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

	Rheumatoid Arthritis	Ankylosing Spondylitis	Juvenile Idiopathic Arthritis	Psoriatic Arthritis	Plaque Psoriasis	Crohn’s Disease	Ulcerative Colitis
Preferred	Actemra SC	Cosentyx	Enbrel	Cosentyx	Cosentyx	Humira	Humira
	Enbrel	Enbrel	Humira	Enbrel	Humira	Stelara SC
	Humira	Humira		Humira	Otezla
	Xeljanz, Xeljanz XR			Stelara SC	Stelara SC
Non-preferred (must try ONE preferred agent)	--	--	Orencia SC	Otezla	Enbrel1*	Cimzia	Simponi SC
							(100 mg)
Non-preferred (must try TWO preferred agents)	Cimzia	Cimzia	--	Cimzia	Taltz	--	--
	Kevzara	Simponi SC		Simponi SC	Siliq
	Kineret	(50 mg)		(50 mg)	Tremfya
	Orencia SC			Orencia SC
	Simponi SC			Taltz
	(50 mg)			Xeljanz, Xeljanz XR

¹Trial of Humira required. *Except in pediatric patients greater than or equal to 4 years of age but less than 18 years of age. (Other preferred products not requiring Humira first include: Cosentyx, Otezla, and Stelara for plaque psoriasis)

 

  I.    Actemra (tocilizumab)

 Actemra is a recombinant humanized anti-human interleukin-6 (IL-6) receptor inhibitor that works to inhibit IL-6 mediated actions at soluble and membrane bound IL-6 receptors. Inhibiting the signaling pathway can lead to inhibition of activated T- and B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 is also produced by synovial and endothelial cells which has an effect on the inflammatory process in rheumatoid arthritis.

 

FDA-Approved Indications:

1.      Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)

2.      Treatment of adult patients with giant cell arteritis (GCA)

 

A.    Initial Authorization  

1.     Rheumatoid Arthritis (ICD-9 714.0, ICD-10 M06.9)

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

a.     Actemra SC is to be used in adult patients with moderately to severely active rheumatoid arthritis (RA).

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for RA (e.g., Cimzia, Enbrel, Humira, infliximab product [e.g., Remicade, Renflexis, Inflectra], Simponi, Kevzara, Kineret, Orencia, or a rituximab product [e.g, Rituxan]), the patient is not required to “step back” and try a nonbiologic DMARD.

 

2.     Giant Cell Arteritis (ICD-9 446.5, ICD-10 M31.5 or M31.6)

When a benefit, Actemra SC will be approved for giant cell arteritis (GCA) when all of the following criteria are met (a. and b.):

a.     Actemra SC is to be used adult patients with giant cell arteritis (GCA).

b.    Treatment with at least one systemic corticosteroid (e.g., prednisone) was ineffective or not tolerated, or all corticosteroids are contraindicated.

 

B.    Reauthorization  

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations 

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis, giant cell arteritis	Four (4) prefilled syringes within the first four (4) weeks of therapy	Two (2) prefilled syringes every four (4) weeks -OR- Four (4) prefilled syringes every four (4) weeks

 

• Coding of quantity level limitations is at the maintenance therapy threshold.
• Claims for quantities of Actemra prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).

 

 

II.    Cosentyx (secukinumab)

 Cosentyx is a human monoclonal antibody that selectively neutralizes interleukin 17-A (IL-17A), which is found in high concentrations in skin affected by psoriasis.

 

FDA-Approved Indications:

1.     Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

2.     Treatment of adult patients with active psoriatic arthritis (PsA)

3.     Treatment of adult patients with moderate to severe chronic plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

 

A.    Initial Authorization

1.     Ankylosing Spondylitis (ICD-9 720.0, ICD-10 M45.X)

When a benefit, Cosentyx will be approved for ankylosing spondylitis (AS) when all of the following criteria are met (a. and b.):

a.     Cosentyx is to be used for the treatment of adults with ankylosing spondylitis.

b.    Treatment with a nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for AS (e.g., Cimzia, Enbrel, Humira, or Simponi), the patient is not required to “step back” and try an NSAID.

2.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Cosentyx may be approved for psoriatic arthritis (PsA) when one of the following criterion is met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i. and ii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID.

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i. and ii.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease.

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. 

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try a nonbiologic DMARD.

c.     Enthesitis and/or dactylitis associated psoriatic arthritis (i. and ii.):

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis

ii.    When treatment with (a. or b.):

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

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

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

3.     Plaque Psoriasis (ICD-9 696.1, ICD-10 L40.X)

When a benefit, Cosentyx will be approved for plaque psoriasis (PsO) when all of the following criteria are met (a. and b.):

a.    Cosentyx is to be used for the treatment of moderate to severe plaque psoriasis.

b.    One of the following criterion is met (i. or ii.):

i.      Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

ii.    Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsO (e.g., Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Siliq, Stelara, Taltz, or Tremfya), the patient is not required to “step back” and try phototherapy or a systemic agent.

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations

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

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

 

• Coding of quantity level limitations is at the maintenance therapy threshold.
• Claims for quantities of Cosentyx prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).

 

 

III.   Enbrel (etanercept) 

Enbrel inhibits the binding of tumor necrosis factor (TNF) α and β to cell surface TNF receptors. TNF is a pro-inflammatory cytokine that is involved in normal inflammatory and immune responses. The binding of etanercept to TNF, a naturally occurring cytokine involved in normal inflammatory and immune responses, renders it biologically inactive. 

