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

 

	RA	AS	JIA	PsA	PsO	CD	UC	nr-axSpA
Step 1 Preferred	Enbrel, Humira	Cosentyx, Enbrel, Humira	Enbrel, Humira	Cosentyx, Enbrel, Humira, Otezla, Skyrizi, Stelara SC, Tremfya	Cosentyx, Humira, Otezla, Skyrizi, Stelara SC, Tremfya, Enbrel	Humira,	Humira, Stelara SC	Cimzia,
						Stelara SC		Cosentyx
Step 2 Non-Preferred (directed to ONE Step 1 agent)	Actemra SC1, Rinvoq, Xeljanz/ Xeljanz XR tablets	Xeljanz/  Xeljanz XR tablets3	Actemra SC1-2, Xeljanz tablets/ oral solution	Rinvoq3, Xeljanz/  Xeljanz XR tablets3		Cimzia1	Simponi SC1, Xeljanz/Xeljanz XR tablet1	--
Step 3a Non-Preferred (directed to TWO Step 1 or 2 agents)	Cimzia, Kevzara, Kineret, Olumiant, Orencia, SC, Simponi SC	Cimzia, Simponi SC, Taltz	Orencia SC	Cimzia, Simponi SC, Orencia SC, Taltz	Cimzia, Siliq, Ilumya	--	--	Taltz
Step 3b Non-Preferred (directed to THREE Step 1 agents)	--	--	--	--	Taltz	--	--	--

¹ Directed to Humira specifically.

² Actemra SC will require a trial of Humira first for Polyarticular Juvenile Idiopathic Arthritis (PJIA) indication only. 

³ Directed specifically to Enbrel or Humira.  

 

I.   Actemra (tocilizumab)

 

A.     Initial Authorization

1.     Rheumatoid Arthritis (RA)(ICD-10: M05, M06)

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

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

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

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

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

 

2.    Giant Cell Arteritis (GCA)) (ICD-10: M31.5, M31.6)

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

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

b.  The member has a diagnosis of GCA.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) systemic corticosteroid (e.g., prednisone), or all corticosteroids are contraindicated.

3.    Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) (ICD-10: M34.81)

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

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

b.  The member has a diagnosis of SSc-ILD.

c.  The member has experienced therapeutic failure or intolerance to at least one (1) immunosuppressant (e.g., mycophenolate mofetil, corticosteroids, azathioprine, cyclophosphamide) or all immunosuppressants are contraindicated

 

4.    Polyarticular Juvenile Idiopathic Arthritis (PJIA)(ICD-10: M08.4)

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

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

b.  The member has a diagnosis of PJIA.

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

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

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

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

 

5.     Systemic Juvenile Idiopathic Arthritis (SJIA)(ICD-10: M08)

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

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

b.  The member has a diagnosis of SJIA.

 

B.  Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.    Quantity Limitations

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

 

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
SSc-ILD	N/A	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

 

N/A=not applicable

 

II.  Cimzia (certolizumab)

 

A.  Initial Authorization

1.     Rheumatoid Arthritis (RA)(ICD-10: M05, M06)

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

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

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

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

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

 

2.     Ankylosing Spondylitis (AS)(ICD-10: M45 excluding M45.A)

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

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

b.  The member has a diagnosis of AS.

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

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

 

3.    Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.    Spinal or axial PsA

When a benefit, coverage of Cimzia may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

b.    PsA without spinal or axial disease

When a benefit, coverage of Cimzia may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

c.      Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Cimzia may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

 

4.    Crohn’s Disease (CD)(ICD-10: K50)

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

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

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

c.    The member has experienced therapeutic failure or intolerance to plan-preferred Humira for the treatment of CD (see Table 1).

 

5.     Plaque Psoriasis (PsO)(ICD-10: L40, excluding L40.5)

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

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

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

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

i.   The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) 

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

iii.  The member is contraindicated to both phototherapy and systemic therapy

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

 

6.     Non-radiographic Axial Spondyloarthritis (nr-axSpA)(ICD-10: M45.A)

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

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

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

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

 

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.    Quantity Limitations

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

 

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.
• Coding of quantity level limitations is at the maintenance therapy threshold except for PsO

 

III.  Cosentyx (secukinumab)

 

A.  Initial Authorization

1.     Ankylosing Spondylitis (AS)(ICD-10: M45)

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

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

b.  The member has a diagnosis of AS.

