ModifiedHealth NetPolicy CP CPA.194

Biologic and Non-biologic DMARDs (Clinical Policy)

Defines medical necessity and prior authorization requirements for biologic and non-biologic disease-modifying anti-rheumatic drugs (DMARDs) for commercial members; specifies diagnostic and step-therapy criteria for multiple indications (e.g., atopic dermatitis, axial spondyloarthritis).

Policy Summary

PayerHealth Net

PolicyBiologic and Non-biologic DMARDs (Clinical Policy)

Policy CodePolicy CP CPA.194

Change TypeMultiple operational and clinical updates (codes, redirection, pediatric expansions)

Effective DateJan 1, 2018

Next Review DateN/A

Key ActionSubmit prior authorization with indication, dosing, and required documentation including prior therapy trials and disease activity scores as specified.

SourceLink

POLICY UPDATE CHANGES

Added multiple new HCPCS/HCPCS-like codes and biosimilars (e.g., C9166, C9168, Q5133, Q5134; Tofidence, Tyenne, Simlandi, Wezlana) and new dosage forms.

Modified redirection/stepwise biosimilar requirements for infliximab products (Inflectra, Renflexis, Avsola, Remicade) to a stepwise 'must use' approach.

Updated pediatric age indications and dosing expansions for multiple agents (e.g., Cosentyx PsO down to 6 years, Rinvoq pediatric extensions, Stelara pediatric dosing updates).

Added numerous new FDA indications and corresponding criteria (e.g., Rinvoq for Crohn's disease and nr-axSpA; Entyvio SC formulation; Skyrizi CD dosing forms).

Clarified restrictions against combination biologic DMARD use and added maximum dose escalation allowances per prescriber information with documentation of inadequate response.

Added multiple newly approved biosimilars, new dosage forms, pediatric indication extensions, and new HCPCS/J-codes across numerous agents.

Modified redirection/step therapy logic for several agents (e.g., Remicade/infliximab biosimilars sequence and redirection changes for PsO, PsA, pJIA).

Clarified that certain criteria apply to California/Oregon Commercial plans and added redirection notes specific to California Exchange.

Updated dosing tables and pediatric dosing for multiple agents and adjusted maximum maintenance dose wording.

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.

~80+listed biologic and non-biologic DMARD products and biosimilars

6 monthstypical initial approval duration

2 NSAIDsrequired failures for axial spondyloarthritis

Multiple biosimilarspolicy lists biosimilar/infliximab sequencing

Prohibitedcombination therapy restriction

55+references/citations

Coverage Criteria and Clinical Requirements

Initial approval — Atopic Dermatitis (California/Oregon commercial only)

Covered when ALL of the following are met

Atopic Dermatitis initial criteria: 1) Diagnosis of atopic dermatitis affecting either: a) at least 10% body surface area (BSA) OR b) involvement of hands, feet, face, neck, scalp, genitals/groin, and/or intertriginous areas; 2) Request is for Rinvoq; 3) Age >= 12 years; 4) Prescribed by or in consultation with a dermatologist, allergist, or immunologist; 5) Failure of BOTH: a) one formulary medium to very high potency topical corticosteroid used for >= 2 weeks; and b) one non-steroidal topical therapy used for >= 4 weeks (e.g., topical calcineurin inhibitor or Eucrisa), unless contraindicated or intolerant; 6) Rinvoq is not prescribed concurrently with another biologic medication or a JAK inhibitor; 7) Dose does not exceed maximum dose indicated in Section V; Approval duration: 6 months or to member's renewal date, whichever is longer.Age >= 12; topical therapy durations as stated

Applies to California/Oregon Commercial plans only; refer to HIM PA.SP60 for California Exchange Plans.

Initial approval — 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 agent listed in policy (examples include adalimumab products, Enbrel, Cosentyx, Rinvoq, Taltz, etc.); 3) Prescribed by or in consultation with a rheumatologist; 4) Age >= 18 years; 5) Failure of at least TWO NSAIDs at up to maximally indicated doses, each used for >= 4 weeks unless contraindicated; 6) Where applicable, additional agent-specific requirements apply (e.g., failure of Cosentyx for >= 3 months for some agents; for nr-axSpA and Bimzelx/Cimzia/Taltz additional criteria apply including consideration of Rinvoq when TNF failure present and CV risk permitting); 7) Complex step therapy sequencing among TNF blockers and infliximab biosimilars/unbranded products as specified in policy; 8) No combination use of biologic DMARDs or JAK inhibitors.NSAIDs >= 4 weeks each; biologic/JAK sequencing and durations as specified

See policy for full product lists, NDCs, and sequencing details.

Axial Spondyloarthritis — Agent and prior therapy requirements

Axial Spondyloarthritis (must meet all):

Agent requested: Request must be for one of the specified agents listed for axial spondyloarthritis (e.g., one of the adalimumab products such as Humira, Hadlima, adalimumab-adaz or Enbrel)

See Appendix and coding tables for NDCs.

Prior TNF failure sequencing: If member has history of failure of one TNF blocker then failure of one of Enbrel, Humira, Hadlima, or adalimumab-adaz used for >= 3 consecutive months is required; if history of failure of two TNF blockers, request must not be for another TNF blocker.>= 3 months

Prior non-TNF options: Either failure of Cosentyx used for >= 3 consecutive months OR failure/intolerance to TNF blockers plus trial of Xeljanz/Xeljanz XR and Rinvoq each used for >= 3 consecutive months (unless cardiovascular risk precludes JAK inhibitor).>= 3 months

Biosimilar and product-specific sequencing (adalimumab and infliximab families)

Product-specific step requirements for biosimilars and originator products:

Adalimumab family sequencing: For many adalimumab biosimilars (e.g., Abrilada, adalimumab-aacf, adalimumab-aaty, adalimumab-adbm, adalimumab-bwwd, adalimumab-fkjp, adalimumab-ryvk, Amjevita, Cyltezo, Hulio, Hyrimoz, Idacio, Simlandi, Yuflyma, Yusimry), member must have used Humira, Hadlima, or adalimumab-adaz unless clinically significant adverse effects or contraindications exist.

Infliximab family sequencing: For Remicade, member must use Inflectra and Renflexis; if member has failed Inflectra and Renflexis then Avsola must be used; if member has failed Inflectra, Renflexis, and Avsola then unbranded Remicade must be used. For Avsola, Inflectra and Renflexis must be tried first unless contraindicated.

JAK inhibitor prerequisite: For Rinvoq, Xeljanz, and Xeljanz XR, member should have not responded to or be intolerant of one or more TNF blockers as applicable per indication.

Behcet's Disease — Otezla

Behcet's Disease (must meet all):

Agent: Request is for Otezla (apremilast)

Diagnosis of oral ulcers in a member with Behcet's disease

Prescriber specialty: Prescribed by or in consultation with a dermatologist or rheumatologist

Age > 18 years> 18 years

Prior therapy: Failure of colchicine at up to maximally indicated doses unless contraindicated or adverse effects experienced

Castleman's Disease (off-label) — IV IL-6 receptor blockade or related agents

Castleman's Disease (off-label) (must meet all):

Diagnosis of Castleman's disease with relapsed, refractory, or progressive disease

Agent and route: Request is for intravenous Actemra (tocilizumab) or other specified IV IL-6 receptor blockade agents (Avtozma, Tofidence, Tyenne)

Disease extent: Member has multicentric disease OR unicentric disease that is HIV-negative and HHV-8-negative

Line of therapy: Prescribed as second-line therapy as a single agent with supporting evidence for off-label use

Prescriber must submit supporting evidence per policy.

