Multiple drug-specific prior authorization criteria (Part 1 of 17)
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Part of a multi-part CareSource drug prior authorization policy listing numerous medical-benefit drugs with indication-specific prior authorization criteria, exclusions, required information, age and prescriber restrictions, and coverage durations.
No material clinical or coverage changes in this policy part.
Coverage Summary
Scope: This file is one segment of a multi-part CareSource medical-benefit drug prior authorization policy covering numerous medical-benefit drugs with indication-specific PA criteria, exclusions, required information, age and prescriber restrictions, and coverage durations.
Coverage stance: Mixed — some products are covered when detailed criteria are met; many entries include exclusions and denial rules.
Common themes / operational points:
- Prior authorization required for listed drugs; prescribers must submit diagnosis, prior therapy history, and specified labs/genetic/biomarker tests when required.
- Specialist prescriber or consultation frequently required (examples: rheumatologist for Actemra; pulmonologist for Arikayce; oncologist for many oncology agents).
- Concurrent-use exclusions are common (e.g., no concurrent biologic DMARD/targeted synthetic DMARD; no combination with other CGRP inhibitors).
- Authorization durations are commonly 1 year or “through end of plan year”; some initial approvals are shorter (examples: 4 months, 6 months, 8 months).
- Continuation approvals typically require prescriber documentation of patient response/benefit.
Major drug categories included in this part:
- Oncology agents (targeted therapies, antibody–drug conjugates, immunotherapies) — multiple tumor- and biomarker-specific criteria (e.g., BRAF, RET, FGFR2, NTRK, MET, IDH, KRAS).
- Biologics / immunology (rheumatology, dermatology, gastroenterology) — many with step requirements and exclusion of concomitant biologics/JAK inhibitors.
- Neurology (antiepileptics, MS disease-modifying therapies, ALS, movement disorders).
- Pulmonology / CF / inhaled antibiotics (e.g., Arikayce, CFTR modulators, inhaled tobramycin).
- Rare metabolic and lysosomal disorders (enzyme replacement and genetic-test–driven approvals).
- Hematology (growth factors, ESAs, thrombopoietins, BTK/venetoclax-era agents, multiple myeloma regimens).
- Cardiometabolic and endocrine specialty drugs (PAH therapies requiring right-heart cath; osteoporosis agents with T-score thresholds).
Key operational reminders for implementers drawn from the part:
- Verify and capture required diagnostic tests or mutation status when specified (eg, BRAF V600, RET, FGFR2, IDH1/2, BRCA, CFTR).
- Enforce documented prior trials or intolerance where listed (step therapy or ‘try X before Y’ requirements).
- Apply explicit exclusions (concurrent agents, Medicare Part D vs ESRD/Part B rules) noted in product rules.
- Use the listed coverage durations and require documented clinical response for renewals.
Initial Therapy Criteria (selected agents)
ACTEMRA INTRAVENOUS - Initial therapy criteria
Approve when ALL of the following are met:
ALL of the following
- Diagnosis consistent with an FDA‑approved indication for intravenous tocilizumab (ACTEMRA IV).
- Exclusion: No concurrent use with another biologic disease‑modifying antirheumatic drug (DMARD) or targeted synthetic DMARD (e.g., other biologic TNFi, JAK inhibitor).
- Required information: documentation of diagnosis, current concurrent medications, and prior therapies tried.
Age / indication specific
- Giant cell arteritis (GCA) or rheumatoid arthritis (RA): age ≥ 18 years (initial therapy).
- Polyarticular juvenile idiopathic arthritis (PJIA) / systemic juvenile idiopathic arthritis (SJIA): age ≥ 2 years (initial therapy).
- Prescriber restriction (initial therapy): prescribed by or in consultation with a rheumatologist for RA, SJIA, PJIA, GCA.
- Coverage duration: approve through end of plan year (initial authorization).
