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CurrentBlue Cross Blue Shield - South CarolinaPolicy N/A

Biologic and specialty drug coverage criteria (selected products)

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This document defines coverage criteria, prescriber restrictions, required medical information, prior-therapy requirements, and coverage durations for multiple specialty and biologic medications for Blue Cross Blue Shield - South Carolina members.

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyBiologic and specialty drug coverage criteria (selected products)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2026

Last ReviewFeb 2, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, required prior-therapy documentation, and supporting test results (eg, genetic or biomarker tests) as specified per product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multiple productsentries

12 monthscommon coverage duration

26220formulary id

variesprerequisite Part D

Coverage Criteria

Initial therapy criteria (selected indications)

Examples of initial approval criteria for various indications (each indication has its own set of required elements):

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

Prescribed by or in consultation with a rheumatologist

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

Prescribed by or in consultation with a rheumatologist

Policy Summary

PayerBlue Cross Blue Shield - South Carolina

PolicyBiologic and specialty drug coverage criteria (selected products)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2026

Last ReviewFeb 2, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with diagnosis, required prior-therapy documentation, and supporting test results (eg, genetic or biomarker tests) as specified per product.

SourceLink

On This Page

Plaque Psoriasis (PsO) - Initial:

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

>=3% BSA or specified locations

Prescribed by or in consultation with a dermatologist

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

Prescribed by or in consultation with a rheumatologist

Crohn's Disease (CD) - Initial: Diagnosis of moderately to severely active CD AND one of: frequent diarrhea and abdominal pain, >=10% weight loss, complications (eg obstruction, fever, abdominal mass), abnormal labs (eg CRP), OR CDAI >220CDAI >220 or listed clinical features

Prescribed by or in consultation with a gastroenterologist

Uveitis - Initial: Diagnosis of non-infectious intermediate, posterior, or panuveitisclinical classification

Prescribed by or in consultation with an ophthalmologist or rheumatologist

Reauthorization / continuation criteria

Reauthorization criteria commonly require documentation of clinical improvement:

RA/PJIA Reauthorization: Patient demonstrates positive clinical response to therapy as evidenced by reduction in total active joint count OR improvement in symptoms (pain, stiffness, inflammation) from baselineclinical improvement

PsA Reauthorization: Patient demonstrates positive clinical response: reduction in active joint count OR symptom improvement OR reduction in BSA involvement from baselineclinical improvement or BSA reduction

HS Reauthorization: Patient demonstrates positive clinical response: reduction in abscess/inflammatory nodule count OR reduced formation of new sinus tracts/scarring OR symptom improvementclinical improvement

CD/UC Reauthorization: Patient demonstrates positive clinical response evidenced by improvement in intestinal inflammation (eg mucosal healing, lab values) OR reversal of high fecal output stateobjective or clinical improvement

UC initial coverage durations differ (12 weeks initial), see coverage duration

CGRP inhibitor (Aimovig) criteria

Migraine preventive therapy (Aimovig) criteria:

Episodic Migraine (EM) - Initial: Diagnosis of episodic migraine AND >=4 migraine days per month>=4 days/month

Medication will not be used with another CGRP inhibitor for prevention

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

Medication will not be used with another CGRP inhibitor for prevention

Augtyro — Initial Therapy

Augtyro — Covered when ALL of the following are met

Augtyro initial criteria: 1) Diagnosis of Mycobacterium avium complex (MAC) lung disease; 2) Used as part of a combination antibacterial regimen; 3) Patient did not achieve at least two negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen (eg, macrolide, rifamycin, ethambutol); 4) Prescribed by or in consultation with an infectious disease specialist or pulmonologist; 5) Coverage duration: 12 months.minimum 6 months of prior regimen

Used when sputum cultures remain positive

Benlysta — SLE and Lupus Nephritis

Benlysta — Covered when ALL of the following are met

Benlysta SLE initial: 1) Diagnosis of active systemic lupus erythematosus (SLE); 2) Autoantibody positive (ANA >=1:80 or anti-dsDNA >=30 IU/mL); 3) Currently receiving at least one standard-of-care treatment for active SLE (eg antimalarials, corticosteroids, or immunosuppressants); 4) Prescribed by or in consultation with a rheumatologist; 5) Coverage duration: 6 months initial and reauth; reauth requires positive clinical response.ANA >=1:80 or anti-dsDNA >=30 IU/mL

Pediatric threshold: age >=5 for IV/SC formulations

Avmapki Fakzynja Co-pack — Oncologic indications

Avmapki Fakzynja Co-pack — Covered when ALL of the following are met

NSCLC & NTRK indications: NSCLC: diagnosis of locally advanced or metastatic NSCLC with ROS1 rearrangement–positive tumor(s). Solid tumors: locally advanced, metastatic, or unresectable solid tumor with NTRK gene fusion; disease progressed following prior treatment or no satisfactory alternatives. Coverage duration: 12 months; approve continuation of prior therapy.NTRK fusion or ROS1 positive by testing

Prerequisite Part D drug required for some indications

Braftovi — BRAF-mutant cancers

Braftovi — Covered when ALL of the following are met

Braftovi indications: Melanoma: unresectable/metastatic with BRAF V600E or V600K mutation detected by FDA-approved test AND used with Mektovi (binimetinib). Colorectal cancer: unresectable/advanced or metastatic BRAF V600E mutant used with Erbitux (cetuximab) and prior therapy or with mFOLFOX6. NSCLC: metastatic with BRAF V600E mutant. Coverage duration: 12 months.BRAF V600E or V600K detected by FDA-approved test

Approve continuation of prior therapy

Tadalafil — BPH

Tadalafil (for BPH) — Covered when ALL of the following are met

Tadalafil BPH: Diagnosis of benign prostatic hyperplasia (BPH); trial and failure, contraindication, or intolerance to an alpha-blocker or a 5-alpha reductase inhibitor; exclusion: concurrent use of nitrates; coverage duration: 12 months.trial and failure of alpha-blocker or 5-alpha reductase inhibitor

Prerequisite Part D drug required

Bile acid synthesis disorder — initial coverage

Bile acid synthesis disorders due to single enzyme defects (initial): Covered when ALL of the following are met

BAS_initial: 1) Diagnosis of a bile acid synthesis disorder due to a single enzyme defect based on abnormal urinary bile acid analysis by mass spectrometry OR molecular genetic testing consistent with the diagnosis; 2) Prescribed by a hepatologist, medical geneticist, gastroenterologist, or other specialist treating inborn errors of metabolism; 3) Coverage duration: 4 months initial; reauth 12 months.

Reauth requires positive clinical response

Hereditary angioedema prophylaxis

Prophylaxis of hereditary angioedema (HAE) with Cinryze (initial): Covered when ALL of the following are met

HAE_prophylaxis: 1) Diagnosis of HAE confirmed by either: (a) low C4 AND C1-INH antigenic or functional deficiency documented (Type I/II), OR (b) normal C4 and C1-INH with presence of specified gene mutation detected by FDA-approved or CLIA test OR family history consistent with HAE with normal C1-INH; 2) Not used in combination with other approved prophylactic HAE treatments; 3) Prescribed by or in consultation with an immunologist or allergist; 4) Age >= 6 years; 5) Coverage duration: 12 months initial and reauth; reauth requires demonstration of positive clinical response.

Do not combine with other prophylactic agents

Onychomycosis topical therapy

Topical agents for onychomycosis (e.g., ciclopirox nail lacquer) — Covered when ALL of the following are met

Onychomycosis_topical: 1) No lunula (matrix) involvement; 2) Diagnosis of onychomycosis of toenails or fingernails; 3) Diagnosis confirmed by KOH preparation OR culture OR histology; 4) If toenail disease, mild-to-moderate disease involving at least 1 target toenail; 5) For fingernail: trial and failure/contraindication/intolerance to oral terbinafine (minimum 6-week supply) OR for toenail: trial and failure/contraindication/intolerance to oral terbinafine (minimum 12-week supply); 6) Coverage duration: 48 weeks.

Diagnosis confirmation required

Cosentyx — indication-specific criteria and reauthorization metrics

Cosentyx (secukinumab) indications — Covered when ALL applicable indication-specific criteria are met

Psoriasis_initial: Plaque psoriasis: Diagnosis of moderate to severe plaque psoriasis with >=3% BSA involvement OR severe scalp OR palmoplantar/facial/genital involvement; minimum 4-week trial and failure/contraindication/intolerance to one topical therapy (steroid, vitamin D analog, tazarotene, calcineurin inhibitor); prescribed by or in consultation with a dermatologist; initial coverage 6 months; reauth 12 months with documented positive clinical response (BSA reduction or symptom improvement).

Topical trial required

PsA_initial: Psoriatic arthritis: Diagnosis of active PsA with actively inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement; prescribed by or in consultation with rheumatologist or dermatologist; initial coverage 6 months; reauth 12 months with clinical response (reduction in swollen/tender joint count or symptom improvement).

AS_nr-axSpA_initial: Ankylosing spondylitis and non-radiographic axial spondyloarthritis: Diagnosis of active disease; AS and nr-axSpA require trial and failure/contraindication/intolerance to NSAIDs (AS: one NSAID; nr-axSpA: two NSAIDs) at maximally tolerated doses; prescribed by or in consultation with rheumatologist; initial coverage 6 months; reauth 12 months with documented improvement in disease activity, labs, function, axial status, or joint count.

NSAID trial required

HS_initial: Hidradenitis suppurativa: Diagnosis of moderate to severe HS; prescribed by or in consultation with dermatologist; initial coverage 6 months; reauth 12 months with reduction in abscess/inflammatory nodule count or reduced formation of new sinus tracts and scarring.

Deferasirox — iron overload coverage

Deferasirox (iron chelation) — Covered when ALL of the following are met

Deferasirox_transfusional: Chronic iron overload due to blood transfusions: Baseline ferritin >1000 mcg/L AND required transfusion of at least 100 mL/kg packed red blood cells; age >=2 years; coverage initial and reauth 12 months; reauth requires reduction from baseline in serum ferritin or liver iron concentration (LIC).> 1000 mcg/L

Deferasirox_NTDT: NTDT-related iron overload: LIC >=5 mg Fe/g dry weight and serum ferritin >300 mcg/L; age >=10 years; initial coverage 6 months; reauth criteria include LIC >=3 mg Fe/g dw and reduction from baseline in serum ferritin or LIC.>= 5 mg Fe/g dw

Cerebrotendinous xanthomatosis — coverage

Ctexli (chenodeoxycholic acid) for cerebrotendinous xanthomatosis — Covered when ALL of the following are met

CTX_initial: Diagnosis of cerebrotendinous xanthomatosis confirmed by pathogenic variant(s) in CYP27A1 detected by an FDA-approved or CLIA test; prescribed by or in consultation with neurologist, geneticist, or metabolic disease specialist; coverage initial and reauth 12 months; reauth requires positive clinical response.

Pyrimethamine — toxoplasmosis coverage

Pyrimethamine — Covered when ALL of the following are met

Pyrimethamine_toxoplasmosis: Patient is using pyrimethamine for active treatment of toxoplasmosis, secondary prophylaxis, or congenital toxoplasmosis; OR primary prophylaxis when TMP-SMX intolerance documented and desensitization failed or prior life-threatening reaction to TMP-SMX; prescribed by or in consultation with an infectious disease specialist; coverage duration 12 months; requests for malaria treatment/prophylaxis are not authorized.

Requests for malaria treatment/prophylaxis are not authorized.

Daurismo — AML coverage

Daurismo (glasdegib) for AML — Covered when ALL of the following are met

Daurismo_AML: Newly-diagnosed acute myeloid leukemia AND used in combination with low-dose cytarabine AND patient is >=75 years old OR has comorbidities precluding intensive induction chemotherapy; coverage 12 months; continuation of prior therapy approved when applicable.

Roflumilast — COPD coverage

Roflumilast for COPD — Covered when ALL of the following are met

Roflumilast_COPD: Diagnosis of COPD with history of exacerbations requiring systemic steroids, antibiotics, or hospitalization; trial and failure/intolerance/contraindication to two prior COPD therapies (eg Combivent, Spiriva); coverage initial and reauth 12 months; reauth requires demonstration of positive clinical response.

