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	Xeljanz4
	Humira	Humira		Humira	Otezla
	Xeljanz, Xeljanz XR			Stelara SC	Stelara SC
					Xeljanz, Xeljanz XR
Non-preferred (must try ONE preferred agent)	--	--	Actemra SC1	Otezla	Enbrel3	Cimzia	Simponi SC (100 mg)
Non-preferred (must try TWO preferred agents)	Cimzia	Cimzia	Orencia SC2	Cimzia	Cimzia	--	--
	Kevzara	Simponi SC		Simponi SC	Taltz
	Kineret	(50 mg)		(50 mg)	Siliq
	Olumiant			Orencia SC	Tremfya
	Orencia SC			Taltz
	Simponi SC (50 mg)

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

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

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

⁴ Xeljanz XR is not indicated in ulcerative colitis (UC) and is not addressed within this indication.

  I.   Actemra (tocilizumab)

 A.    Initial Authorization

 1.     Rheumatoid Arthritis

When a benefit, coverage of Actemra SC may 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.

 2.     Giant Cell Arteritis

When a benefit, coverage of Actemra SC may 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 in 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.

3.     Polyarticular Juvenile Idiopathic Arthritis

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

a.     Actemra SC is to be used for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in patients ≥ 2 years of age.

b.    The patient meets one of the following conditions (i., ii., iii., or iv.):

i.      The patient has tried one other agent for this condition (e.g., methotrexate [MTX], sulfasalazine, leflunomide, or a nonsteroidal anti-inflammatory drug [NSAID]).

ii.    The patient will be starting on Actemra SC concurrently with methotrexate (MTX), sulfasalazine, or leflunomide.

iii.   The patient has an absolute contraindication to methotrexate (MTX) [e.g., pregnancy, breast feeding, alcoholic liver disease, immunodeficiency syndrome, blood dyscrasias], sulfasalazine, or leflunomide.

iv.   The patient has aggressive disease, as determined by the prescribing physician.

c.     Treatment with Humira for the treatment of juvenile idiopathic arthritis (JIA) was ineffective or not tolerated (see Table 1)

4.     Systemic Juvenile Idiopathic Arthritis

When a benefit, coverage of Actemra SC may be approved for systemic juvenile idiopathic arthritis (SJIA) when the following criterion is met (a.):

a.     Actemra SC is to be used for the treatment of systemic juvenile idiopathic arthritis (SJIA) in patients ≥ 2 years of age.

 B.    Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

 C.    Quantity Limitations

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

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

II.     Cosentyx (secukinumab)

 A.    Initial Authorization

 1.     Ankylosing Spondylitis

When a benefit, coverage of Cosentyx may 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.

2.     Psoriatic Arthritis

When a benefit, coverage of 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 (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 (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 (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.

3.     Plaque Psoriasis, including Scalp Psoriasis

When a benefit, coverage of Cosentyx may 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. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

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

B.   Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

 C.     Quantity Limitations

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

 

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

III.   Enbrel (etanercept)

 A.    Initial Authorization

 1.     Rheumatoid Arthritis

When a benefit, coverage of Enbrel may 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.

 2.     Ankylosing Spondylitis

When a benefit, coverage of Enbrel may 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.

3.     Juvenile Idiopathic Arthritis

When a benefit, coverage of Enbrel may 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.

4.     Psoriatic Arthritis

When a benefit, coverage of 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 (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 (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 (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.

5.    Plaque Psoriasis, adults

When a benefit, coverage of Enbrel may 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. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

ii.    Treatment with 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.):

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

6.     Plaque Psoriasis, pediatrics

When a benefit, coverage of Enbrel may 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. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

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

B.   Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

 C.     Quantity Limitations

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

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

N/A=not applicable

IV.  Humira (adalimumab)

 A.    Initial Authorization

 1.   Rheumatoid Arthritis

When a benefit, coverage of Humira may 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.

 2.     Ankylosing Spondylitis

When a benefit, coverage of Humira may 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.

 3.     Juvenile Idiopathic Arthritis

When a benefit, coverage of Humira may 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.

 4.     Psoriatic Arthritis

When a benefit, coverage of Humira 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 (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 (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 (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.

 5.     Plaque Psoriasis

When a benefit, coverage of Humira may 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. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

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

 6.     Crohn’s Disease, adults

When a benefit, coverage of Humira may 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.

7.     Crohn’s Disease, pediatrics

When a benefit, coverage of Humira may 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.

 8.     Ulcerative Colitis

When a benefit, coverage of Humira may 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).

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

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

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

10.  Uveitis

When a benefit, coverage of Humira may 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

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

1.     Clinical documentation of disease stability or improvement must be provided.

C.    Quantity Limitations

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

 

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

 

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

 V.   Otezla (apremilast)

 A.    Initial Authorization

 1.     Psoriatic Arthritis

When a benefit, coverage of Otezla 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 (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.

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 (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.

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.

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

When a benefit, coverage of Otezla may 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. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

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

 B.    Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

VI.   Stelara (ustekinumab)

 A.    Initial Authorization

 1.     Psoriatic Arthritis

When a benefit, coverage of 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 (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 (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 (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.

 2.     Plaque Psoriasis

When a benefit, coverage of Stelara may 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. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

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

3.     Crohn’s Disease

 Patients Initiating Therapy with Stelara SC

 When a benefit, coverage of Stelara may 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.

