Infliximab (Remicade), Infliximab-axxq (Avsola), Infliximab-dyyb (Inflectra, Zymfentra), and Infliximab-abda (Renflexis)
Medicaid clinical coverage policy governing medical necessity, initial and continued authorization criteria, dosing limits, and excluded uses for infliximab products and the subcutaneous infliximab product Zymfentra. Applies to prescribers seeking prior authorization for these agents.
Policy Summary
Payermhn
PolicyInfliximab (Remicade), Infliximab-axxq (Avsola), Infliximab-dyyb (Inflectra, Zymfentra), and Infliximab-abda (Renflexis)
Policy CodePolicy CP.PHAR.254
Change TypeAnnual review / clarifications
Effective Date07.16
Next Review Date
Key ActionSubmit prior authorization with clinical documentation (office notes, labs, disease activity scores, prior therapy trials, and product-specific attestations) demonstrating the member meets all applicable initial or continued therapy criteria.
4wapproval duration for Kawasaki disease (off-label)
1mapproval duration for graft‑versus‑host disease (off‑label)
5 mg/kgcommon maintenance IV dose for CD/UC/PsO/PsA
5
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Request is for Avsola, Inflectra, Remicade/unbranded Remicade, or Renflexis
Prescribed by or in consultation with a rheumatologist
Age ≥ 18 years
Failure of at least TWO non-steroidal anti-inflammatory drugs (NSAIDs) at up to maximally indicated doses, each used for ≥ 4 weeks unless clinically significant adverse effects are experienced, all are contraindicated, or previously failed a biologic agent for AS
Product sequencing for Remicade
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first (unless contraindicated or clinically significant adverse effects); if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors
Dose limit: ≤ 5 mg/kg IV at weeks 0, 2, and 6, then 5 mg/kg every 6 weeks
(end node)
Initial Approval Criteria - Crohn's Disease (CD)
Approved when ALL of the following are met:
ALL of the following
Diagnosis of Crohn's disease (CD)
Prescribed by or in consultation with a gastroenterologist
ANY of the following
Avsola, Inflectra, Remicade/unbranded Remicade, Renflexis: Age ≥ 6 years
Request is for Avsola, Inflectra, Remicade/unbranded Remicade, or Renflexis
Prescribed by or in consultation with a dermatologist or rheumatologist
Age ≥ 18 years
Product sequencing for Remicade
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first; if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
Approved when ALL of the following are met (off-label):
ALL of the following
Diagnosis of steroid-refractory acute graft-versus-host disease (SR-aGvHD)
Request is for Avsola, Inflectra, Remicade/unbranded Remicade, or Renflexis
Prescribed by or in consultation with an oncologist, hematologist, or bone marrow transplant specialist
Used in combination with systemic corticosteroids following no response to first-line therapies
Product sequencing for Remicade
Initial Approval Criteria - Other diagnoses/indications
Approved when ALL of the following are met:
ALL of the following
Product sequencing for Remicade
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first; if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
If the requested use has had a recent label change (within 6 months) refer to CP.PMN.255 (formulary) or CP.PMN.16 (non-formulary) as applicable
If the requested use is not listed and the above does not apply, refer to the off-label use policy CP.PMN.53
Continued Therapy - All other indications (excluding Kawasaki & GvHD)
Re-authorization requires ALL of the following:
ALL of the following
ANY of the following
Currently receiving medication via Centene benefit or previously met initial approval criteria
Currently receiving medication and enrolled in a state/product with continuity of care regulations (see state addendums CC.PHARM.03A/03B)
Response evidence
For RA: member is responding as evidenced by decreased CDAI or RAPID3 from baseline
For RA: if CDAI cannot be done, submit RAPID3 showing disease severity similar or improved from baseline
Continued Therapy - Kawasaki Disease or GvHD (off-label)
Re-authorization:
ALL of the following
Re-authorization is not permitted; members must meet initial approval criteria
(end node)
Diagnoses/Indications Not Authorized
Coverage is NOT authorized for the following:
ALL of the following
Non-FDA approved indications not addressed in this policy unless sufficient documentation exists per CP.PMN.53 or evidence of coverage
Combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or potent immunosuppressants, including but not limited to TNF antagonists, interleukin agents, JAK inhibitors, anti-CD20 antibodies, selective co-stimulation modulators, integrin receptor antagonists, tyrosine kinase 2 inhibitors, and S1P receptor modulators due to additive immunosuppression and infection/malignancy risks
Home infusion therapy, anti-tumor necrosis factor intravenous therapy; (e.g., Infliximab); administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
Prior Authorization, Documentation, and Billing Rules
Prior Authorization
Documentation required for prior authorization
Submit office/chart notes, laboratory results, prior therapy documentation, and objective disease assessments that demonstrate the member meets all applicable initial approval criteria. For Zymfentra requests include the product‑specific attestation that the member completed an IV induction regimen, is responding to IV infliximab, and cannot continue IV therapy due to lack of caregiver/support, inadequate access to facility/home care, or lack of transportation.
