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09-J2000-30

Original Effective Date: 03/15/15

Reviewed: 08/10/16

Revised: 09/15/16

Subject: Secukinumab (Cosentyx®)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Secukinumab (Cosentyx®) was approved by the U.S. Food and Drug Administration (FDA) in January 2015 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. In January 2016 the FDA approved two additional indications, the treatment of adult patients with active psoriatic arthritis and the treatment of adult patients with active ankylosing spondylitis. Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.

The safety and efficacy of secukinumab for plaque psoriasis were evaluated in four multicenter, randomized, double-blind, placebo-controlled trials (Trials 1, 2, 3, and 4) enrolling 2403 subjects (691 randomized to COSENTYX 300 mg, 692 to COSENTYX 150 mg, 694 to placebo, and 323 to a biologic active control) 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, and Psoriasis Area and Severity Index (PASI) score greater than or equal to 12, and who were candidates for phototherapy or systemic therapy. In all trials, the endpoints were the proportion of subjects who achieved a reduction in PASI score of at least 75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the Investigator’s Global Assessment modified 2011 (IGA). Outcomes are seen in table 1 and 2.

Table 1

Clinical Outcomes at Week 12 in Adults with Plaque Psoriasis in Trials 1 and 2

 

Trial 1

Trial 2

 

300 mg
(N=245)
n (%)

150 mg
(N=245)
n (%)

Placebo
(N=248)
n (%)

300 mg
(N=327)
n (%)

150 mg
(N=327)
n (%)

Placebo
(N=326)
n (%)

PASI 75 response

200 (82)

174 (71)

11 (4)

249 (76)

219 (67)

16 (5)

IGA of clear or almost clear

160(65)

125 (51)

6 (2)

202 (62)

167 (51)

9 (3)

Table 2

Clinical Outcomes at Week 12 in Adults with Plaque Psoriasis in Trials 3 and 4

 

Trial 3

Trial 4

 

300 mg
(N=59)
n (%)

150 mg
(N=59)
n (%)

Placebo
(N=59)
n (%)

300 mg
(N=60)
n (%)

150 mg
(N=61)
n (%)

Placebo
(N=61)
n (%)

PASI 75 response

44 (75)

41 (69)

0 (0)

52 (87)

43 (70)

2 (3)

IGA of clear or almost clear

40 (68)

31 (53)

0 (0)

44 (73)

32 (52)

0 (0)

While methotrexate must be avoided in women who are pregnant or trying to become pregnant, cyclosporine and anti-TNF biologics are considered to be low-risk options during pregnancy if systemic therapy cannot be avoided. While not a first-line agent for psoriasis, sulfasalazine has adequate data supporting safe use (pregnancy Category B), and is consider a preferred DMARD if given with folic acid when systemic treatment is clinically necessary.

POSITION STATEMENT:

NOTE: Etanercept (Enbrel), adalimumab (Humira), golimumab (Simponi), and ustekinumab (Stelara) are preferred self-administered products.

*NOTE: Members initiating provider administered (i.e., submitted as a medical claim with J3590 or C9399 with NDC) secukinumab therapy are NOT required to try and fail preferred self-administered (i.e., subcutaneous) products.

NOTE: If the member has failed previous biologic therapy, other than secukinumab, that is FDA-approved for the requested indication listed in Table 1, the member is not required to try and fail additional non-biologic prerequisite therapy (e.g., for psoriasis, if member has previously tried and failed etanercept, but does not have a history of methotrexate failure, they do not have to try and fail methotrexate to meet medical necessity criteria).

Initiation of secukinumab (Cosentyx®) meets the definition of medical necessity when ALL of the following criteria are met:

1. Secukinumab will be used for the treatment of an indication listed in Table 1 and ALL of the indication-specific criteria are met.

2. Secukinumab is NOT administered concomitantly with ANY of the following:

i. Abatacept (Orencia)

ii. Adalimumab (Humira)

iii. Anakinra (Kineret)

iv. Apremilast (Otezla)

v. Certolizumab (Cimzia)

vi. Etanercept (Enbrel)

vii. Golimumab (Simponi)

viii. Infliximab (Remicade)

ix. Ixekizumab (Taltz)

x. Tocilizumab (Actemra)

xi. Tofacitinib (Xeljanz)

xii. Ustekinumab (Stelara)

xiii. Vedolizumab (Entyvio)

3. Member is 18 years of age or older

Table 1

Indications and Specific Criteria†

Indication

Criteria

Max Allowable Dosage

Axial Spondyloarthritis (axSpA)

[including both ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)]

When ALL of the following are met:

1. Member has a diagnosis of axial spondyloarthritis per ASAS criteria

2. Member has tried and failed or has a contraindication to at least TWO NSAID therapies (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindications must be provided)

