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CurrentBlue Cross Complete of MichiganPolicy 26449

Prescription Blue SM PDP Select and Prescription Blue SM PDP Premium Core Comprehensive Formulary Prior Authorization / Step Therapy Program

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Governs prior authorization and step therapy requirements for medications in the 2026 Prescription Blue SM PDP Select and PDP Premium Core formularies; coverage requires applicable clinical or administrative criteria, and step therapy may require prior formulary treatment.

Policy Summary

PayerBlue Cross Complete of Michigan

PolicyPrescription Blue SM PDP Comprehensive Formulary Prior Authorization / Step Therapy Program

Policy CodePolicy 26449

Change TypeNo material change

Effective DateNovember 1, 2026

Next Review DateN/A

Key ActionSubmit the required clinical and/or administrative criteria before coverage is provided.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2026Program year

PA + STUtilization management

1 yearSelected coverage duration

1Explicit exclusions

Medication Coverage Criteria

Product-Specific Coverage Criteria

Covered when the product-specific criteria below are met. Prior authorization applies to the listed products; coverage is generally limited to medically accepted or FDA-approved indications as specified.

Adbry — initial and continuation criteria

ALL of the following
- Patient is at least 12 years of age.
- Patient has moderate-to-severe atopic dermatitis.
- Patient has tried and failed one of the following: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.
- Adbry is not used in combination with another biologic or targeted DMARD indicated for the same condition.

Policy Summary

PayerBlue Cross Complete of Michigan

PolicyPrescription Blue SM PDP Comprehensive Formulary Prior Authorization / Step Therapy Program

Policy CodePolicy 26449

Change TypeNo material change

Effective DateNovember 1, 2026

Next Review DateN/A

Key ActionSubmit the required clinical and/or administrative criteria before coverage is provided.

SourceLink

On This Page

Continuation

Documentation demonstrates positive clinical response to therapy.
For patients weighing less than 100 kg who respond after 16 weeks, dose is limited to 300 mg every 4 weeks unless clinical rationale supports continuing injections every 2 weeks.

Afinitor — oncology criteria

Use is for a medically accepted oncology indication.
For advanced hormone receptor-positive, HER2-negative breast cancer, Afinitor is used in combination with exemestane and requires a trial of letrozole or anastrozole.

Akeega — oncology criteria

Patient has deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer and Akeega is used in combination with prednisone.
For the applicable BRCA2-mutated indication, the diagnosis is documented as required by the product labeling.

Prolastin-C — clinical criteria

Patient is at least 18 years of age.
ONE of
- Diagnosis of necrotizing panniculitis.
- Alpha-1 antitrypsin deficiency with FEV1 less than 80% predicted and symptomatic emphysema.
Documentation confirms congenital alpha-1 antitrypsin deficiency consistent with PIZZ, PIZ (null), or PI (null, null) phenotype.

General indication and prerequisite criteria

Requested product is prescribed for a medically accepted or FDA-approved indication, as applicable.
When the product-specific rule requires prerequisite therapy, the patient has tried, failed, is intolerant of, or has a contraindication to the specified prerequisite Part D therapy.

Cosentyx — indication-specific coverage

ONE applicable indication
- Active psoriatic arthritis.
- Chronic moderate-to-severe plaque psoriasis.
- Ankylosing spondylitis with diagnosis and trial of one NSAID (e.g., diclofenac, ibuprofen, meloxicam, or naproxen).
- Non-radiographic axial spondyloarthritis with objective signs of inflammation and trial of one NSAID.
- Active enthesitis-related arthritis and trial of one NSAID.
- Moderate-to-severe hidradenitis suppurativa.
Cosentyx is not used in combination with another biologic or targeted DMARD for the same condition.
Reauthorization requires documentation of positive clinical response.

Ebglyss — atopic dermatitis

Patient is at least 12 years of age and weighs at least 40 kg.
Patient has moderate-to-severe atopic dermatitis.
Patient has tried and failed high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.
Ebglyss is not used in combination with another biologic or targeted DMARD for the same condition.
Reauthorization requires positive clinical response.

Enbrel — indication-specific coverage

ONE applicable indication
- Moderately-to-severely active rheumatoid arthritis and trial of one DMARD, such as methotrexate, leflunomide, or sulfasalazine.
- Active polyarticular juvenile idiopathic arthritis and trial of leflunomide or methotrexate.
- Active psoriatic arthritis.
- Active juvenile psoriatic arthritis.
- Moderate-to-severe chronic plaque psoriasis.
- Active ankylosing spondylitis and trial of one NSAID.
Enbrel is not used in combination with another biologic or targeted DMARD for the same condition.
Reauthorization requires positive clinical response.

Epidiolex — indication-specific coverage

ONE applicable indication and prerequisite
- Lennox-Gastaut syndrome with trial of two generic seizure-treatment alternatives.
- Dravet syndrome with trial of two of valproic acid, clobazam, or topiramate.
- Seizures associated with tuberous sclerosis complex with trial of two generic seizure-treatment alternatives.

Eprontia — migraine-prevention coverage

Requested for preventive migraine treatment.
ONE
- Patient has tried at least two generic migraine-prevention alternatives.
- Patient is unable to swallow tablets or capsules.

Endari coverage

Patient has had related crises within the past 12 months.
Patient has tried or is intolerant of the required prerequisite therapy.

Fasenra — initial eosinophilic asthma therapy

Diagnosis of eosinophilic asthma with eosinophil count at least 150 cells/µL at treatment initiation.
Inadequate control persists after systemic corticosteroids or high-dose inhaled corticosteroids plus an additional controller: leukotriene modifier, LABA, or LAMA in adults and children at least 12 years of age.
Fasenra is not used with another biologic or targeted DMARD for the same condition.

Fasenra — EGPA coverage

Diagnosis of eosinophilic granulomatosis with polyangiitis and history or presence of asthma.
At least TWO typical EGPA features
- Histopathological evidence of eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatous inflammation.
- Neuropathy.
- Pulmonary infiltrates.
- Allergic rhinitis and nasal polyps.
- Cardiomyopathy.
- Glomerulonephritis.
- Alveolar hemorrhage.

Fasenra — HES coverage

Diagnosis of hypereosinophilic syndrome.
Eosinophil count is at least 1,000 cells/µL at treatment initiation.

Fasenra — continuation therapy

Reauthorization documentation demonstrates positive clinical response to therapy.

