ModifiedCentenePolicy HIM.PA.SP60

Biologic and Non-biologic DMARDs Prior Authorization

Defines prior authorization requirements and medical necessity criteria for a broad list of biologic and non-biologic DMARDs for Centene-affiliated health plans; affects providers requesting coverage for listed agents.

Policy Summary

PayerCentene

PolicyBiologic and Non-biologic DMARDs Prior Authorization

Policy CodePolicy HIM.PA.SP60

Change TypeCriteria, redirection, and coding updates

Effective Date01.01.20

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating diagnosis, prescriber specialty, prior therapy trials, and dose within policy limits.

SourceLink

POLICY UPDATE CHANGES

Redirection and stepwise requirements for infliximab/Remicade and adalimumab families were modified; many biosimilars and HCPCS/Q-codes were added.

Multiple newly FDA-approved indications and pediatric extensions were added for numerous agents (examples: Rinvoq, Orencia IV for aGVHD, Cosentyx ERA, Skyrizi PsA, Xeljanz AS).

Initial approval durations for chronic indications were extended from 6 months to 12 months for many agents and jurisdictions.

~90+DMARD products listed requiring prior authorization

12 monthstypical approval duration for most indications

YesStep therapy required (many indications)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

~60+biologic/JAK products listed as covered when criteria met

1/1/2026Illinois HIM step-therapy exception effective date

Coverage Criteria and Clinical Requirements

Medical necessity general statement

It is the policy of health plans affiliated with Centene Corporation that the listed biologic and targeted agents are medically necessary when the following criteria are met:

Policy-level requirement: Prior authorization is required and provider must submit supporting clinical documentation (office notes, labs, imaging, or other relevant records) demonstrating that the member meets the applicable indication-specific approval criteria in Section I–VII.

See Sections I and II for detailed initial and continued therapy criteria.

Prohibitions and dosing limits: Member must not be receiving combination use of biological DMARDs or JAK inhibitors; requested dose must not exceed the maximum maintenance dose indicated in Section V unless escalation is supported by prescriber documentation of inadequate response per policy guidance.

Combination use exclusions and dose-escalation documentation requirements referenced in policy.

Atopic Dermatitis — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Atopic Dermatitis Criteria: 1. Diagnosis of atopic dermatitis with either: (a) ≥ 10% body surface area affected OR (b) involvement of hands, feet, face, neck, scalp, genitals/groin, or intertriginous areas; 2. Request is for Rinvoq; 3. Prescribed by or in consultation with a dermatologist or allergist; 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 (topical calcineurin inhibitor or Eucrisa) used ≥ 4 weeks, unless contraindicated or intolerant; 6. Rinvoq is not prescribed concurrently with another biologic or JAK inhibitor; 7. Dose does not exceed the maximum in Section V.

Illinois HIM step therapy exception applies per IL HB 5395 where noted.

Axial Spondyloarthritis (AS or nr-axSpA) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Axial Spondyloarthritis Criteria: 1. Diagnosis of ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA); 2. Request is for a listed agent in the policy (examples include TNF blockers, IL-17 inhibitors, or JAK inhibitors as specified); 3. Prescribed by or in consultation with a rheumatologist; 4. Age ≥ 18 years; 5. Failure of at least TWO NSAIDs at maximally indicated doses, each used ≥ 4 weeks unless contraindicated or previously failed a biologic; 6. For nr-axSpA when request is for Bimzelx, Cimzia, or Taltz: failure of Cosentyx for ≥ 3 months; 7. Product-specific step sequences apply (including sequential TNF/IL-17/JAK pathways and required prior trials of specified agents and biosimilars); 8. No combination use of biologic DMARDs or JAK inhibitors; 9. Dose does not exceed maximum in Section V.

Approval duration typically 12 months; complex product-specific sequencing detailed in policy.

Behçet's Disease — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Behçet's Disease Criteria: 1. Diagnosis of Behçet's disease with oral ulcers; 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 maximally indicated doses unless contraindicated or intolerant; 6. Dose does not exceed maximum in Section V.

Illinois HIM step therapy exception referenced where applicable.

Castleman's Disease (off-label) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Castleman's Disease Criteria (off‑label): 1. Diagnosis of Castleman's disease that is relapsed, refractory, or progressive; 2. Request is for IV Actemra, Avtozma, Tofidence, or Tyenne; 3. Member has unicentric HIV-/HHV-8- disease OR multicentric disease; 4. Prescribed as second‑line single‑agent therapy; 5. No combination use of biologic DMARDs or JAK inhibitors; 6. Request meets one of: (a) dose ≤ 8 mg/kg per infusion every 2 weeks; OR (b) dose supported by practice guidelines or peer‑reviewed literature with submitted evidence (prescriber must provide supporting documentation).

Off‑label regimens must be FDA‑approved regimen or recommended by NCCN; prescriber must submit supporting evidence.

Crohn's Disease — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Crohn's Disease Criteria: 1. Diagnosis of Crohn's disease; 2. Request is for an enumerated biologic or targeted agent listed in policy; 3. Prescribed by or in consultation with a gastroenterologist; 4. Age eligibility per agent (some agents ≥ 6 years, others ≥ 18 years) as specified in the policy; 5. Where applicable for adalimumab-family initiations, required trials of specified adalimumab products/biosimilars apply unless contraindicated; 6. For Humira initiations: failure of one listed alternative agent used ≥ 3 months as specified; 7. Member has failed a ≥ 3‑month trial of at least one immunomodulator (e.g., azathioprine, 6‑MP, methotrexate) at maximally indicated doses OR prescriber documents medical justification for inability to use immunomodulators (see Appendix E); 8. For certain agents (Cimzia, Entyvio/Omvoh, Tyruko, Tysabri) failure of multiple listed agents each for ≥ 3 months as specified by agent‑specific pathways; 9. Infliximab family sequencing and biosimilar redirection requirements apply (Inflectra → Renflexis → Avsola → unbranded Remicade where specified) and Zymfentra has attestation/induction requirements; 10. No combination use of biologic DMARDs or JAK inhibitors; 11. Dose does not exceed maximum in Section V.≥ 3 months for many prior therapy trials

Approval duration generally 12 months; Illinois HIM exceptions may apply per IL HB 5395.

Cytokine Release Syndrome (CRS) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Cytokine Release Syndrome (CRS) Criteria: 1. Request is for Actemra, Avtozma, or Tyenne in the IV formulation; 2. Age ≥ 2 years; 3. Member has one of: scheduled CAR T‑cell therapy, severe CRS related to blinatumomab, or use as prophylaxis to reduce CRS risk when administering teclistamab; 4. Dose does not exceed 800 mg per infusion for up to 4 total doses OR dose is supported by practice guidelines/peer‑reviewed literature with submitted evidence; 5. No combination use of biologic DMARDs or JAK inhibitors when contraindicated by policy.800 mg per infusion up to 4 doses

Approval duration: 3 months (12 months for HIM Texas).

Deficiency of Interleukin-1 Receptor Antagonist (DIRA) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

DIRA Criteria: 1. Diagnosis of Deficiency of Interleukin‑1 Receptor Antagonist (DIRA) confirmed by presence of 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: 12 months.

Enthesitis-related Arthritis (ERA) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Enthesitis‑related Arthritis (ERA) Criteria: 1. Diagnosis of enthesitis‑related arthritis; 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. Member meets one of: (a) failure of a ≥ 3‑month trial of methotrexate at maximally indicated doses, OR (b) intolerance/contraindication to methotrexate and failure of a ≥ 3‑month trial of at least one conventional DMARD (e.g., sulfasalazine, leflunomide); 7. No combination use of biologic DMARDs or JAK inhibitors; 8. Dose does not exceed specified weight‑based dosing in Section V.>= 4 weeks for NSAIDs; >= 3 months for MTX/DMARDs

Illinois HIM exceptions apply per IL HB 5395 where noted.

G. Deficiency of Interleukin-1 Receptor Antagonist (DIRA) — criteria group (duplicate/alternate)

Covered when ALL of the following are met

DIRA coverage criteria (duplicate): 1. Diagnosis of DIRA confirmed by presence of loss‑of‑function ILRN mutations; 2. Request is for Kineret; 3. Prescribed by or in consultation with a rheumatologist; 4. Member does not have combination use of biologic DMARDs or JAK inhibitors; 5. Dose does not exceed maximum indicated in Section V.

H. Enthesitis-related Arthritis (ERA) — criteria group (alternate chunk refs)

Covered when ALL of the following are met

ERA coverage criteria (alternate refs): 1. Diagnosis of 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. Failure of a ≥ 3‑month trial of MTX at maximally indicated doses OR intolerance/contraindication to MTX plus failure of ≥ 3 months of another conventional DMARD; 7. No combination biologic/JAK use; 8. Dose per Section V weight‑based limits.

