Biologic Immunomodulators - Enhanced and Essential

Restricted Product(s)

Restriction applies to brand, biosimilar, and generic products

• Actemra® (tocilizumab) 
• Actemra ACTPEN® (tocilizumab)
• Bimzelx® (bimekizumab-bkzx)
• Cibinqo® (abrocitinib)
• Cimzia® (certolizumab)
• Cosentyx® (secukinumab)
• Ebglyss™ (lebrikizumab-lbkz)
• Ebglyss™ (lebrikizumab-lbkz)
• Enbrel® (etanercept) 
• Entyvio® (vedolizumab)
• Kevzara® (sarilumab) 
• Kineret® (anakinra) 
• Olumiant® (baricitinib) 
• Omvoh™ (mirikizumab-mrkz)
• Orencia® (abatacept)
• Rinvoq® (upadacitinib)
• Rinvoq® LQ (upadacitinib) 
• Siliq® (brodalumab) 
• Simponi® (golimumab)
• Skyrizi™ (risankizumab-rzaa) 
• Sotyktu™ (deucravacitinib) 
• Spevigo® (Spesolimab-sbzo) 
• Stelara® (ustekinumab) 
• Taltz® (ixekizumab) 
• Tremfya® (guselkumab) 
• Tyenne® (tocilizumab-aazg) 
• Velsipity™ (etrasimod) 
• Xeljanz® (tofacitinib) 
• Xeljanz XR® (tofacitinib er) 
• Zymfentra™ (infliximab-dyyb)

Adalimumab Products (Preferred products are bolded):

• Abrilada™ (adalimumab-afzb)
• Amjevita™ (adalimumab-atto) 
• Cyltezo® (adalimumab-adbm) 
• Hadlima® (adalimumab-bwwd)
• Hulio® (adalimumab-fkjp) 
• Hyrimoz® (adalimumab-adaz) 
• Humira® (adalimumab) 
• Idacio® (adalimumab-aacf) 
• Simlandi® (adalimumab-ryvk) 
• Yusimry™ (adalimumab-aqvh) 
• Yuflyma™ (adalimumab-aaty)

FDA Approved Use or Indication Supported in Compendia

• Actemra and biosimilars including: Tyenne (tocilizumab-aazg)
  • For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease Modifying Anti-Rheumatic Drugs (DMARDs) 
  • For the treatment of adult patients with giant cell arteritis 
  • For the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA)
  • For the treatment of patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA)
  • For slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) 
• Bimzelx
  • For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or photo therapy
  • For the treatment of adults with active psoriatic arthritis (PsA) 
  • For the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation
  • For the treatment of adults with active ankylosing spondylitis (AS). 
• Cibinqo
  • For the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable 
• Cimzia
  • For reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease that have had an inadequate response to conventional therapy
  • For the treatment of adult patients with moderately to severely active rheumatoid arthritis
  • For the treatment of adult patients with active psoriatic arthritis
  • For the treatment of adult patients with active ankylosing spondylitis
  • For the treatment of adult patients with moderate-to-severe plaque psoriasis
  • For the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation 
  • For the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
• Cosentyx
  • For the treatment of patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy
  • For the treatment of patients 2 years of age and older with active psoriatic arthritis (PsA)
  • For the treatment of adult patients with active ankylosing spondylitis (AS)
  • For the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation
  • For the treatment of patients 4 years of age and older with active enthesitis-related arthritis (ERA)
  • For the treatment of adults with moderate to severe hidradenitis suppurativa (HS)
• Ebglyss
  • For the treatment of adults and pediatric patients 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
• Enbrel
  • For the treatment of adult patients with moderately to severely active rheumatoid arthritis
  • For the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis
  • For the treatment of adult patients with psoriatic arthritis
  • For the treatment of patients 2 years of age and older with juvenile psoriatic arthritis (JPsA) 
  • For the treatment of adult patients with active ankylosing spondylitis 
  • For the treatment of patients 4 years of age and older with chronic moderate to severe plaque psoriasis
• Entyvio
  • For the treatment of adult patients with moderately to severely active ulcerative colitis
• Humira and biosimilars including; Abrilada, Amjevita, Cyltezo (adalimumab-adbm), Hadlima, Hulio (adalimumab-fkjp), Hyrimoz (adalimumabadaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yusimry, Yuflyma (adalimumab-aaty)
  • For reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis
  • For reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older 
  • For reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis 
  • For reducing signs and symptoms in adult patients with active ankylosing spondylitis 
  • For the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate 
  • For the treatment of patients 6 years of age and older with moderately to severely active Crohn’s disease 
  • For the treatment of patients 5 years of age and older with moderately to severely active ulcerative colitis. The effectiveness of adalimumab has not been established in patients who have lost response to or were intolerant to TNF blockers
  • For the treatment of patients 12 years of age and older with moderate to severe hidradenitis suppurativa
  • For the treatment of patients 2 years of age and older with non-infectious intermediate uveitis, posterior uveitis, and panuveitis 
• Kevzara
  • For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs) 
  • For the treatment of adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper 
  • For the treatment of active polyarticular juvenile idiopathic arthritis in patients who weigh at least 63 kg.
• Kineret
  • For the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDs) 
  • For the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) 
  • For the treatment of deficiency of Interleukin-1 Receptor Antagonist (DIRA) 
• Olumiant
  • For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies 
  • For the treatment of adult patients with severe alopecia areata
• Omvoh
  • For the treatment of moderately to severely active ulcerative colitis in adults 
• Orencia
  • For the treatment of adults with moderately to severely active rheumatoid arthritis in adults 
  • For the treatment of patients 2 years of age and older with active psoriatic arthritis 
  • For the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis
• Rinvoq
  • For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF antagonist therapies
  • For the treatment of adult patients and pediatric patients ≥2 years of age with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF antagonist therapies
  • For the treatment of patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable
  • For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF antagonist therapies
  • For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF antagonist therapies
  • For the treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
  • For the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.
  • For the treatment of active polyarticular juvenile idiopathic arthritis in patients ≥2 years of age who have had an inadequate response or intolerance to one or more TNF blockers.
• Siliq
  • For the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies 
• Simponi
  • For the treatment of adult patients with moderately to severely active rheumatoid arthritis in combination with methotrexate 
  • For the treatment of adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate
  • For the treatment of adult patients with active ankylosing spondylitis 
  • For the treatment of adult patients with Moderate to severe Ulcerative colitis with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy
    • Inducing and maintaining clinical response 
    • Improving endoscopic appearance of the mucosa during induction 
    • Inducing clinical remission 
    • Achieving and sustaining clinical remission in induction responders 
• Skyrizi 
  • For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
  • For the treatment of adult patients with active psoriatic arthritis
  • For the treatment of adult patients with moderately to severely active Crohn’s disease
  • For the treatment of moderately to severely active ulcerative colitis in adults
• Sotyktu
  • For the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy 
• Spevigo
  • For treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg 
• Stelara
  • For the treatment of patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy 
  • For the treatment of patients 6 years of age and older with active psoriatic arthritis
  • For the treatment of adult patients with moderately to severely active Crohn’s disease
  • For the treatment of adult patients with moderately to severely active ulcerative colitis 
• Taltz
  • For the treatment of patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy
  • For the treatment of adult patients with active psoriatic arthritis 
  • For the treatment of adult patients with active ankylosing spondylitis 
  • For the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation 
• Tremfya
  • For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy 
  • For the treatment of adult patients with active psoriatic arthritis 
  • For the treatment of adults with moderately to severely active ulcerative colitis
• Velsipity
  • For the treatment of moderately to severely active ulcerative colitis in adults 
• Xeljanz/Xeljanz XR
  • For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers
  • For the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers 
  • For the treatment of adult patients with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers 
  • For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers 
  • For the treatment of patients 2 years of age and older with active polyarticular course juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers 
• Zymfentra
  • For the treatment of adult patients with moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.
  • For the treatment of adult patients with moderately to severely active Crohn’s disease following treatment with an infliximab product administered intravenously.