Office chart notes and labs demonstrating diagnosis and disease severity
Documentation of prior therapy trials (NSAIDs, immunomodulators, MTX, corticosteroids, etc.) at maximally indicated doses where required
Zymfentra-specific attestation of IV induction, response to IV infliximab, and inability to continue IV administration
Documentation Required
Baseline and follow-up disease activity documentation
Provide baseline and follow-up disease activity measures: for rheumatoid arthritis submit a baseline CDAI or RAPID3 and for continued therapy submit evidence of a decreased CDAI or RAPID3 (or RAPID3 if CDAI cannot be obtained). For ulcerative colitis submit Mayo Score, Modified Mayo Score, or Mayo Endoscopic Score at baseline and clinical justification of response for reauthorization.
Age, Disease Severity, Trial and Dose Thresholds
Thresholds
Age thresholdsAvsola/Inflectra/Remicade/Renflexis: age ≥ 6 years for Crohn's disease and ulcerative colitis; Zymfentra: age ≥ 18 years.
Mayo score thresholds (UC)Mayo Score ≥ 6 OR Modified Mayo Score ≥ 5 OR Mayo Endoscopic Score ≥ 2 to define moderate-to-severe UC.
Plaque psoriasis severity≥ 10% total body surface area OR involvement of hands, feet, scalp, face, or genital area to qualify as chronic‑severe psoriasis.
NSAID trial for ASFailure of at least TWO NSAIDs at up to maximally indicated doses, each used for ≥ 4 weeks unless clinically significant adverse effects or contraindications.
Immunomodulator trial for CDFailure of a ≥ 3 consecutive month trial of at least ONE immunomodulator (e.g., azathioprine, 6‑MP, MTX) at up to maximally indicated doses unless contraindicated; or medical justification for inability to use immunomodulators.
Dose limits - common
Clinical Background
Infliximab and its biosimilars are TNF (tumor necrosis factor) blockers used to treat a range of immune‑mediated inflammatory diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Remicade (infliximab) and the listed biosimilars (Avsola, Inflectra, Renflexis) are available as intravenous formulations and are indicated for induction and maintenance therapy in the approved indications across adult and, where specified, pediatric populations. (See prescribing information for individual product age and dosing specifics.)
Zymfentra is a subcutaneous (SC) formulation of infliximab available as single‑dose prefilled syringes and pens (120 mg/mL). It is indicated specifically for maintenance treatment of moderate‑to‑severe Crohn's disease and ulcerative colitis after completion of an intravenous infliximab induction regimen. Zymfentra dosing begins at week 10 with 120 mg SC every 2 weeks for maintenance, and all patients must complete IV induction with an infliximab product prior to initiating Zymfentra. Zymfentra is approved for adults (age ≥ 18) in the IBD indications, whereas IV infliximab products have pediatric approvals (age ≥ 6) for CD and UC.
Defined Terms
Definitions
CDAIClinical Disease Activity Index for RA; composite index summing 28 joint counts plus patient and physician global assessments; score range 0–76 used to quantify RA disease activity.
RAPID3Routine Assessment of Patient Index Data 3; a patient‑reported composite of function, pain, and patient global (each 0–10) with maximum score 30 used to assess RA disease state.
Mayo scoresMayo Score: 4‑parameter composite for UC (stool frequency, rectal bleeding, endoscopy, physician global) range 0–12; Mayo Endoscopic Score: endoscopic severity 0–3 (≥2 indicates moderate‑to‑severe inflammation).
DMARD / MTXDMARD: disease‑modifying antirheumatic drug; MTX: methotrexate (reference conventional DMARD required in many indications and used concomitantly in RA).
bDMARDBiological disease‑modifying antirheumatic drug; policy prohibits combination use of infliximab products with other bDMARDs or JAK inhibitors due to additive immunosuppression risk.
Cross-Reference Policies
Related policies
CP.PMN.53Off‑label use policy (Medicaid).
CP.PMN.255No coverage criteria policy (Medicaid).
CP.PMN.16Non‑formulary policy (Medicaid).
Policy Dates and Change Log
07.16Effective date
Policy effective date set to 07.16 as listed in the document header.
05.26Last review
Last review date recorded as 05.26 in the document header.
01.23.26Annual review — no significant changesLatest
2Q 2026 annual review noted no significant changes; references reviewed and updated (P&T approval date 05.26).