I. Giant Cell Arteritis (GCA) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Giant Cell Arteritis (GCA) Criteria: 1. Diagnosis of giant cell arteritis; 2. Request is for Actemra, Avtozma, Rinvoq, Tofidence, or Tyenne; 3. Prescribed by or in consultation with a rheumatologist; 4. Age ≥ 18 years; 5. Failure of a systemic corticosteroid at up to maximally tolerated doses unless contraindicated or previously failed a biologic for GCA; 6. No combination use of biologic DMARDs or JAK inhibitors; 7. Dose does not exceed maximum in Section V.

Illinois HIM step therapy exception referenced where applicable.

J. Acute Graft-versus-Host Disease (aGVHD) prophylaxis — Initial Therapy

Covered when ALL of the following are met

aGVHD prophylaxis (IV Orencia) Criteria: 1. Prescribed for prophylaxis of acute graft‑versus‑host disease; 2. Request is for intravenous Orencia; 3. Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist; 4. Age ≥ 2 years; 5. Member is undergoing HSCT from a matched or 1 allele‑mismatched unrelated donor; 6. Prescribed in combination with a calcineurin inhibitor and methotrexate; 7. No combination use of other biologic DMARDs or JAK inhibitors; 8. Request does not exceed 4 total doses; 9. Dose does not exceed maximum in Section V.

K. Hidradenitis Suppurativa (HS) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Hidradenitis Suppurativa (HS) Criteria: 1. Diagnosis of hidradenitis suppurativa; 2. Request is for a listed biologic indicated in policy (examples include specified adalimumab products, Abrilada, Bimzelx, Cosentyx, etc.); 3. Prescribed by or in consultation with a dermatologist, rheumatologist, or gastroenterologist; 4. Age eligibility depends on agent (some agents ≥ 12 or ≥ 18 years as specified); 5. Documentation of Hurley stage II or III; 6. For specified adalimumab biosimilars, required prior use of listed adalimumab products applies unless contraindicated; 7. For Humira initiators: failure of one specified alternative or Cosentyx for ≥ 3 months unless contraindicated; 8. Failure of at least TWO therapies from systemic antibiotics, oral retinoids, or hormonal treatments each tried ≥ 3 months; 9. No combination use of biologic DMARDs or JAK inhibitors; 10. Dose within Section V maximums (Cosentyx escalation allowed per prescriber info with documentation where applicable).≥ 3 months for many prior therapies

Approval duration: 12 months; Illinois HIM exceptions may apply per IL HB 5395.

L. Kawasaki Disease (off-label) — infliximab products — Initial Therapy

Covered when ALL of the following are met

Kawasaki Disease (off‑label) — infliximab products: 1. Diagnosis of Kawasaki disease; 2. Request is for an infliximab‑containing product; 3. Prescribed by or in consultation with cardiology, allergy/immunology, infectious disease, or rheumatology; 4. Age ≥ 6 years; 5. Failure of immune globulin therapy (Gammagard preferred) unless contraindicated; 6. For Remicade/Avsola/unbranded Remicade the infliximab biosimilar sequencing requirements apply (Inflectra and Renflexis first; if failed then Avsola; if failed then unbranded Remicade); 7. No combination use of biologic DMARDs or JAK inhibitors; 8. Dose does not exceed Section V maximums.

Approval duration: single‑time 4 weeks (12 months for HIM Texas where applicable).

M. Neonatal-Onset Multisystem Inflammatory Disease (NOMID/CINCA) — Initial Therapy

Covered when ALL of the following are met

NOMID/CINCA Criteria: 1. Diagnosis of neonatal‑onset multisystem inflammatory disease (NOMID/CINCA); 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.

N. Plaque Psoriasis (PsO) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Plaque Psoriasis (PsO) Criteria: 1. Diagnosis of plaque psoriasis meeting agent‑specific severity definitions (e.g., ≥ 3% BSA or involvement of hands/feet/scalp/face/genitals for many agents; ≥ 10% BSA for certain infliximab formulations or special areas as specified); 2. Prescribed by or in consultation with a dermatologist or rheumatologist; 3. Age and weight eligibility per agent as specified; 4. For certain adalimumab biosimilars/products, required prior use of listed adalimumab products may apply unless contraindicated; 5. For Humira initiators: failure of one listed alternative or Cosentyx for ≥ 3 months unless contraindicated; 6. Member meets prior‑therapy failure requirements or specific lines of therapy depending on prior biologic exposure and severity; 7. Agent‑specific multi‑step failures and redirections apply (including ustekinumab/Skyrizi/Tremfya/Bimzelx/Siliq/Sotyktu/Taltz pathways); 8. SC formulation requirements and infliximab biosimilar sequencing apply where specified; 9. No combination use of biologic DMARDs or JAK inhibitors; 10. Dose does not exceed Section V maximums.>= 3% or >=10% BSA per agent rules; many prior trials >=3 months

Agent‑ and formulation‑specific requirements detailed in policy; Illinois HIM exceptions noted where applicable.

Polyarticular Juvenile Idiopathic Arthritis (PJIA) - Initial Therapy — ALL required conditions

Covered when ALL of the following are met

PJIA initial requirements: 1. Diagnosis of polyarticular juvenile idiopathic arthritis with ≥ 5 active joints; 2. Request is for an enumerated biologic listed in the policy; 3. Prescribed by or in consultation with a rheumatologist; 4. Age ≥ 2 years; 5. For certain adalimumab biosimilars, required prior trials of listed adalimumab products apply unless contraindicated.

See agent‑specific step therapy nodes for MTX and other requirements.

PJIA Step Therapy & Specific Agent Requirements — agent-specific step requirements and exceptions

Agent-specific step requirements (must meet as specified unless contraindicated or intolerant)

MTX trial or alternative: Failure of a ≥ 3 consecutive month trial of methotrexate at up to maximally indicated doses; OR if methotrexate intolerant/contraindicated, failure of leflunomide or sulfasalazine for ≥ 3 months.>= 3 months

Applies to PJIA unless previously failed a biologic.

Humira initiation for PJIA: For members initiating Humira: failure of ONE specified alternative agent used for ≥ 3 consecutive months (lists provided in policy).>= 3 months

Agent lists appear in chunks 58–59.

Polymyalgia Rheumatica (PMR) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Polymyalgia Rheumatica (PMR) Requirements: 1. Diagnosis of PMR per ACR/EULAR criteria with symptomatic presentation; 2. Request is for Kevzara; 3. Prescribed by or in consultation with a rheumatologist; 4. Age ≥ 50 years; 5. One of: (a) failure of a systemic corticosteroid at maximally tolerated doses for ≥ 2 weeks; (b) documentation of PMR flare while tapering corticosteroids at ≥ 7.5 mg/day prednisone equivalent; (c) for Illinois HIM requests only: inadequate response to corticosteroids or inability to tolerate taper; 6. No combination use of biologic DMARDs or JAK inhibitors.ESR >=30 mm/hr or CRP >=10 mg/L required per diagnostic criteria

Baseline ESR or CRP documentation required as specified in Appendix N.

Psoriatic Arthritis (PsA) / jPsA — Initial Therapy — ALL required conditions and age-specific criteria

Covered when ALL of the following are met (agent- and age-specific criteria apply)

Psoriatic Arthritis (PsA) / jPsA Basic Requirements: 1. Diagnosis of psoriatic arthritis (PsA) or juvenile PsA (jPsA); 2. Request is for an enumerated biologic or targeted agent listed in policy; 3. Prescribed by or in consultation with a dermatologist or rheumatologist; 4. Age and weight criteria per agent as specified in the policy.

Agent lists and pediatric/weight rules appear in chunks 63–65.

Agent‑specific step therapy: Many agents require failure of TNF blockers, specified adalimumab products, Enbrel, or multiple other biologics each used for ≥ 3 consecutive months, or other multi‑step sequences before approval; exact sequences depend on agent and age group.>= 3 months

See policy for detailed sequences and exceptions; Illinois HIM exceptions may apply.

Infliximab biosimilar sequence: Requests for infliximab (Remicade) require prior trials of Inflectra and Renflexis; if failed both, must trial Avsola; if failed Inflectra, Renflexis, and Avsola, must trial unbranded Remicade. Similar sequences apply for Avsola and unbranded Remicade as specified.

Rheumatoid Arthritis (RA) — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Rheumatoid Arthritis (RA) Basic Requirements: 1. Diagnosis of rheumatoid arthritis per ACR criteria; 2. Request is for an enumerated biologic or targeted agent listed in the policy; 3. Prescribed by or in consultation with a rheumatologist; 4. Age ≥ 18 years; 5. Document baseline disease activity (CDAI or RAPID3) as specified; 6. No combination use of biologic DMARDs or JAK inhibitors; 7. Dose does not exceed Section V maximums.

Step therapy and MTX/conventional DMARD failure requirements follow.

Conventional DMARD step: Failure of a ≥ 3 consecutive month trial of methotrexate at maximally indicated doses; OR if methotrexate intolerant, failure of at least one conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine) for ≥ 3 months.>= 3 months

Illinois HIM exceptions apply per IL HB 5395 where noted.

Humira initiation: For members initiating Humira, failure of one specified biologic or listed agent used for ≥ 3 months is required unless contraindicated.

