Questions related to COVID-19
Reinitiating your patients on Otezla
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).
Specialty pharmacies may furnish patient support by providing:
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.
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 program offers shipment of free Bridge to maintenance supply for commercially insured patients during potential reimbursement delays.
The Resource Center also includes links to the prescription start guide and other patient assistance resources, including comprehensive instructions on how to prepare and submit the prescription as well as the robust support that is available through the Otezla SupportPlus™ program.
For more information, call Otezla SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952)
*To receive a free Bridge supply of Otezla, commercially insured patients must have an on-label diagnosis and be denied or waiting for coverage. If an in-office Starter Pack (Titration) is not available, please check both the 4-week Starter Pack and Bridge Rx boxes.
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
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
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
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.
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.
Prescribing Otezla is a straightforward process that is supported at each step by the Otezla SupportPlus™ team. If you have any questions about prescribing through disbursement, call 1-844-4OTEZLA.
Once you have identified Otezla as the appropriate therapy for your patient, you will need to collect the patient’s information, including their prescription benefit information. As the prescriber, you will need to select a specialty pharmacy (SP) to process the prescription or choose Otezla SupportPlus™ (OSP) to initiate the prescription process, and then provide a Starter Pack, if appropriate. If you need to obtain starter packs, Request Information.
The verification process depends on the insurance carrier’s requirement for prior authorization. Review this
simple flowchart for details about benefit verification options.
For information about insurance coverage for Otezla, review this table, which lists many of the insurance plans that currently cover Otezla. Amgen Inc. continually works to expand the number and location of insurance plans that cover the cost of Otezla.
The Resource Center includes links to the START Form and to the prescription start guide, which includes comprehensive instructions on how to prepare and submit the prescription, as well as how to verify your patients’ insurance benefits. A list of specialty pharmacies that supply Otezla is provided, as are details about financial assistance, reimbursement support, and patient support that is available through the Otezla SupportPlus™ program.
If you have questions related to pharmacy benefit management procedures, please contact Otezla SupportPlus™ (1-844-4OTEZLA) 8 AM – 8 PM 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 twice daily.1
*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.
Warnings and Precautions
Use in Specific Populations
Please click here for Full Prescribing Information.
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.