Criteria for Approval of Restricted Product(s)

Initial Coverage Continued

1. The patient has a diagnosis of moderately to severely active rheumatoid arthritis (RA); AND
   1. The patient has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) for at least 3-months (medical record documentation required); OR
   2. The patient has tried and had an inadequate response to another conventional agent (i.e., hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA for at least 3-months (medical record documentation required); OR 
   3. The patient has an intolerance or hypersensitivity to ONE of the following conventional agents (i.e., maximally tolerated methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA (medical record documentation required); OR
   4. The patient has an FDA labeled contraindication to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA (medical record documentation required); AND 
   5. If the request is for Simponi:
      1. The patient will be taking the requested agent in combination with methotrexate; OR
      2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate (medical record documentation required); OR
2. The patient has a diagnosis of active psoriatic arthritis (PsA); AND
   1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months (medical record documentation required); OR 
   2. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA (medical record documentation required); OR
   3. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA (medical record documentation required); OR
   4. The patient has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) (medical record documentation required); OR
   5. The patient has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) (medical record documentation required); OR
3. The patient has a diagnosis of moderate to severe plaque psoriasis (PS); AND
   1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months (medical record documentation required); OR
   2. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PS (medical record documentation required); OR
   3. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS (medical record documentation required); OR
   4. The patient has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) (medical record documentation required); OR
   5. The patient has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) (medical record documentation required); OR
4. The patient has a diagnosis of moderately to severely active Crohn’s disease (CD); AND
   1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate) used in the treatment of CD for at least 3-months (medical record documentation required); OR
   2. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of CD (medical record documentation required); OR
   3. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of CD (medical record documentation required); AND
   4. If the request is for Stelara, the patient will NOT be treated with the 45mg injection; AND
   5. If the request is for Zymfentra, the patient was previously treated with an infliximab product administered intravenously; OR
5. The patient has a diagnosis of moderately to severely active ulcerative colitis (UC); AND
   1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in the treatment of UC for at least 3-months (medical record documentation required); OR
   2. The patient has severely active ulcerative colitis (medical record documentation required); OR
   3. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC (medical record documentation required); OR
   4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC (medical record documentation required); AND
   5. If the request is for Stelara, the patient will NOT be treated with the 45mg injection; AND
   6. If the request is for Zymfentra, the patient was previously treated with an infliximab product administered intravenously; OR
6. The patient has a diagnosis of non-infectious intermediate uveitis, posterior uveitis, or panuveitis; AND
   1. The patient has tried and had an inadequate response to oral corticosteroids used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis for a minimum of 2 weeks (medical record documentation required); OR
   2. The patient has tried and had an inadequate response to periocular or intravitreal corticosteroid injections in the treatment of noninfectious intermediate uveitis, posterior uveitis, or panuveitis (medical record documentation required); OR 
   3. The patient has an intolerance or hypersensitivity to oral corticosteroids OR periocular/intravitreal corticosteroid injections used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis (medical record documentation required); OR 
   4. The patient has an FDA labeled contraindication to BOTH oral corticosteroids and periocular/intravitreal corticosteroids (medical record documentation required); AND
   5. ONE of the following:
      1. The patient has tried and had an inadequate response to ONE conventional systemic agent (i.e., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus) used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis for at least 3-months (medical record documentation required); OR 
      2. The patient has an intolerance or hypersensitivity to ONE conventional systemic agent used in the treatment of noninfectious intermediate uveitis, posterior uveitis, or panuveitis (medical record documentation required); OR 
      3. The patient has an FDA labeled contraindication to ALL conventional systemic agents used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis (medical record documentation required); OR
7. The patient has a diagnosis of giant cell arteritis (GCA); AND
   1. The patient has tried and had an inadequate response to systemic corticosteroids (e.g., prednisone, methylprednisolone) used in the treatment of GCA for at least 7-10 days (medical record documentation required); OR
   2. The patient has an intolerance or hypersensitivity to systemic corticosteroids used in the treatment of GCA (medical record documentation required); OR
   3. The patient has an FDA labeled contraindication to ALL systemic corticosteroids (medical record documentation required); OR
8. The patient has a diagnosis of active ankylosing spondylitis (AS); AND
   1. The patient has tried and had an inadequate response to two different NSAIDs used in the treatment of AS for at least a 4-week total trial (medical record documentation required); OR 
   2. The patient has an intolerance or hypersensitivity to two different NSAIDs used in the treatment of AS (medical record documentation required); OR
   3. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of AS (medical record documentation required); OR
9. The patient has a diagnosis of active non-radiographic axial spondyloarthritis (nr-axSpA); AND
   1. The patient has tried and had an inadequate response to two different NSAIDs used in the treatment of nr-axSpA for at least a 4- week total trial (medical record documentation required); OR
   2. The patient has an intolerance or hypersensitivity to two different NSAIDs used in the treatment of nr-axSpA (medical record documentation required); OR
   3. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of nr-axSpA (medical record documentation required); OR
10. The patient has a diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA); AND
    1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., methotrexate, leflunomide) used in the treatment of PJIA for at least 3-months (medical record documentation required); OR
    2. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PJIA (medical record documentation required); OR
    3. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PJIA (medical record documentation required); OR
11. The patient has a diagnosis of active systemic juvenile idiopathic arthritis (SJIA); AND
    1. The patient has tried and had an inadequate response to at least ONE NSAID (e.g., ibuprofen, celecoxib) used in the treatment of SJIA for at least 1-month (medical record documentation required); OR
    2. The patient has an intolerance or hypersensitivity to NSAIDs used in the treatment of SJIA (medical record documentation required); OR
    3. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of SJIA (medical record documentation required); OR
