Health Net DMARD Prior Auth & Coverage Update | OpenPayer
ModifiedHealth NetPolicy CP.CPA.194
Biologic and Non-biologic DMARDs — Prior Authorization Criteria
Criteria and prior authorization requirements for a comprehensive list of biologic and non-biologic disease-modifying anti-rheumatic drugs (DMARDs) for Health Net commercial lines of business (excluding California Exchange Plans). Affects providers requesting coverage for the listed agents.
Policy Summary
PayerHealth Net
PolicyBiologic and Non-biologic DMARDs — Prior Authorization Criteria
Added off-label use for Kawasaki disease for infliximab.
Revised redirection from Remicade to biosimilars to 'must use' language and modified stepwise redirection requiring Inflectra and Renflexis before Avsola then Remicade.
Added HCPCS code J2327 and multiple biosimilar Q-codes to the coding list.
Multiple newly approved biologic agents, biosimilars, indications, dosing formulations, and HCPCS codes were added across the policy (examples: Amjevita HS/UV indications, Tremfya UC indication, Simlandi formulation/dosing, Tofidence for COVID-19 and GCA, Pyzchiva SC formulation).
Redirection/step therapy logic was frequently revised (examples: redirection to specific adalimumab products, modification of Remicade stepwise redirection, allowing bypass after failure of two TNF blockers for certain indications, removal of adalimumab redirection for UC per AGA guidance).
New HCPCS/J-codes and removal of others added repeatedly (examples: added C9166, C9168, Q5133, Q5134, later J2267, J3247, Q5137, Q5138; later added J0139, Q5140–Q5145, Q9996–Q9998; added Q5135, Q9999).
Policy geographic applicability clarified for certain criteria (e.g., criteria apply for California/Oregon commercial plans; references to HIM.PA.SP60 for California Exchange Plans).
For giant cell arteritis (GCA), removed requirement for failure of a ≥3 consecutive month trial of systemic corticosteroid and removed requirement for use in conjunction with methotrexate or azathioprine to align with competitor/HIM/Medicaid criteria.
For cytokine release syndrome (CRS), revised criteria to permit use as supportive care in severe CRS related to blinatumomab and added prophylaxis to reduce CRS risk when administering teclistamab-cqyv per NCCN compendium.
Added HCPCS code Q9999 and additionally added multiple HCPCS codes (Q5098, Q5099, Q5100, Q5156) in later updates.
Kawasaki disease dose updated in section V from 5 mg/kg over 2 hours to 10 mg/kg over 2 hours.
Updated injectable agent approval durations from '6 months' to '6 months or to member's renewal date, whichever is longer'.
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Atopic Dermatitis — Covered when ALL of the following are met
Atopic Dermatitis initial criteria: 1) Diagnosis of atopic dermatitis affecting either ≥10% BSA or involving hands/feet/face/neck/scalp/genitals/intertriginous areas; 2) Request is for Rinvoq; 3) Prescribed by or in consultation with a dermatologist, allergist, or immunologist; 4) Age ≥ 12 years; 5) Failure of both: (a) one formulary medium‑to‑very high potency topical corticosteroid used ≥2 weeks; and (b) one non‑steroidal topical therapy used ≥4 weeks (e.g., topical calcineurin inhibitor or Eucrisa); 6) Rinvoq not prescribed concurrently with another biologic or a JAK inhibitor; 7) Dose does not exceed maximum in Section V.
Approval duration: 6 months or to member's renewal date, whichever is longer
Initial Therapy — Axial Spondyloarthritis
Axial Spondyloarthritis — Covered when ALL of the following are met
Axial Spondyloarthritis initial criteria: 1) Diagnosis of ankylosing spondylitis (AS) or non‑radiographic axial spondyloarthritis (nr‑axSpA); 2) Request is for an enumerated agent (examples: adalimumab products, Amjevita, Avsola, Bimzelx, Cimzia, Cosentyx, Enbrel, Humira, Rinvoq, Simponi, Taltz, Xeljanz, etc.); 3) Prescribed by or in consultation with a rheumatologist; 4) Age ≥ 18 years; 5) Failure of at least TWO NSAIDs each used ≥4 weeks unless contraindicated or previously failed a biologic; 6) Product‑specific sequencing requirements apply (e.g., required trials of specified adalimumab products and/or Enbrel; for Remicade family follow biosimilar sequencing Inflectra/Renflexis → Avsola → unbranded Remicade); 7) No combination use of biologic DMARDs or JAK inhibitors; 8) Dose does not exceed maximum in Section V.
Prior authorization and sequencing requirements apply; Approval duration: 6 months or to member's renewal date
Initial Therapy — Behçet's Disease
Behçet's Disease — Covered when ALL of the following are met
Behçet's (oral ulcers): 1) Diagnosis of oral ulcers in members with Behçet's disease; 2) Request is for Otezla or Otezla XR; 3) Prescribed by or in consultation with a dermatologist or rheumatologist; 4) Age ≥ 18 years; 5) Failure of colchicine at up to maximally indicated doses unless contraindicated; 6) Dose does not exceed maximum in Section V.
Approval duration: 6 months or to member's renewal date, whichever is longer
Initial Therapy — Castleman's Disease (off-label)
Castleman's Disease (off-label) — Covered when ALL of the following are met
Castleman's disease off-label criteria: 1) Diagnosis of Castleman's disease that is relapsed/refractory or progressive; 2) Request is for IV Actemra, Avtozma, Tofidence, or Tyenne; 3) Disease is unicentric HIV‑negative/HHV‑8‑negative or multicentric; 4) Prescribed as second‑line monotherapy; 5) No combination use of biologic DMARDs or JAK inhibitors; 6) Dose does not exceed 8 mg/kg per infusion every 2 weeks or is supported by practice guidelines/peer‑reviewed literature with submitted evidence; 7) Prescribed regimen must be FDA‑approved or NCCN‑recommended.
Approval duration: 6 months or to member's renewal date, whichever is longer
Initial Therapy — Crohn's Disease
Crohn's Disease — Covered when ALL of the following are met
Crohn's disease initial criteria: 1) Diagnosis of Crohn's disease; 2) Request is for an enumerated agent (examples include Abrilada, multiple adalimumab products, Amjevita, Avsola, Cimzia, Entyvio, Imuldosa, Omvoh, Otulfi, Skyrizi, Stelara, Tremfya, Zymfentra, etc.); 3) Prescribed by or in consultation with a gastroenterologist; 4) Age requirements per agent (some agents ≥6 years, others ≥18 years as specified); 5) Agent‑specific sequencing may require trials of specific adalimumab products or infliximab biosimilars in order (Inflectra and Renflexis → Avsola → unbranded Remicade); 6) Failure of ≥3 month trial of at least one immunomodulator (azathioprine, 6‑MP, MTX) at maximally indicated doses unless contraindicated or prior biologic failure, or medical justification for inability to use immunomodulators; 7) Additional product‑specific sequences and quantity limits (e.g., Skyrizi vial/cartridge limits); 8) No combination use of biologic DMARDs or JAK inhibitors; 9) Dose does not exceed maximum in Section V.