Crohn's Disease — agent list, prescriber, age, and step requirements

Crohn's Disease (must meet all):

Agent requested: Request must be for one of the specified biologics listed in the policy for Crohn's disease (examples include adalimumab products, infliximab products, vedolizumab/Entyvio, ustekinumab/Stelara, risankizumab/Skyrizi, mirikizumab/Omvoh, etc.)

Diagnosis and prescriber: Diagnosis of Crohn's disease and prescribed by or in consultation with a gastroenterologist

Age/agent-specific criteria: Age requirements vary by agent (some adalimumab products have pediatric age bands; many agents are >=18 years; see policy for agent-specific ages)agent-specific

Immunomodulator trial: For many adalimumab biosimilars and specified agents, failure of a >= 3 consecutive month trial of at least one immunomodulator (e.g., azathioprine, 6-MP, methotrexate) at maximally indicated doses is required unless contraindicated; medical justification for inability to use immunomodulator may be accepted per Appendix E.

Cytokine Release Syndrome (CRS) — Actemra/Tyenne IV

Cytokine Release Syndrome (must meet all):

Agent and route: Request is for intravenous Actemra (tocilizumab) or Tyenne

Indication specifics: Member has scheduled CAR T-cell therapy OR Actemra/Tyenne is requested for treatment of severe CRS related to blinatumomab OR prophylaxis when administering teclistamab as specified

Age >= 22 years>= 22 years

Dosing limit: Dose does not exceed 800 mg per infusion for up to 4 total doses800 mg per infusion; up to 4 doses

Approval duration: up to 4 total doses.

Deficiency of Interleukin-1 Receptor Antagonist (DIRA) — Kineret

DIRA (must meet all):

Diagnosis confirmation: Diagnosis of deficiency of interleukin-1 receptor antagonist (DIRA) confirmed by presence of loss-of-function IL1RN mutations

Agent: Request is for Kineret (anakinra)

Prescriber specialty: Prescribed by or in consultation with a rheumatologist

Dose limit: Dose does not exceed the maximum dose indicated in Section V

Enthesitis-related Arthritis (ERA) — Cosentyx

Enthesitis-related Arthritis (must meet all):

Agent: Request is for Cosentyx (secukinumab)

Diagnosis and prescriber: Diagnosis of enthesitis-related arthritis (ERA) and prescribed by or in consultation with a rheumatologist

Age >= 4 years and < 18 years4-17 years

Prior therapy: Failure of at least two NSAIDs each used for >= 4 weeks OR failure of a >= 3 consecutive month trial of methotrexate at maximally indicated doses OR intolerance/contraindication to MTX plus failure of a >= 3 month trial of another conventional DMARD (e.g., sulfasalazine, leflunomide)>= 4 weeks for NSAIDs; >= 3 months for MTX/conventional DMARDs

Giant Cell Arteritis (GCA)

Giant Cell Arteritis (must meet all):

Agent: Request is for an agent listed for GCA (Actemra, Avtozma, Rinvoq, Tofidence, or Tyenne)

Diagnosis and prescriber: Diagnosis of giant cell arteritis (GCA) and prescribed by or in consultation with a rheumatologist

Prior therapy: Failure of a systemic corticosteroid at up to maximally tolerated doses unless contraindicated or clinically significant adverse effects are experienced

Age >= 18 years>= 18 years

Combination therapy exclusion:

Acute Graft-versus-Host Disease — Orencia IV prophylaxis

Acute Graft-versus-Host Disease (must meet all):

Indication and intent: Prescribed for prophylaxis of acute graft-versus-host disease (aGVHD) in a member undergoing hematopoietic stem cell transplant (HSCT) from a matched or one allele–mismatched unrelated donor

Agent and route: Request is for intravenous formulation of Orencia (abatacept)

Prescriber: Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist

Concomitant therapy: Prescribed in combination with a calcineurin inhibitor and methotrexate

Hidradenitis Suppurativa (HS) — multiple biologics

Hidradenitis Suppurativa (must meet all):

Diagnosis and documentation: Diagnosis of hidradenitis suppurativa (HS) with documentation of Hurley stage II or III

See Appendix D for Hurley stage definitions.

Agent list: Request must be for one of the specified agents listed for HS (examples include adalimumab products, Bimzelx, Cosentyx, Humira, etc.)

Agent-specific age limits apply.

Age: For Humira: age >= 12 years; for many other adalimumab biosimilars and agents: age >= 18 years (agent-specific)agent-specific

Prior step therapy for adalimumab biosimilars:

Hidradenitis Suppurativa (Bimzelx specific requirements)

Covered when ALL of the following are met

HS-Bimzelx: Failure of both of the following, each used for >= 3 consecutive months unless contraindicated or adverse effects: a) one specified adalimumab product (Humira, Hadlima, adalimumab-adaz) unless member has history of failure of two TNF blockers and the request is not for another TNF blocker; and b) Cosentyx.each >= 3 months

Kawasaki Disease (infliximab-containing product)

Covered when ALL of the following are met

Kawasaki-infliximab: Diagnosis of Kawasaki disease; request is for an infliximab-containing product; prescribed by or in consultation with an appropriate specialist (cardiologist, allergist/immunologist, infectious disease specialist, or rheumatologist); failure of immune globulin (IVIG, Gammagard preferred) unless contraindicated; age <= 6 years as applicable; infliximab biosimilar sequencing requirements apply (Inflectra and Renflexis required before Avsola; if those fail, Avsola then unbranded Remicade).Approval duration: 4 weeks (one time)

Provider must document prior IG failure and prescriber specialty.

NOMID (Kineret)

Covered when ALL of the following are met

NOMID-Kineret: Diagnosis of neonatal-onset multisystem inflammatory disease (NOMID/CINCA); request is for Kineret (anakinra); prescribed by or in consultation with a rheumatologist; dose does not exceed Section V maximum; no combination use of biologic DMARDs or JAK inhibitors.

Approval duration: 6 months or to member's renewal date, whichever is longer.

Plaque Psoriasis

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

Psoriasis-general: Diagnosis of moderate-to-severe plaque psoriasis as defined by BSA or involvement of special areas (or chronic-severe for certain infliximab products); request is for an agent listed in policy; prescriber is dermatologist or rheumatologist; agent-specific age limits apply; dose does not exceed Section V maximum.

Agent-specific prior therapy: Depending on requested agent, required failures may include: trial of methotrexate for >= 3 months, cyclosporine or acitretin if MTX intolerant, phototherapy, or failure of specified biologics/TNFs (often two TNF blockers) each used for >= 3 months. Infliximab biosimilar sequencing applies where specified.

