Infliximab (Remicade, Inflectra, Renflexis, Avsola, Zymfentra)
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Medical necessity and prior authorization criteria for infliximab and listed biosimilars for Meridian Medicaid members across labeled inflammatory indications.
Added requirement for Zymfentra requests requiring provider attestation that the member is unable to receive continued IV infliximab due to lack of caregiver/support, inadequate access to facility/home care, or lack of transportation.
For UC initial criteria, added option for documentation of modified Mayo Score ≥ 5 and supplemental information in Appendix F.
Updated maximum Kawasaki disease dose from 5 mg/kg over 2 hours to 10 mg/kg over 2 hours.
Removed 'if new dosing regimen, approve for 6 months' from the continued therapy approval duration.
Updated preferred adalimumab products and removed references to adalimumab-ryvk.
Added Zymfentra (zymfentra) HCPCS/Codes references in coding.
Coverage Criteria
Initial Approval — Crohn's Disease
Covered when ALL of the following are met
Initial Approval — Ulcerative Colitis
Covered when ALL of the following are met
Initial Approval — Rheumatoid Arthritis
Covered when ALL of the following are met
Initial Approval — Ankylosing Spondylitis
Covered when ALL of the following are met
Initial Approval — Psoriatic Arthritis
Covered when ALL of the following are met
General authorization limits
Example induction/maintenance limits and exclusion for combination therapy (applies across multiple indications unless otherwise specified):
applies across listed indications
Psoriatic Arthritis—Initial
Psoriatic Arthritis initial therapy (must meet ALL):
Approval duration: 6 months
Plaque Psoriasis—Initial
Plaque Psoriasis initial therapy (must meet ALL):
Prior authorization required for certain comparators; Approval duration: 6 months
Kawasaki Disease—Initial (off-label)
Kawasaki disease (off‑label) initial therapy (must meet ALL):
Approval duration: 4 weeks (one time)
Continued Therapy
Continued therapy (All indications in Section I must meet ALL):
For RA, specific requirements for prior inadequate response and minimum dosing exposure before escalation
Induction/maintenance and immunomodulator justification
Coverage considerations and clinical justification elements included in appendices
Source: Appendix statement on Zymfentra
See Appendix E for full list
Initial and maintenance dosing
Dosing and indication-specific dosing regimens
Indication-specific dosing
Indication-specific dosing variations
Requests for infliximab (Remicade) or its biosimilars for concomitant use with other biologic disease‑modifying antirheumatic drugs (bDMARDs) or Janus kinase inhibitors (JAKi) are not authorized. The policy excludes combination therapy because of additive immunosuppression and increased risk of neutropenia and serious infections; coverage will be denied when documentation shows concurrent use of infliximab with other listed biologic or JAK inhibitor agents.
Indications that are not FDA‑approved and are not specifically addressed in this policy are not authorized unless the request is supported under the plan's off‑label use policy (CP.PMN.53 for Medicaid) or other evidence of coverage documents. Requests for off‑label use must include sufficient documentation of efficacy and safety consistent with the referenced off‑label policy to be considered.
Infliximab dosing and re‑administration limitations: doses greater than 5 mg/kg are contraindicated in patients with moderate‑to‑severe heart failure, and re‑administration to patients with a history of a severe hypersensitivity reaction to infliximab products will trigger contraindication‑based denial. Per the dosing sections, typical IV maintenance dosing is 5 mg/kg for most indications; any requested dosing above specified limits requires documentation and justification and may be denied for heart failure or prior severe hypersensitivity.
Coding references listed in this policy are provided for informational purposes only. Inclusion or exclusion of specific codes does not guarantee coverage; providers must follow current professional coding guidance when submitting claims.
For Medicaid members, state Medicaid coverage provisions take precedence if they conflict with this clinical policy. Refer to the applicable state Medicaid manual for specific coverage rules and any state‑level exceptions.
Expanded exclusion: Use of infliximab in combination with other listed biologic agents or potent immunosuppressants (including but not limited to TNF antagonists, interleukin inhibitors, anti‑CD20 agents, integrin antagonists, tyrosine kinase 2 inhibitors, and S1P modulators) is considered not authorized due to additive immunosuppression, elevated risk of neutropenia, and increased risk of serious infections. The policy lists multiple classes and examples of agents for which concurrent administration with infliximab is prohibited.
Use of infliximab for unspecified anterior uveitis (iridocyclitis) is not well supported by the evidence in this policy. The document notes that available data are limited to case reports, uncontrolled series, and a small trial with a high incidence of serious adverse events; clinical guidance recommends topical and systemic alternatives before considering infliximab for this indication.
