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CurrentBlue Cross Complete of MichiganPolicy 26449
Medicare Plus Blue and Prescription Blue Group PDP Comprehensive Formulary Prior Authorization / Step Therapy Program
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Governs prior authorization and step therapy requirements for medications covered under Blue Cross Complete of Michigan Medicare Plus Blue Group PPO and Prescription Blue Group PDP plans.
Policy Summary
PayerBlue Cross Complete of Michigan
PolicyComprehensive Formulary Prior Authorization / Step Therapy Program
Policy CodePolicy 26449
Change TypeNo material change
Effective DateNovember 1, 2026
Next Review DateN/A
Key ActionSubmit the applicable clinical and administrative documentation when requesting prior authorization or step therapy coverage.
No material clinical or coverage changes in this revision.
380Total pages
PA/STUtilization management
10Medication sections shown
1 yearCommon coverage duration
Medication Coverage Criteria
Drug-Specific Coverage Criteria
Coverage criteria apply to the affected product(s) and require prior authorization where indicated. Unless otherwise stated, coverage is for medically accepted indications and the stated prerequisite therapy requirements apply.
Adbry: Patients must be at least 12 years of age and have moderate-to-severe atopic dermatitis. Requires a trial and treatment failure of one of the following: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil. Patients weighing less than 100 kg who respond after 16 weeks are limited to 300 mg every 4 weeks unless rationale supports continued every-2-week injections. Prerequisite Part D therapy is required.
Afinitor (everolimus): Advanced hormone receptor-positive, HER2-negative breast cancer requires combination use with exemestane and a trial of letrozole or anastrozole. Prerequisite Part D therapy is required.
Akeega: Deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer requires combination use with prednisone. Prerequisite Part D therapy is not required.
Policy Summary
PayerBlue Cross Complete of Michigan
PolicyComprehensive Formulary Prior Authorization / Step Therapy Program
Policy CodePolicy 26449
Change TypeNo material change
Effective DateNovember 1, 2026
Next Review DateN/A
Key ActionSubmit the applicable clinical and administrative documentation when requesting prior authorization or step therapy coverage.
Alpha-1-proteinase inhibitors (Prolastin-C): Requires necrotizing panniculitis or alpha-1 antitrypsin deficiency with FEV1 less than 80% predicted; patient must be at least 18 years old, have congenital AAT deficiency consistent with PIZZ, PIZ (null), or PI (null,null) phenotype, and symptomatic emphysema. Prerequisite Part D therapy is not required.
Alunbrig: ALK-positive metastatic non-small cell lung cancer requires prior crizotinib. Prerequisite Part D therapy is required.
Arcalyst: Recurrent inflammatory disease requires inflammatory-drug therapy in combination with colchicine. Prerequisite Part D therapy is required.
Auvelity: Major depressive disorder requires a trial of another generic formulary antidepressant. Prerequisite Part D therapy is required.
Balversa: Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations requires at least one prior systemic therapy. Prerequisite Part D therapy is required.
Banzel (rufinamide): Coverage requires a trial of divalproex or other specified prerequisite anticonvulsant therapy. Prerequisite Part D therapy is required.
Beqalzi: Relapsed or refractory mantle cell lymphoma requires a trial of at least one BTK inhibitor. Prerequisite Part D therapy is required.
Besremi: Polycythemia vera requires a trial of hydroxyurea. Prerequisite Part D therapy is required.
Bosulif: Accelerated- or blast-phase Philadelphia chromosome-positive CML requires a trial of prior therapy. Prerequisite Part D therapy is required.
Braftovi: Melanoma with BRAF V600E/V600K requires combination with binimetinib and prior vemurafenib plus cobimetinib; metastatic colorectal cancer requires cetuximab with fluorouracil-based chemotherapy initially or cetuximab after prior therapy; metastatic BRAF V600E NSCLC requires binimetinib. Prerequisite Part D therapy is required.
Briviact: Requires a trial of levetiracetam and one additional specified anticonvulsant. Prerequisite Part D therapy is required.
Brukinsa: MCL requires a trial of Calquence; relapsed/refractory MZL requires at least one anti-CD20 regimen; relapsed/refractory FL requires obinutuzumab combination and at least two systemic-therapy lines; CLL/SLL requires a trial of Calquence or Imbruvica. Prerequisite Part D therapy is required.
Budesonide ER: Coverage is not provided for maintenance of remission in ulcerative colitis. Prerequisite Part D therapy is not required.
Bysanti: Adult schizophrenia requires trials of lurasidone and paliperidone; other indications require trials of at least two specified alternatives. Prerequisite Part D therapy is required.
Cabometyx: First-line advanced RCC requires nivolumab; HCC requires sorafenib; radioactive-iodine-refractory or ineligible locally advanced/metastatic DTC requires VEGFR-targeted therapy. Prerequisite Part D therapy is required.
Calcipotriene: Requires a trial of at least one generic topical therapy. Prerequisite Part D therapy is required.
Calquence: MCL requires at least one prior MCL therapy. Previously untreated MCL in patients ineligible for autologous HSCT requires bendamustine plus rituximab. Prerequisite Part D therapy is required.
Cavhanza: Adult patients with chronic-phase CML that is not newly diagnosed, or accelerated-phase CML, require prior imatinib. Prerequisite Part D therapy is required.
Tadalafil: Coverage requires a diagnosis of benign prostatic hyperplasia; coverage is excluded when the patient is receiving nitrate therapy. Prerequisite Part D therapy is not required.
Cobenfy: Schizophrenia requires prior antipsychotic therapy. Prerequisite Part D therapy is required.
Glatiramer acetate/Glatopa: Covered for medically accepted indications; one-year coverage. Prerequisite Part D therapy is not required.
Copiktra: Relapsed or refractory CLL requires at least two prior therapies. Prerequisite Part D therapy is required.
Cosentyx: PsA requires active disease; plaque psoriasis requires chronic moderate-to-severe disease; AS requires AS diagnosis and NSAID trial; non-radiographic axSpA requires diagnosis, objective inflammation, and NSAID trial; ERA requires active disease and NSAID trial; HS requires moderate-to-severe disease. Prerequisite Part D therapy is required.
Cotellic: Unresectable or metastatic melanoma with BRAF V600E/V600K requires vemurafenib combination. Prerequisite Part D therapy is not required.
