Prior authorization and coverage criteria for infliximab products for Mass General Brigham Health Plan members, covering medical and pharmacy benefits and applicable to Commercial/Exchange and MassHealth UPPL plans.
Change TypeRevisions and clarifications to authorization language and dosing guidance
Effective DateOct 1, 2024
Next Review DateN/A
Key ActionSubmit prior authorization with documentation of diagnosis, prior treatment history (paid claims or attestation), appropriate dosing, and clinical rationale when choosing infliximab over specified comparators.
Appendix C updated to allow more aggressive dosing of infliximab products for pediatric members when standard weight-based dosing is inadequate.
multipleIndications listed
numerousOff-label conditions
required
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Prior authorization
with documentationContinuation allowed
3 moInitial auth (psoriasis/off-label)
6 moInitial auth (other)
Coverage Criteria for Infliximab Products
Moderate to severe rheumatoid arthritis (Initial therapy)
Authorization may be granted when ALL of the following are met:
RA initial criteria: 1) Diagnosis of moderate to severe rheumatoid arthritis; 2) Paid claim or provider attestation of inadequate response or adverse reaction to ONE traditional DMARD or contraindication to traditional DMARDs; 3) Member meets ONE of the following: paid claim or provider attestation of inadequate response or adverse reaction to ONE biologic DMARD that is FDA‑approved for the requested indication OR provider provides clinical rationale for use of the requested agent instead of Enbrel and Humira; 4) Appropriate dosing documented.
from chunks 3-4
Psoriatic arthritis
Authorization may be granted when ALL of the following are met:
PsA initial criteria: 1) Diagnosis of psoriatic arthritis; 2) Appropriate dosing documented; 3) Provider provides clinical rationale for use of the requested agent instead of Enbrel and Humira.
from chunk 5
Ankylosing spondylitis
Authorization may be granted when ALL of the following are met:
AS initial criteria: 1) Diagnosis of ankylosing spondylitis; 2) Paid claims or physician attestation of inadequate response or adverse reaction to TWO NSAIDs or contraindication to ALL NSAIDs; 3) Appropriate dosing documented; 4) Provider provides clinical rationale for use of the requested agent instead of Enbrel and Humira.
from chunk 6
Moderate to severe plaque psoriasis
Authorization may be granted when ALL of the following are met:
Plaque psoriasis initial criteria: 1) Diagnosis of moderate to severe plaque psoriasis; 2) Member meets ONE of the following: paid claims or physician attestation of inadequate response or adverse reaction to ONE or contraindication to ALL conventional therapies (topical agent, phototherapy, or systemic agent) OR paid claims or physician attestation of inadequate response or adverse reaction to ONE biologic DMARD that is FDA‑approved for plaque psoriasis; 3) Appropriate dosing documented; 4) Provider provides clinical rationale for use of the requested agent instead of Enbrel and Humira.
from chunk 7
Crohn's disease (including fistulizing)
Authorization may be granted when ALL of the following are met:
Crohn's disease initial criteria: 1) Diagnosis of moderate to severe Crohn's disease (including fistulizing disease where applicable); 2) Appropriate dosing documented; 3) Provider provides clinical rationale for use of the requested agent instead of Humira (adalimumab).
from chunks 8-9
Ulcerative colitis
Authorization may be granted when ALL of the following are met:
Ulcerative colitis initial criteria: 1) Diagnosis of moderate to severe ulcerative colitis; 2) Appropriate dosing documented; 3) Provider provides clinical rationale for use of the requested agent instead of Humira (adalimumab). Requests for more frequent or higher doses refer to Appendix C.