Initial therapy requirements — indication-specific prior trials/failures
Initial therapy approvals are indication‑specific and require prior trials/failures as detailed per disease.
See indication‑specific nodes
Initial therapy — specialist involvement, age thresholds, prior therapy failures per indication
Initial approval — specialist involvement, age thresholds, and prior therapy failures per indication
Dosing fragments — regimen fragments for various biologics
Dosing regimen fragments for various biologics (reference dosing guidance)
Initial therapy dosing — induction dosing for initial therapy
Induction dosing for initial therapy
Provider Actions and Requirements
Prior authorization required for comparator agents
Prior authorization is required for comparator biologics cited as prior therapies (e.g., Enbrel, adalimumab products, Cimzia, Xeljanz/Xeljanz XR) when those agents are listed as prerequisites in the indication-specific criteria.
- See indication-specific prior-failure requirements that note prior authorization is required for Enbrel, adalimumab products, Cimzia, and Xeljanz/Xeljanz XR.
PA required when comparator biologics listed in psoriasis criteria
Requests for infliximab for psoriasis indications reference prior authorization for certain comparator biologics; submit PA per the psoriasis section when prior‑therapy requirements list Enbrel, adalimumab products, or Cimzia.
- Plaque psoriasis and psoriatic arthritis sections list prior‑therapy biologics and note prior authorization is required for specified comparators.
PA required for off‑label Kawasaki disease
Prior authorization is required for off‑label Kawasaki disease use; follow the off‑label and formulary guidance when the indication is not routinely covered.
- Kawasaki disease is an off‑label indication with a one‑time approval and requires PA per the policy.
- Refer to CP.PMN.53 (off‑label) and CP.PMN.16/CP.PMN.255 for formulary/non‑formulary routing as applicable.
Zymfentra requires prior IV induction
Requests to convert to subcutaneous Zymfentra must document completion of an intravenous infliximab induction regimen prior to initiating SC maintenance.
- Provider attestation must confirm the patient has received three IV induction doses of an infliximab product before starting Zymfentra.
PA required for infliximab and biosimilars (HCPCS codes)
Prior authorization is required for infliximab and listed biosimilars using the specified HCPCS/HCPCS‑like codes; Zymfentra requests also require the additional provider attestation described in the policy.
Formulary / PA note for Marketplace members
For Health Insurance Marketplace members, this policy applies only when the prescribed agent is on the health plan approved formulary; non‑formulary requests must follow the non‑formulary policy (HIM.PA.103).
- Confirm the agent is on the plan formulary for Marketplace members before submitting a PA under this policy.
Required prior trials and documented failures
Documented trials and failures of specified prior therapies are required before approval—examples include 3‑month trials of immunomodulators or biologics as specified per indication.
- Crohn's and UC: failure of ≥3‑month trial of an immunomodulator or adalimumab as specified.
- RA/AS/PsA/PsO: failure of specified biologics each used ≥3 months as detailed in the indication criteria.
Biologic/DMARD failure requirements for PsA and PsO
For Psoriatic Arthritis and Plaque Psoriasis, prior failure of at least two listed agents (each used ≥3 consecutive months) is required before infliximab coverage will be authorized.
- List of required prior agents includes Enbrel, adalimumab products, Simlandi, Cimzia, and Xeljanz/Xeljanz XR where specified.
Immunomodulator and systemic steroid trial documentation
If immunomodulators (e.g., methotrexate) cannot be used or have failed, document medical justification per Appendix E; inability to induce remission with an appropriate systemic glucocorticoid trial (typically 8–12 weeks per criteria) may also be required as part of justification.
- Appendix E lists acceptable medical justifications for inability to use immunomodulators in Crohn's disease.
- UC initial criteria require failure of an 8‑week trial of systemic corticosteroids unless contraindicated.
Adalimumab preferred‑product update (check policy)
Policy language notes updated preferred adalimumab products; follow the policy's referenced preference edits when documenting prior adalimumab trials.
- The policy was updated to reflect preferred adalimumab products—check the policy sections for exact product preferences when submitting prior‑therapy documentation.
Required documentation to support PA
Provider must submit supporting documentation (office chart notes, lab results, or other clinical information) showing the member has met all approval criteria.
- Include relevant specialist consultation notes, trial durations with dates, and objective response measures when applicable.
Documentation required for continued therapy
For continued therapy, submit documentation that the member is currently receiving the medication or previously met initial criteria; for RA, provide objective evidence of response (decrease in CDAI or RAPID3) or a justification if CDAI was not reassessed.
- Continued‑therapy approvals require evidence of ongoing clinical benefit and adherence to dosing and frequency rules (e.g., at least 4 doses if dosing every 8 weeks).