RA / PJIA initial therapy prior-treatment rules
- RA initial: ONE of the following prior trials: etanercept (Enbrel), a preferred adalimumab product (e.g., Hadlima, Simlandi), upadacitinib (Rinvoq), or tofacitinib/XR (Xeljanz/XR). If none of these, prior trials with certolizumab (Cimzia), sarilumab (Kevzara), infliximab, golimumab SC/IV, abatacept (Orencia) or a non‑preferred adalimumab product may be counted.
- Or RA exception: history of heart failure or previously treated lymphoproliferative disorder.
- PJIA initial: ONE of the following prior trials: etanercept (Enbrel), upadacitinib (Rinvoq), tofacitinib (Xeljanz) or a preferred adalimumab product; alternates that may count include sarilumab (Kevzara), infliximab, abatacept (Orencia) or a non‑preferred adalimumab product.
- SJIA (systemic‑onset JIA): approve (initial).
- Other covered indication: cytokine release syndrome associated with CAR T‑cell therapy — approve when indicated.
- Continuation: approve if patient had a response as determined by the prescriber (all indications).
ACTEMRA ACTPEN / SUBCUTANEOUS - Initial therapy
Approve when ALL of the following are met:
ALL of the following
- Diagnosis of an FDA‑approved indication for subcutaneous tocilizumab (ACTEMRA ACTPEN / ACTEMRA SUBCUTANEOUS).
- Exclusion: No concurrent use with another biologic DMARD or targeted synthetic DMARD.
Age / indication
- Giant cell arteritis (GCA) / Rheumatoid arthritis (RA): age ≥ 18 years (initial therapy).
- Polyarticular juvenile idiopathic arthritis (PJIA) / Systemic juvenile idiopathic arthritis (SJIA): age ≥ 2 years (initial therapy).
- Interstitial lung disease associated with systemic sclerosis: age ≥ 18 years (initial and continuation).
- Prescriber restriction (initial therapy): prescribed by or in consultation with a rheumatologist for RA/GCA/PJIA/SJIA; for lung disease prescribe by or in consultation with a pulmonologist or rheumatologist (initial and continuation).
- Coverage duration: approve through end of plan year.
Initial therapy - indication specific prior-treatment rules
- Rheumatoid arthritis (RA) initial: ONE of the following prior trials: etanercept (Enbrel), a preferred adalimumab product (e.g., Hadlima/Simlandi), upadacitinib (Rinvoq) or tofacitinib/XR (Xeljanz/XR). Trials with certolizumab (Cimzia), infliximab, sarilumab (Kevzara), golimumab SC/IV, non‑preferred adalimumab products, or abatacept (Orencia) may also count.
- Polyarticular juvenile idiopathic arthritis (PJIA) initial: ONE of the following prior trials: etanercept (Enbrel), upadacitinib (Rinvoq), tofacitinib (Xeljanz) or a preferred adalimumab product; trials with sarilumab (Kevzara), infliximab, abatacept (Orencia), or non‑preferred adalimumab product may also count.
- Systemic‑onset JIA (SJIA): approve (initial).
- Giant cell arteritis (GCA): patient has tried or is currently taking a systemic corticosteroid, or systemic corticosteroid is contraindicated.
- Interstitial lung disease associated with systemic sclerosis: A) elevated acute phase reactants, and B) diagnosis confirmed by high‑resolution computed tomography (HRCT).
- Continuation: approve if patient had a response to therapy as determined by the prescriber (all indications).
ACTIMMUNE - Criteria
Approve when ALL of the following are met:
ALL of the following
- Diagnosis of chronic granulomatous disease (CGD) or severe malignant osteopetrosis consistent with FDA‑approved indications for interferon gamma‑1b (ACTIMMUNE).
Diagnostic confirmation
- Chronic granulomatous disease: molecular genetic test identifying a pathogenic variant linked to CGD.
- Malignant osteopetrosis, severe: either radiographic (X‑ray) imaging demonstrating skeletal features related to osteopetrosis OR a molecular genetic test identifying a pathogenic variant linked to severe malignant osteopetrosis.
- Prescriber restriction: CGD — prescribed by or in consultation with an immunologist, hematologist, or infectious disease specialist; malignant osteopetrosis — prescribed by or in consultation with an endocrinologist or hematologist.