Initial therapy — Rheumatoid Arthritis — detailed initial criteria group

Covered when ALL of the following are met

RA general requirements: 1. Diagnosis of RA per ACR criteria; 2. Request is for an enumerated biologic/JAK agent listed in policy; 3. Prescribed by or in consultation with a rheumatologist; 4. Age ≥ 18 years; 5. Documentation of baseline CDAI or RAPID3; 6. No combination use of biologic DMARDs or JAK inhibitors; 7. Dose does not exceed maximum in Section V.

See chunks 72 and 76 for product lists and documentation requirements.

Adalimumab biosimilar/product sequencing: If request is for specified adalimumab biosimilars/products, member must trial the listed adalimumab products (adalimumab-aaty, adalimumab-adaz, adalimumab-adbm, Humira, Simlandi, Yuflyma) unless adverse effects or contraindications apply.

Illinois HIM exceptions per IL HB 5395 may apply.

Conventional therapy requirement: Member must meet ONE: (a) failure of ≥ 3 consecutive month trial of methotrexate at maximally indicated doses; OR (b) intolerance/contraindication to methotrexate plus failure of ≥ 3 months of at least one conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine).

Initial therapy — Systemic JIA — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Systemic JIA (sJIA) general requirements: 1. Diagnosis of systemic juvenile idiopathic arthritis (sJIA); 2. Request is for Actemra, Avtozma, Tofidence, or Tyenne; 3. Prescribed by or in consultation with appropriate specialist (rheumatologist); 4. Age ≥ 2 years; 5. No combination use of biologic DMARDs or JAK inhibitors; 6. Dose does not exceed Section V limits.

See additional prior therapy options below.

Prior therapy for sJIA: Member meets ONE: failure of an NSAID at maximally indicated doses; OR failure of a ≥ 3‑month trial of methotrexate or leflunomide; OR failure of a ≥ 2‑week trial of systemic corticosteroid—unless contraindicated or previously failed a biologic.>=3 months or >=2 weeks depending on trial

Illinois HIM exceptions may apply per IL HB 5395.

Initial therapy — SSc-ILD — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

SSc‑ILD (Actemra SC) Requirements: 1. Diagnosis of systemic sclerosis‑associated interstitial lung disease (SSc‑ILD) confirmed by HRCT and systemic sclerosis signs; 2. Request is for subcutaneous Actemra; 3. Prescribed by or in consultation with a pulmonologist or rheumatologist; 4. Failure of a ≥ 3‑month trial of cyclophosphamide or mycophenolate mofetil 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 weekly.FVC >=40% predicted; DLCO >=30% predicted

Approval duration: 12 months.

Initial therapy — Ulcerative Colitis — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Ulcerative Colitis (UC) General Requirements: 1. Diagnosis of ulcerative colitis; 2. Request is for an enumerated agent listed in policy; 3. Prescribed by or in consultation with a gastroenterologist; 4. Age and formulation requirements per agent (examples: Humira age ≥ 5 years; Avsola/Inflectra/Remicade/Remicade biosimilars age ≥ 6 years; other agents per policy); 5. Documentation of disease activity: Mayo Score ≥ 6 OR modified Mayo Score ≥ 5 OR Mayo Endoscopic Score ≥ 2 (Appendix F); 6. Failure of an 8‑week trial of systemic corticosteroids unless contraindicated or previously failed a biologic; 7. Agent‑specific sequencing and step therapy apply (including adalimumab and ustekinumab redirections, infliximab biosimilar sequences, Skyrizi cartridge limits and Zymfentra attestation/induction requirements); 8. No combination use of biologic DMARDs or JAK inhibitors; 9. Dose does not exceed Section V maximums.Mayo >=6 or modified Mayo >=5 or Endoscopic >=2; many prior trials >=3 months

For some agents, redirection to preferred agents and updated step therapy rules apply; Illinois HIM exceptions may apply.

Initial therapy — Uveitis — Initial Therapy — ALL required conditions

Covered when ALL of the following are met

Uveitis General Requirements: 1. Diagnosis of non‑infectious intermediate, posterior, or panuveitis; 2. Request is for an enumerated adalimumab product/biosimilar listed in the policy; 3. Prescribed by or in consultation with an ophthalmologist or rheumatologist; 4. Age and product‑specific eligibility per policy; 5. For certain adalimumab biosimilars, required prior use of listed adalimumab products applies unless contraindicated; 6. For Humira initiators: use of one listed adalimumab product for ≥ 3 months prior to Humira initiation; 7. Failure of a ≥ 2‑week trial of systemic corticosteroids unless contraindicated; 8. Failure of a trial of non‑biologic immunosuppressive therapy (e.g., azathioprine, methotrexate, mycophenolate) at maximally indicated doses unless contraindicated; 9. No combination use of biologic DMARDs or JAK inhibitors; 10. Dose does not exceed Section V maximums.>=2 weeks for steroid trial; >=3 months for biologic trials

Approval duration: 12 months; Illinois HIM exceptions may apply.

Coronavirus-19 Infection authorization stance — single-node decision

COVID‑19 authorization stance: Initiation of outpatient treatment with the listed agents for Coronavirus‑19 infection will not be authorized; specified agents (Kineret, Actemra, Avtozma, Tofidence, Tyenne, Olumiant) are authorized for use only in the hospitalized setting per policy guidance and Appendix M.

Approval duration: not applicable for this stance.

Not covered — Alopecia Areata — exclusion node

Alopecia Areata exclusion: Use of Olumiant for the treatment of alopecia areata is a benefit exclusion and will not be authorized because it is considered cosmetic in nature.

Approval duration: not applicable.

Continuation Therapy — criteria for continuation approvals

Covered when ALL of the following are met for continuation of therapy:

Continuity or prior approval: Member is currently receiving the medication via Centene benefit or previously met initial approval criteria, or is in continuity of care per state regulations.

See chunk 98 for continuity options.

Evidence of clinical response: Documentation demonstrates the member is responding to therapy: e.g., for RA decreased CDAI or RAPID3; for HS ≥ 25% reduction in inflammatory nodules/abscesses; for AD reduction in itching/scratching; for PMR decreased signs/symptoms with reduction in CRP or ESR; or other indication‑specific evidence of response.varies by indication

Prescriber must submit supporting documentation (office notes, labs, imaging) per policy.

Agent/formulation specific continuation rules: If member is currently receiving IV Actemra, IV Avtozma, or IV Tyenne for CAR‑T cell induced CRS and has not received 4 total doses, continuation may be allowed per dosing limits; continuation requests must adhere to formulation and dosing limits in Section V.

Infliximab Products Step Therapy — sequential step requirements and exceptions

Covered when ALL of the following sequential steps are met unless contraindicated or clinically significant adverse effects:

Remicade step sequence: If the request is for Remicade: member must trial Inflectra and Renflexis; if failed both, member must trial Avsola; if failed Inflectra, Renflexis, and Avsola, member must trial unbranded Remicade.sequential failures required

Illinois HIM exception: step therapy requirements do not apply for Illinois HIM requests effective 1/1/2026 per IL HB 5395.

Unbranded Remicade sequence: If the request is for unbranded Remicade: member must trial Inflectra and Renflexis; if failed both, member must trial Avsola.sequential failures required

See policy for applicable biosimilar NDCs and state exceptions.

Avsola requirement: If the request is for Avsola: member must have used both Inflectra and Renflexis prior to Avsola initiation unless contraindicated.

Adalimumab Products Step Therapy — biosimilar-specific step requirements

Covered when ALL of the following are met for requests for specific adalimumab biosimilars:

Required prior adalimumab agents: Requests for certain adalimumab biosimilars (examples listed in policy) require prior use/trials of multiple listed adalimumab biosimilars and reference products (specific NDCs provided) unless clinically significant adverse effects or contraindications exist.trial of listed agents as specified

Illinois HIM exception: step therapy requirements do not apply for Illinois HIM requests effective 1/1/2026 unless biosimilar is interchangeable per FDA Purple Book.

Illinois HIM exception: Step therapy requirements for adalimumab family products do not apply for Illinois HIM requests as of 1/1/2026 per IL HB 5395, unless biosimilar is designated interchangeable.effective 2026-01-01

See chunk 100 for NDC lists and details.

Formulation and Quantity Limits — 3 top-level nodes

Skyrizi cartridge limit: For Crohn's disease or ulcerative colitis, Skyrizi cartridges limited to ≤ 1 prefilled cartridge every 8 weeks when cartridges/vials are requested.<= 1 cartridge / 8 weeks

See Section V for dosing and cartridge frequency details.

Otezla pediatric weight criteria: For PsA and PsO in ages 6 to <18 years: Otezla requires weight ≥ 20 kg; Otezla XR requires weight ≥ 50 kg.weight-based

Applies to pediatric dosing per policy.