Prior authorization and detailed sequencing required; Approval duration: 6 months or to member's renewal date
Initial Therapy — Cytokine Release Syndrome
Cytokine Release Syndrome — Covered when ALL of the following are met
CRS criteria: 1) Request is for Actemra, Avtozma, or Tyenne; 2) IV formulation; 3) Age ≥ 2 years; 4) Member has scheduled CAR T‑cell therapy OR use as supportive care for severe CRS related to blinatumomab OR prophylaxis to reduce CRS risk when administering teclistamab‑cqyv; 5) Dose does not exceed 800 mg per infusion for up to 4 total doses OR dose is supported by guidelines/literature with submitted evidence; 6) Prescribed regimen must be FDA‑approved or NCCN‑recommended.CRS: up to 4 total doses; IV dose ≤800 mg/infusion
Approval duration: Up to 4 total doses
Initial Therapy — DIRA
DIRA — Covered when ALL of the following are met
DIRA criteria: 1) Diagnosis of Deficiency of Interleukin‑1 Receptor Antagonist (DIRA) confirmed by loss‑of‑function ILRN mutations; 2) Request is for Kineret; 3) Prescribed by or in consultation with a rheumatologist; 4) No combination use of biologic DMARDs or JAK inhibitors; 5) Dose does not exceed maximum in Section V.
Approval duration: 6 months or to member's renewal date, whichever is longer
Initial Therapy — Enthesitis-related Arthritis
Enthesitis-related Arthritis — Covered when ALL of the following are met
ERA criteria (Cosentyx): 1) Diagnosis of enthesitis‑related arthritis (ERA); 2) Request is for Cosentyx; 3) Prescribed by or in consultation with a rheumatologist; 4) Age ≥ 4 years and < 18 years; 5) Failure of at least TWO NSAIDs each used ≥4 weeks unless contraindicated; 6) Either failure of ≥3 month trial of MTX at maximally indicated doses OR MTX intolerance/contraindication plus failure of ≥3 month trial of ≥1 conventional DMARD (e.g., sulfasalazine, leflunomide); 7) No combination use of biologic DMARDs or JAK inhibitors; 8) Weight‑based dosing: 15–<50 kg induction/maintenance at 75 mg schedule; ≥50 kg induction/maintenance at 150 mg schedule.
Approval duration: 6 months or to member's renewal date
Deficiency of Interleukin-1 Receptor Antagonist (DIRA) — Initial therapy
Covered when ALL of the following are met
ALL of the following
Diagnosis of DIRA confirmed by presence of loss‑of‑function ILRN mutations
Agent: Request is for Kineret
Prescriber: Prescribed by or in consultation with a rheumatologist
No combination therapy: Member does not have combination use of biological DMARDs or JAK inhibitors
See Section III for disallowed combinations
Enthesitis-related Arthritis (ERA) — Cosentyx
Covered when ALL of the following are met
ALL of the following
Diagnosis of ERA
Agent: Request is for Cosentyx
Prescriber: Prescribed by or in consultation with a rheumatologist
Age ≥4 years and <18 years
NSAID prior trial: Failure of at least TWO NSAIDs at up to maximally indicated doses, each used ≥4 weeks unless contraindicated
Giant Cell Arteritis (GCA)
Covered when ALL of the following are met
ALL of the following
Diagnosis of giant cell arteritis (GCA)
Agent: Request is for Actemra, Avtozma, Rinvoq, Tofidence, or Tyenne
Prescriber: Prescribed by or in consultation with a rheumatologist
Age ≥18 years
Steroid trial: Failure of a systemic corticosteroid at up to maximally tolerated doses unless contraindicated or prior biologic failure
Acute Graft-versus-Host Disease (aGVHD) prophylaxis — Orencia IV
Acute Graft-versus-Host Disease (aGVHD) prophylaxis — Orencia IV — Covered when ALL of the following are met
ALL of the following
Use: Prescribed for prophylaxis of aGVHD
Agent/formulation: Request is for intravenous formulation of Orencia
Prescriber: Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist
Age ≥2 years
Hidradenitis Suppurativa (HS)
Hidradenitis Suppurativa (HS) — Covered when ALL of the following are met
ALL of the following
Diagnosis of hidradenitis suppurativa (HS)
Agent: Request is for an enumerated agent (examples include multiple adalimumab products, Amjevita, Bimzelx, Cosentyx, Simlandi, etc.)
Specific age limits vary by product
Prescriber: Prescribed by or in consultation with a dermatologist, rheumatologist, or gastroenterologist
Age by product: Age requirements differ by product (e.g., many adalimumab products age ≥12; others age ≥18)
See product‑specific policy rows
Initial Therapy — Kawasaki Disease (off-label)
Kawasaki Disease (off-label) — infliximab-containing products — Covered when ALL of the following are met
ALL of the following
Diagnosis of Kawasaki disease
Agent: Request is for an infliximab‑containing product
Specific product sequencing required
Prescriber: Prescribed by or in consultation with a cardiologist, allergist, immunologist, infectious disease specialist, or rheumatologist
Neonatal‑Onset Multisystem Inflammatory Disease (NOMID/CINCA) — Covered when ALL of the following are met
ALL of the following
Diagnosis of NOMID/CINCA
Agent: Request is for Kineret
Prescriber: Prescribed by or in consultation with a rheumatologist
No combination therapy: No combination use of biological DMARDs or JAK inhibitors
Plaque Psoriasis (PsO)
Plaque Psoriasis (PsO) — Covered when ALL of the following are met (agent‑ and severity‑specific criteria apply)
ALL of the following
Diagnosis of plaque psoriasis meeting moderate‑to‑severe or chronic‑severe criteria (examples: ≥3% BSA or involvement of hands/feet/scalp/face/genital area; some agents require ≥10% BSA)
Agent: Request is for an eligible systemic/biologic agent or Otezla/Otezla XR with agent‑specific criteria
Agent‑specific age/weight/minimums apply
Prescriber: Prescribed by or in consultation with a dermatologist or rheumatologist
Age/weight: Agent‑specific age and weight minimums must be met
Polyarticular Juvenile Idiopathic Arthritis (pJIA) — Covered when ALL of the following are met
ALL of the following
Diagnosis of polyarticular JIA as evidenced by ≥5 joints with active arthritis
Agent: Request is for an eligible agent (examples include TNF blockers, IL‑6 agents, abatacept, JAK inhibitors, etc.)
Some agents have age/weight restrictions
Prescriber: Prescribed by or in consultation with a rheumatologist
Age ≥2 years
pJIA initial therapy
pJIA initial therapy — Covered when ALL of the following are met unless previously failed a biologic agent for pJIA
pJIA initial criteria
Conventional therapy options: a. Failure of ≥3 month MTX trial; b. If MTX intolerant/contraindicated, failure of ≥3 months leflunomide or sulfasalazine; c. NSAID trial for axial involvement; d. High disease activity documented.
