Acitretin and selected specialty drug prior authorization and step therapy criteria
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Outlines prior authorization and step therapy requirements, coverage durations (commonly 1 year), prerequisite Part D drug and documentation expectations for acitretin and multiple specialty/Part D products for Medicare Plus Blue Group PDP/PPO plans.
No material clinical or coverage changes in this revision.
Coverage Criteria and Product Summaries
Initial Authorization Criteria (product summaries)
Covered when product-specific PA criteria are met; coverage duration generally 1 year unless otherwise stated.
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Prolastin-c (Alpha-1-proteinase inhibitor) Initial Criteria
Prolastin-c coverage requires ALL of the following:
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Alunbrig Initial Criteria
Alunbrig coverage requires:
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Arcalyst Initial Criteria
Arcalyst coverage for recurrent pericarditis requires:
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Auvelity Initial Criteria
Auvelity coverage for major depressive disorder requires:
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Balversa Initial Criteria
Balversa coverage requires:
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Banzel Initial Criteria
Banzel coverage requires:
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Initial coverage criteria by product (partial list)
Coverage for the listed products is subject to PA and, where specified, requires evidence of prior therapy or combination use as noted below.
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Indication-specific Coverage Criteria
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Glatopa (Glatiramer Acetate)
Glatiramer acetate (Glatopa)
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Copiktra
Copiktra (duvelisib)
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Cosentyx (secukinumab) — indication-specific criteria
Cosentyx (secukinumab)
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Cotellic
Cotellic (cobimetinib)
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Cresemba and Cystaran
Cresemba (isavuconazole) and Cystaran (cysteamine)
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Dalfampridine
Dalfampridine
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Dalfampridine — Baseline functional test requirement
Dalfampridine (Dalfampridine ER): covered when ALL of the following are met
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Diacomit — Trial and combination requirement
Diacomit: covered when ALL of the following are met
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Dihydroergotamine — Triptan trial requirement
Dihydroergotamine nasal spray: covered when ALL of the following are met
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Drizalma — Coverage duration
Drizalma Sprinkle: coverage details provided
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Dupixent — Indication- and trial-based coverage
Dupixent: covered when indication-specific criteria are met
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Ebglyss (selected detailed criteria)
Ebglyss (acitretin section entry) coverage details
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Enbrel
Enbrel coverage details
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Epidiolex
Epidiolex coverage details
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Miscellaneous products
Other product criteria highlights
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Fasenra coverage criteria
Covered when ALL of the following indication-specific requirements are met:
Fasenra overall
- Eosinophilic Asthma (EA): Diagnosis of EA and eosinophil count ≥150 cells/µL at initiation AND failure to maintain adequate control after trial of systemic corticosteroids or high‑dose inhaled corticosteroids in combination with trial of one additional asthma controller (leukotriene modifier OR LABA OR LAMA) in adults and children ≥12 years.>=150 cells/µL
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- EGPA: Diagnosis of eosinophilic granulomatosis with polyangiitis with history or presence of asthma and documentation of typical EGPA features (e.g., histopathology, organ manifestations).
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- HES: Diagnosis of hypereosinophilic syndrome with eosinophil count ≥1000 cells/µL at initiation.>=1000 cells/µL
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Fetzima — Initial Authorization
Covered when ALL of the following are met
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Gilotrif — Covered indication
Covered when ALL of the following are met
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GLP-1 agonists — Covered indications and exclusions
Covered when ALL of the following are met
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Humira — Condition-specific coverage requirements
Covered when ALL of the following are met
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Other specialty products — general coverage notes
Covered when ALL of the following are met
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Product-specific coverage criteria
Coverage is provided for listed products when specific indication and prerequisite therapy requirements described for each product are met. Reauthorization generally requires evidence of positive clinical response.
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Imkeldi — Coverage with criteria
Coverage statements and prerequisites for specific products (partial):
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Inlyta — Combination therapy requirement
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Isotretinoin — Prerequisite therapy
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Itovebi — Coverage note (incomplete)
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Product-level coverage summaries
Coverage is generally provided for medically-accepted or FDA-approved indications with specific prerequisite therapy or prior-treatment requirements for certain drugs/indications.
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Kerendia — Covered when ALL of the following are met
Kerendia: Coverage conditions
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Kevzara — Indication-specific criteria
Kevzara: Indication-specific prerequisites and reauthorization
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Kineret — RA coverage criteria
Kineret: Rheumatoid arthritis coverage
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Kisqali — Covered when specific combination endocrine therapy conditions met
Kisqali: Breast cancer coverage conditions
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Product-level coverage criteria (summaries)
Product-specific PA summaries with stated indications, prerequisites, and durations
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The source extract indicates that for many products in this segment Off‑label uses are listed as N/A, i.e., no off‑label use criteria are provided in the excerpt. Where an off‑label field is shown as N/A in the document, there are no specific off‑label authorization rules in this partial extract to support coverage decisions beyond the listed medically‑accepted indications.
The document explicitly states that coverage will not be provided for maintenance of remission in ulcerative colitis with budesonide ER. This is an explicit exclusion in the budesonide ER product entry and should be applied when evaluating requests for maintenance‑of‑remission use.
No additional miscellaneous coverage notes are present in this excerpt for the referenced product beyond the itemized indication‑specific combination and prerequisite therapy statements already captured in the product entry.
Dalfampridine is excluded for use if the patient is wheelchair bound or becomes wheelchair bound. This explicit exclusion appears in the dalfampridine product entry and should be enforced when evaluating eligibility.
Multiple biologic product entries (for example Cosentyx, Ebglyss, Fasenra, Humira, Kevzara) state that the agent cannot be used in combination with another biologic or targeted DMARD indicated for the same condition. Apply this concurrent‑biologic exclusion when a request documents planned combination use with another biologic/targeted DMARD for the same diagnosis.
