Policy Applies to 

 

• Medicare Part D plans

 

 

Drugs Addressed in this Policy

 

1.     Actemra (tocilizumab) subcutaneous (SC) injection, intravenous (IV) infusion

2.     Cosentyx (secukinumab) SC injection

3.     Enbrel (etanercept) SC injection

4.     Humira (adalimumab) SC injection

5.     Otezla (apremilast) tablets

6.     Stelara (ustekinumab) SC injection, IV infusion

7.     Xeljanz, Xeljanz XR (tofacitinib) tablets

8.     Cimzia (certolizumab) SC injection

9.     Kevzara (sarilumab) SC injection

10.  Kineret (anakinra) SC injection

11.  Orencia (abatacept) SC injection, IV infusion

12.  Remicade (infliximab) IV infusion

13.  Simponi (golimumab) SC injection

14.  Simponi Aria (golimumab) IV infusion

15.  Taltz (ixekizumab) SC injection

 

 

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: 

 

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) – SC injection, IV infusion

·         Reducing signs and symptoms, of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) in pediatric patients 2 years of age and older – IV infusion

·         Treatment of patients 2 years of age and older with active systemic juvenile idiopathic arthritis (SJIA) – IV infusion

·         Treatment of giant cell arteritis (GCA) – SC injection

 

Prior Authorization Criteria:

 

A.    Actemra (tocilizumab) – subcutaneous injection

1.     When a benefit, tocilizumab (Actemra) may be approved when the following criteria is met (a. or b.):

a.     Tocilizumab (Actemra) subcutaneous injection is used in patients with moderately to severely active rheumatoid arthritis (RA) meeting all of the following criteria (i. through iii.):

i.      Adults

ii.    Diagnosis of moderate to severe active rheumatoid arthritis (ICD9 714.0, ICD10 M06.9).

iii.   An adequate trial or intolerance to preferred subcutaneous biologic products indicated for the treatment of rheumatoid arthritis (A and B)

A)     Enbrel

B)     Humira

b.     Tocilizumab (Actemra) subcutaneous injection is used in patients with giant cell arteritis (GCA)

 

B.    Actemra (tocilizumab) – intravenous infusion

1.     When a benefit, tocilizumab (Actemra) may be approved when the following criteria is met (a. or b.):

a.     Tocilizumab (Actemra) solution for intravenous infusion is used in patients with moderately to severely active rheumatoid arthritis (RA) meeting all of the following criteria (i. through iii.):

i.      Adults

ii.    Diagnosis of moderate to severe active rheumatoid arthritis (ICD9 714.0, ICD10 M06.9)

iii.   An adequate trial or intolerance to a preferred intravenous biologic product indicated for the treatment of rheumatoid arthritis (A) or B)

A)    Remicade

B)    Simponi Aria

b.    Tocilizumab (Actemra) solution for intravenous infusion is to be used in reducing the signs and symptoms in patients with juvenile idiopathic arthritis (ICD-9 714.3x, ICD-10 M08.00)

 

 

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

Prior Authorization Criteria:

 

A.    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 both preferred biologic products Enbrel and Humira was ineffective or not tolerated, or both products are contraindicated

 

B.    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. and b.):

a.     Secukinumab (Cosentyx) is to be used for the treatment of adults with psoriatic arthritis

b.    Treatment with both preferred biologic products Enbrel and Humira was ineffective or not tolerated, or both products are contraindicated

 

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

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

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

b.    The member had an inadequate response to systemic (e.g. methotrexate, cyclosporine) therapy OR phototherapy (e.g. PUVA, UVB)

c.     The member has had an adequate trial or experienced an intolerance to the preferred biologic product, Humira, indicated for the treatment of plaque psoriasis

 

D.    Quantity Limitations

1.     **Important Note:

a.     For induction therapy, ten- 150 mg/mL pens (10 mLs total) will be approved during the first 28 days of therapy.

b.    Maintenance therapy dosing is 150mg to 300 mg SC every 4 weeks, and aligned with current quantity level limit (e.g., two- 150 mg/mL pens or 2 mL total every 28 days) per Pharmacy Policy J-32.

