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| Chronic Inflammatory Diseases - Commercial and Healthcare Reform | |
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| Number: J-0558 | Category: Prior Authorization |
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Line(s) of Business:
Commercial |
Benefit(s):
Commercial: Prior Authorization (1. or 2.): 1. Miscellaneous Specialty Drugs Oral = Yes w/ Prior Authorization (Olumiant, Otezla, Xeljanz, Xeljanz XR, Rinvoq) 2. Miscellaneous Specialty Drugs Injectable = Yes w/ Prior Authorization (Actemra, Cosentyx, Enbrel, Humira, Stelara, Cimzia, llumya,Kevzara, Kineret, Orencia, Siliq, Simponi, Skyrizi, Taltz, Tremfya) Quantity Limits (1., 2., 3., or 4.): 1. Rx Mgmt Quantity Limits = Safety/Specialty 2. Rx Mgmt Quantity Limits = Safety/Specialty + Dose Opt 3. Rx Mgmt Quantity Limits = Safety/Specialty + Dose Opt + Watchful 4. Rx Mgmt Performance = MRxC = Yes Healthcare Reform: Not Applicable |
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Region(s):
All |
Additional Restriction(s):
Excluding Commercial National Select formulary |
| Drugs Products |
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| FDA-Approved Indications: |
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| Background: |
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Table 1. Summary of Plan- Preferred Products Given by Oral or Subcutaneous (SC) Administration by Indication
1 Directed to Humira specifically. 2 Actemra SC will require a trial of Humira first for Polyarticular Juvenile Idiopathic Arthritis (PJIA) indication only.
I. Actemra (tocilizumab)
A. Initial Authorization 1. Rheumatoid Arthritis (RA)(ICD-10: M05, M06) When a benefit, coverage of Actemra SC may be approved for RA when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe RA. c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all nonbiologic DMARDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to plan-preferred Humira for the treatment of RA (see Table 1).
2. Giant Cell Arteritis (GCA)) (ICD-10: M31.5, M31.6) When a benefit, coverage of Actemra SC may be approved for GCA when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of GCA. c. The member has experienced therapeutic failure or intolerance to at least one (1) systemic corticosteroid (e.g., prednisone), or all corticosteroids are contraindicated. 3. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) (ICD-10: M34.81) When a benefit, coverage of Actemra SC may be approved for SSc-ILD when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of SSc-ILD. c. The member has experienced therapeutic failure or intolerance to at least one (1) immunosuppressant (e.g., mycophenolate mofetil, corticosteroids, azathioprine, cyclophosphamide) or all immunosuppressants are contraindicated
4. Polyarticular Juvenile Idiopathic Arthritis (PJIA)(ICD-10: M08.4) When a benefit, coverage of Actemra SC may be approved for PJIA when all of the following criteria are met (a. through d.): a. The member is 2 years of age or older. b. The member has a diagnosis of PJIA. c. The member meets one (1) of the following criteria (i. or ii.): i. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. ii. The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage. d. The member has experienced therapeutic failure or intolerance to plan-preferred Humira for the treatment of PJIA (see Table 1).
5. Systemic Juvenile Idiopathic Arthritis (SJIA)(ICD-10: M08) When a benefit, coverage of Actemra SC may be approved for SJIA when all of the following criteria are met (a. and b.): a. The member is 2 years of age or older. b. The member has a diagnosis of SJIA.
B. Reauthorization When a benefit, reauthorization of Actemra SC may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Actemra SC may be authorized in quantities as follows:
N/A=not applicable
II. Cimzia (certolizumab)
A. Initial Authorization 1. Rheumatoid Arthritis (RA)(ICD-10: M05, M06) When a benefit, coverage of Cimzia may be approved for RA when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe RA. c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of RA (see Table 1).
2. Ankylosing Spondylitis (AS)(ICD-10: M45) When a benefit, coverage of Cimzia may be approved for AS when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of AS. c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of AS (see Table 1).
3. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Cimzia may be approved for spinal or axial PsA when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1). b. PsA without spinal or axial disease When a benefit, coverage of Cimzia may be approved for PsA without spinal or axial disease when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1). c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Cimzia may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1).
4. Crohn’s Disease (CD)(ICD-10: K50) When a benefit, coverage of Cimzia may be approved CD when all of the following criteria are met (a.,b.,and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe CD. c. The member has experienced therapeutic failure or intolerance to plan-preferred Humira for the treatment of CD (see Table 1).
5. Plaque Psoriasis (PsO)(ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Cimzia may be approved for PsO when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsO (see Table 1).
6. Non-radiographic Axial Spondyloarthritis (nr-axSpA)(ICD-10: M46.80, M46.81) When a benefit, coverage of Cimzia may be approved for nr-axSpA when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of nr-axSpA. c. The member has experienced therapeutic failure or intolerance to at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs), or all NSAIDs are contraindicated.
B. Reauthorization When a benefit, reauthorization of Cimzia may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Cimzia may be authorized in quantities as follows:
III. Cosentyx (secukinumab)
A. Initial Authorization 1. Ankylosing Spondylitis (AS)(ICD-10: M45) When a benefit, coverage of Cosentyx may be approved for AS when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of AS. c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
2. Psoriatic Arthritis (PsA)(ICD-10: 5) a. Spinal or axial PsA When a benefit, coverage of Cosentyx may be approved for spinal or axial PsA when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. b. PsA without spinal or axial disease When a benefit, coverage of Cosentyx may be approved for PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.) i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Cosentyx may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.) i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
3. Plaque Psoriasis (PsO), including Scalp Psoriasis (ICD-10: L40.0-L40.4; L40.8-L40.9 When a benefit, coverage of Cosentyx may be approved for PsO when all of the following criteria are met (a., b., and c.) a. The member is 6 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy.
4. Non-radiographic Axial Spondyloarthritis (nr-axSpA) (ICD-10: M46.80, M46.90) When a benefit, coverage of Cosentyx may be approved for nr-axSpA when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of nr-axSpA. c. The member has experienced therapeutic failure or intolerance to at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs), or all NSAIDs are contraindicated.
B. Reauthorization When a benefit, reauthorization of Cosentyx may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Cosentyx may be authorized in quantities as follows:
* Pediatric patients with PsO may require 3 pens/prefilled syringes within a four (4) week time frame if switching from pediatric dosing (75mg/mL) to adult dosing (300mg/2mL). ^ Pediatric patients with PsO (≥ 50 kg) are subject to dose optimization of one (1) pen/prefilled syringe (150 mg/mL) every four (4) weeks. † Adult patients < 50 kg with PsO are subject to adult dosing recommendations and quantity limits.
IV. Enbrel (etanercept)
A. Initial Authorization 1. Rheumatoid Arthritis (RA)(ICD-10: M05, M06) When a benefit, coverage of Enbrel may be approved for RA when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe RA c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
2. Ankylosing Spondylitis (AS)(ICD-10: M45) When a benefit, coverage of Enbrel may be approved for AS when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of AS. c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
3. Juvenile Idiopathic Arthritis (JIA)(ICD-10: M08.9) When a benefit, coverage of Enbrel may be approved for JIA when all of the following criteria are met (a., b., and c.): a. The member is 2 years of age or older. b. The member has a diagnosis of moderate to severe JIA. c. The member meets one (1) of the following criteria (i. or ii.): i. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. ii. The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.
