TREMFYA (guselkumab)

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.