Cyclobenzaprine — usage and age-based PA

Cyclobenzaprine — Covered when ALL of the following are met

Cyclobenzaprine_uses: Muscle spasm due to acute painful musculoskeletal conditions OR fibromyalgia-related symptoms OR acute temporomandibular disorder (when used with an NSAID and with specific findings); prescriber must acknowledge anticholinergic risks for patients >=65 years; coverage durations: muscle spasm/TMD 4 weeks, fibromyalgia 12 weeks; PA applies to patients 65 years or older.

Requires prerequisite Part D drug per formulary details.

Chronic iron overload due to blood transfusions (initial)

Covered when ALL of the following are met:

Iron overload transfusional initial: Diagnosis of chronic iron overload due to blood transfusions (transfusional hemosiderosis).

Ferritin threshold: Baseline ferritin level > 1,000 mcg/L.> 1000 mcg/L

Transfusion history: Patient has required the transfusion of at least 100 mL/kg packed red blood cells.>= 100 mL/kg

Myelodysplastic Syndrome (MDS) (initial)

Covered when ALL of the following are met:

Diagnosis of MDS with Low or Intermediate-1 disease or is a potential transplant patient.

Transfusion requirement: Patient has received more than 20 red blood cell transfusions.> 20 transfusions

Non-transfusion-dependent thalassemia (NTDT) (initial)

Covered when ALL of the following are met:

Diagnosis of chronic iron overload due to non-transfusion-dependent thalassemia (NTDT).

LIC threshold: Liver iron concentration (LIC) >= 5 mg Fe/g dry weight.>= 5 mg Fe/g dw

Ferritin: Serum ferritin > 300 mcg/L.> 300 mcg/L

Metyrosine for pheochromocytoma (preop and treatment)

Covered when ALL of the following are met:

Biochemical confirmation: Diagnosis of pheochromocytoma confirmed by plasma free metanephrines OR urinary fractionated metanephrines.

Indication-specific: For preoperative preparation: used for preop prep; for treatment: hormonally active tumor and either not a surgical candidate or chronic treatment for malignant pheochromocytoma.

Adjunct therapy requirement: Trial and failure, contraindication, or intolerance to both an alpha-adrenergic blocker AND a beta-adrenergic blocker prior to use.

Dupixent (various indications) - select examples

Covered when indication-specific requirements are met (examples below):

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

Age and prior controller therapy requirements apply as detailed

Corticosteroid-dependent asthma (init): Diagnosis of moderate-to-severe asthma and current dependence on oral corticosteroids for asthma management.

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

Enbrel (TNF inhibitor) - rheumatologic and dermatologic indications

Covered when ALL of the following are met for a given indication:

Rheumatoid arthritis (init): Diagnosis of moderately to severely active RA AND minimum 3-month TF/C/I to one conventional therapy (methotrexate, leflunomide, or sulfasalazine) at maximally tolerated doses.3 months

Prescribed by or in consultation with a rheumatologist

Polyarticular JIA (init): Diagnosis of moderately to severely active PJIA AND minimum 6-week TF/C/I to methotrexate or leflunomide at maximally tolerated doses.6 weeks

Prescribed by or in consultation with a rheumatologist

Plaque psoriasis criteria: Diagnosis of moderate to severe chronic plaque psoriasis with >=3% BSA involvement OR severe scalp/palmoplantar/facial/genital involvement AND trial/failure of topical therapies (minimum durations as specified).>=3% BSA

Prescribed by or in consultation with a dermatologist

Emgality (migraine and cluster headache)

Covered when ALL applicable indication-specific criteria are met:

Episodic migraine (EM) initial: Diagnosis of episodic migraine AND >=4 migraine days per month (120 mg/mL strength only).>=4 days/month

Will not be used with another injectable CGRP inhibitor

Chronic migraine (CM) initial: Diagnosis of chronic migraine AND >=8 migraine days per month (120 mg/mL strength only); medication overuse headache considered and offending meds discontinued.>=8 days/month

Episodic cluster headache (ECH) initial: Diagnosis of episodic cluster headache with at least 2 cluster periods lasting 7–365 days separated by >=3 months pain-free, 100 mg/mL strength only.

Not used with another CGRP inhibitor

Empaveli (PNH, C3G, primary IC-MPGN)

Covered when ALL applicable criteria are met:

PNH initial: Diagnosis of paroxysmal nocturnal hemoglobinuria; provider requirement: prescribed by or in consultation with a hematologist/oncologist.

C3G / primary IC-MPGN initial: Diagnosis of C3G or primary IC-MPGN, age >=12 years for these indications, and patient treated with a maximally tolerated ACE inhibitor or ARB or SGLT2 inhibitor for >=12 weeks prior to initiation (for proteinuria reduction); for primary IC-MPGN patient must not have had a kidney transplant.>=12 weeks prior ACE/ARB/SGLT2

L-glutamine for sickle cell disease

Covered when ALL of the following are met:

Sickle cell disease initial: Diagnosis of sickle cell disease AND history of >=2 painful sickle cell crises within the past 12 months.>=2 crises/12 months

General reauthorization requirement (disease-specific examples)

Covered when ALL of the following are met for reauthorization:

General reauth: Member demonstrates positive clinical response to therapy as evidenced by disease-specific measures.see children nodes

Examples: RA/PJIA: reduction in active joint count or symptom improvement; PsA: reduction in active joint count, symptom improvement, or BSA; Plaque psoriasis: reduction in BSA or symptom improvement; AS: improvement in disease activity, labs, function, axial status, or joint count.

Evrysdi (risdiplam) initial criteria

Covered when ALL of the following are met:

Evrysdi initial: Diagnosis of SMA type I, II, or III with genetic confirmation (SMN1 mutation/deletion) AND at least 2 copies of SMN2; baseline motor exam performed; not dependent on both invasive ventilation and chronic non-invasive ventilation beyond naps/night; not receiving concomitant chronic SMN-modifying therapy; if prior gene therapy, inadequate response documented over >=6 months.SMN2 >=2 copies; inadequate response period 6 months if prior gene therapy

Baseline motor testing options: HINE-2, HFMSE, RULM, CHOP INTEND, MFM-32, BSID-III item 22.

Icatibant acetate (HAE) initial criteria

Covered when ONE of the following diagnostic pathways is satisfied:

HAE Type I/II: C4 level below lower limit of normal AND C1-INH antigenic or functional deficiency documented (antigenic or functional level below LLN). For HAE with normal C1-INH, require genetic mutation detection or confirmed family history plus normal C4/C1-INH.laboratory below lower limit of normal

For HAE with normal C1-INH require mutation detection or family history.

Procrit (epoetin) anemia coverage criteria

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

CKD anemia initial: Diagnosis of CKD and anemia by labs (Hct <30% or Hgb <10 g/dL) collected within specified timeframe; additional indication-specific conditions (on dialysis vs not) apply; adequate iron stores confirmed (ferritin >100 mcg/L and TSAT >20%).Hct <30% or Hgb <10 g/dL; ferritin >100 mcg/L and TSAT >20%

Reauth requires recent/average Hct/Hgb over 3 months meeting specified cutoffs and demonstration of positive clinical response.

Gamastan — metastatic colorectal cancer

Covered when ALL of the following are met (example: Gamastan metastatic colorectal cancer criteria)

Gamastan for metastatic colorectal cancer: Diagnosis of metastatic colorectal cancer; prior treatment with both: A) fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy AND B) anti-VEGF biologic therapy; plus either RAS mutant tumors OR (RAS wild-type AND prior anti-EGFR therapy AND prior Lonsurf or regorafenib).

Coverage duration 12 months; continuation of prior therapy allowed.

Gavreto — RET fusion–positive NSCLC/thyroid cancer

Covered when ALL of the following are met (Gavreto - RET fusion-positive disease)

Gavreto (pralsetinib): Diagnosis of NSCLC or advanced/metastatic thyroid cancer with RET gene fusion–positive tumor detected by FDA-approved or CLIA-approved test; for thyroid cancer, disease is advanced/metastatic and radioactive iodine–refractory or radioactive iodine therapy not appropriate.

Coverage duration 12 months; continuation of prior therapy allowed.

Humira — inflammatory and autoimmune conditions

Covered when ALL of the following are met (Humira and related biologics immunologic indications)

Humira (adalimumab) indications: Diagnosis consistent with one of listed indications (RA, PJIA, PsA, PsO, AS, CD, UC, HS, uveitis, etc.); documented TF/C/I to required conventional or topical/NSAID therapies with specified minimal durations per indication; prescriber specialty involvement when required; reauth requires documentation of positive clinical response as specified per indication.

Coverage durations: UC initial 12 weeks then reauth 12 months; other indications initial 6 months reauth 12 months per indication specifics.

Growth hormone products — pediatric and adult indications

Covered when ALL of the following are met (growth hormone products)

Genotropin and growth hormone products: Indication-specific diagnostic confirmation (PGHD, PWS, GFSGA, TS/NS, SHOX, AGHD, IGHDA, ISS) with documented growth metrics (height SDS thresholds, growth velocity, bone age) and prescriber restriction (endocrinologist or nephrologist as specified); reauth requires evidence of positive response and expected adult height not yet attained.height/SD thresholds as specified

Coverage duration 12 months; prescriber restrictions apply.

Selected oncology agents — diagnosis and mutation-confirmation requirements

Covered when ALL of the following are met (hematologic/oncology targeted agents)

Iclusig / Idhifa examples: Diagnosis consistent with labeled disease (eg, CML, Ph+ ALL for Iclusig; relapsed/refractory AML with IDH2 mutation for Idhifa detected by FDA-approved or CLIA test); use conditions as specified (eg combination with chemotherapy up to 20 cycles or monotherapy in specific T315I situations for Iclusig).

Coverage duration 12 months; continuation of prior therapy allowed.

Targeted oncology agents

Products covered when documented indication-specific criteria are met

Idhifa (example): Diagnosis of AML; disease relapsed/refractory; IDH2 mutation detected by FDA-approved or CLIA-certified test

Coverage duration 12 months; continuation of prior therapy allowed

Immune globulin (IVIG/SCIG) coverage criteria

IVIG covered when specific diagnostic and laboratory criteria are met

Primary immunodeficiency criteria: Primary immunodeficiency diagnoses (eg CVID, congenital agammaglobulinemia, SCID, Wiskott-Aldrich) with immunologic evaluation and inadequate response to vaccines or low IgGIgG below lab normal for age

Administer at minimum effective dose and frequency; prescriber with specialized expertise required

Secondary/acquired antibody deficiency: B-cell CLL with Ig <500 mg/dL or recurrent infections; HIV with Ig <400 mg/dL and/or active bleeding with low platelets; multiple myeloma in plateau with hypogammaglobulinemianumeric thresholds as listed

Coverage duration 12 months (4 months for solid organ transplant in some uses); subject to Part B vs Part D review

Neuromuscular autoimmune disorders: CIDP, GBS, inflammatory myopathies, Lambert-Eaton, multifocal motor neuropathy, myasthenia gravis with severe exacerbation; many require TF/C/I to corticosteroid and immunosuppressant

Prescribed by or in consultation with a specialist; renewal requires objective improvement and dose optimization

Movement disorder agent

Acute Parkinson's OFF episodes

Inbrija: Diagnosis of Parkinson disease with intermittent OFF episodes; currently treated with carbidopa/levodopa; TF/C/I to two of: MAO-B inhibitor, dopamine agonist, or COMT inhibitor prior to use; prescribed by or in consultation with a neurologist

Coverage duration initial/reauth 12 months; reauth requires positive clinical response

Ivermectin coverage

Antiparasitic therapy

Ivermectin: Diagnosis of intestinal strongyloidiasis due to Strongyloides stercoralis OR onchocerciasis due to Onchocerca volvulus

Coverage durations: strongyloidiasis 3 weeks; onchocerciasis 6 months

Iwilfin — Initial/Continuation

Iwilfin (high-risk neuroblastoma)

Iwilfin initial/continuation: Diagnosis of high-risk neuroblastoma; patient has shown at least a partial response to prior multiagent, multimodality therapy including prior anti-GD2 immunotherapy; coverage duration 12 months; approve continuation of prior therapy.

Prerequisite Part D drug required.

Jakafi — Indications

Jakafi indications aggregated

Jakafi indications: Diagnosis of primary or post-PV or post-ET myelofibrosis OR polycythemia vera with TF/C/I to hydroxyurea OR steroid-refractory aGVHD OR chronic GVHD with TF of >=1 systemic therapy; coverage duration 12 months; continuation of prior therapy approved.