Dalfampridine ER: MS coverage requires baseline timed 25-foot walk before initiation. Coverage is excluded if the patient is wheelchair-bound or becomes wheelchair-bound.
Daurismo: Newly diagnosed disease requires use with low-dose cytarabine. Prerequisite Part D therapy is not required.
Diacomit: Requires two generic anticonvulsant trials and combination use with clobazam. Prerequisite Part D therapy is required.
Dihydroergotamine: Requires trials of two formulary triptans: one oral and one non-oral.
Dulera: Asthma requires an asthma diagnosis and trial of a specified Breo-based prerequisite therapy.
Dupixent: Age and weight requirements vary by indication. AD requires moderate-to-severe disease and failure of high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil. EA requires eosinophils at least 150 cells/microliter and inadequate control despite systemic or high-dose inhaled corticosteroid plus LABA, LAMA, or leukotriene modifier. CDA requires moderate-to-severe oral-corticosteroid-dependent asthma. CRSwNP requires disease recurring despite intranasal corticosteroids. EOE requires symptomatic disease and trial of a PPI or topical esophageal corticosteroid. PN requires diagnosis. COPD requires uncontrolled moderate-to-severe disease, eosinophils at least 300 cells/microliter, and continued LABA, LAMA, and inhaled corticosteroid unless contraindicated. CSU requires symptoms despite H1 antihistamine and trial of a second-generation antihistamine. AFRS requires diagnosis and history of sinonasal surgery. Prerequisite Part D therapy is required.
Ebglyss: Patients must be at least 12 years old and weigh at least 40 kg, with moderate-to-severe AD and trial/failure of high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil. Prerequisite Part D therapy is required.
Emgality: One-year coverage for medically accepted indications; prerequisite Part D therapy is not required.
Emsam: Requires trials with two specified alternatives.
Enbrel: RA requires moderately-to-severely active disease and DMARD trial; polyarticular JIA requires active disease and leflunomide or methotrexate trial; PsA requires active disease; JPsA requires active disease; plaque psoriasis requires moderate-to-severe chronic disease; AS requires active disease and NSAID trial. Prerequisite Part D therapy is required.
L-glutamine: Requires related crises in the past 12 months and trial or intolerance of prerequisite therapy.
Epidiolex: Lennox-Gastaut syndrome requires two generic seizure-therapy trials; Dravet syndrome requires two of valproic acid, clobazam, or topiramate; tuberous sclerosis complex seizures require two generic seizure-therapy trials.
Topiramate oral solution: Migraine prevention requires two generic migraine-prevention trials or inability to swallow tablets/capsules; seizure-disorder coverage has additional prerequisite requirements.
Fasenra: EA requires diagnosis, eosinophils at least 150 cells/microliter, and inadequate control after systemic or high-dose inhaled corticosteroid plus LABA, LAMA, or leukotriene modifier in patients age 12 or older. EGPA requires diagnosis, asthma history or presence, and at least two typical EGPA features, including histopathologic eosinophilic vasculitis, neuropathy, pulmonary infiltrates, allergic rhinitis/nasal polyps, cardiomyopathy, glomerulonephritis, or alveolar hemorrhage. HES requires diagnosis and eosinophils at least 1,000 cells/microliter. Prerequisite Part D therapy is required.
Fintepla: Requires trial of two specified alternatives.
Icatibant acetate: Patients must be at least 18 years old; one-year coverage. Prerequisite Part D therapy is not required.
Fycompa/perampanel: Requires trial of two generic alternatives.
Gavreto: Advanced or metastatic RET fusion-positive thyroid cancer requires systemic therapy when radioactive iodine is appropriate.
Gilotrif: First-line metastatic NSCLC requires non-resistant EGFR mutation confirmed by an FDA-approved test; coverage also applies to metastatic NSCLC progressing after prior therapy.
GLP-1 agonists (Mounjaro, Ozempic, Rybelsus, Trulicity): Excluded when used solely for weight loss. Coverage requires documentation of T2DM or qualifying laboratory evidence: A1C at least 6.5%, fasting plasma glucose at least 126 mg/dL, or 2-hour OGTT plasma glucose at least 200 mg/dL.
Gomekli, Grastek, Genotropin, Haegarda, Hernexeos, tasimelteon, Humulin R U-500, Increlex, Inrebic, gefitinib, ivermectin, deferasirox, Kalydeco, Libervant, leuprolide, and Drizalma Sprinkle: Covered for stated medically accepted indications with the product-specific one-year, pediatric, adult, or lifetime duration noted in the policy; prerequisite requirements apply where specified.
Ibrance: HR-positive/HER2-negative advanced or metastatic breast cancer requires an aromatase inhibitor as initial endocrine therapy or fulvestrant after endocrine progression. Endocrine-resistant, PIK3CA-mutated disease requires inavolisib plus fulvestrant after recurrence following adjuvant endocrine therapy. HR-positive/HER2-positive maintenance after induction requires trastuzumab, with or without pertuzumab, plus endocrine therapy.
Iclusig: Newly diagnosed Ph-positive ALL requires chemotherapy combination. T315I-positive Ph-positive ALL may receive monotherapy when no other kinase inhibitor is indicated. T315I-positive CML is covered in chronic, accelerated, or blast phase. Accelerated- or blast-phase CML is covered when no other kinase inhibitor is indicated. Other chronic-phase CML requires at least two prior kinase-inhibitor trials.
Imkeldi: All indications require inability to swallow tablets or inability to achieve the prescribed dose with tablets. Ph-positive CML in blast crisis, accelerated phase, or chronic phase requires failure of prior therapy.
Iwilfin: High-risk neuroblastoma requires at least a partial response to prior multiagent therapy and immunotherapy. Prerequisite Part D therapy is not required.
Jakafi: Polycythemia vera requires inadequate response or intolerance to hydroxyurea.
Jaypirca: MCL requires two lines of systemic therapy including a BTK inhibitor. Relapsed or refractory CLL/SLL requires the disease-specific prior-treatment criteria in the policy.
Jideytro: Locally advanced or metastatic ROS1-positive NSCLC requires a ROS1 inhibitor.
Kerendia: Covered for CKD associated with T2DM. Heart failure with LVEF at least 40% requires an SGLT2 inhibitor trial, unless contraindicated or intolerant.
Ketoconazole tablets: One-year coverage for medically accepted indications; prerequisite Part D therapy is not required.
