Category Filter
- Advanced Imaging
- Autism Spectrum Mandate
- Behavioral Health
- Blue Advantage Policies
- Chronic Condition Management
- Genetic Testing
- HelpScript Program
- Hemophilia Drugs
- Medical Policies
- Pre-Service Review (Predetermination/Precertification)
- Provider-Administered Drug Policies
- Radiation Therapy
- Self-Administered Drug Policies
- Transgender Services
Asset Publisher
Otezla (Apremilast) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1019
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
07-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Otezla® (apremilast) Tablets |
Treatment of adult patients with active psoriatic arthritis Treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy Treatment of adult patients with oral ulcers associated with Behcet’s disease |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Psoriasis (PS) |
Psoriasis (PS) is a chronic inflammatory skin condition that is often associated with systemic manifestations, especially arthritis. Diagnosis is usually clinical, based on the presence of typical erythematous scaly patches, papules, and plaques that are often pruritic and sometimes painful. Treatment goals for psoriasis include improvement of skin, nail, and joint lesions plus enhanced quality of life.(2) The American Academy of Family Physicians (AAFP) categorizes psoriasis severity into mild to moderate (less than 5% of body surface area [BSA]) and moderate to severe (5% or more of BSA). The AAFP psoriasis treatment guidelines recommend basing treatment on disease severity:(2)
The American Academy of Dermatology (AAD) and National Psoriasis Foundation (NPF) categorize psoriasis severity as limited or mild (less than 3% of BSA), moderate (3% to 10% of BSA), or severe (greater than 10% of BSA). The AAD/NPF guidelines also note that psoriasis can be considered severe irrespective of BSA when is occurs in select locations (e.g., hands, feet, scalp, face, or genital area) or when it causes intractable pruritus.(5) The AAD psoriasis treatment guidelines recommend the following*:(3,4,5,9)
* Strength of recommendation and descriptions
Biologics are routinely used when one or more traditional systemic agents fail to produce adequate response, but are considered first line in patients with moderate to severe psoriasis with concomitant severe PsA. Primary failure is defined as initial nonresponse to treatment. Primary failure to a TNF-α inhibitor does not preclude successful response to a different TNF-α inhibitor. Failure of another biologic therapy does not preclude successful response to ustekinumab.(9) The National Psoriasis Foundation (NPF) medical board recommend a treat-to-target approach to therapy for psoriasis that include the following:(6)
|
||||||||
Psoriatic Arthritis (PsA) |
Psoriatic arthritis (PsA) is a chronic inflammatory musculoskeletal disease associated with psoriasis, most commonly presenting with peripheral arthritis, dactylitis, enthesitis, and spondylitis. Treatment involves the use of a variety of interventions, including many agents used for the treatment of other inflammatory arthritis, particularly spondyloarthritis and RA, and other management strategies of the cutaneous manifestations of psoriasis.(7) The American Academy of Dermatology (AAD) recommends initiating MTX in most patients with moderate to severe PsA. After 12 to 16 weeks of MTX therapy with appropriate dose escalation, the AAD recommends adding or switching to a TNF inhibitor if there is minimal improvement on MTX monotherapy.(3) The American College of Rheumatology (ACR) and the National Psoriasis Foundation (NPF) guidelines for PsA recommend a treat-to-target approach in therapy, regardless of disease activity, and the following:(7)
|
||||||||
Behcet's Disease (BD) |
Behcet's disease (BD) is a type of vasculitis that involves numerous organ systems, such as the skin, mucosa, joints, eyes, veins, arteries, nervous system, and gastrointestinal system. BD runs a relapsing and remitting course and a multidisciplinary approach is necessary for optimal care. The goal of treatment is to suppress inflammatory exacerbations and recurrences to prevent irreversible organ damage.(8) Chronic oral ulceration can cause scaring requiring vigorous treatment to prevent oropharyngeal narrowing. The European League Against Rheumatism recommends topical measures, such as steroids, for the treatment of oral and genital ulcers. Colchicine is recommended for the prevention of recurrent mucocutaneous lesions. Patients with lesions that continue to recur despite colchicine may use immunomodulatory or immunosuppressive agents, such as azathioprine, tumor necrosis factor (TNF) inhibitors, or apremilast.(8) |
