Blue Cross Blue Shield Iowa adalimumab Coverage

Coverage Criteria by Indication

Continuation Criteria by Indication

Continuation therapy: Authorization of 12 months may be granted when the member meets ALL of the following continuation criteria for the specific indication.

ALL of the following

Documentation of initial authorization or previous coverage for adalimumab for the same indication by this or another payor, or documentation that the member has completed an induction/initial treatment period appropriate for the indication (e.g., induction dosing for Crohn's disease or ulcerative colitis).
Member demonstrates clinical response to adalimumab as evidenced by improvement in signs or symptoms or objective measures relevant to the indication (examples: decreased joint pain/swelling or improved function for RA/PsA/AS/JIA; reduction in Bowel Disease Activity Index, stool frequency, CRP, or endoscopic improvement for CD/UC; decrease in PASI or BSA for psoriasis; reduction in abscesses/sinus tracts for hidradenitis suppurativa; improvement in ocular inflammation for uveitis; improvement in severity of immunotherapy-related inflammatory arthritis).
Absence of treatment-limiting toxicity or adverse effects to adalimumab; if adverse effects occurred, documentation that benefits outweigh risks and monitoring plan is in place.
For all indications: negative active tuberculosis screen prior to initiation of biologic therapy (TST or IGRA within 12 months for biologic-naïve members) and no evidence of active TB. If latent TB is identified, documentation that appropriate treatment for latent TB has been started prior to continuation.
Member is not receiving adalimumab concomitantly with another biologic or targeted synthetic agent for the same indication.

Rheumatoid arthritis (RA) - Continuation

Member previously met initial RA criteria and has demonstrated clinical response on adalimumab.
If member is not taking concomitant methotrexate, documentation if dose escalation to 40 mg every week or 80 mg every other week was attempted when clinically indicated and tolerated (consistent with dosing guidance).

Articular juvenile idiopathic arthritis (JIA) - Continuation

Member previously met initial JIA criteria and has demonstrated clinical response on adalimumab.
For pediatric dosing, continuation request includes weight-based maintenance dosing consistent with product labeling (e.g., 10 kg to <15 kg: 10 mg every other week; 15 kg to <30 kg: 20 mg every other week; >=30 kg: 40 mg every other week).

Psoriatic arthritis (PsA) - Continuation

Member previously met initial PsA criteria and has demonstrated clinical response on adalimumab.
If member had mild-moderate disease and prior inadequate response to conventional systemic therapy was required initially, documentation of prior therapies or contraindication/intolerance must be on file.

Ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) - Continuation

Member previously met initial AS/nr-axSpA criteria and has demonstrated clinical response on adalimumab.
Documentation that member had inadequate response or intolerance/contraindication to at least two NSAIDs prior to initiating biologic therapy (if applicable at initiation) should be available in the record.

Crohn's disease (CD) - Continuation and Remission

Member previously met initial CD criteria and completed induction dosing per labeling (including pediatric loading where applicable).
Member demonstrates clinical response or maintenance of remission on adalimumab as documented by symptom control and objective markers (e.g., CRP, fecal calprotectin, endoscopy where appropriate).
For maintenance/continuation, dosing follows FDA-recommended maintenance regimens (weight-based pediatric maintenance and adult maintenance dosing 40 mg every other week or alternative labeled maintenance dosing).
Requests to continue therapy for members in remission should include documentation of the treating clinician's assessment that ongoing biologic therapy is necessary to maintain remission and the risks of discontinuation outweigh risks of continued therapy.

Ulcerative colitis (UC) - Continuation and Remission

Member previously met initial UC criteria and completed induction dosing per labeling (including pediatric loading where applicable).
Member demonstrates clinical response or maintenance of remission on adalimumab as documented by symptom control and objective markers (e.g., stool frequency, CRP, endoscopy where appropriate).
For maintenance/continuation, dosing follows FDA-recommended maintenance regimens (including pediatric maintenance dosing for ages 5 years and up).
Requests to continue therapy for members in remission should include documentation from the treating clinician that continued biologic therapy is required to maintain remission and that there is a monitoring plan for safety and efficacy.

Plaque psoriasis (PsO) - Continuation

Member previously met initial PsO criteria and has demonstrated clinical response on adalimumab (e.g., improvement in BSA, PASI, or involvement of crucial body areas).
If initial approval required prior systemic therapies or phototherapy, documentation of those prior treatments or clinical reasons to avoid them (see Appendix A) should be available.

Hidradenitis suppurativa - Continuation

Member previously met initial hidradenitis suppurativa criteria and has demonstrated clinical response on adalimumab (e.g., reduction in inflammatory nodules/abscesses).
For adolescents and adults, continuation dosing should be consistent with labeled regimens and documentation of prior inadequate response to oral antibiotics for at least 90 days or contraindication/intolerance to antibiotics should be available if required by initial criteria.

Uveitis (non-infectious intermediate, posterior, and panuveitis) - Continuation

Member previously met initial uveitis criteria and has demonstrated clinical response on adalimumab (improvement in ocular inflammation and vision-related symptoms).
Documentation that the member had inadequate response to or intolerance/contraindication to corticosteroids or immunosuppressive therapy (e.g., azathioprine, cyclosporine, methotrexate, mycophenolate) at initiation should be available.