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

 

2.    Psoriatic Arthritis (PsA)(ICD-10: 5)

a.    Spinal or axial PsA

When a benefit, coverage of Cosentyx may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

b.     PsA without spinal or axial disease

When a benefit, coverage of Cosentyx may be approved when all of the following criteria are met (i., ii., and iii.)

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

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

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

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Cosentyx may be approved when all of the following criteria are met (i., ii., and iii.)

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

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

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

 

3.    Plaque Psoriasis (PsO), including Scalp Psoriasis (ICD-10: L40, excluding L40.5)

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

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

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

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

i.   The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) 

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

iii.  The member is contraindicated to both phototherapy and systemic therapy.

 

4.    Non-radiographic Axial Spondyloarthritis (nr-axSpA)(ICD-10: M45.A)

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

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

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

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

 

5.     Enthesitis-Related Arthritis (ERA) (ICD-10: M08.80)

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

a.  The member is 4 years of age or older.

b.  The member has a diagnosis of active ERA.

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

 

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.    Quantity Limitations

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

 

 

Diagnosis	Induction Therapy	Maintenance Therapy
AS	One (1) or Five (5) pens/prefilled syringes (150 mg/mL) within the first four (4) weeks of therapy	One (1) or Two (2) pens/prefilled syringes (150 mg/mL) every four (4) weeks
Adult PsA††	One (1) or Five (5)) pens/prefilled syringes (150 mg/mL) within the first four (4) weeks of therapy	One (1) or Two (2) pens/prefilled syringes (150 mg/mL) every four (4) weeks
ERA and Pediatric PsA (≥ 50 kg)*,^	Five (5) pens/prefilled syringes (150 mg/mL) within the first four (4) weeks of therapy	One (1) pen/prefilled syringe (150 mg/mL) every four (4) weeks
ERA and Pediatric PsA (≥ 15 kg to < 50 kg)*	Five (5) prefilled syringes (75 mg/mL) within the first four (4) weeks of therapy	One (1) prefilled syringe (75mg/mL) every four (4) weeks
Adult PsO with or without PsA, scalp PsO*,†	Ten (10) pens/prefilled syringes (150 mg/mL) within the first four (4) weeks of therapy	One (1) or Two (2) pens/prefilled syringes (150 mg/mL) every four (4) weeks
Pediatric PsO (≥ 50 kg)*,^	Five (5) pens/prefilled syringes (150 mg/mL) within the first four (4) weeks of therapy	One (1) pen/prefilled syringe (150 mg/mL) every four (4) weeks
Pediatric PsO (< 50 kg)*	Five (5) prefilled syringes (75 mg/mL) within the first four (4) weeks of therapy	One (1) prefilled syringe (75mg/mL) every four (4) weeks
nr-axSpA	One (1) or Five (5) pens/prefilled syringes (150 mg/mL) within the first four (4) weeks of therapy	One (1) pen/prefilled syringe (150 mg/mL) every four (4) weeks

Pediatric patients with PsO or PsA may require 3 pens/prefilled syringes within a four (4) week time frame if switching from pediatric dosing (75mg/mL) to adult dosing (300mg/2mL).

^ Pediatric patients with PsO, PsA, or ERA (≥ 50 kg) are subject to dose optimization of one (1) pen/prefilled syringe (150 mg/mL) every four (4) weeks.

^† Adult patients < 50 kg with PsO are subject to adult dosing recommendations and quantity limits.

^†† For adult PsA patients with coexistent moderate to severe PsO, use the dosing for adult PsO.
      

  

IV.  Enbrel (etanercept)

 

A.  Initial Authorization

1.    Rheumatoid Arthritis (RA)(ICD-10: M05, M06)

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

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

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

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

 

2.     Ankylosing Spondylitis (AS)(ICD-10: M45, excluding M45.A)

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

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

b.  The member has a diagnosis of AS.

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

 

3.    Juvenile Idiopathic Arthritis (JIA)(ICD-10: M08.9)

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

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

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

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

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

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

 

4.    Psoriatic Arthritis (PsA)(ICD-10: L40.5)

a.     Spinal or axial PsA

When a benefit, coverage of Enbrel may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

b.     PsA without spinal or axial disease

When a benefit, coverage of Enbrel may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

c.    Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Enbrel may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

 

5.    Plaque Psoriasis (PsO), adults (ICD-10: L40, excluding L40.5)

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

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

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

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

i.   The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). 