Kevzara: RA requires moderately-to-severely active disease and trials of two of Enbrel, adalimumab-aaty, adalimumab-adbm, Rinvoq, tofacitinib, or Orencia. PMR requires corticosteroids above 10 mg prednisone equivalent for at least 8 weeks plus flare during taper above 7.5 mg. Polyarticular JIA requires active disease and two of Enbrel, adalimumab-aaty, adalimumab-adbm, tofacitinib, or Orencia.
Kineret: RA requires moderately-to-severely active disease and trials of two of Enbrel, adalimumab-aaty, adalimumab-adbm, Rinvoq, tofacitinib, or Orencia.
Kisqali: HR-positive/HER2-negative advanced or metastatic breast cancer requires an aromatase inhibitor as initial endocrine therapy or fulvestrant as initial therapy or after endocrine progression. High-risk stage II/III early breast cancer requires an aromatase inhibitor combination.
Komzifti: One-year coverage for medically accepted indications; prerequisite Part D therapy is not required.
The following uses and combinations are excluded or restricted under the policy.
Biologic/targeted-DMARD combination exclusion: Adbry, Cosentyx, Dupixent, Ebglyss, Enbrel, Fasenra, Humira, Kevzara, and Kineret cannot be used in combination with another biologic or targeted DMARD indicated for the same condition.
Budesonide ER: Maintenance of remission in ulcerative colitis is not covered.
Tadalafil: Not covered when the patient is receiving nitrate therapy.
GLP-1 agonists: Mounjaro, Ozempic, Rybelsus, and Trulicity are excluded when used for weight loss only.
Dalfampridine ER: Excluded when the patient is wheelchair-bound or becomes wheelchair-bound.
Initial Therapy and Indication-Specific Requirements
Initial authorization requires the applicable diagnosis, indication-specific clinical findings, formulation requirements, and prior-treatment or combination requirements described below.
Other prerequisite therapy: Where the policy states that prerequisite Part D therapy is required, documentation must identify the prerequisite drug, prior trial, intolerance, contraindication, or required combination. Examples include crizotinib for Alunbrig, colchicine plus anti-inflammatory therapy for Arcalyst, antidepressant therapy for Auvelity, divalproex or other anticonvulsants for Banzel, hydroxyurea for Besremi, imatinib for Cavhanza, antipsychotics for Cobenfy, NSAIDs for Cosentyx and Enbrel, clobazam for Diacomit, asthma-controller therapy for Dupixent and Fasenra, kinase inhibitors for Iclusig, immunotherapy for Iwilfin, and systemic therapy for Krazati.
Combination therapy requirements: Afinitor requires exemestane plus prior letrozole or anastrozole; Akeega requires prednisone; Braftovi requires the specified BRAF-directed combinations; Ibrance requires indication-specific endocrine, inavolisib/fulvestrant, or trastuzumab-based combinations; Kisqali requires the specified endocrine combination; Lenvima requires pembrolizumab or everolimus as applicable; and Iclusig requires chemotherapy for newly diagnosed Ph-positive ALL.
Indication-specific oncology requirements: Balversa requires susceptible FGFR3 alteration and prior systemic therapy; Calquence requires prior MCL therapy or bendamustine/rituximab in previously untreated transplant-ineligible MCL; Cavhanza applies to adult CML phases specified in the policy; Iclusig applies to the specified Ph-positive ALL and CML disease phases and prior kinase-inhibitor history; Imkeldi requires the liquid formulation need and CML prior-treatment requirement; Iwilfin requires partial response after multiagent therapy and immunotherapy; Jakafi requires hydroxyurea failure or intolerance; Jaypirca requires two systemic lines including a BTK inhibitor for MCL; and Jideytro requires ROS1-positive NSCLC.
Neurology and seizure indications: Epidiolex requires indication-specific trials for Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex seizures; Fycompa/perampanel requires two generic trials; Banzel requires divalproex or specified anticonvulsant therapy; Diacomit requires two generic anticonvulsant trials plus clobazam; and formulation-specific topiramate or levetiracetam coverage requires inability to swallow solid dosage forms where stated.
Fasenra initial therapy: Eosinophilic asthma requires eosinophils at least 150 cells/microliter at initiation and failure of adequate control after systemic or high-dose inhaled corticosteroid plus an additional controller. EGPA requires EGPA diagnosis, asthma history or presence, and two typical EGPA features. HES requires HES diagnosis and eosinophils at least 1,000 cells/microliter.
Humira indication-specific therapy: RA, polyarticular JIA, PsA, plaque psoriasis, AS, Crohn’s disease, ulcerative colitis, HS, and noninfectious intermediate/posterior/panuveitis require the applicable disease diagnosis and prior-treatment requirements described in the policy; biologic or targeted-DMARD combination is excluded.
Kerendia and ketoconazole: Kerendia coverage is limited to CKD with T2DM or heart failure with LVEF at least 40% subject to SGLT2 inhibitor prerequisite rules. Ketoconazole tablets are covered for medically accepted indications for one year without prerequisite Part D therapy.
Komzifti: Covered for medically accepted indications for one year without prerequisite Part D therapy.
Korlym/mifepristone: Mifepristone 300 mg tablets are covered for medically accepted indications for one year; prerequisite Part D therapy is not required.
Continuation and Reauthorization
Reauthorization requires the applicable response documentation and continued satisfaction of indication-specific criteria.
Adbry continuation: Reauthorization requires documentation of positive clinical response. For patients weighing less than 100 kg who respond after 16 weeks, dosing is limited to 300 mg every 4 weeks unless clinical rationale supports continued injections every 2 weeks.
Cosentyx continuation: Reauthorization requires documentation of positive clinical response; the same-condition biologic/targeted-DMARD combination restriction continues.
Dupixent continuation: Reauthorization for all indications requires documentation of positive clinical response; the same-condition biologic/targeted-DMARD combination restriction continues.
Ebglyss continuation: Reauthorization requires documentation of positive clinical response; patient must continue to meet the product’s age, weight, diagnosis, and prior-treatment requirements.
Enbrel continuation: Reauthorization for all indications requires documentation of positive clinical response; the same-condition biologic/targeted-DMARD combination restriction continues.
Fasenra reauthorization: Reauthorization for all indications requires documentation of positive clinical response; the same-condition biologic/targeted-DMARD combination restriction continues.
Humira continuation: Reauthorization requires documentation of positive clinical response and continued compliance with the applicable indication-specific criteria; combination with another same-condition biologic or targeted DMARD is excluded.