 

FDA-Approved Indications: 

1.     Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

2.     Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

3.     Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA or JIA) in pediatric patients 2 years of age and older

4.     Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PsA)

5.     Treatment of patients 4 years or older with moderate to severe plaque psoriasis (PsO) who are candidates for systemic or phototherapy

 

A.    Initial Authorization  

1.     Rheumatoid Arthritis (ICD-9 714.0, ICD-10 M06.9)

When a benefit, Enbrel will be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a. and b.):

a.     Enbrel is to be used for the treatment of adults with rheumatoid arthritis (RA).

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. 

NOTE: If the patient has already had a trial of at least one biologic agent for RA (e.g., Actemra, Cimzia, Humira, infliximab product [e.g., Remicade, Renflexis, Inflectra], Simponi, Kevzara, Kineret, Orencia, or a rituximab product [e.g, Rituxan]), the patient is not required to “step back” and try a nonbiologic DMARD.

2.     Ankylosing Spondylitis (ICD-9 720.0, ICD-10 M45.X)

When a benefit, Enbrel will be approved for ankylosing spondylitis (AS) when all of the following criteria are met (a. and b.):

a.     Enbrel is to be used in the treatment of adults with ankylosing spondylitis.

b.    Treatment with a nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for AS (e.g., Cimzia, Cosentyx, Humira, or Simponi], the patient is not required to “step back” and try an NSAID. 

3.     Juvenile Idiopathic Arthritis (ICD-9 714.3x, ICD-10 M08.00)

When a benefit, Enbrel will be approved for juvenile idiopathic arthritis (JIA) when all of the following criteria are met (a. and b.):

a.     Enbrel is to be used for the treatment of juvenile idiopathic arthritis in patients ≥ 2 years of age.

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for JIA, (e.g., Humira or Orencia), the patient is not required to “step back” and try a nonbiologic DMARD. 

4.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Enbrel may be approved for psoriatic arthritis (PsA) when one of the following criterion is met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i. and ii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated. 

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID.

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i. and ii.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease.

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. 

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try a nonbiologic DMARD.

 c.     Enthesitis and/or dactylitis associated psoriatic arthritis (i. and ii.):

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis.

ii.    When treatment with (a. or b.): 

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

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

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

 

5.     Plaque Psoriasis, adults (ICD-9 696.1, ICD-10 L40.X)

When a benefit, Enbrel will be approved for chronic plaque psoriasis (PsO) when all of the following criteria are met (a., b., and c.):

a.     Enbrel is to be used for the treatment of adults 18 years of age and older with chronic plaque psoriasis.

b.    One of the following criteria are met (i. or ii.):

i.      Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

ii.    Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated. 

NOTE: If the patient has already had a previous trial of at least one biologic for PsO (e.g., Cosentyx, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Siliq, Stelara, Taltz, or Tremfya), the patient is not required to “step back” and try phototherapy or a systemic agent.

c.     When the following criterion is met (i.):

                                 i.      Treatment with preferred biologic product (Humira) for plaque psoriasis was ineffective or not tolerated

 

6.     Plaque Psoriasis, pediatrics (ICD-9 696.1, ICD-10 L40.X)

When a benefit, Enbrel will be approved for pediatric patients with chronic plaque psoriasis (PsO) when all of the following criteria are met (a. and b.):

a.     Enbrel is to be used for the treatment of children > 4 but <18 years of age with chronic plaque psoriasis.

b.    One of the following criterion is met (i. or ii.):

i.      Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

ii.    Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated.

 

B.    Reauthorization  

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations 

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
ankylosing spondylitis, juvenile idiopathic arthritis, pediatric plaque psoriasis, psoriatic arthritis, rheumatoid arthritis	N/A	Four (4) 50 mg prefilled syringes every four (4) weeks -OR- Eight (8) 25 mg prefilled syringes every four (4) weeks
plaque psoriasis, adults	Twenty four (24) 50 mg syringes within the first twelve (12) weeks of therapy -OR- Forty eight (48) 25 mg syringes within the first twelve (12) weeks of therapy	Four (4) 50 mg prefilled syringes every four (4) weeks -OR- Eight (8) 25 mg prefilled syringes every four (4) weeks

N/A=not applicable

 

• Coding of quantity level limitations is at the maintenance therapy threshold. Claims for quantities of Enbrel prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).

 

 

IV.   Humira (adalimumab) 

Humira, a recombinant human immunoglobulin G1 (IgG1) monoclonal antibody, targets tumor necrosis factor alpha (TNF-α) and blocks its interaction with the p55 and p75 cell surface TNF receptors. TNF, a naturally occurring cytokine, mediates inflammation and modulates cellular immune responses.

 

FDA-Approved Indications:

1.     Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

2.     Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

3.     Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA or JIA) in pediatric patients 2 years of age and older

4.     Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (PsA)

5.     Treatment of adult patients with moderate to severe chronic plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate

6.     Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn's disease (CD) who have had an inadequate response to corticosteroids or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate, or have lost response to or are intolerant to infliximab (Remicade)

7.     Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP)

8.     Treatment of moderate to severe hidradenitis suppurativa (HS)

9.     Treatment of non-infectious intermediate, posterior and panuveitis (UV)

 

A.    Initial Authorization  

1.     Rheumatoid Arthritis (ICD-9 714.0, ICD-10 M06.9)

When a benefit, Humira will be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a. and b.):

a.     Humira is to be used for the treatment of adults with rheumatoid arthritis (RA).