Polyarticular Juvenile Idiopathic Arthritis (PJIA)

Covered when ALL of the following are met

PJIA-general: Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA) with >= 5 active joints; request for a listed agent; prescribed by or in consultation with a rheumatologist; age <= 22 years; prior trial of methotrexate for >= 3 months or alternative DMARD if MTX intolerant; sacroiliac/axial disease requires >= 4-week NSAID trial; no combination biologic/JAK inhibitor use; dose does not exceed Section V maximum.

PJIA-agent-specific: For certain agents (e.g., some adalimumab biosimilars), member must have used Humira/Hadlima/adalimumab-adaz unless contraindicated; some agents require documentation of high disease activity and prior TNF failures per policy.

Polymyalgia Rheumatica (Kevzara)

Covered when ALL of the following are met

PMR-Kevzara: Diagnosis of polymyalgia rheumatica (PMR) per ACR/EULAR criteria with supportive symptoms; baseline ESR >= 30 mm/hr or CRP >= 10 mg/L; age >= 50 years; prescribed by or in consultation with a rheumatologist; failure of 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; no combination biologic/JAK inhibitor use; dose per Section V.

Psoriatic Arthritis (PsA)

Covered when ALL of the following are met

PsA-general: Diagnosis of psoriatic arthritis (PsA) or juvenile PsA; request for a listed agent; prescribed by or in consultation with a dermatologist or rheumatologist; age criteria vary by agent (some agents age >=2, others >=6 or >=18); dose does not exceed Section V maximum.

PsA-prior therapy and sequencing: Many agents require documented failure of adalimumab products and Enbrel (each >= 3 months) or history of failure of two TNF blockers; some agents require failure of trials of Otezla, Cosentyx, Skyrizi, Stelara, Tremfya (each >= 3 months) as specified; Orencia IV and pediatric criteria have specific sequencing requirements.

Initial therapy for Rheumatoid Arthritis

Rheumatoid Arthritis (must meet all):

RA general requirements: Diagnosis of rheumatoid arthritis per ACR criteria; request is for an enumerated list of agents; prescribed by or in consultation with a rheumatologist.

See Appendix H for ACR criteria.

Prior conventional therapy and biologic trial requirements: For many adalimumab biosimilars and related agents, member must have failed a 3-consecutive-month trial of methotrexate at up to maximally indicated doses or have intolerance/contraindication plus failure of at least one conventional DMARD; many biologics require prior failure of specified TNF blockers or other named agents each used for 3 consecutive months unless contraindicated or intolerant. Sequencing among Inflectra/Renflexis/Avsola/Remicade may apply.3 consecutive months typically

SSc-ILD — Systemic Sclerosis–Associated Interstitial Lung Disease

Systemic Sclerosis–Associated Interstitial Lung Disease (must meet all):

SSc-ILD requirements: Request is for subcutaneous Actemra; diagnosis of SSc-ILD with HRCT evidence of pulmonary fibrosis and additional signs of systemic sclerosis; prescribed by pulmonologist or rheumatologist; baseline FVC >= 40% predicted and DLCO >= 30% predicted; prior failure of a 3-month trial of cyclophosphamide or mycophenolate mofetil unless contraindicated; dose limit 162 mg SC weekly; no combination use with other biologic DMARDs or JAK inhibitors.FVC >= 40% predicted; DLCO >= 30% predicted

See Appendix L for additional signs.

Ulcerative Colitis

Ulcerative Colitis (must meet all):

UC general requirements: Diagnosis of ulcerative colitis; prescribed by or in consultation with a gastroenterologist; request is for a listed biologic or JAK agent with agent-specific age eligibility; documentation of Mayo score >= 6 or modified Mayo >= 5; prior failure of corticosteroid and/or required trials of specified agents depending on product; no combination use of biologic DMARDs or JAK inhibitors; dose limits per Section V.Mayo >= 6 or modified Mayo >= 5

Age restrictions vary by product (e.g., Humira age >= 5).

Specific sequencing for certain agents: For some agents additional sequencing is required (e.g., Inflectra/Renflexis before Avsola/Remicade; trials of Stelara/Skyrizi/Tremfya and other biologics for certain newer agents) each typically used for >= 3 months as specified.>= 3 months commonly

See individual agent bullets for exact sequencing.

Uveitis

Uveitis (must meet all):

Non-infectious uveitis requirements: Diagnosis of non-infectious intermediate, posterior, or panuveitis; prescribed by or in consultation with an ophthalmologist or rheumatologist; age-specific eligibility for products (e.g., Humira age >= 2); failure of a 2-week trial of systemic corticosteroid at up to maximally indicated doses unless contraindicated; failure of a trial of non-biologic immunosuppressive therapy at maximally indicated doses unless contraindicated; no combination use with biologic DMARDs or JAK inhibitors; dose limits per Section V.2-week steroid trial; non-biologic immunosuppressive trial as specified

Some adalimumab biosimilars require prior use of Humira/Hadlima/adaz.

COVID-19 therapies

Coronavirus-19 Infection:

COVID-19 setting restriction: Certain agents (e.g., Kineret) are authorized for emergency use or limited to hospitalized setting; initiation of outpatient treatment will not be authorized.

See Appendix M for details.

Alopecia Areata

Alopecia Areata:

Olumiant coverage by plan type: For California Commercial plans Olumiant requests are reviewed against a separate Alopecia Areata policy; 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

Covered when ALL of the following are met for continuation/re-authorization

Continuation general: Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria; documentation supports current use (e.g., currently receiving IV Actemra or IV Tyenne for CAR T–cell–induced CRS and has not yet received 4 total doses); continuity of care regulations apply as relevant.

See continuation criteria in policy.

Evidence of clinical response: Member demonstrates a response appropriate to indication: e.g., RA — decrease in CDAI or RAPID3 from baseline; AD — reduction in pruritus/itching; HS — >= 25% reduction in inflammatory nodules/abscesses; PMR — reduction in signs/symptoms and CRP or ESR from baseline.See individual measures

Biosimilar/infliximab sequencing: If request is for Remicade/Avsola/unbranded Remicade, member must have used Inflectra and Renflexis; if failed those, then Avsola must be used; if failed Avsola as well, unbranded Remicade may be required. For unbranded Remicade, Inflectra and Renflexis must be tried first, then Avsola if those fail.

Not Authorized / Exclusions

Coverage is NOT authorized for the following conditions or uses

Non-FDA/Off-label without evidence: Non–FDA–approved indications not addressed in this policy are not covered unless there is sufficient documentation of efficacy and safety per the off‑label use policy CP.CPA.09.

Combination therapy prohibited: Combination use with other biologic DMARDs, immunosuppressants, JAK inhibitors, anti‑CD20 agents, selective co‑stimulation modulators, integrin receptor antagonists, tyrosine kinase 2 inhibitors, sphingosine 1‑phosphate receptor modulators, and listed agents is not authorized due to additive immunosuppression and infection risk.

See Section III for full list of prohibited combinations.

Specific agent‑indication exclusions: Specific exclusions include: Siliq for Crohn's disease; Xeljanz/XR and Olumiant for alopecia areata (ICD‑10 L63) are not authorized per policy.

Investigational/Not Medically Necessary: Adalimumab weekly dosing for UC

Dose escalation/alternative dosing stance

Adalimumab weekly dosing for UC: Off‑label weekly dosing of adalimumab for moderate‑to‑severe ulcerative colitis is considered investigational and not medically necessary due to insufficient evidence; requests for weekly adalimumab dosing for UC should be considered investigational and may be denied.