4. Psoriatic Arthritis (PsA)(ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Enbrel may be approved for spinal or axial PsA when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. b. PsA without spinal or axial disease When a benefit, coverage of Enbrel may be approved for PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Enbrel may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
5. Plaque Psoriasis (PsO), adults (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Enbrel may be approved for adult PsO when all of the following criteria are met (a., b., and c.) a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i.,ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy
6. Plaque Psoriasis (PsO), pediatrics (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Enbrel may be approved for pediatric PsO when all of the following criteria are met (a., b., and c.): a. The member is ≥ 4 and < 18 years of age. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii.): i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy
B. Reauthorization When a benefit, reauthorization of Enbrel may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Enbrel may be authorized in quantities as follows:
N/A=not applicable
V. Humira (adalimumab)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Humira may be approved for RA when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe RA. c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
2. Ankylosing Spondylitis (AS) (ICD-10: M45) When a benefit, coverage of Humira may be approved for AS when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of AS. c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
3. Juvenile Idiopathic Arthritis (JIA) (ICD-10: M08.9) When a benefit, coverage of Humira may be approved for JIA when all of the following criteria are met (a., b., and c.): a. The member is 2 years of age or older. b. The member has a diagnosis of moderate to severe JIA. c. The member meets one (1) of the following criteria (i. or ii.): i. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine), or all non-biologic DMARDs are contraindicated. ii. The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.
4. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Humira may be approved for spinal or axial PsA when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. b. PsA without spinal or axial disease When a benefit, coverage of Humira may be approved for PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Humira may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
5. Plaque Psoriasis (PsO) (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Humira may be approved for PsO when all of the following criteria are met (a., b., and c.) a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy.
6. Crohn’s Disease (CD), adults (ICD-10: K50) When a benefit, coverage of Humira may be approved for adult CD when all of the following criteria are met (a.,and b.): a. The member is 6 years of age or older. b. The member has a diagnosis of moderate to severe CD.
7. Ulcerative Colitis (UC) (ICD-10: K51) When a benefit, coverage of Humira may be approved for UC when all of the following criteria are met (a. and b.): a. The member is 5 years of age or older. b. The member has a diagnosis of moderate or severe UC.
8. Hidradenitis Suppurativa (HS) (ICD-10: L37.2) When a benefit, coverage of Humira may be approved for HS when all of the following criteria are met (a. and b): a. The member is 12 years of age or older. b. The member has a diagnosis of moderate to severe HS.
9. Uveitis (UV) (ICD-10: H44.1) When a benefit, coverage of Humira may be approved for UV when all of the following criteria are met (a., b., and c): a. The member is 2 years of age or older. b. The member has a diagnosis of non-infectious intermediate, posterior or panuveitis. c. The member has experienced therapeutic failure or intolerance to at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine), or immunosuppressants are contraindicated.
B. Reauthorization When a benefit, reauthorization of Humira may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Humira pre-filled syringes or auto-injectors may be authorized in quantities as follows:
VI. Ilumya (tildrakizumab-asmn) A. Initial Authorization 1. Plaque Psoriasis (PsO) (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Ilumya may be approved for PsO when all of the following criteria are met (a. through d.) a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i.,ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g., PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g., methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsO (see Table 1).
B. Reauthorization When a benefit, reauthorization of Ilumya may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy. C. Quantity Limitations When prior authorization is approved, Ilumya may be authorized in quantities as follows:
VII. Kevzara (sarilumab)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Kevzara may be approved RA when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe RA. c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of RA (see Table 1).
B. Reauthorization When a benefit, reauthorization of Kevzara may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Kevzara may be authorized in quantities as follows:
VIII. Kineret (anakinra)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Kineret may be approved for RA when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of RA. c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of RA (see Table 1).
2. Neonatal-Onset Multisystem Inflammatory Disease (NOMID) (ICD-10: E85.0) When a benefit, coverage of Kineret may be approved for NOMID when the following criterion is met (a.): a. The member has a diagnosis of NOMID. 3. Deficiency of Interleukin-1 Receptor Antagonist (DIRA) (ICD-10: M04.8) When a benefit, coverage of Kineret may be approved for DIRA when all of the following criteria are met (a. and b.): a. The member has a diagnosis of DIRA. b. The member has experienced therapeutic failure or intolerance to at least one (1) corticosteroid, or all corticosteroids are contraindicated.
