ENBREL (etanercept)

ENBREL (etanercept)

Self-administration – subcutaneous (SC) injection may be given at home using the prefilled syringe, SureClick autoinjector, and prefilled cartridge with the AutoTouch reusable autoinjector.

Indications for Prior Authorization:

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. 

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. 

Psoriatic Arthritis (PsA): Indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. Enbrel can be used with or without MTX. 

Plaque Psoriasis (PsO): Indicated for the treatment of patients 4 years of age and older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 

Ankylosing Spondylitis (AS): Indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Coverage Criteria:

For diagnosis of Rheumatoid Arthritis (RA):

• Documented diagnosis of moderate to severe, active RA; 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: 
  • methotrexate 
  • leflunomide 
  • sulfasalazine
  • hydroxychloroquine

For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA):

• Documented diagnosis of active PJIA; 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: 
  • methotrexate 
  • leflunomide 
  • sulfasalazine 

For diagnosis of psoriatic arthritis (PsA):

• Documented diagnosis of active PsA; AND  
• One of the following:
  • actively inflamed joints 
  • dactylitis 
  • enthesitis 
  • axial disease 
  • active skin and/or nail involvement; AND
• Prescribed by or in consultation with a dermatologist or rheumatologist.

For diagnosis of plaque psoriasis (PsO):

• Documented diagnosis of moderate to severe chronic PsO; AND
• One of the following:
  • Greater than or equal to 3% body surface area involvement 
  • Severe scalp psoriasis 
  • Palmoplantar (i.e., palms, soles), facial, or genital involvement; AND
• Minimum duration of a 4-week trial and failure, contraindication, or intolerance to ONE of the following topical therapies: 
  • corticosteroids (e.g., betamethasone, clobetasol) 
  • vitamin D analogs (e.g., calcitriol, calcipotriene) 
  • tazarotene 
  • calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) 
  • anthralin 
  • coal tar; AND
• Prescribed by or in consultation with a dermatologist.

For diagnosis of ankylosing spondylitis (AS):

• Documented diagnosis of active AS; AND
• Prescribed by or in consultation with a rheumatologist; AND
• Minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses.

Reauthorization Criteria:

For diagnosis of RA, PJIA:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following:
  • Reduction in the total active (swollen and tender) joint count from baseline
  • Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

For diagnosis of PsA:

• Documentation of positive clinical response to therapy as evidenced by at least one of the following: 
  • 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 

For diagnosis of PsO:

• Documentation of positive clinical response to therapy as evidenced by ONE of the following:
  • Reduction the body surface area (BSA) involvement from baseline 
  • Improvement in symptoms (e.g., pruritus, inflammation) from baseline 

For diagnosis of AS:

• Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following: 
  • 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

Dosing:

RA:

• 50 mg once weekly

PJIA:

• 0.8 mg/kg once weekly (up to a maximum of 50 mg once weekly)

PsA:

• 50 mg once weekly

PsO:

• Adults: 50 mg twice weekly for three months, then 50 mg once weekly
• Pediatric patients: 0.8 mg/kg once weekly (up to a maximum of 50 mg once weekly)

AS:

• 50 mg once weekly

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee: 

• Congestive heart failure (CHF), Multiple sclerosis (MS), Recurrent miscarriage, Infertility, Crohn’s disease (CD), Graft vs. Host Disease (GVHD), Interleukin-2 Toxicity, Cachexia, Nephrotic Syndrome, Prevention of Muromonab-CD3-Associated Acute Clinical Syndrome.

Additional Information:

Policy Updates:

• 11/16/2021 - Updated PJIA oral DMARDs criteria.
• 04/01/2022- Criteria updated to include additional preferred medications for AS and PsA.
• 08/16/2022 - Update AS criteria to include all WHA preferred agents for the treatment of AS.
• 01/01/2023 – Remove step edits through immunological agents for all relevant indications; remove age requirement; remove requirement to submit chart notes.

References:

1. Enbrel Prescribing Information. Amgen. Thousand Oaks, CA. June 2022. 
2. 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. 
3. 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. 
4. 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. 
5. 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. 
6. 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. 
7. 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. 
8. 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.