Pharmacy Prior Authorization Criteria

Otezla (apremilast)

Indications for Prior Authorization

Otezla (apremilast)

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

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

  Indicated for pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

• For diagnosis of Oral Ulcers Associated with Behçet’s Disease
  Indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

Criteria

Otezla

Prior Authorization (Initial Authorization)

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

• Diagnosis of active psoriatic arthritis
AND
• One of the following [2]:
• 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

Otezla

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, 2]:
• 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

Otezla

Prior Authorization (Initial Authorization)

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

• Diagnosis of plaque psoriasis
AND
• Both of the following:
• Patient is 6 years of age or older
• Patient weighs at least 20 kg
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

Otezla

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, 4]:
• Reduction in the body surface area (BSA) involvement from baseline
• Improvement in symptoms (e.g., pruritus, inflammation) from baseline

Otezla

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Oral Ulcers Associated with Behçet’s Disease

• Diagnosis of Behçet’s Disease
AND
• Patient has active oral ulcers

Otezla

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Oral Ulcers Associated with Behçet’s Disease

• Patient demonstrates positive clinical response to therapy(e.g., reduction in pain from oral ulcers or reduction in number of oral ulcers)

P & T Revisions

2024-09-15, 2024-06-05, 2023-11-30, 2023-09-28, 2022-10-23, 2022-03-01, 2021-10-24, 2021-05-21, 2020-10-11, 2020-09-18

References

1. Otezla Prescribing Information. Amgen Inc. Thousand Oaks, CA. April 2024.
2. 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.
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. 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.

---

Revision History

• 2024-09-15: Addition of 20 mg tablet and starter pack for pediatric PsO; removed anthralin and coal tar as topical step options for PsO
• 2024-06-05: Updated PsO indication to include pediatric approval; added age and weight criterion to PsO criteria.
• 2023-11-30: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-09-28: Annual review - no criteria changes; background updates
• 2022-10-23: Further clinical detail and criteria added
• 2022-03-01: Updated psoriasis indication and criteria to remove moderate to severe now that Otezla may be used for psoriasis of any severity.
• 2021-10-24: Annual review
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2020-10-11: Annual review - Reference updates; Removal of the following criteria to align with other agents indicated for plaque psoriasis: One of the following: greater than 10% body surface area involvement, palmoplantar involvement, or severe scalp psoriasis.
• 2020-09-18: Addition of objective measures to the psoriasis reauthorization criteria

---