Prerequisite Part D drug required.

Jaypirca — Indications

Jaypirca indications

Jaypirca — MCL: Diagnosis of mantle cell lymphoma that is relapsed or refractory; patient has received >=2 prior therapies including a BTK inhibitor; coverage 12 months.

Prerequisite Part D drug required.

Jaypirca — CLL/SLL: Diagnosis of CLL or SLL; patient has received prior therapy with both a BTK inhibitor and a BCL-2 inhibitor; coverage 12 months.

Prerequisite Part D drug required.

Kalydeco — CF

Kalydeco (ivacaftor) for cystic fibrosis

Kalydeco initial: Diagnosis of cystic fibrosis with at least one CFTR mutation responsive to ivacaftor per FDA-cleared or CLIA-approved assay; prescribed by or in consultation with specialist at CF care center or pulmonologist; patient >=1 month of age; coverage 12 months; reauth requires positive clinical response (eg improved ppFEV1 or fewer exacerbations).

No prerequisite Part D drug required.

Jynarque — ADPKD monitoring

Jynarque (tolvaptan) for ADPKD

Jynarque initial: Diagnosis of rapidly progressing ADPKD. If patient has received Jynarque <=18 months: ALT/AST/bilirubin measured prior to initiation, at 2 and 4 weeks, then monthly for first 18 months. If >18 months: ALT/AST/bilirubin at least every 3 months. Patient must not have significant liver impairment. Coverage 12 months.

Monitoring schedule required

Kesimpta — MS

Kesimpta (MS)

Kesimpta initial: Diagnosis of relapsing form of MS; TF/C/I (minimum 4-week supply), contraindication, or intolerance to one disease-modifying therapy OR continuation of prior therapy; not used in combination with another DMT or another B-cell targeted therapy; prescribed by/with neurologist; coverage 12 months.

Prerequisite Part D drug required.

Kineret — RA and NOMID

Kineret (anakinra) indications

Kineret — RA initial: Diagnosis of moderately to severely active RA; TF/C/I to two listed agents (eg Enbrel, formulary adalimumab, Orencia, Rinvoq, Xeljanz) or attestation that trials are inappropriate, OR continuation of prior therapy; initial 6 months, reauth 12 months.

Prerequisite Part D drug required.

Kineret — NOMID initial: Diagnosis of NOMID with confirmation by NLRP3 mutation OR both characteristic clinical features and elevated acute phase reactants; prescribed by allergist/immunologist/rheumatologist/pediatrician; initial 6 months; reauth requires demonstrated positive clinical response.

Prerequisite Part D drug required.

Kerendia — CKD/T2D and HF

Kerendia (finerenone) indications

Kerendia — CKD/T2D initial: Diagnosis of CKD associated with T2D; UACR >=30 mg/g; eGFR >=25 mL/min/1.73m2; serum potassium <=5.0 mEq/L prior to initiation; trial of maximally tolerated ACE inhibitor/ARB for 30 days OR contraindication/intolerance to ACE/ARB; coverage 12 months; reauth requires positive clinical response and continued ACE/ARB or documented contraindication.UACR >=30 mg/g; eGFR >=25; K+ <=5.0

Prescriber: cardiologist/nephrologist as specified; prerequisite Part D drug required.

Kerendia — HF with LVEF >=40% initial: Diagnosis of HF with LVEF >=40% and NYHA class II–IV, eGFR >=25, serum potassium <=5.0; patient on diuretic >=30 days and not receiving spironolactone/eplerenone; patient on SGLT2 inhibitor or has contraindication/intolerance; prescribed by/with cardiologist; coverage 12 months; reauth requires continued SGLT2 or contraindication.eGFR >=25; K+ <=5.0

Prerequisite Part D drug required.

Livmarli — ALGS and PFIC

Livmarli (maralixibat) indications

Livmarli — ALGS initial: Diagnosis of Alagille syndrome with JAG1 or NOTCH2 mutation confirmed by molecular genetic testing; patient experiencing cholestatic pruritus; inadequate response to at least one pruritus treatment (eg rifampin); patient >=3 months of age; prescribed by hepatologist or gastroenterologist; coverage initial 12 months; reauth requires demonstrated positive clinical response (reduced bile acids/pruritus).

Prerequisite Part D drug required.

Livmarli — PFIC initial: Diagnosis of PFIC with mutation confirmed in ATP8B1, ABCB11, ABCB4, TJP2, NR1H4, or MYO5B; patient experiencing cholestatic pruritus; inadequate response to at least one pruritus treatment; patient >=12 months of age; initial coverage 6 months then reauth 12 months upon positive response.

Prerequisite Part D drug required.

Lonsurf — GI cancers

Lonsurf (trifluridine/tipiracil) for colorectal and gastric cancers

Lonsurf — metastatic colorectal cancer: Diagnosis of metastatic colorectal cancer; used as single agent or with bevacizumab; prior treatments include fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy; if RAS wild-type must have received anti-EGFR therapy; coverage 12 months.

Prerequisite Part D drug required.

Lonsurf — gastric/GEJ adenocarcinoma: Diagnosis of metastatic gastric or gastroesophageal junction adenocarcinoma; patient previously treated with at least two of fluoropyrimidine, platinum, taxane or irinotecan-based regimens; coverage 12 months.

Prerequisite Part D drug required.

Alagille syndrome (initial)

ALGS (initial) — Covered when ALL of the following are met

ALGS initial criteria: 1) Diagnosis of Alagille syndrome; 2) Molecular genetic testing confirms mutation in JAG1 or NOTCH2; 3) Patient experiencing cholestatic pruritus; 4) Inadequate response to one pruritus treatment (eg rifampin); 5) Patient is >=3 months of age; 6) Prescribed by or in consultation with a hepatologist or gastroenterologist; coverage duration: 12 months initial and reauth.

Reauth requires positive clinical response.

Progressive Familial Intrahepatic Cholestasis (initial)

PFIC (initial) — Covered when ALL of the following are met

PFIC initial criteria: 1) Diagnosis of PFIC; 2) Molecular genetic testing confirms mutation in one of ATP8B1, ABCB11, ABCB4, TJP2, NR1H4, or MYO5B; 3) Patient experiencing cholestatic pruritus; 4) Inadequate response to one pruritus treatment (eg rifampin); 5) Patient is >=12 months of age; coverage duration: 6 months initial; reauth 12 months if positive clinical response; prescriber hepatologist/gastroenterologist for initial use.

Neulasta (pegfilgrastim) indications

Neulasta — Covered when ANY of the indicated scenarios apply with required documentation

Neulasta indications: 1) FN prophylaxis: patient receiving prophylaxis for FN due to dose-dense chemotherapy (eg INT C9741), chemotherapy regimens with >20% FN risk, or regimens with 10–20% FN risk plus risk factors; 2) Secondary prophylaxis: history of FN or dose-limiting neutropenic event during prior chemotherapy; 3) Treatment of FN: diagnosis of FN and high risk for infection; 4) Acute radiation syndrome (ARS): exposure to myelosuppressive radiation (hematopoietic subsyndrome).

Prescribed by or in consultation with hematologist/oncologist; ARS 1 month; FN prophylaxis/treatment 3 months or duration of treatment.

FN prophylaxis (initial/secondary)

Covered when ANY one of the following chemotherapy-related conditions is met for FN prophylaxis:

FN prophylaxis qualifying conditions: 1) Receiving NCI Breast Intergroup INT C9741 dose-dense chemotherapy protocol; OR 2) Receiving a dose-dense chemotherapy regimen with unknown FN incidence; OR 3) Receiving chemotherapy regimens with >20% FN incidence; OR 4) Receiving regimens with 10–20% FN incidence AND patient has one or more FN risk factors; OR 5) Receiving myelosuppressive anticancer drugs and history of FN or dose-limiting event during prior chemotherapy (secondary prophylaxis).N/A

Prescriber must be hematologist/oncologist or consult

Posaconazole (suspension) coverage

Posaconazole (suspension) coverage — Covered when ALL of the following apply depending on indication:

Prophylaxis of systemic fungal infections: Patient is at high risk due to severe immunosuppression from HSCT with GVHD or hematologic malignancies with prolonged neutropenia from chemotherapy OR patient has prior fungal infection requiring secondary prophylaxis; age >=13 for prophylaxis in some entries or >=2 in alternate entries; coverage prophylaxis 6 months.N/A

Prerequisite Part D drug required where indicated

Oropharyngeal candidiasis (OPC): Diagnosis of OPC AND trial and failure, contraindication, or intolerance to fluconazole OR susceptibility testing showing fluconazole resistance; age >=13 for OPC; coverage 1 month.N/A

Ofev (nintedanib) coverage

Ofev (nintedanib) coverage — Covered when the specific diagnostic and imaging/functional criteria for each ILD indication are met:

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

Prescribed by or in consultation with pulmonologist or rheumatologist

SSc-ILD initial: Diagnosis of systemic sclerosis-associated ILD with exclusion of other causes AND either imaging consistent with SSc-ILD on HRCT or concordant HRCT and surgical lung biopsy patternsN/A

Prescribed by or in consultation with pulmonologist or rheumatologist

Chronic fibrosing ILD with progressive phenotype: Diagnosis of chronic fibrosing ILD AND HRCT showing >=10% lung volume with fibrotic features AND disease demonstrated to have a progressive phenotype by decline in FVC, worsening respiratory symptoms, or increased extent of fibrosis on imaging≥10% fibrosis on HRCT

Prescribed by or in consultation with pulmonologist or rheumatologist

This document contains product-specific coverage criteria that apply only when all listed elements for a given indication are met. Many entries require prior authorization with submission of the diagnosis, relevant laboratory or diagnostic testing, and documentation of prior trial and failure, contraindication, or intolerance (TF/C/I) to specified conventional therapies where noted. Coverage durations are product- and indication-specific but are commonly 12 months; some initial authorizations list shorter durations (examples: 4 months, 6 months) with reauthorization contingent on evidence of clinical benefit. Prescriber specialty requirements are specified per product when required; where no prescriber restriction is listed, none is implied. Off-label uses are either not addressed or marked as N/A in this excerpt; exclusions and not-medically-necessary statements are specified per product and must be checked for each request.

Requests lacking required documentation (diagnosis, TF/C/I evidence, required biomarker or genetic testing, baseline disease severity measures, or objective response for reauthorization) may be denied. Examples of required documentation include genetic or CLIA/FDA-approved test results for targeted oncology or genetic therapies, baseline functional or laboratory measures for rare-disease therapies, and prior therapy history for biologics and specialty agents.

Concurrent use of nitrates with tadalafil for benign prostatic hyperplasia is an explicit exclusion. Prior authorization for tadalafil requires documentation of the BPH diagnosis and prior trial/failure, contraindication, or intolerance to an alpha-blocker or a 5‑alpha reductase inhibitor; any evidence of concurrent nitrate therapy should result in denial per the exclusion.

Providers should confirm current medication lists for nitrate use before initiating tadalafil and document TF/C/I to the prerequisite therapies as specified in the product entry.

Pyrimethamine is covered only for specified toxoplasmosis indications (active treatment, secondary prophylaxis, congenital disease, or primary prophylaxis when TMP‑SMX intolerance is documented and desensitization failed). Requests for pyrimethamine for the treatment or prophylaxis of malaria are not authorized and will not be approved. Prescribers must supply infectious-disease documentation supporting the approved toxoplasmosis indications.

Cinryze (HAE prophylaxis) must not be used in combination with other approved prophylactic HAE treatments. Initial and reauthorization requests require laboratory or genetic confirmation of HAE and prescriber documentation (immunologist or allergist involvement); combination prophylactic use is an explicit exclusion and should be denied.

For prophylaxis, age and diagnostic criteria specified in the product entry must be met and documented.

Multiple product entries in this extract mark off‑label uses as N/A and do not provide separate off‑label coverage criteria in the excerpt. Where an off‑label use is not expressly detailed, the absence of off‑label criteria in this extract indicates that coverage is limited to the listed medically accepted indications and that specific off‑label requests require separate review or are not supported by this excerpt.

