Otezla - NC Standard

Restricted Product(s):

• Otezla® (apremilast)

FDA Approved Use:

• For the treatment of adult patients with active psoriatic arthritis
• For the treatment of pediatric patients 6 years and older (weighing at least 20 kg) and with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
• For adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy
• For the treatment of adult patients with oral ulcers associated with Behçet’s Disease

Criteria for Approval of Restricted Product(s):

1. The patient is not using Otezla in combination with another biologic immunomodulator agent; AND
2. The provider is aware that if approved, any previous authorizations through Blue Cross NC for biologic agents or Zeposia used for the same indication as the requested agent will be terminated; AND
3. The patient does NOT have any FDA labeled contraindications to Otezla; AND
4. The patient is diagnosed with active psoriatic arthritis (PsA); AND
   1. The patient is 18 years of age or older; AND
   2. The prescriber is a specialist in the area of the patient’s diagnosis or the prescriber has consulted with a specialist in the area of the patient’s diagnosis (e,g., dermatologist, rheumatologist); AND
   3. The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months (medical record documentation required); OR
   4. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of PsA (medical record documentation required); OR
   5. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA (medical record documentation required); OR
   6. The patient has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) (medical record documentation required); OR
   7. The patient has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select
   8. locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) (medical record
   9. documentation required); OR
5. The patient is diagnosed with plaque psoriasis (PS); AND
   1. The patient is 18 years of age or older; AND
      1. The patient has been diagnosed with mild psoriasis (PS); OR
   2. The patient is 6 years of age or older; AND
      1. The patient weighs ≥20 kg; AND
      2. The patient has been diagnosed with moderate or severe plaque psoriasis (PS); AND
      3. The prescriber is a specialist in the area of the patient’s diagnosis or the prescriber has consulted with a specialist in the area of the patient’s diagnosis (e,g., dermatologist, rheumatologist); AND
   3. The patient has tried and had an inadequate response to ONE conventional agent (i.e., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months (medical record documentation required); OR
   4. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of PS (medical record documentation required); OR
   5. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS (medical record documentation required); OR
   6. The patient has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) (medical record documentation required); OR
   7. The patient has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) (medical record documentation required); OR
6. The patient has a diagnosis of Behcet’s Disease (BD); AND
   1. The patient is 18 years of age or older; AND
   2. The prescriber is a specialist in the area of the patient’s diagnosis or the prescriber has consulted with a specialist in the area of the patient’s diagnosis (e,g., dermatologist, rheumatologist); AND
   3. The patient has active oral ulcers associated with BD; AND
   4. The patient has had at least 3 occurrences of oral ulcers in the last 12-months; AND
   5. ONE of the following:
      1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., topical oral corticosteroids [i.e., triamcinolone dental paste], colchicine, azathioprine) used in the treatment of BD (medical record documentation required); OR
      2. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of BD (medical record documentation required); OR
      3. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of BD (medical record documentation required); OR
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)