    4. The patient has tried and had an inadequate response to another conventional agent (i.e., methotrexate, leflunomide, systemic corticosteroids, azathioprine, cyclosporine, tacrolimus) used in the treatment of SJIA for at least 3-months (medical record documentation required); OR
    5. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of SJIA (medical record documentation required); OR
    6. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of SJIA (medical record documentation required); OR
12. The patient has a diagnosis of moderate to severe hidradenitis suppurativa (HS); AND
    1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., oral tetracyclines [doxycycline, minocycline, tetracycline]; oral contraceptives [females only]; metformin [females only]; finasteride [females only]; spironolactone [females only]; intralesional corticosteroids [triamcinolone]; clindamycin in combination with rifampin; combination of rifampin, moxifloxacin, and metronidazole; cyclosporine, oral retinoids) used in the treatment of HS for at least 3-months (medical record documentation required); OR 
    2. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of HS (medical record documentation required); OR
    3. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of HS (medical record documentation required); OR
13. The patient has a diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD); AND
    1. The patient has disease onset (e.g., first non-Raynaud symptom) of 5 years or less; AND
    2. The patient has the presence of elevated inflammatory markers or platelets (e.g., acute-phase reactant levels, C-reactive protein, ESR, or platelet count); AND
    3. The patient has active disease, as defined by at least one of the following:
       1. Disease duration of 18 months or less; OR
       2. Increase in mRSS (modified Rodnan skin score) of at least 3 units over 6 months; OR
       3. Involvement of one new body area and an increase in mRSS of at least 2 units over 6 months; OR
       4. Involvement of two new body areas within the previous 6 months; OR
       5. Presence of at least one tendon friction rub; AND 
    4. The diagnosis of SSc-ILD has been confirmed by the presence of characteristic features of interstitial lung disease (ILD) on chest high-resolution computed tomography (HRCT); AND 
    5. Other known causes of pulmonary parenchymal disease have been excluded (e.g., heart failure, drug-induced lung toxicity, recurrent aspiration, pulmonary vascular disease); AND
    6. The patient has tried and had an inadequate response to immunosuppressant therapy (e.g., mycophenolate mofetil, cyclophosphamide, azathioprine) (medical record documentation required); OR
    7. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL immunosuppressant therapy used in the treatment of SSc-ILD (medical record documentation required); OR
14. The patient has a diagnosis of active enthesitis related arthritis (ERA); AND
    1. The patient has tried and had an inadequate response to TWO different NSAIDs used in the treatment of ERA for at least a 4-week total trial (medical record documentation required); OR
       1. The patient has a documented intolerance or hypersensitivity to TWO different NSAIDs used in the treatment of ERA (medical record documentation required); OR
       2. The patient has an FDA labeled contraindication to ALL NSAIDS used in the treatment of ERA (medical record documentation required); OR
15. The patient has a diagnosis of moderate to severe atopic dermatitis; AND
    1. The patient has tried and failed or has a clinical intolerance/contraindication to a moderate to high potency topical corticosteroid in the last 6 months (medical record documentation required); AND
    2. The patient has tried and failed or has a clinical intolerance/contraindication to a topical calcineurin inhibitor in the last 6 months (medical record documentation required); AND
    3. The patient has Body Surface Area (BSA) involvement of at least 10% OR the patient has involvement of the palms, soles, head and neck, or genitalia, causing disruption in normal daily activities and/or employment (medical record documentation required; OR
16. The patient has a diagnosis of severe alopecia areata; AND
    1. The patient has tried and failed or has a clinical intolerance/contraindication to a high potency topical corticosteroid in the last 6 months (medical record documentation required); AND
    2. The patient has tried and failed or has a clinical intolerance/contraindication to conventional oral immunosuppressant therapy (e.g., corticosteroid, methotrexate, azathioprine) in the last 6 months (medical record documentation required); AND
    3. The patient has at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than 6 months (medical record documentation required; OR
17. The patient has a diagnosis of polymyalgia rheumatica (PMR); AND
    1. The patient has tried and failed or has a clinical intolerance/contraindication to systemic corticosteroids at a dose equivalent to at least 7.5 mg/day of prednisone used in the treatment of PMR for a minimum of 8 weeks (medical record documentation required); OR
    2. The patient is currently treated with systemic corticosteroids at a dose equivalent to at least 7.5 mg/day of prednisone and cannot tolerate a corticosteroid taper (medical record documentation required); OR
18. The patient has a diagnosis of generalized pustular psoriasis (GPP); OR
19. The patient has another FDA labeled indication for the requested agent and route of administration not mentioned previously; AND
20. ONE of the following: (See Preferred agent table below)
    1. The requested indication does NOT require any prerequisite biologic immunomodulator agents; OR
    2. The requested agent is a Step 1a agent for the requested indication; OR
    3. If the requested agent is a Step 1b agent for the requested indication, then ONE of the following:
       1. The patient has tried and had an inadequate response to ONE Tumor Necrosis Factor (TNF) inhibitor for the requested indication for at least 3-months (See Step 1a for preferred TNF inhibitors) (medical record documentation required); OR
       2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to therapy with a TNF inhibitor for the requested indication (medical record documentation required); OR
       3. The patient has an FDA labeled contraindication to ALL TNF inhibitors for the requested indication (medical record documentation required); OR
       4. BOTH of the following:
          1. The prescriber has provided information indicating why ALL TNF inhibitors are not clinically appropriate for the patient; AND
          2. The prescriber has provided a complete list of previously tried agents for the requested indication; OR 
    4. If the requested agent is a Step 2 agent for the requested indication, then ONE of the following:
       1. The patient has tried and had an inadequate response to ONE of the required Step 1 agents for the requested indication for at least 3-months (See Step 2) (medical record documentation required); OR
       2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to ONE of the required Step 1 agents for the requested indication (medical record documentation required); OR 
       3. The patient has an FDA labeled contraindication to ALL required Step 1 agents for the requested indication (medical record documentation required); OR
       4. BOTH of the following:
          1. The prescriber has provided information indicating why ALL of the Step 1 agents are not clinically appropriate for the patient; AND
          2. The prescriber has provided a complete list of previously tried agents for the requested indication; OR
    5. If the requested agent is a Step 3a agent for the requested indication, then ONE of the following:
       1. The patient has tried and had an inadequate response to TWO of the Step 1 agents for the requested indication for at least 3-months (See Step 3a) (medical record documentation required); OR
       2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to TWO of the required Step 1 agents for the requested indication (medical record documentation required); OR 
       3. The patient has an FDA labeled contraindication to ALL of the Step 1 agents for the requested indication (medical record documentation required); OR
       4. BOTH of the following:
          1. The prescriber has provided information indicating why all of the Step 1 agents are not clinically appropriate for the patient; AND
          2. The prescriber has provided a complete list of previously tried agents for the requested indication; OR
    6. If the requested agent is a Step 3b agent for the requested indication, then ONE of the following:
       1. The patient has tried and had an inadequate response to TWO agents from Step 1 and/or Step 2 for the requested indication for at least 3-months (See Step 3b) (medical record documentation required); OR
       2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to TWO of the required Step 1 and/or Step 2 agents for the requested indication (medical record documentation required); OR
       3. The patient has an FDA labeled contraindication to ALL of the required Step 1 AND Step 2 agents for the requested indication (medical record documentation required); OR
       4. BOTH of the following:
          1. The prescriber has provided information indicating why all of the Step 1 AND Step 2 agents are not clinically appropriate for the patient; AND
          2. The prescriber has provided a complete list of previously tried agents for the requested indication; OR
    7. If the requested agent is a Step 3c agent for the requested indication, then ONE of the following:
       1. The patient has tried and had an inadequate response to THREE of the Step 1 agents for the requested indication for at least 3-months (See Step 3c) (medical record documentation required); OR
       2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to THREE of the Step 1 agents for the requested indication (medical record documentation required); OR 
       3. The patient has an FDA labeled contraindication to ALL of the Step 1 agents for the requested indication (medical record documentation required); OR
       4. BOTH of the following:
          1. The prescriber has provided information indicating why all of the Step 1 agents are not clinically appropriate for the patient; AND
          2. The prescriber has provided a complete list of previously tried agents for the requested indication; OR 
       5. If Abrilada, adalimumab-adbm, Amjevita (adalimumab-atto), Hadlima, Hulio (adalimumab-fkjp), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Simlandi (adalimumab-ryvk), Yusimry, or Yuflyma (adalimumab-aaty) is requested:
          1. The patient had documented life-threatening side effect that required medical intervention to ALL preferred adalimumab products (Humira, Cyltezo) that is not anticipated with the requested product; AND
          2. The prescriber completed and submitted an FDA MedWatch Adverse Event Reporting Form (the prescriber must provide a copy of the completed MedWatch form. Authorization will not be considered unless the form is completed and submitted to the FDA); AND 
21. If Simponi 50mg/mL is requested:
    1. The patient has a diagnosis of ankylosing spondylitis, psoriatic arthritis or rheumatoid arthritis; AND
22. If Rinvoq 45 mg is requested:
    1. The patient has a diagnosis of ulcerative colitis or Crohn’s disease; AND
23. If Rinvoq LQ is requested:
    1. The patient has a diagnosis of Polyarticular Juvenile Idiopathic Arthritis and must be at least 2 years of age; OR
    2. The patient has a diagnosis of Psoriatic Arthritis and must be at least 2 years of age but less than 18 years of age; AND
24. If adalimumab 80 mg every 2 weeks is requested, ONE of the following:
    1. The patient has a diagnosis of hidradenitis suppurativa; OR
    2. The patient has a diagnosis of ulcerative colitis AND is a pediatric patient weighing ≥ 40 kg; OR
    3. The patient has a diagnosis of rheumatoid arthritis; AND
       1. The patient is not taking methotrexate concurrently; AND
25. If Stelara 90 mg is requested, ONE of the following:
    1. The patient has a diagnosis of psoriasis AND weighs >100kg (medical record documentation required); OR
    2. The patient has a dual diagnosis of psoriasis AND psoriatic arthritis AND the patient is >100kg (medical record documentation required); OR
    3. The patient has a diagnosis of Crohn’s disease or ulcerative colitis; AND
       1. The patient received Stelara IV for induction therapy; AND
26. If Cosentyx 300 mg every 4 weeks is requested, ONE of the following:
    1. The patient has a diagnosis of moderate to severe plaque psoriasis with or without coexistent active psoriatic arthritis; OR
    2. The patient has a diagnosis of active psoriatic arthritis or active ankylosing spondylitis AND has tried and had an inadequate response to Cosentyx 150 mg every 4 weeks for at least 3-months (medical record documentation required); OR 
    3. The patient has a diagnosis of hidradenitis suppurativa; AND
27. If the request is for Xeljanz oral solution:
    1. The patient has a diagnosis of polyarticular course juvenile idiopathic arthritis; AND
28. If the request is for Cibinqo:
    1. The patient will not be using Cibinqo in combination with Opzelura; AND
29. If Olumiant 4 mg is requested:
    1. The patient has a diagnosis of severe alopecia areata; AND
30. If Skyrizi 180 mg/1.2 mL or Skyrizi 360 mg/2.4 mL is requested:
    1. The patient has a diagnosis of Crohn’s disease or Ulcerative Colitis; AND
       1. The patient received Skyrizi IV for induction therapy; AND
31. If the request is for Zymfentra:
    1. The patient has a diagnosis of ulcerative colitis or Crohn’s disease; AND
       1. Patient has received treatment with an infliximab product administered intravenously; AND 
32. If Entyvio 108 mg/0.68 mL is requested:
    1. The patient has a diagnosis of ulcerative colitis or Crohn’s Disease; AND
       1. The patient received Entyvio IV for induction therapy; AND 
33. If the request is for Omvoh:
    1. The patient has a diagnosis of ulcerative colitis; AND
       1. The patient received Omvoh IV for induction therapy; AND 
34. If the request is for Spevigo:
    1. Patient has a diagnosis of generalized pustular psoriasis (GPP); AND
       1. Patient has or will receive a 600 mg subcutaneous loading doses to be administered by healthcare professional; OR
       2. It is four weeks after the patient has received treatment with intravenous Spevigo for a GPP flare; AND
    2. The patient is NOT experiencing a flare; AND
35.  If the request is for Kevzara and patient has diagnosis of polyarticular juvenile idiopathic arthritis:
    1. The patient must weigh at least 63 kg; AND
36. If the request is for Tremfya and patient has diagnosis of ulcerative colitis:
    1. The patient has received Tremfya IV for induction therapy; AND
37. If the request is for Tremfya 200 mg/2 mL:
    1. The patient has a diagnosis of ulcerative colitis; AND
    2. The patient has received Tremfya IV for induction therapy; AND
38. If the request is for Ebglyss:
    1. The patient has a diagnosis of moderate-to-severe atopic dermatitis; AND
       1. The patient weighs at least 40kg; AND
39. If the request is for Cimzia:
    1. The patient has diagnosis of polyarticular juvenile idiopathic arthritis (PJIA); AND
       1. The patient weighs at least 40 kg; AND
40. If the request is for Bimzelx 160 mg/mL 2 syringes/pens (320 mg) every 56 days:
    1. The patient has a diagnosis of moderate to severe plaque psoriasis with or without coexistent active psoriatic arthritis; AND
41. If the request is for Bimzelx 160 mg/mL 2 syringes/pens (320 mg) every 28 days:
    1. The patient has a diagnosis of Hidradenitis Suppurativa (HS); AND 
42. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist for JIA, PsA, RA, SSc-ILD, AS, or nr-axSpA; gastroenterologist for CD, UC; dermatologist for PS, AD, AA; pulmonologist, radiologist, pathologist for SSc-ILD; allergist, immunologist for AD) or has consulted with a specialist in the area of the patient’s diagnosis; AND
43. The patient will NOT be using the requested agent in combination with another biologic immunomodulator agent, Zeposia or Otezla; AND
44. The provider is aware that if approved, any previous authorizations through Blue Cross NC for biologic agents, Zeposia or Otezla used for the same indication as the requested agent will be terminated; AND
45. The patient does NOT have any FDA labeled contraindications to the requested agent; AND 
46. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB; AND
47. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
    
