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    v1.0.28
    OpenPayerPolicy UpdatesImmunology/Rheumatologyharvard pilgrim adalimumab Prior Auth Policy Updat…
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    Modifiedharvard pilgrim health carePolicy N/A

    Adalimumab products prior authorization

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    Defines prior authorization and medical necessity criteria for coverage of branded and biosimilar adalimumab products for Harvard Pilgrim / Tufts commercial and select public plan members.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Policy Summary
    Payerharvard pilgrim health care
    PolicyAdalimumab products prior authorization
    Policy CodePolicy N/A
    Change TypeMaterial revisions to prescriber requirements, approval durations, and reauthorization rules
    Effective DateJan 1, 2026
    Last ReviewJun 10, 2025
    Next Review DateJan 1, 2026
    Key ActionObtain prior authorization and document required diagnosis, prescriber specialty, prior therapy trials (including Humira where required), and that the patient is not receiving combination biologic or targeted synthetic therapy.
    SourceLink
    POLICY UPDATE CHANGES

    Provider requirements no longer allow treatment 'in consultation with the specialist' and coverage criteria were added to prevent duplicative targeted immunomodulator therapy.

    For hidradenitis suppurativa, plaque psoriasis and psoriatic arthritis, initial approvals limited to 6 months with annual reauthorization criteria added and additional nonbiologic prerequisite and disease severity requirements were added.

    For ankylosing spondylitis, Crohn's disease, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis, approvals limited to 12 months with reauthorization criteria and nonbiologic prerequisites added.

    Coverage criteria to prevent duplicative targeted immunomodulator therapy (patients may not receive the requested medication in combination with another biologic or targeted synthetic oral small molecule drug).

    multipleIndications listed
    Humira requiredHumira trial required
    specialistsPrescriber requirement
    6 moInitial approval (HS/psoriasis/psA)
    12 moAuthorization interval (most)
    6-12 moReauth establishment

    Coverage Criteria for Adalimumab Products

    inv-01: Initial Therapy - Ankylosing Spondylitis

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

    Ankylosing spondylitis initial: 1. Documented diagnosis of active ankylosing spondylitis; 2. Patient is at least 18 years of age; 3. Prescribed by a rheumatologist; 4. Documentation of history of failure to one prescription-strength NSAID (e.g., celecoxib, diclofenac, ibuprofen, naproxen, meloxicam) unless contraindicated (document drug, date and duration); 5. Documentation of history of failure to two of the listed medications from each therapeutic category (only one medication required if only one is available in a category): a) Interleukin antagonists: Bimzelx, Tatlz; b) Janus kinase inhibitors: Rinvoq, Xeljanz; c) Tumor necrosis factor agents: Cimzia, Enbrel, Simponi; 6. Documentation of history of failure to a minimum three (3) month supply of Humira unless contraindicated (document date and duration); 7. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-02: Reauthorization - Ankylosing Spondylitis

    Reauthorization requirements for ankylosing spondylitis:

    Ankylosing spondylitis reauth: 1. Documentation the patient has been established on the requested medication for at least 12 months; 2. Documented diagnosis of active ankylosing spondylitis; 3. Patient is at least 18 years of age; 4. Prescribed by a rheumatologist; 5. Documentation of clinically significant improvement or stabilization in clinical signs and symptoms of disease as determined by the prescriber; 6. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-03: Initial Therapy - Crohn's Disease

    Covered when ALL of the following are met for Crohn's disease (initial):

    Crohn's disease initial: 1. Documented diagnosis of Crohn's disease; 2. Patient is at least 6 years of age; 3. Prescribed by a gastroenterologist; 4. Documentation of history of failure to one of the following unless contraindicated: corticosteroid, 5-aminosalicyclate, 6-mercaptopurine, or methotrexate (document drug, date, duration); 5. Documentation of history of failure to two of the listed medications from each therapeutic category (only one medication required if only one is available in a category): a) Interleukin antagonists: Omvoh, Skyrizi, Tremfya, Yesintek; b) Janus kinase inhibitors: Rinvoq; c) Tumor necrosis factors: Cimzia; 6. Documentation of history of failure to a minimum three (3) month supply of Humira unless contraindicated (document date and duration); 7. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-04: Reauthorization - Crohn's Disease

