CurrentHawaii Medical Service Association (HMSA)Policy N/A

Infliximab and biosimilars prior authorization (Remicade, Inflectra, Renflexis, Avsola)

Prior authorization form and criteria for infliximab and its biosimilars for multiple inflammatory and autoimmune indications for members whose prescription benefit is administered by CVS Caremark for HMSA.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyInfliximab and biosimilars prior authorization (Remicade, Inflectra, Renflexis, Avsola)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionFax the completed prior authorization form to CVS Caremark Specialty Programs at 1-866-237-5512 for coverage determination.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

40+distinct form questions/criteria items

4listed product names

20+covered diagnoses/indications listed

1fax number for submission

Coverage Criteria for Infliximab and Biosimilars

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General requirements: Completed prior authorization form with accurate diagnosis (ICD-10), body weight, product requested, TB screening status, and prior biologic use; form submitted to CVS Caremark via fax

See Section A questions 1-17

Indication of request: Requested use must be for one of the listed diagnoses (e.g., Crohn's disease, ulcerative colitis, RA, AS/axial spondyloarthritis, PsA, chronic severe plaque psoriasis, JIA, Behcet's, Takayasu's arteritis, uveitis, sarcoidosis, hidradenitis suppurativa, immune checkpoint inhibitor toxicity, pyoderma gangrenosum, granulomatosis with polyangiitis, reactive arthritis)

See question 2 for full list

TB screening and management: Documentation of TB testing (e.g., PPD, IGRA, chest x-ray) within required interval or documentation of latent/active TB status and whether treatment for latent TB has been initiated or completed

See Section A questions 8-14

Crohn's disease: If fistulizing disease: qualifies; otherwise requires inadequate response to at least one conventional therapy option or intolerance/contraindication

See Section B questions 18-20

Ulcerative colitis: Acute severe hospitalized UC qualifies; otherwise requires inadequate response to at least one conventional therapy option or intolerance/contraindication

See Section C questions 21-23

Rheumatoid arthritis (RA) and Reactive arthritis: Infliximab should be prescribed in combination with methotrexate or leflunomide unless a clinical reason is provided; alternatively, inadequate response to methotrexate after >=3 months at >=20 mg/week, intolerance, or contraindication meets the requirement>=3 months at >=20 mg/week

See Section D questions 24-27

Ankylosing spondylitis / Axial spondyloarthritis: Requires inadequate response to at least two NSAIDs or intolerance/contraindication to at least two NSAIDs

See Section E question 28

Plaque psoriasis: Qualifies if crucial body areas are affected OR BSA >= 10% OR inadequate response/intolerance to phototherapy or systemic agents (methotrexate, cyclosporine, acitretin) or clinical reason to avoid themBSA >=10%

See Section G questions 29-32

Juvenile idiopathic arthritis (JIA): Requires inadequate response to at least one of: >=1 month NSAIDs, >=2 weeks corticosteroids, >=3 months methotrexate, or >=3 months leflunomide; if yes, no further questions

See Section F question 33

Behcet's disease: Requires inadequate response to at least one nonbiologic medication for Behcet's disease (e.g., apremilast, colchicine, systemic glucocorticoids, azathioprine)

See Section G question 34

Takayasu's arteritis and Uveitis: Requires inadequate response, intolerance, or contraindication to corticosteroids and/or immunosuppressive therapy (e.g., cyclophosphamide, azathioprine, methotrexate, mycophenolate)

See Section 12

Hidradenitis suppurativa: Requires inadequate response to at least 90 days of oral antibiotics or documented intolerance/contraindication>=90 days

See Section I questions 36-38

Immune checkpoint inhibitor toxicity: Requires inadequate response to corticosteroids prior to approval; cardiac toxicity must be documented/assessed

See Section J questions 39-40

Listed Products, Codes and Clinical Thresholds

Listed productsmixed

Remicade	Infliximab reference product
Inflectra	Infliximab biosimilar
Renflexis	Infliximab biosimilar
Avsola	Infliximab biosimilar

inv-05: Body Surface Area (BSA) — >= 10%

Threshold>= 10% body surface area (BSA) affected

ContextApplies to chronic severe plaque psoriasis when determining eligibility for infliximab or biosimilars

Form logicIf BSA >= 10%, no further psoriasis severity questions are required on the form

inv-06: Methotrexate trial duration for RA — >= 3 months at >= 20 mg/week

Required trial duration and dose>= 3 months of methotrexate at >= 20 mg per week

Applies toRheumatoid arthritis (and considered for reactive arthritis as indicated)

Form implicationIf inadequate response after this trial, no further methotrexate questions are required

inv-07: Antibiotic trial for Hidradenitis Suppurativa — >= 90 days

Required antibiotic trial>= 90 days of oral antibiotics with inadequate response

Applies toSevere, refractory hidradenitis suppurativa

Form logicIf inadequate response after >=90 days, no further HS antibiotic questions are required

Provider Requirements and Submission Instructions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Fax the completed HMSA/CVS Caremark Prior Authorization form and all supporting clinical documentation to CVS Caremark Specialty Programs at 1-866-237-5512. Approvals may be subject to dosing limits per FDA labeling, accepted compendia, and evidence-based guidelines. If you have questions regarding prior authorization, call CVS Caremark at 1-808-254-4414; for Specialty Customer Care (eligibility, copay, delivery) call CaremarkConnect® at 1-800-237-2767.