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for RA (e.g., Actemra, Cimzia, Enbrel, infliximab product [e.g., Remicade, Renflexis, Inflectra], Simponi, Kevzara, Kineret, Orencia, or a rituximab product [e.g, Rituxan], the patient is not required to “step back” and try a nonbiologic DMARD. 

2.     Ankylosing Spondylitis (ICD-9 720.0, ICD-10 M45.X)

When a benefit, Humira will be approved for ankylosing spondylitis (AS) when all of the following criteria are met (a. and b.):

a.     Humira is to be used in the treatment of adults with ankylosing spondylitis.

b.    Treatment with a nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated. 

NOTE: If the patient has already had a trial of at least one biologic agent for AS (e.g., Cimzia, Cosentyx, Enbrel, or Simponi], the patient is not required to “step back” and try an NSAID.

          3.     Juvenile Idiopathic Arthritis (ICD-9 714.3x, ICD-10 M08.00)

       When a benefit, Humira will be approved for juvenile idiopathic arthritis (JIA) when all of the following criteria are met (a. and b.):

a.     Humira is to be used for the treatment of juvenile idiopathic arthritis in patients ≥ 2 years of age.

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. 

          NOTE: If the patient has already had a trial of at least one biologic agent for JIA (e.g., Enbrel or Orencia), the patient is not required to “step back” and try a nonbiologic DMARD.

4.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Humira will be approved for psoriatic arthritis (PsA) when one of the following criterion is met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i. and ii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID.

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i. and ii.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease.

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. 

            NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try a nonbiologic DMARD.

c.     Enthesitis and/or dactylitis associated psoriatic arthritis (i. and ii.):

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis.

ii.    When treatment with (a. or b.): 

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

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

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

 

5.     Plaque Psoriasis (ICD-9 696.1, ICD-10 L40.X)

When a benefit, Humira will be approved for chronic plaque psoriasis (PsO) when all of the following criteria are met (a. and b.):

a.     Humira is to be used for the treatment of adults with chronic plaque psoriasis.

b.    One of the following criteria are met (i. or ii.):

i.      Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

ii.    Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsO (e.g., Cosentyx, Enbrel, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Siliq, Stelara, Taltz, or Tremfya), the patient is not required to “step back” and try phototherapy or a systemic agent.

6.     Crohn’s Disease, adults (ICD-9 555, ICD-10 K50.X)

When a benefit, Humira will be approved for adult patients with Crohn’s disease (CD) when all of the following criteria are met (a. and b.):

a.     Humira is to be used in the treatment of adult patients with moderate to severe Crohn's disease.

b.    Treatment with at least two immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or immunosuppressants are contraindicated.  

NOTE: If the patient has already had a previous trial of at least one biologic for CD (e.g., Cimzia, Entyvio, an infliximab product [e.g., Remicade, Inflectra, Renflexis], or Stelara), the patient is not required to “step back” and try two immunosuppressants.

7.     Crohn’s Disease, pediatrics (ICD-9 555, ICD-10 K50.X)

When a benefit, Humira will be approved for pediatric patients with Crohn’s disease (CD) when all of the following criteria are met (a. and b.):

a.     Humira is to be used in reducing the signs and symptoms of pediatric patients ≥ 6 years of age with moderate to severe Crohn's disease.

b.    Treatment with at least one immunosuppressant (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or immunosuppressants are contraindicated. 

NOTE: If the patient has already had a previous trial of at least one biologic for CD (e.g., Cimzia, Entyvio, an infliximab product [e.g., Remicade, Inflectra, Renflexis], or Stelara), the patient is not required to “step back” and try one immunosuppressant.

 

8.     Ulcerative Colitis (ICD-9 556, ICD-10 K51.X)

When a benefit, Humira will be approved for ulcerative colitis (UC) when one of the following criteria are met (a. or b.):

a.     Humira is to be used for treatment of adults with ulcerative colitis who have not responded to treatment with at least two immunosuppressants (e.g. corticosteroids, azathioprine, or 6-mercaptopurine).

NOTE: If the patient has already had a previous trial of at least one biologic for UC [e.g., an infliximab product (e.g., Remicade, Renflexis, Inflectra], Simponi SC, or Entyvio), the patient is not required to “step back” and try two immunosuppressants.

b.    Humira is to be used to induce and maintain clinical remission in adult patients with moderate to severe ulcerative colitis who require continuous steroid therapy.

 

9.     Hidradenitis Suppurativa (ICD-9 705.83, ICD-10 L73.2)

When a benefit, Humira will be approved for hidradenitis suppurativa (HS) when the following criterion is met (a.):

a.     Humira is to be used in the treatment of adults with moderate to severe hidradenitis suppurativa.

 

10.  Uveitis (ICD-9 360.11, ICD-10 H44.13)

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

a.     Humira is to be used in the treatment of non-infectious intermediate, posterior or panuveitis.

b.    Treatment with at least two immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine) was ineffective or not tolerated, or immunosuppressants are contraindicated.

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations

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

 

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

 

• *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.
• Claims for quantities of Humira prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• PLA will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).
• To note, starter package kits are coded for quantity level limitations of one (1) kit per 365 days.     

 

 

V.    Otezla (apremilast)

Otezla is an oral phosphodiesterase 4 (PDE4) inhibitor specific for cyclic adenosine monophosphate (cAMP). PDE4 regulates immune and inflammatory processes through control of intracellular cAMP levels and downstream protein kinase A pathways. The production of a number of key inflammatory cytokines is affected by PDE4 including interferon (IFN)γ, tumor necrosis factor (TNF)α, interleukin (IL)-12, and IL-23, thus shaping the immune response. PDE4 inhibition results in increased intracellular cAMP levels and an inhibitory effect on multiple cytokines involved in the inflammatory process.