Refer to Appendix D for rationale and evidence statement.

Immunomodulator medical justification and TNF-inhibitor postoperative risk factors

Immunomodulator justification for Crohn's disease and surgical risk factors

Medical justification for inability to use immunomodulator in CD: Medical justification may support inability to use immunomodulators (e.g., failure to induce remission with a 3‑month systemic glucocorticoid trial; presence of high‑risk intestinal complications such as extensive perianal/severe rectal disease, extensive ileal/ileocolonic/proximal involvement, fistulizing disease, deep ulcerations, obstruction/abscess, penetrating/stricturing phenotype).

See Appendix E for detailed examples.

High risk factors for postoperative recurrence on TNF inhibitors: High‑risk factors that may justify postoperative biologic therapy include ileocolonic disease location, <10 years between diagnosis and surgery, perianal fistula, corticosteroid use prior to surgery, and prior surgical resection.

Used to justify biologic therapy postoperatively.

Dosing and Administration — agent-specific

Covered dosing when ALL of the following dosing rules are followed for the specified agent and indication

Abatacept (Orencia) — RA, PsA, PJIA, aGVHD: IV weight‑based loading at weeks 0, 2, 4 then every 4 weeks; IV dose tiers: <60 kg = 500 mg, 60–100 kg = 750 mg, >100 kg = 1000 mg. SC maintenance 125 mg once weekly. Pediatric SC weight tiers as specified for PJIA. Maximum IV maintenance dose = 1000 mg every 4 weeks; maximum SC = 125 mg weekly.

Weight and vial rounding per Appendix G.

Adalimumab and biosimilars — multiple indications: Follow induction and maintenance regimens per agent: typical adult maintenance 40 mg SC every other week; pediatric weight‑based induction and maintenance dosing per tables; maximum maintenance dose commonly 40 mg every other week for adults unless documented inadequate response supports escalation per policy.maintenance 40 mg Q2W (adult)

Pediatric maximum maintenance dosing described in Section V.

Infliximab — vial rounding: Use Appendix G dose rounding guidance for weight‑based infliximab vial quantity recommendations; typical induction 5 mg/kg IV at weeks 0,2,6 with maintenance 5 mg/kg IV every 8 weeks, with allowance to increase to 10 mg/kg for CD if supported by documentation.

Disease activity scoring

Disease activity indices and thresholds for interpretation

Mayo and modified Mayo for ulcerative colitis: Mayo score (0–12) with activity bands per Appendix F; modified Mayo (0–9) is FDA‑accepted for pivotal UC trials and may be used where allowed.

Remission/mild/moderate/severe mappings per Appendix F.

CDAI for RA: Clinical Disease Activity Index (CDAI) score ranges and disease state interpretation (remission, low, moderate, high) as described in Appendix I.

RAPID3 score 0–30 with disease state cutoffs: <3 remission, 3.1–6 low, 6.1–12 moderate, >12 high disease activity (Appendix J).

cJADAS-10 for polyarticular JIA: cJADAS‑10 disease activity cutoffs provided in Appendix K; interpret within clinical context for PJIA decisions.

Dosing and maximum maintenance dose guidance

Dosing and maximum maintenance dose guidance (must follow prescriber information; escalations require documentation of inadequate response):

Adalimumab (Humira) adult dosing: Initial/adult induction commonly 160 mg SC day 1 then 80 mg SC day 15; maintenance 40 mg SC every other week; maximum maintenance dose listed as 40 mg every other week unless documented inadequate response supports escalation.maintenance 40 mg Q2W

Adalimumab pediatric UC dosing: Pediatric weight‑based induction and maintenance dosing described with pediatric maximum maintenance dose up to 80 mg every other week or 40 mg every week depending on weight groups; continue pediatric dosing if patient turns 18 while on regimen.pediatric max 80 mg Q2W or 40 mg QW

Anakinra (Kineret): Typical RA dosing 100 mg SC daily; weight‑based dosing for DIRA/NOMID with maximum maintenance dose noted (up to 8 mg/kg/day where indicated); follow Appendix G for syringe counts.

Covered when agent, indication, and dosing match policy

Covered when dosing and indication align with agent-specific induction/maintenance regimens and maximum maintenance doses listed.

Agent-specific coverage: Therapy is covered when the prescribed agent matches an indicated condition listed in the policy and dosing does not exceed the agent‑specific maximum maintenance dose as specified in Section V.dose within listed max maintenance

See individual agent entries for induction and maintenance dosing and pediatric adjustments.

Dose escalation above standard maintenance is allowable only with prescriber documentation of inadequate response and per the agent‑specific escalation rules (documentation requirement applies).documented inadequate response

Policy requires trial durations (e.g., 2–3 months) before escalation where specified.

Pediatric/weight-based dosing: Pediatric dosing and weight‑based dosing must follow the weight and age thresholds provided (examples: tocilizumab, ustekinumab, abatacept pediatric tiers); Appendix G provides dose rounding guidance for weight‑based doses.

General coverage and utilization management requirements

Covered when ALL of the following are met (summary of multiple indication-specific criteria reflected across document):

General: Request is for an FDA‑approved indication (or a specified off‑label use documented in policy) and prescriber provides required prior authorization information, dosing, and documentation of prior therapy failures or contraindications as applicable.

Applies across multiple agent sections; see specific agent sections for details.

Biosimilar redirection: For certain reference biologics (e.g., infliximab/Remicade) the member must trial/use specified biosimilars in the order required by policy (Inflectra and Renflexis first; if failed then Avsola; if failed then unbranded Remicade) prior to coverage of the reference product.stepwise sequence required

Provider must document prior failures per sequencing.

Pediatric age expansions: Agents with updated pediatric indications require age within newly allowed ranges and dosing per pediatric extension when applicable (examples: Cosentyx, Rinvoq, Stelara additions).

Summary coverage logic

Policy contains agent-specific initial and continued therapy criteria, pediatric age/dosing limits, redirection (step therapy) rules, and formulation-specific requirements.

Agent updates and indications: Multiple agents have newly added FDA indications, pediatric expansions, and new formulations incorporated into coverage criteria (examples include pediatric extensions for Cosentyx, Rinvoq, Skyrizi additions for IBD, and new biosimilars).

See agent sections for precise dosing and age thresholds.

Biosimilar and stepwise redirection logic: Where biosimilars and reference products exist, the policy specifies stepwise redirection order (for example, Inflectra and Renflexis required prior to Avsola; if failed Inflectra/Renflexis/Avsola then unbranded Remicade), and redirection requirements have been updated in some cases from triple‑ to double‑step sequences.

Providers must document prior failures per redirection sequencing.

Formulation-specific requirements: Some indications restrict to particular formulations (IV vs SC) and require use of the appropriate code and dosing schedule corresponding to the requested formulation.

Coverage is NOT authorized for the combination use of multiple systemic biologic disease‑modifying antirheumatic drugs (bDMARDs) or Janus kinase (JAK) inhibitors. The policy explicitly states that a member must not have concurrent treatment with biologic DMARDs or JAK inhibitors and that such combination use is a reason for non‑coverage or denial of a request.