Fycompa and perampanel

Requested for a medically accepted indication.
Patient has tried two generic alternatives.

GLP-1 diabetes products — Mounjaro, Ozempic, Rybelsus, and Trulicity

Product is not used solely for weight loss.
Diabetes documentation
- Medical records confirm ongoing treatment for type 2 diabetes mellitus.
- Medical records document diabetes by A1C at least 6.5%, fasting plasma glucose at least 126 mg/dL, or 2-hour plasma glucose at least 200 mg/dL during an oral glucose tolerance test.

Humira — indication-specific criteria

ONE applicable indication
- Moderately-to-severely active rheumatoid arthritis with trial of one DMARD.
- Active polyarticular juvenile idiopathic arthritis with trial of one DMARD.
- Active psoriatic arthritis.
- Moderate-to-severe chronic plaque psoriasis.
- Active ankylosing spondylitis with trial of one NSAID.
- Moderately-to-severely active Crohn’s disease or ulcerative colitis.
- Moderate-to-severe hidradenitis suppurativa.
- Intermediate, posterior, or panuveitis due to noninfectious uveitis.
Humira is not used in combination with another biologic or targeted DMARD for the same condition.
Reauthorization requires positive clinical response.

Ibrance — indication-specific therapy

For HR-positive, HER2-negative advanced or metastatic breast cancer, Ibrance is combined with an aromatase inhibitor as initial endocrine-based therapy or with fulvestrant after progression on endocrine therapy.
For endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer, Ibrance is combined with inavolisib and fulvestrant after recurrence on or after completion of adjuvant endocrine therapy.
For maintenance treatment of HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction, Ibrance is combined with trastuzumab, with or without pertuzumab, and endocrine therapy.

Iclusig — leukemia indication criteria

ONE applicable indication
- Newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia with combination chemotherapy.
- T315I-positive Philadelphia chromosome-positive acute lymphoblastic leukemia when no other kinase inhibitor is indicated; monotherapy may be used.
- T315I-positive chronic myeloid leukemia in chronic, accelerated, or blast phase.
- Accelerated- or blast-phase CML when no other kinase inhibitor is indicated.
- Other chronic-phase CML indications after trials of at least two prior kinase inhibitors.

Imkeldi — formulation and CML criteria

Patient cannot swallow the tablet formulation or cannot achieve the prescribed dose with tablets.
For Philadelphia chromosome-positive CML in blast crisis, accelerated phase, or chronic phase, the patient has failed the required prior therapy.

Imbruvica criteria

Use is for a medically accepted labeled indication, including chronic graft-versus-host disease when applicable.
Required prerequisite Part D therapy has been tried or is otherwise documented as appropriate.

Iwilfin — high-risk neuroblastoma

Patient has high-risk neuroblastoma.
Patient has demonstrated at least a partial response to prior multiagent immunotherapy.

Jakafi — polycythemia vera

Patient has polycythemia vera with inadequate response or intolerance to hydroxyurea.
Required prior systemic therapy has been tried, including one or two lines when specified.

Jaypirca — mantle cell lymphoma

For mantle cell lymphoma, patient has received two lines of systemic therapy, including a BTK inhibitor.
For relapsed or refractory CLL/SLL, the applicable prior-treatment criteria are met.

Jideytro — ROS1-positive NSCLC

Patient has locally advanced or metastatic ROS1-positive non-small cell lung cancer.
Required ROS1 inhibitor prerequisite therapy is documented.

Jylamvo — methotrexate trial

Patient has tried methotrexate tablets or the oral tablet formulation of methotrexate.

Kerendia — CKD and heart failure

ONE applicable indication
- Chronic kidney disease associated with type 2 diabetes mellitus.
- Heart failure with left ventricular ejection fraction at least 40% and a trial of an SGLT2 inhibitor, such as empagliflozin or dapagliflozin, unless contraindicated or intolerant.

Lenvima — indication-specific coverage

ONE applicable indication
- Renal cell carcinoma as first-line therapy in combination with pembrolizumab.
- Renal cell carcinoma after one prior anti-angiogenic therapy, in combination with everolimus.
- Advanced endometrial carcinoma with disease progression following prior systemic therapy, in combination with pembrolizumab.

Other specialty and prescription products

Alosetron, Arikayce, Augtyro, Avmapki Fakzynja Co-pack, Ayvakit, Benlysta, Cystaran, Cometriq, Cresemba, Fingolimod, Fulphila, Genotropin, Haegarda, Hernexeos, Humulin R U-500, Hyrnuo, Ibtrozi, Idhifa, Increlex, Inrebic, Ivermectin, Kalydeco, Koselugo, Libervant, Lupron/leuprolide, and other products listed in this policy are covered for medically accepted indications when the applicable prior authorization requirement is met.
Products with no additional product-specific clinical criterion in the source retain the stated authorization period and prerequisite-therapy status.

Initial Authorization Criteria

Initial Therapy Criteria

Initial coverage requires the applicable diagnosis, prerequisite therapy, prior treatment, or combination regimen.

Adbry: Age at least 12 years; moderate-to-severe atopic dermatitis; trial and treatment failure of one qualifying topical or systemic therapy; no duplicate biologic or targeted DMARD therapy.

Afinitor: Advanced HR-positive/HER2-negative breast cancer; use with exemestane; prior trial of letrozole or anastrozole.

Akeega: BRCA-mutated metastatic castration-resistant prostate cancer; use with prednisone.

Prolastin-C: Age at least 18 years; qualifying necrotizing panniculitis or alpha-1 antitrypsin deficiency with FEV1 below 80% predicted; qualifying phenotype; symptomatic emphysema.

Alunbrig: Prior crizotinib therapy.

Arcalyst: Prior inflammatory drug in combination with colchicine.

Auvelity: Prior generic formulary antidepressant.

Balversa: At least one prior systemic therapy.

Banzel/rufinamide: Prior trial of divalproex or the other prerequisite identified in the policy.

Product-specific initial authorization: Establish the medically accepted indication and satisfy the applicable prerequisite, prior-treatment, or combination regimen for Beqalzi, Besremi, Bosulif, Braftovi, Briviact, Brukinsa, Bysanti, or Calcipotriene.

Calcipotriene: Trial at least one generic topical medication.

Calquence: At least one prior MCL therapy; or previously untreated MCL in a patient ineligible for autologous HSCT with bendamustine plus rituximab.

Cavhanza: Adult with qualifying chronic- or accelerated-phase CML and imatinib prerequisite therapy.