3. Member has tried and failed or has a contraindication to TWO or more of the following* (the specific contraindications must be provided):

a. Adalimumab (Humira)

b. Etanercept (Enbrel)

c. Golimumab (Simponi)

Initial

• 150 mg at weeks 0, 1, 2, 3, and 4

Maintenance:

• 150 mg every 4 weeks (starting no sooner than week 8)

Psoriatic Arthritis (PsA)

[including both axial and non-axial (peripheral) PsA]

When ALL of the following are met:

1. Member’s disease is active

2. EITHER of the following based on the dominate disease type:

a. Axial PsA: Member has tried and failed or has a contraindication to at least TWO different NSAID therapies (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindications must be provided)

b. Peripheral PsA: Member has tried and failed or has a contraindication to at least ONE NSAID therapy (e.g., celecoxib, diclofenac, ibuprofen, meloxicam, naproxen) (the specific contraindication must be provided)

AND

c. Member has tried and failed or has a contraindication to methotrexate, OR, if methotrexate is contraindicated, to another DMARD (e.g., cyclosporine, leflunomide, sulfasalazine) (the specific contraindication must be provided)

3. Member has tried and failed or has a contraindication to TWO or more of the following (the specific contraindications must be provided)*:

a. Adalimumab (Humira)

b. Etanercept (Enbrel)

c. Golimumab (Simponi)

d. Ustekinumab (Stelara)

Initial

• 150 mg at weeks 0, 1, 2, 3, and 4

Maintenance:

• 300 mg every 4 weeks (starting no sooner than week 8)

Plaque Psoriasis

When ALL of the following are met:

1. Member’s disease is moderate to severe as evidenced by documentation of EITHER of the following

a. Psoriasis covers more than 5% of member’s body surface area (BSA)

b. Psoriasis covers less than 5% of member’s BSA but affects crucial body areas necessary for daily living activities (e.g., face, hands, feet, genitals)

2. Member has tried and failed or has a contraindication to methotrexate, or, if methotrexate is contraindicated, the member has tried and failed EITHER cyclosporine or acitretin, OR has a contraindication to BOTH cyclosporine and acitretin (the specific contraindications must be provided; pregnancy is not considered a contraindication to the use of cyclosporine)

3. Member has tried and failed or has a contraindication to TWO or more of the following (the specific contraindications must be provided)*:

a. Adalimumab (Humira)

b. Etanercept (Enbrel)

c. Ustekinumab (Stelara)

Initial

• 300 mg at weeks 0, 1, 2, 3, and 4

Maintenance:

• 300 mg every 4 weeks (starting no sooner than week 8)

Approval duration: 12 weeks

 

ASAS - Assessment of Spondyloarthritis International Society

NSAID - non-steroidal anti-inflammatory drug

*NOTE: Members initiating provider administered (i.e., submitted as a medical claim with J3590 or C9399 with NDC) secukinumab therapy are NOT required to try and fail preferred self-administered (i.e., subcutaneous) products.

NOTE: If the member has failed previous biologic therapy, other than secukinumab, that is FDA-approved for the requested indication listed in Table 1, the member is not required to try and fail additional non-biologic prerequisite therapy (e.g., for psoriasis, if member has previously tried and failed etanercept, but does not have a history of methotrexate failure, they do not have to try and fail methotrexate to meet medical necessity criteria).

Continuation of secukinumab (Cosentyx) meets the definition of medical necessity when all of the following criteria are met:

1. An authorization/reauthorization for secukinumab has been previously approved by Florida Blue or another health plan in the past 2 years for the treatment of an indicated listed in Table 1, OR the member previously met ALL indication-specific initiation criteria.

2. Member has demonstrated a beneficial response to therapy

3. Secukinumab is NOT administered concomitantly with ANY of the following:

a. Abatacept (Orencia)

b. Adalimumab (Humira)

c. Anakinra (Kineret)

d. Apremilast (Otezla)

e. Certolizumab (Cimzia)

f. Etanercept (Enbrel)

g. Golimumab (Simponi)

h. Infliximab (Remicade)

i. Ixekizumab (Taltz)

j. Tocilizumab (Actemra)

k. Tofacitinib (Xeljanz)

l. Ustekinumab (Stelara)

m. Vedolizumab (Entyvio)

4. The dosage does not exceed the following based on indication:

• Plaque Psoriasis - 300 mg every 4 weeks

• Psoriatic Arthritis - 300 mg every 4 weeks

• Axial Spondyloarthritis (including both ankylosing spondylitis and non-radiographic axial spondyloarthritis) – 150 mg every 4 weeks

Duration of approval: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved

• Moderate to severe plaque psoriasis

o 300 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks

o For some patients, a dose of 150 mg may be acceptable

• Psoriatic arthritis

o For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis.

o For other psoriatic arthritis patients, administer with or without a loading dosage by subcutaneous injection.

