Policy Applies to 

 

 

Drugs Addressed in this Policy

 

1.     Actemra (tocilizumab)

2.     Cosentyx (secukinumab)

3.     Enbrel (etanercept)

4.     Humira (adalimumab)

5.     Otezla (apremilast)

6.     Stelara (ustekinumab)

7.     Xeljanz, Xeljanz XR (tofacitinib)

8.     Cimzia (certolizumab)

9.     Kevzara (sarilumab)

10.  Kineret (anakinra)

11.  Orencia (abatacept)

12.  Siliq (brodalumab)

13.  Simponi (golimumab)

14.  Taltz (ixekizumab)

 

 

Limitations of Coverage

 

• The member should be under the supervision of a rheumatologist, gastroenterologist, dermatologist or ophthalmologist.
• Tofacitinib (Xeljanz) should not be used in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine or cyclosporine.
• While taking a biologic DMARD, the member is currently not using tofacitinib (Xeljanz) or another biologic DMARD.

 

• Examples of these agents include:

1.     Etanercept (Enbrel)

2.     Adalimumab (Humira)

3.     Anakinra (Kineret)

4.     Abatacept (Orencia)

5.     Infliximab (Remicade)

6.     Certolizumab (Cimzia)

7.     Golimumab (Simponi)

Approval Criteria: 

 

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

 

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

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

 

I.      Actemra (tocilizumab)

Tocilizumab (Actemra) 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 Indications

·         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)

·         Treatment of giant cell arteritis (GCA)

 

A.    Prior Authorization Criteria

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

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

a.     Tocilizumab (Actemra) SC is to be used in reducing the signs and symptoms and inhibiting the progression of structural damage in members 18 years of age or older 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.

 

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

1.     When a benefit, tocilizumab (Actemra) SC may be approved for giant cell arteritis (GCA) when the following criterion is met:

a.     Tocilizumab (Actemra) SC is to be used in the treatment of giant cell arteritis.

 

B. Quantity Limitations

·         When prior authorization is approved, tocilizumab (Actemra) subcutaneous (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 tocilizumab (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)

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

 

FDA Approved Indications:

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

·         Treatment of adult patients with active psoriatic arthritis (PsA)

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

 

A. Prior Authorization Criteria

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

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

a.     Secukinumab (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

 

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

1.     When a benefit, secukinumab (Cosentyx) may be approved for psoriatic arthritis (PsA) when 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

 

b.    Psoriatic arthritis without spinal or axial disease (also known as peripheral arthritis or psoriatic arthritis with skin and/or nail 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

 

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 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

 

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

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

a.     Secukinumab (Cosentyx) is to be used for the treatment of moderate to severe 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

 

B. Quantity Limitations

·         When prior authorization is approved, secukinumab (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 secukinumab (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)

Etanercept (Enbrel) inhibits tumor necrosis factor (TNF). The binding of etanercept to TNF, a naturally occurring cytokine involved in normal inflammatory and immune responses, renders it biologically inactive. 

 

FDA Approved Indications:

·         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)

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

·         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

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

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

 

A. Prior Authorization Criteria:

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

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

a.     Etanercept (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.

 

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

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

a.     Etanercept (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

 

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

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

a.     Etanercept (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

 

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

1.     When a benefit, etanercept (Enbrel) may be approved for psoriatic arthritis (PsA) when 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

 

b.    Psoriatic arthritis without spinal or axial disease (also known as peripheral arthritis or psoriatic arthritis with skin and/or nail 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

 

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 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

 

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

1.     When a benefit, etanercept (Enbrel) may be approved for chronic plaque psoriasis (PsO) when all of the following criteria are met (a. through c.):

a.     Etanercept (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

c.     When the following criterion is met:

                        i.      Treatment with preferred biologic, Humira for plaque psoriasis was ineffective or not tolerated

 

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

1.     When a benefit, etanercept (Enbrel) may be approved for pediatrics with chronic plaque psoriasis (PsO) when all of the following criteria are met (a. and b.):

a.     Etanercept (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 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

 

B. Quantity Limitations

·         When prior authorization is approved, etanercept (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
chronic 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 etanercept (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)

Adalimumab (Humira), a recombinant human IgG1 monoclonal antibody, targets tumor necrosis factor alpha (TNF-alpha) and blocks its interaction with the p55 and p75 cell surface TNF receptors.

 

FDA Approved Indications:

·         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)

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

·         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

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

·         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

·         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)

·         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)

·         Treatment of moderate to severe hidradenitis suppurativa (HS)

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

 

A. Prior Authorization Criteria

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

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

a.     Adalimumab (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.

