harvard pilgrim adalimumab Prior Auth & Coverage

Coverage Criteria by Indication

Ankylosing Spondylitis - Initial Authorization

Covered when ALL of the following are met

Ankylosing spondylitis initial: 1. Documented diagnosis of active ankylosing spondylitis; 2. Patient is at least 18 years of age or older; 3. Prescribed by a rheumatologist; 4. Documentation of history of failure to one (1) prescription-strength non-steroidal anti-inflammatory drug unless contraindicated (document drug, date and duration of trial); 5. Documentation of history of failure to two (2) of the listed medications from each of the following therapeutic categories (only one medication required if only one is available for a category): (a) Interleukin antagonists (e.g., Bimzelx, Taltz); (b) Janus kinase inhibitors (e.g., Rinvoq, Xeljanz); (c) Tumor necrosis factor agents (e.g., Cimzia, Enbrel, Simponi); 6. Documentation of history of failure to a minimum three (3) month supply of Simlandi 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.

Ankylosing Spondylitis - Reauthorization

Reauthorization 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 or older; 4. Prescribed by a rheumatologist; 5. Documentation of clinically significant improvement or stabilization in clinical signs and symptoms 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.

Crohn's Disease - Initial Authorization

Covered when ALL of the following are met

Crohn's disease initial: 1. Documented diagnosis of Crohn's disease; 2. Patient is at least 6 years of age or older; 3. Prescribed by a gastroenterologist; 4. Documentation of history of failure to one (1) of the following unless contraindicated: corticosteroid, 5-aminosalicyclate, 6-mercaptopurine, or methotrexate (document drug, date, duration); 5. Documentation of history of failure to two (2) of the listed medications from each of the following therapeutic categories (only one medication required if only one is available for 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 Simlandi 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.

Crohn's Disease - Reauthorization

Reauthorization 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.

Hidradenitis Suppurativa - Initial Authorization

Covered when ALL of the following are met

Hidradenitis suppurativa initial: 1. Documented diagnosis of moderate to severe hidradenitis suppurativa; 2. Documentation of Hurley Stage II or III disease; 3. Patient is at least 12 years of age or older; 4. Prescribed by a dermatologist; 5. Documentation of history of failure to three (3) conventional treatments (e.g., local hygiene, weight reduction if obese, antiseptics/antiperspirants, warm compresses, laser hair removal, smoking cessation, medical anti-inflammatory or antiandrogen therapy) unless contraindicated (document treatments, dates, duration); 6. Documentation of history of failure to a minimum three (3) month supply of Simlandi 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.

Hidradenitis Suppurativa - Reauthorization

Reauthorization 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 age and prescriber per initial criteria (see source); 4. Prescribed by a dermatologist; 5. Submission of medical charts documenting a 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); 6. Submission of medical charts documenting improvement in at least one symptom (e.g., decreased pain or drainage of lesions, nodules, or cysts); 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.

Plaque Psoriasis - Initial Authorization

Covered when ALL of the following are met

Plaque psoriasis initial: 1. Documented diagnosis of moderate to severe chronic plaque psoriasis; 2. Severity meeting one of: >=3% body surface area affected, severe scalp disease, or palmoplantar/facial/genital involvement; 3. Patient is at least 18 years of age or older; 4. Prescribed by a dermatologist; 5. Documentation of 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); 6. Documentation of history of failure to two (2) of the listed medications from each of the following therapeutic categories (only one medication required if only one is available for a category): (a) Interleukin antagonists (Bimzelx, Skyrizi, Taltz, Tremfya, Yesintek); (b) Phosphodiesterase 4 inhibitors (Otezla); (c) Tumor necrosis factors (Cimzia, Enbrel); 7. Documentation of history of failure to a minimum three (3) month supply of Simlandi unless contraindicated (document date and duration); 8. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

Plaque Psoriasis - Reauthorization

Reauthorization 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 a beneficial clinical response defined as reduction in body surface area affected by plaque psoriasis from baseline; 4. Submission of medical charts documenting improvement in at least one symptom (e.g., itching, redness, flaking, scaling, burning, cracking, or 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.