    Duration of Approval: 365 days (1 year)

Continuation Coverage

1. The request is for Actemra (all other requests should complete the Initial Coverage section); AND
2. The patient has a diagnosis of systemic sclerosis-associated interstitial lung disease (SSc-ILD); AND
3. The patient was approved through Blue Cross NC initial criteria for approval; OR
   1. The patient would have met initial criteria for approval at the time they started therapy; AND
4. The patient has demonstrated a positive clinical response while using the medication, as demonstrated by improved or maintained annual rate of decline in pulmonary function (i.e., predicted forced vital capacity [FVC% predicted]); AND
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist for JIA, PsA, RA, SSc-ILD; gastroenterologist for CD, UC; dermatologist for PS, AD, AA; pulmonologist, radiologist, pathologist for SSc-ILD; allergist, immunologist for AD) or has consulted with a specialist in the area of the patient’s diagnosis; AND
6. The patient will NOT be using tocilizumab (Actemra®) in combination with another biologic immunomodulator agent, Zeposia or Otezla; AND
7. The provider is aware that if approved, any previous authorizations through Blue Cross NC for biologic agents, Zeposia or Otezla used for the same indication as the requested agent will be terminated.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. If the requested medication is Cimzia for the diagnosis of plaque psoriasis:
   1. The request is for maintenance dosing of up to two kits of 2 x 200mg doses every 28 days; OR
2. If the requested medication is adalimumab for the diagnosis of rheumatoid arthritis:
   1. The request is for maintenance dosing of 40 mg every week (four 40mg injections every 28 days); AND
   2. The patient will not be taking adalimumab along with methotrexate: OR
3. If the requested medication is adalimumab for the diagnosis of hidradenitis suppurativa:
   1. The request is for maintenance dosing of 40 mg every week (four 40mg injections every 28 days); OR
4. If the requested medication is adalimumab for the diagnosis of ulcerative colitis AND is a pediatric patient weighing ≥ 40 kg;:
   1. The request is for maintenance dosing of 40 mg every week (four 40mg injections every 28 days); OR
5. If the requested medication is Xeljanz oral solution for a diagnosis of polyarticular course juvenile idiopathic arthritis:
   1. The requested quantity (dose) does not exceed the maximum labeled dose (i.e., 5mg twice daily); AND
   2. The prescriber has provided information stating why the patient cannot take Xeljanz 5mg tablets; OR
6. If the requested medication is Bimzelx for the diagnosis of plaque psoriasis AND the patient weighs > 120kg:
   1. The request is for maintenance dosing of 320mg every 4 weeks after week 16; OR 
7. If the requested medication is Bimzelx for the diagnosis of active psoriatic arthritis with coexisting moderate to severe plaque psoriasis AND the patient weighs > 120kg:
   1. The request is for maintenance dosing of 320mg every 4 weeks after week 16; OR 
8. If the requested medication is Cosentyx 300mg every 2 weeks:
   1. The patient has a diagnosis of hidradenitis suppurativa AND has tried and had an inadequate response to Cosentyx 300mg every 4 weeks for at least 3-months (medical record documentation required); OR 
9. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
10. The patient has tried and had an inadequate response (at least 3 months) to the FDA approved dose (medical record documentation required); AND
11. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
12. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
13. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