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, coverage of Stelara may 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

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

1.     Clinical documentation of disease stability or improvement must be provided.

Dosing

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

• Psoriasis (Adult)

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

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

• Psoriasis (Adolescent 12 years and older)

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

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

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

• Psoriatic Arthritis

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

• Crohn's Disease

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

C.  Quantity Limitations

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

 

Diagnosis	Induction Therapy	Maintenance Therapy
psoriatic arthritis, plaque psoriasis	Two (2) prefilled syringes within the first four (4) weeks of therapy	One (1) syringe every eighty four (84) days (12 weeks)
Crohn's disease	N/A	One (1) syringe every fifty-six (56) days (8 weeks)

N/A=not applicable

 VII.  Xeljanz (tofacitinib)

 A.    Initial Authorization

 1.    Rheumatoid Arthritis

When a benefit, coverage of Xeljanz or Xeljanz XR may 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.

 2.     Psoriatic Arthritis

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

a.     Spinal or axial psoriatic arthritis (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 (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.

iii.   Xeljanz or Xeljanz XR is used in combination with 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.

         3.   Ulcerative Colitis

When a benefit, coverage of Xeljanz may be approved for adults patients with ulcerative colitis (UC) when all of the following criteria are met (a., b., and c.):

a.     Xeljanz is to be used to for the treatment of moderate to severe ulcerative colitis.

b.    Doses greater than 20 mg per day for Xeljanz will not be approved for ulcerative colitis.

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

B.    Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

 

VIII. Cimzia (certolizumab)

 A.    Initial Authorization

 1.     Rheumatoid Arthritis

When a benefit, coverage of Cimzia may 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.

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

When a benefit, coverage of Cimzia may 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. 

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

When a benefit, coverage of Cimzia 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 (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.

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 (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.

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.

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

When a benefit, coverage of Cimzia may 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.

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

 5.    Plaque Psoriasis

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

a.     Cimzia 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. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

ii.    Treatment with 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.    Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

 C.    Quantity Limitations

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

Diagnosis	Induction Therapy	Maintenance Therapy
rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn’s disease	Ten (10) syringes in first twelve (12) weeks of therapy -OR- One (1) starter package kit	Two (2) syringes every four (4) weeks
plaque psoriasis	Six (6) syringes in first four (4) weeks of therapy	One (1) syringe or two (2) syringes every two (2) weeks

 

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

IX.   Kevzara (sarilumab)

 A.    Initial Authorization

 1.     Rheumatoid Arthritis

When a benefit, coverage of Kevzara may 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.

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

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

1.     Clinical documentation of disease stability or improvement must be provided.

C.     Quantity Limitations

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

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

X.  Kineret (anakinra)

 A.    Initial Authorization

 1.     Rheumatoid Arthritis

When a benefit, coverage of Kineret may 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.

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, coverage of Kineret may 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

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

1.     Clinical documentation of disease stability or improvement must be provided.

Dosing

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

•      Neonatal-Onset Multisystem Inflammatory Disease

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

C.    Quantity Limitations

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

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

XI.    Olumiant (baricitinib)

 A.    Initial Authorization

 1.    Rheumatoid Arthritis

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

a.     Olumiant is to be used for treatment of adults 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.

c.     Treatment with at least one tumor necrosis factor (TNF) antagonist therapy, including adalimumab (Humira), etanercept (Enbrel), golimumab (Simponi), and certolizumab (Cimzia), was ineffective or not tolerated.

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

i.      If the member has tried and failed adalimumab (Humira) and etanercept (Enbrel), the member will not need to try and fail any additional preferred biologic products.

ii.    If the member has tried and failed either adalimumab (Humira) or etanercept (Enbrel), the member will need to try and fail one additional preferred biologic product.

B.    Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

 

XII.    Orencia (abatacept)

 A.    Initial Authorization

 1.     Rheumatoid Arthritis

When a benefit, coverage of Orencia subcutaneous (SC) may 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.

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

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

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

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

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

 3.     Psoriatic Arthritis

When a benefit, coverage of Orencia SC 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 (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.

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 (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.

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

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

C.     Reauthorization

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

2.     Clinical documentation of disease stability or improvement must be provided.

 D.     Quantity Limitations

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

Diagnosis	Induction Therapy	Maintenance Therapy
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

XIII.   Siliq (brodalumab)

 A.    Initial Authorization

 1.     Plaque Psoriasis

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

 When a benefit, initiation of Siliq may 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 and phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

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

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 may 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 and phototherapy (e.g. PUVA, UVB) was ineffective or not tolerated. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

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

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

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

1.     Clinical documentation of disease stability or improvement must be provided.

 C.    Quantity Limitations

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

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

XIV.  Simponi (golimumab)

 A.    Initial Authorization

 1.     Rheumatoid Arthritis

When a benefit, coverage of Simponi SC may 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) in combination with methotrexate.

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).

2.     Ankylosing Spondylitis

When a benefit, coverage of Simponi SC may 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.

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

When a benefit, coverage of 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 (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.

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 (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.

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.

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

When a benefit, coverage of Simponi SC may 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.

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

 B.    Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

 C.    Quantity Limitations

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

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

XV.  Taltz (ixekizumab)

 A.    Initial Authorization

 1.    Psoriatic Arthritis

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

a.     Spinal or axial psoriatic arthritis (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.

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 (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.

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.

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

When a benefit, coverage of Taltz may 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. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

ii.    Treatment with 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.     Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

 C.     Quantity Limitations

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

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

XVI.  Tremfya (guselkumab)

 A.    Initial Authorization

 1.    Plaque Psoriasis

When a benefit, coverage of Tremfya may 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. If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated.

ii.    Treatment with 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.    Reauthorization

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

1.     Clinical documentation of disease stability or improvement must be provided.

 C.    Quantity Limitations

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

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

 

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

II.    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) medication 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.

None