Severity scores to include with requests
Document disease severity using accepted scoring systems where applicable: Mayo or modified Mayo Score for UC, CDAI or RAPID3 for RA to support medical necessity decisions.
- UC: include Mayo Score ≥ 6 or modified Mayo Score ≥ 5 per Appendix F.
- RA: include baseline CDAI or RAPID3 per Appendix I/J.
Modified Mayo Score (UC) accepted documentation
For UC initial criteria, documentation may include a modified Mayo Score ≥ 5 as an alternative to a full Mayo Score to support disease activity.
- Appendix F describes the modified Mayo Score (3‑parameter score, max 9) and its FDA acceptance for UC trials.
Provider responsibility and professional judgment
Providers are expected to exercise professional medical judgment and remain responsible for medical advice and treatment; documentation must substantiate that the request meets policy medical‑necessity requirements.
- This policy guides coverage decisions but does not replace provider clinical judgment.
Denial risk if supporting documentation not provided
Failure to submit required supporting documentation (office notes, labs, or other clinical information) demonstrating that the member meets approval criteria may result in denial of the request.
- Include documentation of prior trials, durations, specialist consultations, and objective scoring where applicable to avoid denial.
Combination therapy excluded — risk of denial
Requests for combination use with other biologic DMARDs, JAK inhibitors, anti‑CD20 agents, interleukin inhibitors, integrin antagonists, tyrosine kinase 2 inhibitors, or S1P modulators are excluded and may be denied due to additive immunosuppression and infection risk.
- Section III lists numerous agents and classes that cannot be used in combination with infliximab products.
Severe hypersensitivity contraindicates re‑administration
Re‑administration to patients with a prior severe hypersensitivity reaction to infliximab products is a contraindication and will trigger denial.
- Document any history of severe hypersensitivity; such history contraindicates re‑administration of infliximab products.
Heart failure dosing contraindication (>5 mg/kg)
Use of infliximab doses greater than 5 mg/kg in patients with moderate‑to‑severe heart failure is contraindicated and may be denied.
- Appendix C lists doses > 5 mg/kg in moderate‑to‑severe heart failure as a contraindication.
Zymfentra provider attestation required (access/caregiver/transportation)
Zymfentra PA requests must include provider attestation that the member is unable to receive continued IV infliximab due to lack of caregiver/support for administration, inadequate access to facility/home care interventions, or lack of transportation to a healthcare facility.
- The attestation requirement applies to CD and UC Zymfentra requests as added in the 2Q 2025 review.
Coverage subject to benefit terms, exclusions, and limitations
Coverage decisions and benefit administration are subject to all terms, conditions, exclusions and limitations of the member's coverage documents; PA approval does not guarantee payment if other benefit limits apply.
- Verify member benefit terms and state Medicaid provisions where applicable; state Medicaid rules take precedence when they conflict with this policy.
Coding and Billing
| No codes listed |
| S9359 | 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. |
Step Therapy Requirements
| Step | Requirement | Supporting details |
|---|---|---|
| 1 | ||
| Documented trial and inadequate response to listed alternatives per indication prior to approval | ||
| Policy requires prior trials/failures of specified agents (e.g., immunomodulators, anti-TNF agents, other listed biologics) for indication-specific initial approval; minimum trials typically ≥3 consecutive months (UC systemic corticosteroids 8 weeks; AS NSAIDs ≥4 weeks). |
| Step | Requirement for PsA and PsO | Supporting details |
|---|---|---|
| 1 | ||
| Failure of two or more listed biologics or agents before infliximab coverage | ||
| Psoriatic arthritis and plaque psoriasis initial criteria require failure of at least TWO listed agents (each used for ≥3 consecutive months) such as Enbrel, adalimumab products, Simlandi, Cimzia, and Xeljanz/Xeljanz XR prior to approval; prior authorization applies for certain comparator agents. |
| Step | Immunomodulator or systemic corticosteroid trial | Supporting details / Appendix guidance |
|---|---|---|
| 1 | ||
| Document prior trials of immunomodulators or systemic corticosteroids per appendix guidance | ||
| Crohn's disease initial criteria: failure of a ≥3 consecutive month trial of at least one immunomodulator (e.g., azathioprine, 6-MP, MTX) at maximally indicated doses unless contraindicated, or inability to induce remission with a 3-month trial of systemic glucocorticoids may be considered per Appendix E; Appendix E lists specific medical-justification factors (e.g., fistulizing disease, deep ulcerations, obstruction). |
| Step | Policy update summary | Notes / location of details |
|---|---|---|
| 1 | ||
| Policy updated preferred adalimumab products and step/preference edits (details outside excerpt) | ||
| Document notes 2Q 2025 Annual Review updated preferred adalimumab products and referenced step/preference edits; specific preference and step details are located in other policy sections not included in this excerpt. |
Continuation (Renewal) Criteria
Continuation therapy rules — rules for continuing infliximab or biosimilars
Continuation therapy rules for infliximab and biosimilars
Zymfentra continuation — switching from IV infliximab to subcutaneous Zymfentra
Switching from IV infliximab to subcutaneous Zymfentra (continuation)
Continuation therapy approval — approval duration and continuation updates
Approval duration and continuation updates
See full policy for exact durations per indication
Continued therapy: show current receipt or prior meeting of initial criteria
For continued therapy, documentation must show the member is currently receiving the medication via the plan benefit or previously met initial criteria and continues to demonstrate clinical response per the policy requirements.