This entry duplicates the dalfampridine exclusion: the product is not covered if the patient is wheelchair bound or becomes wheelchair bound, per the dalfampridine PA notes.
Several product summaries include a common restriction: use in combination with another biologic or targeted DMARD indicated for the same condition is not allowed. Where the product entry contains that statement, concurrent biologic/targeted DMARD combinations should be considered non‑covered.
The Fasenra product entry specifically notes that it cannot be used in combination with another biologic or targeted DMARD indicated for the same condition. Enforce this exclusion when assessing Fasenra requests that propose concurrent use with another biologic/targeted DMARD.
In the excerpt provided there is no explicit exclusion statement for Fetzima; the Fetzima entry documents prerequisite Part D drugs (desvenlafaxine and duloxetine) but does not list a combination‑therapy exclusion in this partial extract.
The GLP‑1 agonist group entry states an explicit exclusion: these agents are excluded if used for the treatment of weight loss only. For requests that indicate weight‑loss‑only use, coverage should be denied per the excerpted policy language.
The Humira entry contains a combination‑therapy exclusion: Humira cannot be used in combination with another biologic or targeted DMARD indicated for the same condition. Apply this restriction when requests propose concurrent biologic/targeted DMARD therapy for the same diagnosis.
Many biologic product entries repeat the combination‑use exclusion language (e.g., Cosentyx, Ebglyss, Enbrel, Humira): where present the policy states the agent cannot be used in combination with another biologic or targeted DMARD indicated for the same condition. This is a common, product‑level exclusion in the provided extract.
Across multiple product summaries in this extract the Off‑Label Uses field is shown as N/A, indicating that for those entries there are no off‑label use criteria listed in the partial excerpt. Where Off‑Label Uses = N/A, no separate off‑label authorization rules are available in the provided text.
Many product summaries in this portion of the document either list 'N/A' for Off‑Label Uses and Exclusion Criteria or contain no explicit exclusion language. Where an entry shows 'N/A' or the exclusion field is blank in the excerpt, there is no excerpted basis to apply an exclusion beyond those explicitly stated.
The Kevzara entry explicitly states that it cannot be used in combination with another biologic or targeted DMARD indicated for the same condition. Enforce this exclusion when evaluating Kevzara requests that propose concurrent biologic/targeted DMARD therapy for the same diagnosis.
The extract repeats entries where Off‑label uses are listed as N/A for multiple products; these repeats indicate that no off‑label criteria are provided in the partial text for those items.
In the Ebglyss (acitretin) section of the extract there is no explicit 'not medically necessary' statement included; the product entry shows Off‑Label Uses and Exclusion Criteria as N/A but does not present a discrete NMN clause in the provided chunks.
For Diacomit the excerpt documents required prior trials and combination use (trial of two generic anticonvulsants and combination with clobazam) but there is no separate 'not medically necessary' statement in the provided text beyond those prerequisite requirements.
Prior Authorization, Documentation, and Denial Risks — What Providers Must Do
Acitretin — Prior authorization required
Acitretin requires prior authorization; coverage duration is 1 year and no prerequisite Part D drug is required.
Adbry — PA with age and trial requirements
Adbry requires prior authorization for atopic dermatitis in patients at least 12 years of age and cannot be used in combination with another biologic or targeted DMARD for the same condition; approval requires trial and treatment failure of one listed topical or systemic therapy.
- Age restriction: at least 12 years
- Trial and treatment failure of one of: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil
- Cannot be used in combination with another biologic/targeted DMARD
Prolastin‑C — PA and diagnostic/FEV1 requirements
Prolastin‑C (alpha‑1‑proteinase inhibitor) requires prior authorization with documented diagnosis of necrotizing panniculitis or alpha‑1 antitrypsin deficiency, documentation of congenital AAT deficiency phenotype, and FEV1 less than 80% predicted; patient must be 18 years or older and have symptomatic emphysema.
- Diagnosis: necrotizing panniculitis or AAT deficiency
- Documentation of congenital AAT phenotype (PIZZ, PIZ null, or PI null/null)
- FEV1 < 80% predicted
- Patient age ≥ 18 years
- Indication: symptomatic emphysema
Alunbrig — Prerequisite crizotinib trial
Alunbrig coverage requires prior authorization and a prerequisite trial of crizotinib as the specified Part D therapy before approval.
- Prerequisite therapy: crizotinib
Arcalyst — NSAID + colchicine trial required
Arcalyst for recurrent pericarditis requires prior authorization and documentation of a trial of a nonsteroidal anti‑inflammatory drug used in combination with colchicine prior to coverage.
- Prerequisite therapy: trial of NSAID in combination with colchicine
Auvelity — Step therapy (prior antidepressant) required
Auvelity requires prior authorization for major depressive disorder and coverage requires prior use of another generic formulary antidepressant.
- Prerequisite therapy: another generic formulary antidepressant
Balversa — Prior systemic therapy required
Balversa requires prior authorization and a documented trial of at least one prior systemic therapy for locally advanced or metastatic urothelial carcinoma prior to coverage.
- Prerequisite therapy: trial of at least one prior systemic therapy
Banzel — Divalproex trial required
Banzel (rufinamide) requires prior authorization and a documented trial of divalproex (or equivalent) as a prerequisite Part D drug before approval.
- Prerequisite therapy: trial of divalproex or equivalent
PA required — prerequisite therapy may be mandated
Prior authorization is required for many listed products; coverage for some drugs additionally requires documented trials of specified alternative therapies or Part D drugs as noted in each product entry.
Benlysta — PA and 1‑year duration
Benlysta requires prior authorization for medically‑accepted indications and is authorized with a coverage duration of 1 year.
- Coverage duration: 1 year
PA with documented prerequisite therapies (oncology examples)
Some products require prior authorization with documentation of prerequisite Part D drug use or disease‑specific prerequisite trials (examples include combination with nivolumab for first‑line advanced RCC, prior sorafenib for HCC, or VEGFR‑targeted therapy for DTC).