Agent-specific TNF/JAK step therapy
Agent-specific TNF/JAK step therapy — Specific agents covered when BOTH conditions met
Agent‑specific prior biologic/TNF logic: a) One of the following (i, ii, or iii): i. Failure of BOTH (each ≥3 months) 1) one adalimumab product AND 2) Enbrel; ii. If history of failure of one TNF blocker, failure of one other TNF blocker (≥3 months); iii. History of failure of two TNF blockers and request is not for another TNF blocker; b) If not responded/intolerant to TNF blockers, Xeljanz and Rinvoq used ≥3 months unless cardiovascular risk outweighs benefit.
Polymyalgia rheumatica
Polymyalgia rheumatica — PMR — must meet ALL
PMR criteria: 1) Diagnosis of PMR per ACR/EULAR criteria with typical symptoms and baseline ESR ≥30 mm/hr or CRP ≥10 mg/L; 2) Request is for Kevzara; 3) Prescribed by or in consultation with a rheumatologist; 4) Age ≥50 years; 5) Either failure of a systemic corticosteroid at maximally tolerated doses for ≥2 weeks OR documentation of an unequivocal PMR flare while tapering corticosteroids at ≥7.5 mg/day prednisone equivalent; 6) No combination use of biologic DMARDs or JAK inhibitors; 7) Dose within maximum in Section V.
Psoriatic arthritis
Psoriatic arthritis — PsA — must meet ALL
PsA general criteria: 1) Diagnosis of PsA or jPsA; 2) Request is for an enumerated agent (examples include multiple adalimumab products, Amjevita, Bimzelx, Cimzia, Cosentyx, Orencia, Otezla, Rinvoq, Simponi, Skyrizi, Stelara, Taltz, Tremfya, etc.); 3) Prescribed by or in consultation with dermatologist or rheumatologist; 4) Agent‑specific age/weight requirements apply; 5) Required prior therapy/sequencing: for many agents, failure of specified adalimumab products and Enbrel each ≥3 months or history of TNF failures; 6) For certain agents, additional failures of Otezla, Cosentyx, Skyrizi, ustekinumab products, Tremfya, and others each ≥3 months may be required; 7) If not responded/intolerant to TNF blockers, Xeljanz/XR and Rinvoq used ≥3 months unless CV risk outweighs benefit; 8) No combination use of biologic DMARDs or JAK inhibitors; 9) Dose within Section V limits.
Rheumatoid arthritis
Rheumatoid arthritis — RA — must meet ALL
RA general criteria: 1) Diagnosis of RA per 2010 ACR classification criteria; 2) Request is for an enumerated agent (examples: adalimumab products, abatacept, Actemra, Kevzara, Orencia, Rituximab alternatives, JAK inhibitors, etc.); 3) Prescribed by or in consultation with a rheumatologist; 4) Age ≥18 years; 5) Failure of ≥3 months MTX at maximally indicated doses OR intolerance/contraindication plus failure of ≥3 months of at least one conventional DMARD; 6) Product‑specific sequencing (adalimumab/Enbrel/Inflectra/Remicade families) and TNF/JAK logic apply; 7) Baseline CDAI or RAPID3 required for documentation of activity; 8) No combination use of biologic DMARDs or JAK inhibitors; 9) Dose within Section V maximums.
Systemic juvenile idiopathic arthritis
Systemic juvenile idiopathic arthritis — sJIA — must meet ALL
sJIA criteria: 1) Diagnosis of sJIA; 2) Request is for Actemra, Avtozma, Tofidence, or Tyenne; 3) Prescribed by or in consultation with appropriate specialist (dermatologist, rheumatologist, or gastroenterologist per policy); 4) Age ≥2 years; 5) Failure of one of: NSAID trial, ≥3 months MTX or leflunomide, or ≥2 week systemic corticosteroid trial at maximally indicated doses unless contraindicated; 6) No combination use of biologic DMARDs or JAK inhibitors; 7) Dose within Section V limits.
Systemic sclerosis–associated interstitial lung disease (SSc-ILD) — must meet ALL
SSc-ILD criteria: 1) Diagnosis of SSc‑ILD with HRCT evidence of pulmonary fibrosis and additional signs of systemic sclerosis; 2) Request is for subcutaneous Actemra; 3) Prescribed by or in consultation with a pulmonologist or rheumatologist; 4) Failure of ≥3 months cyclophosphamide or mycophenolate unless contraindicated; 5) Baseline FVC ≥40% predicted; 6) Baseline DLCO ≥30% predicted; 7) No combination use of biologic DMARDs or JAK inhibitors; 8) Dose does not exceed 162 mg SC weekly.FVC ≥40% predicted; DLCO ≥30% predicted
Approval duration: 6 months or to member's renewal date
Systemic Sclerosis - Associated Interstitial Lung Disease (SSc-ILD) Initial Therapy — Covered when ALL of the following are met
SSc-ILD initial therapy: 1) Diagnosis of SSc‑ILD; 2) Request is for subcutaneous Actemra; 3) Prescribed by or in consultation with pulmonologist or rheumatologist; 4) Pulmonary fibrosis on HRCT plus additional signs of SSc; 5) Failure of ≥3 months cyclophosphamide or mycophenolate at maximally indicated doses unless contraindicated; 6) Baseline FVC ≥40% predicted; 7) Baseline DLCO ≥30% predicted; 8) No combination use with other biologic DMARDs or JAK inhibitors; 9) Dose ≤162 mg SC weekly.
Ulcerative Colitis (UC) Initial Therapy and Sequencing
Ulcerative Colitis (UC) Initial Therapy and Sequencing — Covered when listed diagnosis‑specific and product‑specific criteria are met
UC general: 1) Diagnosis of ulcerative colitis; 2) Request is for an enumerated agent (examples include multiple adalimumab products, Amjevita, Avsola, Entyvio, Imuldosa, Omvoh, Otulfi, Remicade family, Rinvoq, Skyrizi, Stelara, Tremfya, Zeposia, Zymfentra, etc.); 3) Prescribed by or in consultation with a gastroenterologist; 4) Age and product‑specific minimums apply; 5) For select adalimumab products prior use of Humira/Hadlima/adalimumab‑adaz may be required unless contraindicated (note: redirection for adalimumab in UC was later removed per AGA guidance); 6) Documentation of Mayo Score ≥6, modified Mayo ≥5, or Mayo Endoscopic Score ≥2; 7) Failure of an 8‑week systemic corticosteroid trial unless contraindicated or prior biologic failure; 8) Product‑specific sequencing and advanced sequencing rules apply for certain agents (Omvoh, Simponi, Velsipity, Zeposia, Imuldosa/Otulfi/Selarsdi/Starjemza/Wezlana).
