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
Step 1 Preferred	Actemra SC	Cosentyx	Enbrel	Cosentyx	Cosentyx	Humira	Humira
	Enbrel	Enbrel	Humira	Enbrel	Humira	Stelara SC
	Humira	Humira		Humira	Otezla
	Rinvoq Xeljanz, Xeljanz XR			Otezla Stelara SC Xeljanz, Xeljanz XR	Skyrizi Stelara SC Tremfya
Step 2 Non-Preferred (directed to ONE Step 1 agent)	--	--	Actemra SC1	--	Enbrel3	Cimzia4	Simponi SC Stelara SC
							Xeljanz, Xeljanz XR
Step 3a Non-Preferred (directed to TWO Step 1 agents)	Cimzia	Cimzia	--	Cimzia	Cimzia	--	--
	Kevzara	Simponi SC		Simponi SC	Siliq
	Kineret	Taltz		Orencia SC
	Olumiant			Taltz
	Orencia SC			Tremfya
	Simponi SC
Step 3b Non-Preferred (directed to TWO Step 1 or 2 agents)	--	--	Orencia SC2 Xeljanz2	--	--	--	--
Step 3c Non-Preferred (directed to THREE Step 1 agents)	--	--	--	--	Taltz	--	--

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

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

³ Enbrel will require a trial of Humira for patients ≥ 18 years of age for plaque psoriasis indication only.

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

 

I.    Actemra (tocilizumab)

 

A.     Initial Authorization

1.     Rheumatoid Arthritis (RA)

When a benefit, coverage of Actemra SC may be approved for RA when all of the following criteria are met (a., b., and c.):

a.  The member is 18 years of age or older.

b.  The member has a diagnosis of moderate to severe RA.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all nonbiologic DMARDs are contraindicated.

 

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.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic corticosteroid (e.g., prednisone), 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 member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

ii.  The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.

d.  The member has experienced therapeutic failure or intolerance to Humira for the treatment of PJIA (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
RA and GCA	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
PJIA	N/A	One (1) prefilled syringe every two (2) or three (3) weeks
SJIA	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 moderate to severe RA.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (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.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of AS (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. through iv.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of spinal or axial PsA.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

b.    PsA without spinal or axial disease (i. through iv.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of PsA without spinal disease.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

c.    Enthesitis and/or dactylitis associated PsA (i. through iv.):

i.   The member is 18 years of age or older.

ii.  The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (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 moderate to severe CD.

c.  The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate), or all immunosuppressants are contraindicated.

ii.  The member is currently pregnant.

d.  The member has experienced therapeutic failure or intolerance to Humira for the treatment of CD (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 moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsO (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.  The member has experienced therapeutic failure or intolerance to at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs), or all NSAIDs are contraindicated.

 

B.    Reauthorization

When a benefit, reauthorization of Cimzia may be approved when the following criterion is met (1.):

1.  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
RA, AS, PsA, CD, nr-axSpA	Ten (10) syringes in first twelve (12) weeks of therapy -OR- One (1) starter package kit	Two (2) syringes every four (4) weeks
PsO	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.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

 

2.     Psoriatic Arthritis (PsA)

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.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

b.    PsA without spinal or axial disease (i., ii., and iii.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of PsA without spinal disease.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

c.     Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

 

3.     Plaque Psoriasis (PsO), including Scalp Psoriasis

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 moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

 

4.     Non-radiographic Axial Spondyloarthritis (nr-axSpA)

When a benefit, coverage of Cosentyx may be approved for nr-axSpA when all of the following criteria are met (a., b., and c.):

a.  The member is 18 years of age or older.

b.  The member has a diagnosis of nr-axSpA.

c.  The member has experienced therapeutic failure or intolerance to at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs), or all NSAIDs are contraindicated.

 

B.    Reauthorization

When a benefit, reauthorization of Cosentyx may be approved when the following criterion is met (1.):

1.  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
AS	One (1) or Five (5) pens/prefilled syringes within the first four (4) weeks of therapy	One (1) or Two (2) pens/prefilled syringes every four (4) weeks
PsA	One (1) or 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
PsO with or without PsA, scalp PsO	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
nr-axSpA	One (1) or Five (5) pens/prefilled syringes within the first four (4) weeks of therapy	One (1) pen/prefilled syringe 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 moderate to severe

c.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

 

2.     Ankylosing Spondylitis (AS)

When a benefit, coverage of Enbrel may be approved for AS when all of the following criteria are met (a., b., and c.):

a.  The member is 18 years of age or older.

b.  The member has a diagnosis of AS.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

 

3.     Juvenile Idiopathic Arthritis (JIA)

When a benefit, coverage of Enbrel may be approved for JIA when all of the following criteria are met (a., b., and c.):

a.    The member is 2 years of age or older.

b.    The member has a diagnosis of moderate to severe JIA.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.   The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

ii.  The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.