- *Approval durations and dosing history requirements (e.g., number of prior doses at current frequency) are described in continued therapy rules.
Quantity Limits and Vial Rounding
Site of Care and Administration
Zymfentra SC maintenance—first SC dose replaces next IV infusion (infusion center guidance)
When switching to Zymfentra SC maintenance after IV induction, administer the first SC dose in place of the next scheduled IV infusion; the first SC dose should occur at the time the next IV infusion would have been given.
- *Zymfentra SC maintenance begins at week 10 and then every two weeks thereafter after IV induction is complete.
Home infusion recognized (S9359); Zymfentra attestation still required if access/support barriers exist
Home infusion services (S9359) are recognized for anti‑TNF IV therapy; for Zymfentra requests, the provider must still attest if the member cannot access facility or home care supports or lacks transportation to continue IV infliximab.
- *Use S9359 for home infusion administrative/per‑diem coding; include attestation for Zymfentra as required.
Biosimilars and Product Notes
Remicade and biosimilars covered; Zymfentra SC has IV induction and attestation specifics
Remicade and listed biosimilars are included as covered infliximab products; Zymfentra (SC infliximab-dyyb) has the specific requirement that patients complete IV induction prior to SC maintenance and requires provider attestation when continuing IV is not feasible.
- *Biosimilars listed alongside Remicade include Inflectra, Avsola, Renflexis, and Zymfentra (SC formulation).
Infliximab and biosimilars covered; no explicit preference in excerpt
The document covers infliximab and listed biosimilars; explicit product preference rules are not specified in this excerpt—follow coding/HCPCS guidance in policy.
Inflectra (infliximab‑dyyb) covered — HCPCS Q5103
Infliximab biosimilar Inflectra is listed as covered and is associated with HCPCS code Q5103 in the policy's coding table.
Renflexis (infliximab‑abda) covered — HCPCS Q5104
Infliximab biosimilar Renflexis is listed as covered and is associated with HCPCS code Q5104 in the policy's coding table.
Avsola (infliximab‑axxq) covered — HCPCS Q5121
Infliximab biosimilar Avsola is listed as covered and is associated with HCPCS code Q5121 in the policy's coding table.
Zymfentra (J1748) listed — provider attestation required for SC requests
Infliximab product J1748 (Zymfentra) is listed; requests for Zymfentra require provider attestation that the member cannot continue IV infliximab due to lack of caregiver/support, inadequate access to facility/home care, or lack of transportation.
- *J1748 corresponds to Zymfentra in the coding table; attestation elements are specified in UC/CD criteria and Appendix D.
Clinical Documentation and Definitions
Background: Infliximab and listed biosimilars (e.g., infliximab‑dyyb/Inflectra/Zymfentra, infliximab‑abda/Renflexis, infliximab‑axxq/Avsola) are tumor necrosis factor (TNF) blockers used to treat multiple immune‑mediated inflammatory diseases including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Standard IV induction for most indications is an induction series followed by maintenance dosing (commonly 5 mg/kg for many indications), and some indication‑specific dosing variations (for example, RA dosing with methotrexate may use 3 mg/kg). Zymfentra is a subcutaneous infliximab formulation with specific post‑IV induction use requirements noted in the policy.
Revision History
Annual review updated preferred adalimumab products; added Zymfentra provider attestation requirement for CD and UC requests if member is unable to receive continued IV infliximab due to lack of caregiver/support, inadequate access to facility/home care, or lack of transportation; added option to document modified Mayo Score ≥ 5 for UC initial criteria and supplemental Appendix F information; updated Kawasaki disease maximum single infusion dose from 5 mg/kg over 2 hours to 10 mg/kg over 2 hours; removed the sentence 'if new dosing regimen, approve for 6 months' from the continued therapy approval duration.
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