­ With a loading dosage: 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter

­ Without a loading dosage: 150 mg every 4 weeks

­ If a patient continues to have active psoriatic arthritis, consider a dosage of 300 mg.

o May be administered with or without methotrexate

• Ankylosing spondylitis

o May be administered with or without a loading dosage.

­ With a loading dosage: 150 mg at weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter

­ Without a loading dosage: 150 mg every 4 weeks

Dose Adjustments

Refer to prescribing information.

Drug Availability

• Injection: 150 mg/mL solution in a single-use Sensoready® pen

• Injection: 150 mg/mL solution in a single-use prefilled syringe

• For Injection: 150 mg, lyophilized powder in a single-use vial for reconstitution for healthcare professional use only

PRECAUTIONS:

Boxed Warning

None

Contraindications

• Serious hypersensitivity reaction to secukinumab or to any of the excipients

Precautions/Warnings

• Infections: Serious infections have occurred.

• Tuberculosis (TB): Prior to initiating treatment, evaluate for TB.

• Crohn’s Disease: Exacerbations observed in clinical trials. Caution should be exercised when prescribing to patients with active Crohn’s disease

• Hypersensitivity Reactions

• Risk of Hypersensitivity in Latex-sensitive Individuals: The removable cap of the Cosentyx Sensoready pen and the Cosentyx prefilled syringe contains natural rubber latex which may cause an allergic reaction in latex-sensitive individuals.

• Live vaccines should not be given with secukinumab. Non-live vaccinations during treatment may not elicit an immune response sufficient to prevent disease

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J3590

Unclassified biologics

C9399

Unclassified drugs or biologicals

ICD-10 Diagnoses Codes That Support Medical Necessity (Effective 10/01/15)

L40.0

Psoriasis vulgaris

L40.50

Arthropathic psoriasis, unspecified

L40.51

Distal interphalangeal psoriatic arthropathy

L40.52

Psoriatic arthritis mutilans

L40.53

Psoriatic spondylitis

M45.0 – M45.

Ankylosing spondylitis

M46.81 – M46.89

Other specified inflammatory spondylopathies

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Part D: BCBSF has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

Medicare Advantage: No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline review date.

DEFINITIONS:

Axial PsA (a.k.a., psoriatic spondylitis): a subset of psoriatic arthritis that affects the spine (i.e., spondylitis) and/or spinal joints (e.g., the sacroiliac joint between the sacrum and ilium of pelvis). Axial PsA shares similar clinical findings to patients with ankylosing spondylitis (AS); however, patients with axial PsA are often less symptomatic, have asymmetric disease, and tend to have less severe disease. In addition, the psoriatic plaques or nail changes present in patients with axial PsA are absent in patients with AS. About 5% of PsA patients have exclusively axial involvement, and 20 to 50% have both spinal and peripheral involvement, with peripheral joint involvement being the predominant pattern.

Axial Spondyloarthritis (SpA): an inflammatory disease where the main symptom is back pain, and where the x-ray changes of sacroiliitis may or may not be present. In ankylosing spondylitis (AS), the x-ray changes are clearly present. In non-radiographic axial spondyloarthritis (nr-axSpA); the x-ray changes are not present but you have symptoms. It is thought that nr-axSpA may be an earlier form of AS.

Non-axial or peripheral PsA: a subset of psoriatic arthritis that does NOT affect the spine or spinal joints [e.g. elbow, wrist, knees, hands, feet, and digits (dactylitis)]. Peripheral involvement may be polyarticular (5 or more joints affected) or oligoarticular (a.k.a., pauciarticular) (4 or fewer joints affected). Approximately 95% of patients with PsA have involvement of the peripheral joints, predominantly the polyarticular form, whereas a minority has the oligoarticular form.

Plaque psoriasis: It is the most common form of psoriasis. It affects 80 to 90% of people with psoriasis. Plaque psoriasis typically appears as raised areas of inflamed skin covered with silvery white scaly skin. These areas are called plaques.

Psoriatic arthritis (PsA): joint inflammation that occurs in about 5% to 10% of people with psoriasis (a common skin disorder). It is a severe form of arthritis accompanied by inflammation, psoriasis of the skin or nails, and a negative test for rheumatoid factor. Enthesitis refers to inflammation of entheses, the site where ligaments or tendons insert into the bones. It is a distinctive feature of PsA and does not occur with other forms of arthritis. Common locations for enthesitis include the bottoms of the feet, the Achilles' tendons, and the places where ligaments attach to the ribs, spine, and pelvis.