Providers must ensure that prior authorization requests document that the member is not receiving another biologic or JAK inhibitor concurrently; failure to demonstrate absence of combination biologic/JAK therapy may result in denial per the coverage criteria.

The policy reiterates that combination use of biologic DMARDs or JAK inhibitors is not authorized and cross‑references the section listing diagnoses/indications for which coverage is NOT authorized. Requests that propose concurrent use should be reviewed against Section III exclusions and will not meet the policy criteria.

When preparing prior authorization documentation, prescribers should explicitly state whether the member is receiving any other biologic DMARD or JAK inhibitor and confirm that the requested therapy will not be given in combination with these agents to avoid step/PA noncompliance triggers.

Coding, Codes and Key Numeric Criteria

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 productNDC

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

Explicit ICD-10 exclusionsICD-10Not Covered

L63	Alopecia areata (ICD-10)

HCPCS J- and Q-codes (partial list)HCPCS

J0129	Injection, abatacept, 10 mg
J0139	Injection, adalimumab, 1 mg
J0717	Description = mg.
J1438	Injection, etanercept, 25 mg
J1602	Injection, golimumab, 1 mg, for intravenous use
J1628	Injection, guselkumab, 1 mg
J1745	J1745 (listed without full description in excerpt)
J2267	Injection, mirikizumab-mrkz, 1 mg
J2323	Injection, natalizumab, 1 mg
J2327	J2327 (listed as 1 mg)

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Biosimilar Q-codes (continued)HCPCS

Q5098	Injection, ustekinumab-srlf (imuldosa), biosimilar, 1 mg
Q5099	Injection, ustekinumab-stba (steqeyma) biosimilar, 1 mg
additional	Multiple other biosimilar entries and truncated descriptions are present in the excerpt

Referenced J/HCPCS codesHCPCS

J0129	Injection, abatacept_l0 mg.
J0139	Injection, adalimumab; Lmg.
J0717	mg.
J1438	Injection, etanercept_25 mg_.
J1602	Injection, golimumab, Lmg, for intravenous use.
J1628	Injection, guselkumab; 1 mg.
J1745
J2267	Injection, mirikizumab-mrkz Lmg.
J2323	Injection, natalizumab 1 mg.
J2327	1 mg_.

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Referenced Q-codes/biosimilar codesHCPCS

Q5103
Q5104	Injection infliximab-abda biosimilar.
Q5140	Injection, adalimumab-fkip, biosimilar; 1 mg.
Q5141	Injection, adalimumab-aaty, biosimilar.
Q5142	Injection, adalimumab-ryvk biosimilar.
Q5143	Injection, adalimumab-adbm, biosimilar; Lmg.
Q5144	Injection, adalimumab-aacf (idacio) biosimilar; Lmg.

Recently added HCPCS codesHCPCS

C9166	New HCPCS code added (document lists as added).
C9168	New HCPCS code added (document lists as added).
Q5133	New HCPCS-like code added.
Q5134	New HCPCS-like code added.

Other biosimilar/product codesHCPCS

Q9998

Injection, ustekinumab-aekn (selarsdi) Lmg.

HCPCS/J-codes added or referencedHCPCS

J2267	HCPCS code added (documented in policy)
J3247	HCPCS code added (documented in policy)
Q5137	HCPCS code added (documented in policy)
Q5138	HCPCS code added (documented in policy)
Q5135	HCPCS code added for Tyenne
J0139	HCPCS code added
Q5140	HCPCS code added
Q5141	HCPCS code added
Q5142	HCPCS code added
Q5143	HCPCS code added

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Age for Enthesitis-related Arthritis

Age range≥ 4 years and < 18 years

IndicationEnthesitis-related arthritis (ERA) — Cosentyx

Prescriber requirementPrescribed by or in consultation with a rheumatologist

Age for CRS indication

Age requirement≥ 22 years

Provider Requirements, Prior Authorization and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for many biologic and non-biologic DMARD agents listed in this policy. Requests for these agents must include the clinical indication, detailed dosing (including induction and maintenance regimens), and supporting documentation demonstrating that the member meets the applicable clinical criteria and any required step-therapy sequence or biosimilar sequencing. Approvals are typically issued for 6 months or to the member's plan renewal date unless otherwise specified.

Prior authorization required for listed biologic and non-biologic DMARDs (TNF blockers and others).
Provide indication and full dosing (induction and maintenance) on PA submission.
Approvals typically issued for 6 months or to plan renewal date.

Documentation Required

Supportive and Required Clinical Documentation

Providers must submit supportive clinical documentation with all PA requests (e.g., office notes, labs, imaging, prior therapy records) to demonstrate that the member meets the specific criteria. Required documentation varies by indication and may include disease activity scores, Hurley stage for HS, Mayo or modified Mayo score for UC, CDAI or RAPID3 for RA, documentation of prior trial durations, and prescriber specialty attestation when required.

Background and Context

Disease‑modifying antirheumatic drugs (DMARDs), including both biologic and non‑biologic agents, are used to treat autoimmune and inflammatory conditions such as rheumatoid arthritis, axial spondyloarthritis, psoriasis, Crohn's disease, and atopic dermatitis. This policy lists covered agents, indication‑specific criteria, and utilization management requirements (e.g., prior authorization, step therapy, and dosing limits) for those products.

The policy incorporates recent operational and clinical updates including newly added biosimilars, pediatric indication expansions, and formulation changes; it also clarifies that combination biologic or JAK inhibitor therapy is not authorized and that dose escalations above listed maximums require documentation of inadequate response.

Definitions and Abbreviations

Abbreviations

ADatopic dermatitis

ASankylosing spondylitis

nr-axSpAnon-radiographic axial spondyloarthritis

DIRA definition

DefinitionDeficiency of interleukin-1 receptor antagonist confirmed by loss-of-function IL1RN mutations

AgentKineret (anakinra) used for DIRA requests

PrescriberRequires rheumatologist involvement

Policy Change History

2024-02-19coding_added

Added new HCPCS codes (C9166, C9168, Q5133, Q5134) and revised HCPCS J3380 description to support newly added biosimilars and dosage forms.

2024-03-25criteria_updated

Updated cytokine release syndrome criteria to include inadequate response to steroids/vasopressors and added Castleman's disease documentation requirements and pediatric dosing updates in Section V.

2024-05-02indication_added

Policy Summary

PayerHealth Net

PolicyBiologic and Non-biologic DMARDs (Clinical Policy)

Policy CodePolicy CP CPA.194

Change TypeMultiple operational and clinical updates (codes, redirection, pediatric expansions)

Effective DateJan 1, 2018

Next Review DateN/A

Key ActionSubmit prior authorization with indication, dosing, and required documentation including prior therapy trials and disease activity scores as specified.

SourceLink

On This Page

Dose limit: Dose does not exceed 60 mg per day60 mg/day

Dose does not exceed 8 mg/kg per infusion every 2 weeks or dose supported by guidelines/literature

8 mg/kg every 2 weeks

See Appendix E for acceptable justifications.

Infliximab sequencing: Infliximab biosimilar sequencing required: Inflectra and Renflexis must be used prior to Avsola; if those fail, Avsola must be used; if those fail, unbranded Remicade may be required. For Avsola, prior Inflectra and Renflexis are required unless contraindicated.>= 3 months for failures where specified

Provider attestation required for Zymfentra when applicable.