- Coverage duration: 1 year.
Hadlima / Simlandi (adalimumab products) - Initial therapy
Approve when ALL of the following are met:
ALL of the following
- Diagnosis consistent with an FDA‑approved indication for adalimumab products Hadlima or Simlandi (initial therapy).
- Exclusion: No concurrent use with another biologic DMARD or targeted synthetic DMARD (including concurrent biologic or JAK inhibitors).
Age / indication specific limits
- Crohn's disease (CD): age ≥ 6 years (initial therapy).
- Ulcerative colitis (UC): age ≥ 5 years (initial therapy).
- Ankylosing spondylitis (AS), psoriatic arthritis (PsA), rheumatoid arthritis (RA), plaque psoriasis (PP), pyoderma gangrenosum, sarcoidosis, scleritis, sterile corneal ulceration, non‑radiographic axial spondyloarthritis: age ≥ 18 years (initial therapy).
- Juvenile idiopathic arthritis (JIA)/uveitis/Behçet's disease: age ≥ 2 years (initial therapy).
- Hidradenitis suppurativa (HS): age ≥ 12 years (initial therapy).
- Prescriber restrictions (initial therapy): prescribed by or in consultation with an appropriate specialist based on indication (examples: rheumatologist for RA/JIA/AS/nr‑axSpA; dermatologist for PsA/PP/HS/pyoderma gangrenosum; gastroenterologist for UC/CD; ophthalmologist for uveitis/scleritis).
- Coverage duration: approve through end of plan year.
Indication‑specific initial therapy requirements (representative examples)
- Crohn's disease (CD): initial therapy — approve (no additional prior biologic required per policy summary).
- Juvenile idiopathic arthritis (JIA)/JRA: must meet one of the following: A) tried one other systemic therapy (e.g., methotrexate, sulfasalazine, leflunomide, NSAID); B) tried a biologic (e.g., etanercept, abatacept, infliximab, anakinra, tocilizumab); C) will be starting adalimumab concurrently with methotrexate, sulfasalazine, or leflunomide; D) absolute contraindication to methotrexate/sulfasalazine/leflunomide; or E) aggressive disease.
- Hidradenitis suppurativa (HS): tried one other therapy (e.g., intralesional or oral corticosteroid, systemic antibiotics, isotretinoin).
- Plaque psoriasis (PP): either A) tried at least one traditional systemic agent (e.g., methotrexate, cyclosporine, acitretin, PUVA) for ≥ 3 months unless intolerant (a prior biologic trial may count), or B) contraindication to methotrexate.
- Rheumatoid arthritis (RA): tried one conventional synthetic DMARD for ≥ 3 months (a 3‑month biologic trial may also count).
- Ulcerative colitis (UC): initial therapy — approve (per policy summary).
- Behçet's disease: tried one conventional therapy (e.g., systemic corticosteroid, azathioprine, methotrexate, cyclosporine, chlorambucil, cyclophosphamide, interferon alfa) OR has ophthalmic manifestations.
- Sarcoidosis: tried one corticosteroid AND one immunosuppressant (e.g., methotrexate, mycophenolate mofetil, chlorambucil, thalidomide, infliximab, chloroquine).
- Continuation: approve if patient had a response to therapy as determined by the prescriber (all indications).
ADBRY (tralokinumab) - Atopic dermatitis initial and continuation
Initial therapy - approve when ALL of the following are met:
ALL of the following
- Diagnosis of moderate‑to‑severe atopic dermatitis affecting ≥ 10% body surface area (BSA).
- Exclusion: No concurrent use with another monoclonal antibody therapy (examples: dupilumab, mepolizumab, benralizumab, tezepelumab, omalizumab) or with a Janus kinase inhibitor (oral or topical) (examples: abrocitinib, leqseIvi, upadacitinib/rinvoq, topical tofacitinib/opzelura).
- Age restriction (initial therapy): age ≥ 12 years.
- Prescriber restriction (initial therapy): prescribed by or in consultation with an allergist, immunologist, or dermatologist.