- First‑line advanced RCC: must be used in combination with nivolumab
- HCC: prior trial of sorafenib required
- Radioiodine‑refractory DTC: trial of VEGFR‑targeted therapy required
Glatopa — PA; no prerequisite Part D drug
Glatiramer acetate (Glatopa) requires prior authorization with a coverage duration of 1 year; a prerequisite Part D drug is not required.
- Coverage duration: 1 year
- No prerequisite Part D drug required
Copiktra — PA and prior‑lines requirement
Copiktra requires prior authorization for relapsed or refractory CLL and documentation of at least two prior therapies as a prerequisite.
- Prerequisite: at least two prior therapies
Cosentyx — PA with indication‑specific trial requirements
Cosentyx requires prior authorization; coverage varies by indication and may require diagnostic evidence and trial of an NSAID for ankylosing spondylitis and related indications.
- Cannot be used in combination with another biologic/targeted DMARD
- AS/non‑radiographic axSpA/ERA: trial of one NSAID required
- Reauthorization requires documentation of positive clinical response
Cotellic — PA; BRAF‑mutant melanoma requirements
Cotellic requires prior authorization for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation; prerequisite therapy reference includes vemurafenib.
- Prerequisite therapy: vemurafenib (as noted)
Cresemba & Cystaran — PA and 1‑year duration (no prerequisite)
Cresemba and Cystaran each require prior authorization with a coverage duration of 1 year; neither requires a prerequisite Part D drug.
- Coverage duration: 1 year
- No prerequisite Part D drug required
Dalfampridine — PA, baseline T25FW required; exclusion for wheelchair use
Dalfampridine requires prior authorization for multiple sclerosis and mandates documentation of a baseline Timed 25‑Foot Walk (T25FW) test prior to initiation; use is excluded if the patient is wheelchair bound or becomes wheelchair bound.
- Baseline T25FW documentation required prior to initiation
- Excluded if patient is wheelchair‑bound or becomes wheelchair‑bound
Dalfampridine — Baseline T25FW required
Dalfampridine PA requires documentation of a baseline Timed 25‑Foot Walk (T25FW) test for MS prior to initiation.
- Baseline T25FW test must be documented
Drizalma — PA and 1‑year coverage
Drizalma Sprinkle requires prior authorization and is authorized with a coverage duration of 1 year.
- Coverage duration: 1 year
Prior authorization required — general note
Prior authorization is required for many specialty and Part D products; typical coverage duration is commonly set to 1 year and product‑specific prerequisite trials apply as listed.
- Coverage duration commonly 1 year
- Product‑specific prerequisite trials and documentation required per entry
Erivedge — Prescriber restriction and PA
Erivedge requires prior authorization, is authorized for 1 year for medically‑accepted indications, and the prescribing physician must be an oncologist or dermatologist.
- Prescriber restriction: oncologist or dermatologist
- Coverage duration: 1 year
Erleada — PA and 1‑year duration
Erleada requires prior authorization and is authorized for 1 year for medically‑accepted indications.
- Coverage duration: 1 year
ESA (Procrit) — PA and duration
Erythropoiesis stimulating agents (e.g., Procrit) require prior authorization and are authorized for 1 year subject to applicable duration/criteria.
- Coverage duration: 1 year
Esbriet — PA and 1‑year coverage
Esbriet (pirfenidone products) require prior authorization and are authorized for 1 year for medically‑accepted indications.
- Coverage duration: 1 year
Eucrisa — Topical steroid trial required
Eucrisa coverage for atopic dermatitis requires prior authorization and a documented trial of one generic topical steroid (prerequisite Part D drug) prior to approval; coverage duration is 1 year.
- Prerequisite therapy: trial of one generic topical steroid
- Coverage duration: 1 year
Eulexin — Bicalutamide trial required
Eulexin requires prior authorization and coverage requires a trial of generic bicalutamide prior to approval; authorized for 1 year.
- Prerequisite therapy: trial of generic bicalutamide
- Coverage duration: 1 year
Fanapt — Two‑agent step therapy required
Fanapt coverage for schizophrenia requires prior authorization and documented trials of two generic formulary atypical antipsychotics (examples: quetiapine, risperidone, ziprasidone) prior to approval.
- Prerequisite therapies: two generic atypical antipsychotics (e.g., quetiapine, risperidone, ziprasidone)
Fasenra — Detailed PA and documentation requirements
Fasenra prior authorization includes indication‑specific criteria (eosinophil thresholds, prior controller therapy failures, EGPA/HES evidence) and reauthorization requires documented positive clinical response; coverage duration is 1 year.
- Eosinophilic asthma: eosinophils ≥150 cells/µL at initiation and failure of systemic or high‑dose inhaled corticosteroids plus one additional controller
- EGPA: diagnosis and supporting evidence (e.g., histopathology) required
- HES: eosinophils ≥1000 cells/µL at initiation
- Cannot be used in combination with another biologic/targeted DMARD
- Reauthorization: documentation of positive clinical response
- Coverage duration: 1 year
Fetzima — Prerequisite SNRI trials required
Fetzima requires prior authorization for major depressive disorder and coverage requires documented trials of desvenlafaxine and duloxetine (prerequisite Part D drugs) prior to approval.
- Prerequisite therapies: desvenlafaxine and duloxetine
PA requires prerequisite Part D drug trials (antidepressant examples)
Prior authorization for MDD may require documented trials of specified Part D drugs; for Fetzima specifically, trials of desvenlafaxine and duloxetine are required.
Gilotrif — PA and EGFR mutation documentation
Gilotrif requires prior authorization and coverage is provided as first‑line treatment for metastatic NSCLC with non‑resistant EGFR mutations detected by an FDA‑approved test.