SC formulation requirement: Requests for specified ustekinumab biosimilars (Imuldosa, Otulfi, Pyzchiva, Selarsdi, Steqeyma, Wezlana, Yesintek, unbranded Stelara) must be for subcutaneous formulation where indicated.SC formulation

Coverage criteria (supporting documentation and dosing) — documentation/dosing requirements referenced

Clinical justification and dosing documentation requirements for biologic DMARD coverage

Immunomodulator inability justification: For Crohn's disease, when medical justification for inability to use immunomodulators is claimed, provide supporting documentation such as inability to induce remission with a 3‑month systemic glucocorticoid trial or presence of high‑risk intestinal complication features (e.g., fistulizing disease, deep ulcerations, penetrating/stricturing phenotype, prior surgery).

See Appendix E for examples of acceptable justifications.

Dosing and vial calculations: Provide weight‑based dosing regimens, vial/syringe quantity calculations, and indication‑specific dosing details (e.g., abatacept IV/SC weight tiers, infliximab vial counts, Actemra vial recommendations) to support prior authorization requests.

Appendices G and V include dose rounding and vial quantity guidance.

Dosing regimens (per agent and indication) — dosing and maximum maintenance doses

Dosing regimens and maximum maintenance doses per agent and indication.

Agent-specific dosing entries: The policy lists induction and maintenance dosing regimens and maximum maintenance doses for agents across indications (examples include abatacept IV/SC weight‑based dosing and maxima; adalimumab adult and pediatric induction/maintenance regimens and maxima; anakinra weight‑based dosing for NOMID/DIRA; infliximab IV induction/maintenance with allowed escalation up to 10 mg/kg for loss of response; ustekinumab weight‑based IV induction and 90 mg SC maintenance, etc.).

Maximum maintenance doses and allowed dose escalation per prescriber information are specified for many agents; see Section V for full details.

Dose escalation criteria — conditions permitting escalation

Dose escalation covered when ALL of the following are met:

Escalation prerequisites: Documentation supports inadequate clinical response to a ≥ 3 consecutive month trial of the lower‑dose regimen (where the policy requires such a trial) and prescriber provides justification for escalation per product labeling.>= 3 months

Applies to agents with explicit escalation language (e.g., secukinumab, infliximab, others per Section V).

Example covered dosing regimens — representative dosing entries

Standard dosing covered when matching listed induction and maintenance regimens:

Mirikizumab for CD: Induction: 900 mg IV at Weeks 0, 4, and 8; Maintenance: 300 mg SC at Week 12 and every 4 weeks. Maximum maintenance dose: 300 mg every 4 weeks.

Matches Section V dosing entries.

Vedolizumab for CD/UC: Initial: 300 mg IV at weeks 0 and 2 followed by 300 mg IV or 108 mg SC at week 6; Maintenance: 300 mg IV every 8 weeks or 108 mg SC every 2 weeks. Maximum maintenance doses specified by route.

See Section V for formulation‑specific guidance.

Selected dosing/maintenance criteria — dosing and escalation excerpt

Dosing and escalation conditions (excerpt):

Selected ustekinumab dosing: For PsA with coexistent PsO: dose escalation to 90 mg SC at weeks 0 and 4 then every 12 weeks may be allowed for weight > 100 kg with documentation of inadequate response; for CD/UC IV weight‑based induction dosing is specified with maintenance 90 mg SC every 8 weeks.weight > 100 kg for escalation

Maximum maintenance dose examples and weight‑based induction described in Section V.

Vedolizumab dosing excerpt: Initial: 300 mg IV at weeks 0 and 2 followed by IV or SC at week 6; Maintenance: 300 mg IV every 8 weeks or 108 mg SC every 2 weeks. Maximum maintenance doses listed for both routes.

See Section V for full details.

Selected coverage criteria updates — summary of selected changes in extract

Selected coverage rules and criteria changes reflected in this extract include:

Infliximab/biosimilar redirection update: Operationally, Remicade/infliximab redirection was clarified to require stepwise trial of Inflectra and Renflexis first; if failed, then Avsola; subsequent failure may require unbranded Remicade per policy sequencing.

Changes reflected in multiple SDC updates; see policy change history.

Adalimumab family redirection: Redirection and preferred‑agent sequencing for adalimumab family products was modified across multiple indications to require trial of specified preferred adalimumab products (e.g., Humira, Hadlima, or designated adalimumab‑adaz) and in some cases use of all listed preferred adalimumab biosimilars prior to alternative agents.

NDC‑specific preferred lists were added/updated in policy revisions.

TNF inhibitor bypass and pediatric expansions: Policy updates allow TNF inhibitor bypass in some scenarios after documented failure of two TNF blockers; multiple pediatric age extensions and new FDA‑approved indications were also added across agents.

Notable updated coverage/criteria elements — policy updates summary

Policy updates include added/modified criteria for initiation and continuation of biologic DMARDs, expanded indications, and pediatric dosing adjustments.

Redirection/step therapy updates: Redirection to preferred agents (adalimumab and ustekinumab products, Rinvoq LQ, etc.) was added or modified for multiple indications; some redirections were removed or altered based on guideline updates (e.g., adalimumab redirection removed for UC per AGA guidance).

Initial approval durations for chronic indications were extended to 12 months in many updates.

Approval duration changes: Initial approval durations for many chronic indications were extended from 6 months to 12 months across multiple updates and jurisdictions (notably HIM Texas and broader chronic indications).12 months

See change log for effective dates.

Zymfentra attestation requirement: For Zymfentra (infliximab biosimilar) requests in Crohn's disease and ulcerative colitis, provider attestation is required that the member is unable to continue IV infliximab due to lack of caregiver/support, inadequate access to facility/home care, or lack of transportation; absence of this attestation may prevent approval.

Codes, NDCs, and HCPCS/Q-Code Listings

Referenced NDCs for adalimumab productsNDC

NDC 72606-030-09	adalimumab product (listed NDC for certain adalimumab biosimilars)
NDC 72606-030-10	adalimumab product (listed NDC for certain adalimumab biosimilars)
NDC 72606-023-04	adalimumab product (listed NDC)
NDC 72606-023-07	adalimumab product (listed NDC)
NDC 72606-024-01	adalimumab product (listed NDC)
NDC 72606-030-06	adalimumab product (listed NDC)

Referenced NDCs for adalimumab productsNDC

NDC 72606-030-09	listed adalimumab product NDC
NDC 72606-030-10	listed adalimumab product NDC
NDC 72606-023-04	listed adalimumab product NDC
NDC 72606-023-07	listed adalimumab product NDC
NDC 72606-024-01	listed adalimumab product NDC
NDC 72606-030-06	listed adalimumab product NDC

NDCs referenced for adalimumab productsNDC

NDC 72606-030-09	Yuflyma or listed adalimumab product (as cited)
NDC 72606-030-10	Yuflyma or listed adalimumab product (as cited)
NDC 72606-023-04	Listed adalimumab product (as cited)
NDC 72606-023-07	Listed adalimumab product (as cited)
NDC 72606-024-01	Listed adalimumab product (as cited)
NDC 72606-030-06	Listed adalimumab product (as cited)

Not covered ICD-10 — Alopecia AreataICD-10Not Covered

L63	Alopecia areata (ICD-10)

Referenced NDCs for adalimumab productsNDC

NDC 72606-030-09	Humira NDC listed
NDC 72606-030-10	Humira NDC listed
NDC 72606-023-04	Humira NDC listed
NDC 72606-023-07	Humira NDC listed
NDC 72606-024-01	Humira NDC listed
NDC 72606-030-06	Humira NDC listed

Referenced biologic agents and biosimilars — NDC/agent groupmixed

drug list

Actemra, Avtozma, Tofidence, Tyenne, Enbrel (etanercept), Infliximab, Kineret, Orencia (abatacept), Simponi Aria, Stelara/ustekinumab, adalimumab and biosimilars

HCPCS Codes (selection start)HCPCS

J0129	Injection, abatacept, 10 mg.
J0139	Injection, adalimumab, 1 mg

HCPCS and Q-codes (continued)HCPCS

J0717	Injection, certolizumab pegol, 1 mg.
J1438	Injection, etanercept, 25 mg.
J1602	Injection, golimumab, 1 mg, for intravenous use.
J1628	Injection, guselkumab, 1 mg.
J1745	Injection, infliximab, excludes biosimilar, 10 mg.
J2267	Injection, mirikizumab-mrkz, 1 mg.
J2323	Injection, natalizumab, 1 mg.
J2327	Injection, risankizumab-rzaa, intravenous, 1 mg.
J3245	Injection, tildrakizumab, 1 mg.
J3247	Injection, secukinumab, intravenous, 1 mg.