Advanced sequencing examples: For selected agents, requirements include failure of multiple specified biologics (e.g., Skyrizi, ustekinumab products, Tremfya, adalimumab product) and/or TNF/Xeljanz/Rinvoq sequencing per policy; exceptions and bypass rules apply when member has failed two TNF blockers or per updated guidance.
Uveitis Initial Therapy
Uveitis Initial Therapy — Covered when ALL of the following are met
Uveitis criteria: 1) Diagnosis of non‑infectious intermediate, posterior, or panuveitis; 2) Request is for specified adalimumab products or equivalents; 3) Prescribed by or in consultation with an ophthalmologist or rheumatologist; 4) Age criteria per product (some agents ≥2 years, others ≥18 years); 5) For specified biosimilars/products, prior use of listed alternatives may be required unless contraindicated; 6) Failure of a ≥2 week trial of systemic corticosteroid at maximally indicated doses unless contraindicated or prior biologic failure; 7) Failure of trial of non‑biologic immunosuppressive therapy at maximally indicated doses unless contraindicated or prior biologic failure; 8) No combination use with other biologic DMARDs or JAK inhibitors; 9) Dose does not exceed maximum indicated in Section V.
Infliximab product sequencing and Other Indications
Infliximab product sequencing and Other Indications — Covered when product‑sequencing rules and referral policies are met
Infliximab/Avsola/Remicade sequencing: For Remicade requests: member must trial Inflectra and Renflexis; if failed those, then Avsola; if failed Avsola then unbranded Remicade. For unbranded Remicade: trial Inflectra and Renflexis, then Avsola if failed. For Avsola: trial Inflectra and Renflexis first. Sequences required unless clinically significant adverse effects or contraindications exist.
Other/Off‑label pathway: If a drug has a recent label change not yet reflected in this policy (within 6 months), refer to CP.CPA.190; if requested use is not listed and label change does not apply, refer to off‑label policy CP.CPA.09.
Continuation and Response Criteria for All Other Indications
Continuation and Response Criteria for All Other Indications — Covered for continuation when member meets one of continuity or prior authorization conditions AND evidence of response
Continuation eligibility: 1) Member currently receiving medication via Centene benefit or previously met initial approval criteria OR member is in a continuity‑of‑care jurisdiction OR documentation supports current IV Actemra/Avtozma/Tyenne for CAR T cell‑induced CRS with fewer than 4 total doses received; 2) Member meets disease‑specific response criteria: RA—decrease in CDAI or RAPID3 from baseline (or justification for RAPID3); HS—≥25% reduction in inflammatory nodules/abscesses; AD—evidence of symptom reduction (e.g., itching); PMR—decrease in signs/symptoms plus reduction in CRP or ESR; other indications—member is responding positively to therapy.
Alopecia Areata - coverage by line of business: a) For California Commercial: Olumiant requests reviewed against HNCA.CP.CPA.04 Alopecia Areata Treatments; OR b) For California Exchange Plans and all other requests: Olumiant for alopecia areata is a benefit exclusion and will not be authorized (considered cosmetic).
Approval duration: Not applicable
Continuation Therapy / Response Requirements
Continuation Therapy / Response Requirements — Continuation/other indications — all of the following must be met
Continuity and response criteria: 1) Member meets one of: currently receiving medication via Centene benefit or previously met initial approval criteria; OR currently receiving medication and enrolled in a state/product with continuity of care; OR documentation member is currently receiving IV Actemra/Avtozma/Tyenne for CAR T cell‑induced CRS and has not yet received 4 total doses. 2) Member meets indication‑specific response criteria: RA—decrease in CDAI or RAPID3 from baseline (or justified RAPID3); HS—≥25% reduction in inflammatory nodules/abscesses; AD—evidence of symptom reduction; PMR—decrease in signs/symptoms plus reduction in CRP or ESR; other indications—member is responding positively to therapy.
Applies to continuation approvals for indications in Section I
Adalimumab family step requirement: If request is for listed adalimumab biosimilars or alternatives, member must use Humira (including specified NDCs 61314‑0327‑20/96/64/94 40 mg/0.4 mL) unless clinically significant adverse effects, non‑overlapping FDA age limits, or contraindications exist.
Enumerates exact biosimilars/brands requiring prior Humira use
Remicade/Infliximab step sequence: If request is for Remicade, member must trial Inflectra and Renflexis; if failed, then Avsola; if failed, then unbranded Remicade. For unbranded Remicade, trial Inflectra and Renflexis first; for Avsola, member must have used Inflectra and Renflexis.
Exceptions for significant adverse effects or contraindications allowed
Approval Durations and Dosing Limits
Approval Durations and Dosing Limits — Dosing and limits / approval durations
Skyrizi cartridge limit for CD/UC: If request is for Skyrizi cartridges for Crohn's disease or ulcerative colitis, quantity must not exceed 1 prefilled cartridge every 8 weeks.1 cartridge / 8 weeks
Approval duration by indication: CRS: up to 4 doses total; aGVHD: 3 months (4 doses total); all other indications: 6 months or to member's renewal date, whichever is longer.CRS: <=4 doses; aGVHD: 3 months/4 doses; others: 6 months
Label Changes and Off-label Routing
Label Changes and Off-label Routing — Other/Off‑label uses
New label changes or non‑listed uses: If a drug has had a recent label change within the last 6 months not yet reflected in this policy, refer to CP.CPA.190; if requested use is not listed and that does not apply, route to off‑label policy CP.CPA.09.
Preauthorization and medical necessity prerequisites
Preauthorization and medical necessity prerequisites — Coverage considerations and prerequisites referenced in appendices
Prior conventional therapy: Documented failure of a trial of conventional DMARDs (per Appendix D definition) or documented inability to use immunomodulators with medical justification (Appendix E) is required for many biologic therapies.
Includes methotrexate considerations re: pregnancy and alcohol use
Immunomodulator inability justifications: Examples include inability to induce short‑term remission with a 3‑month systemic glucocorticoid trial or presence of high‑risk features for intestinal complications in Crohn's disease (see Appendix E).
Investigational dosing exclusions: Off‑label weekly dosing of adalimumab for moderate‑to‑severe ulcerative colitis is considered investigational and not medically necessary based on available evidence.
Referenced rationale in Appendix D
Coverage linked to adherence to dosing/quantity guidance
Coverage linked to adherence to dosing/quantity guidance — Dosing/quantity guidance and maximum maintenance doses are specified per agent and indication
Dosing and quantity adherence: Prescribed dose and requested quantity must match agent‑ and weight‑specific dosing bands and vial/syringe quantity recommendations in the policy (e.g., Simponi Aria vial counts, Stelara syringe/vial selection, abatacept IV/SC weight‑based dosing).see dosing bands
Providers should include weight‑based dosing and vial/syringe calculations with prior authorization requests
Disease activity documentation for medical necessity
Disease activity documentation for medical necessity — Use of disease activity or classification scores to support medical necessity
Acceptable activity measures: CDAI, RAPID3, cJADAS‑10, or disease‑specific classification criteria (e.g., 2010 ACR RA criteria, PMR algorithm) may be used to document disease activity and justify biologic DMARD therapy.See appendices for cutoffs
Appendices provide exact cutoffs for remission/low/moderate/high activity and classification thresholds for PMR and RA.