- Document EGFR mutation status by FDA‑approved test
GLP‑1 agonists — PA, documentation, and exclusion for weight‑loss only
GLP‑1 agonists (e.g., Mounjaro, Ozempic, Rybelsus, Trulicity) require prior authorization; coverage is limited to medically‑accepted indications (T2DM) with required supporting medical records or lab evidence, and they are excluded if used solely for weight‑loss.
- Submit medical records confirming T2DM or lab evidence (A1c ≥6.5% or FPG ≥126 mg/dL or 2‑hour PG ≥200 mg/dL)
- Excluded if used for weight‑loss only
- Coverage duration: 1 year
Various products — PA and typical 1‑year duration
Other listed specialty products require prior authorization and are typically authorized for 1 year; prerequisite therapy requirements vary by product and must be followed per each product's PA criteria.
Humira — PA, DMARD trial and combination exclusion
Humira products require prior authorization for medically‑accepted indications and typically require condition‑specific prerequisite therapy trials (e.g., trial of one DMARD for RA) and cannot be used in combination with another biologic/targeted DMARD for the same condition.
- RA: trial of one DMARD (e.g., methotrexate, leflunomide, sulfasalazine) required
- Cannot be used in combination with another biologic/targeted DMARD
- Coverage duration commonly 1 year
Prior authorization required — product list summary
Prior authorization is required for the listed specialty/Part D products; coverage durations are commonly 1 year and prerequisite therapy requirements differ by product and indication.
Imkeldi — PA; tablet intolerance/swallowing restriction
Imkeldi requires prior authorization and coverage for all indications requires that the patient is unable to swallow the tablet formulation or unable to achieve the prescribed dose with tablets.
- Coverage prerequisite: inability to swallow tablet formulation OR inability to achieve prescribed dose with tablets
IVIG — PA (no prerequisite Part D drug required)
Immune globulin (IVIG) products are subject to prior authorization and do not require use of a prerequisite Part D drug per the entry.
Inlyta — PA with combination and prerequisite requirements
Inlyta prior authorization requires a prerequisite Part D drug for some indications and mandates combination therapy (e.g., with avelumab or pembrolizumab) for first‑line advanced renal cell carcinoma.
- First‑line advanced RCC: combination with avelumab or pembrolizumab required
- Prerequisite Part D drug required for some indications
Ivermectin 3 mg — PA and FDA‑approved indication limit
Ivermectin tablets (3 mg) require prior authorization; coverage duration is noted as 1 year and indications are limited to FDA‑approved uses.
- Coverage duration: 1 year
- Indications: FDA‑approved uses
Deferasirox (Jadenu) — PA and 1‑year coverage
Deferasirox (Jadenu) tablets require prior authorization and are authorized for 1 year for medically‑accepted indications.
- Coverage duration: 1 year
Kalydeco — PA and 1‑year duration
Ivacaftor (Kalydeco) requires prior authorization for FDA‑approved indications and is authorized for 1 year.
- Coverage duration: 1 year
Prior authorization and coverage duration — general
Prior authorization criteria apply across listed products and coverage duration is commonly set to 1 year unless otherwise stated.
- Typical coverage duration: 1 year
Prerequisite therapy — Kevzara/Kineret examples
Several products (e.g., Kevzara, Kineret) require prior trials of specified therapies (prerequisite Part D drugs) before coverage; document required prior therapies per product PA criteria.
- Kevzara: trial of two specified agents (e.g., Enbrel, adalimumab variants, Rinvoq, Xeljanz/XR, Orencia) for RA
- Kineret: trial of two specified agents for RA
Kerendia — SGLT2 trial required for HFpEF indication
Kerendia coverage for CKD associated with T2DM is permitted; for treatment of heart failure with LVEF ≥40% a trial of an SGLT2 inhibitor (e.g., empagliflozin or dapagliflozin) is required unless contraindicated or intolerant.
- Prerequisite trial: SGLT2 inhibitor for HFpEF (LVEF ≥40%) unless contraindicated/intolerant
Prior authorization required — examples and variations
Prior authorization is required for each listed product; coverage durations and prerequisite therapy requirements vary by product (examples include Koselugo authorized for 1 year and Krazati requiring prior systemic therapy).
- Koselugo: coverage duration 1 year
- Krazati: requires prior systemic therapy (KRAS G12C NSCLC)
- Lenvima: combination and prior anti‑angiogenic therapy requirements for certain indications
Step therapy (ST) — formulary (ST) flag implies required prior trials
Formulary drugs identified with (ST) require prior treatment with specified formulary drugs before coverage; check the individual product entry for the exact step‑therapy drugs required.
Auvelity — Step therapy: prior generic antidepressant
Auvelity requires step therapy: a trial of another generic formulary antidepressant must be documented prior to approval.
- Document trial of another generic formulary antidepressant
Step/combination therapy examples — oncology and hematology
Some products require prior or combination therapy (e.g., Braftovi requires combination with binimetinib; Brukinsa requires prior trial of Calquence for MCL; Cabometyx first‑line RCC requires combination with nivolumab).
- Braftovi: combination with binimetinib required for specified indications
- Brukinsa: trial of Calquence required for MCL
- Cabometyx: first‑line RCC requires combination with nivolumab
Oncology prior‑trial requirements (sorafenib/VEGFR examples)
Certain indications require prior trials of specified therapies before coverage (examples include prior sorafenib for HCC and prior VEGFR‑targeted therapy for DTC); absence of required prior therapy may result in denial.
- HCC: prior trial of sorafenib required
- Radioiodine‑refractory DTC: trial of VEGFR‑targeted therapy required
Step therapy/trial requirements — various products
Multiple products require documented trials of specified prior therapies or formulary alternatives (e.g., Diacomit requires trial of two generic anticonvulsants and combination use with clobazam).