Cobenfy: Schizophrenia treated after prior antipsychotic therapy.

Glatopa, Copiktra, Cresemba, and Cystaran: Glatopa, Cresemba, or Cystaran: medically accepted indication. Copiktra: relapsed or refractory CLL after at least two prior therapies.

Cosentyx: Qualifying psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, enthesitis-related arthritis, or hidradenitis suppurativa indication with the required NSAID trial where applicable; no duplicate biologic or targeted DMARD therapy.

Cotellic: Unresectable or metastatic BRAF V600E/V600K melanoma; vemurafenib-associated therapy as specified.

Dalfampridine ER: Multiple sclerosis and baseline T25FW documented before initiation; patient is not wheelchair-bound.

Daurismo: Newly diagnosed disease treated with low-dose cytarabine.

Diacomit: Trial of two generic anticonvulsants and combination use with clobazam.

Dihydroergotamine: Trial of two formulary triptans: one oral and one non-oral.

Dulera: Asthma diagnosis and trial of Breo therapy.

Dupixent: Meet the indication-specific prerequisite: qualifying topical-therapy failure for atopic dermatitis; inadequate asthma control after corticosteroids and controller therapy; recurring disease despite intranasal corticosteroids for CRSwNP; PPI or topical esophageal corticosteroid for EoE; second-generation antihistamine for CSU; or required COPD/AFRS criteria.

Ebglyss: Trial and treatment failure of one specified topical or systemic therapy for moderate-to-severe atopic dermatitis.

Enbrel: Meet the diagnosis and prerequisite therapy for the requested indication: DMARD for RA/JIA, NSAID for ankylosing spondylitis, or diagnosis-specific criteria for the remaining indications.

Epidiolex: Two generic seizure alternatives for Lennox-Gastaut syndrome or tuberous sclerosis complex; or two of valproic acid, clobazam, or topiramate for Dravet syndrome.

Fasenra: Eosinophilic asthma with eosinophils at least 150 cells/µL and controller-therapy failure; EGPA with asthma and at least two typical criteria; or HES with eosinophils at least 1000 cells/µL.

Icatibant acetate: Medically accepted indication and age 18 years or older.

Fotivda: Advanced renal cell carcinoma after two or more prior systemic therapies.

Fruzaqla: Metastatic colorectal cancer after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy.

Fycompa/perampanel: Trial of two generic drugs.

Gavreto: Advanced or metastatic RET fusion-positive thyroid cancer when systemic radioactive iodine is appropriate.

Gilotrif: Qualifying EGFR-mutated metastatic NSCLC in the stated first-line or post-progression setting.

GLP-1 agonists: Medically accepted indication other than weight loss only; for T2DM, submit chart-note or laboratory confirmation.

Humira: Meet the diagnosis and required DMARD or NSAID trial for RA, JIA, or ankylosing spondylitis, or the diagnosis-specific criteria for the other covered indications; no duplicate biologic or targeted DMARD therapy.

Ibrance: Use the applicable aromatase inhibitor, fulvestrant, inavolisib plus fulvestrant, or trastuzumab-based combination regimen.

Iclusig: Use chemotherapy for newly diagnosed Ph-positive ALL; monotherapy for T315I-positive Ph-positive ALL when appropriate; or use for qualifying T315I-positive or accelerated/blast-phase CML.

Inqovi: Trial with azacitidine.

Isotretinoin products: Trial of the oral therapy identified in the policy; the therapy name is incomplete in the source.

Iwilfin: High-risk neuroblastoma with at least a partial response to prior multiagent immunotherapy.

Jakafi/Jakafi XR: Polycythemia vera with inadequate response or intolerance to hydroxyurea and one or two systemic-therapy lines.

Jaypirca: Mantle cell lymphoma after two systemic-therapy lines, including a BTK inhibitor.

Jideytro: Locally advanced or metastatic ROS1-positive NSCLC with an inhibitor prerequisite.

Jylamvo: Trial of oral tablet methotrexate.

Kerendia: CKD associated with T2DM; or heart failure with LVEF at least 40% after an SGLT2-inhibitor trial unless contraindicated or intolerant.

Kevzara: RA or polyarticular JIA with two specified prerequisite therapies; or PMR with the required corticosteroid history and flare during taper.

Kisqali: HR-positive/HER2-negative advanced or metastatic breast cancer with aromatase inhibitor or fulvestrant; or high-risk stage II/III early breast cancer with an aromatase inhibitor.

Kineret: Moderately-to-severely active RA and trials of two specified therapies.

Krazati: KRAS G12C-mutated locally advanced or metastatic NSCLC with systemic therapy prerequisite.

Lenvima: Use pembrolizumab for first-line RCC; everolimus after one prior anti-angiogenic therapy for RCC; or pembrolizumab after progression on prior systemic therapy for advanced endometrial carcinoma.

Levetiracetam tablet for oral suspension: Unable to swallow tablets or capsules and meets the policy's additional trial requirement.

Libtayo: Basal cell carcinoma with prior Hedgehog pathway inhibitor treatment.

Continuation and Reauthorization Criteria

Reauthorization requires documentation of continued benefit or positive clinical response, as applicable.

Adbry: Document positive clinical response. For patients weighing less than 100 kg with positive response after 16 weeks, dose is limited to 300 mg every 4 weeks unless clinical rationale supports continuing every-two-week injections.Positive response after 16 weeks; weight < 100 kg

Cosentyx: Document positive clinical response to therapy for the requested indication.

Dupixent: Document positive clinical response to therapy for any indication.

Ebglyss: Document positive clinical response to therapy.

Enbrel: Document positive clinical response to therapy for the requested indication.

Fasenra: Document positive clinical response to therapy for any indication.

Humira: Document that the patient remains treated for a medically accepted indication and demonstrates positive clinical response.

Kevzara or Kineret: Document positive clinical response to therapy.

