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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, 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):
None |
| Drugs Products |
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| FDA-Approved Indications: |
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| Background: |
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Table 1. Summary of Preferred Products Given by Oral or Subcutaneous (SC) Administration by Indication
1 Actemra SC will require a trial of Humira first for Polyarticular Juvenile Idiopathic Arthritis (PJIA) indication only. 2 Orencia SC will require a trial of two step 1 (Enbrel, Humira) or step 2 (Actemra) agents. 3 Enbrel will require a trial of Humira for patients > 18 years of age for plaque psoriasis indication only. 4 Cimzia will require a trial of Humira specifically for Crohn’s disease indication only.
I. Actemra (tocilizumab) A. Initial Authorization 1. Rheumatoid Arthritis (RA) When a benefit, coverage of Actemra SC 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 RA. c. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated. 2. Giant Cell Arteritis (GCA) 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. Treatment with at least one (1) systemic corticosteroid (e.g., prednisone) was ineffective or not tolerated, or all corticosteroids are contraindicated. 3. Polyarticular Juvenile Idiopathic Arthritis (PJIA) 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 patient meets one (1) of the following criteria (i., ii., iii., or iv.): i. The patient has tried one other agent for this condition (e.g., methotrexate [MTX], sulfasalazine, leflunomide, or a nonsteroidal anti-inflammatory drug [NSAID]). ii. The patient will be starting on Actemra SC concurrently with methotrexate (MTX), sulfasalazine, or leflunomide. iii. The patient has an absolute contraindication to methotrexate (MTX) [e.g., pregnancy, breast feeding, alcoholic liver disease, immunodeficiency syndrome, blood dyscrasias], sulfasalazine, or leflunomide. iv. 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. Treatment with Humira for the treatment of PJIA was ineffective or not tolerated (see Table 1). 4. Systemic Juvenile Idiopathic Arthritis (SJIA) 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. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Actemra SC may be authorized in quantities as follows:
II. Cimzia (certolizumab) A. Initial Authorization 1. Rheumatoid Arthritis (RA) 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 RA. c. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of RA was ineffective or not tolerated (see Table 1). 2. Ankylosing Spondylitis (AS) 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. Treatment with at least one (1) nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of AS was ineffective or not tolerated (see Table 1). 3. Psoriatic Arthritis (PsA) When a benefit, coverage of Cimzia may be approved for PsA when one (1) of the following criteria is met (a., b., or c.): a. Spinal or axial PsA (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). b. PsA without spinal or axial disease (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). c. Enthesitis and/or dactylitis associated PsA (i., ii., iii., and 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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). 4. Crohn’s Disease (CD) When a benefit, coverage of Cimzia may be approved CD 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 CD. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with at least two immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or immunosuppressants are contraindicated. ii. The member is currently pregnant. d. Treatment with Humira for the treatment of CD was ineffective or not tolerated (see Table 1). 5. Plaque Psoriasis (PsO) 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 PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of PsO was ineffective or not tolerated (see Table 1). 6. Non-radiographic Axial Spondyloarthritis (nr-axSpA) 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. Treatment with at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs) were ineffective or not tolerated, or all NSAIDs are contraindicated. B. Reauthorization When a benefit, reauthorization of Cimzia may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. 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) 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. Treatment with at least one (1) nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated. 2. Psoriatic Arthritis (PsA) When a benefit, coverage of Cosentyx may be approved for PsA when one (1) of the following criterion is met (a., b., or c.): a. Spinal or axial PsA (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. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. b. PsA without spinal or axial disease (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. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA (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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. 3. Plaque Psoriasis (PsO), including Scalp Psoriasis 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 18 years of age or older. b. The member has a diagnosis of PsO. c. One of the following criterion is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. B. Reauthorization When a benefit, reauthorization of Cosentyx may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Cosentyx may be authorized in quantities as follows:
IV. Enbrel (etanercept) A. Initial Authorization 1. Rheumatoid Arthritis (RA) 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 RA. c. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated. 2. Ankylosing Spondylitis (AS) 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. Treatment with at least one (1) nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated. 3. Juvenile Idiopathic Arthritis (JIA) 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 JIA. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine) was ineffective or not tolerated, 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) When a benefit, coverage of Enbrel may be approved for PsA when one of the following criteria is met (a., b., or c.): a. Spinal or axial PsA (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. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. b. PsA without spinal or axial disease (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. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA (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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. 5. Plaque Psoriasis (PsO), adults When a benefit, coverage of Enbrel may be approved for adult 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 PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. d. Treatment with Humira for PsO was ineffective or not tolerated. 6. Plaque Psoriasis (PsO), pediatrics 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 at least 4 years of age or less than 18 years of age. b. The member has a diagnosis of PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. B. Reauthorization When a benefit, reauthorization of Enbrel may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. 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) 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 RA. c. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated. 2. Ankylosing Spondylitis (AS) 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. Treatment with at least one (1) nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated. 3. Juvenile Idiopathic Arthritis (JIA) 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 JIA. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine) was ineffective or not tolerated, 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) When a benefit, coverage of Humira may be approved for PsA when one (1) of the following criteria is met (a., b., or c.): a. Spinal or axial PsA (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. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. b. PsA without spinal or axial disease (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. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA (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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. 5. Plaque Psoriasis (PsO) 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 PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. 6. Crohn’s Disease (CD), adults When a benefit, coverage of Humira 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 CD. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or immunosuppressants are contraindicated. ii. The member is currently pregnant. 7. Crohn’s Disease (CD), pediatrics When a benefit, coverage of Humira may be approved for pediatric CD 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 CD. c. Treatment with at least one immunosuppressant (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or immunosuppressants are contraindicated. 8. Moderate Ulcerative Colitis (UC) When a benefit, coverage of Humira may be approved for moderate 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 UC. c. One (1) of the following criteria is met (i., ii., or iii.): i. Treatment with at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine) was ineffective or not tolerated. ii. The member is currently pregnant. iii. The member requires continuous steroid therapy. 9. Severe Ulcerative Colitis (UC) When a benefit, coverage of Humira may be approved for severe 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 severe UC. c. One (1) of the following criteria is met (i., ii., or iii.): i. Treatment with at least one (1) corticosteroid was ineffective or not tolerated. ii. The member is currently pregnant. iii. The member requires continuous steroid therapy. 10. Hidradenitis Suppurativa (HS) 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 HS. 11. Uveitis (UV) 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. Treatment with at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine) was ineffective or not tolerated, or immunosuppressants are contraindicated. B. Reauthorization When a benefit, reauthorization of Humira may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Humira pre-filled syringes or auto-injectors may be authorized in quantities as follows:
VI. Kevzara (sarilumab) A. Initial Authorization 1. Rheumatoid Arthritis (RA) 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 RA. c. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of RA was ineffective or not tolerated (see Table 1). B. Reauthorization When a benefit, reauthorization of Kevzara may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Kevzara may be authorized in quantities as follows:
VII. Kineret (anakinra) A. Initial Authorization 1. Rheumatoid Arthritis (RA) 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. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of RA was ineffective or not tolerated (see Table 1). 2. Neonatal-Onset Multisystem Inflammatory Disease (NOMID) When a benefit, coverage of Kineret may be approved for NOMID when following criterion is met (a.): a. The member has a diagnosis of NOMID. B. Reauthorization When a benefit, reauthorization of Kineret may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. Dosing In addition, the criteria outlined above, documentation of member weight and prescribed Kineret dose consistent with dosing below is required: . Neonatal-Onset Multisystem Inflammatory Disease a. 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:
VIII. Olumiant (baricitinib) A. Initial Authorization 1. Rheumatoid Arthritis (RA) 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 RA. c. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated. d. Treatment with at least one (1) tumor necrosis factor (TNF) antagonist therapy, including Humira, Enbrel, Simponi, and Cimzia, was ineffective or not tolerated. e. Treatment with at least two (2) preferred biologic products for the treatment of RA was ineffective or not tolerated (see Table 1). i. If the member has tried and failed Humira and Enbrel, the member will not need to try and fail any additional preferred biologic products. ii. If the member has tried and failed either Humira or Enbrel, the member will need to try and fail one additional preferred biologic product. B. Reauthorization When a benefit, reauthorization of Olumiant may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided.
