CurrentMass General Brigham Health PlanPolicy N/A

Adalimumab prior authorization and step therapy

Defines prior authorization, step therapy, and quantity limits for nonpreferred adalimumab products for commercial/exchange members (pharmacy benefit); applies to requests for listed nonpreferred adalimumab formulations.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdalimumab prior authorization and step therapy

Policy CodePolicy N/A

Change TypeClinical and administrative revisions (product list, step therapy, reauthorization language)

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit medical records (e.g., chart notes) for reauthorization or when member is new to the plan to demonstrate current treatment or clinical improvement.

SourceLink

POLICY UPDATE CHANGES

Added adalimumab-bwwd to the policy as a nonpreferred adalimumab product.

Administrative update changing reauthorization language to require 'submission of medical records (e.g., chart notes...)' and updating language for members who are new to the Plan.

Updated criteria for Crohn's disease and ulcerative colitis to allow approval if disease severity warrants systemic biologic as first-line therapy.

Updated preferred and nonpreferred adalimumab product list and clarified step therapy language.

Quantity limits (including starter packs and per-injection limits) were added to the policy.

24 monthsapproval duration (initial / reauth)

90 daysnew-member documentation window

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2required preferred adalimumab trials

variedconventional therapy trial durations

1/365 daysstarter pack limit

Coverage Criteria for Nonpreferred Adalimumab Products

Rheumatoid arthritis (initial)

Covered when ALL of the following are met for moderately to severely active rheumatoid arthritis (RA):

RA initial therapy criteria

3. Trial and failure, intolerance, or contraindication to TWO of the following nonpreferred adalimumab products: a. Humira (Abbvie) b. Hadlima c. Simlandi d. Yuflyma.

Polyarticular juvenile idiopathic arthritis (initial)

Covered when ALL of the following are met for polyarticular juvenile idiopathic arthritis (pJIA):

pJIA initial therapy criteria

3. Trial and failure, intolerance, or contraindication to TWO of the following nonpreferred adalimumab products: a. Humira (Abbvie) b. Hadlima c. Simlandi d. Yuflyma.

Psoriatic arthritis (initial)

Covered when ALL of the following are met for psoriatic arthritis (PsA):

PsA initial therapy criteria

3. Trial and failure, intolerance, or contraindication to TWO of the following nonpreferred adalimumab products: a. Humira (Abbvie) b. Hadlima c. Simlandi d. Yuflyma.

Ankylosing spondylitis (initial)

Covered when ALL of the following are met for ankylosing spondylitis (AS):

AS initial therapy criteria

3. Trial and failure, intolerance, or contraindication to TWO of the following nonpreferred adalimumab products: a. Humira (Abbvie) b. Hadlima c. Simlandi d. Yuflyma.

Crohn's disease (initial)

Covered when ALL of the following are met for Crohn's disease (moderately to severely active):

Crohn's disease initial therapy criteria

3. Trial and failure, intolerance, or contraindication to TWO of the following nonpreferred adalimumab products: a. Humira (Abbvie) b. Hadlima c. Simlandi d. Yuflyma.

Ulcerative colitis (initial)

Covered when ALL of the following are met for ulcerative colitis (moderately to severely active):

Ulcerative colitis initial therapy criteria

3. Trial and failure, intolerance, or contraindication to TWO of the following nonpreferred adalimumab products: a. Humira (Abbvie) b. Hadlima c. Simlandi d. Yuflyma.

Plaque psoriasis (initial)

Covered when ALL of the following are met for moderate to severe chronic plaque psoriasis (PsO):

Plaque psoriasis initial therapy criteria

4. Trial and failure, intolerance, or contraindication to TWO of the following nonpreferred adalimumab products: a. Humira (Abbvie) b. Hadlima c. Simlandi d. Yuflyma.

Hidradenitis suppurativa (initial)

Covered when ALL of the following are met for moderate to severe hidradenitis suppurativa:

Hidradenitis suppurativa initial therapy criteria: 1. Diagnosis of moderate to severe hidradenitis suppurativa (Hurley stage II or III). 2. Trial and failure, intolerance, or contraindication to TWO of the following nonpreferred adalimumab products: a. Humira (Abbvie) b. Hadlima c. Simlandi d. Yuflyma.clinical staging

Preferred adalimumab trial requirement: TWO

Non-infectious uveitis (initial)

Covered when ALL of the following are met for non-infectious uveitis:

Non-infectious uveitis initial therapy criteria: 1. Diagnosis of non-infectious uveitis. 2. Uveitis is classified as ONE of the following: a. Intermediate b. Posterior c. Panuveitis. 3. Trial and failure, intolerance, or contraindication to TWO of the following nonpreferred adalimumab products: a. Humira (Abbvie) b. Hadlima c. Simlandi d. Yuflyma.anatomic classification

Preferred adalimumab trial requirement: TWO

Continuation of therapy (reauthorization)

Covered when ALL of the following are met for continuation of therapy (reauthorization):

Continuation of therapy: Submission of medical records (e.g., chart notes) demonstrating an improvement in member's condition as evidenced by low disease activity or improvement in signs and symptoms of the condition.clinical improvement

Reauthorization documentation requirement

Administrative note: the policy was updated to remove the diagnosis of nonradiographic axial spondyloarthritis from the covered indications. This change is historical and does not alter the clinical criteria for other indications.