Required Prerequisite and Combination Therapy

Product	Applicable indication or setting	Step-therapy, prerequisite-drug, or combination requirement
Adbry	Atopic dermatitis	Try and fail one of: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.
Afinitor	Advanced hormone receptor-positive, HER2-negative breast cancer	Use with exemestane and document a trial of letrozole or anastrozole.
Alunbrig	ALK-positive metastatic non-small cell lung cancer	Use crizotinib before Alunbrig.
Arcalyst	Recurrent disease as specified in the policy	Use an inflammatory drug in combination with colchicine before Arcalyst.
Auvelity	Major depressive disorder	Try another generic formulary antidepressant before Auvelity.
Balversa	Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 alterations	Try at least one prior systemic therapy.
Banzel/rufinamide	Medically accepted indications	Try divalproex; the source also states “or …” without identifying the additional therapy.
Banzel/rufinamide	Medically accepted indications	Trial of divalproex is required.
Beqalzi	Relapsed or refractory mantle cell lymphoma	Try a tyrosine kinase (BTK) inhibitor.
Besremi	Polycythemia vera	Try hydroxyurea.
Bosulif	Accelerated- or blast-phase Philadelphia chromosome-positive CML	Try prior therapy; the source does not identify the complete therapy name.
Braftovi	Indication-specific melanoma, colorectal cancer, or non-small cell lung cancer	Requirements vary: prior vemurafenib plus cobimetinib for specified BRAF-mutated melanoma; combination with binimetinib for melanoma or NSCLC; combination with cetuximab plus fluorouracil-based chemotherapy for initial metastatic BRAF V600E colorectal cancer; or cetuximab after prior therapy for metastatic BRAF V600E colorectal cancer.
Briviact	Medically accepted indications	Try levetiracetam and one additional therapy; the second therapy is not identified in the source.
Brukinsa	Mantle cell lymphoma, marginal zone lymphoma, follicular lymphoma, CLL, or SLL	MCL: try Calquence. Relapsed/refractory MZL: try at least one anti-CD20-based regimen. Relapsed/refractory FL: use with obinutuzumab and try at least two systemic-therapy lines. CLL/SLL: try Calquence or Imbruvica.
Bysanti	Adult schizophrenia	Try lurasidone and paliperidone.
Bysanti	Other indications	Try at least two therapies; the therapies are not identified in the source excerpt.
Cabometyx	First-line advanced renal cell carcinoma	Use in combination with nivolumab.
Cabometyx	Hepatocellular carcinoma	Try sorafenib.
Cabometyx	Locally advanced or metastatic differentiated thyroid cancer that is radioactive iodine-refractory or ineligible	Try VEGFR-targeted therapy.
Calcipotriene	Medically accepted indications	Try at least one generic topical therapy.
Calcipotriene cream or solution	Medically accepted indications	Trial at least one generic topical medication before coverage.
Calquence	Mantle cell lymphoma	Receive at least one prior MCL therapy.
Calquence	Previously untreated MCL in a patient ineligible for autologous HSCT	Use in combination with bendamustine and rituximab.
Cavhanza	Adult chronic-phase CML that is not newly diagnosed, or accelerated-phase CML	Use imatinib as prerequisite therapy.
Cobenfy	Schizophrenia	Use prerequisite antipsychotic therapy.
Copiktra	Relapsed or refractory CLL	Receive at least two prior therapies.
Cosentyx	Ankylosing spondylitis, non-radiographic axial spondyloarthritis, or enthesitis-related arthritis	Try one NSAID, such as diclofenac, ibuprofen, meloxicam, or naproxen.
Cotellic	Unresectable or metastatic melanoma with BRAF V600E or V600K mutation	Vemurafenib is listed as prerequisite therapy.
Diacomit	Medically accepted indications	Try two generic anticonvulsants and use Diacomit in combination with clobazam.
Dihydroergotamine nasal spray	Medically accepted indications	Try two formulary triptans: one oral and one non-oral.
Dulera	Asthma	Try Breo before Dulera.
Dupixent	Atopic dermatitis	Try and fail one of: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.
Dupixent	Eosinophilic or corticosteroid-dependent asthma	Demonstrate inadequate control after systemic or high-dose inhaled corticosteroids plus an additional controller trial when applicable.
Dupixent	Chronic rhinosinusitis with nasal polyposis	Disease must recur despite prior intranasal corticosteroids.
Dupixent	Eosinophilic esophagitis	Try a proton pump inhibitor or topical esophageal corticosteroid.
Dupixent	Chronic spontaneous urticaria	Try at least one second-generation antihistamine; symptoms must persist despite H1 antihistamine treatment.
Ebglyss	Moderate-to-severe atopic dermatitis	Try and fail one of: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.
Enbrel	Rheumatoid arthritis	Try one DMARD, such as methotrexate, leflunomide, or sulfasalazine.
