Otezla is the first and only oral therapy approved across all severities of adult plaque psoriasis SEE NEW DATA
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.
Specialty pharmacies may furnish patient support by providing:
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).
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.
*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.
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The How to Start page also includes an overview of the 3 simple steps to get patients started on Otezla and other resources available through the Otezla SupportPlus™ program.
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
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
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
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.
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
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.
*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.
The Resource Center includes multiple resources to support you.
If you have questions related to the Otezla initiation process, please contact Otezla SupportPlus™ (1-844-4OTEZLA) 8AM–8PM ET, Monday – Friday.
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:
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.
Please read the Prescribing Information for instructions on how to administer Otezla.
After an initial 5-day titration period, the maintenance dosage of Otezla is 30 mg BID. 1
The dosage of Otezla should be reduced to 30 mg once daily in patients with severe renal impairment 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.
Warnings and Precautions
Use in Specific Populations
Please click here for the full Prescribing Information.
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.