Fax: 1-866-237-5512
Prior authorization phone: 1-808-254-4414
Specialty Customer Care: 1-800-237-2767

Step Therapy

Conservative Therapy Required Prior to Biologic

Before a biologic (infliximab or biosimilars) will be approved, document trials of and inadequate response or intolerance to appropriate conservative therapies for the diagnosed condition. Complete the relevant sections on the prior authorization form indicating which conventional/nonbiologic therapies were tried and the reason for failure (inadequate response, intolerance, or contraindication). Examples of conventional therapies to document include (by condition): - Ulcerative colitis/Crohn's: corticosteroids, azathioprine, mercaptopurine, mesalamine, cyclosporine, methotrexate, metronidazole/ciprofloxacin, tacrolimus, rifaximin - Rheumatologic conditions: methotrexate (≥3 months at ≥20 mg/week for RA unless intolerance/contraindication), leflunomide, NSAIDs - Psoriasis: phototherapy (UVB/PUVA), methotrexate, cyclosporine, acitretin - Hidradenitis suppurativa: ≥90 days oral antibiotics If the member has contraindications or intolerances to the listed conventional therapies, document the specific contraindication/intolerance on the form.

Document trial and outcome (inadequate response, intolerance, contraindication) for each listed conventional therapy
For RA: document methotrexate trial ≥3 months at ≥20 mg/week or reason for not using methotrexate
For HS: document ≥90 days of oral antibiotics or reason for avoidance

Documentation Required

Required Clinical Details

Include complete clinical details on the prior authorization form and fax submission: diagnosis and indication, ICD-10 code, specific prior medications tried (names, doses, durations, and outcomes), current weight (kg or lb), current use of infliximab or biosimilar (yes/no), relevant laboratory or hospitalization history (e.g., hospitalization for acute severe UC), and the prescriber's contact information (name, specialty, NPI, office phone/fax). Provide clinical rationale where a standard conservative therapy was not used or not tolerated.

Diagnosis/indication and ICD-10 code
List prior therapies with dose, duration, and reason for failure/intolerance
Patient weight (kg or lbs)
Current infliximab/biosimilar use: Yes/No
Relevant hospitalization or lab history (e.g., acute severe UC)
Prescriber name, specialty, NPI, office phone and fax

Denial Risk

Submission Requirement — Fax to 1-866-237-5512

Failure to fax the completed form and required supporting documentation to 1-866-237-5512 may result in denial or delay of the request. Send the completed form to CVS Caremark Specialty Programs; retain a copy for your records. If you receive this fax in error, notify the sender and destroy the fax.

Fax submissions only to: CVS Caremark Specialty Programs — 1-866-237-5512
Keep copies of submitted documentation
Fax received in error: notify sender and destroy

Definitions and Medication Use Notes

inv-13: TB screening — testing (PPD/IGRA/chest x-ray) and assessment before initiating therapy

Required testing modalitiesTuberculosis testing may include PPD (tuberculin skin test), IGRA (interferon-release assay), or chest x-ray

TimingTB test within 6 months of initiating therapy is asked on the form; elsewhere asks about testing within previous 12 months when risk factors present

AssessmentForm asks whether the patient has latent or active TB and the results of TB testing prior to anti-TNF initiation

Risk-factor evaluationIf risk factors for TB are present, the form asks additional testing and results questions

inv-14: Concomitant methotrexate — documentation when infliximab is prescribed with methotrexate or leflunomide

Documentation requiredIndicate whether infliximab is being prescribed in combination with methotrexate or leflunomide (Yes/No)

If not combined, provide reasonForm requests a clinical reason for not using methotrexate or leflunomide when RA is the diagnosis

Most actionable itemFor RA, the form requires documentation of concomitant methotrexate or leflunomide use or a clinical reason for omission

Related itemsQuestions 25–27 capture prior inadequate response, intolerance, or contraindication to methotrexate

OpenPayer

Infliximab and biosimilars prior authorization (Remicade, Inflectra, Renflexis, Avsola)

Coverage Criteria for Infliximab and Biosimilars

Listed Products, Codes and Clinical Thresholds

Provider Requirements and Submission Instructions

Definitions and Medication Use Notes

Background