Last Review Date: 08/01/2024

Date of Origin: 02/24/2015

Dates Reviewed: 02/2015, 01/2016, 01/2017, 01/2018, 08/2018, 08/2019, 03/2020, 07/2020, 07/2021, 08/2021, 01/2022, 08/2022, 06/2023, 08/2023, 11/2023, 12/2023, 08/2024

1. Length of Authorization

Initial coverage will be provided for 6 months and may be renewed annually thereafter.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Cosentyx 300 mg single-dose UnoReady Pen/prefilled syringe for subcutaneous injection:
  • Loading: 1 pen/prefilled syringe at weeks 0, 1, 2, 3, 4
  • Maintenance: 1 pen/prefilled syringe every 14 days
• Cosentyx 150 mg single-dose Sensoready Pen/prefilled syringe for subcutaneous injection:
  • • Loading: 2 pens/prefilled syringes/vials at weeks 0, 1, 2, 3, 4
    • Maintenance: 2 pens/prefilled syringes/vials every 14 days
• Cosentyx 75 mg single-dose prefilled syringe for subcutaneous injection (for pediatric patients less than 50 kg):
  • Loading: 1 prefilled syringe at weeks 0, 1, 2, 3, 4
  • Maintenance: 1 prefilled syringe every 28 days
• Cosentyx 125 mg single-dose vial for intravenous infusion:
  • Loading: 6 vials at week 0
  • Maintenance: 3 vials every 28 days

2. Max Units (per dose and over time) [HCPCS Unit]:

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age (unless otherwise specified); AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
• Patient is up to date with all age-appropriate vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND

Universal Criteria ¹

• Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND
• Will not be administered concurrently with live vaccines; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Patient is not on concurrent treatment with another biologic therapy (e.g. IL-inhibitor, TNF-inhibitor, integrin receptor antagonist, T cell costimulation modulator, etc.) or targeted synthetic therapy (e.g., apremilast, abrocitinib, tofacitinib, baricitinib, upadacitinib, deucravacitinib, ritlecitinib, ruxolitinib, etrasimod, ozanimod, etc.); AND

Plaque Psoriasis (PsO) † ^{1,13,26,27,32-34,43}

• Patient is at least 6 years of age; AND
• Documented moderate to severe plaque psoriasis for at least 6 months with at least one of the following:
  • Involvement of at least 3% of body surface area (BSA); OR
  • Psoriasis Area and Severity Index (PASI) score of 10 or greater; OR
  • Incapacitation or serious emotional consequences due to plaque location (e.g.., hands, feet, head and neck, or genitalia, etc.) or with intractable pruritus; AND

• Patient meets ALL of the following ¥:

• Patient did not respond adequately (or is not a candidate) to a 4-week minimum trial of topical agents (i.e., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, roflumilast, retinoic acid derivatives, and/or Vitamin D analogues); AND
• Patient did not respond adequately (or is not a candidate) to a 3-month minimum trial of at least one non-biologic systemic agent (i.e., immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND
• Patient did not respond adequately (or is not a candidate*) to a 3-month minimum trial of phototherapy (i.e., psoralens with UVA light (PUVA) OR UVB with coal tar or dithranol)

¥ Note: For patients already established on biologic therapy, targeted synthetic therapy, or those with > 10% BSA involvement, trial and failure of topical agents, non-biologic systemic agents, and phototherapy is not required.

Adult Psoriatic Arthritis (PsA) † ^{1,12,28,35,44,45,51}

• Documented moderate to severe active disease; AND
  • For patients with predominantly axial disease OR enthesitis, a failure of at least a 4-week trial of ONE non-steroidal anti-inflammatory drug (NSAID), unless use is contraindicated; OR
  • For patients with peripheral arthritis OR dactylitis, a failure of at least a 3-month trial of ONE conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) (e.g., methotrexate, azathioprine, sulfasalazine, leflunomide, or hydroxychloroquine, etc.); OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of PsA; AND
• May be used as a single agent or in combination with csDMARDs (e.g., methotrexate, etc.)

Note: Patients new to subcutaneous Cosentyx therapy must initiate treatment at the lower dosing regimen of the 150 mg dose before increasing to the 300 mg dose (unless they have co-existent plaque psoriasis)

Juvenile Psoriatic Arthritis (JPsA) † ^1,36,37

• Patient is at least 2 years of age; AND
• Documented moderate to severe active polyarticular disease; AND
• May be used as a single agent or in combination with methotrexate; AND
  • Patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR a conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) (e.g., methotrexate, leflunomide, sulfasalazine, etc.); OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of JPsA

Ankylosing Spondylitis (AS) † ^1,11,30,46

• Documented active disease; AND
  • Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory drugs (NSAIDs) over 4 weeks (in total), unless use is contraindicated; OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of AS

Note: Patients new to subcutaneous Cosentyx therapy must initiate treatment at the lower dosing regimen of the 150 mg dose before increasing to the 300 mg dose

Non-Radiographic Axial Spondyloarthritis (nr-axSpA) † ^1,30,46

• Patient has objective signs of inflammation noted by an elevation of C-reactive protein (CRP) above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging (MRI); AND
• Patient is without definitive radiographic evidence of structural damage on sacroiliac joints; AND

• Documented active disease; AND
  • Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory drugs (NSAIDs) unless use is contraindicated; OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of nr-axSpA

Enthesitis-Related Arthritis (ERA) † ^1,36,37

• Patient is 4 years of age to < 18 years of age; AND
• Documented moderate to severe active polyarticular disease; AND
  • Patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR an oral conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) (e.g., methotrexate, leflunomide, sulfasalazine, etc.); OR
  • Patient is already established on biologic or targeted synthetic therapy for the treatment of ERA

Hidradenitis Suppurativa (HS) † ^1,48

• Patient has moderate to severe disease; AND
• Patient has a total of at least 5 inflammatory lesions (i.e. abscesses and/or inflammatory nodules); AND
• Patient’s inflammatory lesions affect at least 2 distinct anatomic areas

     † FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND

• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe exacerbations or new onset of inflammatory bowel disease, severe infections, hypersensitivity reactions (e.g. anaphylaxis, urticaria), etc.; AND

Plaque Psoriasis (PsO) ^{10,26,27,43,49,50}

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement (a total BSA involvement ≤ 1%), and/or an improvement on a disease activity scoring tool [e.g.  Psoriasis Area and Severity Index (PASI) score ≤ 3, physician’s global assessment (PGA) score ≤ 1, etc. ].