 

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

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

a.     Adalimumab (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

 

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

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

a.     Adalimumab (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

 

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

1.     When a benefit, adalimumab (Humira) may be approved for psoriatic arthritis (PsA) when 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

 

b.    Psoriatic arthritis without spinal or axial disease (also known as peripheral arthritis or psoriatic arthritis with skin and/or nail 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

 

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 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

 

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

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

a.     Adalimumab (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

 

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

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

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

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

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

ii.    Treatment with infliximab (Remicade) was ineffective or not tolerated 

 

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

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

a.     Adalimumab (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.    One of the following criteria are met (i.):

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

 

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

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

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

b.    Adalimumab (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

 

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

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

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

 

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

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

a.     Adalimumab (Humira) is to be used in the treatment of non-infectious intermediate, posterior and panuveitis

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

 

B. Quantity Limitations

·         When prior authorization is approved, adalimumab (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 adalimumab (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 adalimumab (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)

Apremilast (Otezla) is an oral phosphodiesterase 4 (PDE4) inhibitor specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels.

 

FDA Approved Indications:

·         Treatment of adult patients with active psoriatic arthritis (PsA)

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

 

A.    Prior Authorization Criteria

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

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

 

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i. through 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

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 (also known as peripheral arthritis or psoriatic arthritis with skin and/or nail disease) (ICD-9 696.0, ICD-10 L40.52) (i. through 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

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. through 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

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

 

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

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

a.     Apremilast (Otezla) 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

 

VI.   Stelara (ustekinumab)

Ustekinumab (Stelara) is a human Ig G monoclonal antibody that binds with high affinity and specificity to the p40 subunit, which is part of both 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.  Ustekinumab 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:

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

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

·         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. Prior Authorization Criteria

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

1.     When a benefit, ustekinumab (Stelara) may be approved for psoriatic arthritis (PsA) when 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

 

b.    Psoriatic arthritis without spinal or axial disease (also known as peripheral arthritis or psoriatic arthritis with skin and/or nail 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

 

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 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

 

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

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

a.     Ustekinumab (Stelara) 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

 

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

 

Patients Initiating Therapy

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

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

b.    One of the following criteria are met (i. through iii.):

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

ii.    The patient received a single induction dose of Stelara IV

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

 

Patients Currently Taking Stelara SC

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

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

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

i.      One of the following criteria are met (a. and b.):

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

b.    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)

ii.    The patient received a single induction dose of Stelara IV

iii.   Treatment with preferred biologic product (Humira) for the treatment of Crohn’s disease was ineffective or not tolerated (see Table 1) (Note: a trial of Cimzia, Entyvio, or an infliximab product [e.g. Inflectra, Remicade] also counts)

iv.   One of the following criteria are met (a. or b.):

a.     According to prescribing physician, the patient has experienced a previous intolerance to a TNF inhibitor

b.    The patient has a relative contraindication to the use of a TNF inhibitor (1) or 2))

1)     Demyelinating disease

2)     Heart failure

 

 

Dosing

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

·         Psoriasis

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.

·         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 90mg 8 weeks following the intravenous dose, then every 8 weeks thereafter.

 

B. Quantity Limitations

·         When prior authorization is approved, ustekinumab (Stelara) 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 ustekinumab (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)

Tofacitinib (Xeljanz) is an orally bioavailable, small-molecule inhibitor of the Janus kinase (JAK) family. Tofacitinib 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:

·         Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate

 

A. Prior Authorization Criteria

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

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

a.     Tofacitinib (Xeljanz or Xeljanz XR) is to be used in reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active rheumatoid arthritis

b.    Treatment with methotrexate was ineffective or not tolerated

 

 

VIII.        Cimzia (certolizumab)

Certolizumab pegol (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.

 

FDA Approved Indications

·         Treatment of adults patient with moderately to severely active rheumatoid arthritis (RA)

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

·         Treatment of adult patients with active psoriatic arthritis (PsA)

·         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. Prior Authorization Criteria

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

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

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

b.    Certolizumab pegol (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

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

 

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

1.     When a benefit, certolizumab pegol (Cimzia) may be approved for ankylosing spondylitis (AS) when all of the following criteria are met (a. through c.):

a.     Certolizumab pegol (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 

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

 

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

1.     When a benefit, certolizumab pegol (Cimzia) may be approved for psoriatic arthritis (PsA) when the following criterion is met (a., b., or c.):

 

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i. through 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

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 (also known as peripheral arthritis or psoriatic arthritis with skin and/or nail disease) (ICD-9 696.0, ICD-10 L40.52) (i. through 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

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. through 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

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

 

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

1.     When a benefit, certolizumab pegol (Cimzia) may be approved for adults patients with Crohn’s disease (CD) when all of the following criteria are met (a. through c.):

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

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

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

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

 

B. Quantity Limitations

·         When prior authorization is approved, certolizumab pegol (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 certolizumab pegol (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)

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 Indications:

·         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. Prior Authorization Criteria

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

1.     When a benefit, sarilumab (Kevzara) may be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a. through c.):

a.     Sarilumab (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

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

 

B. Quantity Limitations

·         When prior authorization is approved, sarilumab (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 sarilumab (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)

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

 

FDA Approved Indications:

·         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).