Agent-specific dosing and maximum maintenance criteria
Agent‑specific dosing and maximum maintenance criteria — Covered when dosing follows the listed induction and maintenance regimens and does not exceed the stated maximum maintenance dose
Adalimumab (Humira) pediatric UC: Initial dose 80 mg SC then 40 mg SC every other week (weight bands apply); maintenance up to 80 mg every other week or 40 mg weekly per pediatric guidance; continue pediatric dosing if clinically appropriate.max maintenance: pediatrics 80 mg every other week or 40 mg weekly
See Section V dosing guidance
Anakinra (Kineret): Indications include RA, NOMID, DIRA; dosing examples include 100 mg SC daily and weight‑based initial 1–2 mg/kg SC daily with maintenance up to 8 mg/kg/day or 100 mg/day depending on indication.max maintenance: up to 8 mg/kg/day or 100 mg/day
See Appendix G for rounding
Infliximab family (Avsola/Inflectra/Remicade/Renflexis/Zymfentra):
Agent-specific dosing coverage criteria
Agent‑specific dosing coverage criteria — Covered when dosing aligns with specified induction and maintenance regimens and does not exceed listed maximum maintenance doses
General dosing adherence: Prescribed dosing must match the agent‑specific induction and maintenance regimens documented in the policy (examples include mirikizumab induction/maintenance limits, natalizumab 300 mg IV every 4 weeks, ustekinumab weight‑based IV induction and SC maintenance schedules).
Documentation of induction doses, maintenance schedule, and adherence to maximum maintenance dose required
Weight‑ and age‑based dosing: For pediatric or weight‑based regimens (e.g., ustekinumab, tocilizumab, secukinumab), dosing must follow specified weight and age brackets and Appendix G rounding guidance when applicable.
Weight values and age ranges are specified per agent
Dose escalation above standard maintenance may be permitted only with prescriber documentation of inadequate response as referenced across agents.
Requires clinical justification and documentation
Coverage and step therapy updates
Coverage and step therapy updates — Policy coverage and step therapy updates (summary of documented criteria changes)
Biosimilar/Infliximab step therapy: Revised remicade/infliximab redirection to require use of biosimilars first (Inflectra [Q5103] and Renflexis [Q5104]) prior to Avsola and Remicade; stepwise redirection language changed to 'must use' in revisions.documented failure of prior biosimilars as described
Material policy change; see sequencing rules
TNFi bypass criteria: For select indications, bypass of TNFi requirement allowed if member has documented failure of two TNF blockers.failure of two TNF blockers
Appears in revision notes allowing bypass
Preferred NDC requirement: For specific agents (e.g., Amjevita) PA may require use of preferred formulary NDCs; step therapy and NDC preferences updated in revisions.
Step therapy / Redirection requirements
Step therapy / Redirection requirements — Coverage and redirection logic updated for many indications
General redirection/step therapy: Requests are subject to redirection to specified preferred agents or biosimilars and require documented trials/failures before coverage of non‑preferred products (examples: adalimumab products, Enbrel/Otezla for PsO, Rinvoq LQ for PsA/pJIA, Remicade biosimilar sequences).
Exceptions allowed for contraindications or significant adverse effects
Adalimumab redirection examples: For multiple indications (AS, CD, PsO, pJIA, PsA, RA, UC) redirection modified to require trial of specified adalimumab products (Humira, Hadlima, adalimumab‑adaz); note removal of UC adalimumab redirection per 2024 AGA guidance in later update.
Infliximab class sequencing: For Remicade/unbranded infliximab, member must use Inflectra and Renflexis, then Avsola, before Remicade; failure to follow sequence may result in denial.
Indication and formulation inclusions
Indication and formulation inclusions — New indications, pediatric dosing, and formulation‑specific coverage details
Newly approved indications and formulations: Policy updated to include newly FDA‑approved indications and pediatric dosing expansions (examples: Tremfya for UC, Rinvoq pediatric expansions, Amjevita HS/UV indications, new prefilled syringe strengths and pens for multiple agents); refer to product‑specific sections for exact dosing and age eligibility.
CRS supportive care / prophylaxis
CRS supportive care / prophylaxis — Special‑use clarifications and supportive care indications
CRS and teclistamab prophylaxis/support: Use of select agents (e.g., Actemra, Avtozma, Tyenne) as supportive care in severe CRS related to blinatumomab and as prophylaxis to reduce CRS risk when administering teclistamab‑cqyv is included per NCCN compendium.
Policy clarifies CRS supportive care and prophylaxis roles
Policy updates and indication-specific coverage notes
Policy updates and indication‑specific coverage notes
GCA coverage change: For GCA, removed requirement for failure of a ≥3 consecutive month systemic corticosteroid trial and removed requirement for use in conjunction with methotrexate or azathioprine to align with competitor/HIM/Medicaid criteria.
CRS coverage update: Agents may be used as supportive care in severe CRS related to blinatumomab and may be used prophylactically to reduce CRS risk when administering teclistamab‑cqyv per NCCN compendium.
Kawasaki disease dosing: Intravenous IVIG dosing updated in Section V from 5 mg/kg over 2 hours to 10 mg/kg over 2 hours for Kawasaki disease (policy dosing change).
UC criteria update: Moderate‑to‑severe UC may be defined by Mayo Endoscopic Score >2; bypass of conventional therapies permitted if member has failed a biologic (do not step back to conventional therapy).
These criteria do not apply to California Exchange Plans. Requests for members covered under California Exchange Plans should be evaluated using the separate policy HIM.PA.SP60 Biologic and Non‑biologic DMARD criteria. Using this document to adjudicate California Exchange Plan requests may lead to denial.
Combination use of biologic disease‑modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi) is not authorized due to additive immunosuppression and increased infection risk. The policy prohibits concurrent prescribing of JAK inhibitors (for example, Rinvoq, Xeljanz, Olumiant) with other biologics and explicitly disallows combination use across multiple indications (see Section III). Requests proposing concomitant administration with potent immunosuppressants or other bDMARD classes will be denied unless an exception is documented in this policy or supported by the off‑label policy.
Summary: Combination biologic/JAK therapy is excluded. Section III lists examples of excluded combinations (TNF antagonists, interleukin agents, anti‑CD20 agents, selective co‑stimulation modulators, integrin antagonists, TYK2 inhibitors, S1P modulators, and JAK inhibitors). Providers should not request overlapping biologic or JAK therapies for the same member; such requests will not be authorized absent clear, policy‑defined exceptions.
See Section III for the full list of disallowed combinations and non‑covered indications. The policy specifically states that combination use of bDMARDs and JAK inhibitors is not authorized and lists representative agent classes and examples to illustrate excluded concurrent regimens. Providers must ensure proposed therapy does not contravene these exclusions prior to submission.