from chunk 10
Off-label and less common indications (e.g., Behcet's, hidradenitis suppurativa, sarcoidosis, SAPHO, scleritis, Takayasu arteritis, uveitis)
Authorization may be granted when ALL of the following condition-specific criteria are met:
Behcet's Disease: 1) Diagnosis of Behcet's Disease; 2) Paid claims or physician attestation of inadequate response or adverse reaction to topical corticosteroids OR systemic corticosteroids (as specified); 3) Paid claims or physician attestation of inadequate response or adverse reaction to one of the listed immunomodulatory agents (azathioprine, colchicine, cyclophosphamide, cyclosporine, methotrexate, apremilast); 4) Clinical rationale for use of the requested agent instead of Enbrel and Humira.
from chunk 11
Hidradenitis suppurativa: 1) Diagnosis of moderate to severe hidradenitis suppurativa (Hurley Stage II or III); 2) Paid claims within 6 months or physician attestation of inadequate response or adverse reaction to ONE oral antibiotic or contraindication to ALL oral antibiotics (e.g., rifampin, clindamycin, tetracycline, doxycycline, minocycline); 3) Paid claims or physician attestation of inadequate response, adverse reaction, or contraindication to Humira (adalimumab).
from chunk 12
Neurologic sarcoidosis: 1) Diagnosis of neurologic sarcoidosis; 2) Paid claims or physician attestation of inadequate response or adverse reaction to ONE systemic corticosteroid or contraindication to ALL systemic corticosteroids; 3) Paid claims or physician attestation of inadequate response or adverse reaction to TWO or contraindication to ALL of the following: azathioprine, cyclophosphamide, leflunomide, methotrexate, mycophenolate mofetil.
Uveitis – Initial Therapy
Covered when ALL of the following are met for uveitis:
Uveitis coverage: 1) Diagnosis of uveitis.
from chunk 18
Prior therapy requirement A: 2) Paid claims or physician attestation of inadequate response, adverse reaction, or contraindication to BOTH: (a) ophthalmic (topical), oral, or injectable glucocorticoids; and (b) oral or injectable immunosuppressive therapy (e.g., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus, cyclophosphamide).
from chunk 18
Prior therapy requirement B: 3) ONE of: (a) Paid claims or physician attestation of inadequate response, adverse reaction, or contraindication to adalimumab (Humira); OR (b) clinical rationale for use of the requested agent instead of adalimumab.
from chunk 18
Continuation of therapy
Resubmission criteria for ongoing therapy
Continuation: Resubmission by prescriber will infer a positive response to therapy and request can be recertified if dosing is appropriate.
from chunk 19
More frequent / higher dose requests
More frequent/higher dosing may be approved when ALL of the following are provided:
Dose escalation criteria: 1) Documentation of severe disease; 2) ONE of: (a) inadequate response or adverse reaction to ONE other injectable biologic which is FDA‑approved for the requested indication; OR (b) contraindication to ALL other injectable biologics which are FDA‑approved for the requested indication; 3) Documented partial response to FDA‑approved dosing of current biologic therapy; 4) Documentation of specialist consult for the requested indication. Exceptions: pediatric members where standard weight‑based dosing is inadequate for listed infliximab regimens; or IBD requests with low infliximab trough and low/no antibodies (recommended trough >= 5 mcg/mL).
from chunk 23
Authorizations will be reviewed on a case-by-case basis for members who are new to the plan and are currently receiving the requested infliximab medication. Coverage consideration does not apply when the product was obtained as samples or through the manufacturer's patient assistance programs; these scenarios are excluded from continuity coverage.
If a member has a documented contraindication to ALL of the most commonly used traditional DMARDs — specifically methotrexate, sulfasalazine, and hydroxychloroquine — then a trial with a traditional DMARD may be bypassed when assessing eligibility for infliximab therapy.
Prior Authorization Required: Prior authorization is required for the requested agents. Authorization requests for members who are already receiving the requested medication and are new to the plan will be reviewed on a case‑by‑case basis; approval is not automatic and may be denied if required documentation is missing. Providers should submit complete supporting documentation to avoid delays or denials.
