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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 07/01/2015 Title: Cosentyx (Secukinumab)
Revision Date: 06/01/2018 Document: BI483:00
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)    Cosentyx (Secukinumab) requires prior authorization.

2)    Cosentyx is used to treat psoriasis.

3)    Cosentyx is a specialty drug and must be obtained through the contracted specialty pharmacy.


Medical Statement

Cosentyx (Secukinumab) is considered medically necessary for members meeting the following criteria:

 

Plaque Psoriasis

1)    Member is 18 years of age or older  AND

2)    Member has a diagnosis of moderate to severe plaque psoriasis affecting more than 5% of body surface area (BSA) or affecting crucial body areas such as hands, feet, face, or genitals  AND

3)    Member has a history of failure for at least a 3 month trial of, contraindication, or intolerance to ALL of the following:

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

b.    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 be waived in any of 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

c.    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 (AIDS), c) member is pregnant or breast-feeding, or d) member has anemia, neutropenia, or thrombocytopenia AND

4)    History of failure, contraindication, or intolerance to:

a.    Humira or Stelara or Tremfya

5)     Member does not have an active serious infection (including tuberculosis)  AND

6)    Member has been tested for TB infection  AND

7)    Latent TB infection has been ruled out or is being treated as per guidelines  AND

8)    The medication will not be used with other biologic agents.

 

Authorization for continued use will occur at least every 12 months to confirm:

1)    The member does not have an active serious infection (including TB) AND

2)    The medication will not be used with other biologic agents  AND

3)    The member’s disease has improved or stabilized while on therapy

 

Psoriatic Arthritis

1) Member is 18 years of age or older AND

2) Member has a diagnosis of psoriatic arthritis AND

3) Member has tried and failed at least two (2) NSAIDs AND

4) Member has tried and failed at least one (1) non-biologic DMARD (e.g. methotrexate, cyclosporine, sulfasalazine, leflunomide) or has a labeled contraindication to DMARDs AND

5) Member has a history of failure, contraindication, or intolerance to two of either Humira, Cimzia, Simponi or Stelara.

 

Ankylosing Spondylitis

1) Member is 18 years of age or older AND

2) Member has a diagnosis of ankylosing spondylitis AND

Member has a history of failure, contraindication, or intolerance to at least two of the following products: Humira, Cimzia, and Simponi.


Limits

Cosentyx will be subject to quantity limits under the Rx benefit as follows:

1)    For members taking a 150mg dose:  6 syringes for the first 28 days, followed by a limits of 2 syringes every 56 days thereafter

2)    For members taking a 300mg dose:  10 syringes for the first 28 days, followed by a limit of 2 syringes every 28 days thereafter


Reference

1)    Cosentyx Prescribing Information.  Novartis.  East Hanover, NJ. January 2016

2)    Clinical Pharmacology. Accessed online June 2, 2017.

3)    Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis – results of two phase 3 trials. N Engl J med. 2014; 371:326-38.

4)    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 approved indications of psoriatic arthritis and ankylosing spondylitis with PA criteria.

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

4.     Effective 01/01/2018: Updated prerequisite therapy for psoriasis, psoriatic arthritis, and ankylosing spondylitis.


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.
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