Pharmacy Prior Authorization Criteria

Siliq (brodalumab) - PA, NF

Indications for Prior Authorization

Siliq (brodalumab)

• For diagnosis of Plaque Psoriasis
  Indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

Criteria

Siliq

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

Siliq

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
AND
• Trial and failure, contraindication, or intolerance to BOTH of the following:
• Bimzelx (bimekizumab-bkzx)
• Taltz (ixekizumab)

Siliq

* 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 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:
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to TWO of the following:
• Cimzia (certolizumab pegol)
• Enbrel (etanercept)
• One formulary adalimumab product*
• One formulary ustekinumab product*
• Skyrizi (risankizumab)
• Tremfya (guselkumab)
• Otezla (apremilast)
• Sotyktu (deucravacitinib)
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
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming a trial and failure, contraindication, or intolerance to BOTH of the following:
• Bimzelx (bimekizumab-bkzx)
• Taltz (ixekizumab)

P & T Revisions

2024-12-01, 2024-11-27, 2024-09-15, 2024-06-24, 2024-05-31, 2024-05-01, 2024-04-24, 2024-03-06, 2023-11-30, 2023-06-30, 2023-05-03, 2023-02-01, 2022-10-23, 2022-05-07, 2021-04-23, 2020-09-18, 2020-06-10, 2019-10-31, 2019-09-26

References

1. Siliq Prescribing Information. Valeant Pharmaceuticals Int. Bridgewater, NJ. April 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.

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Revision History

• 2024-12-01: Added Bimzelx as a new step requirement to both initial and reauth criteria; separated Taltz step to remove COT and added to reauth criteria; Otezla and Sotyktu added as preferred alternatives; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
• 2024-11-27: Added Bimzelx as a new step requirement to both initial and reauth criteria; separated Taltz step to remove COT and added to reauth criteria; 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
• 2024-06-24: Updated background table to include CalPERS formulary and specify BI manufacturer for adalimumab-adbm; no criteria changes
• 2024-05-31: Updated background table to include CalPERS formulary; no criteria changes
• 2024-05-01: Annual review - 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
• 2024-03-06: 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
• 2023-11-30: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-06-30: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options
• 2023-05-03: Annual review - no criteria changes
• 2023-02-01: Addition of Amjevita as another preferred step option
• 2022-10-23: Addition of Enbrel as an additional preferred step option; further clinical detail and criteria added
• 2022-05-07: Annual review - no criteria changes
• 2021-04-23: Annual review
• 2020-09-18: Addition of objective measures to the psoriasis reauthorization criteria
• 2020-06-10: Annual review - removed drug name from reauth criteria; references updates
• 2019-10-31: Updated step requirement to a trial of 3 first line agents plus Taltz.
• 2019-09-26: Annual Review; removed the restriction prohibiting use in combination with a biologic DMARD.

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