 

FDA-Approved Indications:

 

1.     Treatment of adult patients with active psoriatic arthritis (PsA)

2.     Treatment of adult patients with moderate to severe chronic plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

 

A.    Initial Authorization

1.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Otezla will be approved for psoriatic arthritis (PsA) when one of the following criterion is met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i., ii., and iii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID.

iii.   Treatment with at least one preferred biologic product for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i., ii., and iii.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease.

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try a nonbiologic DMARD.

iii.   Treatment with at least one preferred biologic product for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

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

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis.

ii.    When treatment with (a. or b.): 

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

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

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

iii.   Treatment with at least one preferred biologic product for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

 

2.     Plaque Psoriasis (ICD-9 696.1, ICD-10 L40.X)

When a benefit, Otezla will be approved for chronic plaque psoriasis (PsO) when all of the following criteria are met (a. and b.):

a.     Otezla is to be used for the treatment of adults with chronic plaque psoriasis.

b.    One of the following criterion is met (i. or ii.):

i.      Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

ii.    Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsO (e.g., Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Siliq, Stelara, Taltz, or Tremfya), the patient is not required to “step back” and try phototherapy or a systemic agent.

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

 

VI.   Stelara (ustekinumab)

Stelara is a human immunoglobulin G (IgG) monoclonal antibody that binds with high affinity and specificity to the p40 subunit, which is part of both interleukin (IL)-12 and IL-23. IL-12 and IL-23 are naturally occurring cytokines that are involved in inflammatory and immune responses, such as natural killer cell activation and CD4+ T-cell differentiation and activation. Stelara binding to the p40 subunit prevents IL-12 and IL-23 from binding to the IL-12 receptor which is the ligand binding subunit of the receptor complexes. Prevention of IL-12 and IL-23 from binding to their respective complexes disrupts IL-12 and IL-23 transduction.

 

FDA-Approved Indications:

 

1.     Treatment of adult patients with active psoriatic arthritis (PsA), alone or in combination with methotrexate

2.     Treatment of adolescent patients (12 years or older) and adult patients with moderate to severe chronic plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

3.     Treatment of adult patients with moderately to severely active Crohn's disease (CD) who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker or failed or were intolerant to treatment with one or more TNF blockers

 

A.    Initial Authorization

1.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Stelara may be approved for psoriatic arthritis (PsA) when one of the following criterion is met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i. and ii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, or Taltz), the patient is not required to “step back” and try an NSAID.

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i. and ii.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, or Taltz), the patient is not required to “step back” and try a nonbiologic DMARD.

c.     Enthesitis and/or dactylitis associated psoriatic arthritis (i. and ii.):

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis.

ii.    When treatment with (a. or b.): 

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

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

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, or Taltz), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

 

2.     Plaque Psoriasis (ICD-9 696.1, ICD-10 L40.X)

When a benefit, Stelara will be approved for chronic plaque psoriasis (PsO) when all of the following criteria are met (a. and b.):

a.     Stelara is to be used for the treatment of adolescents (12 years or older) or adults with chronic plaque psoriasis.

b.    One of the following criterion is met (i. or ii.):

i.      Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

ii.    Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsO (e.g., Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Siliq, Taltz, or Tremfya), the patient is not required to “step back” and try phototherapy or a systemic agent.

 

3.     Crohn’s Disease (ICD-9 555, ICD-10 K50.X)

 

Patients Initiating Therapy with Stelara SC

When a benefit, Stelara will be approved for adult patients with Crohn’s disease (CD) when all of the following criteria are met (a., b., and c.):

a.     Stelara is to be used in the treatment of adult patients with Crohn's disease.

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

c.     One of the following criterion is met (i. or ii.):

i.      Treatment with at least two immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or immunosuppressants are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for CD (e.g., Cimzia, Entyvio, or an infliximab product [e.g., Remicade, Inflectra, Renflexis]), the patient is not required to “step back” and try two immunosuppressants.

ii.    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 of the following (1. or 2.):

1)     Demyelinating disease

2)     Heart failure

 

Patients Currently Taking Stelara SC

When a benefit, Stelara will be approved for adult patients with Crohn’s disease (CD) when all of the following criteria are met (a., b., and c.):

a.     Stelara is to be used in the treatment of adult patients with Crohn's disease.

b.    The patient has been established on Stelara SC for at least 90 days.

c.     Prescription claims history indicates at least a 90 day-supply was dispensed within the past 130 days (Eligible claims includes at least one paid claim that has not been reversed within the 130 day time period).

i.      NOTE: If prescription claims history is not available (e.g., patient is new to plan), provider attests that patient has been established on Stelara SC for at least 90 days.