December 2024: Criteria change (Bimzelx): Added new indication of Hidradenitis Suppurativa (HS) for Bimzelx.

October 2024v2: Criteria change (Bimzelx, Cimzia): Added active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis and active ankylosing spondylitis (AS) for Bimzelx and active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older for Cimzia. Preferred chart was updated. Removed Cimzia vial kit from policy due to it being covered on medical policy.

October 2024: Criteria change: Reformatted the adalimumab products in the restricted products section and bolded preferred products. Simplified the adalimumab products in the preferred and non-preferred biologic immunomodulator table. Added new to market adalimumabaacf starter pack CD/UC/HS and adalimumab-aacf starter pack for Psoriasis/Uveitis, biosimilar for Idacio. Added new indication of Ulcerative colitis for Tremfya and added as step 1a on the preferred chart. Added new to market Tremfya 200mg/2mL products to QL chart. Added Tremfya as t/f agent for Zeposia. Added new to market, Ebglyss, for atopic dermatitis to policy in step 3c position and to QL Chart.

September 2024: Criteria update (adalimumab-aacf): Add new to market adalimumab-aacf 40 mg/0.8ml prefilled syringe kit, biosimilar for Idacio.

August 2024 v2: Criteria update (Taltz): Add new to market Taltz subcutaneous prefilled syringes, 20 mg/0.25ml and 40 mg/0.5ml, that are indicated for Pediatric Plaque Psoriasis. August 2024: Criteria update (Humira, Simlandi biosimilar): Adalimumab-ryvk, biosimilar for Simlandi, prefilled syringes kit (40 mg/0.4ml) launched new to market and was added to quantity limit table. Quantity limit for Pediatric Crohn’s Disease Initial Therapy increased due to discontinuation of Humira pediatric starter kits. Removed discontinued Humira products from quantity limit chart.

July 2024 v3: Criteria change (Skyrizi, Omvoh, Hulio biosimilar): Added new indication of Ulcerative colitis for Skyrizi and added as step 1a on the preferred chart. Preferred chart updated for Omvoh by moving it from a step 3c to a step 3b for UC. Added new to market Hulio and biosimilar to quantity limit section. Removed discontinued Skyrizi 75mg.

July 2024 v2: Criteria update (Tyenne): Added new to market Tyenne (biosimilar for Actemra) to criteria and added to quantity limit section.

July 2024: Criteria change (Amjevita, Sotyktu, Entyvio): Moved Amjevita to step 3c on preferred table. Moved Sotyktu to step 2 on chart for Psoriasis. Moved Entyvio to step 3b for ulcerative colitis and Crohn’s disease.

June 2024 v2: Criteria change (Kevzara): Added new indication for Kevzara for treatment of active polyarticular juvenile idiopathic arthritis in patients who weigh at least 63 kg.

June 2024: Criteria update: added new to market Rinvoq LQ and added to QL table.

May 2024v3: Criteria update: Added new Omvoh prefilled syringe for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Additional adalimumab-adbm (Cyltezo) products launched this week. Additional products by Quallent also launched this week which will be excluded. Updated footnote below preferred and non-preferred biologic immunomodulator table to clarify which NDCs for Cyltezo are covered.

May 2024v2: Criteria change (Rinvoq): Added new indication for Rinvoq for treatment of active polyarticular juvenile idiopathic arthritis in patients ≥2 years of age who have had an inadequate response or intolerance to one or more TNF blockers AND updated added for treatment of active psoriatic arthritis in adults and pediatric patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.

May 2024: Criteria change (Entyvio): Added Entyvio for Crohn’s disease. New adalimumab-adbm (Cyltezo) and adalimumab-ryvk (Simlandi) products by Quallent launched this week which will be excluded. Updated footnote below preferred and non-preferred biologic immunomodulator table to clarify which NDCs for Cyltezo and Simlandi are covered.

April 2024 v2: Criteria update (Spevigo- spesolimab-sbzo): Added new to market Spevigo for generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg. Quantity limits chart updated. Updated typo for Zymfentra and documentation chart.

April 2024 v3: Criteria update: Adalimumab-aaty, biosimilar for Yuflyma, auto-injector kits (40 mg/0.4ml, 80 mg/0.8ml) and syringe kits (20mg/0.2mL, 40 mg/0.4mL) were added new to market and added to quantity limit table.

April 2024: Criteria update: (Simlandi, adalimumab-ryvk) pens 40 mg/0.4 mL- Added new to market Simlandi (biosimilar for Humira) to criteria and added to quantity limit section. Updated policy to align Cibinqo in parity with other moderate to severe AD agents.

March 2024 v2: Criteria update: (Yuflyma, adalimumab-aaty) Yuflyma prefilled syringe Kit 20 mg/0.2 mL added new to market and added to QL table.

March 2024: Criteria update: (Zymfentra, infliximab-dyyb): Added new to market Zymfentra for ulcerative colitis and Crohn’s disease and updated QL table. Added statement that ONLY Humira – AbbVie products are covered (Cordavis NDCs are excluded products).