- Diacomit: trial of 2 generic anticonvulsants and combination with clobazam
- Dihydroergotamine: two triptan trials required (one oral, one non‑oral)
Prerequisite therapy/step requirements — documentation necessary
Many products require trials of specified prior therapies (e.g., DMARDs for Enbrel; two generic alternatives for Epidiolex); document these prerequisite trials when submitting a PA request.
Eucrisa — Step therapy: topical steroid trial
Eucrisa step therapy requires a documented trial of one generic topical steroid prior to authorization for atopic dermatitis.
- Trial of one generic topical steroid required
Fanapt — Two‑agent step therapy
Fanapt requires step therapy: trials of two generic formulary atypical antipsychotics must be documented prior to coverage for schizophrenia.
- Trials of two generic atypical antipsychotics (e.g., quetiapine, risperidone, ziprasidone)
Fasenra — Step therapy: controller failure required
Fasenra step therapy for eosinophilic asthma requires failure to maintain control after systemic corticosteroids or high‑dose inhaled corticosteroids plus trial of one additional controller (leukotriene modifier OR LABA OR LAMA).
- Failure after systemic or high‑dose inhaled corticosteroids
- Trial of one additional controller: leukotriene modifier OR LABA OR LAMA
Fetzima — Prerequisite Part D drug trials required
Fetzima requires prior trials of desvenlafaxine and duloxetine for major depressive disorder; these prerequisite Part D drugs must be trialed and documented before approval.
- Prerequisite Part D drugs: desvenlafaxine and duloxetine
Fetzima — Prerequisite trials (duplicate)
Duplicate: Fetzima prerequisite therapy requires documented trials of desvenlafaxine and duloxetine prior to approval.
Humira — Step therapy: DMARD/NSAID trial required
Humira step therapy for rheumatoid arthritis requires a trial of at least one disease‑modifying antirheumatic drug (DMARD) prior to approval; ankylosing spondylitis requires trial of an NSAID.
- RA: trial of one DMARD (e.g., methotrexate, leflunomide, sulfasalazine)
- AS: trial of one NSAID required
Prerequisite/step therapy requirements — disease‑specific examples
For certain indications, coverage requires prior trials of specified drugs (e.g., DMARDs for RA, methotrexate/leflunomide/sulfasalazine; NSAID for AS); ensure documentation of these trials in PA submissions.
Isotretinoin — Prerequisite antibiotic or benzoyl peroxide required
Isotretinoin coverage requires prior authorization and documented trial of either an oral antibiotic or a benzoyl peroxide topical prior to approval.
- Prerequisite trial: oral antibiotic OR benzoyl peroxide topical
MCL (Jaypirca) — Two‑line systemic therapy trial required
Jaypirca coverage for mantle cell lymphoma requires prior authorization and documentation of a trial of two lines of systemic therapy including a BTK inhibitor; lack of documented prior therapies may result in denial.
- Trial of two lines of systemic therapy (including a BTK inhibitor) required
Jylamvo — Methotrexate trial required
Jylamvo requires prior authorization and a documented trial of methotrexate tablets prior to approval.
- Prerequisite therapy: trial of methotrexate tablets
Kisqali — Combination endocrine therapy required
Kisqali coverage requires combination use with an aromatase inhibitor or fulvestrant as initial endocrine‑based therapy for HR+/HER2‑ advanced/metastatic breast cancer (or following progression on endocrine therapy); prior authorization applies.
- Combination with an aromatase inhibitor or fulvestrant required per indication
Combination/step therapy examples — Lenvima and others
Some products stipulate required combination or prior agents (e.g., Lenvima often requires combination with pembrolizumab or everolimus in specified RCC/EC settings); follow the product‑specific PA language for required partners.
- Lenvima: combination with pembrolizumab or everolimus for certain indications; may require prior anti‑angiogenic therapy
Pharmacy help desk — PA/ST request process
For administrative assistance, the prescribing physician should contact the pharmacy help desk to request prior authorization or step therapy and verify formulary coverage.
Prolastin‑C — Required diagnostic documentation
For Prolastin‑C, prior authorization requests must include documentation of a congenital alpha‑1 antitrypsin deficiency phenotype consistent with PIZZ, PIZ (null), or PI (null, null).
- Document congenital AAT phenotype (PIZZ, PIZ null, or PI null/null)
Prerequisite therapy — Documentation required on PA
PA requests must document indications and prerequisite therapy trials where specified (e.g., trials of listed prior therapies or Part D drugs are required for many products).
Combination/prior‑trial documentation (oncology examples)
When coverage requires combination use with a specific agent (e.g., nivolumab for first‑line RCC) or prior trial of a specified drug (e.g., sorafenib for HCC), documentation that the combination or prior trial is planned or completed must be provided with the PA request.
- Document planned combination with nivolumab for first‑line RCC
- Document prior sorafenib trial for HCC
- Document prior VEGFR‑targeted therapy for eligible DTC
Dalfampridine — Baseline T25FW documentation required
Document a baseline Timed 25‑Foot Walk (T25FW) test prior to initiating dalfampridine for multiple sclerosis; this baseline measurement must be included with the PA request.
- Include baseline T25FW test result with PA
Biologic reauthorization — document positive clinical response
Reauthorization for several biologic agents (e.g., Cosentyx) requires documentation of a positive clinical response to therapy at renewal.
- Provide evidence of positive clinical response for reauthorization
Dupixent — Required PA documentation and reauthorization evidence
Dupixent PA requests must include documentation of diagnosis, indication‑specific prior therapy trials, and positive clinical response upon reauthorization.
- Document indication‑specific prior trials (per Dupixent criteria)
- Provide clinical response evidence for reauthorization
Fasenra — Required clinical documentation and reauthorization
Fasenra PA requests require indication‑specific clinical documentation (e.g., eosinophil counts, histopathology for EGPA, history of asthma) and reauthorization requires documented positive clinical response.
