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
|
|
Step 1
Preferred
|
Actemra SC
|
Cosentyx
|
Enbrel
|
Cosentyx
|
Cosentyx
|
Humira
|
Humira
|
|
Enbrel
|
Enbrel
|
Humira
|
Enbrel
|
Humira
|
Stelara SC
|
|
|
Humira
|
Humira
|
|
Humira
|
Otezla
|
|
|
|
Rinvoq
Xeljanz, Xeljanz XR
|
|
|
Otezla
Stelara SC
Xeljanz, Xeljanz XR
|
Skyrizi
Stelara SC
Tremfya
|
|
|
|
Step 2
Non-Preferred (directed to ONE Step 1 agent)
|
--
|
--
|
Actemra SC1
|
--
|
Enbrel3
|
Cimzia4
|
Simponi SC
Stelara SC
|
|
|
|
|
|
Xeljanz,
Xeljanz XR
|
|
Step 3a
Non-Preferred (directed to TWO Step 1 agents)
|
Cimzia
|
Cimzia
|
--
|
Cimzia
|
Cimzia
|
--
|
--
|
|
Kevzara
|
Simponi SC
|
|
Simponi SC
|
Siliq
|
|
|
|
Kineret
|
Taltz
|
|
Orencia SC
|
|
|
|
|
Olumiant
|
|
|
Taltz
|
|
|
|
|
Orencia SC
|
|
|
|
|
|
|
|
Simponi SC
|
|
|
|
|
|
|
|
Step 3b
Non-Preferred (directed to TWO Step 1 or 2 agents)
|
--
|
--
|
Orencia SC2
|
--
|
--
|
--
|
--
|
|
Step 3c
Non-Preferred (directed to THREE Step 1 agents)
|
--
|
--
|
--
|
--
|
Taltz
|
--
|
--
|
1 Actemra SC will require a trial of Humira first for Polyarticular Juvenile Idiopathic Arthritis (PJIA) indication only.
2 Orencia SC will require a trial of two step 1 (Enbrel, Humira) or step 2 (Actemra) agents.
3 Enbrel will require a trial of Humira for patients ≥ 18 years of age for plaque psoriasis indication only.
4 Cimzia will require a trial of Humira specifically for Crohn’s disease indication only.
I. Actemra (tocilizumab)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Actemra SC may be approved for RA when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe RA.
c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all nonbiologic DMARDs are contraindicated.
2. Giant Cell Arteritis (GCA)
When a benefit, coverage of Actemra SC may be approved for GCA when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of GCA.
c. The member has experienced therapeutic failure or intolerance to at least one (1) systemic corticosteroid (e.g., prednisone), or all corticosteroids are contraindicated.
3. Polyarticular Juvenile Idiopathic Arthritis (PJIA)
When a benefit, coverage of Actemra SC may be approved for PJIA when all of the following criteria are met (a. through d.):
a. The member is 2 years of age or older.
b. The member has a diagnosis of PJIA.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
ii. The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.
d. The member has experienced therapeutic failure or intolerance to Humira for the treatment of PJIA (see Table 1).
4. Systemic Juvenile Idiopathic Arthritis (SJIA)
When a benefit, coverage of Actemra SC may be approved for SJIA when all of the following criteria are met (a. and b.):
a. The member is 2 years of age or older.
b. The member has a diagnosis of SJIA.
B. Reauthorization
When a benefit, reauthorization of Actemra SC may be approved when the following criterion is met (1.):
1. 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
|
|
RA and GCA
|
Four (4) prefilled syringes within the first four (4) weeks of therapy
|
Two (2) prefilled syringes every four (4) weeks
-OR-
Four (4) prefilled syringes
every four (4) weeks
|
|
PJIA
|
N/A
|
One (1) prefilled syringe every two (2) or three (3) weeks
|
|
SJIA
|
N/A
|
One (1) prefilled syringe every week or two (2) weeks
|
II. Cimzia (certolizumab)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Cimzia may be approved for RA when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe RA.
c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (see Table 1).
2. Ankylosing Spondylitis (AS)
When a benefit, coverage of Cimzia may be approved for AS when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of AS.
c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of AS (see Table 1).
3. Psoriatic Arthritis (PsA)
When a benefit, coverage of Cimzia may be approved for PsA when one (1) of the following criteria is met (a., b., or c.):
a. Spinal or axial PsA (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
b. PsA without spinal or axial disease (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
c. Enthesitis and/or dactylitis associated PsA (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA
iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
4. Crohn’s Disease (CD)
When a benefit, coverage of Cimzia may be approved CD when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe CD.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate), or all immunosuppressants are contraindicated.
ii. The member is currently pregnant.
d. The member has experienced therapeutic failure or intolerance to Humira for the treatment of CD (see Table 1).
5. Plaque Psoriasis (PsO)
When a benefit, coverage of Cimzia may be approved for PsO when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsO (see Table 1).