Erythropoiesis‑stimulating agents (ESAs) have defined hematologic thresholds for off‑label use. Requests for ESAs for off‑label indications (except where explicitly allowed, e.g., MDS or HCV) will not be approved when hemoglobin is greater than 10 g/dL or hematocrit is greater than 30%. For labeled anemia indications, the product-specific Hgb/Hct cutoffs and iron‑store criteria (eg, ferritin and TSAT) must be documented as specified in the entry.

Icatibant acetate (for HAE attacks) is not to be used in combination with other approved treatments for acute HAE attacks. The product entry requires diagnostic confirmation of HAE subtype (C4 and C1‑INH antigenic or functional levels) or genetic/family history for HAE with normal C1‑INH; combination acute‑attack therapy is an exclusion and should be denied if documented.

Prescribers must document laboratory confirmation and avoid concurrent use of other acute HAE agents per the exclusion.

Fabrazyme (for Fabry disease) must not be used in combination with other drugs for Fabry disease. Initial and reauthorization requests require diagnostic confirmation (GLA mutation, enzyme deficiency, or significant clinical manifestations); any request proposing combination therapy with other Fabry drugs should be denied in accordance with the exclusion.

Multiple sclerosis disease‑modifying therapies listed in this excerpt include explicit combination‑therapy exclusions. Agents such as fingolimod, glatiramer acetate, and similar MS disease‑modifying therapies must not be used in combination with another disease‑modifying therapy for MS; requests proposing concurrent use should be denied. Prescriber documentation should confirm monotherapy status and neurologist involvement as required.

Across this extract, off‑label uses are frequently marked as N/A and no separate off‑label coverage pathways are provided. When off‑label use guidance is absent in the product entry, approval should be limited to the specified labeled indications and any unlisted off‑label requests should be escalated for clinical review or considered noncovered per plan policy.

Kesimpta (ofatumumab) for relapsing MS must not be used in combination with another disease‑modifying therapy for MS or with another B‑cell targeted therapy (for example, rituximab or ocrelizumab). The entry requires a trial and failure (or contraindication/intolerance) to one disease‑modifying therapy or continuation of prior therapy and specifies neurologist involvement; any combination‑therapy requests are excluded.

Betaseron (interferon beta‑1b) and other MS formulations are listed with an explicit exclusion against combination use with another disease‑modifying MS therapy. Providers must confirm the patient is not receiving concurrent disease‑modifying therapy and document neurologist prescribing or consultation as required.

Requests proposing combination disease‑modifying therapy should be denied in accordance with the MS‑specific exclusions.

Onpattro (patisiran) and other hATTR therapies are not to be used in combination with a TTR silencer (eg, vutrisiran/Amvuttra) or a TTR stabilizer (eg, tafamidis/Vyndaqel). The hATTR entries explicitly state that requested therapy must not be combined with other TTR‑directed agents; prescribers must document the absence of concurrent TTR silencers or stabilizers when submitting authorization requests.

Failure to document that the requested hATTR therapy will be used as monotherapy, or evidence of concurrent TTR‑directed therapy, will risk denial per the exclusion.

The hATTR therapy entries include a general combination‑therapy exclusion: requested hATTR therapies must not be used in combination with a TTR silencer (eg, Amvuttra) or a TTR stabilizer (eg, Vyndaqel). Prior authorization requires genetic confirmation of a pathogenic TTR mutation and baseline neuropathy severity; any combination use is an explicit exclusion and should be denied.

Quinine sulfate is excluded if it is prescribed solely for the treatment or prevention of nocturnal leg cramps. The formulary entry for quinine specifies that such use is an exclusion; requests for quinine for leg cramps should be denied.

Indications for quinine included in the entry (for example, malaria treatment in specified contexts) remain subject to the standard diagnostic and prior‑therapy requirements listed in the product entry.

Rezlidhia initial therapy for MASH requires that the patient does not have cirrhosis. The entry explicitly excludes patients with cirrhosis (including decompensated cirrhosis) from initial therapy. Providers must document absence of cirrhosis and fibrosis staging (F2–F3) per the product criteria; cirrhosis or progression to cirrhosis is a contraindicating exclusion for initial approval.

Spevigo subcutaneous formulation will not be used to treat generalized pustular psoriasis (GPP) flares. The product entry explicitly disallows use of the subcutaneous formulation for GPP flares; prescribers and reviewers should verify the indication and formulation before approving therapy.

Requests for Spevigo SC to manage GPP flares should be denied per the exclusion; other labeled uses remain subject to their respective coverage criteria.

Several product entries include a 'Not used in combination with another disease‑modifying therapy' restriction for disease‑modifying agents (MS examples include fingolimod, dimethyl fumarate, Kesimpta, Betaseron, etc.). For these products, combination use with another disease‑modifying therapy is an exclusion and must be documented as absent. Where combination use is specifically prohibited, prior authorization should be denied if concurrent therapy is documented.

This general restriction also appears across other classes where combination disease‑modifying therapy would increase safety risk or is outside the specified criteria; verify each product entry for any combination‑therapy prohibitions.

Formulary and Coding Identifiers

Formulary Identifiersmixed

Formulary ID: 26220

Formulary identifier and version listed for products in this excerpt

Formulary Identifiermixed

Formulary ID: 26220

Formulary identifier referenced for multiple products

Formulary identifiermixed

Formulary ID: 26220

Applies to listed products

Formulary identifiermixed

Formulary ID: 26220

Formulary identifier and version for the product listings

Formulary Identifiermixed

Formulary ID: 26220

Formulary identifier for listed products

Formulary identifiermixed

Formulary ID: 26220

Formulary identifier referenced for all entries in this excerpt

Immune globulin productsmixedCovered

Bivigam INJ 5GM/50ML	Immune globulin product listed
Privigen	Immune globulin product listed

Selected oncology / hematology agentsmixedCovered

Idhifa	Listed product (enasidenib)
Igalmi	Listed product
Imbruvica CAPS/SUSP/TABS	Ibrutinib formulations

Anti-parasitic productsmixedCovered

Ivermectin TABS

Ivermectin tablets for parasitic infections

Formulary identifiersmixed

Formulary ID: 26220

Formulary identifier repeated for products in these chunks

Formulary identifiersmixed

Formulary ID: 26220

Formulary identifier for entries in this excerpt

No explicit CPT/HCPCS/ICD-10 codes listed in these chunksmixed

No codes listed

Referenced products (no explicit billing codes listed in this extract)mixed

No codes listed

No explicit CPT/HCPCS/ICD codes listedmixed

No codes listed

Formulary identifiermixed

Formulary ID: 26220

Formulary identifier for listed products

Formulary identifiers and product listmixed

Formulary ID 26220

Formulary listing and version for covered products (Version 10, Effective 03/01/2026)

Migraine days per month (key thresholds)

Episodic migraine (EM) threshold>= 4 migraine days per month

Chronic migraine (CM) threshold>= 8 migraine days per month

Age restriction for EM/CM initial18 years or older for initial therapy

CDAI threshold

CDAI disease activity threshold> 220 (Crohn’s Disease Activity Index)

Context of useUsed as an objective criterion for moderately to severely active Crohn’s disease

Associated requirementsPrescribed by or in consultation with a gastroenterologist per initial therapy criteria

Topical therapy trial duration for psoriasis

Topical trial minimumMinimum 30-day supply of topical therapy required prior to biologic for plaque psoriasis

Topical corticosteroid exception14-day supply acceptable for topical corticosteroids

Indication contextApplies when plaque psoriasis meets >=3% BSA or specified anatomic involvement

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required — submit diagnosis, prior trials, prescriber specialty

Prior authorization is required for specialty and biologic products; submit the diagnosis, documentation of required prior trials (trial-and-failure, contraindication, or intolerance per indication), prescriber specialty when specified, and evidence of clinical response for reauthorization.

PA required for listed products under Formulary ID: 26220 (Version 10, effective 03/01/2026).
Reauthorization generally requires documentation of positive clinical response.

Prior Authorization

Augtyro — PA: document MAC diagnosis, ≥6 months multidrug regimen, persistent positive sputum

For Augtyro (MAC lung disease) prior authorization must document diagnosis of MAC lung disease, use as part of a multidrug antibacterial regimen, failure to achieve at least two negative sputum cultures after a minimum of 6 consecutive months of multidrug background therapy, and that the drug is prescribed by or in consultation with an infectious disease specialist or pulmonologist.

Minimum 6 months of prior multidrug background regimen required before Augtyro is approved.
Coverage duration: 12 months.

Prior Authorization

Benlysta — PA: document active SLE, autoantibody positivity, specialty prescriber

Benlysta (IV/SC) requires prior authorization with documentation of active SLE (or lupus nephritis), autoantibody positivity (ANA ≥1:80 or anti-dsDNA ≥30 IU/mL), current standard-of-care treatment, and that therapy is prescribed by or in consultation with a rheumatologist (nephrologist for lupus nephritis).

Initial and reauthorization coverage duration: 6 months; reauth requires positive clinical response.
Benlysta IV/SC: patient ≥5 years of age for these formulations.

Prior Authorization

Bile acid synthesis disorders — PA: submit urinary bile acid mass spectrometry or molecular genetic test

Initial prior authorization for bile acid synthesis disorders (single enzyme defects) must include diagnostic confirmation by abnormal urinary bile acid analysis by mass spectrometry OR molecular genetic testing consistent with the diagnosis and prescriber specialty (hepatologist, medical geneticist, gastroenterologist, or inborn errors specialist).

Initial coverage duration: 4 months; reauthorization: 12 months with documented positive clinical response.

Prior Authorization

HAE prophylaxis — PA: confirm HAE by labs/genetics and specialist prescriber

Prophylactic HAE therapy (Cinryze) requires prior authorization with laboratory or genetic/family-history confirmation of HAE (Type I/II: low C4 plus low/deficient C1‑INH antigenic or functional level; HAE‑nl‑C1INH: normal C4/C1‑INH plus specified pathogenic gene mutation or family history), and prescription by or in consultation with an immunologist or allergist.

Patient age for prophylaxis: ≥6 years.
Coverage duration: 12 months; reauth requires demonstration of positive clinical response.
Not to be used in combination with other approved prophylactic HAE treatments.

Prior Authorization

Onychomycosis topical therapy — PA: confirm diagnosis (KOH/culture/histology) and prior terbinafine trial

Topical onychomycosis agents require prior authorization with confirmed diagnosis (KOH, culture, or histology), absence of lunula/matrix involvement, and documentation of trial-and-failure, contraindication, or intolerance to oral terbinafine (6 weeks fingernail, 12 weeks toenail) as specified.

Coverage duration: 48 weeks.
Prerequisite Part D drug required per formulary listing.

Note

Formulary authorization — use Formulary ID 26220 (Version 10, effective 03/01/2026)

Requests are subject to Formulary ID: 26220, Version 10 (effective 03/01/2026); prior authorization must follow the formulary's requirements for the listed specialty products.

Formulary identifier/version must be referenced on PA submissions.
Effective date and version: 03/01/2026, Version 10.

Prior Authorization

Prerequisite Part D drug — include prior Part D therapy evidence when required

Some products in the formulary require a prerequisite Part D drug prior to approval; check the product-specific entry for a 'Criteria DOES require use of a prerequisite Part D drug' flag and document prior Part D therapy when indicated.

Examples in the formulary note the prerequisite Part D requirement where applicable; include evidence of prior Part D drug use in the PA submission.

Prior Authorization

Authorization duration and reauthorization — provide response documentation

Authorization durations vary by product (commonly initial approvals 6 months and reauthorizations 12 months); reauthorization generally requires documentation of positive clinical response as specified per indication.

Confirm product-specific initial and reauth durations in the formulary entry (examples: many agents initial 6 months, reauth 12 months; some have different durations).
Reauthorization must include objective or clinical evidence of response per product criteria.

Prior Authorization

Prior authorization — include diagnosis, prior therapies, and molecular testing when applicable

Prior authorization for each product must include the specific diagnosis, documentation of required prior therapies (trial/failure/contraindication/intolerance), relevant molecular or genetic testing when applicable, and specialty prescriber information where required.

Include FDA-approved or CLIA lab reports for mutation/fusion testing when required (e.g., RET, BRAF, PIK3CA, FGFR2, IDH2, TTR).
Document prior therapy lines and durations per product-specific requirements.

Billing Rule

Prior authorization and coverage duration — request duration per formulary entry

Approvals are typically issued for up to the stated coverage duration in the formulary (commonly 12 months); some agents have shorter or different initial coverage durations (e.g., Inbrija 14 days, IVIG variable), so include the requested coverage period consistent with the product entry.