Outpatient initiation or outpatient continuation of certain agents for COVID‑19 is not authorized. Agents referenced (e.g., Kineret, Actemra, Avtozma, Tofidence, Tyenne, and Olumiant) are limited to inpatient use per this policy; outpatient use for COVID‑19 will not be approved. Review Appendix M and Section III for details on emergency‑use authorizations and hospital‑only indications.
Combination use of a requested biologic with other potent immunosuppressants or additional biologic/JAK inhibitor agents is not authorized. Section III enumerates classes and examples (TNF antagonists, interleukin agents, anti‑CD20 antibodies, Orencia, integrin receptor antagonists, TYK2 inhibitors, S1P modulators, and JAK inhibitors) and notes the rationale of additive immunosuppression, neutropenia risk, and serious infections. Providers must document monotherapy status or rely on documented, policy‑permitted exceptions.
Off‑label weekly dosing of adalimumab for treatment of moderate‑to‑severe ulcerative colitis is considered investigational and not medically necessary. The policy cites limited evidence for benefit of increased‑frequency (weekly) adalimumab dosing for UC and states that national and international guidelines do not support routine weekly escalation; such dosing will not be approved.
Billing Codes, NDCs and Dosing Codes
Listed DMARD productsmixed
list
Comprehensive list of DMARD products (e.g., adalimumab and biosimilars, tocilizumab, bimekizumab, certolizumab pegol, secukinumab, etanercept, vedolizumab, infliximab and biosimilars, sarilumab, anakinra, baricitinib, mirikizumab, abatacept, apremilast, ustekinumab and biosimilars, upadacitinib, brodalumab, golimumab, risankizumab, deucravacitinib, ixekizumab, natalizumab, tofacitinib, ozanimod, etc.) as enumerated in chunks 1-2.
Specific NDCs referenced for adalimumab-adazNDC
NDC 61314-0327-20
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-96
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-64
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-94
adalimumab-adaz 40 mg/0.4 mL
Referenced NDCs for adalimumab-adazNDC
NDC 61314-0327-20
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-96
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-64
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-94
adalimumab-adaz 40 mg/0.4 mL
Referenced NDCs for adalimumab biosimilarNDC
NDC 61314-0327-20
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-96
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-64
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-94
adalimumab-adaz 40 mg/0.4 mL
Specific NDCs referencedNDC
NDC 61314-0327-20
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-96
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-64
adalimumab-adaz 40 mg/0.4 mL
NDC 61314-0327-94
adalimumab-adaz 40 mg/0.4 mL
Explicit ICD-10 diagnosis referencedICD-10
L63
Alopecia areata (ICD-10)
Dose Rounding / Vial Quantity (no billing codes present)mixed
N/A
No explicit CPT/HCPCS/ICD codes listed in these chunks; tables provide weight-based vial/syringe quantities rather than billing codes.
Product dosing and vial/syringe quantity guidancemixed
NDC-like/vial guidance
Vial and syringe quantity recommendations by mg bands for specific products (e.g., Simponi Aria vial 50 mg/4 mL; Stelara and biosimilar syringe/vial sizes 45 mg/0.5 mL and 90 mg/1 mL); weight-based dose bands and quantity tables provided in Appendix and Section V.
Referenced HCPCS and biosimilar codes (partial list)HCPCS
Rinvoq — minimum ageAge ≥ 12 years for atopic dermatitis
Actemra IV — CRS age and per‑infusion limitAge ≥ 2 years; dose does not exceed 800 mg per infusion (up to 4 total doses)
Cosentyx — ERA pediatric dosing by weightAge ≥ 4 and <18 years with weight-based induction: 75 mg series for 15–<50 kg; 150 mg series for ≥50 kg
Age and weight thresholds — pediatric cutoffs
Prior Authorization, Documentation and Step-Therapy
Prior Authorization
Prior Authorization Required
Prior authorization is required for the comprehensive list of biologic and non-biologic DMARD products named in the policy. California Exchange Plans should not be approved using these criteria; for California Exchange Plans refer to HIM.PA.SP60.
Prior authorization required for all listed biologic and non-biologic DMARDs (see product list in Section I and Description).
Approval durations are typically 6 months or to member's renewal date, whichever is longer (some indications specify different durations).
Documentation Required
Prior Authorization, Step-Therapy and Documentation Requirements
Providers must submit supporting documentation with PA requests and demonstrate adherence to step-therapy sequences and dosing/quantity requirements. Requests that do not meet diagnosis-specific criteria, lack required prior trials, exceed dose limits, request prohibited combination therapy, or are for excluded indications may be denied.
Policy Background and Scope
This policy summarizes FDA‑approved indications and the related coverage requirements for a broad range of biologic and non‑biologic DMARDs across rheumatologic and inflammatory conditions (for example, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, juvenile idiopathic arthritis, systemic sclerosis‑associated ILD, and others). It provides product‑ and indication‑specific initial and continuation criteria, age and weight thresholds, step/sequence requirements (including biosimilar sequencing for infliximab products), dosing regimens and maximum maintenance doses, and documentation expectations for prior therapy and disease activity measures. Prior authorization is required for the comprehensive list of named agents; providers should reference the product‑specific sections for exact prescriber specialty, prior trial, and dosing requirements.
