3 INDICATIONS

3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Read more

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. Read less

FAQs

Find the answers to help your patients access Otezla

Downloadable FAQs

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Expandable FAQs

Which healthcare insurance plans cover Otezla?

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Amgen Inc. continually works to expand the number and location of insurance plans that cover the cost of Otezla. Please reach out to your Otezla sales representative for more information on local coverage.

For benefit verification and additional support, contact Otezla SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952).

Which specialty pharmacies have Otezla?

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Otezla prescriptions can be filled at any specialty pharmacy. However, some payers may mandate a specialty pharmacy for Otezla.

Specialty pharmacies may furnish patient support by providing:

  • Guidance to patients whose insurance programs cover Otezla and to those who lack health insurance
  • Suggestions and service to stay on track with medications
  • Assistance locating co-pay assistance programs and other financial support, such as Otezla SupportPlus™ and the Combined Co-Pay and Bridge Program

You may send an Otezla prescription to one of these specialty pharmacies or to a pharmacy of your choice that is not listed.

You can also find a grid that captures major payers and their mandated or preferred specialty pharmacy, however there are exceptions and carve-outs. For benefit verification and additional support, contact Otezla SupportPlus™ at 1-844-4OTEZLA.

Insurance coverage for Otezla

Otezla is covered by most health plans in the US, including commercial, Medicare, and Medicaid.

Amgen Inc. continually works to expand the number and location of insurance plans that cover the cost of Otezla.

Please reach out to your Otezla sales representative for more information on local coverage.

Does Otezla offer a Bridge program?

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With one simple enrollment, patients can now access both the Otezla Co-pay Card and Bridge Program

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  • Commercially insured patients can get Otezla for $0 per month with the Otezla Co-pay Card*
  • While awaiting coverage approval, the Bridge Program offers your commercially insured patients free Otezla for up to 12 months
Encourage commercially insured patients to enroll in the combined $0 Co-pay and Bridge Program for Otezla

3 Simple Ways to Enroll

Scan the QR code

Visit otezla.com/copay

Call 1-844-4OTEZLA
(1-844-468-3952)

Other resources for starting treatment

The How to Start page also includes an overview of the 3 simple steps to get appropriate patients started on Otelza and other resources available through the Otezla SupportPlus™ program.

For more information, call Otezla SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952)

*The Otezla Co-pay Card is for eligible commercially insured patients. Terms, conditions, and program maximums apply. Other restrictions may apply. Please see full Terms and Conditions. This program is not open to patients receiving prescription reimbursement under any federal, state, or government-funded healthcare program. Not valid where prohibited by law. Patients who are not eligible can call 1-844-4OTEZLA to discuss further financial support opportunities. If the patient’s health plan does not cover Otezla or requires a prior authorization (PA), patients can qualify for the Bridge to Commercial Coverage Offer and receive Otezla free for up to 12 months while pursuing approval from their health plans. No purchase necessary. Please see full Terms and Conditions.

How long was Otezla in clinical trials?

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The Otezla clinical development program began in 2010. Patients in the long-term open-label extension phase of the ESTEEM and PALACE clinical trials were followed for up to 5 years.1,2

The safety and efficacy of Otezla in psoriasis clinical trials were assessed in 1257 subjects in 2 multicenter, randomized, double-blind, placebo-controlled trials (Studies PSOR-1 and PSOR-2). In psoriatic arthritis clinical trials, the safety and efficacy of Otezla were evaluated in 1493 adult patients with active psoriatic arthritis in 3 multicenter, randomized, double-blind, placebo-controlled trials (Studies PsA-1, PsA-2, and PsA-3).3

Moderate to Severe Plaque Psoriasis

Otezla was evaluated in a robust global clinical development program.3,4

Pivotal Studies: ESTEEM 1 and ESTEEM 2

ESTEEM 1 and ESTEEM 2 were two large, pivotal, Phase 3, randomized, placebo-controlled studies evaluating apremilast in patients with a diagnosis of moderate to severe plaque psoriasis for at least 12 months prior to screening, and who were also candidates for phototherapy and/or systemic therapy.1-3

Additional Studies: LIBERATE

LIBERATE was a global, Phase 3b, placebo-controlled, double-blind, double-dummy study that evaluated use of apremilast in biologic-naïve patients with moderate to severe plaque psoriasis for up to 104 weeks.4

Additional Studies: STYLE

STYLE was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of 303 adult moderate to severe plaque psoriasis patients with moderate to severe plaque psoriasis of the scalp.5

Psoriatic Arthritis

In multiple clinical trials, Otezla has been evaluated in more than 1400 patients with psoriatic arthritis.6-8

Pivotal Studies: PALACE 1-3

PALACE 1, PALACE 2, and PALACE 3 were three pivotal, Phase 3, multicenter, randomized, double-blind, placebo-controlled studies in patients with active psoriatic arthritis, despite prior or current DMARD therapy.3,6

Additional Studies: PALACE 4

PALACE 4 was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 527 DMARD-naïve adult patients with active psoriatic arthritis.8

Additional Studies: ACTIVE

ACTIVE was a global, Phase 3b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating apremilast monotherapy in adult patients with active psoriatic arthritis who were biologic-naïve for up to 104 weeks.7

Oral Ulcers in Behçet’s Disease

Otezla was evaluated in adult patients with Behçet’s Disease (BD) with active oral ulcers.3

Pivotal Study: RELIEF

Otezla was evaluated in a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of 207 adult patients with BD and active oral ulcers.3,9

ACTIVE, Assessing Apremilast Monotherapy in a Clinical Trial of Biologic-Naïve Patients with Psoriatic Arthritis; DMARD, disease-modifying antirheumatic drug; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PALACE, Psoriatic Arthritis Long-Term Assessment of Clinical Efficacy; RELIEF, Researching Oral Apremilast Safety and Efficacy in Behçet’s Disease; STYLE, Study of the Efficacy and Safety of Apremilast in Subjects With Moderate to Severe Plaque Psoriasis of the Scalp.