Verify product-specific coverage duration on the formulary entry and request the matching authorization length.
Note exceptions where shorter initial durations apply.

Prior Authorization

Product-specific PA — submit indication-specific documentation as listed

Product-specific prior authorization requires submission of the diagnosis, prior therapy history, and other indication-specific documentation (e.g., age limits, baseline scores), per the formulary entry for each drug.

Most products list required medical information, prerequisite therapies, and prescriber restrictions in the Formulary ID: 26220 entries.

Prior Authorization

Genetic confirmation and specialist prescriber required (ALGS/PFIC)

For ALGS and PFIC (Livmarli), prior authorization requires molecular genetic testing confirming the specified gene mutations (JAG1/NOTCH2 for ALGS; ATP8B1, ABCB11, ABCB4, TJP2, NR1H4, MYO5B for PFIC) and the prescriber must be a hepatologist or gastroenterologist for initial use.

Age restrictions: ALGS ≥3 months; PFIC ≥12 months.
Initial coverage: ALGS 12 months; PFIC initial 6 months then reauth 12 months with positive response.

Prior Authorization

Prior auth for Neulasta — document FN context, chemo regimen, hematology/oncology prescriber

Neulasta (pegfilgrastim) prior authorization must document the specific indication (FN prophylaxis, treatment, secondary prophylaxis, or ARS) and include the qualifying chemotherapy context or FN history; prescriber should be a hematologist/oncologist or documented consultation.

FN prophylaxis qualifying pathways must be stated (e.g., INT C9741 dose-dense, regimens with >20% FN risk, or secondary prophylaxis following prior FN).
Coverage durations: ARS 1 month; FN prophylaxis/treatment typically 3 months or duration of therapy.

Prior Authorization

Product-specific prior authorization requirement — include required clinical/imaging/lab details

Prior authorization requires submission of the specified diagnosis and supporting clinical details for each product (examples include FN prophylaxis criteria for colony-stimulating factors, posaconazole prophylaxis criteria, and diagnostic/imaging criteria for Ofev in ILD).

Follow the formulary's required medical information fields for each product entry.
Include imaging, lab, or biopsy documentation when the product entry specifies such requirements.

Prior Authorization

Prior authorization required — include genetic testing and baseline scores (hATTR example)

Prior authorization is required for hATTR and other specialty agents with documentation as specified (e.g., genetic testing and baseline functional/neuropathy scores for hATTR amyloidosis).

For hATTR, include TTR mutation testing (FDA-approved or CLIA), baseline PND/FAP/NIS scores per formulary criteria, and neurologist involvement.
Requested TTR therapies must not be used in combination with other TTR silencers or stabilizers.

Prior Authorization

Genomic-confirmation prior auth — submit FDA-approved/CLIA test results

Prior authorization for genomic-targeted oncology agents requires tumor genomic confirmation (FDA-approved or CLIA-performed test) and documentation of prior therapies where specified (e.g., FGFR2 fusion for cholangiocarcinoma, BRAF V600 mutations for BRAF-targeted therapy).

Attach the companion diagnostic or CLIA lab report confirming the required mutation/fusion.
Document prior lines of systemic therapy when the product entry requires it.

Prior Authorization

Piqray prior auth — submit PIK3CA mutation report and prior endocrine therapy failure

Piqray prior authorization requires evidence of PIK3CA mutation detected by an FDA-approved test (therascreen PIK3CA RGQ PCR Kit) or CLIA-performed assay and documentation of progression on an endocrine-based regimen; include the fulvestrant combination plan.

Coverage duration: 12 months.
Prerequisite Part D drug requirement applies per formulary entry.

Prior Authorization

Rinvoq prior authorization — document prior DMARD/TNF history and specialty prescriber

Rinvoq prior authorization requires documentation of diagnosis and prior trials, contraindications, or intolerance to specified conventional therapies and prior biologic/TNF inhibitor history as applicable to the indication; do not request combination use with other JAK inhibitors or biologic DMARDs.

Initial coverage commonly 6 months; reauthorization 12 months with documented clinical response.
Include prescriber specialty when required (e.g., rheumatologist for RA/PJIA).

Prior Authorization

Rinvoq Lq prior auth — PJIA/PsA: document methotrexate/leflunomide trial and TNF inhibitor history

Rinvoq Lq (PJIA, PsA) prior authorization requires documentation of trial/failure/intolerance to conventional therapies (e.g., methotrexate, leflunomide) and prior inadequate response or intolerance to TNF inhibitors when specified; include rheumatology consultation for PJIA.

Initial coverage: 6 months; reauth: 12 months with evidence of positive clinical response.
Prescriber restrictions: PJIA initial requests must be from or in consultation with a rheumatologist.

Prior Authorization

Prior authorization/coverage duration — follow per-product initial and reauth rules

Prior authorization and coverage durations are listed per formulary entries; approvals and reauthorizations must adhere to the product-specific initial and reauthorization criteria, including prescriber specialty and evidence of clinical response.

Most products have initial/reauth durations noted (commonly initial 6 months, reauth 12 months).
Ensure PA request includes the information required to determine duration.

Prior Authorization

Prior authorization required for listed indications — meet diagnosis, biomarker, staging, and prior-therapy criteria

Prior authorization is required for the listed indications and requires meeting the diagnosis, biomarker/staging, and prior therapy criteria specified in each formulary entry; document the specific criteria to support approval.

Typical coverage durations are specified in each product entry (commonly 12 months).
Include required biomarker/imaging/biopsy reports when indicated.

Step Therapy

Step therapy / prerequisite trials — document TF/C/I with durations and outcomes

Many initial approvals require documented trial and failure, contraindication, or intolerance (TF/C/I) to specified conventional, topical, or alternative therapies before initiating biologic or specialty agents; include dates, durations, and outcomes of prior trials.

Examples: RA requires ≥3 months TF/C/I to one conventional DMARD; plaque psoriasis requires topical trial minimums (30 days, 14 days for topical steroids).
Document reason for intolerance or contraindication if no trial was possible.

Step Therapy

Caplyta — step therapy: document trial/failure of specified oral atypical antipsychotics

Caplyta requires prior documented trial and failure, contraindication, or intolerance to specified oral generic atypical antipsychotics (lists provided in the formulary) before approval; include the agents tried and duration.

Coverage duration example in formulary: 12 months; show continuation details if applicable.

Step Therapy

Cosentyx step therapy — document TF/C/I to specified alternatives per indication

Cosentyx initiation for PsA, AS, and nr-axSpA requires documented trials/failures, contraindications, or intolerance to specified alternative biologic or targeted therapies as indicated per the formulary; include specialty prescriber consultation.

Initial coverage commonly 6 months; reauth 12 months with documented clinical response.
Document which alternative biologics/targeted therapies were tried and outcomes.

Step Therapy

Dupixent step therapy — trial inhaled controller regimens and document baseline eosinophils

Dupixent requires prior trials of appropriate inhaled corticosteroid regimens and other controller medications (age- and indication-specific) prior to initiation unless contraindicated; include baseline eosinophil counts and exacerbation history where applicable.

For eosinophilic asthma: baseline peripheral blood eosinophils ≥150 cells/mcL and history of exacerbations or hospitalization must be documented.

Step Therapy

Enbrel step therapy — document TF/C/I to conventional therapies (methotrexate, etc.)

Enbrel requires trial and failure of specified conventional therapies (e.g., methotrexate, leflunomide, sulfasalazine, NSAIDs) for defined minimum durations prior to initiation; include rheumatology consultation when indicated.

RA: minimum 3-month TF/C/I to a conventional DMARD; PJIA: minimum 6-week TF/C/I where specified.
Initial 6 months; reauth 12 months with clinical response documentation.

Documentation Required

Therapy prerequisites and concomitant-therapy constraints — document required concomitant-therapy status

Some products require documentation of prior or concomitant therapies or constraints (e.g., Procrit requires other causes ruled out; Evrysdi prohibits concomitant chronic SMN-modifying therapy); ensure the PA includes required concomitant-therapy statements.

Evrysdi: do not combine with chronic SMN-modifying therapies; baseline motor testing and SMN genetic confirmation required.
Procrit: rule out other causes of anemia and document iron stores as specified.

Step Therapy

Step therapy / trial-failure requirements — provide detailed prior therapy records

Many agents require documented trial-and-failure (or contraindication/intolerance) of specified conventional therapies before approval — include agent names, dates, supply durations, and outcomes in the submission.

Example: RA agents require a 3-month trial; psoriasis topical trials require minimum 30 days (14 days for topical steroids).
Insufficient trial documentation is a common reason for denial.

Step Therapy

Step therapy / trial requirements — document TF/C/I to listed alternative therapies

Many products require trial and failure, contraindication, or intolerance to specified alternative therapies (examples include acute agitation agents for Inbrija, multiagent prior therapies for oncology agents); document the alternatives tried and rationale.

Include dates, doses, and reasons for discontinuation (failure, intolerance, or contraindication).
For oncology agents, document prior endocrine or systemic therapies as required.

Step Therapy

Kesimpta step therapy — document 4-week DMT trial/failure and neurologist prescriber

Kesimpta initial use requires trial and failure (minimum 4-week supply), contraindication, or intolerance to one disease-modifying MS therapy; include neurologist involvement and do not combine with another disease-modifying MS therapy.

Coverage duration: 12 months; document prior DMT and reason for switch.
Kesimpta must not be used in combination with another B-cell targeted therapy.

Step Therapy

Prerequisite trial for pruritus indications — document inadequate response to one prior pruritus therapy

For ALGS and PFIC pruritus indications, prior authorization requires documentation that the patient had an inadequate response to at least one prior pruritus treatment (example: rifampin) before approving Livmarli.

Include documentation of prior pruritus treatment and outcome (e.g., rifampin trial and response).

Step Therapy

Odactra prerequisite therapy — document failure of intranasal steroid and antihistamine plus positive HDM testing

Odactra requires prior trial and failure or intolerance/contraindication to an intranasal corticosteroid AND an antihistamine before approval; include allergist/immunologist consultation and positive diagnostic testing for house dust mite sensitivity.

Age restrictions: Odactra initial: 5 to 65 years.
Coverage duration initial and reauth: 12 months; reauth requires symptom improvement or reduced medication use.

Step Therapy

Step therapy/TF/C/I requirements — include documented prior therapy history per product

Several products require trial and failure, contraindication, or intolerance to specific prior therapies (e.g., schizophrenia agents for Opipza; topical therapies for Otezla; bisphosphonate trial for certain bone agents); include the required prior therapy history in the PA.

Document prior systemic and topical therapy attempts with dates and outcomes.
Many entries also require prescriber specialty consultation for approval.

Step Therapy

Repatha step therapy — document maximally tolerated statin/ezetimibe or statin intolerance

Repatha requires documentation of trial of and continued use of other lipid-lowering therapy at maximally tolerated doses (statin ± ezetimibe) unless the patient is statin-intolerant; for HoFH genetic confirmation or LDL criteria are also required.

Include recent LDL-C value and documentation of maximally tolerated statin therapy or statin intolerance.
Genetic confirmation for HoFH is required where specified.

Step Therapy

Vigabatrin step therapy — document failure of two anticonvulsants before approval

Vigabatrin for Complex Partial Seizures requires failure, contraindication, or intolerance to two formulary anticonvulsants prior to approval; include agent names, durations, and reasons for failure.

Infantile Spasms: indicate age and diagnostic confirmation where applicable.
Coverage duration commonly 12 months; prerequisite Part D drug may apply for CPS.

Step Therapy

Topical therapy prerequisite for plaque psoriasis — document 30-day topical trial (14 days for steroids)

Some psoriasis and psoriatic arthritis biologics require trial and failure of topical therapies prior to biologic initiation; document a minimum 30-day supply for topical therapy trials (14 days for topical corticosteroids) and prescriber specialty consultation.

Topical trial minimums: 30 days supply (14 days for topical corticosteroids).
Initial biologic coverage often 6 months; reauth 12 months with clinical response.

Step Therapy

Prerequisite therapy and duration limits — document prior osteoporosis therapy and lifetime limits

Some agents (e.g., osteoporosis parathyroid hormone analogs) require trial and failure, contraindication, or intolerance to specified prior therapies (eg, bisphosphonates) and adherence to duration limits (e.g., parathyroid hormone analogs not exceeding 24 months lifetime); include prior therapy history and cumulative duration.

