UnitedHealthcare adalimumab Prior Auth Policy Update

Coverage Criteria by Indication

Rheumatoid Arthritis - Initial Therapy

Initial authorization for rheumatoid arthritis - covered when ALL of the following are met

RA initial: (1) Diagnosis of moderately to severely active rheumatoid arthritis

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, tofacitinib, baricitinib, upadacitinib)

Rheumatoid Arthritis - Reauthorization

Reauthorization for rheumatoid arthritis - covered when ALL of the following are met

RA reauth: (1) Documentation of positive clinical response to adalimumab therapy

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, tofacitinib, baricitinib, upadacitinib)

Juvenile Idiopathic Arthritis - Initial Therapy

Initial authorization for juvenile idiopathic arthritis - covered when ALL of the following are met

JIA initial: (1) Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, tofacitinib, baricitinib, upadacitinib)

Juvenile Idiopathic Arthritis - Reauthorization

Reauthorization for juvenile idiopathic arthritis - covered when ALL of the following are met

JIA reauth: (1) Documentation of positive clinical response to adalimumab therapy

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, tofacitinib, baricitinib, upadacitinib)

Psoriatic Arthritis - Initial Therapy

Initial authorization for psoriatic arthritis - covered when ALL of the following are met

PsA initial: (1) Diagnosis of active psoriatic arthritis

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, tofacitinib, baricitinib, upadacitinib, apremilast)

Psoriatic Arthritis - Reauthorization

Reauthorization for psoriatic arthritis - covered when ALL of the following are met

PsA reauth: (1) Documentation of positive clinical response to adalimumab therapy

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, tofacitinib, baricitinib, upadacitinib, apremilast)

Plaque Psoriasis - Initial Therapy

Initial authorization for plaque psoriasis - covered when ALL of the following are met

Psoriasis initial: (1) Diagnosis of moderate to severe chronic plaque psoriasis

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab, tildrakizumab, tofacitinib, baricitinib, upadacitinib, apremilast)

Plaque Psoriasis - Reauthorization

Reauthorization for plaque psoriasis - covered when ALL of the following are met

Psoriasis reauth: (1) Documentation of positive clinical response to adalimumab therapy

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, ustekinumab, risankizumab, guselkumab, secukinumab, ixekizumab, brodalumab, tildrakizumab, tofacitinib, baricitinib, upadacitinib, apremilast)

Ankylosing Spondylitis - Initial Therapy

Initial authorization for ankylosing spondylitis - covered when ALL of the following are met

AS initial: (1) Diagnosis of active ankylosing spondylitis

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, tofacitinib, baricitinib, upadacitinib)

Ankylosing Spondylitis - Reauthorization

Reauthorization for ankylosing spondylitis - covered when ALL of the following are met

AS reauth: (1) Documentation of positive clinical response to adalimumab therapy

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, abatacept, tofacitinib, baricitinib, upadacitinib)

Crohn's Disease - Initial Therapy

Initial authorization for Crohn's disease - covered when ALL of the following are met

CD initial: (1) Diagnosis of moderately to severely active Crohn's disease

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, vedolizumab, mirikizumab, guselkumab, abatacept, tofacitinib, baricitinib, upadacitinib, ustekinumab, risankizumab)

Crohn's Disease - Reauthorization

Reauthorization for Crohn's disease - covered when ALL of the following are met

CD reauth: (1) Documentation of positive clinical response to adalimumab therapy

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, vedolizumab, mirikizumab, guselkumab, abatacept, tofacitinib, baricitinib, upadacitinib, ustekinumab, risankizumab)

Ulcerative Colitis - Initial Therapy

Initial authorization for ulcerative colitis - covered when ALL of the following are met

UC initial: (1) Diagnosis of moderately to severely active ulcerative colitis

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (e.g., etanercept, certolizumab, golimumab, vedolizumab, mirikizumab, guselkumab, abatacept, tofacitinib, baricitinib, upadacitinib, ustekinumab, risankizumab)

Ulcerative colitis — Initial authorization

Covered when ALL of the following are met

ALL of the following

Diagnosis of moderately to severely active ulcerative colitis
Concomitant therapy: Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (examples listed)
Authorization issued for 12 months

Ulcerative colitis — Reauthorization

Covered when ALL of the following are met

ALL of the following

Response: Documentation of positive clinical response to adalimumab therapy
Concomitant therapy: Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (examples listed)
Authorization issued for 12 months

Hidradenitis suppurativa — Initial authorization

Covered when ALL of the following are met

ALL of the following

Diagnosis of moderate to severe hidradenitis suppurativa
Concomitant therapy: Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (examples listed)
Authorization issued for 12 months

Hidradenitis suppurativa — Reauthorization

Covered when ALL of the following are met

ALL of the following

Response: Documentation of positive clinical response to adalimumab therapy
Concomitant therapy: Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (examples listed)
Authorization issued for 12 months

Non-infectious uveitis — Initial and Reauthorization

Initial authorization covered when ALL of the following are met; reauthorization requires similar criteria with response documentation

ALL of the following

Diagnosis of non-infectious uveitis
Concomitant therapy: Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (examples listed)
Authorization issued for 12 months

ALL of the following

Response: Documentation of positive clinical response to adalimumab therapy (for reauthorization)

The following adalimumab products are excluded from coverage for the majority of UnitedHealthcare benefits: Abrilada (adalimumab-afzb), Adalimumab-aacf (unbranded Idacio), Adalimumab-adbm (unbranded Cyltezo), Adalimumab-fkjp (unbranded Hulio), Cyltezo (adalimumab-adbm), Hadlima (adalimumab-bwwd), Hulio (adalimumab-fkjp), Humira (adalimumab), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh). Coverage may be denied if the requested product is excluded under the member’s benefit.