 

 

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) 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

 

Prior Authorization Criteria:

 

1.     When a benefit, etanercept (Enbrel) may be approved when all of the following criteria are met:

a.     Rheumatoid arthritis (ICD-9 714.0, ICD-10 M06.9)

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

b.    Ankylosing spondylitis (ICD-9 720.0, ICD-10 M45.X)

                                          i.    Etanercept (Enbrel) is to be used for the treatment of adults with ankylosing spondylitis

c.     Juvenile idiopathic arthritis (juvenile rheumatoid arthritis) [ICD-9 714.3x, ICD-10 M08.00]

                                          i.    Etanercept (Enbrel) is to be used for the treatment of juvenile idiopathic arthritis in patients 2 years of age and older AND

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

d.    Psoriatic arthritis (ICD-9 696.0, ICD-10 L40.52)

                                          i.    Etanercept (Enbrel) is to be used for the treatment of adults with psoriatic arthritis

e.     Plaque psoriasis (ICD-9 696.1, ICD-10 L40.X)

                                          i.    Etanercept (Enbrel) is to be used for the treatment of chronic plaque psoriasis in patients 4 years or older AND

                                        ii.    One of the following criteria are met (1., 2., or 3.):

1.     Treatment with phototherapy was ineffective or not tolerated OR

2.     Treatment with systemic therapy (e.g. methotrexate, cyclosporine) was ineffective or not tolerated

3.     Member has a contraindication to phototherapy or all systemic therapies

 

 

 

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) 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)

 

Prior Authorization Criteria:

 

A.    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 criterion is met:

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

 

**Important Note:  For use in RA without concomitant methotrexate therapy, doses of 40 mg every week will be approved (e.g., 4 syringes of Humira 40 mg/0.8mL or 3.2 mL total per 28 days).  Dosing with concomitant methotrexate therapy in RA, 40 mg every other week, is aligned with current quantity level limit (e.g., 1.6 mL every 28 days) per Pharmacy Policy J-32.

 

B.    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 criterion is met:

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

 

C.    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 moderate to severe 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

 

D.    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.     Adalimumab (Humira) is to be used for the treatment of adults with psoriatic arthritis

 

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

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

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

 

**Important Note:  For induction therapy, 80 mg on day 1 followed by 40 mg every other week starting 1 week after initial 80 mg dose will be approved (e.g., 4 syringes of Humira 40 mg/0.8mL or 3.2 mL total for first 28 days).  Maintenance therapy dosing, 40 mg every other week, is aligned with current quantity level limit (e.g., 1.6 mL every 28 days) per Pharmacy Policy J-32.

 

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

1.     When a benefit, adalimumab (Humira) may be approved for adults 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 

 

G.    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. or ii.):

i.      Treatment with at least one immunosuppressant (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 

 

**Important Note:  Quantity limit on Humira 40 mg/0.8mL Crohn’s disease starter pack permits required initial therapy dosing for HS diagnosis (e.g., six- 40 mg/0.8 mL syringes or 4.8 mL total).  Maintenance therapy dosing for HS is aligned with current quantity level limit (e.g., 1.6 mL every 28 days) per Pharmacy Policy J-32.

 

H.    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. and b.):

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

 

**Important Note:  Quantity limit on Humira 40 mg/0.8mL Crohn’s disease starter pack permits required induction therapy dosing for UC diagnosis (e.g., six- 40 mg/0.8 mL syringes or 4.8 mL total).  Maintenance therapy dosing for UC is aligned with current quantity level limit (e.g., 1.6 mL every 28 days) per Pharmacy Policy J-32.