Parathyroid hormone lifetime limit: ≤24 months total lifetime.
Provide documentation of bisphosphonate trial and reasons for failure/intolerance when required.

Documentation Required

Required clinical documentation — diagnosis, prior trials, and disease-activity measures

Provide the diagnosis, documentation of required prior trials (names, durations, outcomes), and objective evidence of disease activity (e.g., CDAI >220 for Crohn's, BSA% for psoriasis, migraine days per month) as specified for the product; include prescriber specialty when required.

Include objective measures referenced in the formulary (e.g., CDAI, BSA, migraine-day thresholds).
Failure to provide these items is a common reason for denial.

Documentation Required

Benlysta required documentation — SLE diagnosis, autoantibody positivity, SOC treatment, rheumatology involvement

For Benlysta initial requests submit documentation of active SLE, ANA ≥1:80 or anti-dsDNA ≥30 IU/mL, current standard-of-care treatment, and rheumatology involvement as specified in the formulary.

Benlysta IV/SC formulations: patient age ≥5 years for initial use.
Reauthorization requires demonstration of positive clinical response.

Documentation Required

Augtyro required documentation — MAC diagnosis, multidrug regimen, persistent positive sputum cultures

For Augtyro (MAC lung disease) include documentation of MAC lung disease diagnosis, use as part of a combination antibacterial regimen, and failure to achieve two negative sputum cultures after at least 6 months of multidrug background therapy; include infectious disease or pulmonology prescriber or consultation.

Coverage duration: 12 months.
Include sputum culture results and background regimen details.

Documentation Required

Bile acid synthesis disorder documentation — urinary bile acid MS or molecular genetic test required

For bile acid synthesis disorders due to single enzyme defects, submit diagnostic confirmation via abnormal urinary bile acid analysis by mass spectrometry OR molecular genetic testing consistent with the diagnosis and specialist prescriber documentation.

Initial coverage: 4 months; reauth 12 months with evidence of clinical improvement (e.g., improved liver function).

Documentation Required

CTX genetic confirmation — submit CYP27A1 pathogenic variant report and specialist prescriber

For cerebrotendinous xanthomatosis (Ctexli), submit documentation of pathogenic variant(s) in the CYP27A1 gene detected by an FDA-approved or CLIA-performed test and that the prescriber is a neurologist, geneticist, or metabolic disease specialist.

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

Documentation Required

Iron overload required medical information — ferritin >1000 mcg/L and transfusion ≥100 mL/kg

For chronic transfusional iron overload, provide diagnosis, baseline ferritin >1000 mcg/L, and total transfused volume of at least 100 mL/kg packed red blood cells in the PA documentation.

Initial coverage and reauth: 12 months; reauth requires reduction from baseline in ferritin or LIC.
NTDT and MDS entries have their own ferritin/LIC and transfusion thresholds—follow the specific entry.

Documentation Required

Dupixent required medical information — baseline eosinophils, exacerbation history, prior controller trials

For Dupixent requests, include diagnosis, baseline peripheral blood eosinophil count (≥150 cells/mcL for eosinophilic asthma where specified), history of exacerbations or oral corticosteroid dependence, prior controller therapy details, and specialist consultation when required.

Document age- and indication-specific controller trials and outcomes.
Reauthorization requires evidence of clinical response.

Documentation Required

Enbrel required medical information — diagnosis, prior conventional therapy trials, specialist involvement

For Enbrel submissions include diagnosis details (RA, PJIA, PsA, plaque psoriasis, AS), documentation of prior conventional therapy trials and durations (e.g., methotrexate, leflunomide, NSAID trial), and rheumatology/dermatology consultation when specified.

RA: minimum 3-month trial of a conventional DMARD required for initial requests.
PJIA: minimum 6-week trial required where specified.

Documentation Required

Evrysdi required baseline testing and genetic confirmation — submit motor exam and SMN genetic results

Evrysdi requests must include baseline motor function testing (HINE-2, HFMSE, RULM, CHOP INTEND, MFM-32, or BSID-III item 22 as applicable) and genetic confirmation of SMN1 mutation/deletion and SMN2 copy number; note that concomitant chronic SMN-modifying therapy is not permitted.

If prior gene therapy was used, include documentation of inadequate response over ≥6 months where applicable.
Prescriber: specialist involvement (neurology) as required.

Documentation Required

HAE diagnostic documentation — submit C4/C1‑INH labs or genetic/family-history confirmation

HAE acute or prophylaxis requests require laboratory confirmation of HAE subtype (C4 and C1‑INH antigenic or functional levels) OR specified genetic testing/family history for HAE with normal C1‑INH; include immunology/allergy specialist consultation for prophylaxis indications.

Treatment vs prophylaxis entries have age differences (treatment initial: ≥18 years; prophylaxis initial: ≥6 years).
Do not combine with other approved HAE acute or prophylactic treatments as specified.

Documentation Required

Anemia lab documentation — include recent Hgb/Hct and iron studies

For anemia/ESA (Procrit) requests include recent laboratory values (Hgb/Hct and iron studies) within specified timeframes to document anemia severity and adequate iron stores per the indication.

Hemoglobin/hematocrit thresholds and iron-store requirements vary by indication—include ferritin and TSAT when requested.
Off-label ESA uses are not approved when Hgb >10 g/dL or Hct >30% for listed exclusions.

Documentation Required

Molecular test and diagnosis documentation — provide FDA/CLIA test reports for targeted oncology agents

For targeted oncology agents (e.g., Gavreto), submit molecular or biomarker test results showing the required mutation/fusion (e.g., RET fusion positive for Gavreto) detected by an FDA-approved or CLIA-approved test, diagnosis details, and prior therapy status as required.

Attach the CLIA/FDA-approved test report for gene fusions/mutations.
Document prior lines of systemic therapy where the agent's criteria require it.

Documentation Required

Diagnosis, prior therapy, and response documentation — include prior DMARD/topical trials and objective response data

For Humira and similar immunomodulators include the diagnosis (e.g., RA, PsA, PsO, AS, CD, UC), documentation of prior therapy trials and failures with specified agents and durations, and objective measures of response for reauthorization (joint counts, BSA changes, labs).

Provide dates and outcomes of prior conventional therapy trials (e.g., methotrexate).
Reauthorization requires documented improvement per indication-specific metrics.

Documentation Required

Required clinical documentation — include diagnosis, biomarker tests, prior therapy history, and specialty prescriber notes

Product-specific required documentation may include confirmed diagnosis, disease molecular markers detected by FDA-approved or CLIA-certified tests, prior therapy history (TF/C/I), and specialty prescriber documentation for certain agents; include the listed product-specific items in the PA.

Examples: IDH2 mutation for Idhifa; CYP27A1 pathogenic variant for CTX; TTR mutation and baseline neuropathy scores for hATTR agents.

Documentation Required

Diagnosis and prior therapy documentation — oncology/hematology agents (Jakafi/Jaypirca examples)

For Jakafi/Jaypirca/Jylamvo and similar oncology/hematology agents, include diagnosis-specific information (e.g., type of lymphoma), prior therapies (BTK/BCL-2 inhibitors for CLL/SLL), and evidence of prior therapy trials or failures where required.

Document prior lines of therapy and proof of prior agent classes tried.
Many oncology entries flag prerequisite Part D drugs—include those records if applicable.

Documentation Required

Genetic testing and treatment history — Livmarli requires gene mutation confirmation and prior pruritus therapy failure

For Livmarli (ALGS/PFIC) include molecular genetic testing confirming the required gene mutations (JAG1/NOTCH2 for ALGS; ATP8B1, ABCB11, ABCB4, TJP2, NR1H4, MYO5B for PFIC) and documentation of inadequate response to at least one pruritus treatment (e.g., rifampin).

Prescriber must be a hepatologist or gastroenterologist for initial use.
Age restrictions: ALGS ≥3 months; PFIC ≥12 months.

Documentation Required

Required medical information for ALGS and PFIC — submit genetic test, pruritus documentation, and prior therapy failure

For ALGS and PFIC submissions, include diagnosis and molecular genetic testing results (e.g., JAG1/NOTCH2 for ALGS; ATP8B1, ABCB11, ABCB4, TJP2, NR1H4, MYO5B for PFIC), documentation of cholestatic pruritus, and evidence of inadequate response to at least one pruritus therapy.

Initial coverage durations differ: ALGS initial/reauth 12 months; PFIC initial 6 months then reauth 12 months with positive clinical response.

Documentation Required

Required documentation for Neulasta — specify FN prophylaxis pathway and chemotherapy regimen

For febrile neutropenia prophylaxis or treatment with Neulasta, document the qualifying chemotherapy regimen or FN risk factors (e.g., INT C9741 dose-dense, regimens with >20% FN risk, or secondary prophylaxis after prior FN) and that the prescriber is a hematologist/oncologist or consulted one.

Indicate which FN prophylaxis pathway applies in the PA (one of the listed qualifying scenarios).
Coverage durations vary by indication (ARS 1 month; FN 3 months or duration of therapy).

Documentation Required

Onpattro required documentation — TTR mutation and baseline neuropathy scores

Onpattro initial requests must include diagnosis of hATTR with polyneuropathy, presence of a pathogenic TTR mutation detected by an FDA-approved or CLIA test, baseline PND ≤ IIIb or FAP stage 1–2 or NIS 5–130, and clinical signs/symptoms; note that Onpattro must not be used with other TTR silencers or stabilizers.

Prescriber: neurologist involvement required; coverage duration: 12 months; reauth requires positive clinical response.
Attach TTR mutation test report and baseline neuropathy scores.

Documentation Required

FN prophylaxis required information — identify qualifying chemotherapy context

For febrile neutropenia prophylaxis, clearly indicate which qualifying chemotherapy context applies (INT C9741 dose-dense breast protocol; dose-dense regimen of unknown FN incidence; regimens with >20% FN risk; regimens with 10–20% FN risk plus risk factors; or secondary prophylaxis after prior FN) as part of the PA.

Provide supporting chemo protocol notes and FN risk assessment.
Prescriber should be hematology/oncology or document consultation.

Documentation Required

hATTR required medical information — submit TTR mutation report and baseline PND/FAP/NIS

For hATTR amyloidosis requests include diagnosis of hATTR with polyneuropathy, evidence of a pathogenic TTR mutation by an FDA-approved or CLIA test, baseline neuropathy disability/fap/NIS scores within the stated ranges, and that the drug will not be used with other TTR silencers or stabilizers.

Baseline measures: PND ≤ IIIb OR FAP stage 1–2 OR NIS between 5 and 130.
Prescriber: neurologist; reauth requires demonstrated positive clinical response.

Documentation Required

Ozempic (MASH) required medical information — submit FAST/MAST/biopsy and fibrosis F2–F3 confirmation

For Ozempic used for MASH, submit records confirming MASH diagnosis (FAST, MAST, or liver biopsy) and documentation that fibrosis stage is F2 or F3 by FibroScan, FIB-4, or comparable testing; include gastroenterology/endocrinology/hepatology prescriber details.

Coverage duration: 12 months; reauth requires evidence of positive clinical response.
Do not submit Ozempic for MASH without the required diagnostic confirmation and fibrosis staging.

Documentation Required

Orkambi required medical information — homozygous F508del confirmation and CF specialist prescriber

For Orkambi initial requests provide CF diagnosis and documentation of homozygous F508del CFTR mutation by an FDA-cleared or CLIA-approved test and that the patient is ≥6 years of age; include specialist prescriber documentation.

Coverage duration: 12 months; reauth requires clinical benefit (e.g., improved FEV1 or fewer pulmonary exacerbations).

Documentation Required

Cholangiocarcinoma documentation — submit FGFR2 fusion/rearrangement report and prior therapy

For cholangiocarcinoma FGFR-directed therapy (Pemazyre), include diagnosis of unresectable locally advanced or metastatic cholangiocarcinoma, FGFR2 fusion or rearrangement detected by an FDA-approved or CLIA test, and documentation of at least one prior line of therapy.

Attach the FGFR2 fusion/rearrangement test report and prior therapy history.
Coverage duration: 12 months.

Documentation Required

Piqray documentation — submit PIK3CA mutation report and prior endocrine regimen failure

For Piqray, include documentation of HR-positive, HER2-negative advanced/metastatic breast cancer with a PIK3CA mutation detected by an FDA-approved or CLIA test and documentation of progression on an endocrine-based regimen; include planned combination with fulvestrant.

