UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number Program Medication P&T Approval Date Effective Date 2014 P 1129-2 Notification Otezla® (apremilast) 5/2014, 10/2014 1/1/2015 1. Background: Otezla is indicated for the treatment of adult patients with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. 2. Coverage Criteria: A. Psoriatic Arthritis (PsA) 1. Initial Authorization a. Otezla will be approved based on both of the following criteria: (1) Diagnosis of active psoriatic arthritis -AND(2) Patient is not receiving Otezla in combination with either of the following: (a) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Simponi (golimumab), Orencia (abatacept)] (b) Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Authorization will be issued for 12 months. 2. Reauthorization a. Otezla will be approved based on both of the following criteria: (1) Documentation of positive clinical response to Otezla therapy -AND(2) Patient is not receiving Otezla in combination with either of the following: (a) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Simponi (golimumab), Orencia (abatacept)] (b) Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Authorization will be issued for 24 months. Confidential and Proprietary, © 2014 UnitedHealthcare Services, Inc. 1 B. Plaque Psoriasis 1. Initial Authorization a. Otezla will be approved based on both of the following criteria: (1) Diagnosis of moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. -AND(2) Patient is not receiving Otezla in combination with either of the following: (a) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Simponi (golimumab), Orencia (abatacept)] (b) Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Authorization will be issued for 12 months. 2. Reauthorization a. Otezla will be approved based on both of the following criteria: (1) Documentation of positive clinical response to Otezla therapy -AND(2) Patient is not receiving Otezla in combination with either of the following: (a) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Simponi (golimumab), Orencia (abatacept)] (b) Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Authorization will be issued for 24 months. 3. Additional Clinical Rules: Supply limits may be in place. 4. References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation; September 2014. Program 5/2014 10/2014 Otezla (apremilast) Notification Change Control New program. Added new indication for plaque psoriasis. Confidential and Proprietary, © 2014 UnitedHealthcare Services, Inc. 2
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