Adult Psoriatic Arthritis (PsA) ^9,29,45,52

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, improvement on imaging (X-ray, ultrasound, or MRI), and/or an improvement on a disease activity scoring tool [e.g. defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria]; AND
• Dose escalation (up to the maximum dose and frequency specified below) may occur upon clinical review on a case-by-case basis provided that the patient has:
  • Shown an initial improvement or response to therapy; AND
  • Responded to therapy (by treatment week 8) with subsequent loss of response or continued active disease; AND
    • Received loading doses and a minimum of one maintenance dose at the dose and interval specified below; OR
    • Received a minimum of two maintenance doses at the dose and interval specified below

Juvenile Psoriatic Arthritis (JPsA) ^1,38,39,52

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, improvement on imaging (X-ray, ultrasound, or MRI), and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Juvenile Arthritis Disease Activity Score (JADAS) or the American College of Rheumatology (ACR) Pediatric (ACR-Pedi 30) of at least 30% improvement from baseline in three of six variables].

Ankylosing Spondylitis (AS) ^42,46

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, morning stiffness, and/or an improvement on a disease activity scoring tool [e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) or an improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)]; AND
• Dose escalation (up to the maximum dose and frequency specified below) may occur upon clinical review on a case-by-case basis provided that the patient has:
  • Shown an initial improvement or response to therapy; AND
  • Responded to therapy (by treatment week 8) with subsequent loss of response or continued active disease; AND
    • Received loading doses and a minimum of one maintenance dose at the dose and interval specified below; OR
    • Received a minimum of two maintenance doses at the dose and interval specified below

Non-Radiographic Axial Spondyloarthritis (nr-AxSpA) ^31,46

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, reduction of C-reactive protein, and/or an improvement on a disease activity scoring tool [e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS), achievement of an ASDAS-Major Improvement (ASDAS-MI e.g. improvement of ≥ 2.0 in the ASDAS and/or reaching the lowest possible ASDAS),  improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), improvement of the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) score from baseline, or an ASAS40 response (defined as a ≥40% improvement and an absolute improvement from baseline of ≥2 units in ≥3 of 4 domains without any worsening in the remaining domain)].

Enthesitis-Related Arthritis (ERA) ^1,38,39

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Juvenile Arthritis Disease Activity Score (JADAS) or the American College of Rheumatology (ACR) Pediatric (ACR-Pedi 30) of at least 30% improvement from baseline in three of six variables].

Hidradenitis Suppurativa (HS) ^1,48

• Disease response as indicated by a reduction in total abscess and inflammatory nodule count and/or reduction in skin pain, and/or an improvement on a disease activity scoring tool [e.g. a 50% or greater reduction in abscess and inflammatory nodule count with no increase in the number of abscesses or draining fistulas compared with baseline Hidradenitis Suppurativa Clinical Response (HiSCR)]; AND
• Dose escalation (up to the maximum dose and frequency specified below) may occur upon clinical review on a case-by-case basis provided that the patient has:
  • Shown an initial improvement or response to therapy; AND
  • Responded to therapy (by treatment week 8) with subsequent loss of response or continued active disease; AND
    • Received loading doses and a minimum of one maintenance dose at the dose and interval specified below; OR
    • Received a minimum of two maintenance doses at the dose and interval specified below

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code(s):

• J3247 – Injection, secukinumab, intravenous, 1 mg; 1 billable unit = 1 mg (IV formulation ONLY)
• J3590 – Unclassified biologics (SQ formulation ONLY)
• C9399 – Unclassified drugs or biologicals (SQ formulation ONLY)

NDC(s):

• Cosentyx 300 mg/2 mL single-dose UnoReady^® Pen (carton of 1) for subcutaneous injection: 00078-1070-xx
• Cosentyx 150 mg/mL single-dose Sensoready^® Pen (carton of 1 or 2) for subcutaneous injection: 00078-0639-xx
• Cosentyx 300 mg/2 mL single-dose prefilled syringe (carton of 1) for subcutaneous injection: 00078-1070-xx
• Cosentyx 150 mg/mL single-dose prefilled syringe (carton of 1 or 2) for subcutaneous injection: 00078-0639-xx
• Cosentyx 75 mg/0.5 mL single-dose prefilled syringe for subcutaneous injection (for pediatric patients less than 50 kg; carton of 1): 00078-1056-xx
• Cosentyx 125 mg/5 mL solution in a single-dose vial for dilution prior to intravenous injection (carton of 1): 00078-1168-xx

7. References

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3. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
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5. 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.
6. 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. 2015 Dec 7. Pii: annrheumdis-2015-208337. Doi: 10.1136/annrheumdis-2015-208337.
7. Ward MM, Deodhar, A, Akl, EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2015 Sep 24. Doi: 10.1002/art.39298.
8. Smith CH, Jabbar-Lopez ZK, Yiu ZK, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. Doi: 10.1111/bjd.15665.
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Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A