RXMP-11 Infliximab Form

infliximab

Updated on: 10/25/2025

Page 1 of 6 Policy Number RXMP-11 Line of Business Medicaid & Medicare Effective Date 2/1/2019 Revision Date 10/25/2025

Products: Avsola, Inflectra, Ixifi, Remicade, Renflexis

Override(s)
Approval Duration
Prior Authorization
Quantity Limit – see dosing information Initial 3 months Renewal: 12 months

HCPCS Description Medical Benefit, Authorization Required; not covered under the Pharmacy Benefit J1745 Injection, infliximab, excludes biosimilar, 10 mg (Remicade) Q5103 Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg (preferred) Q5104 Injection, infliximab-abda, biosimilar, (renflexis), 10 mg Q5109 Injection, infliximab-qbtx, biosimilar, (ixifi), 10 mg [Product not launched - no NDCs currently available] Q5121 Injection, infliximab-axxq, biosimilar, (avsola), 10 mg (preferred)

Medicare Criteria Medicare Part B Coverage Criteria
Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD/NCD/LCA found as of 10/25/2025. Review using infliximab criteria below Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• No step therapy

Approval Criteria Products J1745 Injection, infliximab, excludes biosimilar, 10 mg (Remicade) Q5103 Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg (preferred) Q5104 Injection, infliximab-abda, biosimilar, (renflexis), 10 mg Q5109 Injection, infliximab-qbtx, biosimilar, (ixifi), 10 mg [Product not launched - no NDCs currently available] Q5121 Injection, infliximab-axxq, biosimilar, (avsola), 10 mg (Preferred) Indications All Approval Length Renewal: 12 months Override Type PA, QL CONTINUATION CRITERIA FOR APPROVAL FOR MEDICARE/MEDICAID:

1. Member is not receiving infliximab in combination with any of the following: a. Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Enbrel (etanercept), Humira adalimumab), Cimzia (certolizumab), Simponi (golimumab)] b. Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] c. Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilas AND

infliximab

Updated on: 10/25/2025

Page 2 of 6

2. For Medicaid: The preferred agent is Avsola or Inflectra. For Ixifi, Remicade, or Renflexis, trial and failure, contraindication, or intolerance to Avsola or Inflectra;
   OR
3. For Medicare: For members previously on Remicade, Renflexis, or Ixifi, review with the continuation of therapy criteria below.
   AND

4. One of the following are met: Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, or Sarcoidosis
   a. Rheumatoid Arthritis (RA) AND documentation of positive clinical response to therapy as evidenced by at least one of the following:
   1) Reduction in the total active (swollen and tender) joint count from baseline; OR 2) Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline. b. Psoriatic Arthritis (PsA) AND documentation of positive clinical response to therapy as evidenced by at least one of the following:
   1) Reduction in the total active (swollen and tender) joint count from baseline; 2) Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline; 3) Reduction in the body surface area (BSA) involvement from baseline; OR c. Plaque Psoriasis (PsO) AND documentation of positive clinical response to infliximab therapy as evidenced by ONE of the following: 1) Reduction the body surface area (BSA) involvement from baseline
   2) Improvement in symptoms (e.g., pruritus, inflammation) from baseline
   d. Ankylosing Spondylitis (AS) AND documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following:
   1) Disease activity (e.g., pain, fatigue, inflammation, stiffness)
   2) Lab values (erythrocyte sedimentation rate, C-reactive protein level)
   3) Function
   4) Axial status (e.g., lumbar spine motion, chest expansion)
   5) Total active (swollen and tender) joint count
   e. Crohn's Disease (CD) or Fistulizing Crohn's Disease AND documentation of positive clinical response to therapy as evidenced by at least one of the following:
   1) Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
   2) Reversal of high fecal output state
   f. Ulcerative Colitis (UC) AND documentation of positive clinical response to therapy as evidenced by at least one of the following:
   1) Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
   2) Reversal of high fecal output state
   g. Sarcoidosis [Off-label] AND documentation of positive clinical response to infliximab therapy,

   Products J1745 Injection, infliximab, excludes biosimilar, 10 mg (Remicade) Q5103 Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg (preferred) Q5104 Injection, infliximab-abda, biosimilar, (renflexis), 10 mg Q5109 Injection, infliximab-qbtx, biosimilar, (ixifi), 10 mg [Product not launched - no NDCs currently available] Q5121 Injection, infliximab-axxq, biosimilar, (avsola), 10 mg (Preferred) Indications All Approval Length Initial 3 months Override Type PA, QL For all diagnosis:

5. Member is not receiving infliximab in combination with any of the following:

infliximab

Updated on: 10/25/2025

Page 3 of 6 a. Biologic disease-modifying antirheumatic drug (DMARD) [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] b. Janus kinase inhibitor [e.g., Xeljanz (tofacitinib), Olumiant (baricitinib)] c. Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilas AND

2. For Ixifi, Remicade, or Renflexis, trial and failure, contraindication, or intolerance to Avsola or Inflectra; AND

3. One of the following criteria below is met: Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Sarcoidosis

   Rheumatoid Arthritis a. Diagnosis of moderately to severely active Rheumatoid Arthritis; AND b. Prescribed by or in consultation with a rheumatologist; AND c. Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses:
   a. methotrexate
   b. leflunomide
   c. sulfasalazine
   AND d. Used in combination with methotrexate
   OR Psoriatic Arthritis a. Diagnosis of active Psoriatic Arthritis; AND b. One of the following:
   1) Actively inflamed joints
   2) Dactylitis
   3) Enthesitis
   4) Axial disease
   5) Active skin and/or nail involvement
   AND c. Prescribed by or in consultation with Dermatologist or Rheumatologist. OR Plaque Psoriasis a. Diagnosis of chronic severe (i.e., extensive and/or disabling) plaque psoriasis; AND b. One of the following:
   1) Greater than or equal to 3% body surface area involvement
   2) Severe scalp psoriasis
   3) Palmoplantar (i.e., palms, soles), facial, or genital involvement
   AND c. Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies:
   1) corticosteroids (e.g., betamethasone, clobetasol)
   2) vitamin D analogs (e.g., calcitriol, calcipotriene)
   3) tazarotene
   4) calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
   5) anthralin
   6) coal tar
   AND d. Prescribed by or in consultation with a dermatologist
   OR Ankylosing Spondylitis

infliximab

Updated on: 10/25/2025

Page 4 of 6 a. Diagnosis of active ankylosing spondylitis; AND b. Prescribed by or in consultation with a rheumatologist; AND c. Trial and failure of a minimum duration of one (1) month, contraindication, or intolerance to two (2) different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses. OR Crohn's Disease or Fistulizing Crohn's Disease a. One of the following diagnoses:
1) Moderately to severely active Crohn's disease; or 2) Fistulizing Crohn's disease. AND b. One of the following:
1) Frequent diarrhea and abdominal pain; 2) At least 10% weight loss; 3) Complications such as obstruction, fever, abdominal mass; 4) Abnormal lab values (e.g., C-reactive protein [CRP]); or 5) CD Activity Index (CDAI) greater than 220. AND c. Prescribed by or in consultation with a gastroenterologist; AND d. Trial and failure, contraindication, or intolerance to one of the following conventional therapies:
1) 6-mercaptopurine; 2) Azathioprine; 3) Corticosteroids (e.g., prednisone); or 4) Methotrexate
OR Ulcerative Colitis a. Diagnosis of moderately to severely active ulcerative colitis; AND b. One of the following:
1) Greater than 6 stools per day; 2) Frequent blood in the stools; 3) Frequent urgency; 4) Presence of ulcers;
5) Abnormal lab values (e.g., hemoglobin, ESR, CRP); or 6) Dependent on, or refractory to, corticosteroids
AND c. Prescribed by or in consultation with a gastroenterologist AND d. Trial and failure, contraindication, or intolerance to one of the following conventional therapies:
a. 6-mercaptopurine; b. Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine); c. Azathioprine; or d. Corticosteroids (e.g., prednisone)
OR Sarcoidosis [Off-label] a. Diagnosis of sarcoidosis AND b. Prescribed by or in consultation with one of the following specialist: Pulmonologist, Dermatologist, Ophthalmologist;
AND c. Trial and failure, contraindication, or intolerance to one corticosteroid (e.g., prednisone); AND d. Trial and failure, contraindication, or intolerance to one immunosuppressant (e.g., methotrexate, cyclophosphamide, or azathioprine).

infliximab

Updated on: 10/25/2025

Page 5 of 6 Exclusion: When used in combination with another Anti-TNF agents.