Enbrel	Polyarticular juvenile idiopathic arthritis	Try leflunomide or methotrexate.
Enbrel	Ankylosing spondylitis	Try one NSAID, such as diclofenac, ibuprofen, meloxicam, or naproxen.
Epidiolex	Lennox-Gastaut syndrome or tuberous sclerosis complex-associated seizures	Try two generic seizure-treatment alternatives.
Epidiolex	Dravet syndrome	Try two of valproic acid, clobazam, or topiramate.
Eprontia	Preventative migraine treatment	Try at least two generic migraine-prevention alternatives, unless the patient cannot swallow tablets or capsules.
Eucrisa	Atopic dermatitis	Try a generic topical steroid.
Eulexin	Medically accepted indications	Try generic bicalutamide.
Fanapt	Schizophrenia	Try two generic formulary atypical antipsychotics, including quetiapine, risperidone, or ziprasidone.
Fasenra	Eosinophilic asthma	Demonstrate inadequate control after systemic or high-dose inhaled corticosteroids plus one additional controller: a leukotriene modifier, LABA, or LAMA.
Fetzima	Major depressive disorder	Try the specified prerequisite antidepressants, including desvenlafaxine and duloxetine.
Fintepla	Medically accepted indications	Try two prerequisite therapies; the source excerpt does not identify them.
Fotivda	Advanced renal cell carcinoma	Try two or more prior systemic therapies.
Fruzaqla	Metastatic colorectal cancer	Try fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and an anti-VEGF therapy.
Fycompa or perampanel	Medically accepted indications	Try two generic drugs.
Gilotrif	Qualifying metastatic NSCLC indications	Use prerequisite Part D therapy.
Humira	Rheumatoid arthritis, polyarticular JIA, or ankylosing spondylitis	RA: try one DMARD. Polyarticular JIA: try leflunomide or methotrexate. Ankylosing spondylitis: try one NSAID.
Ibrance	Indication-specific breast cancer settings	Use the applicable regimen: aromatase inhibitor; fulvestrant; inavolisib plus fulvestrant; or trastuzumab with or without pertuzumab plus endocrine therapy.
Iclusig	Other chronic-phase CML indications	Try at least two prior kinase inhibitors.
Iclusig	Newly diagnosed Ph+ ALL	Use in combination with chemotherapy.
Imkeldi	All indications	Use only when the patient cannot swallow the tablet formulation or cannot achieve the prescribed dose with tablets.
Imkeldi	Ph+ CML in blast crisis, accelerated phase, or chronic phase	Treatment failure is required.
Inluriyo	ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer	Use as monotherapy or in combination with abemaciclib.
Inlyta	First-line advanced renal cell carcinoma	Use in combination with avelumab or pembrolizumab.
Inqovi	Medically accepted indications	Try azacitidine.
Isotretinoin products	Medically accepted indications	Try an oral therapy; the source does not identify the complete therapy name.
Iwilfin	High-risk neuroblastoma	Demonstrate at least a partial response to prior multiagent immunotherapy.
Iwilfin	High-risk neuroblastoma	Immunotherapy is the prerequisite treatment.
Jakafi or Jakafi XR	Polycythemia vera	Try one or two lines of systemic therapy; inadequate response or intolerance to hydroxyurea is required.
Jaypirca	Mantle cell lymphoma	Try two lines of systemic therapy, including a BTK inhibitor.
Jideytro	Locally advanced or metastatic ROS1-positive NSCLC	Use an inhibitor as prerequisite therapy.
Jylamvo	Medically accepted indications	Try the oral tablet formulation of methotrexate.
Kerendia	Heart failure with LVEF ≥40%	Try an SGLT2 inhibitor, such as empagliflozin or dapagliflozin, unless contraindicated or not tolerated.
Kevzara	Rheumatoid arthritis or polyarticular JIA	Try two listed therapies, including Enbrel, adalimumab products, Rinvoq, tofacitinib, or Orencia.
Kineret	Rheumatoid arthritis	Try two of Enbrel, adalimumab-aaty, adalimumab-adbm, Rinvoq, tofacitinib, or Orencia.
Kisqali	HR-positive, HER2-negative advanced/metastatic or early high-risk breast cancer	Use with an aromatase inhibitor or fulvestrant according to the treatment setting.
Krazati	KRAS G12C-mutated locally advanced or metastatic NSCLC	Receive systemic therapy as prerequisite therapy.
Lazcluze	Applicable locally advanced or metastatic indication	Use in combination with amivantamab.
Lenvima	First-line renal cell carcinoma	Use in combination with pembrolizumab.
Lenvima	Renal cell carcinoma after prior therapy	Use in combination with everolimus after one prior anti-angiogenic therapy.
Lenvima	Advanced endometrial carcinoma	Use in combination with pembrolizumab after disease progression following prior systemic therapy.
Levetiracetam tablet for oral suspension	Medically accepted indications	The patient must be unable to swallow tablets or capsules and must meet the policy’s additional trial requirement.
Libtayo	Basal cell carcinoma	Prior treatment with a Hedgehog pathway inhibitor is required.