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

Dosing

In addition, the criteria outlined above, documentation of member weight and prescribed Stelara dose consistent with dosing below is required:

• Psoriasis (Adult)

a.     For patients weighing ≤100 kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.

b.    For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

• Psoriasis (Adolescent 12 years and older)

a.     For patients weighing <60 kg (132 lbs), the recommended dose is 0.75 mg/kg initially and 4 weeks later, followed by 0.75 mg/kg every 12 weeks.

b.    For patients weighing 60 to 100 kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks.

c.     For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

• Psoriatic Arthritis

a.     The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks For patients with co-existent moderate-to-severe plaque psoriasis weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

• Crohn's Disease

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

 

C.    Quantity Limitations

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
psoriatic arthritis, plaque psoriasis	Two (2) prefilled syringes within the first four (4) weeks of therapy	One (1) syringe every eighty four (84) days (12 weeks)
Crohn's disease	N/A	One (1) syringe every fifty-six days (8 weeks)

N/A=not applicable

 

• Coding of quantity level limitations is at the maintenance therapy threshold. Claims for quantities of Stelara prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).

 

 

VII.  Xeljanz (tofacitinib)

Xeljanz is an orally bioavailable, small-molecule inhibitor of the Janus kinase (JAK) family. Xeljanz modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of Signal Transducers and Activators of Transcription (STATs), which modulate intracellular activity including gene expression.

 

FDA-Approved Indications:

 

1.     Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

2.     Treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs)

 

A.    Initial Authorization  

1.     Rheumatoid Arthritis (ICD-9 714.0, ICD-10 M06.9)

When a benefit, Xeljanz or Xeljanz XR will be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a. and b.):

a.     Xeljanz or Xeljanz XR is to be used for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

b.    Treatment with methotrexate was ineffective or not tolerated.

NOTE: If the patient has already had a trial of at least one biologic agent for RA (e.g., Actemra, Cimzia, Enbrel, Humira, infliximab product [e.g., Remicade, Renflexis, Inflectra], Simponi, Kevzara, Kineret, Orencia, or a rituximab product [e.g, Rituxan], the patient is not required to “step back” and try a nonbiologic DMARD.

 

2.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Xeljanz or Xeljanz XR will be approved for psoriatic arthritis (PsA) when all of the following criteria are met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i., ii., and iii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i. through iv.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease.

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. 

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try a nonbiologic DMARD.

iii.   Xeljanz or Xeljanz XR is used in combination with a nonbiologic DMARD.

iv.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

 

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

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis.

ii.    When treatment with (a. or b.): 

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

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

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1). 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

 

VIII.  Cimzia (certolizumab)

Cimzia is a tumor necrosis factor (TNF) inhibitor, which results in an interference in the production of downstream inflammatory mediators, including interleukin-1, prostaglandins, platelet activating factor, and nitric oxide. TNF, a naturally occurring cytokine, mediates inflammation and modulates cellular immune responses.

 

FDA-Approved Indications:

 

1.     Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA)

2.     Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

3.     Treatment of adult patients with active psoriatic arthritis (PsA)

4.     Reducing signs and symptoms and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy

 

A.    Initial Authorization

1.     Rheumatoid Arthritis (ICD-9 714.0, ICD-10 M06.9)

When a benefit, Cimzia will be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a. through d.):

a.     Cimzia is to be used for the treatment of adults with rheumatoid arthritis (RA).

b.    Cimzia is to be used alone or with methotrexate. 

c.     Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for RA (e.g., Actemra, Enbrel, Humira, infliximab product [e.g., Remicade, Renflexis, Inflectra], Simponi, Kevzara, Kineret, Orencia, or a rituximab product [e.g, Rituxan], the patient is not required to “step back” and try a nonbiologic DMARD.

d.    Treatment with at least two preferred biologic products for the treatment of rheumatoid arthritis was ineffective or not tolerated (see Table 1).

 

2.     Ankylosing Spondylitis (ICD-9 720.0, ICD-10 M45.X)

When a benefit, Cimzia will be approved for ankylosing spondylitis (AS) when all of the following criteria are met (a., b., and c.):

a.     Cimzia is to be used for the treatment of adults with ankylosing spondylitis. 

b.    Treatment with a nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated.  

NOTE: If the patient has already had a trial of at least one biologic agent for AS (e.g., Cosentyx, Enbrel, Humira, or Simponi], the patient is not required to “step back” and try an NSAID.

c.     Treatment with at least two preferred biologic products for the treatment of ankylosing spondylitis was ineffective or not tolerated (see Table 1).

 

3.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Cimzia will be approved for psoriatic arthritis (PsA) when one of the following criterion is met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i., ii., and iii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated. 

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i., ii., and iii.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease.

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try a nonbiologic DMARD.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

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

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis.

ii.    When treatment with at least (a. or b.): 

a.     One NSAID or a local glucocorticoid injection was ineffective or not tolerated.

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

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

 

4.     Crohn’s Disease (ICD-9 555, ICD-10 K50.X)

When a benefit, Cimzia will be approved for adults patients with Crohn’s disease (CD) when all of the following criteria are met (a., b., and c.):

a.     Cimzia is to be used in the treatment of adult patients with Crohn's disease.

b.    Treatment with at least two immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated, or immunosuppressants are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for CD (e.g., Entyvio, Humira, an infliximab product [e.g., Remicade, Inflectra, Renflexis], or Stelara), the patient is not required to “step back” and try two immunosuppressants.

c.     Treatment with at least one preferred biologic product for the treatment of Crohn’s disease was ineffective or not tolerated (see Table 1).

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease	Ten (10) syringes in first twelve (12) weeks of therapy -OR- One (1) starter package kit	Two (2) syringes every four (4) weeks

 

• Coding of quantity level limitations is at the maintenance therapy threshold. Claims for quantities of Cimzia prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).
• To note, starter package kits are coded for quantity level limitations of one (1) kit per 365 days.