- Eosinophil counts and other disease‑specific evidence
- EGPA: histopathology or organ‑manifestation documentation
- Reauthorization: positive clinical response
Fetzima — Required medical information (prerequisite trials)
For Fetzima PA, include documentation of trials of desvenlafaxine and duloxetine (the specified prerequisite Part D drugs) when submitting the prior authorization request.
- Document trials of desvenlafaxine and duloxetine
GLP‑1 agonists — Required documentation for T2DM
When requesting PA for GLP‑1 agonists for ongoing T2DM treatment, submit medical records or lab evidence confirming the T2DM diagnosis (A1c ≥6.5% or FPG ≥126 mg/dL or 2‑hour PG ≥200 mg/dL) as required.
- Provide chart notes or labs confirming T2DM (A1c ≥6.5% or FPG ≥126 mg/dL or 2‑hour PG ≥200 mg/dL)
Gilotrif — EGFR mutation documentation required
For Gilotrif coverage as first‑line treatment of metastatic NSCLC, include documentation of EGFR mutation status detected by an FDA‑approved test with the PA submission.
- Attach EGFR mutation test result from an FDA‑approved test
Humira — Required PA documentation and reauthorization
For Humira PA requests (e.g., rheumatoid arthritis), document the diagnosis and a trial of one DMARD (e.g., methotrexate, leflunomide, sulfasalazine); reauthorization requires documentation of positive clinical response.
- Document diagnosis of moderately to severely active RA
- Document trial of one DMARD (e.g., methotrexate, leflunomide, sulfasalazine)
- Provide evidence of clinical response for reauthorization
General required clinical documentation for PA/reauthorization
Providers must document disease‑specific prerequisite therapy trials (e.g., DMARDs for RA, NSAID trial for AS) and submit positive clinical response evidence at reauthorization where specified.
Prior therapy documentation — polycythemia vera example
Some product entries require documentation of prior systemic therapy trials (one or two lines) for coverage of certain conditions such as polycythemia vera; include prior therapy records in the PA request.
- Polycythemia vera: document inadequate response or intolerance to hydroxyurea
Prerequisite therapy documentation — MCL and Jylamvo
Where a specific prerequisite therapy is required (e.g., BTK inhibitor for MCL or methotrexate for Jylamvo), include documentation of those prior trials to avoid denial.
- MCL (Jaypirca): document two prior systemic therapy lines including BTK inhibitor
- Jylamvo: document methotrexate tablet trial
Consequence of missing PA/ST requirements — denial risk
Coverage requires meeting the clinical and/or administrative PA and ST criteria; failure to meet required PA or step‑therapy conditions may result in denial of the request.
Prolastin‑C — Denial risk if FEV1 or diagnosis criteria unmet
For Prolastin‑C, requests may be denied if the patient does not have the required diagnosis and an FEV1 less than 80% predicted; ensure FEV1 and diagnostic phenotype documentation are provided.
- FEV1 must be < 80% predicted
- Diagnosis and congenital AAT phenotype must be documented
Budesonide ER — Explicit exclusion for UC maintenance
Budesonide ER will not be covered for maintenance of remission in ulcerative colitis; do not submit PA requests for that use.
RCC coverage — Combination therapy required (denial risk if absent)
First‑line advanced renal cell carcinoma coverage for several agents (e.g., Cabometyx, Inlyta, Lenvima) requires combination use with specified immune checkpoint inhibitors (e.g., nivolumab, avelumab, pembrolizumab); requests lacking the required combination may be denied.
- Cabometyx: first‑line RCC requires combination with nivolumab
- Inlyta: first‑line RCC requires combination with avelumab or pembrolizumab
- Lenvima: certain RCC indications require combination with pembrolizumab
HCC — Sorafenib prior trial required (denial risk)
Hepatocellular carcinoma coverage for some agents requires a prior trial of sorafenib; absence of documentation of such a trial may lead to denial.
- Document prior sorafenib trial for HCC
DTC — VEGFR‑targeted therapy trial required (denial risk)
Locally advanced or metastatic differentiated thyroid cancer that is radioactive iodine‑refractory or ineligible requires documentation of a trial of a VEGFR‑targeted therapy for coverage; failure to document this prior trial may result in denial.
- Document prior VEGFR‑targeted therapy trial for eligible DTC
Dalfampridine — Exclusion if wheelchair‑bound
Dalfampridine is excluded for use if the patient is wheelchair bound or becomes wheelchair bound; do not approve PA requests for wheelchair‑bound patients.
Dalfampridine — Denial risk if baseline T25FW not provided
Documentation of a baseline Timed 25‑Foot Walk (T25FW) test is required prior to initiating dalfampridine for MS; absence of this baseline may result in denial.
- Baseline T25FW must be provided with PA
Diacomit — Denial risk if prior trials or clobazam combination not documented
Diacomit coverage requires documented trials of two generic anticonvulsants and combination use with clobazam; lack of these documented trials may lead to denial.
- Trial of 2 generic anticonvulsants required
- Combination use with clobazam required
Dihydroergotamine — Triptan trial requirement (denial risk)
Dihydroergotamine nasal spray requires documented trials of two triptans on the formulary (one oral and one non‑oral) prior to coverage; missing these trials may result in denial.
- Trial of one oral triptan and one non‑oral triptan required
Dupixent — Clinical/reauthorization requirements (denial risk)
Dupixent coverage requires adherence to diagnosis‑specific criteria (including age/weight and prior therapy/trial requirements) and reauthorization requires documentation of positive clinical response; failure to meet these may result in denial.
Combination biologic exclusion — Denial risk
Use of any product in combination with another biologic or targeted DMARD indicated for the same condition is not allowed and may trigger denial where explicitly stated in product summaries.
- Combination with another biologic/targeted DMARD for same condition is prohibited where noted
Fasenra — Concurrent biologic exclusion (denial risk)
Fasenra cannot be used in combination with another biologic or targeted DMARD indicated for the same condition; requests that include concurrent biologics may be denied.