 

4.     Psoriatic Arthritis (PsA)

When a benefit, coverage of Enbrel 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.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

b.     PsA without spinal or axial disease (i., ii., and iii.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of PsA without spinal disease.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

c.     Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

 

5.    Plaque Psoriasis (PsO), adults

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 moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to Humira for the treatment of PsO (see Table 1).

 

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 ≥ 4 and < 18 years of age.

b.   The member has a diagnosis of moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), 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
AS, JIA, pediatric PsO, PsA, RA	N/A	Four (4) 50 mg prefilled syringes/ autoinjectors every four (4) weeks -OR- Eight (8) 25 mg prefilled syringes every four (4) weeks
PsO, adults	Twenty four (24) 50 mg syringes/ autoinjectors within the first twelve (12) weeks of therapy -OR- Forty eight (48) 25 mg syringes/ autoinjectors within the first twelve (12) weeks of therapy	Four (4) 50 mg prefilled syringes/ autoinjectors every four (4) weeks -OR- Eight (8) 25 mg prefilled syringes/ autoinjectors 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 moderate to severe RA.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

 

2.     Ankylosing Spondylitis (AS)

When a benefit, coverage of Humira may be approved for AS when all of the following criteria are met (a., b., and c.):

a.  The member is 18 years of age or older.

b.  The member has a diagnosis of AS.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

 

3.     Juvenile Idiopathic Arthritis (JIA)

When a benefit, coverage of Humira may be approved for JIA when all of the following criteria are met (a., b., and c.):

a.    The member is 2 years of age or older.

b.    The member has a diagnosis of moderate to severe JIA.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine), or all non-biologic DMARDs are contraindicated.

ii.  The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.

 

4.     Psoriatic Arthritis (PsA)

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.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

b.    PsA without spinal or axial disease (i., ii., and iii.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of PsA without spinal disease.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

c.    Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

 

5.    Plaque Psoriasis (PsO)

When a benefit, coverage of Humira may be approved for PsO when all of the following criteria are met (a., b., and c.):

a.   The member is 18 years of age or older.

b.   The member has a diagnosis of moderate to severe PsO.

c.   The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), 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.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate), or all 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.  The member has experienced therapeutic failure or intolerance to at least one (1) immunosuppressant (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate), or all immunosuppressants are contraindicated.

 

8.     Ulcerative Colitis (UC)

When a benefit, coverage of Humira may be approved for UC when all of the following criteria are met (a. and b.):

a.  The member is 18 years of age or older.

b.  The member has a diagnosis of moderate or severe UC.

 

9.    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 moderate to severe HS.

 

10.  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.  The member has experienced therapeutic failure or intolerance to at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine), or immunosuppressants are contraindicated.

 

B.     Reauthorization

When a benefit, reauthorization of Humira may be approved when the following criterion is met (1.):

1.  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
RA, AS, PsA	Two (2) prefilled syringes within the first four (4) weeks of therapy	Two (2) prefilled syringes every four (4) weeks
RA*	-----	One (1) prefilled syringe every week (Without concurrent methotrexate therapy)
JIA, pediatric UV	Two (2) prefilled syringes within the first four (4) weeks of therapy	Two (2) prefilled syringes every four (4) weeks
chronic PSO	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 CD	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 CD (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 CD (≥ 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†
UC	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†
HS 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
HS 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 UV	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 moderate to severe RA.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (see Table 1).

 

B.    Reauthorization

When a benefit, reauthorization of Kevzara may be approved when the following criterion is met (1.):

1.  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
RA	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.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (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
RA, NOMID*	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 moderate to severe RA.

c.    The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

d.    The member has experienced therapeutic failure or intolerance to at least one (1) tumor necrosis factor (TNF) antagonist therapy, including Humira, Enbrel, Simponi, and Cimzia.

e.    The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (see Table 1).

i.  To note: If the member has tried and failed Humira and Enbrel, the member will not need to try and fail any additional preferred biologic products. 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 moderate to severe RA.

c.   The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

d.   The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (see Table 1).

 

2.     Juvenile Idiopathic Arthritis (JIA)

When a benefit, coverage of Orencia SC may be approved for JIA when all of the following criteria are met (a. through d.):

a.    The member is 2 years of age or older.

b.    The member has a diagnosis of moderate to severe JIA.

c.     The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to at least one (1) nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine), or all nonbiologic DMARDs are contraindicated.

ii.  The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.

d.  The member has experienced therapeutic failure or intolerance to two step 1 (Enbrel, Humira) or step 2 (Actemra) agents for the treatment of JIA (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. through iv.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of spinal or axial PsA.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

b.  PsA without spinal or axial disease (i. through iv.):

i.    The member is 18 years of age or older.