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

iii.  The member is contraindicated to both phototherapy and systemic therapy

 

6.     Plaque Psoriasis (PsO), pediatrics (ICD-10: L40, excluding L40.5)

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

a.    The member is ≥ 4 and < 18 years of age.

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

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

i.   The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB)

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

iii.  The member is contraindicated to both phototherapy and systemic therapy

  

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.    Quantity Limitations

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

 

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) (ICD-10: M05, M06)

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

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

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

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

 

2.    Ankylosing Spondylitis (AS) (ICD-10: M45, excluding M45.A)

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

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

b.   The member has a diagnosis of AS.

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

 

3.    Juvenile Idiopathic Arthritis (JIA) (ICD-10: M08.9)

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

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

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

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

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

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

 

4.      Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.     Spinal or axial PsA

When a benefit, coverage of Humira may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

b.    PsA without spinal or axial disease

When a benefit, coverage of Humira may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Humira may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

 

5.     Plaque Psoriasis (PsO) (ICD-10: L40, excluding L40.5)

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

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

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

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

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB)

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

iii.   The member is contraindicated to both phototherapy and systemic therapy.

 

6.    Crohn’s Disease (CD), adults (ICD-10: K50)

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

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

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

 

7.    Ulcerative Colitis (UC) (ICD-10: K51)

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

a.  The member is 5 years of age or older.

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

 

8.    Hidradenitis Suppurativa (HS) (ICD-10: L37.2)

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

a.  The member is 12 years of age or older.

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

 

9.  Uveitis (UV) (ICD-10: H44.1)

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

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

b.  The member has a diagnosis of non-infectious intermediate, posterior or panuveitis.

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

 

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.    Quantity Limitations

When prior authorization is approved, Humira pre-filled syringes, pens, or auto-injectors may be authorized in quantities as follows:

 

 

Diagnosis	Induction Therapy	Maintenance Therapy
RA, AS, PsA	N/A	Two (2) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  every four (4) weeks
RA*	N/A	Four (4) prefilled pen/syringes (40 mg/0.4 mL or 40 mg/0.8 mL) every four (4) weeks (Without concurrent methotrexate therapy) -OR- Two (2) prefilled pens/syringes (80 mg/0.8 mL) every four (4) weeks (Without concurrent methotrexate therapy)
JIA, pediatric UV	N/A	Two (2) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL) every four (4) weeks
chronic PSO	Four (4) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL) within the first four (4) weeks of therapy   -OR-   One (1) starter package kit	Two (2) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL) every four (4) weeks   -OR-   Four (4) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL) every four (4) weeks†
adult CD	Six (6) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL) within the first four (4) weeks of therapy   -OR-   Three (3) prefilled pens/syringes (80 mg/0.8 mL) within the first four (4) weeks of therapy   -OR-   One (1) starter package kit	Two (2) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  every four (4) weeks   -OR-   Four (4) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  every four (4) weeks†
pediatric CD (37 lbs - 88 lbs)	Three (3) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  within the first four (4) weeks of therapy   -OR-   One (1) starter package kit	Two (2) prefilled pens/syringes (20 mg/0.2 mL or 20 mg/0.4 mL) every four (4) weeks   -OR-   Four (4) prefilled pens/syringes (20 mg/0.2 mL or 20 mg/0.4 mL)  every four (4) weeks†
pediatric CD (≥ 88 lbs)	Six (6) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  within the first four (4) weeks of therapy   -OR- Three (3) prefilled pens/syringes (80 mg/0.8 mL) within the first four (4) weeks of therapy   -OR-   One (1) starter package kit	Two (2) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL) every four (4) weeks -OR- Four (4) prefilled syringes (40 mg/0.4 mL or 40 mg/0.8 mL) every four (4) weeks†
adult UC	Six (6) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  within the first four (4) weeks of therapy   -OR- Three (3) prefilled pens/syringes (80 mg/0.8 mL) within the first four (4) weeks of therapy   -OR- One (1) starter package kit	Two (2) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  every four (4) weeks   -OR-   Four (4) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  every four (4) weeks†
pediatric UC (44 lbs - 88 lbs)	Four (4) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  within the first four (4) weeks of therapy	Two (2) prefilled pens/syringes(40 mg/0.4 mL or 40 mg/0.8 mL)  every four (4) weeks   -OR-   Four (4) prefilled pens/syringes (20 mg/0.4 mL or 20 mg/0.2 mL) every four (4) weeks††
pediatric UC (≥ 88 lbs)**	Eight (8) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL) within the first four (4) weeks of therapy   -OR- Four (4) prefilled pens/syringes (80 mg/0.8 mL) within the first four (4) weeks of therapy -OR-   One (1) starter package kit	Four (4) prefilled pens/syringes(40 mg/0.4 mL or 40 mg/0.8 mL)   every four (4) weeks   -OR-   Two (2) prefilled pens/syringes (80 mg/0.8 mL) every four (4) weeks
HS in adults and adolescents (12 years and older) ≥ 60 kg*	Seven (7) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL) within the first four (4) weeks of therapy   -OR-   One (1) starter package kit	Four (4) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  every four (4) weeks -OR- Two (2) prefilled pens/syringes (80 mg/0.8 mL) every four (4) weeks
HS in adolescents (12 years and older) 30 kg to < 60 kg*	Five (5) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  within the first four (4) weeks of therapy   -OR-   One (1) starter package kit	Two (2) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  every four (4) weeks
adult UV	Four (4) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  within the first four (4) weeks of therapy -OR- One (1) starter package kit	Two (2) prefilled pens/syringes (40 mg/0.4 mL or 40 mg/0.8 mL)  every four (4) weeks