Agents requiring multiple prior biologics: For some agents (e.g., Cimzia, Omvoh, Imuldosa and others) failure of specified other biologics (Skyrizi, Stelara, Tremfya, etc.) each used for >= 3 consecutive months is required as detailed in policy.>= 3 months

See individual agent bullets for exact sequences.

Dose limits: Dose does not exceed the specified weight-based regimen per policy (e.g., 75 mg at weeks 0,1,2,3,4 then every 4 weeks for weights >=15 kg and <50 kg)weight-based

See dosing tables in Section V.

Member does not have combination use of biologic DMARDs or JAK inhibitors

See Section III for non-authorized combinations.

Duration: Approval duration: 3 months (4 doses total)4 doses

If request is for certain adalimumab biosimilars, member must have used Humira, Hadlima, or adalimumab-adaz unless adverse effects/contraindications exist

Prior therapy requirements for Bimzelx: For Bimzelx: failure of BOTH one adalimumab product (or equivalent where history of two TNF failures prohibits another TNF) AND Cosentyx, each used for >= 3 months; plus prior trials of systemic antibiotics and failure of at least two other therapeutic classes each tried for >= 3 months as specified>= 3 months

Combination therapy exclusion and dosing: Member must not have combination use of biologic DMARDs or JAK inhibitors; dose must not exceed maximums in Section V (Cosentyx escalation allowed with documentation)

Dose limits: If request is for a dose increase, the new dose must not exceed the maximum maintenance dose indicated in Section V unless escalation is supported by documentation of inadequate response per prescriber information.Maximum dose per Section V

See Appendix G and infliximab dosing entries.

Other agents with vial/syringe rounding: Follow Appendix G weight‑based vial/syringe quantity recommendations for agents such as Kineret, Orencia SC, Simponi Aria, Actemra, etc.

Consult specific agent dosing tables in Section V.

Apremilast (Otezla): Titration over 5 days to maintenance 30 mg PO twice daily for adults; maximum maintenance dose 60 mg/day for adults; pediatric weight/age requirements apply for PsO where noted.maintenance 30 mg BID (adults)

Bimekizumab (Bimzelx): Psoriasis and HS dosing includes loading and maintenance up to 320 mg with alternate schedules for patients >= 120 kg; maximum maintenance listed per indication (see Section V).up to 320 mg q4–8w depending on weight/indication

Certolizumab (Cimzia): Induction 400 mg SC at 0, 2, 4 weeks; maintenance 200 mg SC every other week or 400 mg every 4 weeks depending on indication; maximum maintenance dose 400 mg every 4 weeks.max 400 mg q4w

Etanercept (Enbrel): Adult dosing typically 25 mg SC twice weekly or 50 mg SC once weekly; pediatric weight‑based dosing where specified; maximum maintenance 50 mg/week.max 50 mg/week

Guselkumab (Tremfya): Induction and maintenance dosing described with maximum maintenance doses varying by indication (e.g., 100 mg every 8 weeks for PsO/PsA; higher regimens for CD per Section V).100 mg q8w or higher per indication

Infliximab and biosimilars (Avsola, Inflectra, Remicade, Renflexis, Zymfentra): Typical induction 5 mg/kg IV at weeks 0, 2, 6 with maintenance 5 mg/kg IV every 8 weeks; for CD some patients may be increased to 10 mg/kg IV every 8 weeks if loss of response and documentation supports escalation.up to 10 mg/kg q8w for CD when supported

weight/age within listed ranges

Document in prior authorization request.

Dose escalation: Maximum dose escalation is allowed per prescriber information only with documentation of inadequate response as required by the policy.documentation required

Examples include Entyvio SC addition and new SC/pen forms for multiple agents.

Documentation requirements: Certain agents require provider attestation (e.g., Zymfentra attestation of inability to continue IV infliximab) or disease activity scores (e.g., Mayo or modified Mayo for UC) to support the prior authorization request.

Attestations and scores must be included in PA documentation.

Agent/routeIntravenous Actemra or Tyenne for CRS

Dose limitDose does not exceed 800 mg per infusion for up to 4 total doses

Age for aGVHD prophylaxis (Orencia IV)

Age requirement≥ 2 years

Agent/routeIntravenous Orencia (abatacept) for aGVHD prophylaxis

ContextUsed in HSCT prophylaxis with concomitant calcineurin inhibitor and methotrexate

Prior therapy duration

Minimum prior trial duration≥ 3 consecutive months (commonly required for prior therapies)

Applies toSpecified prior agents including conventional DMARDs, biologics, and NSAIDs where noted

DocumentationProvider must document trials and durations in prior authorization submission

ESR threshold

ESR threshold≥ 30 mm/hr

Use caseSupports diagnosis of polymyalgia rheumatica per ACR/EULAR criteria

Evidence exampleImprovement in ESR is an example of positive response to therapy per Appendix D

CRP threshold

CRP threshold≥ 10 mg/L

Use caseSupports diagnosis of polymyalgia rheumatica per ACR/EULAR criteria

Response monitoringReduction in CRP from baseline cited as evidence of response for PMR and continuation criteria

Forced Vital Capacity (FVC)

FVC threshold≥ 40% of predicted

IndicationBaseline requirement for SSc-ILD when considering subcutaneous Actemra

Additional requirementHRCT evidence of pulmonary fibrosis and other systemic sclerosis signs per Appendix L

DLCO

DLCO threshold≥ 30% of predicted

IndicationBaseline requirement for SSc-ILD when considering subcutaneous Actemra

Combined thresholdsBoth FVC ≥40% and DLCO ≥30% are required baseline criteria

Mayo Score

Mayo score requirementMayo score ≥ 6

Alternate optionModified Mayo score ≥ 5 is an allowed documentation option

ContextRequired baseline disease activity documentation for ulcerative colitis initial criteria

Skyrizi quantity for CD/UC

Maximum dispensing frequencyNo more than 1 pre-filled Skyrizi cartridge every 8 weeks for CD/UC

Applies toSkyrizi (risankizumab) requests for Crohn's disease or ulcerative colitis

DocumentationQuantity limits enforced in prior authorization and dosing sections

Otezla pediatric weight requirement

Pediatric weight requirementIf age 6 to <18 years for psoriasis, documentation that member weighs ≥ 20 kg

Applies toOtezla (apremilast) pediatric psoriasis indication

Documentation noteWeight must be included in prior authorization to confirm dosing eligibility

HS response threshold

HS response thresholdAt least a 25% reduction in inflammatory nodules and abscesses

Use caseRequired measure to document clinical response for continuation/re-authorization in hidradenitis suppurativa

DocumentationProvider should submit clinical notes showing lesion count reduction or equivalent assessment

Mayo Score severity thresholds

RemissionDecoding = Remission (per Appendix F table)

Mild activityMayo 3–5 = Mild activity

Moderate activityMayo 6–10 = Moderate activity

Severe activity>10 = Severe activity

Weight thresholds for pediatric/weight-based dosing

Weight thresholdsMultiple thresholds used (examples: 10 kg, 15 kg, 20 kg, 30 kg, 50 kg, 100 kg) to determine pediatric/weight-based dosing