    Reauthorization requirements for Crohn's disease:

    Crohn's disease reauth: 1. Documentation the patient has been established on the requested medication for at least 12 months; 2. Documented diagnosis of moderately to severely active Crohn's disease; 3. Documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber; 4. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-05: Initial Therapy - Hidradenitis Suppurativa

    Covered when ALL of the following are met for hidradenitis suppurativa (initial):

    Hidradenitis suppurativa initial: 1. Documented diagnosis of moderate to severe hidradenitis suppurativa; 2. Hurley Stage II or III disease; 3. Patient is at least 12 years of age; 4. Prescribed by a dermatologist; 5. Documentation of history of failure to three conventional treatments (e.g., local hygiene, weight reduction if obese, ordinary soaps/antiseptics/antiperspirants, warm compresses, laser hair removal, smoking cessation, medical anti-inflammatory or antiandrogen therapy such as oral/topical antibiotics, intralesional triamcinolone, spironolactone, finasteride) unless contraindicated (document treatments, dates, durations); 6. Documentation of history of failure to a minimum three (3) month supply of Humira unless contraindicated (document date and duration); 7. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-06: Reauthorization - Hidradenitis Suppurativa

    Reauthorization requirements for hidradenitis suppurativa:

    Hidradenitis suppurativa reauth: 1. Documentation the patient has been receiving the requested medication for at least six (6) months; 2. Documented diagnosis of moderate to severe hidradenitis suppurativa; 3. Patient is at least 6 years of age or older (note: source contains mixed age statements); 4. Prescribed by a dermatologist; 5. Submission of medical charts documenting beneficial clinical response defined as improvement from baseline in at least one objective measure (e.g., Hurley staging, Sartorius score, Physician Global Assessment, Hidradenitis Suppurativa Severity Index) and improvement in at least one symptom (e.g., decreased pain or drainage); 6. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-07: Initial Therapy - Plaque Psoriasis

    Covered when ALL of the following are met for plaque psoriasis (initial):

    Plaque psoriasis initial: 1. Documented diagnosis of moderate to severe chronic plaque psoriasis; 2. Documentation of extent/severity (e.g., >=3% BSA, severe scalp, palmoplantar/facial/genital involvement) as applicable; 3. Failure to a minimum three (3) month supply of at least one traditional systemic agent (methotrexate, cyclosporine, acitretin, or phototherapy) unless contraindicated (document drug, date, duration); 4. Documentation of history of failure to two of the listed medications from each therapeutic category (only one medication required if only one is available in a category): a) Interleukin antagonists: Bimzelx, Skyrizi, Taltz, Tremfya, Yesintek; b) Phosphodiesterase-4 inhibitor: Otezla; c) Tumor necrosis factors: Cimzia, Enbrel; 5. Documentation of history of failure to a minimum three (3) month supply of Humira unless contraindicated (document date and duration); 6. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-08: Reauthorization - Plaque Psoriasis

    Reauthorization requirements for plaque psoriasis:

    Plaque psoriasis reauth: 1. Documentation the patient has been receiving the requested medication for at least six (6) months; 2. Documented diagnosis of moderately to severe plaque psoriasis; 3. Submission of medical charts documenting beneficial clinical response defined as reduction in body surface area affected from baseline; 4. Submission of medical charts documenting improvement in at least one symptom (e.g., itching, redness, flaking, scaling, burning, cracking, pain); 5. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-09: Plaque Psoriasis — Initial Authorization (alternate indexing)

    Covered when ALL of the following are met

    plaque_psoriasis_initial: Documented diagnosis of moderate to severe chronic plaque psoriasis; failure to a >=3 month trial of at least one traditional systemic agent (methotrexate, cyclosporine, acitretin, or phototherapy) unless contraindicated; failure to two medications from listed therapeutic categories (Interleukin antagonists: Bimzelx, Skyrizi, Taltz, Tremfya, Yesintek; PDE4: Otezla; TNFs: Cimzia, Enbrel); failure to a >=3 month supply of Humira unless contraindicated; patient not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-10: Plaque Psoriasis — Reauthorization (alternate indexing)