RELATED GUIDELINES:

Adalimumab (Humira®), 09-J0000-46

Apremilast (Otezla®) Tablet, 09-J2000-19

Certolizumab Pegol (Cimzia®), 09-J0000-77

Etanercept (Enbrel®), 09-J0000-38

Golimumab (Simponi®, Simponi® Aria™), 09-J1000-11

Infliximab (Remicade®) and Infliximab-dyyb (Inflectra®), 09-J0000-39

Ixekizumab (Taltz) Injection, 09-J2000-62

Psoralens with Ultraviolet A (PUVA), 09-10000-16

Ustekinumab (Stelara), 09-J1000-16

OTHER:

DMARDs

DMARD Generic Name

DMARD Brand Name

Auranofin (oral gold)

Ridaura

Azathioprine

Imuran

Cyclophosphamide

Cytoxan

Cyclosporine

Neoral, Sandimmune

Gold sodium thiomalate (injectable gold)

Myochrysine

Hydroxychloroquine sulfate

Plaquenil

Leflunomide

Arava

Methotrexate

Rheumatrex, Trexall

Minocycline

Minocin

Penicillamine

Cuprimine, Depen

Sulfasalazine

Azulfidine, Azulfidine EN-Tabs

Assessment of Spondyloarthritis International Society (ASAS) Diagnostic Criteria for Axial Spondylarthritis (SpA)

Patients with chronic (≥3 months) back pain, the onset of which occurs at <45 years of age, AND EITHER of the following:

1. Imaging arm:

a. Sacroiliitis on imaging*

AND

b. ≥1 SpA feature

2. Clinical arm:

a. HLA-B27 positive

AND

b. ≥2 other SpA features

SpA features:

• Inflammatory back pain

• Arthritis

• Enthesitis (heel)

• Uveitis

• Dactylitis

• Psoriasis

• Crohn’s/colitis

• Good response to NSAIDs

• Family history of SpA

• HLA-B27

• Elevated CRP

*Active (acute) inflammation on MRI highly suggestive of sacroiliitis associated with SpA, or definite radiographic sacroiliitis according to modified New York criteria

REFERENCES:

  1. Blauvelt A, Prinz JC, Gottlieb AB, et al. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol 2015;172(2):484-93.
  2. Clinical Pharmacology [Internet]. Tampa (FL): Gold Standard, Inc.; 2016 [cited 2016 July 14]. Available from: http://www.clinicalpharmacology.com/.
  3. Cosentyx (secukinumab) injection [package insert]. Novartis Pharmaceuticals Corporation. East Hanover, NJ. January 2016.
  4. DRUGDEX® System [Internet]. Greenwood Village (CO): Thomson Micromedex; Updated periodically [cited 2016 July 14]. Available from: http://www.thomsonhc.com/.
  5. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Mar;75(3):499-510.
  6. Gottlieb A, Korman NJ, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol. 2008 May;58(5):851-64. doi: 10.1016/j.jaad.2008.02.040.
  7. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol 2012;148(1):95-102.
  8. Krause ML, Amin A, and Makol A. Use of DMARDs and biologics during pregnancy and lactation in rheumatoid arthritis: what the rheumatologist needs to know. Ther Adv Musculoskelet Dis. 2014 Oct; 6(5): 169–184.
  9. 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.
  10. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. Am Acad Dermatol. May 2008; 58(5):826-850.
  11. Menter A, Korman, NJ, Elmets, CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case-based presentations and evidence-based conclusions. J Am Acad Dermatol 2011; 65:137-74.
  12. National Institute for Health and Clinical Excellence (NICE). Psoriasis: the assessment and management of psoriasis. London (UK): National Institute for Health and Clinical Excellence (NICE); 2012 Oct. 61 p. (NICE clinical guideline; no. 153).
  13. Orphan Drug Designations and Approval [Internet]. Silver Spring (MD): US Food and Drug Administration; 2015 [cited 2015 July 16]. Available from: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm/.
  14. Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety and usability of secukinumab administered by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2014 Sep 22.
  15. Rahimi R, Nikfar S, Rezaie A, et al. Pregnancy outcome in women with inflammatory bowel disease following exposure to 5-aminosalicylic acid drugs: a meta-analysis. Reprod. Toxicol;2008:25,271–275.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 08/10/16. .

GUIDELINE UPDATE INFORMATION:

03/15/15

New Medical Coverage Guideline.

04/15/15

Revision to guideline; updated HCPCS coding

06/15/15

Revision to guideline; updated position statement

09/15/15

Review and revision to guideline; consisting of updating position statement, precautions, and references.

11/01/15

Revision: ICD-9 Codes deleted.

03/15/16

Revision to guidelines consisting of description, position statement, dosage/administration, billing/coding, definitions, and references resulting from two new FDA-approved indications.

09/15/16

Review and revision to guideline consisting of updating position statement, precautions, billing/coding, related guidelines, and references.

Date Printed: June 26, 2017: 01:22 AM