Scope and applicability: this policy applies to the pharmacy benefit only for Commercial/Exchange members. Requests for adalimumab under the medical benefit are not applicable and should be routed per the payer’s medical benefit processes.

Coding, Durations, and Limits

Plaque psoriasis BSA threshold — policy value

Plaque psoriasis BSA threshold>= 3% body surface area (BSA)

Alternate thresholdInvolvement of crucial body areas (hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)

Applicable indicationModerate to severe chronic plaque psoriasis (PsO)

Reauthorization / initial approval duration

Initial approval duration24 months

Reauthorization duration24 months

Quantity limits note

Provider Requirements, Step Therapy, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required for nonpreferred adalimumab products under the pharmacy benefit. Submit PA requests to the plan prior to dispensing.

Applies to Commercial/Exchange members under the Pharmacy Benefit
Contact: Phone: 800-711-4555; Fax: 844-403-1029

Step Therapy

Step Therapy / Preferred Agent Trial Requirement

Step therapy: members must have trialed preferred adalimumab agents or specified conventional therapies before nonpreferred adalimumab products will be authorized. Requirements vary by diagnosis; see diagnosis-specific criteria for required trials and minimum trial durations.

RA, PsA, AS, CD, UC, PsO, pJIA, hidradenitis suppurativa, non-infectious uveitis — trial and failure, intolerance, or contraindication to TWO preferred adalimumab products (e.g., Humira, Hadlima, Simlandi, Yuflyma) is required unless clinical exceptions apply
RA: prior trial of ONE conventional therapy (methotrexate, leflunomide, or sulfasalazine) for ≥3 months before biologic

Background and Drug Information

Background: Adalimumab is a recombinant monoclonal antibody that binds and neutralizes tumor necrosis factor-alpha (TNF-α), interfering with TNFα receptor binding and downstream inflammatory signaling. It is used to treat multiple inflammatory conditions including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, hidradenitis suppurativa, and non-infectious uveitis. The policy’s indication-specific criteria describe required prior conventional therapy trials or, where specified, allowance for first-line biologic use when disease severity warrants.

Definitions and Thresholds

Adalimumab — definition

DefinitionAdalimumab is a recombinant monoclonal antibody that binds to human tumor necrosis factor alpha (TNF‑alpha), interfering with binding to TNFα receptor sites and subsequent cytokine‑driven inflammatory processes.

MechanismNeutralizes TNF‑alpha to reduce inflammation across multiple immune‑mediated conditions

Typical useUsed for inflammatory conditions such as RA, pJIA, PsA, AS, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and non‑infectious uveitis

Body surface area (BSA) threshold for plaque psoriasis — definition

BSA threshold (definition)>= 3% BSA or involvement of crucial body areas

Purpose

Policy Summary

PayerMass General Brigham Health Plan

PolicyAdalimumab prior authorization and step therapy

Policy CodePolicy N/A

Change TypeClinical and administrative revisions (product list, step therapy, reauthorization language)

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit medical records (e.g., chart notes) for reauthorization or when member is new to the plan to demonstrate current treatment or clinical improvement.

SourceLink

On This Page

Quantity limits and starter pack frequency specified separately in policy limitations

Body surface area (BSA) threshold for plaque psoriasis

BSA threshold>= 3% BSA OR involvement of crucial body areas

Crucial body areas exampleshands, feet, face, neck, scalp, genitals/groin, intertriginous areas

Clinical contextUsed to define moderate to severe chronic plaque psoriasis for coverage criteria

pJIA: prior trial of ONE conventional therapy (methotrexate or leflunomide) for ≥6 weeks before biologic

AS: trial and failure of TWO different NSAIDs (≥1 month total) required prior to biologic

CD and UC: trial and failure of at least ONE conventional therapy (e.g., 6‑MP, azathioprine, corticosteroids, methotrexate, or aminosalicylates) unless disease severity warrants first‑line biologic

PsO: topical therapy trial ≥4 weeks (or severe disease warranting first‑line biologic)

Documentation Required

Required Documentation for New Members and Continuation

For members new to the plan (coverage effective date ≤ 90 days), include medical records demonstrating current treatment with the requested drug when submitting the PA. For continuation/reauthorization, submit chart notes showing improvement or low disease activity.

New members (≤90 days coverage effective date): provide medical records confirming active treatment with the requested agent (exclude samples or manufacturer patient assistance program supplies)
Reauthorization: provide documentation of clinical improvement (e.g., chart notes documenting low disease activity or symptom improvement)

Denial Risk

Denial Triggers and Risk

Denials may occur if required documentation or step-therapy criteria are not met. Failure to submit records for new members or to document required trials/failures, contraindications, or intolerances to preferred agents or conventional therapies are common denial triggers.

Missing medical records for members new to plan (coverage effective date ≤90 days)
Insufficient documentation of trial and failure, intolerance, or contraindication to required preferred adalimumab products or conventional therapies per diagnosis-specific criteria
Requests that do not meet diagnosis-specific eligibility (e.g., lacking required disease severity, failed therapies, or objective signs of improvement for reauthorization)

Defines moderate to severe chronic plaque psoriasis for coverage determinations

Crucial body areas listedhands, feet, face, neck, scalp, genitals/groin, intertriginous areas