Coverage Durations and Quantity Constraints

Quantity Limits and Coverage Durations

Adbry dose limitationFor patients weighing less than 100 kg who have a positive clinical response after 16 weeks, dosage is limited to 300 mg every 4 weeks unless clinical rationale supports continuing injections every 2 weeks

Deferasirox tabletsCoverage duration: 1 year

Tolvaptan tabletsCoverage duration: 1 year

KalydecoCoverage duration: 1 year

KerendiaCoverage duration: 1 year

Prior Authorization and Submission Requirements

Prior Authorization

Prior Authorization Required: PA Submission and Listed Products

Submit a prior authorization request through the pharmacy help desk for each medication listed below before coverage is provided. PA criteria are based on medically accepted indications and applicable clinical or administrative requirements; verify formulary coverage and include the product, indication, treatment history, and requested duration.

Standard PA products generally require medically accepted use and are authorized for 1 year unless otherwise noted: Alosetron hydrochloride; Teriflunomide; Benlysta (1 year); Betaseron (1 year); Caprelsa (1 year); Cayston (1 year); Tadalafil (1 year); Cometriq (12 months); Glatiramer acetate and Glatopa (1 year); Cresemba (1 year); Cystaran (1 year); Dalfampridine ER; Emgality (1 year); Ensacove (1 year); Erivedge (1 year; oncologist or dermatologist prescriber); Erleada (1 year); Procrit; Pirfenidone (1 year); Fetzima; Fintepla; Icatibant acetate (age 18 years and older; 1 year); Fulphila (1 year); Fingolimod; Inrebic (1 year); Gefitinib (1 year); Ivermectin tablets (1 year); Jadenu/deferasirox (1 year); Jynarque/tolvaptan (1 year); Koselugo (1 year); Leuprolide (1 year); Libervant (1 year); and topical lidocaine products (3 years).
Adbry: PA is required for patients at least 12 years of age with moderate-to-severe atopic dermatitis; document failure of one high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil. Authorization is 1 year; do not combine with another biologic or targeted DMARD for the same condition, and reauthorization requires positive clinical response; patients under 100 kg are limited to 300 mg every 4 weeks after response at week 16 unless rationale supports every-2-week dosing.
Afinitor/everolimus: oncology PA is required. For advanced hormone-receptor-positive, HER2-negative breast cancer, submit documentation of combination use with exemestane and a trial of letrozole or anastrozole; prerequisite therapy is required.
Akeega: oncology PA requires use with prednisone for deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, including the BRCA2-mutated population; document the mutation and combination regimen.
Prolastin-C/alpha-1-proteinase inhibitor: submit diagnosis of necrotizing panniculitis or alpha-1 antitrypsin deficiency with FEV1 below 80% predicted, age 18 years or older, symptomatic emphysema, and congenital AAT deficiency consistent with PIZZ, PIZ(null), or PI(null,null) phenotype.
Banzel/rufinamide: PA requires a trial of divalproex. Benlysta and Betaseron have 1-year authorization periods. Beqalzi requires relapsed or refractory mantle cell lymphoma and a prior BTK-inhibitor trial. Besremi requires polycythemia vera and hydroxyurea trial.
Bosulif/bosutinib: document accelerated- or blast-phase Philadelphia chromosome-positive CML and required prior therapy. Braftovi: document mutation and indication-specific combinations—binimetinib for BRAF V600E/V600K melanoma or BRAF V600E NSCLC; cetuximab with fluorouracil-based chemotherapy for initial BRAF V600E metastatic CRC; and cetuximab after prior therapy for metastatic CRC; also document the vemurafenib plus cobimetinib trial for melanoma.
Briviact/brivaracetam requires prior levetiracetam and another antiseizure therapy. Brukinsa requires indication-specific prerequisites: Calquence for MCL; an anti-CD20 regimen for relapsed/refractory MZL; obinutuzumab plus at least two systemic-therapy lines for relapsed/refractory FL; or Calquence or Imbruvica for CLL/SLL.
Budesonide ER: do not submit for maintenance of remission in ulcerative colitis; that indication is excluded. Bysanti requires lurasidone and paliperidone trials for schizophrenia, or at least two specified formulary therapies for other indications.
Cabometyx: first-line advanced RCC requires nivolumab; HCC requires a sorafenib trial; radioactive-iodine-refractory or ineligible DTC requires prior VEGFR-targeted therapy. Calcipotriene requires a trial of at least one generic topical medication.
Calquence: MCL requires at least one prior MCL therapy; previously untreated MCL in patients ineligible for autologous HSCT requires bendamustine plus rituximab. Caprelsa, Cavhanza, Cayston, Cobenfy, Cometriq, glatiramer, Glatopa, Copiktra, Cosentyx, Cotellic, Cresemba, Cystaran, dalfampridine, Daurismo, Dulera, Emgality, Emsam, Enbrel, Endari, Ensacove, Epidiolex, Eprontia, Erivedge, Erleada, Procrit, pirfenidone, Eucrisa, Eulexin, Fanapt, Fasenra, Fetzima, Fintepla, icatibant, Fotivda, Fruzaqla, Fulphila, Fycompa/perampanel, Gavreto, fingolimod, Gilotrif, GLP-1 agonists, growth hormone products, Tasimelteon, Humira products, IVIG products, Increlex, Inluriyo, Inlyta, Inqovi, Inrebic, gefitinib, isotretinoin, Itovebi, ivermectin, Iwilfin, Jadenu/deferasirox, Jakafi/Jakafi XR, Jynarque/tolvaptan, Kerendia, Kevzara, Kisqali, Kineret, Koselugo, Krazati, Lazcluze, Lenvima, leuprolide, Libervant, Libtayo, and topical lidocaine also require PA under the criteria below or the applicable standard PA criteria.
Cavhanza: coverage is for adults with chronic-phase CML that is not newly diagnosed and accelerated-phase disease, and requires prior imatinib. Cobenfy: schizophrenia coverage requires prior antipsychotic therapy. Daurismo: newly diagnosed disease requires combination use with low-dose cytarabine.
Dulera: asthma PA requires an asthma diagnosis and a trial of Breo. Dupixent: use indication-specific criteria and age/weight requirements; do not combine with another biologic or targeted DMARD for the same condition. Ebglyss: patients must be at least 12 years old and weigh at least 40 kg, have moderate-to-severe atopic dermatitis, fail a specified topical or systemic prerequisite, and show positive response for reauthorization.
Eucrisa requires a topical steroid or generic topical trial. Eulexin requires generic bicalutamide. Fanapt requires two generic formulary atypical-antipsychotic trials. Fasenra requires indication-specific asthma, EGPA, or HES criteria, including required eosinophil counts and controller/systemic-steroid history; exclude duplicate biologic/targeted-DMARD therapy and document response at renewal.
Fetzima requires the specified antidepressant trials, including desvenlafaxine and duloxetine. Fintepla requires two prior therapies. Fotivda requires at least two prior systemic therapies for advanced RCC. Fruzaqla requires prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy plus anti-VEGF therapy.
Gavreto requires RET fusion-positive advanced/metastatic thyroid cancer and appropriate prior or planned radioactive iodine where applicable. Gilotrif requires first-line metastatic NSCLC with a non-resistant EGFR mutation detected by an FDA-approved test, or the applicable prior-treatment pathway. GLP-1 agonists are excluded when used for weight loss only and require T2DM documentation; acceptable diagnostic evidence includes A1C at least 6.5%, fasting plasma glucose at least 126 mg/dL, or 2-hour OGTT glucose at least 200 mg/dL.
Growth hormone products: Genotropin/Genotropin Miniquick PA is 1 year for pediatrics and lifetime for adults. Tasimelteon requires PA. Humira products require diagnosis- and indication-specific PA. IVIG products are subject to additional Part D requirements. Increlex requires PA.
Inluriyo: document ER-positive, HER2-negative, ESR1-mutated advanced/metastatic breast cancer and permitted monotherapy or abemaciclib combination use. Inlyta: first-line advanced RCC requires avelumab or pembrolizumab combination. Inqovi requires an azacitidine trial. Iwilfin requires high-risk neuroblastoma with at least a partial response to prior multiagent immunotherapy and response documentation.
Itovebi: endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer requires combination with fulvestrant. Ivermectin tablets require PA for FDA-approved indications. Jakafi/Jakafi XR: polycythemia vera requires inadequate response or intolerance to hydroxyurea and the applicable systemic-therapy history. Jynarque/tolvaptan has 1-year PA.
Kerendia: coverage includes CKD associated with T2DM; heart-failure use with LVEF at least 40% requires an SGLT2-inhibitor trial unless contraindicated or intolerant. Kevzara: RA requires moderately-to-severely active disease and two prior agents; PMR requires prolonged prednisone exposure and flare during taper; polyarticular JIA requires active disease and two prior agents. Kineret: RA requires two prior agents. Kisqali requires the applicable endocrine combination for advanced/metastatic or high-risk early breast cancer.
Krazati requires KRAS G12C-mutated locally advanced or metastatic NSCLC and prior systemic therapy. Lazcluze requires combination with amivantamab. Lenvima requires indication-specific combinations: pembrolizumab for first-line RCC, everolimus after one anti-angiogenic therapy for RCC, or pembrolizumab after prior systemic therapy for advanced endometrial cancer. Libtayo for BCC requires prior Hedgehog-pathway inhibitor treatment.

Step Therapy

Step Therapy and Combination Requirements

When a product has a prerequisite or combination requirement, include the failed, inadequate, or intolerable therapy, dates or duration when available, and the proposed combination in the PA submission. Failure to document the required treatment history may result in denial.