FDA Indications & Dosing Indication Dosing/Administration Ankylosing spondylitis, Active ▪ Induction, 5 mg/kg IV over at least 2 hours given at week 0, 2 and 6, followed by maintenance therapy ▪ Maintenance, 5 mg/kg IV over at least 2 hours every 6 weeks Crohn's disease, Fistulizing ▪ Induction, 5 mg/kg IV over at least 2 hours at weeks 0, 2, and 6 followed by maintenance therapy ▪ Maintenance, 5 mg/kg IV over at least 2 hours every 8 weeks; 10 mg/kg IV every 8 weeks may be considered for patients who initially respond and then become unresponsive; patients unresponsive at week 14 are unlikely to respond with continued dosing, consider discontinuation Crohn's disease (Moderate to Severe), In patients with an inadequate response to conventional therapy
▪ Induction, 5 mg/kg IV over at least 2 hours at weeks 0, 2, and 6 followed by maintenance therapy ▪ Maintenance, 5 mg/kg IV over at least 2 hours every 8 weeks; 10 mg/kg IV every 8 weeks may be considered for patients who initially respond and then become unresponsive; patients unresponsive at week 14 are unlikely to respond with continued dosing and discontinuation should be considered Plaque psoriasis, chronic (Severe)
▪ Initial, 5 mg/kg IV over at least 2 hours at weeks 0, 2, and 6, followed by maintenance therapy (FDA dosage)
▪ Maintenance, 5 mg/kg IV over at least 2 hours every 8 weeks (FDA dosage)
▪ Initial, 5 mg/kg IV infusion at weeks 0, 2, and 6, followed by 5 mg/kg every 8 weeks. For better disease control in some patients, a more frequent interval (less than 8 weeks and as frequently as every 4 weeks during maintenance) and/or a higher dose up to 10 mg/kg) may be necessary Polyarteritis nodosa
5 mg/kg IV at 0, 2, and 6 weeks, then every 8 weeks; given with prednisoLONE tapered to 10 mg/day (off-label dosage)
Psoriatic arthritis ▪ Induction, 5 mg/kg IV over at least 2 hours given at week 0, 2 and 6; followed by maintenance therapy (FDA dosage)
▪ Maintenance, 5 mg/kg IV over at least 2 hours every 8 weeks (FDA dosage)
▪ Concomitant medication, may be given with or without methotrexate (FDA dosage)
▪ Dose escalation: 10 mg/kg IV every 8 weeks from week 0 through week 32 produced improvements in patients with loss of efficacy on standard dosage (off-label dosage) Rheumatoid arthritis (Moderate to Severe), In combination with methotrexate
▪ Induction, 3 mg/kg IV over at least 2 hours given at weeks 0, 2, and 6; followed by maintenance therapy ▪ Maintenance, 3 mg/kg IV every 8 weeks; may increase dose up to 10 mg/kg IV every 8 weeks OR give 3 mg/kg IV every 4 weeks in patients with an incomplete response ▪ Concomitant medication, give with methotrexate Sarcoidosis, Refractory; Adjunct ▪ 3 to 5 mg/kg IV at week 0 and 2, then once every 4 to 6 weeks (guideline dosage) Takayasu's disease, Refractory ▪ 3 mg/kg or 5 mg/kg IV every 4 to 8 weeks was administered in a 12-month, multicenter, retrospective study (n=15) Ulcerative colitis (Moderate to Severe), In patients with an ▪ Induction, 5 mg/kg IV over at least 2 hours at weeks 0, 2, and 6 followed by maintenance therapy

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Updated on: 10/25/2025

Page 6 of 6 Indication Dosing/Administration inadequate response to conventional therapy
▪ Maintenance, 5 mg/kg IV over at least 2 hours every 8 weeks

Indication Remicade Inflectra Renflexis Ixifi Avsola Ankylosing spondylitis, Active X X X X X Crohn's disease, Fistulizing X X X X X Crohn's disease (Moderate to Severe), In patients with an inadequate response to conventional therapy
X X X X X Plaque psoriasis, chronic (Severe)
X X X X X Polyarteritis nodosa
X

Psoriatic arthritis X X X X X Rheumatoid arthritis (Moderate to Severe), In combination with methotrexate
X X X X X Sarcoidosis, Refractory; Adjunct X

Takayasu's disease, Refractory X

Ulcerative colitis (Moderate to Severe), In patients with an inadequate response to conventional therapy
X X X X X

References

1. OptumRx, PA criteria, accessed May 2023.
2. CodeSource, accessed May 2023.

3. Micromedex, accessed May 2023.

   Review History

4. Biologics & Immunologics, retired May 2023, HB.
5. Infliximab, new as of 5/31/2023, HB.
6. Added Continuity of Care requirement, 4/2/2025, AP