N/A=not applicable

• *Patients diagnosed with rheumatoid arthritis (without concurrent methotrexate therapy) or hidradenitis suppurativa may receive weekly dosing of Humira prefilled syringes. Patient Level Authorization (PLA) input - Retail: 4 syringes; Mail: 12 syringe
• ** Continuation of pediatric UC dosing in patients who turn 18 years of age may be approved when documentation of stability or beneficial response to therapy.
• Coding of quantity level limitations is at the maintenance therapy threshold except for RA, HS, and pediatric UC weekly dosing administration.
• ^†Four (4) prefilled syringes every four (4) weeks may be approved when there is clinical documentation that treatment with two (2) prefilled syringes every four (4) weeks was ineffective.
• ^†† Only Humira 20 mg prefilled syringe may be approved for every week dosing.
• Humira starter packs have a quantity limit of 1 kit per 274 days but can be billed as a quantity/dispensing size of 2, 3, 4, or 6 pens or syringes depending on indication

 

 VI.  Ilumya (tildrakizumab-asmn)

A.    Initial Authorization

1.    Plaque Psoriasis (PsO) (ICD-10: L40, excluding L40.5)

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

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

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

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

i.    The member has experienced therapeutic failure or intolerance to phototherapy (e.g., PUVA, UVB).

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

iii.  The member is contraindicated to both phototherapy and systemic therapy

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

 

B.     Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

C.    Quantity Limitations

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

Diagnosis	Induction Therapy	Maintenance Therapy
PsO	Two (2) prefilled syringes within the first four (4) weeks of therapy	One (1) prefilled syringe every twelve (12) weeks

• Ilumya is coded as MSI to reject for prior authorization if select groups do not take global exclusion benefit.

 

VII.  Kevzara (sarilumab)

 

A.    Initial Authorization

1.    Rheumatoid Arthritis (RA) (ICD-10: M05, M06)

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

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

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

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

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

 

B.     Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.     Quantity Limitations

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

 

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

 

VIII.  Kineret (anakinra)

 

A.    Initial Authorization

1.    Rheumatoid Arthritis (RA) (ICD-10: M05, M06)

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

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

b.  The member has a diagnosis of RA.

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

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

 

2.     Neonatal-Onset Multisystem Inflammatory Disease (NOMID) (ICD-10: M04.2)

When a benefit, coverage of Kineret may be approved when the following criterion is met (a.):

a.  The member has a diagnosis of NOMID.

 

3.     Deficiency of Interleukin-1 Receptor Antagonist (DIRA) (ICD-10: M04.8)

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

a.  The member has a diagnosis of DIRA.

b.  The member has experienced therapeutic failure or intolerance to at least one (1) corticosteroid, or all corticosteroids are contraindicated.