    Covered for continuation when ALL of the following are met

    plaque_psoriasis_reauth: Patient has been receiving the requested medication for at least six (6) months; documented diagnosis of moderate to severe plaque psoriasis; submission of medical charts documenting beneficial clinical response defined as reduction in body surface area from baseline; documentation of improvement in at least one symptom (itching, redness, flaking, scaling, burning, cracking, or pain); patient not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-11: Polyarticular Juvenile Idiopathic Arthritis — Initial and Reauthorization

    Initial authorization covered when ALL of the following are met

    pjia_initial: 1. Documented diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis; 2. Patient is at least 2 years of age; 3. Prescribed by a rheumatologist; 4. Documentation of history of failure to one traditional DMARD (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) unless contraindicated (document drug, date, duration); 5. Documentation of history of failure to two of the listed medications from each therapeutic category (only one medication required if only one is available in a category): a) Interleukin antagonists: Actemra; b) Janus kinase inhibitors: Rinvoq, Xeljanz; c) Selective T Cell Costimulation: Orencia; d) Tumor necrosis factors: Cimzia, Enbrel; 6. Documentation of history of failure to a minimum three (3) month supply of Humira unless contraindicated (document date and duration); 7. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.
    pjia_reauth: Patient established on requested medication for at least 12 months; documented diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis; documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber; documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-12: Psoriatic Arthritis — Initial and Reauthorization

    Initial authorization covered when ALL of the following are met

    psa_initial: 1. Documented diagnosis of active psoriatic arthritis with at least one of: actively inflamed joints, dactylitis, enthesitis, axial disease, or active skin/nail involvement; 2. Patient is at least 18 years of age; 3. Prescribed by a rheumatologist or dermatologist; 4. Documentation of failure to a minimum three (3) month supply of at least one DMARD (e.g., methotrexate, sulfasalazine, cyclosporine) unless contraindicated (document drug, date, duration); 5. Documentation of history of failure to two of the listed medications from each therapeutic category (only one medication required if only one is available in a category): a) Interleukin antagonists: Bimzelx, Skyrizi, Taltz, Tremfya, Yesintek; b) Janus kinase inhibitors: Rinvoq, Xeljanz; c) Phosphodiesterase-4 inhibitor: Otezla; d) Selective T Cell Stimulators: Orencia; e) Tumor necrosis factors: Cimzia, Enbrel, Simponi; 6. Documentation of history of failure to a minimum three (3) month supply of Humira unless contraindicated (document date and duration); 7. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.
    psa_reauth: Patient has been receiving the requested medication for at least six (6) months; documented diagnosis of active psoriatic arthritis; patient is at least 18 years of age; prescribed by a rheumatologist or dermatologist; submission of medical charts documenting beneficial clinical response defined as improvement from baseline in at least one objective measure (e.g., body surface area affected or total active joint count) and documentation of improvement in at least one symptom (e.g., joint pain, morning stiffness, fatigue, swelling); documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-13: Rheumatoid Arthritis — Initial and Reauthorization

    Initial authorization covered when ALL of the following are met

    ra_initial: 1. Documented diagnosis of moderately to severely active rheumatoid arthritis; 2. Patient is at least 18 years of age; 3. Prescribed by a rheumatologist; 4. Documentation of history of failure to one traditional DMARD (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) unless contraindicated (document drug, date, duration); 5. Documentation of history of failure to two of the listed medications from each therapeutic category (only one medication required if only one is available in a category): a) Interleukin antagonists: Actemra; b) Janus kinase inhibitors: Olumiant, Rinvoq, Xeljanz; c) Selective T Cell Stimulators: Orencia; d) Tumor necrosis factors: Cimzia, Enbrel, Simponi; 6. Documentation of history of failure to a minimum three (3) month supply of Humira unless contraindicated (document date and duration); 7. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.
    ra_reauth: Member has been established on the requested medication for at least 12 months; documented diagnosis of moderately to severely active rheumatoid arthritis; documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber; documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-14: Ulcerative Colitis — Initial and Reauthorization