References: 1. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 2. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 3. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 4. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517. 5. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 6. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 7. Nash P, Ohson K, Walsh J, et al. Ann Rheum Dis. 2018;77(5):690-698. 8. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 9. Hatemi G, Mahr A, Ishigatsubo Y, et al. N Engl J Med. 2019;381(20):1918-1928.

What is the mechanism of action (MOA) for Otezla?

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Otezla is a non-biologic, oral PDE4 inhibitor with a distinct MOA.1

Otezla works by inhibiting phosphodiesterase 4 (PDE4) intracellularly and has anti-inflammatory properties. By elevating cyclic adenosine monophosphate (cAMP) levels, Otezla is thought to indirectly modulate production of pro-inflammatory and anti-inflammatory mediators.1,2

PDE4 and cAMP
Learn more about the role of PDE4 and cAMP in controlling inflammation.3

Otezla MOA
Learn how Otezla’s inhibition of PDE4 within cells is thought to affect the production of inflammatory mediators.3

The specific mechanism(s) by which apremilast exerts its therapeutic action in patients is not well defined.1

References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Schafer PH, Parton A, Capone L, et al. Cell Signal. 2014;26(9):2016-2029. 3. Schafer PH, Parton A, Gandhi AK, et al. Br J Pharmacol. 2010;159(4):842-855.

How to start Otezla

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3 simple steps to get appropriate patients started on Otezla

Step 1

Step 1

Provide an Otezla Starter Pack so patients can start
taking Otezla right away

  • Provide an in-office sample of the 14-day Starter Pack to patients before they leave the office or include the 28-day Starter Pack in your prescription

Step 2

Step 2

Send prescriptions to the specialty pharmacy of your choice or
to Otezla SupportPlus™

  • Unless a specific specialty pharmacy is mandated by the patient’s payer, Otezla can be filled at any specialty pharmacy of your choice

Step 3

Step 3

Initiate a prior authorization (PA) process

  • Otezla electronic prior authorization (ePA) process is available through CoverMyMeds*

*Amgen, the marketer of Otezla, has entered into a fee-for-service arrangement with CoverMyMeds® to provide a more streamlined ePA experience after you have chosen to prescribe Otezla.

*Amgen, the marketer of Otezla, has entered into a fee-for-service arrangement with CoverMyMeds® to provide a more streamlined ePA experience after you have chosen to prescribe Otezla.

Resource Center
The Resource Center includes multiple resources to support you.

  • If you prefer to work directly with a specialty pharmacy, you can e-scribe to them or fax the Otezla Specialty Pharmacy Start Form
  • If you need Otezla SupportPlus™ to assist you with prescription triage, benefit investigation, PA or appeals support, please fax the Otezla SupportPlus™ Request Form to 1-855-850-2955
  • The Otezla Specialty Pharmacy List includes a list of specialty pharmacies that can process Otezla and the Payers who mandate specific specialty pharmacies
  • Otezla offers this PA Checklist to help organize PA information and documentation. Detailed clinical documentation may expedite PA approval for patients to access Otezla

If you have questions related to the Otezla initiation process, please contact Otezla SuportPlus™ (1-844-4OTEZLA) 8AM-8PM ET, Monday- Friday.

Financial Assistance
The Otezla SupportPlus™ program offers multiple resources for you and your patients, including insurance and reimbursement support. Financial assistance options are available to patients who face a wide variety of insurance scenarios:

  • Patients with commercial health insurance plans
  • Patients covered by Medicare and Medicaid
  • Patients without health insurance coverage
  • Underinsured patients

Click here to learn more about Otezla SupportPlus™ or contact an Amgen Inc. representative at 1-844-4OTEZLA to discuss which financial assistance program may be appropriate for your patients.

How to administer Otezla

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Otezla is administered orally1

Please read the Prescribing Information for instructions on how to administer Otezla.

Dosing
After an initial 5-day titration period, the maintenance dosage of Otezla is 30 mg twice daily.1

  • This titration is intended to reduce the gastrointestinal symptoms associated with initiation of therapy1
  • Otezla can be administered without regard to meals1
  • Patients should not crush, split, or chew the tablet1

The dosage of Otezla should be reduced to 30 mg once daily in patients with severe renal impairment1,*

  • For initial dosage titration, it is recommended that Otezla be titrated using only the AM schedule shown above and the PM doses be skipped1
  • From day 6 on, the dose of Otezla is 30 mg once daily1

*Creatinine clearance (CrCl) <30 mL/min estimated by the Cockcroft-Gault equation.

How to Start
Information on how to start patients on Otezla is included in the Prescribing Information. Additional guidance for starter packs or for 28-day or 30-day packs of Otezla is included here. If you need to obtain starter packs, please Request Information.

Reference: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc.

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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% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla 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% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) 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
    • Behçet’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% (19/382) 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 in 3.9% (4/102) of patients taking placebo
  • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

  • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): 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 least 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 (2.0, 0.2)
  • Behçet’s Disease: Adverse reactions reported in ≥5% of patients taking Otezla, 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://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 breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed 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/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please click here for Full Prescribing Information.

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of adult 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.