Attach PIK3CA companion diagnostic report (therascreen) or CLIA equivalent.
Coverage duration: 12 months; prerequisite Part D drug requirement applies.

Documentation Required

Rezdiffra documentation — provide fibrosis F2–F3 confirmation and metabolic risk factor

For Rezdiffra initial requests for MASH, submit documentation of non-cirrhotic MASH with fibrosis stage F2 or F3 confirmed by the required serum and imaging biomarkers or biopsy within 12 months, and presence of at least one metabolic risk factor; include specialist prescriber details.

Coverage duration: initial and reauth 12 months; reauth requires positive response and no progression to cirrhosis.
Attach biomarker/imaging/biopsy reports and metabolic risk factor documentation.

Documentation Required

Rybelsus diagnostic documentation — submit T2DM diagnosis or confirmatory lab values

For Rybelsus initial requests include medical records confirming diagnosis of type 2 diabetes mellitus or laboratory evidence (A1c ≥6.5% or fasting plasma glucose ≥126 mg/dL or 2-hour OGTT ≥200 mg/dL); include ongoing treatment rationale and prescriber details.

Coverage duration: 12 months; reauth requires evidence of positive clinical response.
Attach labs or chart notes demonstrating T2DM diagnosis.

Documentation Required

Rezlidhia diagnostic documentation — submit fibrosis F2–F3 confirmation and metabolic risk factor

For Rezlidhia initial MASH requests, document fibrosis stage F2 or F3 confirmed by specified biomarker/imaging or biopsy methods within 12 months and presence of one metabolic risk factor as required by the formulary.

Prescriber: gastroenterologist, endocrinologist, or hepatologist.
Coverage duration: initial and reauth 12 months; reauth requires positive clinical response and no progression to cirrhosis.

Documentation Required

Required clinical documentation — product-specific genetic/cardiac therapy evidence

Provide diagnosis and supporting product-specific information (e.g., genetic testing for FXN mutation for Skyclarys, Ph+ BCR-ABL for dasatinib, TTR mutation or biopsy/imaging for Vyndamax) when requesting specialty genetic or cardiomyopathy therapies.

Include required lab, imaging, or genetic reports and specialist prescriber documentation.
Coverage durations and reauth criteria vary by product—follow the formulary entry.

Documentation Required

Required clinical and biomarker documentation — include disease stage and FDA/CLIA test results

Required clinical and biomarker documentation must include diagnosis, disease stage (e.g., unresectable/metastatic), and results of requisite FDA-approved or CLIA-performed biomarker tests (e.g., THxID-BRAF for BRAF V600 mutations, RET/FGFR/PIK3CA reports) where applicable.

Attach FDA-approved companion diagnostic or CLIA lab reports as specified.
Document prior therapy lines and treatment intent (adjuvant, metastatic, etc.).

Documentation Required

Testosterone-specific lab documentation — submit two pre-treatment total T <300 ng/dL or qualifying alternative

For testosterone therapy, include documentation of hypogonadism with required pre-treatment testosterone measurements (two total T <300 ng/dL or equivalent alternative testing) or other qualifying conditions (e.g., bilateral orchiectomy) as specified in the formulary.

Follow age and formulation-specific restrictions (e.g., testosterone cypionate initial ≥12 years where noted).
Include follow-up T level if continuing therapy, drawn within the past 12 months.

Denial Risk

Missing prior therapy documentation — risk of denial if TF/C/I not documented

Failure to document required prior therapy trials (trial-and-failure, contraindication, or intolerance) to specified conventional therapies — for example methotrexate, leflunomide, sulfasalazine for RA — may trigger denial for initial therapy requests.

Provide dates, doses, duration (e.g., 3 months for RA), and reason for discontinuation.
Insufficient documentation of TF/C/I is a frequent denial cause.

Denial Risk

Contraindicated concurrent therapy — e.g., nitrates with tadalafil leads to denial

Concurrent use of contraindicated therapies specified in the formulary will trigger denial; for example, concurrent use of nitrates with tadalafil is an explicit exclusion.

Verify medication lists for contraindicated combinations before PA submission.

Denial Risk

Documentation and diagnostic confirmation required for topical nail therapy — include KOH/culture/histology

Requests for topical onychomycosis therapy may be denied if the diagnosis is not confirmed by KOH, culture, or histology, or if lunula (matrix) involvement is present; ensure diagnostic confirmation is attached.

Attach KOH, culture, or histology report and document absence of lunula involvement.
Document prior oral terbinafine trial details when required.

Denial Risk

HAE diagnostic confirmation required — missing labs/genetic evidence risks denial

HAE prophylaxis requests will be denied if diagnostic criteria are not met — submit C4 and C1‑INH antigenic or functional levels for Type I/II or genetic mutation/family-history evidence for HAE‑nl‑C1INH.

Include lab reports or genetic test reports demonstrating the required diagnostic criteria.
Prophylaxis requires specialist prescriber involvement.

Denial Risk

Iron overload documentation — missing ferritin or transfusion history may trigger denial

Iron overload requests may be denied if required baseline labs or transfusion history thresholds are not documented (e.g., ferritin >1000 mcg/L or transfusion ≥100 mL/kg packed RBCs for transfusional iron overload).

Provide baseline ferritin and transfusion volume documentation as specified in the formulary entry.
For NTDT include LIC and ferritin thresholds per product criteria.

Denial Risk

Dupixent eosinophilic asthma criteria — missing eosinophil or exacerbation history risks denial

Dupixent requests for eosinophilic asthma require baseline peripheral blood eosinophils ≥150 cells/mcL and a history of exacerbations or hospitalization as specified; absence of these data can result in denial.

Include baseline eosinophil count and exacerbation/hospitalization history in the PA.
Document prior controller therapy trials and outcomes.

Denial Risk

Hemoglobin/Hct threshold for approval — Hgb >10 g/dL or Hct >30% may preclude ESA approval

For erythropoiesis-stimulating agents and certain anemia indications, off-label uses will not be approved if hemoglobin >10 g/dL or hematocrit >30% as specified — confirm and submit up-to-date Hgb/Hct values.

Ensure labs are within the required thresholds and attach recent lab results.
Provide rationale if off-label use is being considered under listed exceptions (e.g., MDS, HCV).

Denial Risk

Missing prior therapy documentation — oncology/specialty agents risk denial if prior regimens not shown

Missing documentation of required prior treatments (e.g., prior chemotherapy regimens, prior biologic therapy) for oncology and specialty agents may result in denial; attach prior therapy history and dates.

For agents requiring specific prior regimens (e.g., Gamastan), document the listed chemotherapy and biologic treatments.
Include chart notes or infusion records showing prior therapy exposure.

Denial Risk

Insufficient documentation of trials/failures — include objective measures and TF/C/I evidence

Failure to document required trials and failures (TF/C/I) of specified conventional therapies or required disease activity measures (e.g., joint counts, BSA, CDAI) can lead to coverage denial; include objective measures and prior therapy details.

Provide objective baseline and follow-up measures when requesting reauthorization.
Specify why prior therapies were inadequate (lack of efficacy) or unsuitable (contraindication/intolerance).

Denial Risk

Documentation-linked denials — missing mutation/diagnostic confirmation risks denial

Failure to provide diagnosis-specific required medical information (e.g., mutation status for targeted agents, diagnostic confirmation for IVIG indications) may trigger denial; include the exact biomarker or lab reports required by the product entry.

Attach CLIA/FDA-approved test reports for mutations/fusions and lab reports for immunologic thresholds where applicable.
Document specialist consultations when required.

Denial Risk

Laboratory monitoring requirement — missing required liver monitoring (Jynarque example) risks denial

For products with required laboratory monitoring (e.g., Jynarque), failure to document baseline and ongoing lab monitoring (ALT/AST/bilirubin per schedule) may risk non-approval or reauthorization denial; include the monitoring schedule and recent lab results.

Jynarque monitoring: ALT/AST/bilirubin prior to initiation, at 2 and 4 weeks, then monthly for first 18 months; thereafter at least every 3 months if >18 months.
Attach serial lab results demonstrating adherence to monitoring.

Denial Risk

Missing diagnostic/genetic proof — genetic test absence or missing prior pruritus trial risks denial (ALGS/PFIC)

Failure to provide required genetic confirmation (e.g., JAG1/NOTCH2 for ALGS; ATP8B1/ABCB11/ABCB4/TJP2/NR1H4/MYO5B for PFIC) or lack of documentation of prior trial and inadequate response to at least one pruritus therapy may trigger denial.

Attach molecular genetic testing reports and prior pruritus therapy trial documentation.
Prescriber must be hepatologist or gastroenterologist for initial use.

Denial Risk

Posaconazole prophylaxis eligibility — lack of high-risk criteria or prior fungal infection may lead to denial

Posaconazole prophylaxis requests require the patient to meet high-risk criteria (e.g., HSCT with GVHD or hematologic malignancy with prolonged neutropenia) or have prior fungal infection requiring secondary prophylaxis; absence of these qualifying conditions may trigger denial.

Prophylaxis age restriction: ≥13 years for prophylaxis and OPC in formulary entries.
Provide supporting oncology/transplant clinic notes or infectious disease consultation.

Denial Risk

hATTR documentation missing — TTR mutation or baseline neuropathy scores absent risks denial

For hATTR therapies, requests may be denied if required confirmatory testing (FDA-approved or CLIA TTR mutation test) or documentation of baseline disease severity (PND, FAP, or NIS scores) is not provided; include the test reports and baseline scores.

Attach TTR mutation report and baseline neuropathy measures (PND/FAP/NIS) per product criteria.
State that requested TTR therapy will not be used with other TTR silencers or stabilizers.

Denial Risk

MASH documentation missing — FAST/MAST/biopsy and F2–F3 fibrosis staging required for Ozempic

For Ozempic used for MASH, lack of confirmatory diagnostic test results (FAST, MAST, or liver biopsy) or absence of documented fibrosis stage F2–F3 will trigger denial; include the required imaging/biomarker/biopsy reports.

Ensure gastroenterology/endocrinology/hepatology consultation notes and fibrosis staging reports are attached.
Coverage limited to non-cirrhotic MASH with F2–F3 fibrosis.

Denial Risk

Quinine exclusion — PA will be denied if used only for nocturnal leg cramps

Quinine sulfate is explicitly excluded if used solely for treatment or prevention of nocturnal leg cramps; such uses will be denied.

Do not submit PAs for quinine for nocturnal leg cramps as this is an exclusion.

Denial Risk

cGVHD prerequisite failure — document failure of ≥2 systemic therapy lines to avoid denial

Initial chronic GVHD (cGVHD) therapy requests may be denied if documentation does not show trial and failure of two or more lines of systemic therapy; include prior systemic therapy records and reasons for failure.

Provide prior systemic therapy names, durations, and documented inadequate response.
Coverage duration: 12 months initial and reauth as specified in the formulary.

Denial Risk

Stelara induction dosing — must match FDA weight-based IV induction dosing or risk denial

Stelara intravenous induction dosing must follow FDA-labeled weight-based dosing (260 mg for ≤55 kg; 390 mg for >55–85 kg; 520 mg for >85 kg); requests not matching labeled induction dosing may be denied.

Attach weight and the proposed induction dosing to match FDA labeling.
Induction is administered as one-time IV dose per labeling; coverage is for that administration.

Denial Risk

Mutation test and combination therapy documentation — missing mutation or combo plan risks denial

Requests lacking documentation of specified mutation testing (e.g., BRAF V600E/V600K by an FDA-approved test or CLIA lab) or lacking required combination use (e.g., trametinib with BRAF agents) may be denied; attach the mutation report and combination therapy plan.

For BRAF-targeted therapy, include THxID-BRAF Kit or CLIA-equivalent report.
If combination therapy is required by the product entry, document both agents.

Denial Risk

Prior therapy requirements — missing prior systemic chemo or PD-(L)1 history may cause denial

For products with prior-therapy prerequisites (e.g., Tevimbra), absence of required prior systemic chemotherapy or PD-(L)1 inhibitor history inconsistent with stated criteria may trigger denial; include prior systemic therapy history and dates.

Provide prior systemic chemotherapy records and PD-(L)1 inhibitor exposure history when required by product criteria.
Attach chart notes or infusion records documenting prior lines of therapy.