 

B.     Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

Dosing

In addition to the initial authorization and reauthorization criteria outlined above, documentation that member weight and prescribed Kineret dose is consistent with dosing below:

*NOMID and DIRA: The recommended starting dose is 1-2 mg/kg daily. The dose can be individually adjusted to a maximum of 8 mg/kg daily. Kineret may be divided into twice daily dosing. A new syringe must be used for each dose and any unused portion after each dose should be discarded

 

C.     Quantity Limitations

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
RA, NOMID*, DIRA*	One (1) prefilled syringe once daily	One (1) prefilled syringe once daily

 

IX.  Olumiant (baricitinib)

 

A.    Initial Authorization

1.     Rheumatoid Arthritis (RA) (ICD-10: M05, M06)

When a benefit, coverage of Olumiant may be approved when all of the following criteria are met (a. through e.):

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

b.    The member has a diagnosis of moderate to severely active RA.

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

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

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

i.  To note: If the member has tried and failed Humira and Enbrel, the member will not need to try and fail any additional plan-preferred biologic products. If the member has tried and failed either Humira or Enbrel, the member will need to try and fail one (1)  additional plan-preferred biologic product.

 

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

X.  Orencia (abatacept)

 

A.    Initial Authorization

1.     Rheumatoid Arthritis (RA) (ICD-10: M05, M06)

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

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

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

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

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

 

2.    Juvenile Idiopathic Arthritis (JIA) (ICD-10: M08.9)

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

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

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

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

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

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

d.  The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of JIA (see Table 1)

 

3.     Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.     Spinal or axial PsA

When a benefit, coverage of Orencia may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

b.    PsA without spinal or axial disease

When a benefit, coverage of Orencia may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Orencia may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

 

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.     Quantity Limitations

 

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

 

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

 

XI.  Otezla (apremilast)

 

A.    Initial Authorization

1.     Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.     Spinal or axial PsA

When a benefit, coverage of Otezla may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

b.    PsA without spinal or axial disease

When a benefit, coverage of Otezla may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

c.      Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Otezla may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

 

2.     Plaque Psoriasis (PsO) (ICD-10: L40, excluding L40.5)

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

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

b.    The member has a diagnosis of PsO.

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

i.    The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB)

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

iii.   The member is contraindicated to both phototherapy and systemic therapy.

 

 3.     Oral Ulcers associated with Behçet’s Disease (ICD-10: M35.2)

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

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

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

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

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

 

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

XII.  Rinvoq (upadacitinib)

 

A.    Initial Authorization

1.     Rheumatoid Arthritis (RA) (ICD-10: M05, M06)

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

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

b.  The member has a diagnosis of moderate to severely active RA.

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

d.  The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of RA (see Table 1).

2.     Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.     Spinal or axial PsA

When a benefit, coverage of Rinvoq may be approved when all of the following criteria are met (i. through iv.):

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

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

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

iv.  The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1).

b.     PsA without spinal or axial disease

When a benefit, coverage of Rinvoq may be approved when all of the following criteria are met (i. through iv.):

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

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

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

iv.  The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1).

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Rinvoq may be approved when all of the following criteria are met (i. through iv.):

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

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

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

iv.  The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1).

3.     Atopic Dermatitis

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

a.     The member is 12 years of age or older.

b.    A specialist (dermatologist, allergist, or immunologist) submits attestation that the member has a diagnosis of atopic dermatitis (ICD-10: L20) classified as all of the following (i. and ii.):

i.      Moderate-to-severe

ii.     Refractory

c.     The member meets all of the following criteria (i. and ii.):

i.      The member meets one (1) of the following criteria (A), B), or C)):

A)    The member has experienced therapeutic failure or intolerance to one (1) generic topical corticosteroid.

B)    The member has atopic dermatitis with facial or anogenital involvement.

C)    The prescriber submits documentation that the member has severe atopic dermatitis and topical corticosteroids would not be advisable for maintenance therapy as evidenced by one (1) of the following (1) or 2)):

1)    The member is incapable of applying topical therapies due to the extent of body surface area (BSA) involvement.

2)    Topical therapies are contraindicated due to severely damaged skin.

ii.     The member meets one (1) of the following criteria (A) or B)):

A)    The member has experienced therapeutic failure or intolerance to one (1) generic topical calcineurin inhibitor (i.e., tacrolimus, pimecrolimus)

B)    The prescriber submits documentation that the member has severe atopic dermatitis and topical calcineurin inhibitors would not be advisable for maintenance therapy as evidenced by one (1) of the following (1) or 2)):

1)    The member is incapable of applying topical therapies due to the extent of body surface area (BSA) involvement.