B. Reauthorization When a benefit, reauthorization of Kineret may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
Dosing In addition to the criteria outlined above, documentation of member weight and prescribed Kineret dose consistent with dosing below is required: *NOMID and DIRA: The recommended starting dose is 1-2 mg/kg daily. The dose can be individually adjusted to a maximum of 8 mg/kg daily. Kineret may be divided into twice daily dosing. A new syringe must be used for each dose and any unused portion after each dose should be discarded.
C. Quantity Limitations When prior authorization is approved, Kineret may be authorized in quantities as follows:
IX. Olumiant (baricitinib)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Olumiant may be approved for RA when all of the following criteria are met (a. through e.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe RA. c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least one (1) tumor necrosis factor (TNF) antagonist therapy, including Humira, Enbrel, Simponi, or Cimzia. e. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of RA (see Table 1). i. To note: If the member has tried and failed Humira and Enbrel, the member will not need to try and fail any additional plan-preferred biologic products. If the member has tried and failed either Humira or Enbrel, the member will need to try and fail one (1) additional plan-preferred biologic product.
B. Reauthorization When a benefit, reauthorization of Olumiant may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
X. Orencia (abatacept)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Orencia SC may be approved for RA when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe RA. c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of RA (see Table 1).
2. Juvenile Idiopathic Arthritis (JIA) (ICD-10: M08.9) When a benefit, coverage of Orencia SC may be approved for JIA when all of the following criteria are met (a. through d.): a. The member is 2 years of age or older. b. The member has a diagnosis of moderate to severe JIA. c. The member meets one (1) of the following criteria (i. or ii.): i. The member has experienced therapeutic failure or intolerance to at least one (1) nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine), or all nonbiologic DMARDs are contraindicated. ii. The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of JIA (see Table 1)
3. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Orencia may be approved for spinal or axial PsA when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1). b. PsA without spinal or axial disease When a benefit, coverage of Orencia may be approved for PsA without spinal or axial disease when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1). c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Orencia may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1).
B. Reauthorization When a benefit, reauthorization of Orencia SC may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations
When prior authorization is approved, Orencia SC may be authorized in quantities as follows:
XI. Otezla (apremilast)
A. Initial Authorization 1. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Otezla may be approved for spinal or axial PsA when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. b. PsA without spinal or axial disease When a benefit, coverage of Otezla may be approved for PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Otezla may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
2. Plaque Psoriasis (PsO) (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Otezla may be approved for PsO when all of the following criteria are met (a., b., and c.) a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i.,ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy.
3. Oral Ulcers associated with Behçet’s Disease (ICD-10: M35.2) When a benefit, coverage of Otezla may be approved for oral ulcers associated with Behçet’s Disease when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of oral ulcers associated with Behçet’s Disease. c. The member has experienced therapeutic failure or intolerance to at least one (1) topical triamcinolone product for acute flare-up of oral ulcers. d. The member has experienced therapeutic failure or intolerance to colchicine for prevention of recurrent oral ulcers.
B. Reauthorization When a benefit, reauthorization of Otezla may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
XII. Rinvoq (upadacitinib)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Rinvoq may be approved for RA when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe RA. c. The member has experienced therapeutic failure, contraindication or intolerance to methotrexate.
B. Reauthorization When a benefit, reauthorization of Rinvoq may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
XIII. Siliq (brodalumab)
A. Initial Authorization 1. Plaque Psoriasis (PsO)(ICD-10: L40.0-L40.4; L40.8-L40.9) Initiation (0 to < 4 months previous therapy for Siliq) When a benefit, initiation of Siliq may be approved for PsO when all of the following criteria are met (a. through d.) a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsO (see Table 1).
Maintenance (≥ 4 months previous therapy for Siliq) When a benefit, maintenance of Siliq may be approved for PsO when all of the following criteria are met (a. through e.) a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsO (see Table 1). e. Improvement in the physician's global assessment score, psoriasis area severity index score, or a decrease in the affected body surface area of psoriatic plaque lesions has been documented.