    Initial authorization covered when ALL of the following are met

    uc_initial: 1. Documented diagnosis of moderately to severely active ulcerative colitis; 2. Patient is at least 5 years of age (when prescribed by a gastroenterologist) or per source lines; 3. Prescribed by a gastroenterologist (or rheumatologist per some lines); 4. Documentation of history of failure to one of the following unless contraindicated: corticosteroid, 5-aminosalicyclate, 6-mercaptopurine, or methotrexate (document drug, date, duration); 5. Documentation of history of failure to two of the listed medications from each therapeutic category (only one medication required if only one is available in a category): a) Interleukin antagonists: Omvoh, Skyrizi, Tremfya, Yesintek; b) Janus kinase inhibitors: Rinvoq, Xeljanz; c) Sphingosine 1-phosphate receptor modulator: Zeposia; d) Tumor necrosis factors: Simponi; 6. Documentation of history of failure to a minimum three (3) month supply of Humira unless contraindicated (document date and duration); 7. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.
    uc_reauth: Patient has been established on the requested medication for at least 12 months; documented diagnosis of moderately to severely active ulcerative colitis; documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber; documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-15: Non-infectious Uveitis — Initial and Reauthorization

    Initial authorization covered when ALL of the following are met

    uveitis_initial: 1. Documented diagnosis of non-infectious intermediate, posterior, or panuveitis; 2. Prescribed by an ophthalmologist, ocular immunologist, or rheumatologist; 3. Documentation of history of failure to conventional therapy (e.g., periocular, intraocular, or systemic corticosteroids; immunosuppressants) unless contraindicated (document drug, date, duration); 4. Documentation of history of failure to a minimum three (3) month supply of Humira unless contraindicated (document date and duration); 5. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.
    uveitis_reauth: Patient has been established on the requested medication for at least 12 months; documented diagnosis of non-infectious intermediate, posterior, or panuveitis; prescribed by an ophthalmologist, ocular immunologist, or rheumatologist; documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber; documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    inv-16: Reauthorization — Uveitis specific reauthorization nodes

    Covered when ALL of the following are met for uveitis reauthorization:

    Reauthorization requirements: 1) Patient established on requested medication for at least 12 months; 2) Documented diagnosis of non-infectious intermediate, posterior, or panuveitis; 3) Prescribed by an ophthalmologist, ocular immunologist, or rheumatologist; 4) Documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber; 5) Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

    Items 1-5 must all be satisfied for reauthorization.

    Humira is identified as the preferred adalimumab product for plan members and requires prior authorization. Other branded and biosimilar adalimumab products are managed under this guideline and are subject to the same coverage framework described herein.

    The requested adalimumab product must not be used in combination with another biologic drug or with a targeted synthetic oral small molecule drug. Each indication-specific coverage criterion includes a requirement that the patient is not receiving the requested medication in combination with another biologic or targeted synthetic oral small molecule agent.

    This combination therapy prohibition is explicitly carried forward into reauthorization criteria. Reauthorization for listed indications requires documentation that the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug as a condition of continued coverage.

    Documentation that a member is a social drinker does not qualify as a medically acceptable contraindication or clinical inappropriateness to methotrexate therapy and therefore is not an acceptable reason to bypass required prior-treatment steps in the guideline.

    Provider Actions, Documentation, and Step Therapy

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for all Adalimumab products prior to benefit coverage. Submit a completed prior authorization request to the payer; authorizations are required for commercial and public plan products listed in the header. Failure to obtain prior authorization may result in claim denial or member liability.

    • Applies to all Adalimumab products (all formulations/brands)
    • Fax/submission per header (Harvard Pilgrim / Tufts commercial fax: 617-673-0988)
    • Members new to the plan who are already stable on therapy should still meet Initial Authorization criteria
    Documentation Required

    Prior Authorization Clinical Requirements

    Prior authorization will be approved only when clinical requirements specific to the diagnosis, prescriber specialty, age thresholds, prior therapy trials, and concomitant therapy exclusions are documented.