Kevzara continuation: Reauthorization requires documentation of positive clinical response and continued compliance with the applicable RA, PMR, or polyarticular JIA criteria; same-condition biologic/targeted-DMARD combination is excluded.
Kineret continuation: Reauthorization requires documentation of positive clinical response and continued compliance with RA criteria; same-condition biologic/targeted-DMARD combination is excluded.
Clinical Thresholds and Documentation Values
Clinical thresholds and required documentation
Pulmonary and functional testingFEV1 less than 80% predicted; baseline timed 25-foot walk test documentation is required before multiple sclerosis treatment initiation.
Weight thresholdsDupixent eosinophilic esophagitis: at least 15 kilograms; Ebglyss: at least 40 kilograms.
Eosinophil thresholdsDupixent and Fasenra eosinophilic asthma: at least 150 cells per microliter at treatment initiation; Dupixent COPD: at least 300 cells per microliter; Fasenra hypereosinophilic syndrome: at least 1000 cells per microliter at treatment initiation.
Type 2 diabetes laboratory evidenceA1C greater than or equal to 6.5%; fasting plasma glucose greater than or equal to 126 mg/dL; or 2-hour plasma glucose greater than or equal to 200 mg/dL during an oral glucose tolerance test.
Age thresholdsHaegarda coverage requires patients to be 6 years and older; alpha-1-proteinase inhibitor coverage requires patients to be 18 years of age or older.
Heart failure LVEFKerendia heart failure coverage applies when left ventricular ejection fraction is greater than or equal to 40%.
Corticosteroid treatment historyPolymyalgia rheumatica requires corticosteroid treatment greater than 10 mg/day prednisone equivalent for at least 8 weeks, with disease flare during taper at greater than 7.5 mg/day prednisone equivalent.
Prior Authorization and Provider Requirements
Prior Authorization
Prior Authorization Required
Submit prior authorization for the listed medications before coverage is provided. Coverage is generally limited to medically accepted indications and is authorized for one year unless a product-specific duration is stated.
Acitretin — PA required; all medically accepted indications; no prerequisite Part D drug.
Actimmune — PA required; all medically accepted indications; no prerequisite Part D drug.
Adbry — PA required.
Adempas — PA required; all medically accepted indications; no prerequisite Part D drug.
Afinitor / everolimus tablets — PA required.
Afinitor Disperz / everolimus suspension — PA required; no prerequisite Part D drug.
Aimovig — PA required; no prerequisite Part D drug.
Akeega — PA required.
Alecensa — PA required; no prerequisite Part D drug.
Alosetron — PA required; no prerequisite Part D drug.
Prolastin-C — PA required.
Alunbrig — PA required.
Arcalyst — PA required.
Arikayce — PA required; no prerequisite Part D drug.
Teriflunomide — PA required; no prerequisite Part D drug.
Augtyro — PA required; no prerequisite Part D drug.
Auvelity — PA required.
Avmapki Fakzynja Co-pack — PA required; no prerequisite Part D drug.
Ayvakit — PA required; no prerequisite Part D drug.
Balversa — PA required.
Banzel / rufinamide — PA required.
BeqAlzi — PA required; BTK-inhibitor prerequisite for relapsed or refractory mantle cell lymphoma.
Besremi — PA required.
Bosulif / bosutinib — PA required.
Braftovi — PA required.
Briviact / brivaracetam — PA required.
Brukinsa — PA required.
Budesonide ER — PA required.
Bysanti — PA required.
Cabometyx — PA required.
Calcipotriene — PA required.
Calquence — PA required.
Caprelsa — PA required; no prerequisite Part D drug.
Cavhanza — PA required.
Cayston — PA required; no prerequisite Part D drug.
Tadalafil — PA required; no prerequisite Part D drug.
Clomid / clomiphene — PA required; no prerequisite Part D drug.
Cobenfy — PA required.
Cometriq — PA required; authorization duration is 12 months; no prerequisite Part D drug.
Glatiramer acetate / Glatopa — PA required; no prerequisite Part D drug.
Copiktra — PA required.
Cosentyx — PA required.
Cotellic — PA required.
Cresemba — PA required; no prerequisite Part D drug.
Cystaran — PA required; no prerequisite Part D drug.
Dalfampridine ER — PA required.
Daurismo — PA required.
Diacomit — PA required.
Dihydroergotamine — PA required.
Drizalma Sprinkle — PA required; no prerequisite Part D drug.
Dulera — PA required.
Dupixent — PA required.
Ebglyss — PA required.
Emgality — PA required; no prerequisite Part D drug.
Emsam — PA required.
Enbrel — PA required.
Endari / L-glutamine — PA required.
Ensacove — PA required; no prerequisite Part D drug.
Epidiolex — PA required.
Eprontia / topiramate solution — PA required.
Erivedge — PA required; prescriber must be an oncologist or dermatologist; no prerequisite Part D drug.
Erleada — PA required; no prerequisite Part D drug.
Procrit — PA required; erythropoiesis-stimulating-agent rules apply; no prerequisite Part D drug.
Esbriet / pirfenidone — PA required; no prerequisite Part D drug.
Eucrisa — PA required.
Eulexin — PA required.
Fanapt — PA required.
Fasenra — PA required.
Fetzima — PA required.
Fintepla — PA required.
Icatibant — PA required for patients 18 years and older; no prerequisite Part D drug.
Fotivda — PA required.
Fruzaqla — PA required.
Fulphila — PA required; no prerequisite Part D drug.
Fycompa / perampanel — PA required.
Gavreto — PA required; no prerequisite Part D drug.
Gefitinib — PA required; no prerequisite Part D drug.
Fingolimod — PA required; no prerequisite Part D drug.
Gilotrif — PA required.
Mounjaro, Ozempic, Rybelsus, and Trulicity — PA required; no prerequisite Part D drug.
Gomekli — PA required; no prerequisite Part D drug.
Grastek — PA required; no prerequisite Part D drug.
Genotropin / Genotropin Miniquick — PA required; pediatric duration is one year and adult duration is lifetime; no prerequisite Part D drug.
Haegarda — PA required for age six years and older; no prerequisite Part D drug.
Hernexeos — PA required; no prerequisite Part D drug.
Hetlioz / tasimelteon — PA required; no prerequisite Part D drug.
Humulin R U-500 — PA required; no prerequisite Part D drug.