2)    Topical therapies are contraindicated due to severely damaged skin.

d.     The member has experienced therapeutic failure or intolerance to one (1) systemic therapy for atopic dermatitis, or all systemic therapies are contraindicated.

 

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

 

XIII.  Siliq (brodalumab)

 

A.    Initial Authorization

1.     Plaque Psoriasis (PsO)(ICD-10: L40, excluding L40.5)

When a benefit, initiation of Siliq may be approved when all of the following criteria are met (a. through d.)

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

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

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

i.   The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) 

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

iii.  The member is contraindicated to both phototherapy and systemic therapy

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

  

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.    Quantity Limitations

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

 

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

 

 

XIV.  Simponi (golimumab)

 

A.     Initial Authorization

1.     Rheumatoid Arthritis (RA) (ICD-10: M05, M06)

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

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

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

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

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

 

2.     Ankylosing Spondylitis (AS) (ICD-10: M45, excluding M45.A)

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

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

b.  The member has a diagnosis of AS.

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

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

 

3.     Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.     Spinal or axial PsA

When a benefit, coverage of Simponi SC may be approved when all of the following criteria are met (i. through iv.)

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

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

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

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

b.    PsA without spinal or axial disease

When a benefit, coverage of Simponi SC may be approved when all of the following criteria are met (i. through iv.)

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

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

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

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

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Simponi SC may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

 

4.     Ulcerative Colitis (UC) (ICD-10: K51)

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

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

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

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

 

B.  Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.     Quantity Limitations

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

 

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

 

XV.  Skyrizi (risankizumab)

 

A.     Initial Authorization

1.    Plaque Psoriasis (PsO) (ICD-10: L40.0-L40.4; L40.8-L40.9)

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

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

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

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

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) 

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

iii.  The member is contraindicated to both phototherapy and systemic therapy.

2.     Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.     Spinal or axial PsA  

When a benefit, coverage of Skyrizi may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

b.    PsA without spinal or axial disease

When a benefit, coverage of Skyrizi may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Skyrizi may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

 B.  Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.     Quantity Limitations

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
PsO, PsA	Two (2) prefilled syringes/pens (150 mg/mL) within the first four (4) weeks of therapy   -OR-   Four (4) prefilled syringes (75 mg/0.83 mL) per 28 days within the first four (4) weeks of	One (1) prefilled syringe/pen (150 mg/mL) every twelve (12) weeks   -OR-   Two (2) prefilled syringes (75 mg/0.83 mL) every twelve (12) weeks

 

XVI.  Stelara (ustekinumab)

 

A.    Initial Authorization

1.    Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.    Spinal or axial PsA

When a benefit, coverage of Stelara may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

b.     PsA without spinal or axial disease

When a benefit, coverage of Stelara may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Stelara may be approved when all of the following criteria are met (i., ii., and iii.)

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

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

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

 

2.     Plaque Psoriasis (PsO) (ICD-10: L40, excluding L40.5)

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

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

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

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

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) 

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

iii.  The member is contraindicated to both phototherapy and systemic therapy.

 

3.     Crohn’s Disease (CD) (ICD-10: K50)

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

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

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

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

 

 

4.     Ulcerative Colitis (UC) (ICD-10: K51)

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

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

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

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

 

B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

Dosing

In addition to the initial authorization and reauthorization criteria outlined above, documentation that member weight and prescribed Stelara dose is consistent with dosing below:

.    Psoriasis (18 years of age or older)

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

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

 .    Psoriasis (6 to 17 years of age)

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

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

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

.      Psoriatic Arthritis

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

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

  .    Crohn's Disease

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

  .    Ulcerative Colitis

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

 

C.     Quantity Limitations

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
PsA, PsO	Two (2) prefilled syringes within the first four (4) weeks of therapy	One (1) syringe every twelve (12) weeks
CD*,†	N/A	One (1) syringe every eight (8) weeks  or  One (1) syringe every four (4) weeks
UC*	N/A	One (1) syring every eight (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 per 42 days.

•  ^†One (1) prefilled syringe every four (4) weeks may be approved for Crohn’s Disease if clinical documentation is provided that the member is a non-responder or partial responder to treatment with one (1) prefilled syringe every eight (8) weeks. PLA input – One (1) prefilled syringe per 21 days.