 

I.      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

 

J.     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 criterion is met:

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

 

 

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

 

Prior Authorization Criteria:

 

A.    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 criteria are met (a. through c.):

a.     Apremilast (Otezla) is to be used for the treatment of adults with psoriatic arthritis

b.    Treatment with both preferred biologic products [etanercept (Enbrel) and adalimumab (Humira)] was ineffective or not tolerated, or both products are contraindicated.

c.     Maintenance dose does not exceed 30 mg twice daily.

 

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

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

a.     Apremilast (Otezla) is to be used for the treatment of adults with moderate to severe chronic plaque psoriasis

b.    Treatment with both preferred biologic products [etanercept (Enbrel) and adalimumab (Humira)] was ineffective or not tolerated, or both products are contraindicated.

c.     Maintenance dose does not exceed 30 mg twice daily.

 

 

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

Section I:  Approval Criteria: 

                      I.        Plaque Psoriasis (ICD9 696.1, ICD10 L40.0)

 

When a benefit, Stelara subcutaneous injection may be approved when all of the following criteria are met (A. through D.):

A.    Treatment of moderate to severe plaque psoriasis

B.    Previous trial (1. or 2.)

1.     Phototherapy

2.    One systemic therapy  (e.g. methotrexate, cyclosporine)

C.    Adequate trial or intolerance to Humira

D.    Documentation of member weight and prescribed Stelara dose is consistent with dosing outlined in Section II.

 

 

                    II.        Psoriatic Arthritis (ICD9 696.0, ICD10 L40.50)

 

When a benefit, Stelara subcutaneous injection may be approved when all of the following criteria are met (A. through C.):

A.    Treatment of psoriatic arthritis

B.    Adequate trial or intolerance of (1. and 2.)

1.     Enbrel

2.     Humira

C.    Documentation of member weight and prescribed Stelara dose is consistent with dosing outlined in Section II.

 

                   III.        Crohn's Disease (ICD (555.9, ICD10 K50.01X, 50.1X, 50.8X, 50.9X)

 

When a benefit, Stelara intravenous injection may be approved when all of the following criteria are met (A. through B.):

 

A.    Treatment of moderate to severely active Crohn's disease

B.    Adequate trial or intolerance of at least 2 immunosuppressants (corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate)

 

When a benefit, Stelara subcutaneous injection (90 mg only) may be approved when all of the following criteria are met (A. through D.):

A.    Treatment of moderate to severely active Crohn's disease

B.    Failure or intolerance to (1. and 2.)

1.     At least one immunosuppressant (corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate)

2.     Humira, a tumor necrosis factor (TNF) blocker approved for the treatment of Crohn's disease

C.    Achieve clinical remissionollowing an intravenous injection of Stelara

D.    Documentation of member weight and prescribed Stelara dose is consistent with dosing outlined in Section II.

 

Section II: Dosing:

 

Psoriasis (45 mg, 90 mg)

·         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.

·         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 (45 mg, 90 mg)

·         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 (90 mg)

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

 

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

 

Prior Authorization Criteria:

 

A.    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. through d.):

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

b.    The dose of tofacitinib (Xeljanz) does not exceed 10 mg per day and the dose of Xeljanz XR does not exceed 11 mg per day

c.     The member has had an inadequate response or intolerance to methotrexate

d.    The member has had an adequate trial or experienced an intolerance to the preferred biologic products, Enbrel and Humira, indicated for the treatment of rheumatoid arthritis.

 

 

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 adult patients 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

 

Prior Authorization Criteria:

 

A.    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. and b.):

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

b.    Treatment with both preferred biologic products [etanercept (Enbrel) and adalimumab (Humira)] was ineffective or not tolerated, or both products are contraindicated

 

B.    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. and b.):

a.     Certolizumab pegol (Cimzia) is to be used for the treatment of adults with ankylosing spondylitis 

b.    Treatment with both preferred biologic products [etanercept (Enbrel) and adalimumab (Humira)] was ineffective or not tolerated, or both products are contraindicated

 