    Coding and Key Values

    Codes listedmixed
    No codes listed
    Minimum prior trial duration — typical 3 months Humira or traditional systemic trial requirement
    Minimum prior trial durationA minimum 3-month trial is required for Humira or other specified traditional/systemic therapies prior to authorization (document drug, date, and duration).
    Applies to which indicationsPlaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn's disease, hidradenitis suppurativa, polyarticular JIA and ankylosing spondylitis per individual criteria where indicated.
    Documentation requirementProvider must document drug name, dates and duration of the prior trial(s).
    ExceptionsOnly when Humira is contraindicated or clinically significant adverse effects occurred (must be documented).
    Established on therapy prior to reauthorization — typical 6 or 12 months depending on indication

    Background

    Adalimumab is a tumor necrosis factor (TNF) inhibitor with multiple FDA‑approved inflammatory indications, including ankylosing spondylitis, Crohn's disease, hidradenitis suppurativa, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, and uveitis. The guideline covers both branded and biosimilar adalimumab products and sets prior authorization requirements, prescriber specialty, age, prior‑treatment, and reauthorization expectations for these indications.

    Definitions and Product Names

    Adalimumab products — branded and biosimilar list
    Branded and biosimilar products listedAdalimumab-aacf; Adalimumab-aaty; Adalimumab-adaz; Adalimumab-adbm; Adalimumab-fkjp; Adalimumab-ryvk; Abrilada; Amjevita; Cyltezo; Hadlima; Hulio; Hyrimoz; Idacio; Simlandi; Yuflyma; Yusimry.
    ScopeThese adalimumab products are included in the Medical Necessity Guideline and are managed under the policy's prior authorization requirements.
    ReferenceHumira is separately identified as the preferred adalimumab product (see Humira guideline).
    Humira — preferred adalimumab product and referenced required prior trial
    Preferred productHumira is the preferred adalimumab product and requires prior authorization.
    Role in step therapyA documented minimum 3-month trial of Humira is required for many indications prior to authorization of other adalimumab products unless contraindicated.

    Revision History

    2026-01-01policy_effective_dateLatest

    Authorization intervals defined: 12-month approvals for ankylosing spondylitis, Crohn's disease, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis; initial approvals limited to 6 months for hidradenitis suppurativa, plaque psoriasis, and psoriatic arthritis with annual reauthorization criteria added.

    2025-06-10committee_review

    Reviewed by the Pharmacy & Therapeutics Committee (effective 2025-09-01).

    2024-10-14
    Policy Summary
    Payerharvard pilgrim health care
    PolicyAdalimumab products prior authorization
    Policy CodePolicy N/A
    Change TypeMaterial revisions to prescriber requirements, approval durations, and reauthorization rules
    Effective DateJan 1, 2026
    Last ReviewJun 10, 2025
    Next Review DateJan 1, 2026
    Key ActionObtain prior authorization and document required diagnosis, prescriber specialty, prior therapy trials (including Humira where required), and that the patient is not receiving combination biologic or targeted synthetic therapy.
    SourceLink
    On This Page
    Coverage Criteria for Adalimumab ProductsProvider Actions, Documentation, and Step TherapyCoding and Key ValuesBackgroundDefinitions and Product NamesRevision History
    • Documented diagnosis matching the indication-specific criteria (see Initial Authorization and Reauthorization sections for diagnosis-specific requirements)
    • Prescriber specialty as required by indication (e.g., rheumatologist, dermatologist, gastroenterologist, ophthalmologist, ocular immunologist; see indication criteria)
    • Age thresholds per indication (e.g., ≥2 years for juvenile idiopathic arthritis, ≥5 years for pediatric ulcerative colitis, adults where specified)
    • Documentation of required prior therapy trials (NSAID/traditional DMARDs, specified therapeutic-class agents, and a minimum 3-month Humira trial when required) with drug name, dates, and duration
    • Statement that the patient is not receiving the requested medication in combination with another biologic or a targeted synthetic oral small molecule
    Denial Risk

    Triggers for Prior Authorization Denial

    Missing or incomplete documentation of required prior trials, contraindications, prescriber specialty, age, or diagnosis are common triggers for denial. Also deny when requests document concurrent use of excluded biologic or targeted synthetic therapies.