1–10 of 22

1/3

Sample HCPCS codes (document header)HCPCS

J0129	Injection, abatacept, 10 mg
J0139	Injection, adalimumab, 1 mg

Covered HCPCS (listed)HCPCSCovered

J0717	Injection, certolizumab pegol, 1 mg
J1438	Injection, etanercept, 25 mg
J1602	Injection, golimumab, 1 mg, for intravenous use
J1628	Injection, guselkumab, 1 mg
J1745	Injection, infliximab, excludes biosimilar, 10 mg
J2267	Injection, mirikizumab-mrkz, 1 mg
J2323	Injection, natalizumab, 1 mg
J2327	Injection, risankizumab-rzaa, intravenous, 1 mg
J3245	Injection, tildrakizumab, 1 mg
J3247	Injection, secukinumab, intravenous, 1 mg

1–10 of 14

1/2

Biosimilar HCPCS codes (listed)HCPCSCovered

Q5103	Injection, infliximab-dyyb (inflectra), 10 mg
Q5104	Injection, infliximab-abda (renflexis), 10 mg
Q5140	Injection, adalimumab-fkjp, biosimilar, 1 mg
Q5141	Injection, adalimumab-aaty, biosimilar, 1 mg
Q5142	Injection, adalimumab-ryvk, biosimilar, 1 mg
Q5143	Injection, adalimumab-adbm, biosimilar, 1 mg
Q5144	Injection, adalimumab-aacf (idacio), biosimilar, 1 mg
Q5145	Injection, adalimumab-afzb (abrilada), biosimilar, 1 mg
Q5133	Injection, tocilizumab-bavi (tofidence), biosimilar, 1 mg
Q5135	Injection, tocilizumab-aazg (tyenne), biosimilar, 1 mg

1–10 of 17

1/2

Additional HCPCS/Q-codes addedHCPCSCovered

Q9996	Injection, ustekinumab-ttwe (pyzchiva), subcutaneous, 1 mg
Q9997	Injection, ustekinumab-ttwe (pyzchiva), intravenous, 1 mg
Q9998	Injection, ustekinumab-aekn (selarsdi), 1 mg
Q9999	Injection, ustekinumab-aauz (otulfi), biosimilar, 1 mg
Q5131	HCPCS code added (Amjevita/related additions referenced)
C9399	Added HCPCS code referenced in policy updates

Added HCPCS/Q codes (sample from update)HCPCS

J3247
Q5137
Q5138
J2267

Added HCPCS/Q codes (later update)HCPCS

J0139
Q5140
Q5141
Q5142
Q5143
Q5144
Q5145
Q9996
Q9997
Q9998

Additional HCPCS/Q codes addedHCPCS

Q9999
Q5098
Q5099
Q5100
Q5156

Atopic dermatitis BSA threshold

Atopic dermatitis BSA threshold>= 10% of body surface area or involvement of hands/feet/face/neck/scalp/genitals/groin/intertriginous areas

Age requirementAge ≥ 12 years for Rinvoq requests

Topical therapy failure durationOne medium–very high potency topical corticosteroid used ≥ 2 weeks

Non‑steroidal topical failure duration

Prior Authorization, Documentation and Step Therapy Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for the biologic and targeted therapies listed in this policy. Providers must submit clinical documentation (office notes, labs, prior therapy records, weight/age, dosing calculations, quantity or vial/syringe needs, and prescriber specialty or consultation notes) that demonstrates the member meets the indication-specific criteria. Requests without supporting documentation demonstrating that criteria are met will be denied.

Prior authorization required for listed agents (see Section I and drug list).
Providers must supply documentation of diagnosis, prescriber specialty, age/weight, prior therapy trials and durations, and dosing calculations including vial/syringe quantity for weight-based IV or pediatric dosing.
Failure to submit required documentation may result in denial.

Step Therapy

Step Therapy — Adalimumab Products

Many indications require step therapy through preferred adalimumab products before approval for other adalimumab family agents. For members initiating therapy with Humira or other adalimumab products, the criteria specify use of preferred adalimumab products (Humira, Hadlima, unbranded adalimumab-adaz, and other listed biosimilars) as step therapy unless contraindicated or prior intolerance. Illinois HIM state exceptions may bypass these step requirements per IL HB 5395 as noted in criteria.

Policy Background and Scope

This policy establishes prior authorization and medical necessity requirements for a broad portfolio of biologic and non‑biologic DMARDs used to treat immune‑mediated inflammatory diseases. It applies to Centene‑affiliated health plans and lists covered agents, indication‑specific initial and continuation criteria, dosing/maximum maintenance doses, formulation and quantity limits, and referenced HCPCS/J and Q‑codes for informational purposes. Providers must submit supporting clinical documentation (for example, office notes, lab results, and disease activity scores) to show members meet the applicable approval criteria.

Coverage determinations are made per indication‑specific sections (I–VII) that define required prescriber specialty, age/weight thresholds, prior therapy or step‑therapy trials and minimum durations, contraindications to combination biologic/JAK use, and documentation of clinical response for continuation. Typical approval durations are 12 months for most chronic indications and 3 months for selected acute indications (e.g., CRS/aGVHD), with some jurisdictional or program exceptions noted in the policy.

The policy includes operational rules for biosimilar redirection and stepwise sequencing (for example, infliximab and adalimumab families), dose‑escalation provisions that require prescriber documentation of inadequate response, and explicit exclusions (for example, combination biologic/JAK therapy and Olumiant for alopecia areata). Coding entries and listed HCPCS/J and Q‑codes are informational and do not by themselves guarantee coverage.

Providers should reference the detailed per‑diagnosis criteria, appendices (disease activity scoring, dosing rounding, therapeutic alternatives), and the dosing tables in Section V when preparing prior authorization requests to ensure submitted documentation aligns with the policy requirements.

Definitions, Abbreviations and Scoring Systems

Abbreviations — common acronyms defined

ADatopic dermatitis

BSAbody surface area

CRPc-reactive protein

DLCOcarbon monoxide diffusing capacity

ESRerythrocyte sedimentation rate

Atopic dermatitis severity definition (BSA)

Atopic dermatitis severity definitionInvolvement of at least 10% BSA or disease affecting hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas

Policy Summary

PayerCentene

PolicyBiologic and Non-biologic DMARDs Prior Authorization

Policy CodePolicy HIM.PA.SP60

Change TypeCriteria, redirection, and coding updates

Effective Date01.01.20

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation demonstrating diagnosis, prescriber specialty, prior therapy trials, and dose within policy limits.

SourceLink

On This Page

State exceptions apply per IL HB 5395 effective 1/1/2026 where noted.

See chunk 73 for partial agent lists and sequencing.

Unless previously failed a biologic agent for RA.

Product‑specific step therapy: Product‑specific additional requirements apply (e.g., for Humira: failure of one listed adalimumab product or other specified agents for ≥ 3 months; for Kevzara: meeting two of listed conditions; for Remicade and biosimilars: sequential Inflectra → Renflexis → Avsola → unbranded Remicade where applicable).varies (often >=3 months)

Refer to chunks 74–77 for details.

4 doses total for CRS IV agents

See chunk 99 for examples of required evidence for continuation.

both agents required prior use

State exceptions per IL HB 5395 apply where noted.

Illinois HIM exception: Step therapy sequencing requirements do not apply for Illinois HIM requests as of 1/1/2026 per IL HB 5395 unless otherwise specified.effective 2026-01-01

Applies to infliximab and related biosimilar sequences as indicated.

See policy for agent‑ and formulation‑specific exceptions.

failure of 2 TNF blockers for bypass where specified

Refer to agent‑specific sections for details.

Dose escalation allowance: Several agents (Cosentyx, Rinvoq, infliximab family, others) now include allowance for maximum dose escalation per prescriber information when prescriber documents inadequate response.documented inadequate response required

Documentation requirements apply as per Section V and policy guidance.

Policy update specifies attestation and induction/response prerequisites for Zymfentra initiation.

One non‑steroidal topical therapy used ≥ 4 weeks (e.g., topical calcineurin inhibitor or Eucrisa)

Prior therapy duration — common thresholds

Common short prior‑therapy threshold>= 4 weeks (e.g., topical corticosteroids, NSAIDs per indication)

Common systemic/DMARD trial duration>= 3 consecutive months for conventional DMARDs or specified biologic comparators

MTX trial expectation≥ 3 consecutive months at maximally indicated doses (unless intolerant/contraindicated)

NSAID trial for axSpA/ERAEach NSAID used ≥ 4 weeks unless contraindicated

Body Surface Area (BSA) thresholds for psoriasis criteria

Psoriasis BSA (general biologics)≥ 3% total body surface area or involvement of hands/feet/scalp/face/genital area indicates moderate‑to‑severe disease

Infliximab family (chronic‑severe) BSA≥ 10% total body surface area or involvement of special areas for Avsola/Inflectra/Remicade/ Renflexis requests

Pediatric Otezla PsO BSAFor ages 6 to <18, moderate‑to‑severe PsO defined as ≥ 3% BSA or involvement of hands/feet/scalp/face/genitals plus weight criteria

Weight thresholds for pediatric dosing and products

Otezla pediatric weight minimumOtezla: ≥ 20 kg (ages 6 to <18)

Otezla XR pediatric weight minimumOtezla XR: ≥ 50 kg (ages 6 to <18)

Tremfya pediatric weight thresholdTremfya: if age <18 years, weight ≥ 40 kg

Weight‑based dosing referencesWeight tiers and vial rounding guidance in Appendix G and Section V dosing (weight‑based pediatric regimens)

