Medical Policy

Effective Date:09/01/2014 Title:Otezla (Apremilast)
Revision Date:10/01/2019 Document:BI454:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Otezla (Apremilast) requires prior authorization.

2)    Otezla is an oral specialty medication used to treat active psoriatic arthritis and plaque psoriasis.

3)    Otezla must be obtained through the contracted specialty pharmacy provider.

Medical Statement

Otezla (Apremilast) is considered medically necessary for members who meet the following criteria:

 

1)    Diagnosis of active psoriatic arthritis as evidenced by:

a.    At least 3 swollen joints AND

b.    At least 3 tender joints    AND

2)    Greater than 18 years of age AND

3)    Inadequate response to at least one non-biologic DMARD (e.g. methotrexate, cyclosporine, sulfasalazine, leflunomide) or has a contraindication to DMARDs   OR

 

4)    Diagnosis of moderate to severe plaque psoriasis who meet the following criteria:

a.    The psoriasis has been present for more than one year AND

b.    The psoriasis is present on over 10% of the body surface AND

c.    History of failure for at least a 3 month trial, contraindication, or intolerance to ALL of the following:

                                          i.    Topical therapy with corticosteroids, Vitamin D analogs (e.g. calcitriol, calcipotriene), calcineurin inhibitor (e.g. tacrolimus, pimecrolimus), or salicylic acid combination product AND

                                        ii.    Phototherapy of at least 3 months duration with narrow-band UVB (in the office or at home) used alone or in combination with topical or systemic therapy (See BI 029 for additional information regarding UV light therapy). This requirement may by waived in the following situations: a) history or presence of melanoma or other skin cancer, lupus erythematosus, or xeroderma pigmentosum, b) psoriasis involving areas around the eye where eye protection may cause blockage of phototherapy to affected area,c) documented systemic disease involving the joints (meeting specific criteria for psoriatic arthritis), or d) very severe plaque thickness or scaling (4 on a scale of 0 to 4) AND

                                       iii.    Systemic therapy of at least 3 months duration with methotrexate or other non-biologic DMARD. This requirement may be waived in any of the following situations: a) member has chronic hepatic disease, b) member has acquired immunodeficiency syndrome, c) member is pregnant or breast-feeding, or d) member has anemia, neutropenia, or thrombocytopenia.

Limits

As a specialty drug, Otezla is limited to no more than a 30 day supply per fill.

Reference

1)    Otezla Package Information.  Celgene Corporation. March 2014

2)    Clinical Pharmacology. Accessed online May 2014.

3)    Cutolo M, Myerson GE, Fleischmann RM, Liote F, Diaz-Gonzalez F, Van den Bosch F, et al. Long-term (52-week) results of a Phase 3, randomized, controlled trial of Apremilast, an oral Phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis (PALACE 2). Abstract session presented at: The American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting; 2013 October 25-30; San Diego, CA.

4)    Edwards CJ, Blanco FJ, Crowley J, Chia Chi Hu, Stevens RM, Birbara CA, et al. Long-term (52-week) results of a Phase 3, randomized, controlled trial of Apremilast, an oral Phosphodiesterase 4 inhibitor, in patients with psoriatic arthritis and current skin involvement (PALACE 3). Poster session presented at: The American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting; 2013 October 25-30; San Diego, CA.

5)    Menter A, Gottlieb A, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. J Am Acad Dermatol 2008; 58:826-50.

Addendum:

1.     Effective 01/01/2017: Added step therapy through both Humira and Stelara to criteria.

2.     Effective 07/01/2017: Added inadequate response to topical corticosteroids (Class 1 or 2) for plaque psoriasis and step requirement through Humira or Stelara and Taltz.

3.     Effective 09/01/2017: Updated prerequisite therapy for treatment of psoriasis.

 

4.     Effective 01/01/2018: updated perquisite therapy to only one DMARD.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.