C.    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. and b.):

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

b.    Treatment with both preferred biologic products [etanercept (Enbrel) and adalimumab (Humira)] was ineffective or not tolerated, or both products are contraindicated

 

D.    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 moderate to severe Crohn's disease

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

i.      An adequate trial or intolerance to infliximab (Remicade)

ii.    An adequate trial or intolerance to least one corticosteroid (e.g. prednisone or hydrocortisone)

c.     Treatment with adalimumab (Humira) was ineffective, not tolerated or is contraindicated

 

 

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)

 

Prior Authorization Criteria:

 

A.    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.     The member has had an adequate trial or experienced an intolerance to at least two biologic products indicated for the treatment of RA (e.g. Humira, Enbrel, Actemra, Xeljanz, Xeljanz XR)

 

 

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)

 

Prior Authorization Criteria:

 

A.    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 moderate to severe rheumatoid arthritis (RA)

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

c.     Treatment with both preferred biologic products [etanercept (Enbrel) and adalimumab (Humira)] was ineffective or not tolerated, or both products are contraindicated

 

B.    Neonatal-Onset Multisystem Inflammatory Disease

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

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

 

 

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) – SC injection, IV infusion
• 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 – SC injection
• Treatment of moderate to severe active juvenile idiopathic arthritis in pediatric patients 2 years of age or older, as monotherapy or concomitantly with methotrexate – SC injection
• Treatment of moderate to severe active juvenile idiopathic arthritis in pediatric patients 6 years of age or older, as monotherapy or concomitantly with methotrexate – IV infusion

 

Prior Authorization Criteria:

 

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

 

Orencia (abatacept) – subcutaneous (SC) injection

 

1.     When a benefit, abatacept (Orencia) may be approved when the following are met (a. and b.):

a.     Abatacept (Orencia) SC is to be used in adults with moderately to severely active rheumatoid arthritis (ICD9 714.0, ICD-10 M06.9)

b.    The member has had an adequate trial or experienced an intolerance to both preferred biologic products, Humira and Enbrel

 

Orencia (abatacept) – intravenous (IV) infusion 

 

2.     When a benefit, abatacept (Orencia) may be approved when the following are met (a. and b.):

a.     Abatacept (Orencia) IV is to be used in used in adults with moderately to severely active rheumatoid arthritis (ICD9 714.0, ICD-10 M06.9)

b.    The member has had an adequate trial or experienced an intolerance to one preferred intravenous biologic products, Remicade or Simponi Aria

 

B.    Juvenile idiopathic arthritis (juvenile rheumatoid arthritis) [ICD-9 714.3x, ICD-10 M08.00]

 

Orencia (abatacept) – subcutaneous (SC) injection

 

1.     When a benefit, abatacept (Orencia) SC may be approved when the following are met (a.):

a.     Abatacept (Orencia) is to be used reducing the signs and symptoms in patients with moderately to severely active polyarticular juvenile idiopathic arthritis

 

Orencia (abatacept) – intravenous (IV) infusion 

 

1.     When a benefit, abatacept (Orencia) may be approved when the following are met (a.):

a.     Abatacept (Orencia) IV is to be used reducing the signs and symptoms in patients with moderately to severely active polyarticular juvenile idiopathic arthritis

 

 

 

XII. Remicade (infliximab)

 

Infliximab (Remicade) neutralizes tumor necrosis factor-alpha (TNF-alpha). It binds to high affinity soluble and transmembrane forms of TNF-alpha and inhibits the binding of TNF-alpha with its receptors, resulting in inhibition of pro-inflammatory cytokines, such as interleukin IL-1 and IL-6.

 

FDA-Approved Indications:

 

• Reducing signs and symptoms in adult patients with active ankylosing spondylitis
• 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 who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate
• The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate
• Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis
• 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 when used in combination with methotrexate
• Inducing and sustaining clinical remission in patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP).