B. Reauthorization When a benefit, reauthorization of Siliq may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Siliq may be authorized in quantities as follows:
XIV. Simponi (golimumab)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Simponi SC may be approved for RA when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all nonbiologic DMARDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of RA (see Table 1).
2. Ankylosing Spondylitis (AS) (ICD-10: M45) When a benefit, coverage of Simponi SC may be approved for AS when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of AS. c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of AS (see Table 1).
3. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Simponi SC may be approved for spinal or axial PsA when all of the following criteria are met (i. through iv.) i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1). b. PsA without spinal or axial disease When a benefit, coverage of Simponi SC may be approved for PsA without spinal or axial disease when all of the following criteria are met (i. through iv.) i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1). c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Simponi SC may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1).
4. Ulcerative Colitis (UC) (ICD-10: K51) When a benefit, coverage of Simponi SC may be approved for UC when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate or severe UC. c. The member has experienced therapeutic failure or intolerance to plan-preferred Humira for the treatment of UC (see Table 1).
B. Reauthorization When a benefit, reauthorization of Simponi SC may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Simponi SC may be authorized in quantities as follows:
XV. Skyrizi (risankizumab)
A. Initial Authorization 1. Plaque Psoriasis (PsO) (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Skyrizi may be approved for PsO when all of the following criteria are met (a., b., and c.) a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy.
B. Reauthorization When a benefit, reauthorization of Skyrizi may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Skyrizi may be authorized in quantities as follows:
XVI. Stelara (ustekinumab)
A. Initial Authorization 1. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Stelara may be approved for spinal or axial PsA when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. b. PsA without spinal or axial disease When a benefit, coverage of Stelara may be approved for PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Stelara may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.) i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
2. Plaque Psoriasis (PsO) (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Stelara may be approved for PsO when all of the following criteria are met (a., b., and c.): a. The member is 6 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii): i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy.
3. Crohn’s Disease (CD) (ICD-10: K50) When a benefit, coverage of Stelara may be approved for adult CD when all of the following criteria are met (a.,b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe CD. c. The member received a single induction dose of Stelara IV within 2 months of initiating therapy with Stelara SC and achieved clinical response or remission.
4. Ulcerative Colitis (UC) (ICD-10: K51) When a benefit, coverage of Stelara may be approved for UC when all of the following criteria are met (a.,b., and c.,): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate or severe UC. c. The member received a single induction dose of Stelara IV within 2 months of initiating therapy with Stelara SC and achieved clinical response or remission.
B. Reauthorization When a benefit, reauthorization of Stelara may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
Dosing In addition, the criteria outlined above, documentation of member weight and prescribed Stelara dose consistent with dosing below is required: . Psoriasis (18 years of age or older) a. ≤ 100 kg (220 lbs): 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. b. > 100 kg (220 lbs): 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. . Psoriasis (6 to 17 years of age) a. < 60 kg (132 lbs): 0.75 mg/kg initially and 4 weeks later, followed by 0.75 mg/kg every 12 weeks. b. 60 to 100 kg (220 lbs): 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. c. > 100 kg (220 lbs): 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. . Psoriatic Arthritis a. 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks b. For patients with co-existent moderate-to-severe plaque psoriasis weighing > 100 kg (220 lbs): 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. . Crohn's Disease a. Following a weight-based intravenous dose, the recommended dose is 90 mg 8 weeks following the intravenous dose, then every 8 weeks thereafter. . Ulcerative Colitis a. Following a weight-based intravenous dose, the recommended dose is 90 mg 8 weeks following the intravenous dose, then every 8 weeks thereafter.