Abbreviations and Definitions
Abbreviations — key terms
ADatopic dermatitis
ASankylosing spondylitis
nr‑axSpAnon‑radiographic axial spondyloarthritis
CDCrohn's disease
UCulcerative colitis
GCAgiant cell arteritis
Abbreviations (duplicate)
AD
Policy Summary
PayerHealth Net
PolicyBiologic and Non-biologic DMARDs — Prior Authorization Criteria
Dose limit: Dose does not exceed maximum dose indicated in Section V
MTX or alternative: Either failure of ≥3 month MTX trial at up to maximally indicated doses OR MTX intolerance/contraindication plus failure of ≥3 month trial of ≥1 conventional DMARD
Appendix D for MTX contraindications
No combination therapy: No combination use of biological DMARDs or JAK inhibitors
Dose per weight: 75 mg series for 15–<50 kg; 150 mg series for ≥50 kg
Dose schedule detailed in policy
No combination therapy: No combination use of biological DMARDs or JAK inhibitors
Dose limit: Dose does not exceed maximum in Section V
Transplant type:
Member is undergoing HSCT from a matched or 1 allele‑mismatched unrelated donor
Concomitant therapy: Prescribed in combination with a calcineurin inhibitor and MTX
No combination therapy: No combination use of biological DMARDs or JAK inhibitors
Dose limit: Dose does not exceed maximum in Section V
ALL of the following
Approval duration: 3 months (4 doses total)
Hurley stage: Documentation of Hurley stage II or III
Appendix D
Prior therapies: Required prior therapies include trial(s) from different classes (systemic antibiotics, oral retinoids, hormonal) each ≥3 months; some agents require prior use of specific adalimumab products or Humira/Hadlima unless exceptions apply
No combination therapy: No combination use of biological DMARDs or JAK inhibitors
Dose limit: Dose does not exceed maximum in Section V; Cosentyx maximum escalation allowed per prescriber information with documentation of inadequate response
IVIG trial:
Failure of immune globulins (Gammagard preferred) unless contraindicated
Product sequencing: If request is for Remicade/Avsola/unbranded Remicade, member must have tried specific biosimilars in required order (Inflectra and Renflexis then Avsola then unbranded Remicade) unless contraindicated
No combination therapy: No combination use of biological DMARDs or JAK inhibitors
Dose limit: Dose does not exceed maximum in Section V
Dose limit:
Dose does not exceed maximum in Section V
Prior therapy: Failure of topical therapies and required systemic/conventional DMARDs (e.g., MTX, cyclosporine, acitretin) or phototherapy per agent requirements; some biologics require multiple prior biologic failures and/or specific sequencing
See product‑specific rows for exact sequences and required trials
Formulation: Some agents require specific formulation (SC vs IV) for coverage
No combination therapy: No combination use of biological DMARDs or JAK inhibitors except where policy allows (e.g., certain Otezla combinations with conditions)
Dose limit: Dose does not exceed maximum in Section V
Prior trials: Failure of ≥3 months of MTX at maximally indicated doses unless previously failed a biologic or intolerance/contraindication documented; additional product‑specific sequencing (adalimumab/Humira use, TNF/JAK logic) applies
Appendix D for MTX considerations
No combination therapy: No combination use of biological DMARDs or JAK inhibitors
Dose limit: Dose does not exceed maximum in Section V
Weight‑based IV induction 5 mg/kg at weeks 0,2,6 with maintenance intervals; for CD adults may increase to 10 mg/kg for loss of response; Zymfentra SC dosing and other formulations noted.
max maintenance: up to 10 mg/kg every 4–8 weeks or 120 mg SC every 2 weeks for Zymfentra
Provider must follow biosimilar sequencing requirements
use of preferred NDCs when applicable
Added per policy revisions
Approval duration update: Injectable agent approval durations updated from '6 months' to '6 months or to member's renewal date, whichever is longer'.
ERA pediatric age windowAge ≥ 4 years and < 18 years (Cosentyx)
Cosentyx weight cutoffs15 kg to <50 kg (75 mg series) and ≥50 kg (150 mg series) for induction/maintenance
Ustekinumab pediatric weight bandsAge 6–17 years: weight <60 kg = 0.75 mg/kg; 60–100 kg = 45 mg; >100 kg = 90 mg
Baseline forced vital capacity (FVC)
Baseline FVC requirement for SSc-ILDBaseline forced vital capacity (FVC) ≥ 40% of predicted
PMR classification scorePMR classification: score ≥4 without ultrasound or ≥5 with ultrasound
Weight thresholds for ustekinumab and vedolizumab IV induction
Ustekinumab IV induction weight bandsIV induction: ≤55 kg, >55–85 kg, >85 kg (260 mg, 390 mg, 520 mg respectively) — maintenance 90 mg SC every 8 weeks
Vedolizumab IV/SC weight noteVedolizumab IV induction 300 mg at weeks 0 and 2 then maintenance 300 mg IV q8w or 108 mg SC q2w; weight categories inform dosing in some agents
BSA thresholds for psoriasis severity
Moderate‑to‑severe psoriasis BSA criterionModerate‑to‑severe PsO: ≥ 3% body surface area or involvement of hands/feet/scalp/face/genital area
Chronic‑severe psoriasis BSA criterionChronic‑severe PsO (certain agents): ≥ 10% BSA or involvement of specified areas
Modified Mayo Score threshold
Modified Mayo Score accepted cutoffModified Mayo Score ≥ 5 may be used to document UC severity
Kawasaki disease IVIG dosing — updated dose
Kawasaki disease IVIG dosing (updated)IV infliximab dosing guidance updated in Section V: changed IVIG dosing from 5 mg/kg over 2 hours to 10 mg/kg over 2 hours
Provider must submit office chart notes, lab results, baseline assessments (e.g., CDAI, RAPID3, Mayo/modified Mayo score, HRCT for SSc‑ILD) and other clinical information supporting therapy necessity.
Documentation of prior therapy trials and durations (e.g., ≥3 months for conventional DMARDs, specified NSAID or steroid trial lengths) is required unless contraindicated or medically justified (see Appendix D and Appendix E).
Step therapy: many indications require failure of specific agents/classes (e.g., methotrexate, other conventional DMARDs, specific TNF blockers or biosimilars) prior to approval; Remicade-related therapies require stepwise biosimilar redirection (Inflectra and Renflexis → Avsola → unbranded Remicade).
Denial triggers include: insufficient documentation, lack of required prior trials, prescriber specialty nonconformance, age nonconformance, dose exceeding maximum maintenance dose in Section V, combination biologic or JAK inhibitor use, and requests for excluded indications (e.g., alopecia areata for JAKi outside applicable plans).
Outpatient initiation or continuation of listed agents for COVID-19 is not authorized (these agents are authorized for hospitalized use only per Appendix M).
For Zymfentra requests, provider attestation is required that member cannot receive IV infliximab (IV infliximab access barrier justification).
For certain agents (e.g., Skyrizi, Omvoh, Actemra/IV formulations), formulation-specific quantity limits apply (vial/cartridge vs prefilled syringe/cartridge) — providers must specify formulation when requesting quantities.
Prior Authorization
Weight‑Based Dosing, Vial Quantity and Dose Limits
Weight-based dosing, vial/syringe quantity recommendations, dose limits and dose-escalation justification must be provided with the prior authorization request.
Provide member weight and calculation of intended mg dose and corresponding vial/syringe quantity using Appendix F and the weight-based vial quantity recommendation tables (e.g., Actemra/Avtozma/Tofidence/ Tyenne, Infliximab, Kineret, Orencia, Simponi Aria, Stelara/ustekinumab products).
Follow Appendix G dose rounding guidance for weight‑based doses.
Requests for dose escalation above standard maintenance doses require documentation of inadequate response to prior regimen and justification per prescriber information; maximum maintenance doses listed in Section V must not be exceeded.
Quantity/format limits: examples — Skyrizi vials/cartridges: one single dose vial or prefilled cartridge per dose; for Skyrizi in CD/UC cartridges: one prefilled cartridge per dose; for Orencia/infliximab weight bands see Appendix F tables.
Step Therapy
Biosimilar Redirection and Preferred Agent Requirements
Policy enforces biosimilar redirection and preferred-product requirements for certain products; providers must follow the stepwise redirection and preferred NDC usage where specified.
Remicade/unbranded Remicade/Avsola redirection: Inflectra and Renflexis must be used first; if failed, use Avsola; if failed, use unbranded Remicade (stepwise).
For some adalimumab/biosimilar approvals the member must use all preferred adalimumab products (e.g., Humira, Hadlima, adalimumab-adaz NDCs) prior to approval of other adalimumab biosimilars per redirection rules (see policy updates).
