Enbrel (etanercept)
Indications for Prior Authorization
Enbrel (etanercept)
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For diagnosis of Rheumatoid Arthritis (RA)
Indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. Enbrel can be initiated in combination with methotrexate (MTX) or used alone. -
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older. -
For diagnosis of Psoriatic Arthritis (PsA)
Indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in adult patients with psoriatic arthritis. Enbrel can be used with or without MTX.Also indicated for the treatment of active juvenile psoriatic arthritis (JPsA) in pediatric patients 2 years of age and older.
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For diagnosis of Plaque Psoriasis (PsO)
Indicated for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. -
For diagnosis of Ankylosing Spondylitis (AS)
Indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
Criteria
Enbrel
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Diagnosis of moderately to severely active rheumatoid arthritis AND
- Prescribed by or in consultation with a rheumatologist AND
- Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [2, 3]:
- methotrexate
- leflunomide
- sulfasalazine
Enbrel
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-3]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
Enbrel
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis AND
- Prescribed by or in consultation with a rheumatologist AND
- Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses [4]:
- leflunomide
- methotrexate
Enbrel
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 4]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
Enbrel
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)
- Diagnosis of active psoriatic arthritis AND
- One of the following [5]:
- Actively inflamed joints
- Dactylitis
- Enthesitis
- Axial disease
- Active skin and/or nail involvement
- Prescribed by or in consultation with one of the following:
- Dermatologist
- Rheumatologist
Enbrel
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 5]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline
- Reduction in the body surface area (BSA) involvement from baseline
Enbrel
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis (PsO)
- Diagnosis of moderate to severe chronic plaque psoriasis AND
- One of the following [6]:
- Greater than or equal to 3% body surface area involvement
- Severe scalp psoriasis
- Palmoplantar (i.e., palms, soles), facial, or genital involvement
- Minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies [7]:
- corticosteroids (e.g., betamethasone, clobetasol)
- vitamin D analogs (e.g., calcitriol, calcipotriene)
- tazarotene
- calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
- Prescribed by or in consultation with a dermatologist
Enbrel
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis (PsO)
- Patient demonstrates positive clinical response to therapy as evidenced by ONE of the following [1, 6]:
- Reduction in the body surface area (BSA) involvement from baseline
- Improvement in symptoms (e.g., pruritus, inflammation) from baseline
Enbrel
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)
- Diagnosis of active ankylosing spondylitis AND
- Prescribed by or in consultation with a rheumatologist AND
- Minimum duration of one month trial and failure, contraindication, or intolerance to two different NSAIDs (e.g., ibuprofen, naproxen) at maximally tolerated doses [8]
Enbrel
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Ankylosing Spondylitis (AS)
- Patient demonstrates positive clinical response to therapy as evidenced by improvement from baseline for at least one of the following [1, 8]:
- Disease activity (e.g., pain, fatigue, inflammation, stiffness)
- Lab values (erythrocyte sedimentation rate, C-reactive protein level)
- Function
- Axial status (e.g., lumbar spine motion, chest expansion)
- Total active (swollen and tender) joint count
P & T Revisions
2024-09-15, 2024-04-04, 2023-11-30, 2023-08-22, 2023-04-05, 2022-10-21, 2022-06-02, 2022-04-07, 2022-03-01, 2021-09-27, 2021-05-19, 2021-04-08, 2020-12-03, 2020-09-02, 2020-03-19, 2019-10-31, 2019-10-31, 2019-10-23
References
- Enbrel Prescribing Information. Amgen. Thousand Oaks, CA. October 2023.
- Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25.
- Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. 2021;73(7):924-939.
- Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Rheumatol. 2019;71(6):846-863.
- Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32.
- Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029-72.
- Elmets CA, Korman NJ, Farley Prater E, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021;84:432-70.
- Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613.
End Notes
- Patients who are candidates for systemic/and or phototherapy have significant disease, typically affecting 5% or more of the body surface area (BSA). Some of these candidates may also have less than 5% BSA affected but have psoriasis in vulnerable areas such as the face, genitals, hands, or feet (palmer-plantar), nails, scalp, or intertriginous areas.
Revision History
- 2024-09-15: Removed anthralin and coal tar as topical step options for PsO
- 2024-04-04: Annual review - no criteria changes
- 2023-11-30: Updated PsA indication to include pediatric patients; no criteria changes
- 2023-08-22: Program update to standard reauthorization language. No changes to clinical intent.
- 2023-04-05: Annual review - no criteria changes; background updates
- 2022-10-21: Removed biologic/JAK step requirements; further clinical detail and criteria added
- 2022-06-02: Added Rinvoq and Xeljanz/XR as additional preferred step options for AS
- 2022-04-07: Annual review - no criteria changes; reference updates
- 2022-03-01: Formulary strategy update for AS to add Xeljanz/XR as a secondary step option.
- 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
- 2021-04-08: Annual review - No clinical changes; background and reference updates
- 2020-12-03: Addition of Xeljanz as a required step for PJIA. Addition of attestation bypass verbiage to Humira step in PJIA.
- 2020-09-02: Addition of Tremfya as a preferred step option for psoriatic arthritis; formulary strategy update to remove Simponi Aria as a preferred step option for RA, PsA, and AS; removal of separation of steps by age in the psoriasis criteria to align with criteria for other indications and agents.
- 2020-03-19: Annual review - Added objective measures to the psoriasis reauthorization criteria; Updated references
- 2019-10-31: A trial of 3 first line agents (instead of one) plus Taltz is now required for psoriasis.
- 2019-10-31: NSAID examples were added in the AS criteria section
- 2019-10-23: Added Cosentyx as a second-line step for ankylosing spondylitis. Step requires two first-line agents plus Cosentyx.
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