Background & Scope

This excerpt summarizes coverage rules for multiple specialty and biologic medications across immunology, rheumatology, dermatology, neurology, gastroenterology, oncology, and rare‑disease indications. Each product listing prescribes indication‑specific requirements (diagnostic confirmation, required biomarkers or genetic testing, prior trials of conventional therapies, prescriber specialty when required), exclusion statements (including prohibited concomitant therapies), and reauthorization requirements tied to documented clinical benefit. Prior authorization is required for the listed products and is issued for the coverage durations specified in each entry (commonly 12 months); reauthorization generally requires objective or clinical improvement as defined per indication.

Providers should consult the specific product entry for exact documentation requirements (for example, genetic testing results for targeted agents, baseline Hgb/Hct and iron studies for ESAs, or baseline PND/FAP/NIS for hATTR) and be aware that missing or insufficient documentation is a common cause for denial.

Definitions and Abbreviations

TF/C/I definition

DefinitionTF/C/I = Trial and failure, contraindication, or intolerance to a prior therapy

DocumentationA documented trial that either failed, was contraindicated, or not tolerated is required

Use in step therapyFrequently required before initiation of biologics or specialty agents (duration specified per indication)

CDAI definition

TermCDAI = Crohn’s Disease Activity Index

Threshold cited> 220 indicates moderately to severely active disease

RoleUsed as one objective criterion for Crohn’s initial therapy authorization

ROS1 rearrangement definition

DefinitionROS1 rearrangement = tumor genomic rearrangement positive for ROS1 detectable by FDA-approved or CLIA-performed test

Clinical useRequired biomarker for targeted therapy in NSCLC and other indications per formulary entries

Testing requirementDetection must be by an FDA-approved assay or at a CLIA-certified facility as specified

BRAF V600E/V600K mutant definition

DefinitionBRAF V600E/V600K mutant = presence of BRAF V600E or V600K mutation detected by an FDA-approved test (eg, THxID-BRAF) or CLIA-performed assay

Clinical implicationPresence of these mutations qualifies tumors for BRAF-targeted regimens (e.g., Braftovi) often combined with trametinib or other agents

Testing noteTesting method must be FDA-approved or performed at a CLIA-certified laboratory as stated in product criteria

HAE-nl-C1INH definition

DefinitionHAE-nl-C1INH = hereditary angioedema with normal C1 inhibitor levels (formerly HAE Type III) where diagnosis is supported by specified gene mutations or family history

Diagnostic criteriaNormal C4 and C1-INH levels plus presence of pathogenic gene mutation (eg, factor XII, plasminogen, ANGPT1, KNG1, MYOF, HS3ST6) detected by FDA-approved or CLIA test OR confirmed family history

Clinical relevanceDifferentiates from Type I/II HAE (which have low C4 and low/functional C1-INH) for prophylaxis and treatment decisions

Chronic transfusional iron overload definition

DefinitionChronic transfusional iron overload = history of transfusion-related iron accumulation with baseline ferritin > 1,000 mcg/L and transfusion of at least 100 mL/kg packed RBCs

Age thresholdInitial criteria apply to patients >= 2 years of age

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

Eosinophilic asthma definition

DefinitionEosinophilic asthma = moderate-to-severe asthma with baseline peripheral blood eosinophils >= 150 cells/mcL

Clinical qualifiersPlus history of >=2 exacerbations requiring systemic corticosteroids in past 12 months OR prior asthma-related hospitalization in past 12 months

Age/therapy contextAge- and controller-therapy requirements apply per indication before initiation

SMN-related genetic criteria

Genetic requirementSMN-related criteria = mutation or deletion in chromosome 5q affecting SMN1 plus at least 2 copies of SMN2

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

Concomitant therapyConcomitant chronic SMN-modifying therapy is prohibited for Evrysdi initiation

HAE diagnostic confirmation

HAE diagnostic confirmation (Type I/II)Low C4 plus low C1-INH antigenic or functional level (Type I/II) documented by antigenic or functional assay

HAE-nl-C1INH pathwayNormal C4 and C1-INH with detection of specific gene mutation by FDA-approved or CLIA test OR family history supports diagnosis

Testing methodsGenetic testing may be performed by FDA-approved assays or at CLIA-certified facilities as specified

CLIA-approved test definition

DefinitionCLIA-approved test = laboratory test performed at a facility certified under Clinical Laboratory Improvement Amendments (CLIA)

PurposeUsed to detect gene fusions or mutations (eg, RET, ROS1, IDH1/2, FGFR2) required for targeted therapy eligibility

EquivalencyCLIA-performed assays are acceptable where FDA-approved companion diagnostics are not specified

TF/C/I — definition variant

TF/C/I (variant)TF/C/I indicates a documented trial and failure, contraindication, or intolerance to a specified prior therapy required before initiating advanced therapy

Documentation expectationsRecords should show duration and reason for discontinuation (failure, contraindication, or intolerance)

Common durationsMinimal trial durations are specified per indication (eg, 3 months for RA, 6 weeks for PJIA, 30 days for topical psoriasis therapies)

TF/C/I — duplicate definition reference

TF/C/I (duplicate ref)Trial and failure, contraindication, or intolerance — documented inability to use or benefit from specified prior therapies

Role in prior authOften required for initial approval and step therapy enforcement across multiple indications

ReauthorizationReauth commonly requires documentation of positive clinical response rather than repeat TF/C/I

FDA-approved or CLIA-approved test definition

FDA-approved or CLIA-approved testMolecular or biomarker testing must be performed with an FDA-approved assay (companion diagnostic) or at a CLIA-certified laboratory as required for targeted therapies

Examplestherascreen PIK3CA kit (FDA) and THxID-BRAF Kit (FDA) cited as examples; CLIA-performed tests acceptable where specified

Use caseRequired for eligibility determination of oncology agents (eg, Piqray, BRAF-targeted agents)

NOMID diagnostic confirmation

NOMID confirmationNOMID diagnostic confirmation: NLRP3 mutation OR combination of characteristic clinical features plus elevated acute phase reactants

Clinical featuresUrticaria-like rash, sensorineural hearing loss, musculoskeletal symptoms, chronic aseptic meningitis, skeletal abnormalities

PrescriberPrescribed by or in consultation with appropriate specialist (eg, rheumatologist/immunologist) per indication

CKD/T2D definition (UACR/eGFR/serum K)

CKD with T2D criteriaUACR >= 30 mg/g AND eGFR >= 25 mL/min/1.73 m2 with baseline serum potassium <= 5.0 mEq/L prior to initiation

Therapy prerequisitesMinimum 30-day trial of maximally tolerated ACE inhibitor or ARB OR documented contraindication/intolerance to ACE/ARB

PrescriberPrescribed by or in consultation with appropriate specialist per indication (eg, nephrologist) as noted

ALGS definition

ALGS definitionAlagille syndrome (ALGS): diagnosis confirmed with molecular genetic testing demonstrating JAG1 or NOTCH2 mutation and cholestatic pruritus with inadequate response to at least one pruritus therapy

Age thresholdPatient must be >= 3 months of age for initial therapy

PrescriberPrescribed by or in consultation with a hepatologist or gastroenterologist

PFIC definition

PFIC definitionProgressive Familial Intrahepatic Cholestasis (PFIC): diagnosis confirmed by molecular genetic testing in ATP8B1, ABCB11, ABCB4, TJP2, NR1H4, or MYO5B and cholestatic pruritus with inadequate response to at least one pruritus therapy

Age thresholdPatient must be >= 12 months of age for initial therapy

Initial coverageInitial duration noted (6 months) with reauth 12 months upon positive clinical response

hATTR amyloidosis with polyneuropathy definition

DefinitionhATTR amyloidosis with polyneuropathy = hereditary transthyretin-mediated amyloidosis confirmed by pathogenic TTR mutation detected by FDA-approved or CLIA test

Baseline severity measuresBaseline PND <= IIIb OR FAP stage 1-2 OR NIS between 5 and 130 required for eligibility

Combination therapy exclusionRequested drug must not be used in combination with other TTR silencers or stabilizers (eg, Amvuttra, Vyndaqel)

Chronic fibrosing ILD with progressive phenotype

DefinitionChronic fibrosing ILD with progressive phenotype = chronic fibrosing ILD with HRCT showing >=10% lung volume fibrosis plus evidence of progression by declining FVC, worsening symptoms, or increased fibrosis on imaging

Imaging requirementHRCT demonstrating >=10% lung volume with fibrotic features is required

PrescriberPrescribed by or in consultation with a pulmonologist or rheumatologist

PND/FAP/NIS measures reference

PND/FAP/NIS referencePND score, FAP stage, and Neuropathy Impairment Score (NIS) are baseline neuropathy severity measures used for hATTR eligibility

Range exampleNIS baseline range cited: 5 to 130

PurposeUsed to confirm baseline disease severity for initial authorization and reauthorization assessments

MASH definition

DefinitionMASH = metabolic dysfunction-associated steatohepatitis (formerly NASH); non-cirrhotic disease with fibrosis staging required

Fibrosis stagingRequires confirmation of F2 or F3 fibrosis by FibroScan, FIB-4, ELF, FAST/MAST/MEFIB, MRI-PDFF, or liver biopsy per product criteria

PrescriberPrescribed by or in consultation with gastroenterologist, endocrinologist, or hepatologist for MASH indications

CLIA-approved test duplicate reference

CLIA-approved test (duplicate)Test performed at a CLIA-certified laboratory acceptable for detecting genomic alterations required for targeted therapies

ExamplesUsed for detection of RET, ROS1, IDH1/2, FGFR2, PIK3CA alterations where FDA-approved tests or CLIA assays are referenced

InterchangeabilityCLIA-performed assays are accepted where FDA-approved companion diagnostics are not mandated

FDA-approved companion diagnostic definition

FDA-approved companion diagnosticAn FDA-cleared test (eg, therascreen PIK3CA RGQ PCR Kit) used to identify mutations that determine eligibility for certain therapies

Clinical roleRequired for selection of targeted agents when explicitly specified in product criteria

AlternativeIf not available, CLIA-certified laboratory testing may be acceptable per criteria wording

Susceptible IDH1 mutation definition

DefinitionSusceptible IDH1 mutation = presence of an IDH1 mutation detected by an FDA-approved or CLIA-performed test used to select therapy in relapsed/refractory AML

Testing examplesAbbott RealTime IDH1 assay cited as an example of an FDA-approved test

Clinical useRequired for agent eligibility and prior authorization in AML indications

MASH (formerly NASH) with fibrosis F2 6F3 definition

Confirmation methodsELF+imaging (FibroScan, MRI-PDFF), FAST, MAST, MEFIB, or liver biopsy within 12 months may be used per product criteria

RequirementPresence of at least one metabolic risk factor (eg, T2DM, hypertension, obesity) is required

Friedreich's ataxia definition

DefinitionFriedreich's ataxia = genetic disorder confirmed by FXN gene mutation on molecular testing

Additional thresholdBNP value <= 200 pg/mL is cited as an eligibility metric for Skyclarys

Age requirementInitial therapy: patient is 16 years of age or older for Skyclarys

Ph+ BCR-ABL CML/ALL definition

Clinical useRequired diagnostic information for agents like dasatinib and other TKIs

Authorization noteContinuation of prior therapy is approved per formulary entries

BRAF V600E/V600K testing definition

DefinitionBRAF V600E/V600K testing = detection of BRAF V600E or V600K mutation by an FDA-approved test (eg, THxID-BRAF Kit) or a CLIA-performed assay

PurposeRequired to determine eligibility for BRAF-targeted therapies (eg, Braftovi, combination with trametinib)

Testing standardFDA-approved companion diagnostic preferred where specified; CLIA-performed testing acceptable when allowed

FRAX thresholds definition

FRAX thresholds (US)Major osteoporotic fracture >= 20% OR Hip fracture >= 3% (10-year probability)

Use caseApplied as qualification thresholds for certain osteoporosis therapies (eg, teriparatide) when BMD and fracture history pathways are not met

ContextFRAX probabilities referenced alongside BMD and clinical fracture history in formulary criteria

Revision History

2026-03-01formulary_effective_dateLatest

Formulary ID 26220, Version 10 became effective.

2026-02-02last_updated

Formulary listings were last updated on this date (document last updated).