ii.    The member has a diagnosis of PsA without spinal disease.

iii.   The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

iv.   The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

c.  Enthesitis and/or dactylitis associated PsA (i. through iv.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

 

C.     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.

 

D.      Quantity Limitations

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
RA, JIA, PsA	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., and iii.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of spinal or axial PsA.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

b.     PsA without spinal or axial disease (i., ii., and iii.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of PsA without spinal disease.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

c.     Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):

i.    The member is 18 years of age or older.

ii.   The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

 

2.     Plaque Psoriasis (PsO)

When a benefit, coverage of Otezla may be approved for PsO when all of the following criteria are met (a., b., and c.):

a.    The member is 18 years of age or older.

b.    The member has a diagnosis of moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), 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. through d.):

a.  The member is 18 years of age or older.

b.  The member has a diagnosis of oral ulcers associated with Behçet’s Disease.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) topical triamcinolone product for acute flare-up of oral ulcers.

d.  The member has experienced therapeutic failure or intolerance to colchicine for prevention of recurrent oral ulcers.

 

B.     Reauthorization

When a benefit, reauthorization of Otezla may be approved when the following criterion is met (1.):

1.  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 moderate to severe 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 moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsO (see Table 1).

 

Maintenance (≥ 4 months previous therapy for Siliq)

When a benefit, maintenance of Siliq may be approved for PsO when all of the following criteria are met (a. through e.):

a.    The member is 18 years of age or older.

b.    The member has a diagnosis of moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsO (see Table 1).

e.  Improvement in the physician's global assessment score, psoriasis area severity index score, or a decrease in the affected body surface area of psoriatic plaque lesions has been documented.

 

B.     Reauthorization

When a benefit, reauthorization of Siliq may be approved when the following criterion is met (1.):

1.  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
PsO	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 moderate to severe

c.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all nonbiologic DMARDs are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (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.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of AS (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. through iv.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of spinal or axial PsA.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

b.    PsA without spinal or axial disease (i. through iv.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of PsA without spinal disease.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

c.    Enthesitis and/or dactylitis associated PsA (i. through iv.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

 

4.     Ulcerative Colitis (UC)

When a benefit, coverage of Simponi SC may be approved for UC when all of the following criteria are met (a., b., and c.):

a.  The member is 18 years of age or older.

b.  The member has a diagnosis of moderate or severe UC.

c.  The member has experienced therapeutic failure or intolerance to preferred biologic product (Humira) for the treatment of UC (see Table 1).

 

B.     Reauthorization

When a benefit, reauthorization of Simponi SC may be approved when the following criterion is met (1.):

1.  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
RA, AS, PsA	One (1) 50 mg syringe/ autoinjector within the first four (4) weeks of therapy	One (1) 50 mg syringe/ autoinjector every four (4) weeks
UC	Three (3) 100 mg syringes/ autoinjector within the first four (4) weeks of therapy	One (1) 100 mg syringe/ autoinjector 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 moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), 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
PsO	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.

iii.  Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

c.  Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of enthesitis and/or dactylitis associated with PsA.

iii.  When treatment with (1. or 2.):

1.  At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated.

2.  All NSAIDs and all local glucocorticoid injections are contraindicated.

 

2.    Plaque Psoriasis (PsO)

When a benefit, coverage of Stelara may be approved for PsO when all of the following criteria are met (a., b., and c.):

a.   The member is 6 years of age or older.

b.   The member has a diagnosis of moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

 

3.     Crohn’s Disease (CD)

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 moderate to severe CD.

c.    The member received a single induction dose of Stelara IV within 2 months of initiating therapy with Stelara SC and achieved clinical response or remission.

d.    The member meets one (1) of the following criteria (i., ii., or iii.):

i.  The member is currently pregnant.

ii.  The member has experienced therapeutic failure or intolerance to at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate), 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

 

4.     Ulcerative Colitis (UC)

When a benefit, coverage of Stelara may be approved for 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 or severe UC.

c.   The member received a single induction dose of Stelara IV within 2 months of initiating therapy with Stelara SC and achieved clinical response or remission.

d.  The member has experienced therapeutic failure or intolerance to preferred product Humira for the treatment of UC. Note: A trial of a Remicade, Inflectra, Entyvio, or Simponi SC would be accepted.

 

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 (18 years of age or older)

a.  ≤ 100 kg (220 lbs): 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.

b.  > 100 kg (220 lbs): 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

.   Psoriasis (6 to 17 years of age)

a.  < 60 kg (132 lbs): 0.75 mg/kg initially and 4 weeks later, followed by 0.75 mg/kg every 12 weeks.

b.  60 to 100 kg (220 lbs): 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.

c.  > 100 kg (220 lbs): 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

.    Psoriatic Arthritis

a.  45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks

b.  For patients with co-existent moderate-to-severe plaque psoriasis weighing > 100 kg (220 lbs): 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

.    Crohn's Disease

a.  Following a weight-based intravenous dose, the recommended dose is 90 mg 8 weeks following the intravenous dose, then every 8 weeks thereafter.