ApplicationUsed across pediatric dosing tables and Appendix G dose rounding guidance

Provider requirementDocument patient weight on prior authorization to select correct weight-tier dosing

Dose escalation documentation

Escalation supportDocumentation of inadequate response required to allow maximum dose escalation per prescriber information

Policy examplesSeveral agents include explicit maximum dose escalation allowances contingent on documented inadequate response

Prior authorization implicationRequests for higher-than-standard maintenance dosing must include prescriber justification and clinical evidence

Modified Mayo Score

Modified Mayo thresholdModified Mayo score ≥ 5

ContextAllowed alternative for UC baseline disease activity documentation per criteria updates

ReferenceAppendix F describes Modified Mayo and its FDA acceptance for UC trials

Office chart notes, labs, imaging, and prior therapy documentation are required.
Baseline and follow-up disease activity measures: CDAI, RAPID3, Mayo/modified Mayo, Hurley stage, etc.
Prescriber specialty documentation required for many indications (e.g., rheumatologist, dermatologist, gastroenterologist, cardiologist).

Documentation Required

Therapeutic Alternatives and Dosing Must Be Provided

PA requests must list therapeutic alternatives and dosing tried, including duration of each prior therapy. Use Appendix B (Therapeutic Alternatives) and Appendix-listed alternatives when making step-therapy decisions. If a trial or intolerance of prior agents is claimed, include dates, doses, and reason for discontinuation.

List therapeutic alternatives tried and dosing with start/stop dates.
Use Appendix B for preferred alternatives and dosing guidance.
Document reasons for intolerance or failure.

Documentation Required

Dose Escalation Requires Justification

Dose escalations above standard maintenance dosing require prescriber justification and documentation of inadequate response to lower doses. Weight-based dosing must match indicated weight bands and documented patient weight. Maximum dose limits and allowed escalations are specified in Section V (Dosage and Administration) and require supporting clinical rationale.

Document inadequate response to support dose escalation requests.
Provide patient weight for weight-based dosing and match to policy dosing bands.
Requests exceeding maximum maintenance doses may be denied without justification.

Step Therapy

Step Therapy and Product Sequencing (Infliximab / Adalimumab)

Step therapy and biosimilar sequencing requirements must be followed. For infliximab products, the policy requires stepwise redirection: Inflectra and Renflexis first; if both are failed, Avsola next; if Inflectra, Renflexis, and Avsola are failed, unbranded Remicade is required. For certain adalimumab/UC situations and other agents, redirection to preferred products applies per policy updates.

Infliximab sequencing: Inflectra and Renflexis → Avsola → unbranded Remicade.
Adalimumab redirection updates for UC and preferred adalimumab products per policy.
TNFi bypass allowed when history documents failure of two TNF blockers.

Billing Rule

Product-Specific Coding and HCPCS/J-Code Updates

PA submissions must include product-specific coding (HCPCS/J- and Q-codes) referenced in this policy. Inclusion or exclusion of codes in the policy does not guarantee coverage; providers must use current professional coding guidance when submitting claims. An updated HCPCS/J-code list is maintained in the policy's Coding Implications section.

Reference the Coding Implications section for current J-, Q-, and HCPCS codes (e.g., J0129, J0139, Q5103, Q5140–Q5144, etc.).
Inclusion or exclusion of a code here does not guarantee coverage — verify up-to-date coding guidance.
Use correct codes on PA and claims submissions.

Note

COVID-19 Therapies Setting Restriction

Some therapies (e.g., agents authorized for COVID-19 emergency use or limited to hospitalized setting) have setting restrictions. Initiation of outpatient treatment for certain COVID-19–related agents will not be authorized; refer to Appendix M and the Coronavirus-19 Infection section for authorized settings.

Outpatient initiation for certain COVID-19 therapies (e.g., Kineret, Actemra, others) will not be authorized — hospitalization-only in many cases.
See Appendix M for COVID-19 specific authorization language.

Denial Risk

Requests and Step-Therapy Noncompliance May Lead to Denial

Requests that do not follow step-therapy sequences, fail to include required prior biologic/biosimilar trials (including specified durations, commonly ≥ 3 consecutive months), lack prescriber specialty documentation, or omit necessary dosing/indication information may be denied. Providers are responsible for ensuring submissions follow the policy requirements.

Document prior trials and durations (commonly ≥ 3 consecutive months) with dates and outcomes.
Prescriber specialty requirement must be met or documented consultation provided.
Failure to submit supporting documentation may lead to denial.

Note

No Denial Triggers Stated Here — Coding and Coverage Caution

The policy does not list explicit denial triggers in every product availability chunk; however, failure to meet the documented criteria in Section III, omission of required documentation, or not following biosimilar/step sequences are operational denial risks. Providers should reference clinical criteria, appendices, and coding guidance when preparing PAs.

No single denial list is present in product availability — refer to clinical criteria for denial conditions.
Coding and coverage cautions: inclusion of a code is informational only and not a guarantee of coverage.

Note

Use Prescribing Information for Dosing and Administration

Use current prescribing information (FDA-approved product labels) to determine administration, dosing regimens, permitted escalations, and maximum doses. The policy includes maximum maintenance doses and allowed escalations per prescriber information; PA requests should reference and align with the product PI.

Reference product Prescribing Information for dosing, weight-based calculations, and allowable escalations.
Section V (Dosage and Administration) contains dose bands and maximum maintenance dosing guidance.

Step Therapy

Step Therapy Not Specified? Provide Justification and Use Appendices

When step therapy or sequencing is required but not specified for a particular product in this section, follow the policy's step therapy rules elsewhere in the document or use Appendix-listed alternatives. If no step therapy rules are provided for a product, include clinical justification and supporting documentation describing why the requested agent is medically necessary.

If policy does not specify step therapy for a product, reference appendices and clinical sections for guidance.
Providers should supply clinical justification when requesting bypass of step therapy.

PMR criteria

PMR supportive labsESR ≥ 30 mm/hr or CRP ≥ 10 mg/L

Diagnostic criteriaDiagnosis per ACR/EULAR criteria (see Appendix N) with supportive symptoms

PrescriberPrescribed by or in consultation with a rheumatologist

NOMID/CINCA definition

NOMID/CINCANeonatal-Onset Multisystem Inflammatory Disease (CINCA) — diagnosis requiring Kineret; prescribed by/with rheumatologist

Dose limitDose does not exceed maximum indicated in Section V

Combination therapyMember must not have combination use of biologic DMARDs or JAK inhibitors

CDAI used as baseline assessment

UseCDAI used as a baseline assessment for some indications (e.g., RA) and is in Appendix I

Score rangeCDAI ranges from 0–76; used to document disease activity and response

DocumentationProviders should submit CDAI or RAPID3 as applicable for baseline/continuation assessment

Mayo Score used to document ulcerative colitis disease activity

PurposeMayo Score used to document ulcerative colitis disease activity

ScoringMayo 0–12 evaluates stool frequency, rectal bleeding, endoscopy, and physician global assessment

Modified MayoModified Mayo (0–9) omits physician global and is FDA-accepted for UC trials