 

 

IX.  Kevzara (sarilumab)

 Kevzara is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody that works to inhibit IL-6 mediated actions at soluble and membrane bound IL-6 receptors. Inhibiting the signaling pathway can lead to inhibition of activated T- and B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 is also produced by synovial and endothelial cells which has an effect on the inflammatory process in rheumatoid arthritis.

 

FDA-Approved Indication(s):

 

1.     Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs)

 

A.    Initial Authorization

1.     Rheumatoid Arthritis (ICD-9 714.0, ICD-10 M06.9)

When a benefit, Kevzara will be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a., b., and c.):

a.     Kevzara is to be used for the treatment of adults with rheumatoid arthritis (RA).

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for RA (e.g., Actemra, Cimzia, Enbrel, Humira, infliximab product [e.g., Remicade, Renflexis, Inflectra], Simponi, Kineret, Orencia, or a rituximab product [e.g, Rituxan]), the patient is not required to “step back” and try a nonbiologic DMARD.

        c.   Treatment with at least two preferred biologic products for the treatment of rheumatoid arthritis was ineffective or not tolerated (see Table 1).

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations

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

 

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

 

• Coding of quantity level limitations is at the maintenance therapy threshold.
• Claims for quantities of Kevzara prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations.

 

 

X.    Kineret (anakinra)

Kineret blocks interleukin 1 (IL-1), a protein involved in the inflammatory process.

 

FDA-Approved Indications:

 

1.     Reducing signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed one or more disease-modifying antirheumatic drugs (DMARDs).

2.     Treatment of neonatal-onset multisystem inflammatory disease (NOMID).

 

A.    Initial Authorization

1.     Rheumatoid Arthritis (ICD-9 714.0, ICD-10 M06.9)

When a benefit, Kineret will be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a., b., and c.):

a.     Kineret is to be used for the treatment of adults with rheumatoid arthritis (RA).

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for RA (e.g., Actemra, Cimzia, Enbrel, Humira, infliximab product [e.g., Remicade, Renflexis, Inflectra], Simponi, Kevzara, Orencia, or a rituximab product [e.g, Rituxan]), the patient is not required to “step back” and try a nonbiologic DMARD. 

c.     Treatment with at least two preferred biologic products for the treatment of rheumatoid arthritis was ineffective or not tolerated (see Table 1).

 

2.     Neonatal-Onset Multisystem Inflammatory Disease

When a benefit, Kineret will be approved for Neonatal-Onset Multisystem Inflammatory Disease (NOMID) when following criterion is met (a.):

a.     Kineret is to be used for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations

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

 

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

 

• Coding of quantity level limitations is at the maintenance therapy threshold.
• Claims for quantities of Kineret prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations.

 

 

XI.  Orencia (abatacept)

 Orencia is a fully human recombinant fusion protein categorized as a co-stimulatory or second-signal blocker of T cell activation. Orencia disrupts the activation pathway of T cells causing a disturbance in key mechanisms of inflammation and progressive joint destruction in rheumatoid arthritis.

 

FDA-Approved Indications:

 

1.     Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA)

2.     Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA or JIA) in pediatric patients 2 years of age and older

3.     Treatment of adult patients with active psoriatic arthritis (PsA)

 

A.    Initial Authorization

1.     Rheumatoid Arthritis (ICD-9 714.0, ICD-10 M06.9)

When a benefit, Orencia subcutaneous (SC) will be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a., b., and c.):

a.     Orencia SC is to be used in reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderate to severe active rheumatoid arthritis.

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for RA (e.g., Actemra, Cimzia, Enbrel, Humira, infliximab product [e.g., Remicade, Renflexis, Inflectra], Simponi, Kevzara, Kineret, or a rituximab product [e.g, Rituxan], the patient is not required to “step back” and try a nonbiologic DMARD.

c.    Treatment with at least two preferred biologic products for the treatment of rheumatoid arthritis was ineffective or not tolerated (see Table 1).

 

2.     Juvenile Idiopathic Arthritis (ICD-9 714.3x, ICD-10 M08.00)

When a benefit, Orencia SC will be approved for juvenile idiopathic arthritis (JIA) when all of the following criteria are met (a., b., and c.):

a.     Orencia SC is to be used for the treatment of juvenile idiopathic arthritis in patients ≥ 2 years of age.

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for JIA, (e.g., Enbrel or Humira), the patient is not required to “step back” and try a nonbiologic DMARD.

c.     Treatment with at least one preferred biologic product for the treatment of juvenile idiopathic arthritis (JIA) was ineffective or not tolerated (see Table 1)

 

3.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Orencia SC will be approved for psoriatic arthritis (PsA) when one of the following criterion is met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i., ii., and iii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

 

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i., ii., and iii.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease.

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try a nonbiologic DMARD.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

 

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

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis

ii.    When treatment with at least (a. or b.): 

a.     One NSAID or a local glucocorticoid injection was ineffective or not tolerated

b.    All NSAIDs and all local glucocorticoid injections are contraindicated

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Simponi SC, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1)

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations

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

 

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

 

• Coding of quantity level limitations is at the maintenance therapy threshold.
• Claims for quantities of Orencia SC prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations.

 

 

XII. Siliq (brodalumab)

 Siliq is human monoclonal IgG2 antibody that binds to IL-17A inhibiting its interactions with multiple IL-17 family cytokines ultimately inhibiting the inflammatory response that plays a role in the development of plaque psoriasis.