IX. Orencia (abatacept) A. Initial Authorization 1. Rheumatoid Arthritis (RA) 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 RA. c. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of RA was ineffective or not tolerated (see Table 1). 2. Juvenile Idiopathic Arthritis (JIA) When a benefit, coverage of Orencia SC may be approved for juvenile idiopathic arthritis (JIA) when all of the following criteria are met (a., b., and c.): a. Orencia SC is to be used for the treatment of juvenile idiopathic arthritis in patients ≥ 2 years of age. b. One (1) of the following criteria is met (i. or ii.): i. Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine) was ineffective or not tolerated, 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. c. Treatment with two step 1 (Enbrel, Humira) or step 2 (Actemra) agents for the treatment of juvenile idiopathic arthritis (JIA) was ineffective or not tolerated (see Table 1) 3. Psoriatic Arthritis (PsA) When a benefit, coverage of Orencia SC may be approved for PsA when one (1) of the following criteria is met (a., b., or c.): a. Spinal or axial PsA (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). b. PsA without spinal or axial disease (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). c. Enthesitis and/or dactylitis associated PsA (i., ii., iii., and 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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). B. Reauthorization When a benefit, reauthorization of Orencia SC may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Orencia SC may be authorized in quantities as follows:
X. Otezla (apremilast) A. Initial Authorization 1. Psoriatic Arthritis (PsA) When a benefit, coverage of Otezla may be approved for PsA when one (1) of the following criteria is met (a., b., or c.): a. Spinal or axial PsA (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. iv. Treatment with at least one (1) preferred biologic product for the treatment of PsA was ineffective or not tolerated (see Table 1). b. PsA without spinal or axial disease (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. iv. Treatment with at least one (1) preferred biologic product for the treatment of PsA was ineffective or not tolerated (see Table 1). c. Enthesitis and/or dactylitis associated PsA (i., ii., iii., and 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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. iv. Treatment with at least one (1) preferred biologic product for the treatment of PsA was ineffective or not tolerated (see Table 1). 2. Plaque Psoriasis (PsO) 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 PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. 3. Oral Ulcers associated with Behçet’s Disease 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., b., and c.): 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. One (1) of the following criteria is met (i. or ii.): i. Treatment with at least one (1) topical corticosteroid product was ineffective or not tolerated for acute flare-up of oral ulcers. ii. Treatment with colchicine was ineffective or not tolerated 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. Clinical documentation of disease stability or improvement must be provided.
XI. Rinvoq (upadacitinib) A. Initial Authorization 1. Rheumatoid Arthritis (RA) 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 RA. c. The member has experienced therapeutic failure, intolerance or contraindication to methotrexate. B. Reauthorization When a benefit, reauthorization of Rinvoq may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided.
XII. Siliq (brodalumab) A. Initial Authorization 1. Plaque Psoriasis (PsO) 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 PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of PsO was ineffective or not tolerated (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 PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of PsO was ineffective or not tolerated (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. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Siliq may be authorized in quantities as follows:
XIII. Simponi (golimumab) A. Initial Authorization 1. Rheumatoid Arthritis (RA) When a benefit, coverage of Simponi SC 50 mg 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. Treatment with at least one non-biologic DMARD as monotherapy (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of RA was ineffective or not tolerated (see Table 1). 2. Ankylosing Spondylitis (AS) When a benefit, coverage of Simponi SC 50 mg 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. Treatment with at least one (1) nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of AS was ineffective or not tolerated (see Table 1). 3. Psoriatic Arthritis (PsA) When a benefit, coverage of Simponi SC 50 mg may be approved for PsA when one of the following criteria is met (a., b., or c.): a. Spinal or axial PsA (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). b. PsA without spinal or axial disease (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). c. Enthesitis and/or dactylitis associated PsA (i., ii., iii., and 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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). 4. Moderate Ulcerative Colitis (UC) When a benefit, coverage of Simponi SC may be approved for moderate UC 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 UC. c. One (1) of the following criteria is met (i., ii., or iii.): i. Treatment with at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine) was ineffective or not tolerated. ii. The member requires continuous steroid therapy. iii. The member is currently pregnant. d. Treatment with preferred biologic product (Humira) for the treatment of UC was ineffective or not tolerated (see Table 1). 5. Severe Ulcerative Colitis (UC) When a benefit, coverage of Simponi SC may be approved for severe UC 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 UC. c. One (1) of the following criteria is met (i., ii., or iii.): i. Treatment with at least one (1) corticosteroid was ineffective or not tolerated. ii. The member requires continuous steroid therapy. iii. The member is currently pregnant. d. Treatment with preferred biologic product (Humira) for the treatment of ulcerative colitis was ineffective or not tolerated (see Table 1). B. Reauthorization When a benefit, reauthorization of Simponi SC may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Simponi SC may be authorized in quantities as follows:
XIV. Skyrizi (risankizumab) A. Initial Authorization 1. Plaque Psoriasis (PsO) 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 PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. B. Reauthorization When a benefit, reauthorization of Skyrizi may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Skyrizi may be authorized in quantities as follows:0
XV. Stelara (ustekinumab) A. Initial Authorization 1. Psoriatic Arthritis (PsA) When a benefit, coverage of Stelara may be approved for PsA when one of the following criteria is met (a., b., or c.): a. Spinal or axial PsA (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. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. b. PsA without spinal or axial disease (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. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA (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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. 2. Plaque Psoriasis (PsO) 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 12 years of age or older. b. The member has a diagnosis of PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. 3. Crohn’s Disease (CD) Patients Initiating Therapy with Stelara SC When a benefit, coverage of Stelara may be approved for adult CD 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 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. d. One (1) of the following criteria is met (i., ii., or iii.): i. The member is currently pregnant. ii. Treatment with at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or immunosuppressants are contraindicated. iii. According to prescribing physician, the patient has experienced a previous intolerance to a TNF inhibitor or the patient has a relative contraindication to the use of a TNF inhibitor due to one (1) of the following (1. or 2.): 1. Demyelinating disease 2. Heart failure Patients Currently Taking Stelara SC 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 CD. c. Prescription claims history indicates at least a 90 day-supply was dispensed within the past 130 days (Eligible claims includes at least one paid claim that has not been reversed within the 130 day time period). i. NOTE: If prescription claims history is not available (e.g., patient is new to plan), provider attests that patient has been established on Stelara SC for at least 90 days. 4. Ulcerative Colitis (UC) Patients Initiating Therapy with Stelara SC When a benefit, coverage of Stelara may be approved for adult UC 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 UC. c. One (1) of the following criteria is met (i. or ii.): i. The member has tried Humira. Note: A trial of an infliximab product (e.g., Remicade, Inflectra, Renflexis) or Simponi SC also counts. ii. The member has already received a single induction dose with Stelara IV. d. One (1) of the following criteria is met (i. through iv.): i. The member is currently pregnant. ii. Treatment with at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or immunosuppressants are contraindicated. iii. According to prescribing physician, the patient has experienced a previous intolerance to a TNF inhibitor or the patient has a relative contraindication to the use of a TNF inhibitor due to one (1) of the following (1. or 2.): 1) Demyelinating disease 2) Heart failure Patients Currently Taking Stelara SC When a benefit, coverage of Stelara may be approved for adult 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 UC. c. One (1) of the following criteria is met (i., ii., or iii.): i. Prescription claims history indicates at least a 90 day-supply was dispensed within the past 130 days (Eligible claims includes at least one paid claim that has not been reversed within the 130 day time period). a. NOTE: If prescription claims history is not available (e.g., patient is new to plan), provider attests that patient has been established on Stelara SC for at least 90 days. ii. The member has tried Humira. Note: A trial of an infliximab product (e.g., Remicade, Inflectra, Renflexis) or Simponi SC also counts. iii. The member has already received a single induction dose with Stelara IV.
B. Reauthorization When a benefit, reauthorization of Stelara may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. Dosing In addition, the criteria outlined above, documentation of member weight and prescribed Stelara dose consistent with dosing below is required: • Psoriasis (Adult) a. For patients weighing ≤100 kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. b. For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. • Psoriasis (Adolescent 12 years and older) a. For patients weighing <60 kg (132 lbs), the recommended dose is 0.75 mg/kg initially and 4 weeks later, followed by 0.75 mg/kg every 12 weeks. b. For patients weighing 60 to 100 kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. c. For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. • Psoriatic Arthritis a. The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks For patients with co-existent moderate-to-severe plaque psoriasis weighing >100 kg (220 lbs), the recommended dose is 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
XVI. Taltz (ixekizumab) A. Initial Authorization 1. Psoriatic Arthritis (PsA) When a benefit, coverage of Taltz may be approved for PsA when one of the following criteria are met (a., b., or c.): a. Spinal or axial PsA (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of spinal or axial PsA. iii. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). b. PsA without spinal or axial disease (i., ii., iii., and iv.): i. The member is 18 years of age or older. ii. The member has a diagnosis of PsA without spinal disease. iii. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). c. Enthesitis and/or dactylitis associated PsA (i., ii., iii., and 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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. iv. Treatment with at least two (2) preferred biologic products for the treatment of PsA was ineffective or not tolerated (see Table 1). 2. Plaque Psoriasis (PsO) 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 18 years of age or older. b. The member has a diagnosis of PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. d. Treatment with at least three (3) preferred biologic products for the treatment of PsO was ineffective or not tolerated (see Table 1). 3. Ankylosing Spondylitis (AS) 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. Treatment with at least one (1) nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated. d. Treatment with at least two (2) preferred biologic products for the treatment of AS was ineffective or not tolerated (see Table 1). B. Reauthorization When a benefit, reauthorization of Taltz may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Taltz may be authorized in quantities as follows:
XVII. Tremfya (guselkumab) A. Initial Authorization 1. Plaque Psoriasis (PsO) 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 PsO. c. One (1) of the following criteria is met (i. or ii.): i. Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated. ii. Treatment with at least one (1) systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. B. Reauthorization When a benefit, reauthorization of Tremfya may be approved when the following criterion is met (1.): 1. Clinical documentation of disease stability or improvement must be provided. C. Quantity Limitations When prior authorization is approved, Tremfya may be authorized in quantities as follows:
XVIII. Xeljanz (tofacitinib) A. Initial Authorization 1. Rheumatoid Arthritis (RA) 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 RA. c. Treatment with methotrexate was ineffective or not tolerated. 2. Psoriatic Arthritis (PsA) When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for PsA when one (1) of the following criteria are met (a., b., or c.): a. Spinal or axial PsA (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. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated. b. PsA without spinal or axial disease (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. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. c. Enthesitis and/or dactylitis associated PsA (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. When treatment with (1. or 2.): 1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated. 2. All NSAIDs and all local glucocorticoid injections are contraindicated. 3. Moderate Ulcerative Colitis (UC) When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for moderate UC 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 UC. c. The dose requested is not greater than 20 mg per day. d. One (1) of the following criteria is met (i. or ii.): i. Treatment with at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine) was ineffective or not tolerated. ii. The member is currently pregnant. e. Treatment with preferred biologic product (Humira) for the treatment of UC was ineffective or not tolerated (see Table 1). 4. Severe Ulcerative Colitis (UC) When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for severe UC 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 severe UC. c. The dose requested is not greater than 20 mg per day. d. One (1) of the following criteria is met (i. or ii.): i. Treatment with at least one (1) corticosteroid was ineffective or not tolerated. ii. The member is currently pregnant. e. Treatment with preferred biologic product (Humira) for the treatment of UC was ineffective or not tolerated (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. Clinical documentation of disease stability or improvement must be provided.
XIX. 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 nonbiologic agent.
XX. For Commercial and HCR members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made based on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform. |
| Limitations of Coverage |
|---|
|
I. For Commercial and HCR members, coverage of a Chronic Inflammatory Disease (CID) medication for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions. 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. |
| Authorization Duration |
|---|
|
Initial Authorization
Reauthorization
|
| Automatic Approval Criteria |
|---|
|
None
|
| Version: J-0558-014 |
| Effective Date Begin: 02/05/2020 |
| Effective End Begin: 06/15/2020 |
| Original Date: 07/15/2017 |
| Review Date: 01/29/2020 |
References:
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- Cimzia [package insert]. Smyrna, GA: UCB, Inc.; March 2019.
- Cosentyx [package insert]. East Hanover, NJ: Novartis; January 2018.
- Enbrel [package insert]. Thousand Oaks, CA: Immunex Corporation; October 2018.
- Humira [package insert]. North Chicago, IL: AbbVie, Inc.; October 2018.
- Kevzara [package insert]. Bridgewater, NJ and Tarrytown, NY: Sanofi-Aventis and Regeneron; April 2018.
- Kineret [package insert]. Waltham, MA: SOBI, Inc. (Swedish Orphan Biovitrum); June 2018.
- Olumiant [package insert]. Indianapolis, IN: Eli Lilly; May 2018.
- Orencia [package insert]. Princeton, NJ: Bristol-Myers Squibb; June 2017.
- Otezla [package insert]. Summit, NJ: Celgene Corporation; July 2019.
- Rinvoq [package insert] North Chicago, IL: Abbvie, Inc.; August 2019.
- Siliq [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals International; February 2017.
- Simponi [package insert]. Horsham, PA: Janssen; March 2018.
- Skyrizi [package insert]. North Chicago, IL: AbbVie, Inc.; April 2019.
- Stelara [package insert]. Horsham, PA: Janssen; November 2019.
- Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; August 2019.
- Tremfya [package insert]. Horsham, PA: Janssen; July 2017.
- Xeljanz [package insert]. New York, NY: Pfizer, Inc.; July 2019.
- Xeljanz XR [package insert]. New York, NY: Pfizer, Inc.; December 2019.
- 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.
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- 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.
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- 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.
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- 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.
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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.