Clinical Disease Activity Index

DefinitionClinical Disease Activity Index (CDAI) — composite RA activity score

UseUsed for baseline assessment and monitoring of RA per policy Appendix I

Score detailsCDAI sums tender/swollen joint counts plus patient and physician global VAS

RAPID3 — Routine Assessment of Patient Index Data 3

DefinitionRAPID3 — Routine Assessment of Patient Index Data 3, patient-reported index (function, pain, patient global)

Score range0–30 with disease activity cutoffs included in Appendix J

UsageAcceptable alternative to CDAI in some prior authorization baseline assessments

Failure of a trial of conventional DMARDs

DefinitionFailure of a trial of conventional DMARDs is defined in Appendix D/General Information

Examples of positive responseImprovement in ESR/CRP, reduction in joint pain/swelling, improved activities of daily living

ApplicationRequired to document prior DMARD failure for certain Crohn's and rheumatologic indications

Mayo and Modified Mayo Score definitions

DefinitionMayo and Modified Mayo Score detailed definitions provided in Appendix F

ComponentsMayo (0–12): stool frequency, rectal bleeding, endoscopy, physician global; Modified Mayo (0–9) omits physician global

InterpretationScore bands map to remission, mild, moderate, severe activity

Mayo Score / Modified Mayo Score — composite scoring

Composite scoringMayo Score (0–12) assesses UC severity using stool frequency, rectal bleeding, endoscopy, and physician global assessment

Modified MayoModified Mayo (0–9) excludes physician global and is FDA-accepted

Use in policyRequired for baseline and continuation assessments in UC criteria

CDAI detailed definition

CDAI definitionCDAI: composite RA activity score (0–76) summing tender/swollen joint counts plus patient and physician global VAS

UseUsed for baseline assessment and to demonstrate response in RA continuation criteria

ReferenceAppendix I describes scoring details

RAPID3 detailed definition

RAPID3 definitionRAPID3: patient-reported pooled index (function, pain, patient global) scored 0–30

Disease state cutoffs<3 remission; 3.1–6 low; 6.1–12 moderate; >12 high disease activity

Use caseAcceptable when CDAI cannot be performed or documented

Maximum Maintenance Dose definition

Maximum Maintenance DoseThe highest routinely recommended maintenance dose as provided in prescribing/dosing entries; escalations require documentation

Policy implicationRequests exceeding maximum maintenance dose need prescriber justification and documentation of inadequate response

ExamplesAdalimumab pediatric maximums and other agent-specific maximums listed in Section V and dosing tables

Appendix G — Dose Rounding Guidelines

Appendix GDose Rounding Guidelines for Weight-Based Doses

PurposeProvides rules for rounding and maintenance limits for weight-based agents (vial/syringe counts)

ApplicabilityUsed for agents such as tocilizumab, infliximab, Kineret, and others with weight-based dosing

Maintenance dose definition

Maintenance doseRegular dosing schedule after induction/loading doses (examples provided for vedolizumab, ustekinumab)

Policy requirementDose must not exceed maximum maintenance dose listed in Section V unless escalation justified

ExamplesVedolizumab maintenance: 300 mg IV every 8 weeks; ustekinumab 45–90 mg every 12 weeks depending on weight/indication

Product Availability

DefinitionProduct Availability lists formulations, container types, and strengths available for each biologic or DMARD

UseReferences for selecting appropriate HCPCS/J- or NDC codes and formulation-specific dosing

ExamplesPrefilled syringes, pens, vials, autoinjectors and IV formulations listed in Section VI

DMARDs and biologic agents

DefinitionDMARDs and biologic agents encompass the disease-modifying antirheumatic drugs referenced and guided by clinical guidelines

ScopeIncludes biologics and non-biologic DMARDs for RA, JIA, axial spondylitis, IBD, psoriasis, and other included conditions

Guideline tie-inPolicy references ACR, EULAR, ASAS and other guideline bodies for sequencing and use

Biosimilar redirection

Biosimilar redirectionPolicy requires preferred biosimilar be used in specified sequence in place of reference biologic (e.g., Inflectra and Renflexis prior to Avsola/Remicade)

ImplicationFailure to trial required biosimilars in sequence may trigger denial

ExamplesRemicade redirection: Inflectra & Renflexis → Avsola → unbranded Remicade as specified

Maximum dose escalation allowance

Maximum dose escalation allowanceDefined upper limit for dosing increase allowed when inadequate response is documented per prescriber information

RequirementEscalation must be supported by clinical documentation of inadequate response

Policy noteMultiple agents updated to include explicit maximum escalation allowances in criteria and Section V

Clinical policy

Clinical policy definitionGuideline to assist coverage decisions and administration of benefits; not a contract or substitute for medical judgment

Legal noteCoverage decisions subject to terms of evidence of coverage and applicable law/regulation

PurposeProvides criteria for medical necessity determinations for listed biologic and non-biologic DMARDs

Added multiple FDA-approved indications including Rinvoq for AD and AS, Rinvoq for UC and PsA, IV Orencia for aGVHD, and Cosentyx ERA; revised Remicade redirection to 'must use' biosimilars.

2024-05-09formulation_and_coding_update

Removed an Appendix D option and incorporated IV formulation clarifications for certain CD criteria and other formulation-specific updates.

2024-08-23redirection_and_coding_change

Modified Remicade redirection to stepwise sequencing (Inflectra/Renflexis -> Avsola -> unbranded Remicade) and added/updated HCPCS codes and Skyrizi CD dosage forms.

2024-09-09pediatric_extension

Stelara pediatric dosing and criteria updated per FDA pediatric extension; template changes applied across continued therapy sections.

2024-12-04biosimilar_and_coding_update

Added new biosimilars (Imuldosa) and multiple HCPCS/Q-codes (J0139, Q5140-Q5145, Q9996-Q9998) and adjusted redirection logic (agent redirection from triple- to double-step).

2025-01-07biosimilar_additions

Added multiple new adalimumab biosimilars and other biosimilars to criteria (e.g., adalimumab-aacf, -aaty, -adbm, -bwwd, -ryvk) and updated agent redirection rules and prescriber options.

2025-03-25operational_coding_and_biosimilar_updates

Added newly approved biosimilars, new dosage forms, clarified biosimilar stepwise sequences, and added examples supporting documentation requirements for Zymfentra and other agents.

2025-06-25indication_and_coding_additionLatest

Added Rinvoq GCA indication and new HCPCS codes (Q5098, Q5099, Q5100), plus continued updates to pediatric dosing and maximum maintenance dose columns in Section V.

Summary of recent coverage‑logic changes: the policy added multiple newly approved biosimilars and HCPCS/Q‑codes, expanded pediatric indications and dosing for several agents (for example, Cosentyx and Rinvoq pediatric extensions), and added new dosage forms and formulation entries.

Step‑therapy and redirection rules were revised for several infliximab and adalimumab product families to a more explicit stepwise sequencing (e.g., Inflectra and Renflexis required before Avsola; if those fail, Avsola required before unbranded Remicade). The policy also removed or modified some prior redirection to preferred adalimumab products based on updated guidance.

Dosing updates include clarified maximum maintenance doses and explicit requirements that dose escalation be supported by documentation of inadequate response. Operational changes require use of newly added HCPCS/HCPCS‑like codes for claims submission where applicable.