- Required prior topical therapy: patient has tried at least one medium‑, medium‑high, high‑, or super‑high‑potency prescription topical corticosteroid and demonstrated inadequate efficacy with that therapy.
- Initial authorization length: 4 months for atopic dermatitis. Continuation criteria (not included here) require clinical response after the initial period.
Combined immunologic/biologic initial‑therapy pattern (examples: CIMZIA, ENBREL, COSENTYX, DUPIXENT)
Representative initial‑therapy structural rules for immunologic / biologic agents (apply in addition to indication‑specific criteria):
ALL of the following
- Exclusion: No concurrent use with other biologic disease‑modifying antirheumatic drugs (DMARDs) or targeted biologic/targeted synthetic agents (examples include other biologic TNFi, IL‑targeted mAbs, JAK inhibitors) unless the product labeling or clinical program allows combination therapy.
- Prescriber specialty requirement: initial prescriptions must be by or in consultation with an appropriate specialist for the indication (examples: rheumatologist for RA/JIA; dermatologist for psoriasis/HS; gastroenterologist for IBD; pulmonologist for certain lung disease indications; neurologist for select neurologic biologics).
Common age limits (examples)
- Pediatric JIA/JIA‑related indications: may require age ≥ 2 years.
- Atopic dermatitis and some biologics: may require age ≥ 12 years or older depending on agent.
- Adult rheumatologic, dermatologic, or gastroenterologic indications: typically age ≥ 18 years for initial therapy.
- Typical induction / prior therapy requirements: many agents require documented trial(s) of conventional systemic agents (e.g., methotrexate, sulfasalazine, leflunomide), a TNF inhibitor, or other indicated prior biologic(s) as specified by indication. Examples of agents following this structure include: CIMZIA (certolizumab pegol), ENBREL (etanercept), COSENTYX (secukinumab), DUPIXENT (dupilumab) — verify indication‑specific prior therapy rules for each product.
- Provider note / step‑therapy: ensure documentation of prior therapies and reason for discontinuation (lack of efficacy, intolerance, or contraindication) to support exceptions to step requirements.
Continuation Therapy Criteria
ACTEMRA INTRAVENOUS - Continuation therapy
Continuation approved when the following is met:
Prescriber-determined response is required for continuation
ACTEMRA ACTPEN / SUBCUTANEOUS - Continuation therapy
Continuation criteria
Prescriber-determined response required
CONTINUATION THERAPY: ALL INDICATIONS
General continuation rule used across indications and products
Continuation often requires documentation of benefit per prescriber; typical continuation durations are 1 year or through end of plan year unless otherwise specified (some initial approvals shorter, e.g., 4 months induction)
Exclusions / Not Covered
Explicit exclusions / disallow rules collected from brief
Explicit exclusions / disallow rules collected from the brief
Exclusions
- No concurrent Biologic/Targeted Synthetic DMARD: No concurrent use with a Biologic DMARD or Targeted Synthetic DMARD (explicit exclusion in multiple biologic/RA/CIMZIA/Actemra/Infliximab entries)
Refs: Actemra, CIMZIA, Infliximab
- No concurrent monoclonal antibody or JAK inhibitor: No concurrent use with another monoclonal antibody therapy or JAK inhibitors (e.g., for tralokinumab, dupilumab and some atopic dermatitis agents)
Ref: Adbry
- No concurrent CGRP inhibitors: No concurrent combination therapy with another cGRP inhibitor for migraine prevention (e.g., Aimovig, Emgality, Qulipta exclusions)
Ref: Aimovig, Emgality, Qulipta
- No concomitant CF cysteamine products: No concomitant use of Cystagon and Procysbi (explicit exclusion)
Ref: CYSTAGON
- ESAs Medicare Part D ESRD exclusion: Anemia/ESRD-related denials: Erythropoiesis-stimulating agents for anemia in patients with chronic renal failure on dialysis are denied under Medicare Part D (claim should be submitted under ESRD bundled payment benefit)
Ref: RETACRIT / PROCRIT
Other common denial scenarios called out in the part include: Medicare Part D denials when treatment falls under the ESRD bundled benefit (e.g., cinacalcet for secondary hyperparathyroidism on dialysis), explicit exclusions for concurrent use of specified agents (e.g., no concurrent CGRP inhibitors with Aimovig/Qulipta/Emgality; no concurrent biologics or JAK inhibitors with many biologic entries), exclusions of cosmetic indications (e.g., topical / systemic agents for cosmetic weight gain), and exclusions of acute procedural or sedation uses for certain high-risk medications (HRMs) such as benzodiazepines or promethazine where sedation/insomnia use is disallowed.