.    Ulcerative Colitis

a.  Following a weight-based intravenous dose, the recommended dose is 90 mg 8 weeks following the intravenous dose, then every 8 weeks thereafter.

 

C.     Quantity Limitations

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
PsA, PsO	Two (2) prefilled syringes within the first four (4) weeks of therapy	One (1) syringe every eighty four (84) days (12 weeks)
CD, UC	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. through iv.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of spinal or axial PsA.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

b.  PsA without spinal or axial disease (i. through iv.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of PsA without spinal disease.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

c.      Enthesitis and/or dactylitis associated PsA (i. through iv.):

i.     The member is 18 years of age or older.

ii.    The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.   The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

iv.   The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (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 6 years of age or older.

b.    The member has a diagnosis of moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

d.  If the member is 18 years of age or older, the member has experienced therapeutic failure or intolerance to at least three (3) preferred biologic products for the treatment of PsO (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.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

d.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of AS (see Table 1).

 

4.  Non-radiographic Axial Spondyloarthritis (nr-axSpA)

When a benefit, coverage of Taltz may be approved for nr-axSpA when all of the following criteria are met (a., b., and c.):

a.  The member is 18 years of age or older.

b.  The member has a diagnosis of nr-axSpA.

c.  The member has experienced therapeutic failure or intolerance to at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs), or all NSAIDs are contraindicated.

 

B.     Reauthorization

When a benefit, reauthorization of 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
PsO with or without PsA	Eight (8) autoinjector/prefilled syringes within the first twelve (12) weeks of therapy	One (1) autoinjector/prefilled syringe every four (4) weeks
PsA, AS	Two (2) autoinjector/prefilled syringes within the first four (4) weeks of therapy	One (1) autoinjector/prefilled syringe every four (4) weeks
nr-axSpA	N/A	One (1) autoinjector/prefilled syringe every four (4) weeks

N/A=Not Applicable

 

XVII.  Tremfya (guselkumab)

 

A.    Initial Authorization

 

1.     Psoriatic Arthritis (PsA)

When a benefit, coverage of Tremfya may be approved for PsA when one (1) of the following criteria are met (a., b., or c.):

a.    Spinal or axial PsA (i. through iv.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of spinal or axial PsA.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

b.    PsA without spinal or axial disease (i. through iv.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of PsA without spinal disease.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

c.     Enthesitis and/or dactylitis associated PsA (i. through iv.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

iv.  The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).

 

2.     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 moderate to severe PsO.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.

ii.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), 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
PsO	Two (2) prefilled syringes (100 mg/mL) per 28 days	One (1) prefilled syringe per 56 days

 

 

XIII.  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 moderate to severe RA.

c.  The member has experienced therapeutic failure or intolerance to methotrexate.

 

2.     Juvenile Idiopathic Arthritis (JIA)

When a benefit, coverage of Xeljanz tablet or Xeljanz oral solution may be approved for JIA when all of the following criteria are met (a. through d.):

a.    The member is 2 years of age or older.

b.    The member has a diagnosis of JIA.

c.    The member meets one (1) of the following criteria (i. or ii.):

i.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine), or all non-biologic DMARDs are contraindicated.

ii.  The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.

d.  The member has experienced therapeutic failure or intolerance to two step 1 (Enbrel, Humira) or step 2 (Actemra) agents for the treatment of JIA (see Table 1).

 

3.     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.  The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.

b.  PsA without spinal or axial disease (i., ii., and iii.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of PsA without spinal disease.

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.

c.    Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):

i.  The member is 18 years of age or older.

ii.  The member has a diagnosis of enthesitis and/or dactylitis associated with PsA

iii.  The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.

 

4.     Ulcerative Colitis (UC)

When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for UC when all of the following criteria are met (a., b., and c.):

a.  The member is 18 years of age or older.

b.  The member has a diagnosis of moderate or severe UC.

c.  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 non-biologic agent.

XX.  An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.

I.   For Commercial and HCR members, coverage of drug(s) addressed in this policy for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

II.  For Commercial and HCR members with a closed formulary, a non-formulary product will only be approved if the member meets the criteria for a formulary exception in addition to the criteria outlined within this policy.

 

Initial Authorization

 

• Commercial and HCR Plans:
• For all medications listed (except Siliq):
• If approved, up to a 12 month authorization may be granted.
• For Siliq:
• If approved for initiation therapy, up to a 4 month authorization may be granted.
• If approved for maintenance therapy, up to a 12 month authorization may be granted.

 

Reauthorization

 

• Commercial and HCR Plans: If approved, up to a 12 month authorization may be granted.

None