COSENTYX (secukinumab)

COSENTYX (secukinumab)

Self-administration – Subcutaneous (SC) injection may be given at home by the UnoReady pen, Sensoready pen, and prefilled syringe.

Office-administration – Solution in vials is for healthcare professional use only.

 

Indications for Prior Authorization:

 

Plaque Psoriasis (PsO): Indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis (PsA): Indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older.

Ankylosing Spondylitis (AS): Indicated for the treatment of adult patients with active ankylosing spondylitis.

Non-radiographic axial spondyloarthritis (nr-axSpA): Indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Enthesitis-related arthritis (ERA): Indicated for the treatment of active enthesitis-related arthritis in patients 4 years of age and older.

Hidradenitis Suppurativa (HS): Indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS).

 

Coverage Criteria:

 

For diagnosis of plaque psoriasis (PsO):

• Documented diagnosis of moderate to severe PsO; AND
• Patient is 6 years of age or older; AND
• One of the following:
  • Greater than or equal to 3% body surface area involvement 
  • Severe scalp psoriasis 
  • Palmoplantar (i.e., palms, soles), facial, or genital involvement; AND
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 4-week trial and failure, contraindication, or intolerance to one of the following topical therapies: 
  • corticosteroids (e.g., betamethasone, clobetasol) 
  • vitamin D analogs (e.g., calcitriol, calcipotriene) 
  • tazarotene 
  • calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) 
  • anthralin 
  • coal tar; AND
• Prescribed by or in consultation with a dermatologist; AND
• Both of the following:
  • One of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to THREE of the following: 
      • Cimzia (certolizumab pegol) 
      • Enbrel (etanercept) 
      • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz  
      • Skyrizi (risankizumab) 
      • Stelara (ustekinumab) 
      • Tremfya (guselkumab)
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior Cosentyx therapy, defined as no more than a 45-day gap in therapy
      • Documentation of positive clinical response to therapy as evidenced by ONE of the following:
        • Reduction the body surface area (BSA) involvement from baseline 
        • Improvement in symptoms (e.g., pruritus, inflammation) from baseline
  • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Taltz (ixekizumab).

 

For diagnosis of psoriatic arthritis (PsA):

• Documented diagnosis of active PsA; AND
• One of the following:
  • actively inflamed joints 
  • dactylitis 
  • enthesitis 
  • axial disease 
  • active skin and/or nail involvement; AND
• Patient is 2 years of age or older; AND
• Prescribed by or in consultation with a rheumatologist or dermatologist; AND
• One of the following:
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to TWO of the following: 
      • Cimzia (certolizumab pegol)
      • Enbrel (etanercept)
      • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
      • Simponi (golimumab)
      • Stelara (ustekinumab)
      • Tremfya (guselkumab)
      • Skyrizi (risankizumab-rzaa)
      • Rinvoq (upadacitinib)
      • Xeljanz/XR (tofacitinib/ER)
    • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to BOTH of the following:
      • Taltz (ixekizumab)
      • Orencia (abatacept) 
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior Cosentyx therapy, defined as no more than a 45-day gap in therapy
    • Documentation of positive clinical response to therapy as evidenced by at least one of the following:
      • Reduction in the total active (swollen and tender) joint count from baseline 
      • Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline.
      • Reduction in the body surface area (BSA) involvement from baseline.

 

For diagnosis of ankylosing spondylitis (AS):

• Documented diagnosis of active AS; AND
• Prescribed by or in consultation with a rheumatologist; AND
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses; AND
• One of the following:
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*: 
      • Cimzia (certolizumab pegol)
      • Enbrel (etanercept)
      • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
      • Simponi (golimumab)
      • Rinvoq (upadacitinib)
      • Xeljanz/XR (tofacitinib/ER)
    • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Taltz (ixekizumab).
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior Cosentyx therapy, defined as no more than a 45-day gap in therapy
    • Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following:
      • Disease activity (e.g., pain, fatigue, inflammation, stiffness) 
      • Lab values (erythrocyte sedimentation rate, C-reactive protein level) 
      • Function 
      • Axial status (e.g., lumbar spine motion, chest expansion) 
      • Total active (swollen and tender) joint count

*Includes attestation that a total of two TNF inhibitors have already been tried in the past, and the patient should not be made to try a third TNF inhibitor.

 

For diagnosis of Non-radiographic Axial Spondyloarthritis (nr-axSpA):

• Documented diagnosis of active nr-axSpA; AND
• Prescribed by or in consultation with a rheumatologist; AND
• Patient has objective signs of inflammation (e.g. C-reactive protein [CRP] levels above the upper limit of normal, or sacroiliitis on magnetic resonance imaging [MRI], indicative of inflammatory disease, but without definitive radiographic evidence of structural damage on sacroiliac joints); AND
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses; AND
• One of the following:
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to ALL of the following:
      • Cimzia (certolizumab pegol) 
      • Rinvoq (upadacitinib)† 
      • Taltz (ixekizumab)
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior Cosentyx therapy, defined as no more than a 45-day gap in therapy
    • Documentation of positive clinical response to therapy as evidenced by improvement from baseline for least one of the following:
      • Disease activity (e.g., pain, fatigue, inflammation, stiffness) 
      • Lab values (erythrocyte sedimentation rate, C-reactive protein level) 
      • Function 
      • Axial status (e.g., lumbar spine motion, chest expansion) 
      • Total active (swollen and tender) joint count

† Requires inadequate response or intolerance to one or more TNF-inhibitors.

