WHA

KINERET (anakinra)

Self-Administration – subcutaneous (SC) injection

 

Indication for Prior Authorization:

 

Rheumatoid Arthritis (RA): Indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs). Kineret can be used alone or in combination with DMARDs other than tumor necrosis factor (TNF) blocking agents. 

Neonatal-Onset Multisystem Inflammatory Disease (NOMID), a form of Cryopyrin-Associated Periodic Syndromes (CAPS): Indicated for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID). 

Deficiency of Interleukin-1 Receptor Antagonist (DIRA): Indicated for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA). 

Systemic Juvenile Idiopathic Arthritis (SJIA): Has been used for the treatment of systemic juvenile idiopathic arthritis. (Off Label)

 
Coverage Criteria:

 

For diagnosis of Rheumatoid Arthritis (RA):

  • Documented diagnosis of moderately to severely active RA; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses: 
    • methotrexate 
    • leflunomide 
    • sulfasalazine
    • hydroxychloroquine; AND
  • One of the following: 
    • Both of the following:
      • 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 
        • Rinvoq (upadacitinib) 
        • Simponi (golimumab) 
        • Xeljanz/XR (tofacitinib/ER) 
      • Trial and failure, contraindication, or intolerance to BOTH of the following:
        • Actemra (tocilizumab)
        • Orencia (abatacept)
    • For continuation of prior Kineret therapy, defined as no more than a 45-day gap in therapy.

*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 a diagnosis of Neonatal-Onset Multisystem Inflammatory Disease (NOMID):

  • Documented diagnosis of NOMID; AND
  • Diagnosis of NOMID has been confirmed by one of the following:
    • NLRP3 gene mutation (for nucleotide-binding domain and leucine-rich repeat containing [NLR] family pyrin domain containing 3); also known as Cold-Induced Auto-inflammatory Syndrome-1 (CIAS1) mutation. 
    • Both of the following:
      • Two of the following clinical symptoms:
        • Urticaria-like rash 
        • Cold/stress triggered episodes 
        • Sensorineural hearing loss 
        • Musculoskeletal symptoms (e.g., arthralgia, arthritis, myalgia) 
        • Chronic aseptic meningitis 
        • Skeletal abnormalities (e.g., epiphyseal overgrowth, frontal bossing) 
      • Elevated acute phase reactants (e.g., erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], serum amyloid A [SAA]); AND
  • Prescribed by or in consultation with an allergist/Immunologist, rheumatologist or pediatrician.

 

For a diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA):

  • Diagnosis of DIRA has been confirmed by genetic testing for mutations involving IL1RN.

 

For a diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA) (off-label):

  • Diagnosis of SJIA; AND
  • Prescribed by or in consultation with a rheumatologist; AND
  • Trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses:
    • Minimum duration of a 3-month trial and failure of methotrexate
    • Minimum duration of a 1-month trial of a nonsteroidal anti-inflammatory drug (NSAID) (e.g., ibuprofen, naproxen)
    • Minimum duration of a 2-week trial of a systemic glucocorticoid (e.g., prednisone)

 

Reauthorization Criteria:

 

For diagnosis of RA:

  • 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, inflammation) from baseline 

 

For diagnosis of NOMID/CAPS, DIRA:

  • Documentation of positive clinical response to therapy. 

 

For diagnosis of SJIA (off-label):

  • 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, fever, inflammation, rash, lymphadenopathy, serositis) from baseline.

 

Dosing:

 

RA (adults): 

  • 100 mg/day administered daily by subcutaneous injection.

 

NOMID/CAPS, DIRA: 

  • Starting dose is 1-2 mg/kg daily. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation.

 

SJIA (off-label):

  • Starting dose is up to 2 mg/kg daily. The dose can be individually adjusted to a of 4 mg/kg daily or higher to control active inflammation.

 

Coverage Duration:

 

  • Initial: 1 year
  • 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:
  • Perform test for latent tuberculosis (TB); if positive, start treatment for TB prior to starting an Kineret.

 

Policy Updates:
  • 02/18/2020 – Criteria reviewed.
  • 01/01/2023 – Update prerequisite drugs for RA; remove TB requirements; update coverage duration of initial authorization; add criteria for NOMID and DIRA; add reauthorization criteria for all indications. (P&T 11/15/2022)
  • 09/01/2023 - Addition of Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options for RA. Addition of off label criteria for SJIA. (P&T 08/15/2023). 
  • 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only.

 

References:
  1. Kineret Prescribing Information. Swedish Orphan Biovitrum. Stockholm, Sweden. December 2020. 
  2. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2021;73(7):1108-23. 
  3. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25. 
  4. Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. UpToDate. Updated March 16, 2021. http:www.uptodate.com. Accessed November 2, 2021. 
  5. Yu JR and Leslie KS. Cryopyrin-associated periodic syndrome: an update on diagnosis and treatment response. Curr Allergy Asthma Rep. 2011;11(1):12-20 
  6. Kuemmerle-Deschner JB, Ozen S, Tyrrell PN, et al. Diagnostic criteria for cryopyrin-associated periodic syndrome (CAPS). Ann Rheum Dis. 2017 Jun;76(6):942-947. 
  7. Onel KB, Horton DB, Lovell DJ, et al. 2021 American College of Rheumatology guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for oligoarthritis, temporomandibular joint arthritis, and systemic juvenile idiopathic arthritis. Arthritis Rheumatol. 2022;74(4):553-569. 
  8. Aksentijevich I, Masters SL, Ferguson PJ, Dancey P, Frenkel J, van Royen-Kerkhoff A, Laxer R, Tedgård U, Cowen EW, Pham TH, Booty M. An autoinflammatory disease with deficiency of the interleukin-1–receptor antagonist. New England Journal of Medicine. 2009 Jun 4;360(23):2426-37.

Last review date: November 14, 2023