Requests may be redirected to preferred agents or NDCs; continued therapy requests may require use of specified alternatives before approval.
Billing Rule
Coding and Billing Note
Coding inclusion in this policy is informational only and does not guarantee coverage. Providers should verify coding guidance prior to claim submission.
Codes referenced are for informational purposes only; inclusion or exclusion of codes does not guarantee coverage.
Providers should reference the most up-to-date professional coding guidance and applicable HCPCS/J‑codes when submitting claims (policy has added/updated HCPCS codes in revisions).
Documentation Required
Supporting Dosing, Escalation and Continuation Documentation
Support required for dose escalation, continuity and continued therapy requests: document clinical response, baseline and follow-up disease activity measures, and prior inadequate response to justify escalation or continuation.
For continuation requests, document member is responding positively to therapy using disease specific measures (e.g., decrease in CDAI or RAPID3 for RA, reduction in CRP/ESR for PMR, decreased lesion counts for HS, clinical improvement for AD).
If unable to perform CDAI reassessment, submit RAPID3 with medical justification (alternate disease activity documentation accepted with justification).
Dose escalation requires documentation of inadequate response to current dosing; maximum allowable escalations per product are delineated in Section V and must be supported by prescriber documentation.
Prescribing information references are provided in the policy and should be consulted for product‑specific dosing, administration and monitoring details (see Prescribing Information list).
atopic dermatitis
ASankylosing spondylitis
nr‑axSpAnon‑radiographic axial spondyloarthritis
CDCrohn's disease
UCulcerative colitis
PMRpolymyalgia rheumatica
DIRA definition
DIRA — definitionDeficiency of Interleukin‑1 Receptor Antagonist confirmed by loss‑of‑function ILRN mutations; Kineret required for coverage
ERA definition and pediatric dosing notes
ERA — definitionEnthesitis‑related arthritis; Cosentyx coverage requires age ≥4 to <18 years and prior NSAID and MTX (or alternative DMARD) trials
Psoriasis severity definitions
Moderate‑to‑severe PsO — definitionModerate‑to‑severe plaque psoriasis: ≥3% BSA or involvement of hands/feet/scalp/face/genital areas
Chronic‑severe PsO — definitionChronic‑severe PsO (for some agents): ≥10% BSA or involvement of specified areas
PMR diagnosis per ACR/EULAR
PMR diagnostic standardPMR diagnosis per ACR/EULAR criteria with typical symptoms plus elevated ESR or CRP
RA baseline assessments — CDAI/RAPID3 requirement
RA baseline assessmentsBaseline disease activity must be documented with CDAI or RAPID3 (CDAI required when available)
SSc‑ILD definition and required imaging/labs
SSc‑ILD — definition and required testingSystemic sclerosis‑associated interstitial lung disease: HRCT evidence of pulmonary fibrosis plus additional signs of systemic sclerosis; baseline FVC and DLCO required
Mayo Score definition summary
Mayo scoring systems — summaryMayo (0–12), Modified Mayo (0–9), Mayo Endoscopic Score (0–3); thresholds used to define moderate/severe disease
CDAI / RAPID3 — disease activity measures
CDAIClinical Disease Activity Index for RA (0–76), used to document baseline and response
RAPID3Routine Assessment of Patient Index Data 3 (0–30), acceptable alternative with justification
CRS / aGVHD definitions and constraints
CRS — supportive care/prophylaxis notesCRS criteria permit use as supportive care for severe CRS related to blinatumomab and prophylaxis for teclistamab administration per NCCN
CRS dosing constraintsTocilizumab (Actemra) IV max 800 mg per infusion, up to 4 doses; intervals ≥8 hours between doses
Failure of a trial of conventional DMARDs — Appendix D
Failure of conventional DMARDs — referenceDefinition and considerations for failure of MTX or other DMARDs described in Appendix D (required for many biologic approvals)
Mayo Score / Modified Mayo / Mayo Endoscopic Score — scoring systems
Mayo / Modified Mayo / Mayo Endoscopic Score — usagesAppendix F describes each score and thresholds (Mayo ≥6; modified Mayo ≥5 accepted; Mayo Endoscopic ≥2 indicates moderate‑to‑severe inflammation)
2010 ACR Classification Criteria for RA — reference
2010 ACR RA criteria2010 ACR Classification Criteria for RA referenced as diagnostic standard
CDAI definition
CDAI definitionCDAI = sum of 28‑joint tender and swollen counts plus patient and physician global assessments (range 0–76)
RAPID3 definition
RAPID3 definitionRAPID3 = pooled patient‑reported index (function, pain, global) scored 0–30
cJADAS-10 definition
cJADAS‑10 definitioncJADAS‑10 = physician global + parent global + active joint count (max 30); inactive ≤1
Appendix G — Dose Rounding Guidelines
Appendix G — dose rounding guidanceAppendix G provides dose rounding guidelines for weight‑based doses and should be used when submitting weight‑based vial/syringe calculations
Induction vs Maintenance — definitions
Induction vs Maintenance — definitionInduction = initial higher‑frequency dosing (e.g., weeks 0,4,8); Maintenance = ongoing dosing after induction with specified max maintenance dose
Weight-based dosing — definition and rounding guidance
Weight‑based dosing — guidanceWeight‑based dosing uses mg/kg bands with pediatric brackets and Appendix G rounding; documentation of weight and dose calculations required
Weight-based dosing examples for specific agents
Weight‑based dosing examplesExamples: Ustekinumab IV induction: ≤55 kg = 260 mg; >55–85 kg = 390 mg; >85 kg = 520 mg. Ustekinumab SC maintenance weight cutoffs: <60 kg, ≥60 kg, >100 kg
RA classification reference2010 Aletaha et al. RA classification referenced for diagnostic confirmation
Juvenile idiopathic arthritis guidance reference
JIA guidance reference2011 ACR recommendations for juvenile idiopathic arthritis initiation and monitoring referenced
Kawasaki disease references
Kawasaki disease referencesMcCrindle et al. Circulation 2017 and related ACR/VF guidance cited for Kawasaki disease management
Polymyalgia rheumatica references
PMR referencesEULAR/ACR recommendations and provisional classification criteria by Dejaco et al. cited for PMR
modified Mayo Score — policy note
Modified Mayo Score — policy acceptancePolicy accepts modified Mayo Score ≥ 5 as an option for UC initial criteria documentation
CRS supportive care/prophylaxis — clarification
CRS supportive care clarificationPolicy clarifies use of select agents as supportive care in severe CRS related to blinatumomab and prophylaxis when administering teclistamab per NCCN
CRS definition and policy clarification
CRS definition in policyCRS may be treated with tocilizumab IV (Actemra) up to 4 doses; policy permits supportive care and prophylaxis roles per NCCN/label
Moderate-to-severe UC — update
Moderate‑to‑severe UC per updatePolicy update allows Mayo Endoscopic Score > 2 to define moderate‑to‑severe UC