Prior authorization required for all indications
Special-case review for members new to plan who are currently receiving treatment
Step Therapy
Step Therapy / Prior Treatment Requirements
Step therapy and prior treatment requirements vary by indication. Provide paid claims or provider attestation documenting prior therapies, inadequate response, adverse reaction, or contraindication as indicated below.
Rheumatoid arthritis: inadequate response or adverse reaction to ONE traditional DMARD or contraindication to traditional DMARDs; AND inadequate response or adverse reaction to ONE biologic DMARD approved for the indication, plus clinical rationale if requesting an alternative to etanercept (Enbrel) or adalimumab (Humira)
Coding, Definitions and Product List
Infliximab products
Avsolainfliximab-axxq
Inflectrainfliximab-dyyb
Remicadeinfliximab
Renflexisinfliximab-adba
Traditional DMARDs / Conventional therapies
MethotrexateExample traditional DMARD used in step therapy requirements
SulfasalazineExample traditional DMARD used in step therapy requirements
Background
Infliximab is an anti-TNF biologic agent with multiple FDA‑approved indications. It is approved for conditions including rheumatoid arthritis, Crohn's disease (including fistulizing disease), ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and moderate to severe plaque psoriasis.
Policy Revision History
2024-10-01revisionLatest
Removed language about approvals for new members currently stable on specific infliximab products; eliminated stability-based preferred-product language.
2023-06-05revision
Separated pharmacy (Rx) versus medical benefit (MB) policies and removed the preferred product requirement.
Change TypeRevisions and clarifications to authorization language and dosing guidance
Effective DateOct 1, 2024
Next Review DateN/A
Key ActionSubmit prior authorization with documentation of diagnosis, prior treatment history (paid claims or attestation), appropriate dosing, and clinical rationale when choosing infliximab over specified comparators.
Pulmonary sarcoidosis: 1) Diagnosis of pulmonary sarcoidosis; 2) Inadequate response, adverse reaction, or contraindication to systemic glucocorticoids AND one traditional DMARD (methotrexate, azathioprine, leflunomide, or mycophenolate); 3) Paid claims or physician attestation of inadequate response, adverse reaction, or contraindication to Humira (adalimumab); 4) Prescriber must document clinical rationale for use of infliximab products.
from chunk 14
SAPHO syndrome: 1) Diagnosis of SAPHO; 2) Paid claims or physician attestation of inadequate response or adverse reaction to ONE NSAID or contraindication to ALL NSAIDs; 3) Paid claims or physician attestation of inadequate response or adverse reaction to ONE systemic corticosteroid or contraindication to ALL systemic corticosteroids; 4) Clinical rationale for use instead of Enbrel and Humira.
from chunk 15
Scleritis: 1) Diagnosis of scleritis; 2) Paid claims or physician attestation of inadequate response, adverse reaction, or contraindication to BOTH: ophthalmic (topical), oral or injectable glucocorticoids AND oral or injectable immunosuppressive therapy (e.g., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus, cyclophosphamide).
from chunk 16
Takayasu arteritis: 1) Diagnosis of Takayasu arteritis; 2) Paid claims or physician attestation of inadequate response, adverse reaction, or contraindication to systemic glucocorticoids AND one traditional DMARD (methotrexate, azathioprine, leflunomide, or mycophenolate); 3) Paid claims or physician attestation of inadequate response, adverse reaction, or contraindication to Humira (adalimumab) and Enbrel (etanercept); 4) Prescriber must document clinical rationale for using infliximab products instead of Humira and Enbrel.
from chunk 17
Uveitis (off‑label group): 1) Diagnosis of uveitis; 2) Paid claims or physician attestation of inadequate response, adverse reaction, or contraindication to BOTH ophthalmic (topical), oral or injectable glucocorticoids AND oral or injectable immunosuppressive therapy (e.g., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus, cyclophosphamide); 3) Either inadequate response/adverse reaction/contraindication to Humira (adalimumab) OR clinical rationale for use of the requested agent instead of Humira.