C. Quantity Limitations When prior authorization is approved, Stelara SC may be authorized in quantities as follows:
N/A=Not Applicable
XVII. Taltz (ixekizumab)
A. Initial Authorization 1. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Taltz may be approved for spinal or axial PsA when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1). b. PsA without spinal or axial disease When a benefit, coverage of Taltz may be approved for PsA without spinal or axial disease when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1). c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Taltz may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i. through iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated. iv. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of PsA (see Table 1).
2. Plaque Psoriasis (PsO) (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Taltz may be approved for PsO when all of the following criteria are met (a. through d.): a. The member is 6 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy. d. If the member is 18 years of age or older, the member has experienced therapeutic failure or intolerance to at least three (3) step 1 plan-preferred agents for the treatment of PsO (see Table 1).
3. Ankylosing Spondylitis (AS) (ICD-10: M45) When a benefit, coverage of Taltz may be approved for AS when all of the following criteria are met (a. through d.) a. The member is 18 years of age or older. b. The member has a diagnosis of AS. c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan- preferred agents for the treatment of AS (see Table 1).
4. Non-radiographic Axial Spondyloarthritis (nr-axSpA) (ICD-10: M46.80, M46.90) When a benefit, coverage of Taltz may be approved for nr-axSpA when all of the following criteria are met (a. through d.): a. The member is 18 years of age or older. b. The member has a diagnosis of nr-axSpA. c. The member has experienced therapeutic failure or intolerance to at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs), or all NSAIDs are contraindicated. d. The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of nr-axSpA (see Table 1).
B. Reauthorization When a benefit, reauthorization of Taltz may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Taltz may be authorized in quantities as follows:
N/A=Not Applicable
XVIII. Tremfya (guselkumab)
A. Initial Authorization
1. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Tremfya may be approved for spinal or axial PsA when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. b. PsA without spinal or axial disease When a benefit, coverage of Tremfya may be approved for PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Tremfya may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
2. Plaque Psoriasis (PsO) (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Tremfya may be approved for PsO when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe PsO. c. The member meets one (1) of the following criteria (i., ii., or iii.) i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) iii. The member is contraindicated to both phototherapy and systemic therapy.
B. Reauthorization When a benefit, reauthorization of Tremfya may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
C. Quantity Limitations When prior authorization is approved, Tremfya may be authorized in quantities as follows:
XiX. Xeljanz (tofacitinib)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for RA when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate to severe RA. c. The member has experienced therapeutic failure contraindication or intolerance to methotrexate.
2. Juvenile Idiopathic Arthritis (JIA) (ICD-10: M08.9) When a benefit, coverage of Xeljanz tablet or Xeljanz oral solution may be approved for JIA when all of the following criteria are met (a., b., and c.): a. The member is 2 years of age or older. b. The member has a diagnosis of JIA. c. The member meets one (1) of the following criteria (i. or ii.): i. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine), or all non-biologic DMARDs are contraindicated. ii. The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.
3. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for spinal or axial PsA when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated. b. PsA without spinal or axial disease When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for enthesitis and/or dactylitis associated PsA without spinal or axial disease when all of the following criteria are met (i., ii., and iii.): i. The member is 18 years of age or older. ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
4. Ulcerative Colitis (UC) (ICD-10: K51) When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for UC when all of the following criteria are met (a., b., and c.): a. The member is 18 years of age or older. b. The member has a diagnosis of moderate or severe UC. c. The member has experienced therapeutic failure or intolerance to plan-preferred Humira for the treatment of UC (see Table 1).
B. Reauthorization When a benefit, reauthorization of Xeljanz or Xeljanz XR may be approved when the following criterion is met (1.): 1. The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.
XX. If the patient has already had a trial of at least one biologic agent the patient is not required to “step back” and try a non-biologic agent. XXI. An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.
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| Limitations of Coverage |
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I. Coverage of drugs addressed in this policy for disease states outside of the FDA-approved indications should be denied based on the lack of clinical data to support effectiveness and safety in other conditions unless otherwise noted in the approval criteria. II. For Commercial and HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.