Prerequisite Part D trials — Denial risk if undocumented
Failure to document required prerequisite Part D drug trials (e.g., desvenlafaxine and duloxetine for Fetzima) may trigger denial of the PA request.
GLP‑1 agonists — Weight‑loss‑only exclusion (denial risk)
Requests to use GLP‑1 agonists solely for weight‑loss purposes are excluded and may be denied; ensure indication documentation supports T2DM when submitting PA.
- GLP‑1 agonists excluded if used for weight‑loss only
Humira — Combination therapy exclusion (denial risk)
Humira requests proposing combination use with another biologic or targeted DMARD for the same condition are not permitted and may be denied.
Combination therapy exclusion — General
General exclusion language: products noted in the document cannot be used in combination with another biologic or targeted DMARD for the same condition where the product entry states this exclusion; non‑compliance may cause denial.
Reauthorization — Positive clinical response required
Reauthorization of most specialty biologic therapies requires documentation of positive clinical response to therapy; lack of response documentation may prevent renewal.
Imkeldi — Swallowing/tablet dosing documentation required (denial risk)
Imkeldi coverage requires documentation that the patient is unable to swallow tablet formulation or cannot achieve the prescribed dose with tablets; absence of this documentation may result in denial.
- Document inability to swallow tablets or inability to achieve prescribed tablet dose
Inlyta — Combination requirement for first‑line RCC (denial risk)
Coverage for first‑line advanced renal cell carcinoma with Inlyta requires combination use with avelumab or pembrolizumab; missing documentation of the combination may trigger denial.
- Document planned combination with avelumab or pembrolizumab for first‑line RCC
Itovebi — Prerequisite fulvestrant noted (incomplete)
Itovebi coverage notes a requirement related to fulvestrant for endocrine‑resistant, PIK3CA‑mutated HR‑positive disease; source text is truncated—confirm full prerequisite in the product PA entry.
Polycythemia vera — Prerequisite therapy documentation may trigger denial
For polycythemia vera and similar indications, failure to document inadequate response or intolerance to the required prior therapy (e.g., hydroxyurea) may lead to denial of coverage.
- Document inadequate response or intolerance to hydroxyurea for polycythemia vera
MCL (Jaypirca) — Step requirement and denial risk
Mantle cell lymphoma coverage (Jaypirca) requires documentation of two prior lines of systemic therapy including a BTK inhibitor; absence of this documented history may result in denial.
- Two prior systemic therapy lines including BTK inhibitor must be documented
Kevzara — Combination biologic exclusion (denial risk)
Kevzara must not be used in combination with another biologic or targeted DMARD for the same condition; such combination requests are not permitted and may be denied.
Prerequisite systemic therapy — Denial risk if unmet
Requests may be denied if prerequisite systemic therapy or prior Part D drug requirements are not met (e.g., Krazati requires prior systemic therapy; some Lenvima indications require prior anti‑angiogenic therapy or specific combinations).
- Krazati: prior systemic therapy for KRAS G12C‑mutated NSCLC required
- Lenvima: prior anti‑angiogenic therapy or combination partner documentation may be required
Background — PA/ST program purpose
Background: This formulary document lists drugs subject to prior authorization and/or step therapy to ensure appropriate and cost‑effective therapy; clinical criteria are based on the Blues' Pharmacy & Therapeutics Committee recommendations.
Initial Therapy / First Authorization Requirements
Reauthorization and Continuation Requirements
Step Therapy / Prerequisite Drug Requirements
| Coverage label | Explanation |
|---|---|
| ST flag on formulary | Drugs identified with (ST) on the formulary require prior treatment with one or more specified formulary drugs before coverage is provided. See individual product entries for the specific prerequisite agents and trial requirements. |
| How ST interacts with PA | Some products are subject to both prior authorization (PA) and step therapy (ST); meeting clinical PA criteria plus documentation of required prior/formulary therapy (per ST) is required for approval. |
| Provider action | Physicians should consult the formulary to confirm ST/PA status and contact the pharmacy help desk to request prior authorization or document required prior therapy trials as part of the PA submission. |
| Coverage label | Step therapy requirement |
|---|---|
| Adbry for atopic dermatitis | Requires prior authorization. For atopic dermatitis in patients ≥12 years, coverage requires diagnosis of moderate to severe AD and a trial and treatment failure of one of: high-potency topical corticosteroid, tacrolimus, pimecrolimus, cyclosporine, azathioprine, or mycophenolate mofetil. Criteria requires use of a prerequisite Part D drug. |
| Eucrisa (related topical alternative) | Eucrisa requires a trial of one generic topical steroid prior to coverage for atopic dermatitis, as an example of the required formulary alternative prior to biologic or second-line agents. |
| Coverage label | Required prior therapy |
|---|---|
| Auvelity for major depressive disorder | Coverage requires prior use of another generic formulary antidepressant (prerequisite Part D drug) before Auvelity will be approved. |
| Product (example) | Trial / combination requirement |
|---|---|
| Banzel (rufinamide) | Coverage requires trial of divalproex (or equivalent) prior to approval (prerequisite Part D drug). |
| Braftovi (encorafenib) | Certain melanoma and other indications require combination use (e.g., with binimetinib) and prior vemurafenib + cobimetinib in some settings; prerequisite Part D drug required. |
| Briviact (brivaracetam) | Coverage requires trial of levetiracetam and one other specified agent prior to approval (prerequisite Part D drug). |
| Cabometyx (cabozantinib) | First-line advanced RCC requires combination use with nivolumab; HCC requires prior trial of sorafenib; radioactive iodine–refractory DTC requires trial of VEGFR-targeted therapy. Prerequisite Part D drug required where noted. |