PJIA joint count threshold

PJIA active joint count requirement>= 5 joints with active arthritis

Prescriber requirementPrescribed by or in consultation with a rheumatologist

Age minimumAge ≥ 2 years for PJIA coverage

PMR ESR threshold

PMR ESR thresholdBaseline ESR ≥ 30 mm/hr

Diagnostic criteria referenceDiagnosis per ACR/EULAR criteria required (see Appendix N)

Prescriber requirementPrescribed by or in consultation with a rheumatologist

PMR CRP threshold

PMR CRP thresholdBaseline CRP ≥ 10 mg/L

Diagnostic criteria referenceDiagnosis per ACR/EULAR criteria required (see Appendix N)

Age requirement for KevzaraAge ≥ 50 years

Baseline FVC threshold for SSc-ILD

Baseline FVC threshold (SSc‑ILD)>= 40% of predicted

Diagnostic requirementHRCT showing pulmonary fibrosis plus additional signs of systemic sclerosis (see Appendix L)

Prior therapy trialFailure of ≥ 3 consecutive month trial of cyclophosphamide or mycophenolate mofetil unless contraindicated

Baseline DLCO threshold for SSc-ILD

Baseline DLCO threshold (SSc‑ILD)>= 30% of predicted

Diagnostic requirementHRCT evidence of pulmonary fibrosis required (see Appendix L)

No combination biologic/JAK useCombination use of biologic DMARDs or JAK inhibitors is not permitted

Mayo or modified Mayo Score thresholds for UC

Mayo Score threshold (UC)Mayo Score ≥ 6 indicates moderate‑to‑severe UC

Modified Mayo Score threshold (UC)Modified Mayo Score ≥ 5 (added option for documentation of moderate‑to‑severe UC)

Mayo Endoscopic Score thresholdMayo Endoscopic Score ≥ 2 indicates moderate‑to‑severe endoscopic inflammation

Skyrizi cartridge frequency limit

Skyrizi cartridge frequency limit≤ 1 prefilled cartridge every 8 weeks for Crohn's disease or UC

Applies to formulationsQuantity limit specified for prefilled cartridge formulation only

DocumentationRequests must adhere to dosing in Section V and PA documentation requirements

Otezla pediatric weight minimums

Otezla pediatric minimum weightOtezla: ≥ 20 kg (ages 6 to <18)

Otezla XR pediatric minimum weightOtezla XR: ≥ 50 kg (ages 6 to <18)

Otezla adult maintenanceStandard adult maintenance 30 mg PO twice daily (see Section V)

Score thresholds (Mayo bands and others)

Mayo Score bandsMayo Score: 0–2 remission; 3–5 mild; 6–10 moderate; >10 severe

Modified Mayo maximumModified Mayo Score maximum = 9 (FDA‑accepted trial instrument)

cJADAS10 thresholds (PJIA)cJADAS10: ≤1 inactive; 1.1–2.5 low; 2.51–8.5 moderate; >8.5 high

Castleman's disease duration (key value)

Castleman's disease minimum duration6 months (updated language: duration referenced as 6 months for renewal)

Indication contextUsed as second‑line single‑agent therapy for relapsed/refractory or progressive disease per policy criteria

Agent examplesIV Actemra, Avtozma, Tofidence, or Tyenne are listed options for Castleman's disease

Modified Mayo Score threshold (key value)

Modified Mayo Score policy threshold>= 5 as an added option to document moderate‑to‑severe UC

Reference for scoring detailsSee Appendix F for supplemental information on Modified Mayo Score and Mayo scoring bands

Alternative UC thresholdsMayo Score ≥ 6 or Mayo Endoscopic Score ≥ 2 are acceptable per policy

Adalimumab step requirements: members must trial preferred adalimumab products (e.g., Humira, Hadlima, adalimumab-adaz and other specified biosimilars) as specified in indication criteria and Appendix D/Section V references.
Weekly off-label adalimumab dosing for UC is investigational and not medically necessary.
Illinois HIM: step therapy bypasses may apply per IL HB 5395 where indicated.

Step Therapy

Step Therapy — Infliximab Products

For infliximab-containing products (Remicade and biosimilars), a stepwise redirection sequence is required: Inflectra and Renflexis must be tried first; if failed, member must trial Avsola; if failed, then unbranded Remicade is required. Zymfentra requests require provider attestation per Appendix D and infliximab IV induction therapy prior to initiation in most circumstances. State-specific exceptions (e.g., Illinois HIM) to step sequencing are noted in the policy.

Infliximab sequence: Inflectra → Renflexis → Avsola → unbranded Remicade (as applicable per indication).
Zymfentra: provider attestation required that member completed IV infliximab induction and is responding, or for Illinois HIM requests has prior IV infliximab.
Illinois HIM: step therapy sequences may not apply per IL HB 5395 in specified situations.

Note

Therapeutic Alternatives and Dosing for Prior Authorization

Therapeutic alternatives and dosing guidance (Appendix B and Section V) should be used when submitting prior authorization requests. Appendix B lists conventional and biologic alternatives and common dosing regimens; Section V provides detailed dosing, maximum maintenance doses, and notes on maximum allowed escalation with documentation of inadequate response.

Refer to Appendix B for recommended therapeutic alternatives and dosing regimens.
Refer to Section V for dosing, maximum maintenance doses, and allowable dose escalation requirements (documentation of inadequate response required).

Documentation Required

Provide Weight-Based Dosing and Vial/Syringe Quantity

When weight-based dosing applies, providers must provide the member's weight and a clear vial/syringe quantity calculation. Appendix G (Dose Rounding) and the weight-based vial/syringe tables (e.g., Actemra, Infliximab, Orencia) illustrate recommended vial/syringe counts per weight range — include these calculations in the request.

Provide weight-based dose calculation and the exact number and type of vials or prefilled syringes required per dose (see weight-based tables in Section V and Appendix G).
Skyrizi cartridge and vial quantity limits: one single-dose vial or pre-filled cartridge allowed per dose (CD/UC specific limits).

Prior Authorization

Prior Authorization for Dose Escalation

Dose escalation or maintenance doses higher than listed maximum maintenance doses require documentation of inadequate response to lower doses and prescriber justification. Requests to escalate beyond the policy maximums must include objective evidence of inadequate response (disease activity scores, lab changes, clinical course) and rationale for dose rounding if applicable.

Prior authorization required for dose escalation above standard maintenance; include documentation of inadequate response to lower dose.
Provide clinical measures of inadequate response (e.g., CDAI, RAPID3, Mayo/modified Mayo, reduction in ESR/CRP, symptom worsening) and prescriber justification for dose increase.
Dose rounding guidance in Appendix G should be followed and documented when applicable.

Billing Rule

Dose/Regimen Matching for Authorization

Authorization will only be issued for dosing regimens that match the listed, indication-specific regimens and do not exceed the maximum maintenance doses in Section V. Operational limits (e.g., Skyrizi single-cartridge per dose) and allowable escalation per prescriber information with documented inadequate response are enforced.

Dosing must match regimens and maximum maintenance doses shown in Section V.
Operational quantity limits (e.g., Skyrizi cartridges) apply and will be enforced at authorization.
Maximum dose escalation allowance requires documented inadequate response per prescriber information.

Note

Dosing/Regimen Reference (Informational)

The dosing/regimen tables in Section V are informational for prescribers and reviewers; inclusion of a dosing regimen in Section V is not an authorization by itself — a prior authorization request must still meet indication-specific criteria.

Section V dosing/regimen reference provides approved regimens and maximum maintenance doses for each agent.
Inclusion in Section V does not imply automatic coverage — clinical criteria and PA must be met.

Billing Rule

Codes Referenced (Informational)

Coding references (HCPCS/J-codes, Q-codes) are provided for informational purposes only. Inclusion of codes in the policy does not guarantee coverage; providers should reference current professional coding guidance prior to claim submission.

Examples: J0139 (adalimumab, 1 mg), J1745 (infliximab, 10 mg), Q5103/Q5104 (infliximab biosimilars), Q5140–Q5145 (adalimumab biosimilars) — see Coding Implications section for full list.
Codes are informational and subject to change; verify coding prior to billing.

Note

Prior Authorization Updated for New Codes and Biosimilars

The prior authorization criteria and redirections have been updated periodically to incorporate new biosimilars, HCPCS/Q-codes, and product formulations (cartridges, autoinjectors). Providers should review the policy change history and most recent criteria when submitting requests.

Recent operational updates include addition of new biosimilars (e.g., Pyzchiva, Avtozma, Wezlana), new HCPCS/Q-codes (see Coding Implications and revision history), and new dosage forms (prefilled cartridges, autoinjectors).
Policy change history (revision timeline) documents redirections and code additions — consult policy effective/revision dates.

Documentation Required

Documentation Submission Required

Documentation submission is required. Requests must include clinical records supporting diagnosis and prior therapy trials/durations, baseline disease activity measures where required (e.g., CDAI, RAPID3, Mayo/modified Mayo, ESR/CRP), evidence of response for continuation requests, and prior authorizations or proof of current receipt when continuity applies.

