Are You a Healthcare Professional?

You are leaving the Otezla® (apremilast) website

Do you wish to leave this site?

On November 21, 2019, Amgen acquired from Celgene Corporation the worldwide rights to Otezla® (apremilast).

Effective November 21, 2019, refer to the Amgen's Terms of Use relating to the access of Amgen websites, applications and digital services and Privacy Statement concerning the collection and use of your personal information.

For information collected by Celgene prior to November 21, 2019, refer to Celgene's Terms of Use and Privacy Policy.

Formulary Coverage

For patients with commercial insurance

Getting Otezla® (apremilast) keeps getting easier

Improved step-edit status for many prescription benefit plans

This is not a complete list of plans. If you don't see a plan you're looking for, request a rep for more information

Plaque Psoriasis
Psoriatic Arthritis
Plan
National Aetna Prescription Drug Benefit No biologic step No biologic step
Cigna Prescription Drug List No biologic step No biologic step
CVS Caremark Formularies* No biologic step No DMARD or biologic step-edit required
Express Scripts National Preferred Formulary No biologic step No biologic step
OptumRx No DMARD or biologic step-edit required No DMARD or biologic step-edit required
Prime Therapeutics No biologic step No biologic step
UnitedHealthcare No DMARD or biologic step-edit required No DMARD or biologic step-edit required
  • No biologic step
  • No DMARD or biologic step-edit required
*

Basic, Standard, and Advanced Control Formularies.

SafeGuardRx® Program has 1 biologic step for patients on certain Otezla indications.

 

DMARD, disease-modifying antirheumatic drug.

State Plan
AL BCBS AL No biologic step No biologic step
AR Arkansas BCBS No biologic step No biologic step
AZ Healthnet No biologic step No biologic step
CA Healthnet No biologic step No biologic step
CT Connecticare No biologic step One biologic step
FL Florida Blue No biologic step No biologic step
GA ProCare No biologic step No biologic step
IL BCBS IL No biologic step No biologic step
KS BCBS KS No biologic step No biologic step
LA BCBS of LA No biologic step One biologic step
MA BCBS MA No biologic step One biologic step
MI Priority Health No biologic step One biologic step
MN BCBS MN No biologic step No biologic step
HealthPartners MN No biologic step No biologic step
Medica No biologic step No biologic step
MO BCBS Kansas City No biologic step No biologic step
MS BCBS of MS No biologic step No biologic step
MT BCBS MT No biologic step No biologic step
NC BCBS NC No biologic step No biologic step
ND BCBS ND No biologic step No biologic step
NE BCBS NE No biologic step No biologic step
NJ Horizon BCBS NJ No biologic step No biologic step
1199 SEI No biologic step One biologic step
NM BCBS NM No biologic step No biologic step
NY Excellus BCBS Plans No biologic step No biologic step
Univera Healthcare No biologic step No biologic step
HealthNow No biologic step One biologic step
1199 SEI No biologic step One biologic step
OH Medical Mutual of Ohio No biologic step One biologic step
OK BCBS OK No biologic step No biologic step
OR Healthnet No biologic step No biologic step
Regence No biologic step No biologic step
RI BCBS RI No biologic step No biologic step
TX BCBS TX No biologic step No biologic step
VT BCBS VT No biologic step One biologic step
WA Healthnet No biologic step No biologic step
Regence No biologic step No biologic step
WY BCBS WY No biologic step No biologic step
  • No biologic step
  • One biologic step§¶

Available only in Arkansas. Soliciting agent only. Not authorized to issue policies.

§

Documented failure through one of the following: Cosentyx® (secukinumab), Enbrel® (etanercept), Humira® (adalimumab), Stelara® (ustekinumab).

Plan has 1 biologic step for patients with a diagnosis of psoriatic arthritis only.

Next: Letter of Medical Necessity

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

Otezla® (apremitast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients In the formulation

Warnings and Precautions

  • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment In some cases patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
  • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
    • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1 308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1%(1/1 308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezia attempted suicide; one patient on placebo committed suicide
    • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1 441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1 441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • Behcet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1%(1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
    • Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (1 9/382) of patients treated with placebo. Body weight loss of 10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
    • Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
    • Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and ¡n 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rilampin, a strong CYP4SO enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP45O enzyme inducers (e.g., rifampin. phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, ptacebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
  • Psoriatic Arthritis: Adverse reactions reported in at (east 2% of patients taking OtezLa, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2M, 0.2)
  • Behçet’s Disease: Adverse reactions reported in 5% of patients taking Otezta, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

Use in Specific Populations

  • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertoaby.org/ongoing-study/otezla/
  • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastleeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastled child from Otezla or from the underlying maternal condition
  • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 ml/mm); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

Otezla® (apremitast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients In the formulation

Warnings and Precautions

  • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment In some cases patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
  • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur
    • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1 308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1%(1/1 308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezia attempted suicide; one patient on placebo committed suicide
    • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1 441) oF patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1 441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
    • Behcet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1%(1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
  • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
    • Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (1 9/382) of patients treated with placebo. Body weight loss of 10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
    • Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
    • Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and ¡n 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rilampin, a strong CYP4SO enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP45O enzyme inducers (e.g., rifampin. phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, ptacebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
  • Psoriatic Arthritis: Adverse reactions reported in at (east 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2M, 0.2)
  • Behçet’s Disease: Adverse reactions reported in 5% of patients taking Otezta, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

Use in Specific Populations

  • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of letal loss. Consider pregnancy planning and prevention for females of reproductive potential There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
  • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastleeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastled child from Otezla or from the underlying maternal condition
  • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 ml/mm); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.