Hyrnuo — PA required; no prerequisite Part D drug.
Ibrance — PA required.
Ibtrozi — PA required; no prerequisite Part D drug.
Iclusig — PA required.
Idhifa — PA required; no prerequisite Part D drug.
Imbruvica — PA required.
Imkeldi — PA required.
Immune globulin products — PA required and subject to Part B requirements.
Increlex — PA required; no prerequisite Part D drug.
Inluriyo — PA required.
Inlyta — PA required.
Inqovi — PA required.
Inrebic — PA required; no prerequisite Part D drug.
Isotretinoin products — PA required.
Itovebi — PA required; no prerequisite Part D drug.
Ivermectin tablets — PA required for all FDA-approved indications; no prerequisite Part D drug.
Iwilfin — PA required.
Jadenu / deferasirox — PA required; no prerequisite Part D drug.
Jakafi / Jakafi XR — PA required.
Jaypirca — PA required.
Jideytro — PA required.
Jylamvo — PA required.
Jynarque / tolvaptan — PA required; no prerequisite Part D drug.
Kalydeco — PA required; no prerequisite Part D drug.
Kerendia — PA required.
Ketoconazole tablets — PA required; no prerequisite Part D drug.
Kevzara — PA required.
Kineret — PA required.
Kisqali / Kisqali Femara — PA required.
Komzifti — PA required; no prerequisite Part D drug.
Koselugo — PA required; no prerequisite Part D drug.
Krazati — PA required.
Lazcluze — PA required.
Lenvima — PA required.
Leuprolide / Lupron Depot — PA required; no prerequisite Part D drug.
Levetiracetam TB3D — PA required.
Libervant — PA required; no prerequisite Part D drug.
Libtayo — PA required.
Mifepristone 300 mg — PA required; no prerequisite Part D drug.
Step Therapy
Prerequisite Therapy, Step Therapy, and Combination Requirements
When a prerequisite is specified, document the required prior treatment, inadequate response, intolerance, or combination regimen in the authorization request. Product-specific prerequisites and step therapy include the following.
Breast cancer combinations: Afinitor requires exemestane plus a trial of letrozole or anastrozole; Akeega requires prednisone for BRCA-mutated metastatic castration-resistant prostate cancer; Ibrance requires the applicable aromatase-inhibitor, fulvestrant, inavolisib, trastuzumab, pertuzumab, and endocrine combinations; Kisqali requires the applicable endocrine combination; Inluriyo requires monotherapy or abemaciclib as specified; and Lenvima requires pembrolizumab or everolimus combinations and prior systemic therapy where applicable.
Urothelial and other solid tumors: Balversa requires at least one prior systemic therapy; Cabometyx requires nivolumab for first-line renal cell carcinoma, sorafenib for hepatocellular carcinoma, or prior VEGFR-targeted therapy for differentiated thyroid cancer; Krazati requires prior systemic therapy; and Libtayo requires prior Hedgehog-pathway inhibitor treatment for basal cell carcinoma.
Hematology and oncology: Alunbrig requires prior crizotinib for eligible ALK-positive metastatic NSCLC; Bosulif requires prior therapy for accelerated- or blast-phase Ph-positive CML; Calquence requires prior MCL therapy or bendamustine/rituximab combination in previously untreated transplant-ineligible MCL; Copiktra requires at least two prior therapies; Iclusig requires chemotherapy or, for applicable CML/ALL indications, prior kinase inhibitors or lack of alternatives; Imkeldi requires failure of prior therapy for applicable Ph-positive CML; Inqovi requires an azacitidine trial; Iwilfin requires prior multiagent immunotherapy with at least a partial response; Jakafi requires inadequate response or intolerance to hydroxyurea for polycythemia vera and one or two prior systemic lines as applicable; Jaypirca requires two systemic lines including a BTK inhibitor for MCL; and Jideytro requires a prior ROS1 inhibitor.
Documentation Required
Documentation Required for Authorization and Reauthorization
Include clinical records that establish the indication, prior treatment history, relevant laboratory or biomarker findings, dosing, and response. Reauthorization requests must include updated response documentation when required.
Adbry: Document age 12 years or older, moderate-to-severe atopic dermatitis, prior treatment failure, positive clinical response for reauthorization, and dosing justification when a patient under 100 kg continues 300 mg every two weeks after 16 weeks.
Alpha-1-proteinase inhibitor / Prolastin-C: Document 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 the specified PIZZ, PIZ-null, or PI-null/null phenotypes.
Balversa: Submit documentation of locally advanced or metastatic urothelial carcinoma and a susceptible FGFR3 alteration, together with prior systemic therapy.
Cosentyx: Document the diagnosis and disease activity for the requested indication, NSAID trial where applicable, absence of duplicate biologic or targeted DMARD therapy, and positive clinical response for reauthorization.
Dalfampridine: Provide a baseline timed 25-foot walk (T25FW) before initiation; do not use when the patient is wheelchair-bound.
Dupixent: Document the indication-specific diagnosis, age or weight requirements, eosinophil count when applicable, prior therapy, controller medications, and positive clinical response for reauthorization. Eosinophilic asthma requires at least 150 cells/µL at initiation; COPD requires uncontrolled moderate-to-severe disease and eosinophils at least 300 cells/µL.
Denial Risk
Denial Risks and Exclusion Rules
Requests may be denied when the indication, age, biomarker, prior-treatment, combination, dosing, or documentation requirements are not met. Review the product-specific exclusions below before submitting an authorization.
Duplicate therapy: Adbry, Cosentyx, Dupixent, Ebglyss, Enbrel, Fasenra, Humira products, Kevzara, and Kineret cannot be used in combination with another biologic or targeted DMARD indicated for the same condition.
Atopic dermatitis criteria: Adbry, Dupixent, Ebglyss, and Eucrisa may be denied when moderate-to-severe atopic dermatitis, required age or weight criteria, the generic topical or systemic treatment trial, or positive response documentation is missing.
Adbry dosing: Coverage may be denied when dosing exceeds 300 mg every four weeks in a patient under 100 kg who has responded after 16 weeks, unless clinical rationale supports continued every-two-week injections.
Dupixent criteria: Deny when the indication-specific diagnosis, age/weight threshold, eosinophil count, controller therapy, prior treatment, or reauthorization response is not documented. Asthma, nasal-polyposis, urticaria, eosinophilic esophagitis, COPD, and atopic-dermatitis requirements differ by indication.