||||||||
Efficacy |
The efficacy of Otezla for the treatment of oral ulcers associated with BD was established in a multicenter, randomized, placebo-controlled trial. Patients were required to have active oral ulcers at the time of enrollment, have had at least 3 occurrences of oral ulcers within the previous 12 months, and have received treatment with at least one non-biologic therapy. All subjects had a history of recurrent oral ulcers that were currently active. Otezla had a greater reduction in the number of oral ulcers and patient reported ulcer pain when compared to placebo.(1) |
||||||||
Safety |
Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.(1) |
REFERENCES
Number |
Reference |
1 |
Otezla Prescribing Information. Celgene Corporation. December 2021. |
2 |
Weigle, Nancy, MD, et al. Psoriasis. American Academy of Family Physicians. May 2013. 87 (9): 626-633. |
3 |
Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol. 2011;65(1):137–174. |
4 |
Menter, Alan et al. (2019). Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. doi: https://doi.org/10.1016/j.jaad.2018.11.057. |
5 |
Menter, Alan et al. (2019). Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal of the American Academy of Dermatology. doi: https://doi.org/10.1016/j.jaad.2018.11.057. |
6 |
Armstrong AW, Siegel MP, Bagel J, et al. From the medical board of the National Psoriasis Foundation: treatment targets for plaque psoriasis. Journal of the American Academy of Dermatology. 2017;76(2):290-298. doi: 10.1016/j.jaad.2016.10.017. |
7 |
Singh, J. A., et al. (2019). 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Care Res, 71: 2-29. doi:10.1002/acr.23789. |
8 |
Hatemi G, Christensen R, Bang D, et al. 2018 update of the EULAR recommendations for the management of Behçet's syndrome. Ann Rheum Dis 2018; 77:808. |
9 |
Elmets CA, et al. Joint AAD-NPF Guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol Volume 84 Number 2:432-470. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Otezla |
apremilast tab ; apremilast tab starter therapy pack |
10 & 20 & 30 MG ; 30 MG |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Otezla |
apremilast tab |
30 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Otezla |
apremilast tab starter therapy pack |
10 & 20 & 30 MG |
1 |
Kit |
180 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Otezla |
apremilast tab ; apremilast tab starter therapy pack |
10 & 20 & 30 MG ; 30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Otezla |
apremilast tab |
30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Otezla |
apremilast tab starter therapy pack |
10 & 20 & 30 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||
|
Initial Evaluation Target Agent(s) will be approved when the ALL of the following are met:
Compendia Allowed: AHFS or DrugDex 1 or 2a level of evidence Length of approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
CONTRAINDICATION AGENTS
Contraindicated as Concomitant Therapy |
Agents NOT to be used Concomitantly Abrilada (adalimumab-afzb) Actemra (tocilizumab) Adalimumab Adbry (tralokinumab-ldrm) Amjevita (adalimumab-atto) Arcalyst (rilonacept) Avsola (infliximab-axxq) Benlysta (belimumab) Bimzelx (bimekizumab-bkzx) Cibinqo (abrocitinib) Cimzia (certolizumab) Cinqair (reslizumab) Cosentyx (secukinumab) Cyltezo (adalimumab-adbm) Dupixent (dupilumab) Enbrel (etanercept) Entyvio (vedolizumab) Fasenra (benralizumab) Hadlima (adalimumab-bwwd) Hulio (adalimumab-fkjp) Humira (adalimumab) Hyrimoz (adalimumab-adaz) Idacio (adalimumab-aacf) Ilaris (canakinumab) Ilumya (tildrakizumab-asmn) Inflectra (infliximab-dyyb) Infliximab Kevzara (sarilumab) Kineret (anakinra) Litfulo (ritlecitinib) Nucala (mepolizumab) Olumiant (baricitinib) Omvoh (mirikizumab-mrkz) Opzelura (ruxolitinib) Orencia (abatacept) Otezla (apremilast) Remicade (infliximab) Renflexis (infliximab-abda) Riabni (rituximab-arrx) Rinvoq (upadacitinib) Rituxan (rituximab) Rituxan Hycela (rituximab/hyaluronidase human) Ruxience (rituximab-pvvr) Siliq (brodalumab) Simponi (golimumab) Simponi ARIA (golimumab) Skyrizi (risankizumab-rzaa) Sotyktu (deucravacitinib) Stelara (ustekinumab) Taltz (ixekizumab) Tezspire (tezepelumab-ekko) Tremfya (guselkumab) Truxima (rituximab-abbs) Tysabri (natalizumab) Velsipity (etrasimod) Wezlana (ustekinumab-auub) Xeljanz (tofacitinib) Xeljanz XR (tofacitinib extended release) Xolair (omalizumab) Yuflyma (adalimumab-aaty) Yusimry (adalimumab-aqvh) Zeposia (ozanimod) Zymfentra (infliximab-dyyb) |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
Commercial _ PS _ Otezla_PAQL _ProgSum_ 07-01-2024