 

For diagnosis of enthesitis-related arthritis (ERA):

• Documented diagnosis of active ERA; AND
• Patient is 4 years of age or older; AND
• Prescribed by or in consultation with a rheumatologist; AND
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of one-month trial and failure, contraindication, or intolerance to TWO different nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, naproxen, indomethacin, meloxicam, diclofenac) at maximally tolerated doses.

 

For diagnosis of hidradenitis suppurativa (HS):

• Diagnosis of moderate to severe hidradenitis suppurativa; AND
• Prescribed by or in consultation with a dermatologist; AND
• One of the following:
  • Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz, or Brand Adalimumab-adaz
  • Both of the following:
    • Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior Cosentyx therapy, defined as no more than a 45-day gap in therapy
    • Documentation of positive clinical response to therapy

 

Reauthorization Criteria:

 

For diagnosis of PsO:

• Documentation of a positive clinical response to therapy as evidenced by ONE of the following:
  • Reduction the body surface area (BSA) involvement from baseline
  • Improvement in symptoms (e.g., pruritus, inflammation) from baseline

 

For diagnosis of PsA:

• Documentation of a positive clinical response to therapy as evidenced by at least one of the following: 
  • Reduction in the total active (swollen and tender) joint count from baseline
  • Improvement in symptoms (e.g., pain, stiffness, pruritus, inflammation) from baseline
  • Reduction in the body surface area (BSA) involvement from baseline

 

For diagnosis of AS:

• Documentation of a positive clinical response to therapy as evidenced by improvement from baseline for least one of the following: 
  • Disease activity (e.g., pain, fatigue, inflammation, stiffness)
  • Lab values (erythrocyte sedimentation rate, C-reactive protein level)
  • Function
  • Axial status (e.g., lumbar spine motion, chest expansion)
  • Total active (swollen and tender) joint count 

 

For diagnosis of nr-axSpA:

• Documentation of a positive clinical response to therapy as evidenced by improvement from baseline for least one of the following: 
  • Disease activity (e.g., pain, fatigue, inflammation, stiffness)
  • Lab values (erythrocyte sedimentation rate, C-reactive protein level)
  • Function
  • Axial status (e.g., lumbar spine motion, chest expansion)
  • Total active (swollen and tender) joint count

 

For diagnosis of ERA:

• Documentation of a positive clinical response to therapy as evidenced by at least one of the following:
  • Reduction in the total active (swollen and tender) joint count from baseline
  • Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline

 

For diagnosis of HS:

• Patient demonstrates positive clinical response to therapy

 

Dosing:

 

PsO:

• Adults: 300 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks
• Pediatrics, age 6-17 years (50 kg or more): 150 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 150 mg every 4 weeks
• Pediatrics, age 6-17 years (less than 50 kg): 75 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 75 mg every 4 weeks

PsA:

• Adults: 150 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by up to 300 mg every 4 weeks thereafter
• Pediatrics, age 2-17 years (50 kg or more): 150 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 150 mg every 4 weeks
• Pediatrics, age 2-17 years (l5kg to 49 kg): 75 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by 75 mg every 4 weeks
• For PsA patients with coexistent moderate to severe plaque psoriasis, use the dosing and administration recommendations for plaque psoriasis

AS:

• 150 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4, followed by up to 300 mg every 4 weeks thereafter

Non-radiographic axial spondyloarthritis (nr-axSpA):

• 150 mg by subcutaneous injection at weeks 0, 1, 2, 3, and 4 followed by up to 150 mg every 4 weeks thereafter

ERA:

• Patients weighing 15 kg to less than 50 kg: 75 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
• Patients weighing 50 kg or more: 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter

HS:

• 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3 and 4 and every 4 weeks thereafter
• If a patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks. Each 300 mg dosage is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg

 

Coverage Duration:

For diagnosis of PsO, PsA, AS, nr-axSpA, or ERA:

• Initial: 1 year
• Reauthorization: 1 year

For diagnosis of HS:

• Initial: 6 months
• Reauthorization: 1 year

 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information:

• Patients should be tested for latent tuberculosis (TB) (e.g. TB skin test, QuantiFERON TB Gold test, or chest x-ray) before Cosentyx use and during therapy. Treatment for latent infection should be initiated prior to Cosentyx use.
• Axial disease involvement affects the spine and the sacroiliac (SI) joints that connect the lower spine to the pelvis.

 

Policy Updates:

• 07/01/2020 - Annual review.
• 11/16/2021 - Added coverage criteria for nr-axSpA; updated format.
• 04/05/2022 - New criteria for new indication of ERA. Addition of additional preferred agents for PsA.
• 08/16/2022 - Update AS criteria to include all WHA preferred agents for the treatment of AS. 
• 01/01/2023 - Addition of Enbrel as an additional preferred step option for PsO, PsA, and AS. Further clinical detail and criteria added.
• 09/01/2023 - Addition of Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options for PsO, PsA, and AS. (P&T 08/15/2023).
• 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only. (P&T, 11/14/2023)
• 12/18/2023 — New criteria for new indication of HS (P&T vote, 12/18/23)

 

References:

1. Cosentyx prescribing information. Novartis Pharmaceuticals Corp. East Hanover, NJ. October 2023. 
2. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029-72. 
3. Elmets CA, Korman NJ, Farley Prater E, 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 2021;84:432-70. 
4. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation guideline for the treatment of psoriatic arthritis. Arthritis Rheumatol. 2019;71(1):5-32. 
5. Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613. 
6. Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Care Res. 2019;71(6):717-734.