Pharmacy Policy Bulletin

Chronic Inflammatory Diseases - Commercial and Healthcare Reform
Number: J-0558	Category: Prior Authorization
Line(s) of Business: Commercial Healthcare Reform Medicare	Benefit(s): Commercial Prior Authorization (1. or 2.) Miscellaneous Specialty Drugs Oral = Yes w/ Prior Authorization (Olumiant, Otezla, Xeljanz, Xeljanz XR, Rinvoq) 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.) Rx Mgmt Quantity Limits = Safety/Specialty Rx Mgmt Quantity Limits = Safety/Specialty + Dose Opt Rx Mgmt Quantity Limits = Safety/Specialty + Dose Opt + Watchful Rx Mgmt Performance = MRxC = Yes Healthcare Reform: Not Applicable
Region(s): All Delaware New York Pennsylvania West Virginia	Additional Restriction(s): None

Table 1. Summary of Preferred Products Given by Oral or Subcutaneous (SC) Administration by Indication

	Rheumatoid Arthritis	Ankylosing Spondylitis	Juvenile Idiopathic Arthritis	Psoriatic Arthritis	Plaque Psoriasis	Crohn’s Disease	Ulcerative Colitis
Preferred	Actemra SC Enbrel Humira Rinvoq Xeljanz, Xeljanz XR	Cosentyx Enbrel Humira	Enbrel Humira	Cosentyx Enbrel Humira Stelara SC Xeljanz, Xeljanz XR	Cosentyx Humira Otezla Stelara SC Skyrizi Tremfya	Humira Stelara SC	Humira
Non-preferred (must try ONE preferred agent)	--	--	Actemra SC¹	Otezla	Enbrel³	Cimzia⁴	Simponi SC (100 mg) Xeljanz⁵
Non-preferred (must try TWO preferred agents)	Cimzia Kevzara Kineret Olumiant Orencia SC Simponi SC (50 mg)	Cimzia Simponi SC (50 mg) Taltz	Orencia SC²	Cimzia Simponi SC (50 mg) Orencia SC Taltz	Cimzia Taltz Siliq	--	--

¹Actemra SC will require a trial of Humira first within the Polyarticular Juvenile Idiopathic Arthritis (PJIA) indication only.

²Orencia SC will now require a trial of two step 1 (Enbrel, Humira) or step 2 (Actemra) agents.

³Enbrel will require a trial of Humira for patients greater than or equal to 18 years of age within the plaque psoriasis indication only.

⁴Cimzia will require a trial of Humira specifically for Crohn’s disease indication only.

⁵Xeljanz XR is not indicated in ulcerative colitis (UC) and is not addressed within this indication.

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:

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis, giant cell arteritis	Four (4) prefilled syringes within the first four (4) weeks of therapy	Two (2) prefilled syringes every four (4) weeks -OR- Four (4) prefilled syringes every four (4) weeks
polyarticular juvenile idiopathic arthritis	N/A	One (1) prefilled syringe every two (2) or three (3) weeks
systemic juvenile idiopathic arthritis	N/A	One (1) prefilled syringe every week or two (2) weeks

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.

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:

Diagnosis

Induction Therapy

Maintenance Therapy

rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis,

Crohn’s disease,

non-radiographic axial spondyloarthritis

Ten (10) syringes in first twelve (12) weeks of therapy

-OR-

One (1) starter package kit

Two (2) syringes every four (4) weeks

plaque psoriasis

Six (6) syringes in first four (4) weeks of therapy

One (1) syringe or two (2) syringes every two (2) weeks

To note, starter package kits are coded for quantity level limitations of one (1) kit per 365 days.

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.

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.):

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:

Diagnosis	Induction Therapy	Maintenance Therapy
ankylosing spondylitis	Five (5) pens/prefilled syringes within the first four (4) weeks of therapy	Two (2) pens/prefilled syringes every four (4) weeks
psoriatic arthritis	Five (5) or Ten (10) pens/prefilled syringes within the first four (4) weeks of therapy	One (1) or Two (2) pens/prefilled syringes every four (4) weeks
plaque psoriasis with or without psoriatic arthritis, scalp psoriasis	Ten (10) pens/prefilled syringes within the first four (4) weeks of therapy	Two (2) pens/prefilled syringes every four (4) weeks

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.

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.

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.):

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.):

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:

Diagnosis

Induction Therapy

Maintenance Therapy

ankylosing spondylitis, juvenile idiopathic arthritis, pediatric plaque psoriasis, psoriatic arthritis, rheumatoid arthritis

N/A

Four (4) 50 mg prefilled syringes every four (4) weeks

-OR-

Eight (8) 25 mg prefilled syringes every four (4) weeks

plaque psoriasis, adults

Twenty four (24) 50 mg syringes within the first twelve (12) weeks of therapy

-OR-

Forty eight (48) 25 mg syringes within the first twelve (12) weeks of therapy

Four (4) 50 mg prefilled syringes every four (4) weeks

-OR-

Eight (8) 25 mg prefilled syringes every four (4) weeks

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.

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.

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.