Polyarticular Juvenile Idiopathic Arthritis - Initial Authorization

Covered when ALL of the following are met

Polyarticular JIA initial: 1. Documented diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis; 2. Patient is at least 2 years of age or older; 3. Prescribed by a rheumatologist; 4. Documentation of history of failure to one (1) traditional DMARD (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) unless contraindicated (document drug, date, duration); 5. Documentation of history of failure to two (2) of the listed medications from each of the following therapeutic categories (only one medication required if only one is available for 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 Simlandi 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.

Plaque psoriasis reauthorization

Covered when ALL of the following are met

Plaque psoriasis reauth (duplicate): 1. 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 by plaque psoriasis from baseline; 4. Submission of medical charts documenting improvement in at least one symptom (e.g., itching, redness, flaking, scaling, burning, cracking, or 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.

Polyarticular juvenile idiopathic arthritis initial

Covered when ALL of the following are met

Polyarticular juvenile idiopathic arthritis initial (additional): 1. Documented diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis; 2. Patient is at least 2 years of age or older; 3. Prescribed by a rheumatologist; 4. Documentation of history of failure to one (1) traditional DMARD unless contraindicated (document drug, date, duration); 5. Documentation of history of failure to two (2) of the listed medications from therapeutic categories (interleukin antagonists; JAK inhibitors; selective T cell costimulation; TNF inhibitors) with documentation (only one required if only one drug available in category); 6. Documentation of failure to a minimum three (3) month supply of Simlandi unless contraindicated (document date and duration); 7. Patient not receiving requested medication in combination with another biologic or targeted synthetic oral small molecule drug.

Polyarticular juvenile idiopathic arthritis reauthorization

Covered when ALL of the following are met

Polyarticular juvenile idiopathic arthritis reauth: 1. Patient established on requested medication for at least 12 months; 2. Documented diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis; 3. Documentation of clinically significant improvement or stabilization in clinical signs and symptoms as determined by the prescriber; 4. Patient not receiving requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

Psoriatic arthritis initial

Covered when ALL of the following are met

Psoriatic arthritis initial: 1. Documented diagnosis of active psoriatic arthritis; 2. One of: actively inflamed joints, dactylitis, enthesitis, axial disease, or active skin and/or nail involvement; 3. Patient is at least 18 years of age; 4. Prescribed by a rheumatologist or dermatologist; 5. 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); 6. Documentation of history of failure to two (2) of the listed medications from therapeutic categories (interleukin antagonists; JAK inhibitors; PDE4 inhibitors; selective T cell stimulators; TNF inhibitors) (only one required if only one drug available in category); 7. Documentation of history of failure to a minimum three (3) month supply of Simlandi unless contraindicated; 8. Documentation the patient is not receiving the requested medication in combination with another biologic drug or with a targeted synthetic oral small molecule drug.

Psoriatic arthritis reauthorization

Covered when ALL of the following are met

Psoriatic arthritis reauth: 1. Documentation the patient has been receiving the requested medication for at least six (6) months; 2. Documented diagnosis of active psoriatic arthritis; 3. Patient is at least 18 years of age or older; 4. Prescribed by a rheumatologist or dermatologist; 5. Submission of medical charts documenting a beneficial clinical response (improvement from baseline in body surface area or total active joint count); 6. Submission of medical charts documenting improvement in at least one symptom (e.g., joint pain, morning stiffness, fatigue, swelling); 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.

Rheumatoid arthritis initial

Covered when ALL of the following are met

Rheumatoid arthritis initial: 1. Documented diagnosis of moderately to severely active rheumatoid arthritis; 2. Patient is at least 18 years of age or older; 3. Prescribed by a rheumatologist; 4. Documentation of history of failure to one (1) traditional DMARD (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine) unless contraindicated (document drug, date, duration); 5. Documentation of history of failure to two (2) of the listed medications from each of the following therapeutic categories (only one medication required if only one is available for 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 Simlandi 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.