·         Treatment of neonatal-onset multisystem inflammatory disease (NOMAD)

 

A. Prior Authorization Criteria

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

1.     When a benefit, anakinra (Kineret) may be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a. through c.):

a.     Anakinra (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

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

 

·         Neonatal-Onset Multisystem Inflammatory Disease

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

a.     Anakinra (Kineret) is to be used for the treatment of neonatal-onset multisystem inflammatory disease (NOMID) in children and adults

 

B. Quantity Limitations

·         When prior authorization is approved, anakinra (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 anakinra (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)

Abatacept (Orencia) is a fully human recombinant fusion protein categorized as a co-stimulatory or second-signal blocker of T cell activation. Abatacept 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:

·         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)

·         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

 

A. Prior Authorization Criteria

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

1.     When a benefit, abatacept (Orencia) subcutaneous (SC) may be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a. through c.):

a.     Abatacept (Orencia) SC is to be used in reducing the signs and symptoms and inhibiting the progression of structural damage in adults (≥ 18 years of age) 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

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

 

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

1.     When a benefit, abatacept (Orencia) SC may be approved for juvenile idiopathic arthritis (JIA) when all of the following criteria are met (a. through c.):

a.     Abatacept (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

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)

 

 

B. Quantity Limitations

·         When prior authorization is approved, abatacept (Orencia) subcutaneous (SC) may be authorized in quantities as follows:

 

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis, juvenile idiopathic 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 abatacept (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)

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 Indications:

·         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. Prior Authorization Criteria

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

 

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

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

i.      The member is 18 years of age or older

ii.    Treatment of moderate to severe psoriasis

iii.   One of the following criteria are 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

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

 

2.     Maintenance (> 4 months previous therapy for Siliq)

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

i.      The member is 18 years of age or older

ii.    Treatment of moderate to severe psoriasis

iii.   One of the following criteria are 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

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

v.     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.    Quantity Limits

·         When prior authorization is approved, brodalumab (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 brodalumab (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)

Golimumab (Simponi) is a fully human anti–TNF-alfa (TNF-α) monoclonal antibody. Golimumab 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:

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

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

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

·         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. Prior Authorization Criteria

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

1.     When a benefit, golimumab (Simponi) may be approved for rheumatoid arthritis (RA) when all of the following criteria are met (a. through c.):

a.     Golimumab (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

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

 

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

1.     When a benefit, golimumab (Simponi) may be approved for ankylosing spondylitis (AS) when all of the following criteria are met (a. through c.):

a.     Golimumab (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 

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

 

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

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

 

a.     Spinal or axial psoriatic arthritis (ICD-10 L40.53) (i. through 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

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 (also known as peripheral arthritis or psoriatic arthritis with skin and/or nail disease) (ICD-9 696.0, ICD-10 L40.52) (i. through 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

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. through 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

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

 

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

1.     When a benefit, golimumab (Simponi) may be approved for adults patients with ulcerative colitis (UC) when all of the following criteria are met (a. through c.):

a.     Golimumab (Simponi) 100 mg is to be used to induce and maintain clinical remission in adult patients with moderate to severe ulcerative colitis

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

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

ii.    Treatment is required with continuous steroid therapy

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

 

B. Quantity Limitations

·         When prior authorization is approved, golimumab (Simponi) 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 golimumab (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)

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:

·         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.    Prior Authorization Criteria

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

1.     When a benefit, ixekizumab (Taltz) may be approved for chronic plaque psoriasis (PsO) when all of the following criteria are met (a. through c.):

a.     Ixekizumab (Taltz)  is to be used for the treatment of adults with moderate to severe 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

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

 

B. Quantity Limitations

·         When prior authorization is approved, ixekizumab (Taltz) may be authorized in quantities as follows:

 

Diagnosis	Induction Therapy	Maintenance Therapy
plaque psoriasis	Eight (8) pens/prefilled syringes within the first twelve (12) 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 ixekizumab (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).

 

 

·         For Commercial and Healthcare Reform 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.

·         For Commercial and Healthcare Reform 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.

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

Authorization Duration

 

·         Commercial and Healthcare Reform plans:

o    For all medications listed (except Siliq):

§  If approved, up to a 12 month authorization may be granted.

o    For brodalumab (Siliq):

§  Initiation – 4 months

§  Maintenance – 12 months

 

·         Authorization shall be reviewed at least annually to confirm that current medical necessity criteria are met and that the medication is effective.

 

Reauthorization for ongoing treatment

 

·         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 for diagnoses of rheumatoid arthritis or neonatal-onset multisystem inflammatory disease.

 

 

 

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