    • Absent documentation of NSAID or nonbiologic trial where required (drug name, dates, duration)
    • Absent documentation of required failures from the listed therapeutic categories (names, dates, durations)
    • Absent documentation of a minimum three (3) month Humira trial when required
    • No documented prescriber specialty or age consistent with indication
    • Request documents concurrent biologic or targeted synthetic oral small molecule therapy
    Denial Risk

    Prior Therapy and Combination Therapy Risks

    The policy requires failure trials of specified therapies and prohibits concurrent use of certain agents; requests showing lack of required prior therapy or combination biologic/tsdm therapy present material risk of denial.

    • Failure to document trials of required nonbiologic/systemic agents (e.g., methotrexate, cyclosporine, acitretin, phototherapy, corticosteroids, 5-ASA, 6-MP) increases likelihood of denial
    • Failure to document trials of at least two agents from the listed therapeutic classes (interleukin antagonists, JAK inhibitors, TNF inhibitors, PDE4 inhibitors, S1P modulators, selective T-cell modulators) as required per indication is a denial risk
    • Requests that indicate concurrent use of another biologic or a targeted synthetic small molecule are not eligible for approval
    Denial Risk

    Denial Triggers for Reauthorization

    For reauthorization, the policy requires evidence the member has been established on therapy for the required duration (6 or 12 months as specified), documented diagnosis, prescriber specialty, and objective evidence of clinical response or stability. Failure to meet these reauthorization elements may result in denial.

    • Reauthorization timeframes: 12-month intervals for ankylosing spondylitis, Crohn's disease, polyarticular JIA, rheumatoid arthritis, ulcerative colitis, and uveitis; initial approvals for hidradenitis suppurativa, plaque psoriasis and psoriatic arthritis are 6 months with subsequent 12-month reauthorizations
    • Member must have been established on the requested medication for the policy-specified duration (≥6 months or ≥12 months depending on indication)
    • Documented clinically significant improvement, stabilization, or other indication-specific response metrics as described in Reauthorization Criteria
    • Requests that do not show the required duration on therapy, lack a non-infectious diagnosis where required, or show concurrent excluded therapies are at high risk for denial
    Documentation Required

    Required Documentation

    Provide complete documentation of prior therapies, dates, durations, outcomes, diagnosis, age, and prescriber specialty. Samples and free goods do not count as evidence of an established response.

    • Document each prior medication tried: name, start and stop dates, and duration of trial
    • Document clinical outcome of each prior trial (failure due to lack of efficacy, intolerance, contraindication, or adverse effects)
    • Document diagnosis with relevant severity (e.g., moderate to severe plaque psoriasis) and objective measures when requested (e.g., body surface area, joint counts)
    • Include prescriber specialty and patient age consistent with indication-specific requirements
    • Samples, free goods, or similar offerings do NOT qualify as evidence of prior effective therapy or established response
    Documentation Required

    Required Documentation and Outcomes

    Clinical documentation for approval and reauthorization must include specific outcomes demonstrating beneficial response compared to baseline where required (e.g., reduction in body surface area, improvement in joint counts, stabilization of signs and symptoms). Chart notes, objective measures, and prescriber assessment should be submitted.

    • For plaque psoriasis: charts documenting reduction in body surface area and improvement in symptoms (itching, redness, flaking, scaling, burning, cracking, pain)
    • For psoriatic arthritis: improvement in body surface area or total active swollen and tender joint count
    • For rheumatoid arthritis, ulcerative colitis, Crohn's disease, uveitis and other indications: documentation of clinically significant improvement or stabilization as determined by the prescriber
    • Include baseline measures and follow-up assessments to demonstrate response
    Documentation Required

    Required Documentation for Reauthorization

    Reauthorization-specific documentation requirements: show the member has been on therapy for the policy-specified duration (≥6 or ≥12 months), submit objective clinical response data, confirm prescriber specialty and continued absence of excluded concurrent therapies.

    • Proof of continuous therapy for the required reauthorization period (e.g., pharmacy fill records, chart notes) — samples do not qualify
    • Documented diagnosis consistent with initial approval (non-infectious where applicable)
    • Charts or provider assessment demonstrating clinically significant improvement or stabilization compared to baseline
    • Confirmation patient is not receiving another biologic or a targeted synthetic oral small molecule concurrently
    Step Therapy

    Step / Step-Up Therapy Expectations

    Step therapy expectations vary by indication but generally require failure of step-up nonbiologic/systemic therapies and specified biologic classes before Adalimumab products are authorized. Initial approval durations vary by indication (6 or 12 months) as noted in Limitations.