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.):

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:

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis	Two (2) prefilled syringes within the first four (4) weeks of therapy	Two (2) prefilled syringes every four (4) weeks
rheumatoid arthritis*	-----	One (1) prefilled syringe every week (Without concurrent methotrexate therapy)
juvenile idiopathic arthritis, pediatric uveitis	Two (2) prefilled syringes within the first four (4) weeks of therapy	Two (2) prefilled syringes every four (4) weeks
chronic plaque psoriasis	Four (4) prefilled syringes within the first four (4) weeks of therapy -OR- One (1) starter package kit	Two (2) prefilled syringes every four (4) weeks OR- Four (4) prefilled syringes every four (4) weeks^†
adult Crohn's disease	Six (6) prefilled syringes within the first four (4) weeks of therapy -OR- One (1) starter package kit	Two (2) prefilled syringes every four (4) weeks -OR- Four (4) prefilled syringes every four (4) weeks^†
pediatric Crohn's disease (37 lbs - 88 lbs)	Three (3) prefilled syringes within the first four (4) weeks of therapy -OR- One (1) starter package kit	Two (2) prefilled syringes every four (4) weeks -OR- Four (4) prefilled syringes every four (4) weeks^†
pediatric Crohn's disease (≥ 88 lbs)	Six (6) prefilled syringes within the first four (4) weeks of therapy -OR- One (1) starter package kit	Two (2) prefilled syringes every four (4) weeks -OR- Four (4) prefilled syringes every four (4) weeks^†
ulcerative colitis	Six (6) prefilled syringes within the first four (4) weeks of therapy	Two (2) prefilled syringes every four (4) weeks -OR- Four (4) prefilled syringes every four (4) weeks^†
hidradenitis suppurativa in adults and adolescents (12 years and older) ≥ 60 kg*	Seven (7) prefilled syringes within the first four (4) weeks of therapy	One (1) prefilled syringe every week
hidradenitis suppurativa in adolescents (12 years and older) 30 kg to < 60 kg*	Five (5) prefilled syringes within the first four (4) weeks of therapy	One (1) prefilled syringe every (2) weeks
adult uveitis	Four (4) prefilled syringes within the first four (4) weeks of therapy -OR- One (1) starter package kit	Two (2) prefilled syringes every four (4) weeks

*Patients diagnosed with rheumatoid arthritis (without concurrent methotrexate therapy) or hidradenitis suppurativa may receive weekly dosing of Humira prefilled syringes. Patient Level Authorization (PLA) input - One (1) prefilled syringe every week within 28 days.
Coding of quantity level limitations is at the maintenance therapy threshold except for rheumatoid arthritis and hidradenitis suppurativa weekly dosing administration.
^†Four (4) prefilled syringes every four (4) weeks may be approved when there is clinical documentation that treatment with two (2) prefilled syringes every four (4) weeks was ineffective.

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.

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:

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis	One (1) prefilled syringe every two weeks	One (1) prefilled syringe every two (2) weeks

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.

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:

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis, neonatal-onset multisystem inflammatory disease*	One (1) prefilled syringe once daily	One (1) prefilled syringe once daily

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.

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.

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.

c. Treatment with at least two preferred biologic products 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.

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:

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis	Four (4) prefilled syringes within the first four (4) weeks of therapy	Four (4) prefilled syringes every four (4) weeks

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.

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.):

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.):

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.):

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:

Diagnosis	Induction Therapy	Maintenance Therapy
plaque psoriasis	Three (3) prefilled syringes within the first two (2) weeks of therapy	Two (2) prefilled syringes every four (4) weeks

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.

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:

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis	One (1) 50 mg syringe/pen within the first four (4) weeks of therapy	One (1) 50 mg syringe/pen every four (4) weeks
ulcerative colitis	Three (3) 100 mg syringes/pen within the first four (4) weeks of therapy	One (1) 100 mg syringe/pen every four (4) weeks

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.):

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:

Diagnosis	Induction Therapy	Maintenance Therapy
plaque psoriasis	Four (4) prefilled syringes (75 mg/0.83 mL) per 28 days	Two (2) prefilled syringes per 84 days

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.

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.):

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.

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.

C. Quantity Limitations

When prior authorization is approved, Stelara SC may be authorized in quantities as follows:

Diagnosis

Induction Therapy

Maintenance Therapy

psoriatic arthritis,

plaque psoriasis

Two (2) prefilled syringes within the first four (4) weeks of therapy

One (1) syringe every eighty four (84) days (12 weeks)

Crohn's disease

N/A

One (1) syringe every fifty-six (56) days (8 weeks)

N/A=not applicable

*Patients diagnosed with Crohn’s disease or ulcerative colitis may receive every 8-week dosing of Stelara. Patient Level Authorization (PLA) input - One (1) prefilled syringe every 42 days.

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.

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.):

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).

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:

Diagnosis	Induction Therapy	Maintenance Therapy
plaque psoriasis with or without psoriatic arthritis	Eight (8) pens/prefilled syringes within the first twelve (12) weeks of therapy	One (1) pen/prefilled syringe every four (4) weeks
psoriatic arthritis	Two (2) pens/prefilled syringes within the first four (4) weeks of therapy	One (1) pen/prefilled syringe every four (4) weeks
ankylosing spondylitis	Two (2) pens/prefilled syringes within the first four (4) weeks of therapy	One (1) pen/prefilled syringe every four (4) weeks

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.):

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:

Diagnosis	Induction Therapy	Maintenance Therapy
plaque psoriasis	Two (2) prefilled syringes (100 mg/mL) per 28 days	One (1) prefilled syringe per 56 days

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.

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 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 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.