Required step therapy and prerequisite documentation includes: Adbry prerequisite therapy; Afinitor letrozole or anastrozole trial; Alunbrig prior crizotinib; Arcalyst anti-inflammatory therapy with colchicine; Auvelity another generic formulary antidepressant; Balversa at least one prior systemic therapy; Banzel divalproex; Beqalzi a BTK inhibitor; Besremi hydroxyurea; Bosulif prior therapy; Braftovi vemurafenib plus Cotellic where applicable and required combination therapy; Briviact levetiracetam plus another therapy; Brukinsa Calquence, anti-CD20, obinutuzumab/systemic lines, or Calquence/Imbruvica by indication; Bysanti lurasidone and paliperidone or at least two other therapies; Cabometyx nivolumab, sorafenib, or VEGFR-targeted therapy by indication; Calcipotriene a generic topical; Calquence prior MCL therapy or bendamustine/rituximab; Cavhanza imatinib; Cobenfy an antipsychotic; and at least two prior therapies when the indication requires it.
Additional step therapy includes a vemurafenib-associated therapy requirement, two-triptan therapy for dihydroergotamine, Breo before Dulera, topical/systemic prerequisite therapy for atopic dermatitis, indication-specific Dupixent prerequisites, Ebglyss prerequisite therapy, two therapies before Emsam, indication-specific Enbrel therapy, Endari prerequisite therapy, Epidiolex seizure-treatment alternatives, Eprontia migraine-prevention alternatives, Eucrisa topical steroid/generic therapy, Eulexin bicalutamide, Fanapt atypical antipsychotics, Fasenra asthma controllers, Fetzima antidepressants, Fintepla prior therapy, prior systemic therapy for Fotivda, prior chemotherapy and anti-VEGF therapy for Fruzaqla, two generic-drug trials for Fycompa/perampanel, and Gilotrif prerequisite therapy.
Humira requires indication-specific prerequisite therapy. Ibrance requires the applicable endocrine therapy and, for specified breast-cancer indications, inavolisib/fulvestrant or trastuzumab with or without pertuzumab plus endocrine therapy. Iclusig requires at least two prior kinase inhibitors for other chronic-phase CML indications. Imbruvica requires prerequisite therapy for applicable indications. Imkeldi requires inability to swallow tablets or achieve the prescribed tablet dose and treatment failure for specified Ph+ CML. Inluriyo requires the permitted breast-cancer combination; Inlyta requires avelumab or pembrolizumab where specified; Inqovi requires azacitidine; Iwilfin requires prior multiagent immunotherapy and response.

Documentation Required

Documentation and Supporting Evidence

Attach clinical records supporting the diagnosis, severity, eligibility, prerequisite treatment history, requested regimen, and response when renewal is requested. Documentation must be specific to the product and indication rather than a generic statement of medical necessity.

Adbry documentation must include age, weight when relevant, moderate-to-severe atopic dermatitis diagnosis, prerequisite therapy and failure, combination-therapy review, and positive response for reauthorization. Prolastin-C documentation must include alpha-1 antitrypsin phenotype, FEV1, symptomatic emphysema or necrotizing panniculitis, age, and clinical eligibility. Balversa documentation must include susceptible FGFR3 alteration, urothelial-carcinoma indication, and prior systemic therapy.
Tadalafil requires documentation of benign prostatic hyperplasia and absence of nitrate therapy. Calquence requires MCL diagnosis and treatment history or the bendamustine/rituximab combination. Cavhanza requires chronic-phase CML disease phase, non-newly-diagnosed status, and imatinib history. Cosentyx requires diagnosis, indication-specific prerequisite therapy, absence of duplicate biologic/targeted-DMARD treatment, and positive response for reauthorization.
Dalfampridine requires multiple-sclerosis documentation and a baseline Timed 25-Foot Walk (T25FW) before initiation. Copiktra requires relapsed/refractory CLL or the applicable lymphoma diagnosis and at least two prior therapies. Cotellic requires melanoma diagnosis, BRAF V600E/V600K mutation documentation, and the required vemurafenib combination. Dupixent requires supporting indication, age/weight, severity, prerequisite treatment, and response documentation.
Ebglyss requires weight of at least 40 kg, age at least 12 years, moderate-to-severe atopic dermatitis, prior treatment failure, no duplicate biologic/targeted-DMARD therapy, and positive response at renewal. Enbrel requires diagnosis-specific records: active moderate-to-severe RA plus DMARD trial; active polyarticular JIA plus leflunomide or methotrexate; active PsA, JPsA, or AS; moderate-to-severe plaque psoriasis; or applicable indication and NSAID trial. Reauthorization requires positive response.

Denial Risk

Denial Risks, Exclusions, and Response Requirements

Review the denial risks below before submitting. Coverage may be denied when the requested indication is excluded, the disease phase or mutation does not match the criterion, required prior therapy or combination treatment is missing, or the member is receiving a prohibited duplicate therapy.

Do not cover Adbry, Dupixent, Ebglyss, Enbrel, Fasenra, Humira, Kevzara, Kineret, or Cosentyx with another biologic or targeted DMARD indicated for the same condition. Do not cover tadalafil when the patient receives nitrate therapy. Do not cover GLP-1 agonists for weight loss only. Do not cover budesonide ER for maintenance of remission in ulcerative colitis. Do not cover dalfampridine when the patient is wheelchair-bound or becomes wheelchair-bound.
Denial risks include incomplete required treatment history, insufficient prior systemic therapy, failure to complete generic prerequisite therapy, missing disease severity, absent mutation or disease-phase documentation, absent endocrine or other required combination, missing SGLT2-inhibitor trial, inadequate PMR corticosteroid history, or lack of positive response for reauthorization.
Balversa is not eligible without the required FGFR3-altered urothelial-cancer indication and prior systemic therapy. Calquence is not eligible without MCL treatment history or the required bendamustine/rituximab regimen. Cavhanza is not eligible without the required chronic-phase CML phase and imatinib prerequisite. Gilotrif is not eligible when EGFR mutation, first-line status, or applicable prior-treatment criteria are not met.
Ibrance, Itovebi, Inluriyo, Inlyta, Kisqali, Lenvima, and Braftovi may be denied when the required endocrine, antibody, chemotherapy, targeted, or other combination is absent. Iclusig may be denied without the required prior kinase-inhibitor history. Imkeldi may be denied when tablet formulation failure or inability to swallow is not documented. Iwilfin may be denied without high-risk neuroblastoma, prior immunotherapy, and at least partial response.