Rheumatoid arthritis reauthorization

Covered when ALL of the following are met

Rheumatoid arthritis reauth: 1. Documentation the member has been established on the requested medication for at least 12 months; 2. Documented diagnosis of moderately to severely active rheumatoid arthritis; 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.

Ulcerative colitis initial

Covered when ALL of the following are met

Ulcerative colitis initial: 1. Documented diagnosis of moderately to severely active ulcerative colitis; 2. Patient is at least 18 years of age or older (adult pathway) or at least 5 years of age or older (pediatric pathway); 3. Prescribed by a gastroenterologist (pediatric/adult as specified); 4. Documentation of history of failure to one (1) of the following unless contraindicated: corticosteroid, 5-aminosalicyclate, 6-mercaptopurine, or methotrexate (document drug, date, duration); 5. Documentation of history of failure to two (2) of the listed medications from each of the following therapeutic categories (only one medication required if only one is available for a category): (a) Interleukin antagonists (Omvoh, Skyrizi, Tremfya, Yesintek); (b) Janus kinase inhibitors (Rinvoq, Xeljanz); (c) S1P receptor modulators (Zeposia); (d) Tumor necrosis factors (Simponi); 6. Documentation of history of failure to a minimum three (3) month supply of Simlandi 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.

Ulcerative colitis - Reauthorization

Covered when ALL of the following are met

Ulcerative colitis 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 ulcerative colitis; 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.

Uveitis - Initial Authorization

Covered when ALL of the following are met

Uveitis initial: 1. Documented diagnosis of uveitis (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 Simlandi 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 - Reauthorization

Covered when ALL of the following are met

Uveitis reauth: 1. Documentation the patient has been established on the 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.

Coverage criteria and authorization intervals

Coverage requires meeting indication-specific prerequisites and documentation requirements:

General prerequisites: 1. 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; 2. Samples, free goods, or similar offerings do not qualify as evidence of established clinical response and will not be accepted; 3. Adhere to nonbiologic prerequisite therapies and disease severity requirements as specified per indication.

Humira-specific prerequisite: Documentation of history of failure to listed adalimumab products/brands (Adalimumab-aacf, Adalimumab-aaty, Adalimumab-adaz, Adalimumab-adbm, Adalimumab-fkjp, Adalimumab-ryvk, Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yuflyma, Yusimry) unless contraindicated (document drugs, dates and duration of trials).

Authorization duration by indication: For hidradenitis suppurativa, plaque psoriasis, and psoriatic arthritis, initial approval is for six (6) months with reauthorization provided in 12-month intervals. For ankylosing spondylitis, Crohn's disease, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, ulcerative colitis, and uveitis, authorizations will be provided in 12-month intervals. Members new to the plan who are stable on the requested medication should be reviewed against Initial Authorization Criteria.

The policy explicitly prohibits using the requested adalimumab product concurrently with other targeted immunomodulators. Providers must document 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 approval. Lack of this documentation or evidence of concomitant targeted therapy may lead to denial of the request.

Across indications the policy disallows combination therapy: authorization and reauthorization criteria require explicit 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. This requirement appears in initial and reauthorization nodes for multiple conditions and is a standing exclusion that prevents duplicative biologic or targeted synthetic therapy.

Samples, free goods, or similar promotional offerings of the requested medication do not qualify as evidence of an established clinical response and will not be considered for prior authorization. Providers should submit documented trials and objective clinical response from prescribed therapy rather than relying on sample exposure.

Requests may be deemed not medically necessary if required prior therapy trials or documentation are missing. The policy requires documentation of prior trials (including drug name, dates and duration) — for many indications this includes failure of specified therapeutic categories and a documented minimum trial of the preferred product Simlandi for three (3) months unless contraindicated. Failure to provide this evidence or to confirm the patient is not on concomitant biologic/targeted synthetic therapy may result in denial.

