Pharmacy Prior Authorization Criteria

Ilumya (tildrakizumab-asmn) - PA, NF

Indications for Prior Authorization

Ilumya (tildrakizumab-asmn)

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

Criteria

Ilumya

* For review process only: Refer to the table in the Background section for carrier-specific formulary products

Prior Authorization (Initial Authorization)

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

• 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
AND
• One of the following:
• Both of the following:
• Trial and failure, contraindication, or intolerance to THREE of the following:
• Cimzia (certolizumab pegol)
• Enbrel (etanercept)
• One formulary adalimumab product*
• One formulary ustekinumab product*
• Taltz (ixekizumab)
• Skyrizi (risankizumab)
• Tremfya (guselkumab)
• Otezla (apremilast)
• Sotyktu (deucravacitinib)
AND
• Trial and failure, contraindication, or intolerance to Bimzelx (bimekizumab-bkzx)
OR
• For continuation of prior therapy, defined as no more than a 45-day gap in therapy

Ilumya

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Plaque Psoriasis

• 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

Ilumya

* For review process only: Refer to the table in the Background section for carrier-specific formulary products

Non Formulary

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

• Submission of medical records (e.g., chart notes) confirming a 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
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum 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
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to THREE of the following:
• Cimzia (certolizumab pegol)
• Enbrel (etanercept)
• One formulary adalimumab product*
• One formulary ustekinumab product*
• Taltz (ixekizumab)
• Skyrizi (risankizumab)
• Tremfya (guselkumab)
• Otezla (apremilast)
• Sotyktu (deucravacitinib)
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to Bimzelx (bimekizumab-bkzx)
OR
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy
AND
• 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

P & T Revisions

2024-12-01, 2024-11-27, 2024-09-15, 2024-07-03, 2024-06-24, 2024-05-30, 2024-04-24, 2024-03-07, 2023-10-03, 2023-07-04, 2023-02-01, 2022-10-23, 2022-07-07, 2021-06-30, 2020-09-18, 2020-07-13, 2019-10-31, 2019-07-05

References

1. Ilumya prescribing information. Merck & Co., Inc. Whitehouse Station, NJ. April 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.

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Revision History

• 2024-12-01: Bimzelx added as an additional step and Taltz moved to the first list of preferred alternatives; Otezla and Sotyktu added as preferred alternatives; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
• 2024-11-27: Bimzelx added as an additional step and Taltz moved to the first list of preferred alternatives; Otezla and Sotyktu added as preferred alternatives; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
• 2024-09-15: Removed anthralin and coal tar as topical step options for PsO; addition of EHB formulary and NF criteria
• 2024-07-03: Annual review - no criteria changes; background updates
• 2024-06-24: No criteria changes; updated background table to specify BI manufacturer for adalimumab-adbm
• 2024-05-30: Updated background table to include CalPERS formulary; no criteria changes
• 2024-04-24: Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2024-03-07: Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2023-10-03: Program update to standard reauthorization language. No changes to clinical intent
• 2023-07-04: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options; Annual review - no criteria changes
• 2023-02-01: Addition of Amjevita as another preferred step option
• 2022-10-23: Addition of Enbrel as another preferred step option. Further clinical detail and criteria added
• 2022-07-07: Annual review - no criteria changes
• 2021-06-30: Annual review
• 2020-09-18: Addition of objective measures to the psoriasis reauthorization criteria
• 2020-07-13: Annual review - removed drug name from reauth criteria
• 2019-10-31: Updated step requirement to 3 first line agents plus Taltz.
• 2019-07-05: 2019 Annual Review - Removed the restriction prohibiting use in combination with a biologic disease modifying antirheumatic drug (DMARD). AJL 7/5/19

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