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| Authorization Duration |
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Initial Authorization
Reauthorization
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| Automatic Approval Criteria |
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None
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| Version: J-0558-025 |
| Effective Date Begin: 09/03/2021 |
| Effective End Begin: 10/14/2021 |
| Original Date: 07/15/2017 |
| Review Date: 08/04/2021 |
References:
- Actemra [package insert]. San Francisco, CA: Genentech; March 2021
- Cimzia [package insert]. Smyrna, GA: UCB, Inc.; September 2019.
- Cosentyx [package insert]. East Hanover, NJ: Novartis; May 2021.
- Enbrel [package insert]. Thousand Oaks, CA: Immunex Corporation; March 2020.
- Humira [package insert]. North Chicago, IL: AbbVie, Inc.; February 2021
- Kevzara [package insert]. Bridgewater, NJ and Tarrytown, NY: Sanofi-Aventis and Regeneron; April 2018.
- Kineret [package insert]. Waltham, MA: SOBI, Inc. (Swedish Orphan Biovitrum); December 2020.
- Olumiant [package insert]. Indianapolis, IN: Eli Lilly; July 2020.
- Orencia [package insert]. Princeton, NJ: Bristol-Myers Squibb; June 2020.
- Otezla [package insert]. Summit, NJ: Celgene Corporation; April 2020.
- Rinvoq [package insert] North Chicago, IL: AbbVie, Inc.; July 2020.
- Siliq [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals International; February 2017.
- Simponi [package insert]. Horsham, PA: Janssen; September 2019.
- Skyrizi [package insert]. North Chicago, IL: AbbVie, Inc.; April 2021.
- Stelara [package insert]. Horsham, PA: Janssen; July 2020.
- Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; May 2020.
- Tremfya [package insert]. Horsham, PA: Janssen; July 2020.
- Xeljanz, Xeljanz XR [package insert]. New York, NY: Pfizer, Inc.; September 2020.
- Langley R., Eleweksi B, Lebwhol M et al. Secukinumab in plaque Psoriasis. Results of Two Phase 3 trials. N Engl J Med. 2014 July 24; 371:326-338.
- Takei S, Groh D, Bernstein B, et al: Safety and efficacy of high dose etanercept in treatment of juvenile rheumatoid arthritis. J Rheumatol 2001; 28(7):1677-1680.
- Leonardi CL, Powers JL, Matheson RT, et al: Etanercept as monotherapy in patients with psoriasis. N Engl J Med 2003; 349(21):2014-2022.
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- Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as Monotherapy in Patients with Psoriasis. N Engl J Med. 2003;349: 2014-2022.
- Colombel JF, Sandborn WJ, Rutgeerts P, et al: Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007; 132(1):52-65.
- Gladman DD, Mease PJ, Cifaldi MA, et al: Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial. Ann Rheum Dis 2007; 66(2):163-168.
- Gordon KB, Langley RG, Leonardi C, et al: Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study. J Am Acad Dermatol 2006; 55(4):598-606.
- Mease PJ, Gladman DD, Ritchlin CT, et al: Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial. Arthritis Rheum 2005; 52(10):3279-3289.
- Menter A, Tyring SK, Gordon K, et al: Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial. J Am Acad Dermatol 2008; 58(1):106-115.
- Peters BP, Weissman FG, Gill MA. Pathophysiology and treatment of psoriasis. Am J Health Sys Pharm. 2000; 57: 645-662.
- Griffiths CE , Strober BE , van de,Kerkhof P. , et al: Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med 2010; 362(2):118-128.
- Leonardi CL, Kimball AB, Papp KA, et al: Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 2008; 371(9625):1665-1674.
- Papp KA, Langley RG, Lebwohl M, et al: Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet 2008; 371(9625):1675-1684.
- Meyer DM, Jesson MI, Li X, et al. Anti-inflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis. J Inflamm (Lond). 2010; 7:41.