Required baseline documentation examples: ACR/EULAR criteria for PMR, baseline ESR/CRP for PMR, Mayo/modified Mayo or Mayo Endoscopic Score for UC, CDAI or RAPID3 for RA.
Evidence of response for continuation: documented improvement in disease activity scores, lab improvements, or clinical notes describing response.
Continuity: documentation of current receipt through Centene benefit or prior approval evidence supports continued therapy per Section E continued therapy criteria.

Denial Risk

Dose Limit Denial Risk

Requests that exceed the policy dose limits or maximum maintenance doses risk denial. Providers must ensure requested doses do not exceed the maximums in Section V unless escalation is justified with documentation of inadequate response.

Dose exceedance is a denial risk — verify maximum maintenance dose in Section V before submitting.
If requesting doses above the maximum, include objective documentation of inadequate response and prescriber justification.

Denial Risk

Combination Therapy and Dosing Limits

Combination use of biological DMARDs or JAK inhibitors is not authorized due to additive immunosuppression and increased risk of serious infections. Requests that propose concurrent use of multiple biologic agents or biologic plus JAK inhibitor will be denied.

Combination therapy of bDMARDs with other bDMARDs or JAK inhibitors is excluded (see Section III B and III).
Examples: concurrent use of Rinvoq with another biologic, or Olumiant with a biologic, is not permitted.

Denial Risk

Alopecia Areata Exclusion

Olumiant (baricitinib) and Xeljanz/XR are not authorized for alopecia areata; Olumiant use for alopecia areata is excluded as cosmetic. Requests for JAK inhibitors for alopecia areata will be denied.

Alopecia areata: Olumiant, Xeljanz/XR, and other JAK inhibitors are excluded (ICD-10: L63) and not covered for this indication.
Olumiant for alopecia areata is considered cosmetic and will not be authorized.

Denial Risk

Non-Approved Indications and Prohibited Combinations

Non–FDA-approved indications not addressed in this policy are not authorized unless sufficient off-label evidence is provided per the off-label use policy (HIM.PA.154) or state-specific coverage applies. Certain products (e.g., Siliq) are not authorized for specific off-label diseases such as Crohn's disease per Section I criteria.

Non-FDA indications require sufficient documentation per HIM.PA.154 or evidence of coverage.
Siliq is not authorized for Crohn's disease (see Section I exclusions).

Documentation Required

Documentation Triggers for Crohn's Disease Immunomodulator Justification

For Crohn's disease requests, prescribers must provide immunomodulator justification (failure of ≥3 months trial of azathioprine, 6-MP, or MTX or medical justification for inability to use) and other documentation triggers listed in Appendix E. Provider attestation or documentation is required when immunomodulator use is not possible.

CD immunomodulator justification: document failed trial of immunomodulator or provide medical justification per Appendix E (examples include severe phenotype, fistulizing disease, inability to tolerate).
Appendix E lists acceptable medical justifications to support inability to use immunomodulators.

Prior Authorization

Escalation Requires Documentation

Dose escalation approvals require documentation of inadequate response to the lower-dose regimen. Prescribers must document the lower-dose trial, objective measures of continued disease activity, and rationale for escalation; dose rounding practices should be documented as described in Appendix G.

Escalation requires documentation of inadequate response to lower dose or frequency before higher maintenance dosing is approved.
Include objective clinical measures (disease activity scores, labs, symptom progression) and note if dose rounding per Appendix G was applied.

Documentation Required

Required Baseline Documentation

Required baseline documentation varies by indication and is necessary for initial authorization: examples include ACR/EULAR PMR criteria and baseline ESR/CRP; CDAI or RAPID3 for RA; Mayo/modified Mayo or Mayo Endoscopic Score for UC; pulmonary function or disease activity scores where specified. Include these in initial requests.

PMR: ACR/EULAR criteria and baseline ESR ≥30 mm/hr or CRP ≥10 mg/L required.
RA: baseline CDAI or RAPID3 scores as noted in criteria.
UC: Mayo Score ≥6, modified Mayo ≥5, or Mayo Endoscopic Score ≥2 as applicable.

Documentation Required

Evidence of Response for Continuation

For continuation of therapy, providers must supply evidence of clinical response as described in Section II Continued Therapy (examples: reduction in CDAI or RAPID3, reduction in ESR/CRP, decrease in inflammatory lesions for HS, symptom improvement for AD). Continuation approvals depend on documentation of ongoing benefit.

Continuation evidence examples: CDAI/RAPID3 decrease for RA, ≥25% reduction in inflammatory nodules/abscesses for HS, symptom reduction for AD, or lab/imaging improvements as applicable.
Continuity can be supported by prior Centene benefit receipt or prior approvals per Section E continued therapy criteria.

Documentation Required

Continuity / Previous Approval Documentation

Continuity/previous approval documentation: members currently receiving therapy through Centene or with prior documented approvals may qualify for continuation under continuity of care rules; include prior authorization numbers or therapy records to support continuity requests.

Continuity is supported by current Centene benefit receipt or prior approval documentation.
State/product-specific continuity of care regulations may apply (refer to addendums CC.PHARM.03A/03B).

Documentation Required

Failure of DMARD/MTX and Immunomodulator Justification

Failure of conventional DMARDs (e.g., MTX) and immunomodulators must be documented per indication-specific requirements (typically ≥ 3 months at maximally indicated doses) or provide medical justification for inability to use. Appendix D defines failure and examples of acceptable supporting evidence.

Document failed trials of MTX or other conventional DMARDs (usually ≥ 3 consecutive months) or provide contraindication/intolerance evidence.
Appendix D contains definitions of failure and examples of acceptable supporting documentation.

Documentation Required

Dose Escalation and Rounding Documentation

Dose escalation and rounding documentation: if requesting nonstandard vial counts or rounding, include prescriber justification and reference Appendix G dose rounding guidance. Operational vial-count tables in Section V should be used to justify requested supplies.

Document any dose rounding and provide rationale per Appendix G.
Ensure vial/syringe quantity requests match weight-based vial quantity recommendations in Section V.

Documentation Required

Inadequate Response Documentation

Inadequate response documentation is required to support dose escalation or change in therapy. Prescribers must document treatment failure, loss of response, or intolerance to prior therapies using objective measures or clear clinical narrative.

Provide objective measures of inadequate response (disease activity scores, labs, endoscopy scores, imaging, or documented clinical worsening).
Describe prior therapies tried, durations, and reasons for discontinuation (inefficacy, intolerance, contraindication).

Documentation Required

Supporting Documentation

Supporting documentation such as prescribing information, relevant clinical trial or guideline references, and source documents should be available upon request. Providers are expected to have source records to substantiate clinical assertions in PA requests.

Keep prescribing information, lab reports, imaging, and clinical notes available to support the PA.
Appendices (B, D, E, F, G, I, J, K) provide reference criteria and scoring tools to support documentation submissions.

Documentation Required

Dose Escalation Documentation

Dose escalation requests higher than typical maintenance require specific dose escalation documentation at the time of PA submission (see Dose Escalation and Rounding Documentation). Failure to provide adequate escalation justification will result in denial.

Include prior dose history, duration on prior dose, objective evidence of loss of response, and prescriber rationale for higher maintenance dose.
Reference product-specific maximum maintenance dose and allowable escalation statements in Section V.

Step Therapy

Step / Continued Therapy Referenced

Step therapy and continued therapy requirements are referenced throughout the policy. Initial and continuation criteria include required trials of specified agents, duration thresholds (commonly ≥3 months), and sequencing for TNF inhibitors and other drug classes. Providers must follow the specified sequences unless contraindicated or exception criteria are met.

Step/continued therapy requirements specify initial and continued therapy criteria for each indication (see Section I and II).
Many steps require documented failure of specified agents for ≥3 consecutive months unless contraindicated.

Step Therapy

Specified Step Sequences and Failures

Specified step sequences and example failures are detailed per product and indication (e.g., required trials of Enbrel and adalimumab products before certain agents). Providers must document prior agent trials and durations to demonstrate step completion.

Examples: For some indications, failure of both an adalimumab product and Enbrel (each ≥3 months) is required before other agents are approved.
Documentation should list dates, doses, and reasons for discontinuation for prior agents.

Step Therapy

Step Therapy Sequences and State Exception

Step therapy sequences for infliximab products are stepwise as described (Inflectra and Renflexis first; Avsola next; unbranded Remicade last). State exceptions (e.g., Illinois HIM per IL HB 5395) may modify step therapy requirements — providers should identify state/product applicability in the request.

Infliximab step sequence enforced per indication; provide prior trial documentation for Inflectra and Renflexis before advancing to Avsola or Remicade.
State exceptions like Illinois HIM (IL HB 5395) may bypass step therapy in some circumstances; indicate state/product on request.