Documented social alcohol use alone is not an acceptable contraindication to required methotrexate therapy and therefore does not substitute for documented contraindication or failure to nonbiologic therapies. Providers must document true medical contraindications or intolerance rather than social drinking when justifying avoidance of prerequisite therapies.

Coding and Code Lists

Humira-related biosimilars/alternativesmixed

Adalimumab-aacf	Adalimumab biosimilar
Adalimumab-aaty	Adalimumab biosimilar
Adalimumab-adaz	Adalimumab biosimilar
Adalimumab-adbm	Adalimumab biosimilar
Adalimumab-fkjp	Adalimumab biosimilar
Adalimumab-ryvk	Adalimumab biosimilar
Abrilada	Adalimumab product
Amjevita	Adalimumab product
Cyltezo	Adalimumab product
Hadlima	Adalimumab product

1–10 of 15

1/2

Therapeutic agents referenced for prior therapy requirementsmixed

Actemra	Interleukin antagonist (tocilizumab)
Bimzelx	Interleukin antagonist
Skyrizi	Interleukin antagonist
Taltz	Interleukin antagonist
Tremfya	Interleukin antagonist
Yesintek	Interleukin antagonist
Rinvoq	Janus Kinase inhibitor (upadacitinib)
Xeljanz	Janus Kinase inhibitor (tofacitinib)
Olumiant	Janus Kinase inhibitor (baricitinib)
Orencia	Selective T cell costimulation modulator (abatacept)

1–10 of 16

1/2

Codesmixed

No codes listed

Established use duration — >= 6 months (selected indications)

Hidradenitis suppurativa reauthorization durationPatient has been receiving the requested medication for at least 6 months

Plaque psoriasis reauthorization durationPatient has been receiving the requested medication for at least 6 months

Psoriatic arthritis reauthorization durationPatient has been receiving the requested medication for at least 6 months

General noteInitial approvals for hidradenitis suppurativa, plaque psoriasis, and psoriatic arthritis are time-limited to 6 months before reauthorization review

Established use duration — >= 12 months (selected indications)

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for Adalimumab products (including Humira and biosimilars) for Harvard Pilgrim Health Care commercial and Tufts-aligned products. Ensure PA is obtained prior to billing; fax numbers: Harvard Pilgrim/Tufts commercial: 617-673-0988.

Affected products: all Adalimumab brands and biosimilars (see policy list)

Step Therapy

Required Prior Therapy Trials (what to document)

Document all required prior therapy trials before submission. For each required trial include the medication name, start and stop dates, and duration. Trials must show failure, intolerance, contraindication, or adverse event as applicable.

Document failures to conventional DMARDs or listed traditional/systemic agents where indicated (e.g., methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, cyclosporine, acitretin, phototherapy).
Document failures to two medications from each required therapeutic category (interleukin antagonists, JAK inhibitors, TNF agents, PDE4 inhibitors, selective T‑cell agents, S1P modulators where specified).

Background and Scope

Adalimumab is a tumor necrosis factor (TNF) blocker with multiple FDA‑approved indications that include ankylosing spondylitis, Crohn's disease, hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, uveitis, and juvenile idiopathic arthritis. The policy covers branded and biosimilar formulations and requires indication‑specific prerequisite therapies and documentation prior to authorization.

Definitions and Preferred Products

Adalimumab products — branded and biosimilar formulations referenced

Preferred productSimlandi (preferred Adalimumab product; requires prior authorization)

Other branded products listedHumira

Biosimilar examplesAdalimumab-aacf, Adalimumab-aaty, Adalimumab-adaz, Adalimumab-adbm, Adalimumab-fkjp, Adalimumab-ryvk

Simlandi — preferred product and step requirement context

Preferred product contextSimlandi is the preferred adalimumab product and requires prior authorization

Step requirement contextMany indications require documentation of failure to a minimum three (3) month supply of Simlandi prior to authorization of other adalimumab products

OpenPayer

Adalimumab products prior authorization

Coverage Criteria by Indication

Coding and Code Lists

What Providers Must Do

Background and Scope

Definitions and Preferred Products