UnitedHealthcare notes that specific adalimumab products are excluded from coverage for the majority of benefits; the policy text repeats the exclusion list (including Abrilada, multiple unbranded adalimumab presentations, several biosimilars, and Humira) and states that authorization will be issued for 12 months when criteria are met. The document also explains that coverage status varies by product and benefit, that state mandates and member-specific benefit plans may affect coverage, and that other policies or utilization programs may apply.

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required for adalimumab. Initial approval is granted when the applicable indication criteria are met and the patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for the same indication. Authorization (initial and reauthorization) will be issued for 12 months unless otherwise specified by program rules.

Prior authorization required for all indications listed in this policy.
Initial authorization: must meet the indication-specific diagnosis criteria and patient must NOT be receiving adalimumab in combination with another systemic targeted immunomodulator for the same indication (examples include Enbrel, Cimzia, Simponi, Orencia, Xeljanz, Olumiant, Rinvoq; indication-specific biologics and small molecules are listed in policy).
Reauthorization: documentation of positive clinical response to adalimumab therapy is required and patient must NOT be receiving adalimumab in combination with another systemic targeted immunomodulator for the same indication.
Authorization will be issued for 12 months for both initial approvals and reauthorizations.
UnitedHealthcare may use automated approval/re-approval based on prior claims/medication history, diagnosis codes (ICD-10), and claim logic; supply limits and medical necessity rules may apply.

Initial Authorization Rules (General)

Initial authorization - general

Initial authorization criteria per indication require diagnosis of the active disease and absence of combination therapy with another systemic targeted immunomodulator for the same indication.

Initial general: (1) Diagnosis of the specified active disease

AND (2) Patient is not receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication

Initial authorization rules

Initial authorization for each listed indication requires diagnosis and absence of concurrent systemic targeted immunomodulator therapy for the same indication.

ALL of the following

Diagnosis: Appropriate diagnosis for the indication (e.g., RA, JIA, PsA, AS, Crohn's disease, UC, plaque psoriasis, hidradenitis suppurativa, non-infectious uveitis)

Reauthorization / Continuation Requirements

Reauthorization

Reauthorization requirements

Reauth general: Documentation of positive clinical response to adalimumab therapy is required

AND patient not receiving adalimumab in combination with another systemic targeted immunomodulator for the same indication

Reauthorization criteria

Reauthorization requires evidence of clinical benefit

ALL of the following

Response: Documentation of positive clinical response to adalimumab therapy
Authorization will be issued for 12 months

Concomitant Therapy and Step Rules

Step	Requirement
1
Patient must not be receiving adalimumab in combination with another systemic targeted immunomodulator for treatment of the same indication (examples include: Enbrel [etanercept], Cimzia [certolizumab], Simponi [golimumab], Orencia [abatacept], Xeljanz [tofacitinib], Olumiant [baricitinib], Rinvoq [upadacitinib], and indication-specific biologic or targeted agents).

Step	Program note
1
Program historically included step/try-fail elements and concomitant therapy restrictions; the current program language emphasizes non-concurrent use of adalimumab with other systemic targeted immunomodulators and allows automated approvals based on prior claims/medication history and diagnosis codes where applicable.

Program Operations and Site-of-Care Rules

Billing Rule

Supply limits and automated approvals

Supply limits may apply and the program allows automated approval processes based on prior claims, medication history, and diagnosis codes.

Automated approval and re-approval processes vary by program and therapeutic class.

Products and Biosimilar Notes

Billing Rule

Adalimumab products listed (brands/biosimilars)

Policy lists multiple adalimumab brands and biosimilars; specific products and presentations are identified in the program, and coverage status varies by product and benefit.

Billing Rule

Coverage status varies by adalimumab product

Multiple adalimumab biosimilars and unbranded products are listed in the program; the policy notes that some products are excluded from coverage for the majority of benefits and coverage status varies by specific product and benefit.

Background

Adalimumab is a tumor necrosis factor (TNF) blocker with labeled indications across rheumatology, dermatology, gastroenterology, and ophthalmology. Indications include rheumatoid arthritis, juvenile idiopathic arthritis (polyarticular), psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and non-infectious uveitis. It may be used alone or concomitantly with non-biologic disease-modifying antirheumatic drugs; for some populations (for example ulcerative colitis patients who lost response to or were intolerant of TNF blockers) effectiveness may be limited.

Definitions and Key Terms

Adalimumab

Typical useCan be used alone or in combination with non-biologic DMARDs (e.g., methotrexate) for several indications (RA, JIA, AS); specific pediatric age indications noted per disease.

Limitations notedIn ulcerative colitis, effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.

positive clinical response

DefinitionPositive clinical response — documentation demonstrating clinical improvement on adalimumab therapy sufficient to support reauthorization, as determined by the treating clinician.

Reauthorization requirementFor reauthorization, documentation of positive clinical response to adalimumab therapy is required for covered indications (e.g., uveitis, ulcerative colitis, hidradenitis suppurativa).

Concomitant therapy rule

OpenPayer

Adalimumab (Humira and biosimilars) — Prior Authorization and Reauthorization

Coverage Criteria by Indication

What Providers Must Do

Initial Authorization Rules (General)

Reauthorization / Continuation Requirements

Concomitant Therapy and Step Rules

Program Operations and Site-of-Care Rules

Products and Biosimilar Notes

Background

Definitions and Key Terms