma, NSCLC, colorectal cancer, ATC, and select solid tumors require documented BRAF V600 mutation per product-specific criteria

Combination regimensMany indications require combination with MEK inhibitor (eg, trametinib) as specified

inv-312: FIP1L1-PDGFRA-negative

FIP1L1‑PDGFRA negative requirementFIP1L1‑PDGFRA negative molecular testing required before initiating certain HES therapies

HES clinical thresholdsUncontrolled HES defined by >=2 flares in past 12 months and pre‑treatment eosinophils >=1000 cells/µL for some approvals

SpecialistPrescribed by or in consultation with allergist/immunologist or hematologist per product criteria

inv-313: OSA diagnosis threshold

OSA diagnosis threshold (definition)Defined as >=15 obstructive respiratory events/hour on sleep study, or >=5 events/hour plus daytime symptoms

Study requirementSleep study documentation required unless prescriber provides justification that study is not feasible

ApplicationUsed to determine eligibility for therapies indicated for OSA-related disorders

inv-314: Progressive fibrosing ILD

Progressive fibrosing ILD definitionChronic fibrosing ILD with HRCT showing >=10% lung fibrotic features plus clinical/radiographic/physiologic evidence of progression

Evidence of progressionExamples include decline in FVC or worsening symptoms despite standard therapy

SpecialistPrescribed by or in consultation with a pulmonologist

inv-315: PIK3CA-mutated breast cancer

PIK3CA‑mutated breast cancer testingPIK3CA mutation must be detected by an FDA‑approved test (eg, therascreen PIK3CA RGQ PCR Kit) or equivalent CLIA test for Piqray eligibility

Combination therapyUse in combination with fulvestrant when disease progressed on or after an endocrine-based regimen

DocumentationAttach mutation test report from FDA‑approved kit or CLIA lab

inv-316: MASH (formerly NASH)

MASH definitionMetabolic dysfunction‑associated steatohepatitis (MASH) diagnosed by imaging or biopsy with fibrosis stage F2 or F3 confirmed by FibroScan, MAST, or liver biopsy

Cirrhosis exclusionPatient must not have decompensated cirrhosis (Child‑Pugh B or C) per policy

PrescriberPrescribed by or in consultation with gastroenterologist/hepatologist

inv-317: Chronic hemolysis

Chronic hemolysis laboratory evidenceEvidence includes increased indirect bilirubin, elevated LDH, decreased haptoglobin, and increased reticulocyte count

Use in hemolytic anemia policiesRequired for diagnosis of chronic hemolytic anemias and eligibility for specific therapies (eg, PK deficiency agents)

SpecialistPrescribed by or in consultation with a hematologist when specified

inv-318: CDAI (Crohn's Disease Activity Index)

CDAI definitionCrohn's Disease Activity Index (CDAI) >220 used to define moderately to severely active Crohn's disease for biologic eligibility

Clinical applicationCDAI >220 may be combined with objective signs (weight loss, CRP) to support therapy initiation

DocumentationProvide CDAI calculation or equivalent clinical documentation in medical record

inv-319: NTRK gene fusion

NTRK gene fusion requirementPresence of NTRK gene fusion detected by an FDA‑approved or CLIA‑certified test required for Rozlytrek eligibility

Tumor contextApplies to metastatic or unresectable solid tumors with no satisfactory alternative treatments or progression after prior therapy

DocumentationSubmit molecular testing report from FDA‑approved kit or CLIA lab

inv-320: Febrile neutropenia (FN) prophylaxis criteria

Febrile neutropenia prophylaxis criteriaQualifying conditions include dose-dense chemo regimens, regimens with >20% FN risk, or 10–20% FN risk with additional patient risk factors

Step requirementTrial and failure or intolerance to specified G‑CSF agents (eg, Neulasta/Onpro or Udenyca) may be required before Rolvedon

PrescriberPrescribed by or in consultation with hematologist/oncologist

inv-321: Friedreich's ataxia diagnostic requirement

Friedreich's ataxia diagnostic requirementDiagnosis confirmed by genetic testing demonstrating mutation in the FXN gene

BNP thresholdBNP <= 200 pg/mL required for Skyclarys initial eligibility where specified

PrescriberPrescribed by or in consultation with neurologist, neurogeneticist, or physiatrist

inv-322: IV induction weight-based dosing (specified drug)

IV induction weight-based dosingInduction dosing: 260 mg for patients <=55 kg; 390 mg for >55–85 kg; 520 mg for >85 kg

ApplicationApplies to one‑time IV induction biologic dosing for Crohn's disease/UC as specified in policy entries

DocumentationProvide patient weight and induction administration record for prior authorization

inv-323: FDA-approved or CLIA-certified test

FDA‑approved or CLIA‑certified test requirementBiomarker/mutation testing must be performed by an FDA‑approved test or in a CLIA‑certified laboratory when specified by the drug indication

ExamplesTHxID‑BRAF Kit, Abbott RealTime IDH1 assay, therascreen PIK3CA Kit cited as examples

DocumentationAttach laboratory or test report demonstrating mutation/fusion to support prior authorization