Policy Summary
Payermhn
PolicyInfliximab (Remicade), Infliximab-axxq (Avsola), Infliximab-dyyb (Inflectra, Zymfentra), and Infliximab-abda (Renflexis)
Policy CodePolicy CP.PHAR.254
Change TypeAnnual review / clarifications
Effective Date07.16
Next Review Date
Key ActionSubmit prior authorization with clinical documentation (office notes, labs, disease activity scores, prior therapy trials, and product-specific attestations) demonstrating the member meets all applicable initial or continued therapy criteria.
Failure of a ≥ 3 consecutive month trial of at least ONE immunomodulator (e.g., azathioprine, 6-MP, MTX) at up to maximally indicated doses, unless clinically significant adverse effects are experienced, all are contraindicated, or previously failed a biologic agent for CD
Medical justification supports inability to use immunomodulators (see Appendix E)
Product sequencing for Remicade
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first; if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
Zymfentra specific attestation (if request is for Zymfentra)
Has received three IV induction doses of an infliximab product prior to initiation
Member is responding positively to an IV infliximab product
Member is unable to receive continued therapy with IV infliximab due to lack of caregiver/support for administration and/or inadequate access to healthcare facility or home care interventions and/or lack of transportation to healthcare facility
No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors
Dose limit
Avsola, Inflectra, Remicade/unbranded Remicade, Renflexis IV: 5 mg/kg at weeks 0, 2, and 6, then 5 mg/kg every 8 weeks
Zymfentra SC: 120 mg every 2 weeks starting at week 10
Failure of a ≥ 3 month trial of MTX at up to maximally indicated doses
Intolerance/contraindication to MTX and failure of a ≥ 3 month trial of cyclosporine or acitretin at up to maximally indicated doses
Intolerance/contraindication to MTX, cyclosporine, and acitretin, and failure of phototherapy unless contraindicated
Product sequencing for Remicade
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first; if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors
Dose limit: 5 mg/kg IV at weeks 0, 2, and 6, then 5 mg/kg every 8 weeks
(end node)
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors
Dose limit: 5 mg/kg IV at weeks 0, 2, and 6, then 5 mg/kg every 8 weeks
(end node)
Intolerance/contraindication to MTX and failure of a ≥ 3 consecutive month trial of at least ONE conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine) at up to maximally indicated doses
Baseline assessment
Documentation of CDAI score
Documentation of RAPID3 score
Prescribed concomitantly with MTX, or another DMARD if MTX intolerance/contraindication
Product sequencing for Remicade
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first; if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors
Dose limit: 3 mg/kg IV at weeks 0, 2, and 6, then 3 mg/kg every 8 weeks
(end node)
Mayo Score ≥ 6
Modified Mayo Score ≥ 5
Mayo Endoscopic Score ≥ 2
Failure of an 8-week trial of systemic corticosteroids unless contraindicated, clinically significant adverse effects are experienced, or previously failed a biologic agent for UC
Product sequencing for Remicade
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first; if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
Zymfentra specific attestation (if request is for Zymfentra)
Has received three IV induction doses of an infliximab product prior to initiation
Member is responding positively to an IV infliximab product
Member is unable to receive continued therapy with IV infliximab due to lack of caregiver/support for administration and/or inadequate access to healthcare facility or home care interventions and/or lack of transportation to healthcare facility
No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors
Dose limit
Avsola, Inflectra, Remicade/unbranded Remicade, Renflexis IV: 5 mg/kg at weeks 0, 2, and 6, then 5 mg/kg every 8 weeks
Zymfentra SC: 120 mg every 2 weeks starting at week 10
(end node)
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first; if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors
Dose limit: single infusion of 10 mg/kg IV given over 2 hours
(end node)
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first; if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
Dose limit or evidence requirement
Dose ≤ 10 mg/kg IV once weekly
Or dose supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence)
Prescribed regimen must be FDA-approved or recommended by NCCN (where applicable)
(end node)
(end node)
For all other indications: member is responding positively to therapy (medical justification)
Product sequencing for Remicade
If request is for Remicade, member must use Avsola, Inflectra, and Renflexis first; if member has failed Avsola, Inflectra, and Renflexis, then member must use unbranded Remicade
For unbranded Remicade, member must use Avsola, Inflectra, and Renflexis first unless all are contraindicated or clinically significant adverse effects are experienced
No combination use with biological disease-modifying antirheumatic drugs or Janus kinase inhibitors
If request is for a dose increase, new regimen must not exceed specified limits
CD: Avsola/Inflectra/Remicade/unbranded Remicade/Renflexis IV: 5 mg/kg every 8 weeks or 10 mg/kg every 8 weeks if age ≥ 18 and documentation supports inadequate response
CD: Zymfentra SC: 120 mg every 2 weeks (age ≥ 18)
UC: Avsola/Inflectra/Remicade/unbranded Remicade/Renflexis IV: 5 mg/kg every 8 weeks
UC: Zymfentra SC: 120 mg every 2 weeks (age ≥ 18)
PsA, PsO: 5 mg/kg every 8 weeks
RA dose increase constraints
RA: baseline 3 mg/kg every 8 weeks; dose/frequency increases must not exceed 10 mg/kg and/or every 4 weeks
Documentation must support inadequate response to adherent use with MTX or other DMARD
ANY of the following
If current frequency is every 8 weeks: member has received at least 4 doses (14 weeks total therapy) at current regimen
If current frequency is < every 8 weeks: member has received at least 2 doses at current frequency
AS: 5 mg/kg every 6 weeks
(end node)
RA baseline: CDAI or RAPID3 (Appendices I and J); follow-up showing decrease from baseline or RAPID3 comparable/improved if CDAI unavailable
UC baseline: Mayo Score ≥ 6, Modified Mayo Score ≥ 5, or Mayo Endoscopic Score ≥ 2; follow-up clinical response documentation for continued therapy
When requesting branded Remicade or unbranded Remicade, document prior use, failure, or intolerance of Avsola, Inflectra, and Renflexis unless all are contraindicated or cause clinically significant adverse effects; if those three are failed, unbranded Remicade may be used.