6. Non-radiographic Axial Spondyloarthritis (nr-axSpA)
When a benefit, coverage of Cimzia may be approved for nr-axSpA when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of nr-axSpA.
c. The member has experienced therapeutic failure or intolerance to at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs), or all NSAIDs are contraindicated.
B. Reauthorization
When a benefit, reauthorization of Cimzia may be approved when the following criterion is met (1.):
1. 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
|
|
RA, AS, PsA,
CD, nr-axSpA
|
Ten (10) syringes in first twelve (12) weeks of therapy
-OR-
One (1) starter package kit
|
Two (2) syringes every four (4) weeks
|
|
PsO
|
Six (6) syringes in first four (4) weeks of therapy
|
One (1) syringe or two (2) syringes every two (2) weeks
|
- To note, starter package kits are coded for quantity level limitations of one (1) kit per 365 days.
III. Cosentyx (secukinumab)
A. Initial Authorization
1. Ankylosing Spondylitis (AS)
When a benefit, coverage of Cosentyx may be approved for AS when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of AS.
c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
2. Psoriatic Arthritis (PsA)
When a benefit, coverage of Cosentyx may be approved for PsA when one (1) of the following criterion is met (a., b., or c.):
a. Spinal or axial PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
b. PsA without spinal or axial disease (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
c. Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA
iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
3. Plaque Psoriasis (PsO), including Scalp Psoriasis
When a benefit, coverage of Cosentyx may be approved for PsO when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
4. Non-radiographic Axial Spondyloarthritis (nr-axSpA)
When a benefit, coverage of Cosentyx may be approved for nr-axSpA when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of nr-axSpA.
c. The member has experienced therapeutic failure or intolerance to at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs), or all NSAIDs are contraindicated.
B. Reauthorization
When a benefit, reauthorization of 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
|
|
AS
|
One (1) or Five (5) pens/prefilled syringes within the first four (4) weeks of therapy
|
One (1) or Two (2) pens/prefilled syringes every four (4) weeks
|
|
PsA
|
One (1) or 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
|
|
PsO with or without PsA, scalp PsO
|
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
|
|
nr-axSpA
|
One (1) or Five (5) pens/prefilled syringes within the first four (4) weeks of therapy
|
One (1) pen/prefilled syringe every four (4) weeks
|
IV. Enbrel (etanercept)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Enbrel may be approved for RA when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe
c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
2. Ankylosing Spondylitis (AS)
When a benefit, coverage of Enbrel may be approved for AS when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of AS.
c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
3. Juvenile Idiopathic Arthritis (JIA)
When a benefit, coverage of Enbrel may be approved for JIA when all of the following criteria are met (a., b., and c.):
a. The member is 2 years of age or older.
b. The member has a diagnosis of JIA.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
ii. The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.
4. Psoriatic Arthritis (PsA)
When a benefit, coverage of Enbrel may be approved for PsA when one (1) of the following criteria is met (a., b., or c.):
a. Spinal or axial PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
b. PsA without spinal or axial disease (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
c. Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA
iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
5. Plaque Psoriasis (PsO), adults
When a benefit, coverage of Enbrel may be approved for adult PsO when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
d. The member has experienced therapeutic failure or intolerance to Humira for the treatment of PsO (see Table 1).
6. Plaque Psoriasis (PsO), pediatrics
When a benefit, coverage of Enbrel may be approved for pediatric PsO when all of the following criteria are met (a., b., and c.):
a. The member is ≥ 4 and < 18 years of age.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), 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
|
|
AS, JIA, pediatric PsO, PsA, RA
|
N/A
|
Four (4) 50 mg prefilled syringes/ autoinjectors every four (4) weeks
-OR-
Eight (8) 25 mg prefilled syringes every four (4) weeks
|
|
PsO, adults
|
Twenty four (24) 50 mg syringes/ autoinjectors within the first twelve (12) weeks of therapy
-OR-
Forty eight (48) 25 mg syringes/ autoinjectors within the first twelve (12) weeks of therapy
|
Four (4) 50 mg prefilled syringes/ autoinjectors every four (4) weeks
-OR-
Eight (8) 25 mg prefilled syringes/ autoinjectors every four (4) weeks
|
N/A=not applicable
V. Humira (adalimumab)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Humira may be approved for RA when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe RA.
c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
2. Ankylosing Spondylitis (AS)
When a benefit, coverage of Humira may be approved for AS when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of AS.
c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
3. Juvenile Idiopathic Arthritis (JIA)
When a benefit, coverage of Humira may be approved for JIA when all of the following criteria are met (a., b., and c.):
a. The member is 2 years of age or older.
b. The member has a diagnosis of JIA.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine), or all non-biologic DMARDs are contraindicated.
ii. The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.