Fasenra criteria: Deny when eosinophilic asthma, EGPA, or HES criteria are not met; required eosinophil counts, EGPA findings, asthma history, or positive response are absent.
Combination and prerequisite failures: Deny Afinitor, Akeega, Braftovi, Cabometyx, Calquence, Ibrance, Inlyta, Kisqali, Lazcluze, Lenvima, and related products when the required partner therapy or prior treatment is missing.
Program and Clinical Definitions
Definitions and clinical terminology
Prior authorization (PA)Clinical and/or administrative criteria that must be met before coverage is provided for a medication.
Step therapy (ST)A requirement for previous treatment with one or more formulary drugs before coverage of the requested drug.
Respiratory abbreviationsEA means eosinophilic asthma; CDA means corticosteroid-dependent asthma; CRSWNP means chronic rhinosinusitis with nasal polyposis; EOE means eosinophilic esophagitis; PN means prurigo nodularis; CSU means chronic spontaneous urticaria; AFRS means allergic fungal rhinosinusitis; LABA means long-acting beta-2 agonist; LAMA means long-acting muscarinic antagonist.
Laboratory evidence of type 2 diabetes mellitusA1C 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.
Rheumatology and oncology abbreviationsDMARD means disease-modifying antirheumatic drug; HER2 means human epidermal growth factor receptor 2; HR means hormone receptor; Ph+ ALL means Philadelphia chromosome-positive acute lymphoblastic leukemia; CML means chronic myeloid leukemia.
Disease-state terminologyCovered uveitis means non-infectious uveitis classified as intermediate, posterior, or panuveitis. ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer refers to estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer. Advanced renal cell carcinoma refers to renal cell carcinoma in an advanced stage.
Renal, metabolic, and cardiac terminologyCKD associated with T2DM means chronic kidney disease associated with type 2 diabetes mellitus. An SGLT2 inhibitor is a sodium-glucose cotransporter-2 inhibitor, such as empagliflozin or dapagliflozin. LVEF greater than or equal to 40% means left ventricular ejection fraction at least 40 percent.
Program Background
The Medicare Part D prior authorization and step therapy program is designed to help members receive appropriate and cost-effective drug therapy. Prior authorization requires applicable clinical and/or administrative criteria to be met before coverage is provided, while step therapy may require prior treatment with one or more formulary drugs before the requested medication is covered. Criteria are based on current medical information and recommendations from the Blues' Pharmacy and Therapeutics Committee.
Required Prior Therapies and Combinations
Medication
Step-therapy requirement
Alunbrig
Trial of crizotinib before coverage.
Arcalyst
Prior use of an inflammatory drug in combination with colchicine.
Auvelity
Prior use of another generic formulary antidepressant.
Balversa
Trial of at least one prior systemic therapy for locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations.
Banzel (rufinamide)
Trial of divalproex or another prerequisite therapy.
Beqalzi
For relapsed or refractory mantle cell lymphoma, trial of at least one BTK inhibitor.
Besremi
For polycythemia vera, trial of hydroxyurea.
Braftovi
Requirements vary by indication: vemurafenib plus cobimetinib trial and binimetinib for specified melanoma; cetuximab plus fluorouracil-based chemotherapy for initial metastatic colorectal cancer; cetuximab after prior therapy for metastatic colorectal cancer; or binimetinib for metastatic NSCLC.
Briviact
Trial of levetiracetam and one additional therapy; the additional therapy is not specified.
Brukinsa
Mantle cell lymphoma: trial of Calquence. Marginal zone lymphoma: trial of at least one anti-CD20-based regimen. Follicular lymphoma: obinutuzumab plus two or more lines of systemic therapy. CLL/SLL: trial of Calquence or Imbruvica.
Bysanti
Adult schizophrenia: trials of lurasidone and paliperidone. Other indications: trials of at least two therapies; the list is not provided.
Cabometyx
Advanced renal cell carcinoma: combination with nivolumab. Hepatocellular carcinoma: trial of sorafenib. Radioactive-iodine-refractory or ineligible differentiated thyroid cancer: trial of VEGFR-targeted therapy.
Calcipotriene
Trial of at least one generic topical Part D drug.
Calquence
Mantle cell lymphoma: at least one prior MCL therapy. Previously untreated MCL in patients ineligible for autologous HSCT: combination with bendamustine and rituximab.
Cavhanza
Use of imatinib for adults with policy-specified chronic-phase or accelerated-phase CML.
Cobenfy
Prior antipsychotic therapy for schizophrenia.
Copiktra
Treatment after at least two prior therapies for relapsed or refractory CLL.
Cosentyx
For ankylosing spondylitis, non-radiographic axial spondyloarthritis, or enthesitis-related arthritis: trial of one NSAID.
Cotellic
Vemurafenib is identified as prerequisite therapy.
Diacomit
Trial of two generic anticonvulsants and combination use with clobazam.
Dihydroergotamine nasal spray
Trial of two formulary triptans: one oral and one non-oral.
Dulera
For asthma, diagnosis of asthma and trial of Breo therapy.
Dupixent — atopic dermatitis
Trial and treatment failure of one qualifying therapy: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.
Dupixent — eosinophilic or corticosteroid-dependent asthma
Failure to maintain adequate control after systemic corticosteroids or high-dose inhaled corticosteroids plus an additional controller trial, such as a leukotriene modifier, LABA, or LAMA.
Dupixent — chronic rhinosinusitis with nasal polyposis
Trial of either a proton pump inhibitor or topical esophageal corticosteroids.
Dupixent — chronic spontaneous urticaria
Symptoms despite H1 antihistamine treatment and trial of at least one second-generation antihistamine.
Dupixent — COPD
Current and continued LABA, LAMA, and inhaled corticosteroid therapy unless contraindicated.
Ebglyss
Trial and treatment failure of one qualifying atopic dermatitis therapy: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil.
Emsam
Trial with two therapies specified in the full criteria; the therapy names are not provided.
Enbrel — rheumatoid arthritis
Trial of one DMARD, such as methotrexate, leflunomide, or sulfasalazine.
Trial of one NSAID, such as diclofenac, ibuprofen, meloxicam, or naproxen.
Endari
Trial of, or intolerance to, the prerequisite therapy identified in the full criteria; the therapy name is not provided.
Epidiolex — Lennox-Gastaut syndrome or tuberous sclerosis complex seizures
Trial of two generic seizure-treatment alternatives.