Immune checkpoint inhibitor-related toxicity - Continuation

Member previously met initial criteria for treatment of immune checkpoint inhibitor-related toxicity and has demonstrated clinical response to adalimumab for moderate or severe immunotherapy-related inflammatory arthritis.
Documentation that member had inadequate response to corticosteroids or a conventional synthetic DMARD (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine) or has intolerance/contraindication to these agents, per initial criteria.

All other indications - Continuation

Member previously met initial criteria for the specific FDA-labeled indication and has demonstrated clinical response on adalimumab.
Continuation requests must include documentation of ongoing benefit, adherence to recommended dosing regimens, and absence of contraindications (including active TB).

ALL of the following

Operational note: Requests for continuation beyond 12 months require documentation of ongoing clinical benefit and adherence to monitoring and safety requirements; quantity limits and dosing must be consistent with the product-specific dosing tables and standard quantity limits (see Quantity Limits section).

ALL of the following

Adalimumab is considered not medically necessary and will be denied if the member does not meet the continuation criteria above, is using adalimumab concomitantly with another biologic/targeted synthetic for the same indication, or has active TB infection.

Initial Therapy Authorization Rules

Continuation and Renewal Requirements

Provider Requirements and Actionable Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for all adalimumab products. Initial prior authorization requests must include clinical documentation such as chart notes, medical records, or claims history that document prior therapies tried (if applicable) and the member's response, laboratory results and biomarker testing where relevant (e.g., RF, anti-CCP, CRP, ESR), and any clinical rationale for avoiding specific therapies when therapy is not advisable.

Submit chart notes, medical records, or claims history documenting prior medications tried and response
Include laboratory results/biomarker testing when applicable (e.g., RF, anti-CCP, CRP, ESR)
Document clinical reason to avoid prior therapies if therapy is not advisable

Prior Authorization

12-Month Authorization When Criteria Met

When indication-specific criteria are met, authorizations may be granted for up to 12 months. This applies to a range of labeled and compendial indications (see criteria list) and may be granted for both adults and pediatric members when the approval conditions for the specific indication are satisfied.

Procedures and Billing

Procedures and billingmixed

No codes listed

Step Therapy Requirements

Step	Requirement
1
Must meet Preferred Drug Plan Design AND the indication-specific criteria for initial approval/continuation of therapy.

Step	Requirement
1
Documented inadequate response to specified prior therapies, or intolerance/contraindication to those therapies, OR prior biologic use for the indication (examples include: inadequate response to ≥90 days of oral antibiotics for hidradenitis suppurativa; inadequate response to corticosteroids or immunosuppressives for uveitis or pyoderma gangrenosum; inadequate response to at least one nonbiologic for Behcet's disease; inadequate response to corticosteroids or a conventional synthetic DMARD for immune checkpoint inhibitor-related inflammatory arthritis).

Step

Requirement

Documented inadequate response to specified prior therapies, or intolerance/contraindication to those therapies, OR prior biologic use for the indication (examples include: inadequate response to ≥90 days of oral antibiotics for hidradenitis suppurativa; inadequate response to corticosteroids or immunosuppressives for uveitis or pyoderma gangrenosum; inadequate response to at least one nonbiologic for Behcet's disease; inadequate response to corticosteroids or a conventional synthetic DMARD for immune checkpoint inhibitor-related inflammatory arthritis).

Quantity Limits by Presentation

Adalimumab-aacf 40 mg/0.8 mL

ProductAdalimumab-aacf 40 mg/0.8 mL single-use prefilled syringe/pen

Standard limit4 syringes/pens per 28 days

FDA-recommended typical adult dosing40 mg every other week (may increase for RA patients not on methotrexate)

Adalimumab-adbm 10 mg/0.2 mL

ProductAdalimumab-adbm 10 mg/0.2 mL single-use prefilled syringe

Standard limit4 syringes per 28 days

NotesFDA-recommended dosing aligns with 40 mg every other week for most adult indications (see dosing tables)

Definitions, Preferred Product, and Abbreviations

Preferred product

Preferred productadalimumab-aacf is designated as the preferred adalimumab product for this program

Coverage for non-preferred productsCoverage for Humira and Hadlima is available only when clinical circumstances exclude use of the preferred product and may require documentation

Exception reviewClinical exception review requires medical records, physician evaluation information, and supporting compendia/literature as applicable

TB screening requirement

DefinitionDocumented negative tuberculosis test (TST or IGRA) within 12 months prior to initiating therapy for persons naive to biologic or targeted synthetic drugs

If positivePositive screening requires further evaluation to confirm no active disease (e.g., chest x-ray); do not administer adalimumab to members with active TB

Background

Adalimumab is an anti–tumor necrosis factor (TNF) biologic with labeled indications across multiple immune-mediated inflammatory diseases, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (≥2 years), psoriatic arthritis, ankylosing spondylitis, Crohn’s disease (≥6 years), ulcerative colitis (≥5 years), moderate to severe plaque psoriasis, hidradenitis suppurativa (≥12 years), and non-infectious uveitis (≥2 years). The policy also notes that effectiveness has not been established for patients who lost response to or were intolerant to other TNF blockers and that pediatric labeling differs between specific adalimumab products.

OpenPayer

Adalimumab (including biosimilars) — Coverage Criteria and Prior Authorization

Coverage Criteria by Indication

Initial Therapy Authorization Rules

Continuation and Renewal Requirements

Provider Requirements and Actionable Rules

Procedures and Billing

Step Therapy Requirements

Quantity Limits by Presentation

Definitions, Preferred Product, and Abbreviations

Background