 

Prior Authorization Criteria:

 

A.    When a benefit, infliximab may be approved when ONE of the following criteria are met (1., 2., 3., 4., 5., or 6.):

1.     Infliximab is to be used in combination with methotrexate to reduce the signs and symptoms and inhibit the progression of structural damage in adults with moderate to severe active rheumatoid arthritis (ICD-9 714.0, ICD-10 M06.9)

2.     Infliximab is to be used in reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis (ICD-9 696.0, ICD-10 L40.59)

3.     Infliximab is to be used in reducing the signs and symptoms of patients with ankylosing spondylitis (ICD-9 720.0, ICD-10 M45.X)

4.     Infliximab is to be used in reducing the signs and symptoms of patients (≥6 years of age) with moderate to severe Crohn's disease (ICD-9 555, ICD-10 K50.X) who have not responded to treatment with at least two immunosuppressants

5.     Infliximab is to be used to induce and maintain clinical remission in patients (≥6 years of age) with moderate to severe ulcerative colitis (ICD-9 556, ICD-10 K51.8-K51.9) who have not responded to treatment with at least two immunosuppressants

6.     Infliximab is to be used for the treatment of moderate to severe psoriasis ( ICD-9 696.1, ICD-10 L40.X) in patients who have had an inadequate response to systemic (e.g. methotrexate, cyclosporine) therapy OR phototherapy (e.g. PUVA, UVB)

 

 

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

 

Prior Authorization Criteria:

 

A.    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. and b.):

a.     Golimumab (Simponi) is to be used for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate

b.    The member has had an adequate trial or experienced an intolerance to both preferred biologic products, Humira and Enbrel

 

B.    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. and b.):

a.     Golimumab (Simponi) is to be used for reducing the signs and symptoms in patients with ankylosing spondylitis

b.    The member has had an adequate trial or experienced an intolerance to both preferred biologic products, Humira and Enbrel

 

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

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

a.     Simponi (golimumab) is to be used for the treatment of adult patients with active psoriatic arthritis

b.    The member has had an adequate trial or experienced an intolerance to both preferred biologic products, Humira and Enbrel

 

D.    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. or b. and c.):

a.     Simponi (golimumab) is to be used to induce and maintain clinical remission in adult patients with moderate to severe ulcerative colitis who have not responded to treatment with at least two immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine OR

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

c.     The member has had an adequate trial or experienced intolerance to the preferred biologic product Humira

 

XIV. Simponi Aria (golimumab)

 

Golimumab (Simponi Aria) 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

 

Prior Authorization Criteria:

 

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

1.     When a benefit, golimumab may be approved when all of the following criteria are met:

a.     Golimumab (Simponi Aria) solution for IV infusion is to be used in combination with methotrexate for the treatment of adult patients with moderately to severely active rheumatoid arthritis

 

 

XV.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

 

Prior Authorization Criteria:

 

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

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

a.     Treatment of moderate to severe psoriasis

b.    The member had an inadequate response or contraindication to systemic therapy (e.g. methotrexate, cyclosporine) OR phototherapy (e.g. PUVA, UVB)

c.     The member has had an adequate trial or experienced an intolerance to the preferred biologic product Humira which is indicated for the treatment of plaque psoriasis

 

**Important Note: For induction therapy, eight -80mg mg/mL pens/syringes will be approved during the first 12 weeks of therapy starting with 160mg (2 syringes) initially, followed by 80mg subcutaneously at weeks 2, 4, 6, 8, 10, and 12.  Maintenance therapy dosing is 80mg subcutaneously every 4 weeks, and aligned with current quantity level limit (e.g., one - 80 mg/mL pen/syringe 4 weeks per Pharmacy Policy J-32.

 

 

·         For Medicare Part D beneficiaries, the Chronic Inflammatory Disease (CID) medications may be approved when used for a medically accepted indication as defined by the Centers for Medicare & Medicaid Services (CMS). 

 

Authorization Duration

 

·         Medicare Part D plans:

o    For all medications listed:

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

 

 

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