December 2023 v2: Criteria update (Amjevita, Yuflyma, adalimumab-aacf): Added new to market Amjevita high concentration, Yuflyma and adalimumab-aacf products to QL table. Updated footnote below preferred and non-preferred biologic immunomodulator table to clarify Amjevita NDCs that are covered. Added adalimumab-aacf to preferred and non-preferred biologic immunomodulator table.

December 2023: Criteria update: Removed mesalamine from list of conventional treatment agents for Crohn’s disease.

November 2023 v2: Criteria change (Omvoh, Cosentyx, Orencia, Enbrel): Added new to market product Omvoh for ulcerative colitis. Added new indication for Cosentyx for hidradenitis suppurativa, added expanded indication for Orencia for patients 2 years and older with active psoriatic arthritis, added new indication for Enbrel for juvenile psoriatic arthritis in children 2 years of age and older.

November 2023: Criteria update (Velsipity and Bimzelx): Added new to market Velsipity for ulcerative colitis. Added new to market Bimzelx for plaque psoriasis. Preferred and non-preferred biologic immunomodulators and quantity limits chart updated with both products. Added Abrilada to quantity limits chart.

October 2023: Criteria update (Entyvio): Added new to market Enytvio for ulcerative colitis indication. Updated Preferred and Nonpreferred Biologic Immunomodulators chart and quantity limits section to include adalimumab-adbm, adalimumab-fkjp, adalimumab-adaz for clarification. Updated quantity limits section to include additional Hyrimoz products.

August 2023: Criteria update: Added Yuflyma syringe kit to quantity limit section and updated Yuflyma quantity limit for single and two pack products. Updated Cosentyx quantity limit section to include the 300 mg/2 mL auto injector.

July 2023 v2: Criteria update: Added Yuflyma (biosimilar for Humira) to criteria. Added Humira biosimilars Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yusimry, and Yuflyma individually to quantity limit section.

July 2023: Criteria change: Net results only policy created. Updated to prefer Humira, Amjevita, Cyltezo. Added Humira biosimilars Abrilada, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Yusimry to criteria. Updated preferred chart. If non preferred agent (Abrilada, Hadlima, Hulio, Hyrimoz, Idacio, or Yusimry) requested, the patient must have a documented life-threatening side effect with MedWatch form. Added note ONLY Amjevita NDCs starting with 55513 will be covered.

May 2023v2: Criteria change (Amjevita, Cimzia, and Rinvoq): Added new to market Amjevita 10 mg/0.2 mL (biosimilar for Humira) to criteria. Added new indication of Crohn’s disease for Rinvoq and preferred chart updated. Updated Rinvoq 45 mg quantity limit section for new indication.

May 2023: Criteria change (Skyrizi, Stelara): Added requirement to use IV induction therapy for Stelara and Skyrizi for indications of Crohn’s disease and ulcerative colitis.

March 2023: Criteria change (Kevzara): Added new indication of polymyalgia rheumatica for Kevzara.

February 2023: Criteria update (Amjevita and Cibinqo): Added new to market Amjevita (biosimilar for Humira) to criteria. Amjevita will share all indications with Humira. Updated preferred chart and quantity limits section to include Amjevita. Updated Cibinqo for expanded age indication to include treatment of pediatric patients 12 years of age and older.

January 2023: Criteria update (Skyrizi): Added new to market Skyrizi 180 mg/1.2 mL cartridge to criteria for Crohn’s disease and quantity limits section.

December 2022: Criteria change (Olumiant): Formatting change to correct numbering within criteria. Clarified additional oral immunosuppressant options (listed examples) of tried and failed/clinical intolerance/contraindication agents for treatment of alopecia areata with Olumiant.

November 2022: Criteria change (Rinvoq): Added new indication of non-radiographic axial spondyloarthritis for Rinvoq.

October 2022: Criteria change (Sotyktu): Added new to market Sotyktu for plaque psoriasis indication.

September 2022: Criteria change (Rinvoq, Skyrizi, Stelara, Xeljanz, Cimzia): Added new indication of Crohn’s disease for Skyrizi. Added newly available Skyrizi product to quantity limit section. Added expanded age indication for active psoriatic arthritis for Stelara. Preferred chart updated by Adbry moved to Step 1a for AD. Preferred chart updated by Rinvoq, Xeljanz, Xeljanz XR moved to step 1b for UC. Preferred chart updated by Skyrizi added to step 1a and Cimzia moved to step 3a for CD.

June 2022: Criteria change (Olumiant): Added new indication of severe alopecia areata for Olumiant.

May 2022: Criteria change (Rinvoq): Added ankylosing spondylitis indication for Rinvoq. Preferred chart updated to include new indication for Rinvoq. Updated the prescriber is a specialist in the area of the patient’s diagnosis to include all indications for both initial and continuation criteria.

April 2022: Criteria update: Removed “preferred” and “non preferred” labels from preferred product table. Removed step through DMARDS for patients with enthesitis related arthritis (ERA).

March (V2) 2022: Criteria change (Humira): Added pediatric ulcerative colitis to criteria point allowing Humira 80 mg every 2 weeks. Updated QL exception criteria for ulcerative colitis AND is a pediatric patient weighing ≥ 40 kg.

March 2022: Criteria change (Rinvoq): Added new to market strength for Rinvoq. Added ulcerative colitis indication for Rinvoq. Preferred chart updated to include Rinvoq. Added new to market Rinvoq 45 mg tablet to quantity limit section.

February (V2) 2022: Criteria change (Skyrizi, Cosentyx): Added new to market Cibinqo and added criteria specific for Cibinqo. Added psoriatic arthritis indication for Skyrizi. Added criteria for enthesitis related arthritis (ERA). Preferred chart updated to include Dupixent and Adbry.

February 2022: Criteria change (Rinvoq, Xeljanz, Cosentyx): Updated step designations from step 1 to step 1a/1b. Added psoriatic arthritis and atopic dermatitis indication for Rinvoq. Added new to market Rinvoq 30mg tablet to quantity limit section. Added ankylosing spondylitis indication for Xeljanz. Added enthesitis-related arthritis (ERA) indication for Cosentyx.