Step Therapy

Therapy Sequencing and TNF Inhibitors

Therapy sequencing for TNF inhibitors and related redirections is enforced to promote use of preferred biosimilars and reference products. Providers should document clinical justification when requesting agents out of sequence, including prior failures or contraindications.

TNF inhibitor sequencing and redirections (including adalimumab and infliximab families) are applied per indication; provide prior therapy trial documentation.
If requesting an agent out of sequence, include clinical justification and documentation of prior adverse effects or contraindications to preferred agents.

Documentation Required

Required Lower-Dose Trial Before Escalation

Required lower-dose trial before escalation: escalation to a higher maintenance dose generally requires prior inadequate response to the lower approved maintenance dose documented in the medical record.

Document the lower-dose trial duration and objective evidence of inadequate response before seeking higher maintenance dosing.
Refer to product-specific statements in Section V regarding allowable escalation with documentation.

Step Therapy

Biosimilar Stepwise / Redirection Requirements

Biosimilar stepwise/redirection requirements: biosimilars are included in step sequences and redirections (e.g., adalimumab and infliximab biosimilars Q-codes listed). Providers must trial preferred biosimilars per policy sequencing unless an exception or contraindication applies.

Biosimilar redirection examples: Inflectra (Q5103) and Renflexis (Q5104) required prior to Avsola for many infliximab indications; adalimumab biosimilars (Q5140–Q5145) are included in adalimumab family sequencing.
Provider attestation and NDC documentation may be required for biosimilar redirection compliance.

Agent specifiedCriteria example applies to Rinvoq requests for AD

Topical/systemic prior therapyRequires prior topical corticosteroid and non‑steroidal topical therapy trials unless contraindicated

DIRA definition — genetic confirmation

DIRA diagnostic requirementDiagnosis confirmed by presence of loss‑of‑function ILRN mutations

Agent for therapyKineret (anakinra) is the listed agent for DIRA in policy

Prescriber requirementPrescribed by or in consultation with a rheumatologist

DIRA definition (duplicate) — diagnostic criteria

DIRA diagnostic criteria summaryDeficiency of interleukin‑1 receptor antagonist diagnosed by loss‑of‑function ILRN mutations

Coverage durationApproval duration: 12 months per policy

Combination therapy exclusionNo combination use with other biologic DMARDs or JAK inhibitors allowed

Hurley stage — HS severity staging referenced

Hurley stage II descriptionModerate HS: recurrent abscesses, sinus tracts, scarring, separated lesions

Hurley stage III descriptionSevere HS: diffuse or near‑diffuse involvement with multiple interconnected tracts and abscesses

Policy requirementDocumentation of Hurley stage II or III required for HS coverage (see Appendix D)

PMR diagnostic criteria — ACR/EULAR criteria and lab thresholds

PMR diagnostic criteriaDiagnosis per ACR/EULAR criteria with symptomatic presentation (e.g., bilateral shoulder aching) and elevated baseline ESR ≥30 mm/hr or CRP ≥10 mg/L

Age requirementAge ≥ 50 years for Kevzara requests

Prior steroid trialFailure of systemic corticosteroid ≥2 weeks or PMR flare while tapering at ≥7.5 mg/day

Diagnosis of RA — ACR criteria reference

RA diagnosis referenceRheumatoid arthritis diagnosed per ACR criteria (see Appendix H)

Prescriber requirementPrescribed by or in consultation with a rheumatologist

Conventional therapy expectationsFailure of MTX or other DMARDs typically required prior to biologic initiation (≥3 months) unless contraindicated

SSc-ILD — definition and diagnostic references

SSc‑ILD diagnostic elementsSystemic sclerosis‑associated ILD requires HRCT demonstrating pulmonary fibrosis plus additional systemic sclerosis signs (see Appendix L)

Baseline lung function thresholdsBaseline FVC ≥40% predicted and DLCO ≥30% predicted required per policy

Specialist requirementPrescribed by or in consultation with a pulmonologist or rheumatologist

CDAI — Clinical Disease Activity Index reference

CDAIClinical Disease Activity Index (see Appendix I for details)

Use in RA monitoringRequired baseline CDAI or RAPID3 documentation referenced for RA initial criteria

Appendix referenceSee Appendix I for scoring details

RAPID3 — Routine assessment of patient index data 3 reference

RAPID3Routine assessment of patient index data 3 (see Appendix J for details)

Use caseReferenced as a baseline/response measure for RA in documentation requirements

Appendix referenceSee Appendix J for scoring details

Failure of DMARD/MTX — definition of failure

Failure of DMARD/MTX definitionFailure defined as lack of adequate clinical response (examples: reduced joint pain/swelling, improved ESR/CRP, improved ADLs)

Pregnancy/alcohol notesChild‑bearing age and social alcohol use are not absolute contraindications to MTX; excessive alcohol use may preclude use

Documentation expectationProvide clinical evidence of inadequate response to conventional DMARD trial

Ulcerative colitis maintenance failure — definition

UC maintenance failure definitionFailure defined as having two or more exacerbations requiring steroid therapy

ImplicationUsed to document maintenance therapy failure in UC criteria

Appendix referenceSee Appendix D for examples and context

HS Hurley staging definitions

Hurley stage definitionsHurley stage II = moderate HS; stage III = severe HS (definitions and examples in Appendix D)

Coverage requirementDocumentation of Hurley stage II or III required for HS coverage

Therapies prior to biologicsFailure of systemic antibiotics/retinoids/hormonal treatments (each ≥3 months) often required

Mayo Score / Modified Mayo / Mayo Endoscopic Score definitions

Mayo Score definitionMayo Score (0–12) based on stool frequency, rectal bleeding, endoscopy, physician global; bands: 0–2 remission, 3–5 mild, 6–10 moderate, >10 severe

Modified MayoModified Mayo Score (0–9) omits physician global; FDA‑accepted for trials

Mayo Endoscopic ScoreRange 0–3; score ≥2 = moderate‑to‑severe inflammation

cJADAS10 — PJIA disease activity score reference

cJADAS10 descriptionComposite JIA activity score (0–30) using physician global, parent global, and active joint count (max 10)

Disease activity bands≤1 inactive; 1.1–2.5 low; 2.51–8.5 moderate; >8.5 high

Use in PJIAReferenced as disease‑activity measure to support severity and response documentation

Dose rounding — reference to Appendix G

Dose rounding guidance referenceRefer to Appendix G for guidance on rounding weight‑based biologic doses to practical vial sizes or standard doses

Applies toWeight‑based IV and SC biologic dosing (e.g., abatacept, infliximab, Actemra)

DocumentationProviders should calculate vial/syringe quantity and document rounding rationale

Induction vs Maintenance — definition and examples

Induction vs maintenanceInduction = initial loading doses (e.g., mirikizumab 900 mg IV at weeks 0,4,8); Maintenance = ongoing dosing after induction (e.g., 300 mg SC q4w)

ExamplesMirikizumab, vedolizumab, ustekinumab weight‑based IV induction followed by SC maintenance per Section V

PA implicationPA requests must match induction/maintenance regimens in Section V or provide documentation for deviations

Maximum maintenance dose — definition and examples

Maximum maintenance dose definitionHighest routine maintenance dosing frequency/amount referenced for an indication (e.g., ustekinumab 90 mg every 8 or 12 weeks)

Policy useRequests exceeding maximum maintenance dose require documentation of inadequate response for escalation

ExamplesVedolizumab SC: 108 mg every 2 weeks (max maintenance); ustekinumab: 90 mg every 8 weeks (max for some indications)

Disease activity indices — RA activity measures referenced

RA disease activity indices listedCDAI, SDAI, DAS28‑CRP referenced with comparative performance notes

Use in documentationBaseline and follow‑up CDAI or RAPID3 used to demonstrate response for continuation approvals

Appendix referencesSee Appendices I–J for scoring details

Uveitis systemic therapy guidance — reference to noncorticosteroid systemic therapy guidance

Uveitis systemic therapy guidanceNon‑corticosteroid systemic immunomodulatory therapy guidance cited (FOCUS initiative and consensus guidelines)

Prescriber requirementPrescribed by or in consultation with an ophthalmologist or rheumatologist for noninfectious uveitis

Prior therapy expectationsFailure of ≥2 week systemic corticosteroid trial and trial of non‑biologic immunosuppressive therapy expected before biologic initiation

Redirection — definition and operational meaning

Redirection definitionOperational redirecting of requests to preferred biologic/biosimilar product sequences as specified in policy (stepwise requirements)

ImplicationFailure to follow redirection/stepwise sequencing may trigger denial or require attestation/exceptions

ExamplesInfliximab biosimilar sequence: Inflectra → Renflexis → Avsola → unbranded Remicade (where specified)

Modified Mayo Score — definition and policy addition

Modified Mayo Score definitionModified Mayo Score (0–9) evaluates stool frequency, rectal bleeding, and endoscopy; policy adds Modified Mayo ≥ 5 as an option to document moderate‑to‑severe UC

Appendix referenceSee Appendix F for supplemental information on modified Mayo Score

Policy change noteAdded as an alternative documentation option in 2Q 2025 updates