Applicable Codes
| ZEPOSIA | Ozanimod (brand ZEPOSIA) — oral sphingosine 1‑phosphate receptor modulator |
| ZEPZELCA | Zepzelca (lurbinectedin) — IV antineoplastic agent |
| ZIIHERA | Ziihera — (specified biologic/agent) |
| ZOLINZA | Zolinza (vorinostat) — oral histone deacetylase inhibitor |
| ZTALMY | Ztalmy (zavegepant) — intranasal CGRP receptor antagonist |
| ZYDELIG | Zydelig (idelalisib) — oral PI3K inhibitor |
| ZYKADIA | Zykadia (ceritinib) — oral ALK inhibitor |
| ZYMFENTRA | Zymfentra — (specified biologic/agent) |
| ZYNLONTA | Zynlonta (loncastuximab tesirine) — antibody‑drug conjugate |
| ZYNYZ | Zynyz — (specified agent) |
| ZURZUVAE-20MG | ZURZUVAE oral capsule 20 mg |
| ZURZUVAE-25MG | ZURZUVAE oral capsule 25 mg |
| ZURZUVAE-30MG | ZURZUVAE oral capsule 30 mg |
| ABIRATERONE-250MG | Abiraterone oral tablet 250 mg |
| ABIRATERONE-500MG | Abiraterone oral tablet 500 mg |
Provider Actions — Prior Authorization & Documentation
Prior authorization required
Prior authorization is required for all drugs in this policy part; submit diagnosis, required lab/genetic test results, prior therapy history, and prescriber specialty as specified per drug. Part B vs Part D determinations will be made at prior authorization review for many oncology agents.
- Examples of required molecular/genetic tests: BRAF V600 mutation (e.g., BRAFTOVI, MEKINIST, TAFINLAR) — see BRAFTOVI/MEKINIST/TAFINLAR criteria
- RET gene rearrangement testing (e.g., CABOMETYX, COMETRIQ, GAVRETO) — see CABOMETYX/COMETRIQ/GAVRETO criteria
- EGFR mutation testing (examples: exon 19 deletions, exon 21 L858R, L861Q, G719X, S768I) for EGFR-directed TKIs (e.g., erlotinib, gefitinib, Tagrisso)
- CFTR genotyping/sweat chloride or nasal potential difference for CFTR modulators (e.g., Kalydeco, Orkambi, Trikafta)
- FLT3/IDH/IDH2/ALK/MET/KRAS/NRG1 and other tumor biomarkers as specified per oncology agent
- Microbiology/culture results where required (e.g., positive MAC sputum culture for Arikayce)
- Functional C1-INH and C4 levels for HAE therapies (e.g., Cinryze)
Document prior therapy trials and clinical response
Document dates, agents, reason for failure/intolerance, and objective evidence of benefit for continuation (lab values, imaging, functional scores, reduced exacerbations).
- Migraine: reduction in migraine days/month (Aimovig/Emgality/Nurtec/Qulipta examples)
- Arikayce (MAC): sputum culture results (positive MAC; negative cultures timeline for continuation)
- Erythropoiesis-stimulating agents (ESAs): hemoglobin thresholds (e.g., Hb <10 g/dL for many initial indications; continuation thresholds ≤12 g/dL)
- Interstitial lung disease/IPF: FVC values and HRCT findings for antifibrotic therapies (Ofev, pirfenidone)
- Dalfampridine: objective ambulation measures (timed 25-foot walk, MSWS-12)
- Benlysta: dates of prior immunosuppressive/concomitant standard therapy and response documentation for continuation (SLE/Lupus nephritis)
- Dupilumab/Nucala/other biologics: reductions in exacerbations, steroid dose reductions, improved pulmonary function or eosinophil counts
Specialist prescriber requirement
Many initial approvals require prescribing by or consultation with a specialist — oncologist, rheumatologist, pulmonologist, neurologist, geneticist, etc.