    • Most inflammatory and dermatologic indications require failure of at least one traditional systemic/nonbiologic agent (e.g., methotrexate, cyclosporine, acitretin, phototherapy) unless contraindicated
    • Humira (adalimumab) trial: documentation of failure to a minimum three (3) month supply of Humira is required for many indications unless contraindicated
    • Initial authorization periods: 6 months for hidradenitis suppurativa, plaque psoriasis and psoriatic arthritis; 12 months for ankylosing spondylitis, Crohn's, polyarticular JIA, RA, UC, uveitis
    Step Therapy

    Step Therapy and Required Failure Trials

    Where specified by indication, documentation must show failure to two agents from the listed therapeutic classes (or one if only one agent is available in a class). These therapeutic-class failure requirements and nonbiologic prerequisites are mandatory before considering Adalimumab products.

    • Therapeutic-class failure requirement examples (indication-specific):
    • - Interleukin antagonists (examples vary by indication: Bimzelx, Skyrizi, Taltz, Tremfya, Yesintek, Omvoh, Actemra, etc.)
    • - Janus kinase inhibitors (Rinvoq, Xeljanz, others as listed per indication)
    • - Tumor necrosis factor inhibitors (Cimzia, Enbrel, Simponi)
    • - Phosphodiesterase 4 inhibitor (Otezla) and S1P modulators (Zeposia) where listed
    • Only one medication is required from a therapeutic category if only one is available for that category; document drugs, dates, and durations of each trial
    Documentation Required

    Nonbiologic Prerequisites and Disease Severity Requirements

    Some indications require additional nonbiologic prerequisites and specific disease severity documentation prior to initial authorization. Initial authorization durations reflect disease severity and indication-specific rules.

    • Nonbiologic prerequisites include trials of NSAIDs for certain indications and traditional DMARDs for rheumatologic conditions (document drug, date, duration, and outcome)
    • Disease severity requirements (e.g., documented moderate to severe plaque psoriasis) must be provided with objective measures when applicable
    • Initial authorization duration adjustments: hidradenitis suppurativa, plaque psoriasis and psoriatic arthritis initial approvals limited to 6 months; other listed indications are authorized for 12-month intervals
    Established-on-therapy period for reauthorization
    Members must generally be established on the requested medication for at least 12 months for many indications (e.g., ankylosing spondylitis, Crohn's disease, RA, UC, uveitis, polyarticular JIA).
    Shorter reauthorization intervalSome indications (hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis) require the member to have been receiving the medication for at least 6 months for reauthorization.
    Documentation requiredMedical charts must show clinically significant improvement or stabilization as determined by the prescriber for reauthorization (objective measures where specified).
    See alsoHumira Medical Necessity Guideline referenced for details on Humira-specific requirements.
    Failure — definition used in criteria
    Definition of failureDocumented lack of adequate clinical response, a contraindication, or clinically significant adverse effects during the specified trial (commonly a minimum three-month trial); documentation must include drug name, dates, and duration of trial.
    Documentation standardProviders must document drug, dates, duration, and reason for discontinuation (lack of response, intolerance, or contraindication).
    Applies to step requirementsFailure criteria are used to meet required prior therapy steps (e.g., failure to two medications from listed therapeutic categories).
    Uveitis definition — non-infectious intermediate, posterior or panuveitis
    Clinical definitionNon-infectious intermediate, posterior, or panuveitis as the documented diagnosis required for initial authorization and reauthorization.
    Prescriber requirementMust be prescribed by an ophthalmologist, ocular immunologist, or rheumatologist for uveitis indications and reauthorization.
    Associated requirementsInitial criteria include failure to conventional therapy (e.g., periocular/intraocular/systemic corticosteroids, immunosuppressants) unless contraindicated; reauthorization requires ≥12 months on therapy and documentation of clinically significant improvement or stabilization.
    policy_revision

    Updated provider requirements to remove 'in consultation with the specialist' language and added coverage criteria to prevent duplicative targeted immunomodulator therapy; added disease severity and nonbiologic prerequisite requirements and updated initial authorization language for multiple indications.