Document trials of Avsola, Inflectra, and Renflexis and reasons for failure or intolerance if applicable
If member has failed Avsola, Inflectra, and Renflexis, indicate use of unbranded Remicade per sequencing rules
Denial Risk
Combination therapy exclusion
Requests will be denied if the member is receiving infliximab concurrently with other biological DMARDs or JAK inhibitors because combination use is not authorized due to additive immunosuppression and increased infection/malignancy risk.
Verify current medications and do not combine infliximab with other bDMARDs or JAK inhibitors at initiation or continuation
Documentation Required
Off-label evidence submission
For off-label indications or dosing that exceed stated limits (for example certain GvHD regimens beyond 10 mg/kg), the prescriber must submit supporting peer‑reviewed literature or guideline recommendations to justify the requested dose or regimen.
Submit practice guideline or peer-reviewed evidence when requested dose/regimen is outside the policy limits (e.g., SR-aGvHD dosing supported by literature or NCCN)
Documentation Required
Provider attestation for Zymfentra (certain CD and UC requests)
For Crohn's disease and ulcerative colitis requests for Zymfentra (J1748), the provider must attest that the member has completed three IV induction doses, is responding to IV infliximab, and is unable to receive continued IV therapy due to lack of caregiver/support, inadequate access to facility/home care, or lack of transportation.
Include HCPCS code J1748 on request when applicable
Attestation must state: three IV induction doses received; member responding to IV infliximab; inability to continue IV administration due to caregiver/support, access, or transportation barriers
Note
Biosimilar / branded product redirection policy
Policy requires requests to indicate which infliximab product is being requested and redirects to biosimilars/branded products per sequencing rules. Include the applicable HCPCS/J- and Q-codes (J1745, J1748, Q5103, Q5104, Q5121) on submissions and document product requested and prior biosimilar use or failures.
Specify the requested product (Avsola, Inflectra, Remicade, Renflexis, or Zymfentra) on the prior authorization
Include codes: J1745, J1748, Q5103, Q5104, Q5121
Follow sequencing language: must use Avsola/Inflectra/Renflexis before Remicade/unbranded Remicade unless contraindicated or failed
Note
Initial approval duration extended
Initial approvals for chronic infliximab indications are authorized for 12 months. Off-label initial durations differ (Kawasaki disease: 4 weeks one-time; graft‑versus‑host disease: 1 month).
Typical maintenance IV doses: RA 3 mg/kg (initial/maintenance) with possible escalation to ≤ 10 mg/kg and/or every 4 weeks in select circumstances; CD/UC/PsO/PsA: 5 mg/kg IV maintenance (adults) with CD adults allow escalation to 10 mg/kg every 8 weeks if inadequate response; AS maintenance 5 mg/kg IV every 6 weeks; Zymfentra SC: 120 mg every 2 weeks starting at week 10.
Kawasaki disease maximum dose (updated)Off‑label Kawasaki disease maximum dose: single infusion of 10 mg/kg given over 2 hours (updated from 5 mg/kg over 2 hours).
Modified Mayo Score threshold (Ulcerative Colitis)Modified Mayo Score ≥ 5 is an accepted option for UC disease severity documentation (policy added option alongside Mayo Score and Mayo Endoscopic Score).
Zymfentra
Infliximab‑dyyb product available as a 120 mg/mL single‑dose prefilled syringe/pen for subcutaneous maintenance after completion of IV infliximab induction; requires IV induction and specific attestations for CD/UC requests.
Modified Mayo Score (definition)Three‑parameter Mayo derived from the full Mayo Score (stool frequency, rectal bleeding, endoscopic evaluation) with maximum score of 9; accepted by FDA for UC clinical trials and included as an option in this policy (≥5).