- Sandborn W., Feagan B., Stoinov S. et al. Certolizumab pegol for the treatment of Crohn’s disease. N Eng J Med 2007; 357:228-38.
- Schreiber S., Kareemi M., Lawrence I. et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Eng J Med 2007; 357:239-50.
- Genovese MC, Fleischmann R, Kivitz AJ, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III study (MOBILITY). Arthritis Rheumatol. 2015 Jun;67(6):1424-37.
- Fleischmann R, van Adelsberg J, Lin Y, et al. Sarilumab and nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis and inadequate response or intolerance to tumor necrosis factor inhibitors (TARGET). Arthritis Rheumatol. 2017 Feb;69(2):277-290.
- Jiang Y, Genant HK, Watt I, et al: A multicenter, double-blind, dose-ranging, randomized, placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis. Radiologic progression and correlation of Genant and Larsen scores. Arthritis Rheum 2000; 43(5):1001-1009.
- Jiang Y, Genant HK, Watt I, et al: A multicenter, double-blind, dose-ranging, randomized, placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis. Radiologic progression and correlation of Genant and Larsen scores. Arthritis Rheum 2000a; 43(5):1001-1009.
- Lebwohl M, Strober B, Menter A, et al. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. NEJM 373(Oct). 2015:1318-1328.
- Zhou H, Jang H, Fleischmann RM, et al. Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis. J Clin Pharmacol. 2007;47(3):383-396.
- Griffiths CEM, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet 2015; 386: 541-51.
- Singh, Jasvinder A, Saag KG, Bridges SL, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis & Rheumatol Jan (68) (2016):1-26.
- Braun, J. von, et al. "2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis." Annals of the rheumatic diseases6 (2011): 896-904.
- Lichtenstein GR, Loftus EV, Isaacs KL, et al. The American College of Gastroenterology Guidelines - Management of Crohn's Disease in Adults. Am J Gastroenterol. 2018; 113: 481-517.
- Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB, 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. Journal of the American Academy of Dermatology5 (2008):826-50.
- Gottlieb, Alice, 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. Journal of the American Academy of Dermatology 58.5 (2008): 851-864.
- Ringold S, Weiss PF, Colbert RA et al. Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment plans New Onset Polyarticular Juvenile Idiopathic Arthritis. Arthritis Care Res (Hoboken). 2014. July; 66(7):1063-72.
- Mahadevan Uma, et al. Inflammatory Bowel Diseases in Pregnancy Clinical Care Pathway: A Report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology. Available at: https://www.gastrojournal.org/article/S0016-5085(18)35437-4/fulltext. Accessed March 1, 2019.
- 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.
- Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Care Res. 2019 Jan;71(1):2-29.
- 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 Rheumatol. 2019 Jun;71(6):846-863.
- Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019 Mar;114(3):384-413.
- Hatemi G, Christensen R, Bang D, et al. 2018 update of the EULAR recommendations for the management of Behçet’s syndrome. Ann Rheum Dis. 2018 Jun;77(6):808-818.
- Blok JL, Li K, Brodmerkel C, Horvatovich P, Jonkman MF, Horvath B. Ustekinumab in hidradenitis suppurativa: clinical results and a search for potential biomarkers in serum. Br J Dermatol 2016; 174 (4): 839–846.
- Feuerstein JD, Ho EY, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology. 2021;160(7):2496-2508.
- Rathod DG. Phototherapy. StatPearls. Available at: https://www.ncbi.nlm.nih.gov/books/NBK563140/. Accessed September 3, 2021.
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Pharmacy policies do not constitute medical advice, nor are they intended to govern physicians' prescribing or the practice of medicine. They are intended to reflect Highmark's coverage and reimbursement guidelines. Coverage may vary for individual members, based on the terms of the benefit contract.
Highmark retains the right to review and update its pharmacy policy at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the pharmacy policies is prohibited; however, limited copying of pharmacy policies is permitted for individual use.
