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3 INDICATIONS Otezla® (apremilast) is indicated for the treatment of adult patients with 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. Read less

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Otezla is the first and only oral therapy approved across all severities of adult plaque psoriasis SEE THE DATA

FAQs

Find the answers to help your patients access Otezla

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

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

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 (1-844-468-3952).

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, commercially ensured patients can now access both the combined $0 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 *

Graphic of Otezla swoosh icon surrounded by a solid line border and Otezla Bridge Program logo

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

*The Otezla Co-pay Card is for eligible commercially insured patients. Terms, conditions, and program maximums apply. Other restrictions may apply. Click here for 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 (1-844-468-3952) to discuss further financial support opportunities. If the patient’s health plan requires a prior authorization or if patient experiences a delay in obtaining approval for Otezla, 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. Click here for Terms and Conditions.

ENCOURAGE COMMERCIALLY INSURED PATIENTS TO ENROLL IN THE COMBINED
$0 CO-PAY AND BRIDGE PROGRAM FOR OTEZLA

3 SIMPLE WAYS TO ENROLL

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Scan the QR code

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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 Otezla and other resources available through the Otezla SupportPlus™ program.

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

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 moderate to severe plaque psoriasis clinical trials were assessed in 1,257 subjects in 2 multicenter, randomized, double-blind, placebo-controlled trials (Studies PSOR-1 and PSOR-2). In mild to moderate plaque psoriasis, the safety and efficacy of Otezla were evaluated in 595 subjects in a multicenter, randomized, placebo-controlled, double-blind study. In PsA clinical trials, the safety and efficacy of Otezla were evaluated in 1493 adult patients with active PsA in 3 multicenter, randomized, double-blind, placebo-controlled trials (Studies PsA-1, PsA-2, and PsA-3). 3

Plaque Psoriasis

Otezla was evaluated in a robust global clinical development program. 3-5

Pivotal Study: ADVANCE

ADVANCE was a multicenter, randomized, placebo-controlled, double-blind study of biologic-naïve adults with mild to moderate plaque psoriasis. 3

Pivotal Studies: ESTEEM 1 and ESTEEM 2

ESTEEM 1 and ESTEEM 2 were 2 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. 6

PsA

In multiple clinical trials, Otezla has been evaluated in more than 1400 patients with PsA. 7-9

Pivotal Studies: PALACE 1-3

PALACE 1, PALACE 2, and PALACE 3 were 3 pivotal, Phase 3, multicenter, randomized, double-blind, placebo-controlled studies in patients with active PsA, despite prior or current DMARD therapy. 3,7

Additional Studies: PALACE 4

PALACE 4 was a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 527 csDMARD-naïve and biologic-naïve adult patients with active PsA. 9

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 PsA who were biologic-naïve for up to 104 weeks. 8

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. 3,10

csDMARD, conventional synthetic disease-modifying antirheumatic drug; DMARD, disease-modifying antirheumatic drug; PsA, psoriatic arthritis.

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. Stein Gold L, Papp K, Pariser D, et al. J Am Acad Dermatol. 2022;86(1):77-85. 6. Van Voorhees AS, Gold LS, Lebwohl M, et al. J Am Acad Dermatol. 2020;83(1):96-103. 7. Kavanaugh A, Gladman DD, Edwards CJ, et al. Arthritis Res Ther. 2019;21(1):118. 8. Nash P, Ohson K, Walsh J, et al. Ann Rheum Dis. 2018;77(5):690-698. 9. Wells AF, Edwards CJ, Kivitz AJ, et al. Rheumatology (Oxford). 2018;57(7):1253-1263. 10. 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' icon showing the Otezla Starter Pack, which is upright on top of a solid colored circle background

STEP 1

Provide an Otezla Starter Pack so patients can start taking Otezla right away
  • Provide the 14-day Starter Pack to patients before they leave the office or prescribe the 28-day Starter Pack through the Otezla START Form
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STEP 2

Send prescriptions to the specialty pharmacy (SP) of your choice
  • Unless a specific specialty pharmacy is mandated by the patient’s payer, Otezla can be filled at any specialty pharmacy of your choice
  • If you have insurance questions or need help identifying a specialty pharmacy, call Otezla SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952)
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STEP 3

Initiate a prior authorization (PA) process
  • You can initiate prior authorizations (PAs) by paper or electronic PA (ePA)
 

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 SupportPlus™ (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 orally 1

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 BID. 1

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

Otezla 5-day dosing titration schedule
  • This titration is intended to reduce the gastrointestinal symptoms associated with initiation of therapy 1
  • Otezla can be administered without regard to meals 1
  • Patients should not crush, split, or chew the tablet 1

The dosage of Otezla should be reduced to 30 mg once daily in patients with severe renal impairment 1,*

  • For initial dosage titration, it is recommended that Otezla be titrated using only the AM schedule shown above and the PM doses be skipped 1
  • From day 6 on, the dose of Otezla is 30 mg once daily 1

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

Start your patients on Otezla right away

Provide the 14-day Starter Pack to patients before they leave the office or prescribe the 28-day Starter Pack.

BID, twice daily.

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

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IMPORTANT SAFETY INFORMATION

Contraindications

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

Warnings and Precautions

  • Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance. If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy
  • 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
    • Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials in patients with moderate to severe plaque psoriasis, 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
    • Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis 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

  • Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache. Overall, the safety profile of Otezla in patients with mild to moderate plaque psoriasis was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis
  • Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache
  • Behçet’s Disease: The most common adverse reactions (≥10%) are diarrhea, nausea, headache, and upper respiratory tract infection

Use in Specific Populations

  • Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss

Please click here for the full Prescribing Information.

INDICATIONS

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