 

FDA-Approved Indication(s):

 

1.     Treatment of adult patients with moderate to severe chronic plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies

 

A.    Initial Authorization

1.     Plaque Psoriasis (ICD-9 696.1, ICD-10 L40.X)

Initiation (0 to < 4 months previous therapy for Siliq)

When a benefit, initiation of Siliq will be approved when all of the following criteria are met (i., ii., and iii.):

i.      Siliq is to be used for the treatment of adults with moderate to severe psoriasis.

ii.    One of the following criterion is met (a. or b.):

a.     Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated.

b.    Treatment with systemic therapy and phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsO (e.g., Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Stelara, Taltz, or Tremfya), the patient is not required to “step back” and try phototherapy or a systemic agent.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriasis was ineffective or not tolerated (see Table 1).

 

Maintenance (≥ 4 months previous therapy for Siliq)

When a benefit, maintenance of Siliq will be approved when all of the following criteria are met (i. through iv.):

                                  i.    Siliq is to be used for the treatment of adults with moderate to severe psoriasis.

                                ii.    One of the following criterion is met (a. or b.):

a.     Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated.

b.    Treatment with systemic therapy and phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsO (e.g., Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Stelara, Taltz, or Tremfya), the patient is not required to “step back” and try phototherapy or a systemic agent.

                               iii.    Treatment with at least two preferred biologic products for the treatment of psoriasis was ineffective or not tolerated (see Table 1).

                               iv.    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

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations

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

 

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

 

• Coding of quantity level limitations is at the maintenance therapy threshold.
• Claims for quantities of Siliq prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).

 

 

XIII.  Simponi (golimumab)

Simponi is a fully human anti-TNF-alfa (TNF-α) monoclonal antibody. Simponi binds to both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNFα (a cytokine protein).

 

FDA-Approved Indications:

 

1.     Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate

2.     Reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS)

3.     Treatment of adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate

4.     Treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for inducing and maintaining clinical response, improving endoscopic appearance of the mucosa during induction, inducing clinical remission, and achieving and sustaining clinical remission in induction responders

 

A.    Initial Authorization

1.    Rheumatoid Arthritis (ICD-9 714.0, ICD-10 M06.9)

When a benefit, Simponi SC will be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a., b., and c.):

a.     Simponi 50 mg is to be used for the treatment of adults with rheumatoid arthritis (RA).

b.    Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a trial of at least one biologic agent for RA (e.g., Actemra, Cimzia, Enbrel, Humira, infliximab product [e.g., Remicade, Renflexis, Inflectra], Kevzara, Kineret, Orencia, or a rituximab product [e.g, Rituxan], the patient is not required to “step back” and try a nonbiologic DMARD.

c.     Treatment with at least two preferred biologic products for the treatment of rheumatoid arthritis was ineffective or not tolerated (see Table 1).

 

2.     Ankylosing Spondylitis (ICD-9 720.0, ICD-10 M45.X)

When a benefit, Simponi SC will be approved for ankylosing spondylitis (AS) when all of the following criteria are met (a., b., and c.):

a.     Simponi 50 mg is to be used for the treatment of adults with ankylosing spondylitis. 

b.    Treatment with a nonsteroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated, or all NSAIDs are contraindicated. 

 NOTE: If the patient has already had a trial of at least one biologic agent for AS (e.g., Cimzia, Cosentyx, Enbrel, or Humira], the patient is not required to “step back” and try an NSAID.

c.     Treatment with at least two preferred biologic products for the treatment of ankylosing spondylitis was ineffective or not tolerated (see Table 1)

 

3.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Simponi SC 50 mg may be approved for psoriatic arthritis (PsA) when one of the following criterion is met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i., ii., and iii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i., ii., and iii.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated. 

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Stelara, or Taltz), the patient is not required to “step back” and try a nonbiologic DMARD.

 iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

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

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis.

ii.    When treatment with (a. or b.): 

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

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

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia Otezla, Stelara, or Taltz), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

4.     Ulcerative Colitis (ICD-9 556, ICD-10 K51.X)

When a benefit, Simponi SC will be approved for adults patients with ulcerative colitis (UC) when all of the following criteria are met (a. and b.):

a.     Simponi 100 mg is to be used to induce and maintain clinical remission in adult patients with moderate to severe ulcerative colitis and one of the following (i. or ii.):

i.      Treatment with at least two immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine) was ineffective or not tolerated.

ii.    The member requires continuous steroid therapy.

NOTE: If the patient has already had a previous trial of at least one biologic for UC (e.g., Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], or Entyvio), the patient is not required to “step back” and try two immunosuppressants or continuous steroid therapy.

b.    Treatment with preferred biologic product (Humira) for the treatment of ulcerative colitis was ineffective or not tolerated (see Table 1).

 

B.    Reauthorization  

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations

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

 

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

 

• Coding of quantity level limitations is at the maintenance therapy threshold.
• Claims for quantities of Simponi prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).

 

 

XIV. Taltz (ixekizumab)

Taltz is a human monoclonal antibody that selectively neutralizes interleukin 17-A (IL-17A) which is found in psoriatic skin lesions that plays a role in driving underlying inflammation in psoriasis.

