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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.):
Quantity Limits (1., 2., 3., or 4.):
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. 3 Directed specifically to Enbrel or Humira.
I. Actemra (tocilizumab)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Actemra SC may be approved 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 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 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 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 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 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, excluding M45.A) When a benefit, coverage of Cimzia may be approved 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 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 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 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 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, excluding L40.5) When a benefit, coverage of Cimzia may be approved 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). 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: M45.A) When a benefit, coverage of Cimzia may be approved 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 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: L40.5) a. Spinal or axial PsA When a benefit, coverage of Cosentyx may be approved when all of the following criteria are met (i., ii., and iii.): i. The member is 2 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 when all of the following criteria are met (i., ii., and iii.): i. The member is 2 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 when all of the following criteria are met (i., ii., and iii.): i. The member is 2 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, excluding L40.5) When a benefit, coverage of Cosentyx may be approved 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). iii. The member is contraindicated to both phototherapy and systemic therapy.
4. Non-radiographic Axial Spondyloarthritis (nr-axSpA) (ICD-10: M45.A) When a benefit, coverage of Cosentyx may be approved 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.
5. Enthesitis-Related Arthritis (ERA) (ICD-10: M08.80) When a benefit, coverage of Cosentyx may be approved when all of the following criteria are met (a., b., and c.): a. The member is 4 years of age or older. b. The member has a diagnosis of active ERA. 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.
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 or PsA 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, PsA, or ERA (≥ 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. †† For adult PsA patients with coexistent moderate to severe PsO, use the dosing for adult PsO.
IV. Enbrel (etanercept)
A. Initial Authorization 1. Rheumatoid Arthritis (RA) (ICD-10: M05, M06) When a benefit, coverage of Enbrel may be approved 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, excluding M45.A) When a benefit, coverage of Enbrel may be approved 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 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 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 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 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, excluding L40.5) When a benefit, coverage of Enbrel may be approved 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). iii. The member is contraindicated to both phototherapy and systemic therapy
6. Plaque Psoriasis (PsO), pediatrics (ICD-10: L40, excluding L40.5) When a benefit, coverage of Enbrel may be approved 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). 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 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, excluding M45.A) When a benefit, coverage of Humira may be approved 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 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 Humira may be approved 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 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 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, excluding L40.5) When a benefit, coverage of Humira may be approved 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). iii. The member is contraindicated to both phototherapy and systemic therapy.
6. Crohn’s Disease (CD) (ICD-10: K50) When a benefit, coverage of Humira may be approved 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 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 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 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 prefilled syringes, pens, or auto-injectors may be authorized in quantities as follows:
N/A=not applicable
*Patients diagnosed with rheumatoid arthritis (without concurrent methotrexate therapy) or hidradenitis suppurativa may receive weekly dosing of Humira prefilled syringes. Patient Level Authorization (PLA) input – Retail: 4 syringes; Mail: 12 syringes ** Continuation of pediatric UC dosing in patients who turn 18 years of age may be approved when documentation of stability or beneficial response to therapy. Coding of quantity level limitations is at the maintenance therapy threshold except for RA, HS, and pediatric UC weekly dosing administration. †Four (4) prefilled syringes every four (4) weeks may be approved when there is clinical documentation that treatment with two (2) prefilled syringes every four (4) weeks was ineffective. †† Only Humira 20 mg prefilled syringe may be approved for every week dosing. Humira starter packs have a quantity limit of 1 kit per 274 days but can be billed as a quantity/dispensing size of 2, 3, 4, or 6 pens or syringes depending on indication. VI. Ilumya (tildrakizumab-asmn) A. Initial Authorization 1. Plaque Psoriasis (PsO) (ICD-10: L40, excluding L40.5) When a benefit, coverage of Ilumya may be approved 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). 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 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 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: M04.2) When a benefit, coverage of Kineret may be approved 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 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 initial authorization and reauthorization criteria outlined above, documentation that member weight and prescribed Kineret dose is consistent with dosing below: *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 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 severely active 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. 2. Alopecia Areata (AA) (ICD-10: L63) When a benefit, coverage of Olumiant may be approved 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 severe AA defined as ≥ 50% scalp hair loss. c. The member has a current episode of AA lasting for ≥ 6 months without spontaneous re-growth. d. The member has experienced therapeutic failure or intolerance to one (1) of the following, or contraindication to all (i. or ii.): i. Systemic therapy (e.g., corticosteroid, methotrexate, cyclosporine) ii. High potency topical corticosteroid (e.g., clobetasol propionate, betamethasone dipropionate)
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 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 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, cyclosporine), 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 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 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 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 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 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 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, excluding L40.5) When a benefit, coverage of Otezla may be approved 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 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). iii. The member is contraindicated to both phototherapy and systemic therapy.
3. Oral Ulcers associated with Behçet’s Disease (ICD-10: M35.2) 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 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 severely active RA. c. The member has experienced therapeutic failure, contraindication, or intolerance to methotrexate. d. The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of RA (see Table 1).
2. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Rinvoq may be approved 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 plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1). b. PsA without spinal or axial disease When a benefit, coverage of Rinvoq may be approved 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 plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1). c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Rinvoq may be approved 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 plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1). 3. Atopic Dermatitis When a benefit, coverage of Rinvoq may be approved when all of the following criteria are met (a. through d.): a. The member is 12 years of age or older. b. A specialist (dermatologist, allergist, or immunologist) submits attestation that the member has a diagnosis of atopic dermatitis (ICD-10: L20) classified as all of the following (i. and ii.): i. Moderate-to-severe ii. Refractory c. The member meets one (1) of the following criteria (i. or ii.): i. The member has experienced therapeutic failure or intolerance to one (1) of the following (A) or B)): A) One (1) generic topical corticosteroid B) One (1) generic topical calcineurin inhibitor (i.e., tacrolimus, pimecrolimus) ii. The prescriber submits documentation that the member has severe atopic dermatitis and topical therapy would not be advisable for maintenance therapy as evidenced by one (1) of the following (A) or B)): A) The member is incapable of applying topical therapies due to the extent of body surface area (BSA) involvement. B) Topical therapies are contraindicated due to severely damaged skin. d. The member has experienced therapeutic failure or intolerance to one (1) systemic therapy for atopic dermatitis, or all systemic therapies are contraindicated. 4. Ulcerative Colitis (UC) (ICD-10: K51) When a benefit, coverage of Rinvoq may be approved when all of the following criteria are met (a., b., and c.): i 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).
5. Ankylosing Spondylitis (AS) (ICD-10: M45, excluding M45.A) When a benefit, coverage of Rinvoq may be approved 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 plan-preferred Humira or Enbrel for the treatment of AS (see Table 1).
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, excluding L40.5) When a benefit, initiation of Siliq may be approved 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). 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 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 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 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, excluding M45.A) When a benefit, coverage of Simponi SC may be approved 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 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 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 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 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 SC (risankizumab)
A. Initial Authorization 1. Plaque Psoriasis (PsO) (ICD-10: L40.0-L40.4; L40.8-L40.9) When a benefit, coverage of Skyrizi SC pen/syringe may be approved 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). iii. The member is contraindicated to both phototherapy and systemic therapy. 2. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Skyrizi SC pen/syringe may be approved 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 Skyrizi SC pen/syringe may be approved 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 Skyrizi SC pen/syringe may be approved 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. Crohn’s Disease (CD) (ICD-10: K50) When a benefit, coverage of Skyrizi SC cartridge with on-body injector may be approved 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 three (3) induction doses of Skyrizi IV within 3 months of initiating therapy with Skyrizi SC cartridge with on-body injector and meets the following criterion (i.): i. The member achieved clinical response or remission.
B. Reauthorization When a benefit, reauthorization of Skyrizi 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, Skyrizi SC may be authorized in quantities as follows:
N/A=Not Applicable
XVI. Stelara SC (ustekinumab)
A. Initial Authorization 1. Psoriatic Arthritis (PsA) (ICD-10: L40.5) a. Spinal or axial PsA When a benefit, coverage of Stelara SC may be approved 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 SC may be approved 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 SC may be approved 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, excluding L40.5) When a benefit, coverage of Stelara SC may be approved 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). 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 SC may be approved 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 meets the following criterion (i.): i. The member achieved clinical response or remission.
4. Ulcerative Colitis (UC) (ICD-10: K51) When a benefit, coverage of Stelara SC may be approved 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 meets the following criterion (i.): i. The member achieved clinical response or remission.
B. Reauthorization When a benefit, reauthorization of Stelara 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.
Dosing In addition to the initial authorization and reauthorization criteria outlined above, documentation that member weight and prescribed Stelara dose is consistent with dosing below: · 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
*Patients diagnosed with Crohn’s disease or ulcerative colitis may receive every 8-week dosing of Stelara. Patient Level Authorization (PLA) input - One (1) prefilled syringe per 42 days.
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 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 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 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, excluding L40.5) When a benefit, coverage of Taltz may be approved 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). 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, excluding M45.A) When a benefit, coverage of Taltz may be approved 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: M45.A) When a benefit, coverage of Taltz may be approved 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 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 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 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, excluding L40.5) When a benefit, coverage of Tremfya may be approved 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). 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 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 severely active RA. c. The member has experienced therapeutic failure, contraindication, or intolerance to methotrexate. d. The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of RA (see Table 1).
2. Juvenile Idiopathic Arthritis (JIA) (ICD-10: M08.9) When a benefit, coverage of Xeljanz tablet or Xeljanz oral solution may be approved 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 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. d. The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel 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 Xeljanz or Xeljanz XR may be approved 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 plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1). b. PsA without spinal or axial disease When a benefit, coverage of Xeljanz or Xeljanz XR may be approved 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 plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1). c. Enthesitis and/or dactylitis associated PsA When a benefit, coverage of Xeljanz or Xeljanz XR may be approved 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 plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1).
4. Ulcerative Colitis (UC) (ICD-10: K51) When a benefit, coverage of Xeljanz or Xeljanz XR may be approved 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).
5. Ankylosing Spondylitis (AS) (ICD-10: M45, excluding M45.A) When a benefit, coverage of Xeljanz or Xeljanz XR may be approved 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 plan-preferred Humira or Enbrel for the treatment of AS (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. Olumiant for treatment of COVID-19 in hospitalized patients will not be approved under the pharmacy benefit. II. Coverage of drug(s) 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. III. For Commercial or 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. |
| Authorization Duration |
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| Automatic Approval Criteria |
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None
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| Version: J-0558-035 |
| Effective Date Begin: 08/16/2022 |
| Effective End Begin: |
| Original Date: 07/15/2017 |
| Review Date: 08/03/2022 |
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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.
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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.