Epidiolex — Dravet syndrome
Trial of two of valproic acid, clobazam, or topiramate.
Eprontia — migraine prevention
Trial of at least two generic migraine-prevention alternatives, unless the patient cannot swallow tablets or capsules.
Eucrisa
For atopic dermatitis, trial of one generic topical steroid.
Eulexin
Trial of generic bicalutamide.
Fanapt
For schizophrenia, trial of two generic formulary atypical antipsychotics; quetiapine, risperidone, and ziprasidone are listed.
Fasenra — eosinophilic asthma
Failure to maintain adequate control after systemic corticosteroids or high-dose inhaled corticosteroids plus a leukotriene modifier, LABA, or LAMA trial.
Fetzima
Displayed prerequisite references desvenlafaxine and duloxetine; the source text is truncated and does not state complete trial logic.
Fintepla
Trial of two prerequisite therapies; the therapies are not identified.
Fotivda
For advanced renal cell carcinoma, trial of two or more prior systemic therapies.
Fruzaqla
For metastatic colorectal cancer, prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy plus anti-VEGF therapy.
Fycompa / perampanel
Trial of two generic therapies; the therapies are not identified.
Humira — rheumatoid arthritis
Trial of one DMARD, such as methotrexate, leflunomide, or sulfasalazine.
Trial of one NSAID, such as diclofenac, ibuprofen, meloxicam, or naproxen.
Ibrance
Indication-specific combination regimen: aromatase inhibitor or fulvestrant; inavolisib plus fulvestrant; or trastuzumab with or without pertuzumab plus endocrine therapy.
Iclusig
For other chronic-phase CML indications, trial of at least two prior kinase inhibitors. Newly diagnosed Ph+ ALL requires chemotherapy combination use.
Imbruvica
Prerequisite Part D therapy is required; the specific drug or sequence is not displayed.
Imkeldi
Prerequisite Part D therapy is required; the specific drug is not displayed.
Inluriyo
Prerequisite Part D drug required.
Inlyta
Prerequisite Part D drug required; first-line advanced renal cell carcinoma use must be combined with avelumab or pembrolizumab.
Inqovi
Trial with azacitidine and use of a prerequisite Part D drug.
Isotretinoin
Trial of an oral therapy and use of a prerequisite Part D drug.
Iwilfin
For high-risk neuroblastoma, prior immunotherapy; the prerequisite does not have to be a Part D drug.
Jakafi
For polycythemia vera, inadequate response to or intolerance of hydroxyurea and a trial of one or two lines of systemic therapy.
Jaypirca
For mantle cell lymphoma, two lines of systemic therapy including a BTK inhibitor.
Jideytro
Inhibitor prerequisite; the complete inhibitor description is not provided.
Jylamvo
Trial of the oral tablet formulation of methotrexate.
Kerendia
For heart failure with LVEF at least 40%, trial of an SGLT2 inhibitor such as Jardiance or Farxiga, unless contraindicated or intolerant.
Kevzara — rheumatoid arthritis
Trial of two of Enbrel, adalimumab-aaty or adalimumab-adbm, Rinvoq, tofacitinib, or Orencia.
Kevzara — polymyalgia rheumatica
Corticosteroid treatment greater than 10 mg/day prednisone equivalent for at least 8 weeks, with flare during taper at greater than 7.5 mg/day.
Trial of two of Enbrel, adalimumab-aaty or adalimumab-adbm, tofacitinib, or Orencia.
Kineret — rheumatoid arthritis
Trial of two of Enbrel, adalimumab-aaty or adalimumab-adbm, Rinvoq, tofacitinib, or Orencia.
Kisqali
Advanced or metastatic HR-positive, HER2-negative breast cancer: aromatase inhibitor or fulvestrant. High-risk stage II or III early breast cancer: aromatase inhibitor.
Krazati
Systemic therapy prerequisite.
Lazcluze
Combination use with amivantamab.
Lenvima
Pembrolizumab for first-line renal cell carcinoma; everolimus after one prior anti-angiogenic therapy for renal cell carcinoma; or pembrolizumab after prior systemic therapy for advanced endometrial carcinoma.
Levetiracetam tablet for oral suspension
A trial is required, and the patient must be unable to swallow tablets or capsules; the required trial is not further specified.
Libtayo
For basal cell carcinoma, prior treatment with a Hedgehog pathway inhibitor.
Quantity and Dosing Limits
Quantity limits
ProductAdbry.
Standard dosing-frequency limitFor patients weighing less than 100 kg who achieve a positive clinical response after 16 weeks of treatment, dosing is limited to 300 mg every 4 weeks.
ExceptionInjections every 2 weeks may continue when clinical rationale supporting the more frequent dosing is provided.
Braftovi: Use in melanoma requires binimetinib and a trial of vemurafenib plus Cotellic; initial metastatic colorectal cancer requires cetuximab plus fluorouracil-based chemotherapy; previously treated colorectal cancer requires cetuximab; and BRAF V600E metastatic NSCLC requires binimetinib.
Neurology and seizure therapy: Banzel requires a divalproex trial; Briviact requires levetiracetam plus one additional therapy; Diacomit requires two generic anticonvulsant trials and clobazam combination therapy; Epidiolex requires the applicable two prior seizure therapies; Eprontia/topiramate solution requires two generic migraine-prevention trials unless the patient cannot swallow tablets or capsules; Fintepla requires two prerequisite therapies; Fycompa requires two generic therapies; and levetiracetam TB3D requires a prior formulation trial and inability to swallow tablets or capsules.
Dermatology: Adbry, Dupixent for atopic dermatitis, Ebglyss, and Eucrisa require the applicable generic topical corticosteroid or other topical/systemic therapy trial; isotretinoin requires an oral or topical prerequisite therapy; and Eulexin requires a generic bicalutamide trial.
Respiratory and allergy therapy: Dulera requires a diagnosis of asthma and a trial of the specified controller, including Breo where applicable; Dupixent requires indication-specific prior therapy for atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, chronic spontaneous urticaria, or COPD; Ebglyss requires the specified atopic-dermatitis trial; and Fasenra requires systemic or high-dose inhaled corticosteroid therapy plus an additional asthma controller for eosinophilic asthma.
