TREMFYA (guselkumab)

Self-Administration – subcutaneous (SC) injection by prefilled syringe or single dose One-Press patient-controlled injector.

 

Indications for Prior Authorization:

 

Plaque Psoriasis (PsO): Indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 

Psoriatic Arthritis (PsA): Indicated for the treatment of adult patients with active psoriatic arthritis.

 

Coverage Criteria:

 

For diagnosis of plaque psoriasis (PsO):

  • Documented diagnosis of moderate to severe 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 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.

 

Reauthorization Criteria:

 

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 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 

 

Dosing:

 

PsO, PsA:

  • 100 mg administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter.

 

Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year

 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:
  • Patients should be evaluated for latent tuberculosis infection with a TB skin test.  Treatment of latent tuberculosis infection should be initiated prior to therapy with Tremfya.

 

Review History:
  • 10/01/2020 - annual review.
  • 02/16/2021 - updated format; removed requirement for BSA or body involvement; removed requirement of topical therapy and methotrexate, cyclosporine, acitretin, or light therapy for psoriasis. Removed requirement for DMARDs for psoriatic arthritis. Removed TB testing requirements. Extended initial authorization approval to 1 year.
  • 01/01/2023 - Update prerequisite drugs for PsO; add symptom requirements for PsO, PsA; update reauthorization criteria for PsO, PsA

 

References:
  1. Tremfya prescribing information. Janssen Biotech, Inc. Horsham, PA. July 2020. 
  2. 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. 
  3. 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. 
  4. 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.

Last review date: February 16, 2020