 

XVII.  Taltz (ixekizumab)

 

A.    Initial Authorization

1.    Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.     Spinal or axial PsA

When a benefit, coverage of Taltz may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

b.     PsA without spinal or axial disease

When a benefit, coverage of Taltz may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Taltz may be approved when all of the following criteria are met (i. through iv.):

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

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

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

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

 

2.     Plaque Psoriasis (PsO) (ICD-10: L40, excluding L40.5)

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

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

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

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

i.  The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB)

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

iii.  The member is contraindicated to both phototherapy and systemic therapy.

d.  If the member is 18 years of age or older, the member has experienced therapeutic failure or intolerance to at least three (3) step 1 plan-preferred agents for the treatment of PsO (see Table 1).

 

3.     Ankylosing Spondylitis (AS) (ICD-10: M45, excluding M45.A) 

When a benefit, coverage of Taltz may be approved  when all of the following criteria are met (a. through d.)

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

b.  The member has a diagnosis of AS.

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

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

 

4.    Non-radiographic Axial Spondyloarthritis (nr-axSpA)(ICD-10: M45.A)

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

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

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

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

d.  The member has experienced therapeutic failure or intolerance to at least two (2) step 1 or 2 plan-preferred agents for the treatment of nr-axSpA (see Table 1).

 

B.     Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.     Quantity Limitations

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

 

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

 

XVIII.  Tremfya (guselkumab)

 

A.     Initial Authorization

 

1.    Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.     Spinal or axial PsA

When a benefit, coverage of Tremfya may be approved  when all of the following criteria are met (i., ii., and iii.):

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

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

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

b.     PsA without spinal or axial disease

When a benefit, coverage of Tremfya may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Tremfya may be approved when all of the following criteria are met (i., ii., and iii.):

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

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

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

 

2.    Plaque Psoriasis (PsO) (ICD-10: L40, excluding L40.5)

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

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

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

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

i.   The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB) 

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

iii.  The member is contraindicated to both phototherapy and systemic therapy.

 

 B.    Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

C.     Quantity Limitations

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
PsA. PsO	Two (2) prefilled syringes (100 mg/mL) per 28 days within the first four (4) weeks of therapy	One (1) prefilled syringe every eight (8) weeks

 

 

XIX.  Xeljanz (tofacitinib)

 

A.    Initial Authorization

1.     Rheumatoid Arthritis (RA) (ICD-10: M05, M06)

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

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

b.     The member has a diagnosis of moderate to severely active RA.

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

d.     The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of RA (see Table 1).

 

2.     Juvenile Idiopathic Arthritis (JIA) (ICD-10: M08.9)

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

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

b.     The member has a diagnosis of JIA.

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

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

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

d.     The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of JIA (see Table 1).

 

3.     Psoriatic Arthritis (PsA) (ICD-10: L40.5)

a.     Spinal or axial PsA  

When a benefit, coverage of Xeljanz or Xeljanz XR may be approved when all of the following criteria are met (i. through iv.):

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

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

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

iv.    The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1).

b.     PsA without spinal or axial disease

When a benefit, coverage of Xeljanz or Xeljanz XR may be approved when all of the following criteria are met (i. through iv.):

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

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

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

iv.    The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1).

c.     Enthesitis and/or dactylitis associated PsA

When a benefit, coverage of Xeljanz or Xeljanz XR may be approved when all of the following criteria are met (i. through iv.):

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

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

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

iv.    The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of PsA (see Table 1).

 

4.   Ulcerative Colitis (UC) (ICD-10: K51)

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

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

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

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

 

5.     Ankylosis Spondylitis (AS) (ICD-10: M45, excluding M45.A)

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

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

b.     The member has a diagnosis of AS.

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

d.     The member has experienced therapeutic failure or intolerance to plan-preferred Humira or Enbrel for the treatment of AS (see Table 1).

 

B.  Reauthorization

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

1.  The prescriber attests that the member has demonstrated disease stability or a beneficial response to therapy.

 

XX.    If the patient has already had a trial of at least one biologic agent the patient is not required to “step back” and try a non-biologic agent.

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

 

I.      Coverage of drug(s) addressed in this policy for disease states outside of the FDA-approved indications should be denied based on the lack of clinical data to support effectiveness and safety in other conditions unless otherwise noted in the approval criteria.

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.

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

 

None