December 2021: Criteria change (Siliq, Simponi): Move Siliq from a step 3a agent to a step 3c agent. Added diagnosis check for Simponi 50mg/mL requests. Removed sulfasalazine as conventional agent for Crohn’s disease.

September 2021: Criteria change: Allow bypassing conventional agents for severely active UC. Products will not be used in combination with Zeposia to treat the same indication. Removal of steroid suppositories in list of conventional agents for UC. Specified one NSAID required for SJIA. Addition of Zeposia to preferred table for diagnosis of UC as a step 3b agent. Updated QL for Xeljanz 10mg and Xeljanz XR 22mg.

June 2021: Criteria change (Cosentyx): Added new to market Cosentyx 75mg prefilled syringe. Cosentyx indication expanded to pediatric patients 6 years and older for moderate to severe plaque psoriasis.

June 2021: Criteria change: Medical record documentation required for all indications. Skyrizi 150mg/mL product added to policy. Removed criteria points regarding medication history indicating use of another biologic immunomodulator agent FDA labeled for the treatment of the same condition.

April 2021: Criteria update: Added new indication for Actemra of systemic sclerosis-associated interstitial lung disease.

April 2021: Criteria change: Humira required step before Simponi for Ulcerative Colitis. Patients must have a trial of dosing within FDA labeled dose for at least 3 months prior to approval of higher quantities. Medical record documentation required on criteria for psoriatic arthritis and plaque psoriasis. Updated Humira for expanded indication for UC for pediatric patients 5 years of age and older. Duration of approval changed to 365 days (1 year) for all diagnoses.

January 2021: Criteria change: Added new Humira 80mg/0.8mL pen-injection to the policy. Added criteria point regarding Humira 80mg dosing. Removed psoriatic arthritis and ankylosing spondylitis from Humira QL section (Humira dosing above 40mg every other week is not indicated per PI)

January 2021: Criteria update: Added new indication for Kineret of deficiency of interleukin-1 receptor antagonist.

January 2021: Criteria change: Removed single step on Stelara for UC, removed single step on Enbrel for psoriasis, add single step on Actemra through Humira for RA. Added expanded indication for Tremfya (psoriatic arthritis) Added expanded indication for Cosentyx (nraxSpA). Added expanded indication for Xeljanz for active polyarticular course juvenile idiopathic arthritis and Xeljanz oral solution.

August 2020: Criteria update: Added expanded age indication for Stelara (plaque psoriasis).

August 2020: Criteria update: Removed Cimzia vial kit from policy due to moving to medical policy and added new Enbrel 25mg/0.5 mL single use vial to the policy.

July 2020: Criteria change: (All medications) Modified diagnosis specific requirements for all diagnoses. Require prescriber to be specialist in area of patient’s diagnosis. Preferred product chart updated. Actemra and Xeljanz/Xeljanz XR added as preferred products. Enbrel moved to secondary preferred product in PS. Actemra added as secondary preferred product in PJIA. Stelara moved to secondary preferred product in UC. Ilumya removed from policy. Any previous authorizations through Blue Cross NC for biologic agents or Otezla used for the same indication as the requested agent will be terminated.

June 2020: Criteria update (Taltz): Added new indication for Taltz for the treatment of non-radiographic axial spondyloarthritis and require a trial and failure of Cimzia for Taltz requests in this indication.

May 2020: Criteria update: Updated QL for Cosentyx initial dosing must use Two pack.

April 2020: Criteria change (Actemra): Changed duration of approval for SJIA is 365 days.

April 2020: Criteria update (Taltz): Added expanded indication for Taltz for the treatment of plaque psoriasis in patients aged 6 years and older.

April 2020: Criteria change: All separate biologic policies combined into one policy. Changed requirement to try and fail the required number of preferred agents for the requested indication or have a contraindication/intolerance to ALL required preferred agents for the requested indication.

January 2020: Criteria changes:
Actemra - Removal of Simponi and Xeljanz as preferred in RA; Rinvoq added as preferred in RA; Duration of approval for RA and GCA changed to 3 years.
Cimzia - Removed Simponi and Xeljanz as a preferred products in RA; added Rinvoq as a preferred product in RA; removed Simponi as a preferred agent in PsA; removed Simponi as a preferred agent in AS; updated duration of approval to 3 years; decreased requirement to 2 preferred products for diagnoses of AS and PsA.
Ilumya - Added Cimzia as a secondary preferred agent.
Kevzara - Simponi removed from preferred and Rinvoq added; duration of approval updated to 3 years.
Kineret - Simponi removed from preferred agent and Rinvoq added; Xeljanz removed as second line preferred agent and Cimzia and Actemra added; duration of approval updated to 3 years.
Olumiant - Simponi and Xeljanz removed as preferred agents; Rinvoq, Actemra, and Cimzia added; duration of approval updated to 3 years.
Orencia - Actemra added as secondary preferred product in PJIA; Simponi and Xeljanz removed from preferred in RA and Rinvoq, Actemra, and Cimzia added; Simponi removed as a preferred agent in PsA and Stelara added with Cimzia added as secondary preferred; duration of approval updated to 3 years for RA and PsA; decreased requirement to 2 preferred products for diagnosis of PsA.
Rinvoq - Requirement for preference of other biologics prior to use of Rinvoq removed; extended authorization to 3 years.
Siliq - Cimzia added as secondary preferred agent; duration of approval updated to 3 years.
Simponi - Preferred status removed in all indication, trial of/ contraindication to preferred product added; duration of approval updated to 3 years; decreased requirement to 2 preferred products for diagnoses of AS and PsA.
Taltz - Simponi removed as a preferred agent; Cimzia added as secondary preferred agent; duration of approval for PsA and AS updated to 3 years; decreased requirement to 2 preferred products for diagnoses of AS and PsA.
Xeljanz/ Xeljanz XR: Simponi removed as a preferred product in RA and Rinvoq, Actemra, and Cimzia added; Simponi removed from preferred agent and Cimzia added as secondary preferred agent in PsA; Simponi removed as a preferred product in UC; duration of approval updated to 3 years; decreased requirement to 2 preferred products for diagnosis of PsA.
*Further historical criteria changes and updates available upon request from Corporate Pharmacy.