Policy Terms and Clinical Abbreviations

Definitions and Abbreviations

PAPrior authorization: clinical and/or administrative criteria that must be met before coverage is provided

STStep therapy: a requirement for previous treatment with one or more formulary drugs before coverage of the requested medication

Alpha-1 antitrypsin deficiencyA congenital deficiency of alpha-1 antitrypsin documented with phenotypes PIZZ, PIZ (NULL), or PI (NULL, NULL) of AAT

Autologous HSCTAutologous hematopoietic stem cell transplantation using the patient's own hematopoietic stem cells

CML phasesCML disease phases referenced in the criteria include chronic phase and accelerated phase; CML may also be identified in blast phase

T25FWTimed 25-foot walk test used as a baseline functional assessment before Dalfampridine initiation for multiple sclerosis

Clinical abbreviations and treatment termsHR-positive/HER2-negative means hormone receptor-positive, human epidermal growth factor receptor 2-negative; Ph+ ALL means Philadelphia chromosome-positive acute lymphoblastic leukemia; ER-positive, HER2-negative, ESR1-mutated disease refers to estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer; a biologic or targeted DMARD is a biologic or targeted disease-modifying antirheumatic drug used for the same condition

Program Background

The formulary program monitors selected medications to promote appropriate and cost-effective drug therapy. Prior authorization criteria are based on current medical information and recommendations from the plan’s Pharmacy and Therapeutics Committee. The program distinguishes medications requiring prior authorization from those subject to step therapy and directs providers to verify formulary coverage before submitting a request.

For medications requiring prior authorization, clinical and/or administrative criteria must be met before coverage is provided. Step therapy may require previous treatment with one or more formulary drugs before the requested medication is covered.

General Submission Rules

Prior Authorization

Prior authorization is required before coverage

Medications identified with prior authorization require the applicable clinical and/or administrative criteria to be met before coverage is provided. Submit the request through the pharmacy help desk or the plan’s designated authorization process.

Verify that the requested medication is covered on the formulary.
Include the requested indication and all applicable supporting clinical or administrative information.

Step Therapy

Complete formulary step therapy

Medications subject to step therapy may require previous treatment with one or more formulary drugs before coverage is provided. Document the required trial, treatment failure, intolerance, contraindication, or required combination regimen when applicable.

The prerequisite varies by product and indication.
Examples include a trial of Breo before Dulera, two formulary triptans before dihydroergotamine nasal spray, and an SGLT2 inhibitor before Kerendia for heart failure with LVEF at least 40%, unless contraindicated or not tolerated.

Isotretinoin requires an oral-therapy trial. Jakafi requires hydroxyurea for polycythemia vera and one or two lines of systemic therapy where applicable. Jaypirca requires two systemic-therapy lines for MCL, including a BTK inhibitor, or the applicable prior systemic treatment for CLL/SLL. Jideytro requires a prior inhibitor for ROS1-positive NSCLC. Jylamvo requires a trial of oral methotrexate tablets.

Kerendia requires an SGLT2-inhibitor trial for specified heart-failure coverage unless contraindicated or intolerant. Kineret requires two prior agents for RA. Kisqali requires the required endocrine combination. Krazati requires prior systemic therapy. Lazcluze requires amivantamab. Lenvima requires the applicable pembrolizumab or everolimus combination and prior anti-angiogenic/systemic therapy. Libtayo for BCC requires a Hedgehog inhibitor.

Do not approve or submit as covered when a required prerequisite is incomplete, the requested use is weight-loss-only, a prohibited duplicate biologic or targeted DMARD is being used, a prohibited nitrate combination exists, or the requested indication is excluded. For all products with prerequisite therapy, document the specific agent, trial, failure/intolerance, and date.

Endari requires related crises within the prior 12 months and prerequisite therapy or intolerance. Fasenra requires EGPA supporting documentation, asthma diagnosis and eosinophil count of at least 150 cells/microliter where applicable, HES diagnosis and eosinophil count of at least 1,000 cells/microliter, controller/systemic-steroid treatment history, and positive response at renewal.

GLP-1 agonists require T2DM diagnosis documentation and laboratory or chart-note support; weight-loss-only use is excluded. Humira requires diagnosis, indication-specific prerequisite therapy, no duplicate biologic/targeted-DMARD therapy, and positive response documentation. Kevzara requires RA, PMR, or polyarticular JIA clinical documentation, required treatment history, and renewal response. Kisqali requires breast-cancer indication, HR/HER2 status, and the required endocrine combination. Kerendia requires CKD/T2DM or heart-failure indication documentation and SGLT2-inhibitor history or contraindication/intolerance.

For reauthorization, provide objective or narrative evidence of positive clinical response whenever required, including for Adbry, Cosentyx, Dupixent, Ebglyss, Enbrel, Fasenra, Humira, Kevzara, and other biologic or targeted therapies. Missing diagnosis, severity, baseline testing, treatment history, mutation status, combination regimen, or response evidence is a documentation deficiency and may prevent approval.

Krazati may be denied without KRAS G12C-mutated locally advanced/metastatic NSCLC and prior systemic therapy. Lazcluze may be denied without amivantamab. Libtayo for BCC may be denied without prior Hedgehog-pathway inhibitor treatment. Fotivda may be denied without two prior systemic therapies; Fruzaqla without prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy plus anti-VEGF therapy; and Gavreto without the applicable RET fusion-positive thyroid-cancer criteria.

Dihydroergotamine requires two formulary triptan trials, one oral and one non-oral. Diacomit requires failure of two generic anticonvulsants and combination with clobazam. Epidiolex requires the specified seizure-treatment history. Eprontia requires migraine-prevention treatment history or inability to swallow tablets/capsules. Fintepla, Fanapt, Fetzima, Emsam, Briviact, Banzel, Besremi, Bosulif, Brukinsa, Bysanti, and Fycompa/perampanel may be denied when the required number or type of prior therapies is not documented.

Dupixent may be denied for an age, weight, indication, prerequisite, controller-therapy, or response deficiency. Fasenra may be denied for missing eosinophil counts, EGPA criteria, asthma history, HES criteria, controller/systemic-steroid history, or response. Enbrel, Humira, Kevzara, Kineret, and Cosentyx may be denied for inactive or unsupported disease, incomplete prerequisite trials, prohibited combination use, or absent response at renewal.

Kerendia may be denied for an unsupported CKD/T2DM or heart-failure indication, missing LVEF criterion, or missing SGLT2-inhibitor trial without documented contraindication or intolerance. Missing required endocrine combination, insufficient prior systemic therapy, incomplete treatment history, uncompleted generic prerequisite therapy, or failure to show positive response should be resolved before submission.