 

FDA-Approved Indications:

 

1.     Treatment of adult patients with active psoriatic arthritis (PsA)

2.     Treatment of adult patients with moderate to severe chronic plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies

 

A.    Initial Authorization

1.     Psoriatic Arthritis (ICD-9 696.0, ICD-10 L40.52)

When a benefit, Taltz will be approved for psoriatic arthritis (PsA) when one of the following criteria are met (a., b., or c.):

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i., ii., and iii.):

i.      For the treatment of adults with predominant spinal or axial psoriatic arthritis.

ii.    When treatment with at least one NSAID was ineffective or not tolerated or all NSAIDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi, or Stelara), the patient is not required to “step back” and try an NSAID.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

b.    Psoriatic arthritis without spinal or axial disease (ICD-9 696.0, ICD-10 L40.52) (i., ii., and iii.):

i.      For the treatment of adults with psoriatic arthritis without spinal disease

ii.    When treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia, Otezla, Simponi, or Stelara), the patient is not required to “step back” and try a nonbiologic DMARD.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

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

i.      For the treatment of adults with active enthesitis and/or dactylitis associated with psoriatic arthritis.

ii.    When treatment with (a. or b.): 

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

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

NOTE: If the patient has already had a previous trial of at least one biologic for PsA (e.g., Cimzia, Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Orencia Otezla, Simponi, or Stelara), the patient is not required to “step back” and try an NSAID or glucocorticoid injection.

iii.   Treatment with at least two preferred biologic products for the treatment of psoriatic arthritis was ineffective or not tolerated (see Table 1).

 

2.     Plaque Psoriasis (ICD-9 696.1, ICD-10 L40.X)

When a benefit, Taltz will be approved for chronic plaque psoriasis (PsO) when all of the following criteria are met (a., b., and c.):

a.     Taltz is to be used for the treatment of adults with moderate to severe psoriasis

b.    One of the following criterion is met (i. or ii.):

i.      Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

ii.    Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsO (e.g., Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Siliq, Stelara, or Tremfya), the patient is not required to “step back” and try phototherapy or a systemic agent.

c.     Treatment with at least two preferred biologic products for the treatment of plaque psoriasis was ineffective or not tolerated (see Table 1).

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations 

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

 

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

 

• Coding of quantity level limitations is at the maintenance therapy threshold.
• Claims for quantities of Taltz prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).

 

 

XV.Tremfya (guselkumab)

Tremfya is a human monoclonal antibody that selectively antagonizes interleukin 23 (IL-23) to inhibit the release of pro-inflammatory cytokines and chemokines.

 

FDA-Approved Indication(s):

 

1.     Treatment of adult patients with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

A.    Initial Authorization

1.     Plaque Psoriasis (ICD-9 696.1, ICD-10 L40.X)

When a benefit, Tremfya will be approved for chronic plaque psoriasis (PsO) when all of the following criteria are met (a., b., and c.):

a.     Tremfya is to be used for the treatment of adults with moderate to severe psoriasis.

b.    One of the following criterion is met (i. or ii.):

i.      Treatment with phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated.

ii.    Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated, or all systemic therapies are contraindicated.

NOTE: If the patient has already had a previous trial of at least one biologic for PsO (e.g., Cosentyx, Enbrel, Humira, an infliximab product [e.g., Remicade, Renflexis, Inflectra], Otezla, Siliq, Stelara, or Taltz), the patient is not required to “step back” and try phototherapy or a systemic agent.

c.     Treatment with at least two preferred biologic products for the treatment of plaque psoriasis was ineffective or not tolerated (see Table 1)

 

B.    Reauthorization

Continued authorization or re-authorization (after the initial authorization period) shall be reviewed at least annually, and clinical documentation indicating that there is disease stability or improvement must be provided.

 

C.    Quantity Limitations

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

 

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

 

• Coding of quantity level limitations is at the maintenance therapy threshold.
• Claims for quantities of Tremfya prefilled syringes that exceed maintenance therapy limitations will reject at point of sale.
• Patient Level Authorization (PLA) will be needed for authorized quantities of pre-filled syringes that exceed maintenance therapy limitations (i.e. induction therapy).

 

I.      For Commercial and HCR members enrolled in a West Virginia Plan, an exception to the step therapy within this policy may be made based on Policy J-513 – West Virginia – Step Therapy Override Exception – Commercial and Healthcare Reform.

I.      For Commercial and HCR members, coverage of the Chronic Inflammatory Disease (CID) medications 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 brodalumab (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.

 

1. Actemra [prescribing information]. San Francisco, CA: Genentech. August 2017.
2. Cosentyx [prescribing information]. East Hanover, NJ: Novartis. September 2017.
3. Langley R., Eleweksi B, Lebwhol M et al. Secukinumab in plaque Psoriasis. Results of Two Phase 3 trials. N Engl J Med. 2014 July 24; 371:326-338.
4. Enbrel [prescribing information]. Thousand Oaks, CA: Immunex Corporation; October 2017. 
5. Takei S, Groh D, Bernstein B, et al: Safety and efficacy of high dose etanercept in treatment of juvenile rheumatoid arthritis. J Rheumatol 2001; 28(7):1677-1680.
6. Leonardi CL, Powers JL, Matheson RT, et al: Etanercept as monotherapy in patients with psoriasis. N Engl J Med 2003; 349(21):2014-2022.
7. Gorman JD, Sack KE, & Davis JC Jr: Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med 2002; 346(18):1349-1356.
8. Leonardi CL, Powers JL, Matheson RT, et. al. Etanercept as Monotherapy in Patients with Psoriasis. N Engl J Med. 2003;349:2014-2022.
9. Humira [prescribing information]. AbbVie, Inc., North Chicago, IL: December 2017.

  10.  Colombel JF, Sandborn WJ, Rutgeerts P, et al: Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007; 132(1):52-65.