from chunk 18
Psoriatic arthritis: diagnosis plus appropriate dosing and clinical rationale for use instead of Enbrel or Humira
Ankylosing spondylitis: inadequate response or adverse reaction to TWO NSAIDs or contraindication to ALL NSAIDs, appropriate dosing, and clinical rationale vs Enbrel/Humira
Plaque psoriasis: inadequate response/adverse reaction to ONE conventional therapy (topical, phototherapy, or systemic) or contraindication to all; OR inadequate response/adverse reaction to ONE biologic FDA‑approved for plaque psoriasis; plus dosing and clinical rationale vs Enbrel/Humira
Crohn's disease and Ulcerative colitis: diagnosis, appropriate dosing, and clinical rationale when requesting an alternative to Humira; requests for more frequent/higher doses require additional documentation
Hidradenitis suppurativa: diagnosis (Hurley Stage II or III), inadequate response/adverse reaction to ONE oral antibiotic (or contraindication to ALL), and inadequate response/adverse reaction/contraindication to Humira
Traditional DMARDs examples: methotrexate, sulfasalazine, hydroxychloroquine, azathioprine, leflunomide, cyclosporine; if member has contraindication to ALL commonly used traditional DMARDs (methotrexate, sulfasalazine, hydroxychloroquine), a trial may be bypassed
Step Therapy
Uveitis Prior Therapy Requirement
Uveitis prior therapy requirement: For uveitis, submit documentation of diagnosis and paid claims or physician attestation showing inadequate response, adverse reaction, or contraindication to BOTH ophthalmic (topical), oral or injectable glucocorticoids AND oral or injectable immunosuppressive therapy (examples: azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus, cyclophosphamide). Also provide either inadequate response/adverse reaction/contraindication to Humira (adalimumab) or clinical rationale for use of the requested agent instead of adalimumab.
Diagnosis of uveitis required
Documentation of inadequate response/adverse reaction/contraindication to BOTH topical/oral/injectable glucocorticoids AND oral/injectable immunosuppressive therapy
Evidence of inadequate response/adverse reaction/contraindication to Humira or clinical rationale for alternative agent
Documentation Required
Required Documentation
Required Documentation: Submit clinical documentation to support the request. Incomplete documentation may result in denial, especially for members new to the plan.
Diagnosis and relevant clinical findings
Paid pharmacy or medical claims showing prior therapies and dates OR signed provider attestation describing prior therapies, inadequate response, adverse reaction, or contraindication
Current and prior medication dosing and dates
Clinical rationale when requesting an agent instead of etanercept (Enbrel) or adalimumab (Humira)
Specialist consult notes when applicable
Documentation Required
Documentation for Dose Escalation
Documentation for Dose Escalation / More Frequent or Higher Doses: Requests for more frequent or higher doses of injectable biologics must include documentation supporting the need for escalation.
Documentation of severe disease
Documented partial response to FDA‑approved dosing of the current biologic therapy
Evidence of inadequate response or adverse reaction to ONE other injectable biologic FDA‑approved for the indication OR documentation of contraindication to ALL other FDA‑approved injectable biologics
Specialist consultation for the requested indication
Situations where a trial may be bypassed (see Appendix C): e.g., specific infliximab products with documentation that standard weight‑based dosing is inadequate in pediatric members, or low drug levels with no/low antibodies for IBD with infliximab and documented trough level ≥5 mcg/mL
HydroxychloroquineExample traditional DMARD used in step therapy requirements
AzathioprineExample traditional DMARD used in step therapy requirements
LeflunomideExample traditional DMARD used in step therapy requirements
Clarified initial authorization durations by indication and added multiple off-label indications (Behcet's disease, hidradenitis suppurativa, neurologic and pulmonary sarcoidosis, SAPHO, scleritis, Takayasu arteritis, uveitis).
2023-01-11revision
Updated wording to replace generic 'appropriate diagnosis' with specific indications and added initial off-label indications; included provisional stability-language for certain infliximab products (later removed).