Kineret (anakinra)
Indications for Prior Authorization
Kineret (anakinra)
-
For diagnosis of 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. -
For diagnosis of Cryopyrin-Associated Periodic Syndromes (CAPS): Neonatal-Onset Multisystem Inflammatory Disease (NOMID) [A]
Indicated for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID). -
For diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
Indicated for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA). -
For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA)
Has been used for the treatment of systemic juvenile idiopathic arthritis. [7]
Criteria
Kineret
*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 review process only: Refer to the table in the Background section for carrier-specific formulary adalimumab products
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Diagnosis of moderately to severely active rheumatoid arthritis (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 [2, 3]:
- methotrexate
- leflunomide
- sulfasalazine
- One of the following:
- All 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)
- One formulary adalimumab product**
- Simponi (golimumab)
- Rinvoq (upadacitinib)
- Xeljanz/XR (tofacitinib/ER)
- Trial and failure, contraindication, or intolerance to BOTH of the following:
- Actemra (tocilizumab)
- Orencia (abatacept)
- For continuation of prior therapy, defined as no more than a 45-day gap in therapy
Kineret
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-3]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
Kineret
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) [A]
- Diagnosis of neonatal-onset multisystem inflammatory disease (NOMID) AND
- Diagnosis of NOMID has been confirmed by one of the following: [5-6, B]
- NLRP-3 (nucleotide-binding domain, leucine rich family (NLR), pyrin domain containing 3-gene (also known as Cold-Induced Auto-inflammatory Syndrome-1 [CIAS1]) mutation OR
- 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])
- Prescribed by or in consultation with one of the following
- Allergist/Immunologist
- Rheumatologist
- Pediatrician
Kineret
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) [A]
- Patient demonstrates positive clinical response to therapy
Kineret
Prior Authorization
Length of Approval: 12 Month(s)
For diagnosis of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
- Diagnosis of deficiency of interleukin-1 receptor antagonist (DIRA)
Kineret
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA) (Off-Label)
- Diagnosis of active systemic juvenile idiopathic arthritis [7] 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 [7]:
- 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)
Kineret
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Systemic Juvenile Idiopathic Arthritis (SJIA) (Off-Label)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [7]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in clinical features or symptoms (e.g., pain, fever, inflammation, rash, lymphadenopathy, serositis) from baseline
P & T Revisions
2024-12-02, 2024-06-24, 2024-05-30, 2024-04-23, 2024-03-06, 2024-01-31, 2023-11-14, 2023-06-30, 2023-02-01, 2023-01-31, 2022-10-23, 2022-01-23, 2021-09-27, 2021-05-19, 2021-02-03, 2020-09-15, 2020-03-23, 2019-10-23
References
- Kineret Prescribing Information. Swedish Orphan Biovitrum. Stockholm, Sweden. December 2020.
- 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.
- 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.
- Nigrovic PA. Cryopyrin-associated periodic syndromes and related disorders. UpToDate. Updated February 6, 2023. http:www.uptodate.com. Accessed January 28, 2024.
- 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
- 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.
- 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.
End Notes
- Three clinically overlapping, interleukin-1-associated, autoinflammatory disorders are known collectively as the cryopyrin-associated periodic syndromes (CAPS) or cryopyrinopathies: familial cold autoinflammatory syndrome (FCAS), Muckle-Wells syndrome (MWS), and neonatal onset multisystem inflammatory disorder (NOMID, also known as chronic infantile neurological cutaneous and articular [CINCA] syndrome). [4]
- In addition to clinical symptoms, a diagnosis should be made using a combination of procedures including laboratory assessments, skin biopsy, and genetic testing. [5] Diagnostic criteria developed by a multidisciplinary team of international experts in the care of children and adults with CAPS found that the best diagnosis criteria model included: raised inflammatory markers (CRP/SAA) plus two or more of six CAPS-typical signs/symptoms including (1) urticaria-like rash, (2) cold-triggered episodes, (3) sensorineural hearing loss, (4) musculoskeletal symptoms (arthralgia/arthritis/myalgia), (5) chronic aseptic meningitis, and (6) skeletal abnormalities (epiphyseal overgrowth/frontal bossing). This proposed model had a sensitivity of 81% and a specificity of 94%. It performed equally well for all CAPS subtypes and in subgroups with and without evidence of NLRP3 mutation (p < 0.001). [4, 6]
Revision History
- 2024-12-02: Update to remove manufacturer information from "one formulary adalimumab product"; updated background table
- 2024-06-24: No criteria changes; updated background table to specify BI manufacturer for adalimumab-adbm
- 2024-05-30: Updated background table to include CalPERS formulary; no criteria changes
- 2024-04-23: Updated verbiage in the RA step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
- 2024-03-06: Updated verbiage in the RA step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
- 2024-01-31: Annual review - no criteria changes; background updates
- 2023-11-14: Program update to standard reauthorization language. No changes to clinical intent.
- 2023-06-30: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options for RA
- 2023-02-01: Annual review - no criteria changes
- 2023-01-31: Addition of Amjevita as another preferred step option for RA
- 2022-10-23: Enbrel added as an additional preferred step option for RA; further clinical detail added to RA and SJIA
- 2022-01-23: Annual review
- 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
- 2021-05-19: Addition of EHB formulary to guideline, no changes to criteria
- 2021-02-03: Addition of criteria for new DIRA indication.
- 2020-09-15: Formulary strategy update to remove Simponi Aria as a preferred step option for RA
- 2020-03-23: Annual review - no clinical changes; updated references
- 2019-10-23: Added Rinvoq (upadacitinib) as a step option for RA.
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