OTEZLA (apremilast)

OTEZLA (apremilast)

Self-Administration – oral tablet

Indications for Prior Authorization:

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

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

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

Coverage Criteria:

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.

For diagnosis of plaque psoriasis (PsO):

• Documented diagnosis of PsO; 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 or rheumatologist.

For diagnosis of oral ulcers associated with Behçet’s Disease:

• Documented diagnosis of Behçet’s Disease; AND
• Patient has active oral ulcers.

Reauthorization Criteria:

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 

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 oral ulcers associated with Behçet’s Disease:

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

Dosing:

PsA, PsO, Behçet’s Disease (adults):

• 30 mg twice daily.
  • To reduce risk of gastrointestinal symptoms, titrate to recommended dosage of 30 mg twice daily according to the following schedule:
    • Day 1: 10 mg in morning
    • Day 2: 10 mg in morning and 10 mg in evening
    • Day 3: 10 mg in morning and 20 mg in evening
    • Day 4: 20 mg in morning and 20 mg in evening
    • Day 5: 20 mg in morning and 30 mg in evening
    • Day 6 and thereafter: 30 mg twice daily

Coverage Duration:

PsA, PsO, Behçet’s Disease:

• 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 Committee.

Additional Information:

The recommended dose for patients with severe renal impairment (i.e., creatine clearance of less than 30 mL per minute estimated by the Cockcroft-Gault equation) is Otezla 30 mg once daily

Review History:

• 7/01/2020 - annual review.
• 02/16/2021 - updated format; P&T Ad Hoc review of PA guidelines: removed reference to chart note requirement; removed oral DMARD and topical therapy requirements; added medical necessity guidance for reauthorization requests; added FDA approval to treat oral ulcers associated with Behçet’s Disease; updated approval duration to 1 year.
• 04/20/2021 - added coverage criteria for Behçet’s Disease
• 04/01/2022- criteria updated. Criteria for plaque psoriasis updated to remove reference to disease severity and addition of PsO specific reauthorization criteria.
• 01/01/2023 - Update prerequisite drugs for PsO; update use duration for prerequisite drugs; add symptom requirements for PsA; add reauthorization criteria for all indications.

References:

1. Otezla Prescribing Information. Celgene Corp. Summit, NJ. December 2021. 
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.