| Coverage label | Prior trial required (indication examples) |
|---|---|
| First-line advanced RCC (Cabometyx) | Requires combination use with nivolumab for first-line advanced renal cell carcinoma. |
| Hepatocellular carcinoma (Cabometyx) | Requires prior trial of sorafenib before coverage is provided. |
| Differentiated thyroid cancer (Cabometyx) | Locally advanced or metastatic radioiodine-refractory or ineligible DTC requires a trial of VEGFR-targeted therapy prior to coverage. |
| Coverage label | Prior trial required |
|---|---|
| Arcalyst for recurrent pericarditis | Coverage requires trial of a nonsteroidal anti-inflammatory drug in combination with colchicine prior to Arcalyst approval. |
| Coverage label | Prior therapy history required |
|---|---|
| Copiktra (duvelisib) | Coverage for relapsed or refractory CLL requires history of at least two prior therapies before Copiktra will be approved. |
| Coverage label | Step therapy requirement |
|---|---|
| Dihydroergotamine nasal spray | Coverage requires documented trial of two triptans on the formulary: one oral triptan and one non-oral triptan prior to approval. |
| Product group | Common prerequisite requirement |
|---|---|
| Antiepileptics (examples) | Several anticonvulsant or antiepileptic agents require documented trials of specified generic alternatives (e.g., Briviact requires levetiracetam trial). |
| Oncology targeted agents (examples) | Many oncology agents require prior systemic therapy or combination use depending on indication (e.g., Braftovi, Cabometyx, Lenvima); prerequisite Part D drugs or combination partners are often required. |
| Psychotropic agents (examples) | Antipsychotic products (e.g., Bysanti, Fanapt) require trials of specified generic atypical antipsychotics prior to coverage. |
| Coverage label | Prerequisite example |
|---|---|
| Drizalma Sprinkle | Prior authorization applied; coverage duration listed as 1 year (example of common coverage duration for many products). |
| Cabometyx indications | Example reminder that specific indications may require prior trials or combination therapy per product entry (see Cabometyx: nivolumab combination, sorafenib trial, VEGFR-targeted therapy trial). |
| Coverage label | Required prior therapy |
|---|---|
| Eucrisa for atopic dermatitis | Coverage requires a trial of one topical steroid (generic) prior to approval; coverage duration 1 year. |
| Coverage label | Step therapy requirement |
|---|---|
| Fanapt for schizophrenia | Coverage requires documented trials of two generic formulary atypical antipsychotics (examples listed include quetiapine, risperidone, ziprasidone) prior to approval. |
| Coverage label | Required prior therapy / controller |
|---|---|
| Fasenra for eosinophilic asthma | Coverage requires diagnosis of eosinophilic asthma with eosinophil count ≥150 cells/µL at initiation and failure to maintain control after trial of systemic corticosteroids or high-dose inhaled corticosteroids plus trial of one additional controller (leukotriene modifier OR LABA OR LAMA). |
| Fasenra other indications (EGPA/HES) | Indication-specific diagnostic criteria apply (EGPA: typical features; HES: eosinophil count ≥1000 cells/µL). Reauthorization requires documented positive clinical response. |
| Coverage label | Prerequisite Part D drugs |
|---|---|
| Fetzima (major depressive disorder) | Coverage requires prior documented trials of desvenlafaxine and duloxetine (prerequisite Part D drugs) before Fetzima will be approved. |
| Coverage label | Note (duplicate) |
|---|---|
| Fetzima prerequisite drugs (duplicate) | As noted in the Fetzima entry, prerequisite trials of desvenlafaxine and duloxetine are required prior to coverage; documentation of these trials should be included in the PA request. |
| Coverage label | DMARD / NSAID trial requirement |
|---|---|
| Humira for rheumatoid arthritis | Coverage for RA requires trial of at least one disease-modifying antirheumatic drug (DMARD) such as methotrexate, leflunomide, or sulfasalazine prior to Humira approval. |
| Humira for ankylosing spondylitis | Coverage for AS requires trial of one NSAID (e.g., diclofenac, ibuprofen, meloxicam, naproxen) prior to biologic therapy. |
| Coverage label | General prior trials required |
|---|---|
| PA with prerequisite therapy (general) | Many products require prior trials of specified agents or Part D drugs and documentation of those trials as part of the PA request; coverage durations are commonly 1 year. |
| Coverage label | Required prior therapy |
|---|---|
| Isotretinoin (Accutane and brands) | Coverage requires trial of either an oral antibiotic OR a benzoyl peroxide–containing topical prior to isotretinoin approval. |
| Coverage label | MCL step therapy |
|---|---|
| Jaypirca for mantle cell lymphoma (MCL) | Coverage requires documented trial of two lines of systemic therapy, including a BTK inhibitor, prior to approval. |
| Coverage label | Prerequisite |
|---|---|
| Jylamvo | Coverage requires a trial of methotrexate tablets prior to approval; document trial in the PA request. |
| Group example | Grouped prerequisite therapies |
|---|---|
| Kevzara | Indication-specific prerequisites: RA and other indications require trials of specified biologics/DMARDs (e.g., Enbrel, adalimumab products, Rinvoq, Xeljanz/XR, Orencia); reauthorization requires positive clinical response. |
| Kineret | RA coverage requires trial of two of listed biologics/DMARDs prior to approval; prerequisite Part D drug required. |
| Kerendia (group example) | For HFpEF (LVEF ≥40%) indication, requires trial of an SGLT2 inhibitor unless contraindicated; other CKD/T2DM criteria apply per product entry. |
Clinical Thresholds and Coding-Adjacent Key Values
Definitions, Background, and Scope
This document lists drugs subject to prior authorization and/or step therapy in the Medicare Plus Blue Group PDP/PPO formularies to ensure appropriate and cost‑effective therapy. Clinical and administrative criteria (e.g., prerequisite Part D drug trials, baseline diagnostic tests, combination‑therapy requirements, and explicit exclusions) are used to determine coverage. For many products the typical coverage duration is 1 year and PA or ST is required prior to approval.
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