Inflammatory and rheumatologic therapy: Arcalyst requires prior anti-inflammatory therapy with colchicine where applicable; Cosentyx requires an NSAID trial for selected spondyloarthritis or enthesitis-related indications; Enbrel requires a DMARD or NSAID trial according to indication; Humira products require indication-specific prior systemic therapy; Kevzara and Kineret require two specified prior therapies for rheumatoid arthritis or polyarticular JIA; and biologic or targeted DMARD duplication is not permitted.
Psychiatric therapy: Auvelity requires another generic formulary antidepressant; Bysanti requires lurasidone and paliperidone for schizophrenia or at least two generic alternatives for other indications; Emsam requires a two-therapy trial; Fanapt requires two generic atypical antipsychotic trials; and Fetzima requires the specified antidepressant trials, including desvenlafaxine and duloxetine.
Other step therapy: Calcipotriene requires a generic topical trial; Dihydroergotamine requires one oral and one non-oral formulary triptan; Jylamvo requires oral methotrexate tablet therapy; Kerendia requires an SGLT2-inhibitor trial for applicable heart-failure indications unless contraindicated or intolerant; and Daurismo requires low-dose cytarabine combination therapy.
Ebglyss: Document age 12 years or older, weight at least 40 kg, moderate-to-severe atopic dermatitis, prior therapy failure, and positive clinical response for reauthorization.
Enbrel and Humira products: Document the indication, disease activity, prior DMARD or NSAID/systemic therapy, absence of duplicate biologic or targeted DMARD use, and positive clinical response for reauthorization.
Endari: Document sickle-cell-related crises within the past 12 months and the required prior treatment or intolerance.
Epidiolex: Document seizure diagnosis and treatment history, including the required generic alternatives or specified valproic acid, clobazam, or topiramate trials.
Fasenra: Document eosinophilic asthma and eosinophil count of at least 150 cells/µL, EGPA diagnosis with at least two characteristic clinical findings and asthma history or presence, or HES diagnosis with eosinophils at least 1,000 cells/µL. Reauthorization requires positive clinical response.
Gilotrif: Submit an FDA-approved EGFR test showing a qualifying non-resistant EGFR mutation for metastatic NSCLC and document the applicable line of therapy.
GLP-1 products: Submit chart notes documenting type 2 diabetes mellitus or qualifying laboratory evidence: A1C at least 6.5%, fasting plasma glucose at least 126 mg/dL, or two-hour OGTT plasma glucose at least 200 mg/dL. Weight-loss-only use is excluded.
Kevzara: Document the diagnosis, specified prior therapies or corticosteroid history for the indication, and positive clinical response for reauthorization.
Kineret: Document the indication, required prior therapies, absence of duplicate biologic or targeted DMARD therapy, and reauthorization response.
Imatinib-related products / Imkeldi: Document inability to swallow the tablet formulation or inability to achieve the prescribed dose with tablets, plus the applicable Ph-positive CML disease phase and prior treatment failure.
Iclusig: Document Philadelphia chromosome status, T315I mutation when applicable, disease phase, chemotherapy combination when required, and prior kinase-inhibitor history or lack of indicated alternatives.
Jynarque / tolvaptan, Jadenu / deferasirox, Kalydeco, Hyrnuo, Ibtrozi, Idhifa, and other no-prerequisite products: Submit the diagnosis and medically accepted indication; a prerequisite Part D drug is not required unless separately stated.
Lenvima: Document renal cell carcinoma or endometrial carcinoma diagnosis, line of therapy, disease progression, and pembrolizumab or everolimus combination as applicable.
Reauthorization generally: Submit objective evidence of ongoing benefit, adherence, current dosing, and absence of excluded concurrent biologic or targeted DMARD therapy.
Balversa: Deny without a qualifying FGFR3 alteration and at least one prior systemic therapy for locally advanced or metastatic urothelial carcinoma.
Banzel and seizure products: Deny when the divalproex trial, required generic anticonvulsant trials, clobazam combination, two generic therapies, or required levetiracetam/additional therapy is not documented.
Budesonide ER: Coverage is excluded for maintenance of remission in ulcerative colitis.
Calcipotriene and Eucrisa: Deny when the required generic topical therapy or generic topical steroid trial is not documented.
Calquence: Deny MCL requests without prior MCL therapy or the required bendamustine/rituximab combination for previously untreated transplant-ineligible MCL.
Tadalafil: Deny when nitrate therapy is being used or benign prostatic hyperplasia is not diagnosed.
Bysanti and Fanapt: Deny when the schizophrenia-specific or other-indication antipsychotic prerequisite is not met, including the required two generic atypical antipsychotic trials.
Copiktra, Jaypirca, and oncology line-of-therapy products: Deny when the required number of prior systemic therapies or prior therapy class is not documented.
Eulexin: Deny without a generic bicalutamide trial.
Eprontia/topiramate solution: Deny migraine-prevention requests without two generic preventive trials, unless the patient cannot swallow tablets or capsules.
Dulera: Deny when asthma is not diagnosed or the required controller trial is absent.
Emsam and antidepressants: Deny without the required two-therapy trial or specified prerequisite antidepressants.
Enbrel, Cosentyx, Kevzara, Kineret, and other inflammatory products: Deny when the disease-specific diagnosis, activity, NSAID or DMARD trial, concurrent-therapy restriction, or positive response is not documented.
Procrit and alpha-1 products: Deny when required clinical criteria, age, diagnosis, laboratory evidence, or supporting documentation is absent.
Imkeldi: Deny when tablet formulation can be swallowed and used at the prescribed dose, or when the applicable CML disease and prior-treatment criteria are not met.
Iclusig: Deny chronic-phase CML requests without at least two prior kinase inhibitors, unless a specified T315I, accelerated-phase, blast-phase, or no-alternative exception applies.
Kerendia: Deny when the indication is not CKD associated with type 2 diabetes or when an SGLT2 inhibitor trial is required and neither trial nor contraindication/intolerance is documented.
Libtayo: Deny basal-cell-carcinoma requests without prior Hedgehog-pathway inhibitor treatment.
Coverage duration: Most authorizations are limited to one year; Genotropin is one year in pediatrics and lifetime in adults, and Cometriq is authorized for 12 months. Reauthorization requires current clinical evidence.
General denial risks: Off-label use, missing medically accepted indication, missing biomarker or laboratory evidence, absent clinical history, failure to satisfy step therapy, missing combination therapy, excluded concurrent therapy, unsupported dosing, or absent positive response documentation may result in denial.