Pharmacy Prior Authorization Criteria

Tremfya (guselkumab)

Indications for Prior Authorization

Tremfya SC (guselkumab)

• For diagnosis of Plaque Psoriasis (PsO)
  Indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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

• For diagnosis of Ulcerative Colitis (UC)
  Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Tremfya IV (guselkumab)

• For diagnosis of Ulcerative Colitis (UC)
  Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

Criteria

Tremfya SC 100 mg

If patient meets criteria above, please approve at GPI-14

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Plaque Psoriasis (PsO)

• Diagnosis of moderate-to-severe plaque psoriasis
AND
• One of the following [2]:
• 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 [3]:
• corticosteroids (e.g., betamethasone, clobetasol)
• vitamin D analogs (e.g., calcitriol, calcipotriene)
• tazarotene
• calcineurin inhibitors (e.g., tacrolimus, pimecrolimus)
AND
• Prescribed by or in consultation with a dermatologist

Tremfya SC 100 mg

If patient meets criteria above, please approve at GPI-14

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 [1-3]:
• Reduction in the body surface area (BSA) involvement from baseline
• Improvement in symptoms (e.g., pruritus, inflammation) from baseline

Tremfya SC 100 mg

If patient meets criteria above, please approve at GPI-14

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Psoriatic Arthritis (PsA)

• Diagnosis of active psoriatic arthritis (PsA)
AND
• One of the following [4]:
• Actively inflamed joints
• Dactylitis
• Enthesitis
• Axial disease
• Active skin and/or nail involvement
AND
• Prescribed by or in consultation with one of the following:
• Dermatologist
• Rheumatologist

Tremfya SC 100 mg

If patient meets criteria above, please approve at GPI-14

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, 4]:
• 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

Tremfya IV

Prior Authorization

Length of Approval: 3 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Diagnosis of moderately to severely active ulcerative colitis
AND
• One of the following [5, 6]:
• Greater than 6 stools per day
• Frequent blood in the stools
• Frequent urgency
• Presence of ulcers
• Abnormal lab values (e.g., hemoglobin, erythrocyte sedimentation rate, C-reactive protein)
• Dependent on, or refractory to, corticosteroids
AND
• Trial and failure, contraindication, or intolerance to one of the following conventional therapies [5, 6]:
• 6-mercaptopurine
• Azathioprine
• Corticosteroid (e.g., prednisone)
• Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
AND
• Will be administered as an intravenous induction dose
AND
• Prescribed by or in consultation with a gastroenterologist

Tremfya SC

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Diagnosis of moderately to severely active ulcerative colitis
AND
• Will be used as a maintenance dose following the intravenous induction doses
AND
• Prescribed by or in consultation with a gastroenterologist

Tremfya SC

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Ulcerative Colitis (UC)

• Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 5, 6]:
• Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
• Reversal of high fecal output state

P & T Revisions

2024-10-10, 2024-09-15, 2024-03-04, 2023-12-20, 2023-10-16, 2023-02-26, 2022-10-24, 2022-03-02, 2021-09-27, 2021-05-26, 2021-05-25, 2021-03-02, 2020-09-02, 2020-03-03

References

1. Tremfya Prescribing Information. Janssen Biotech, Inc. Horsham, PA. September 2024.
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.
5. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
6. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461.

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Revision History

• 2024-10-10: Addition of criteria for ulcerative colitis
• 2024-09-15: Removed anthralin and coal tar as topical step options for PsO
• 2024-03-04: Annual review - no criteria changes; background updates
• 2023-12-20: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-10-16: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-02-26: Annual review - no criteria changes; background updates
• 2022-10-24: Further clinical detail and criteria added
• 2022-03-02: Annual review - no criteria changes
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2021-03-02: Annual review - no clinical changes; background updates
• 2020-09-02: Addition of criteria for new psoriatic arthritis indication.
• 2020-03-03: Annual review - added objective measures to the reauth criteria; reference updates

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