- Actemra (RA, GCA, JIA): rheumatology consultation required
- Arikayce (MAC lung disease): pulmonologist, infectious disease, or MAC specialist required
- CFTR modulators (Kalydeco, Trikafta, Orkambi, Symdeko): prescribed by or in consultation with a CF specialist or pulmonologist
- Oncology agents (many entries): prescribed by or in consultation with an oncologist; Part B/Part D determinations done at PA review
Coverage duration & renewal
Authorizations commonly issued for 1 year or through end of plan year; some agents have shorter initial durations. Request renewals with documentation of continued benefit.
- Camzyos: initial authorization 8 months (continuation 1 year)
- Arikayce: authorization 1 year
- Benlysta (SLE): initial 4 months, continuation 1 year
Common denial risks
Denials likely when exclusion criteria or concurrent prohibited therapies are present, when required diagnostic testing is missing, or when Part B/Part D determinations are not addressed.
- ESRD/Medicare Part D denial for certain cinacalcet uses (secondary hyperparathyroidism on dialysis) — submit under ESRD bundle instead
- Concurrent prohibited therapies: concomitant biologic or JAK inhibitor use listed as exclusions for many biologics
- Missing required diagnostic testing: e.g., lack of right-heart catheterization for PAH agents (Opsumit/Opsynvi/Treprostinil) or missing mutation testing for targeted oncology agents (BRAF, RET, MET, FGFR, etc.)
- Failure to provide prior therapy history or specialist prescriber documentation for drugs with step or specialist requirements
Step therapy / trial requirements
Many agents require prior trials of specified agents or classes (e.g., trials of TNF inhibitors, preferred adalimumab products, or specific chemotherapies). Document trial duration and outcome.
- Actemra/RA: trial of Enbrel, a preferred adalimumab product (Hadlima/Simlandi), Rinvoq, or Xeljanz/XR (one of these) prior to initial approval
- Rheumatology agents: many require 3-month trials of TNF inhibitors or other specified biologics per indication (see Rinvoq/Cimzia criteria)
- Nexletol/Nexlizet (hyperlipidemia): requirements for trials of high-intensity statin (± ezetimibe) or statin intolerance prior to approval
- Oncology (e.g., Lonsurf, Pemazyre, Blenrep, Blenrep combinations): require specified prior systemic regimens or lines of therapy
Clinical Evidence & Metrics
Evidence posture and documentation guidance: Approvals are tied to FDA‑approved indications and in many cases to specified "some medically-accepted/off‑label" uses; numerous indications require laboratory, imaging, or genetic/biomarker confirmation (examples: BRAF/RET/NRG1/EGFR/IDH/FGFR2/FLT3/KRAS/BRCA/CFTR testing, right‑heart catheterization for PAH, functional C1‑INH and C4 for HAE).
Required diagnostic tests are explicitly specified by drug/indication (eg, CLAUDIN 18.2 positivity ≥75% IHC, TmP/GFR and serum phosphorus for Crysvita).
Continuation authorizations commonly require prescriber attestation of clinical response (not necessarily replicating numeric utilization metrics), and metric_cards or other UI elements need not duplicate the policy's stats_bar — do not duplicate metrics where not required.
Populators should include direct links to primary FDA labeling or guideline sources (eg, FDA prescribing information, AASLD/IDSA guidance for HCV agents) when available to support the documented test thresholds and biomarker definitions.
Background
Part of a multi-part CareSource drug prior authorization policy listing numerous medical-benefit drugs with indication-specific prior authorization criteria, exclusions, required information, age and prescriber restrictions, and coverage durations.
This file is one segment (part X of 17) of the overall multi-part PA policy.
Revision History
Policy part reviewed; effective date 2026-04-01; no material changes recorded in this part.
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