4. Psoriatic Arthritis (PsA)
When a benefit, coverage of Humira may be approved for PsA when one (1) of the following criteria is met (a., b., or c.):
a. Spinal or axial PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
b. PsA without spinal or axial disease (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
c. Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA
iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
5. Plaque Psoriasis (PsO)
When a benefit, coverage of Humira may be approved for PsO when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
6. Crohn’s Disease (CD), adults
When a benefit, coverage of Humira may be approved for adult CD when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of CD.
c. The member meets one (1) of the following criteria(i. or ii.):
i. The member has experienced therapeutic failure or intolerance to at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate), or all immunosuppressants are contraindicated.
ii. The member is currently pregnant.
7. Crohn’s Disease (CD), pediatrics
When a benefit, coverage of Humira may be approved for pediatric CD when all of the following criteria are met (a., b., and c.):
a. The member is 6 years of age or older.
b. The member has a diagnosis of CD.
c. The member has experienced therapeutic failure or intolerance to at least one (1) immunosuppressant (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate), or all immunosuppressants are contraindicated.
8. Ulcerative Colitis (UC)
When a benefit, coverage of Humira may be approved for UC when all of the following criteria are met (a. and b.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate or severe UC.
9. Hidradenitis Suppurativa (HS)
When a benefit, coverage of Humira may be approved for HS when all of the following criteria are met (a. and b):
a. The member is 12 years of age or older.
b. The member has a diagnosis of moderate to severe HS.
10. Uveitis (UV)
When a benefit, coverage of Humira may be approved for UV when all of the following criteria are met (a., b., and c):
a. The member is 2 years of age or older.
b. The member has a diagnosis of non-infectious intermediate, posterior or panuveitis.
c. The member has experienced therapeutic failure or intolerance to at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine), or immunosuppressants are contraindicated.
B. Reauthorization
When a benefit, reauthorization of Humira may be approved when the following criterion is met (1.):
1. Clinical documentation of disease stability or improvement must be provided.
C. Quantity Limitations
When prior authorization is approved, Humira pre-filled syringes or auto-injectors may be authorized in quantities as follows:
|
Diagnosis
|
Induction Therapy
|
Maintenance Therapy
|
|
RA,
AS,
PsA
|
Two (2) prefilled syringes within the first four (4) weeks of therapy
|
Two (2) prefilled syringes every four (4) weeks
|
|
RA*
|
-----
|
One (1) prefilled syringe every week
(Without concurrent methotrexate therapy)
|
|
JIA,
pediatric UV
|
Two (2) prefilled syringes within the first four (4) weeks of therapy
|
Two (2) prefilled syringes every four (4) weeks
|
|
chronic PSO
|
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
OR-
Four (4) prefilled syringes every four (4) weeks†
|
|
adult CD
|
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 CD
(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 CD
(≥ 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†
|
|
UC
|
Six (6) 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†
|
|
HS 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
|
|
HS 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
|
|
adult UV
|
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
|
- *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.
VI. Kevzara (sarilumab)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Kevzara may be approved RA when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe RA.
c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (see Table 1).
B. Reauthorization
When a benefit, reauthorization of Kevzara may be approved when the following criterion is met (1.):
1. 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
|
|
RA
|
One (1) prefilled syringe every two weeks
|
One (1) prefilled syringe every two (2) weeks
|
VII. Kineret (anakinra)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Kineret may be approved for RA when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of RA.
c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (see Table 1).
2. Neonatal-Onset Multisystem Inflammatory Disease (NOMID)
When a benefit, coverage of Kineret may be approved for NOMID when following criterion is met (a.):
a. The member has a diagnosis of 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
|
|
RA, NOMID*
|
One (1) prefilled syringe once daily
|
One (1) prefilled syringe once daily
|
VIII. Olumiant (baricitinib)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Olumiant may be approved for RA when all of the following criteria are met (a. through e.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe RA.
c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least one (1) tumor necrosis factor (TNF) antagonist therapy, including Humira, Enbrel, Simponi, and Cimzia.
e. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (see Table 1).
i. To note: If the member has tried and failed Humira and Enbrel, the member will not need to try and fail any additional preferred biologic products. If the member has tried and failed either Humira or 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.
IX. Orencia (abatacept)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Orencia SC may be approved for RA when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe RA.
c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (see Table 1).
2. Juvenile Idiopathic Arthritis (JIA)
When a benefit, coverage of Orencia SC may be approved for juvenile idiopathic arthritis (JIA) when all of the following criteria are met (a. through d.):
a. The member is 2 years of age or older.
b. The member has a diagnosis of JIA.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to at least one (1) nonbiologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine), or all nonbiologic DMARDs are contraindicated.
ii. The member requires initial biologic therapy due to involvement of high-risk joints (e.g., cervical spine, wrist, or hip), high disease activity, and/or those judged by their physician to be at high risk of disabling joint damage.
d. The member has experienced therapeutic failure or intolerance to two step 1 (Enbrel, Humira) or step 2 (Actemra) agents for the treatment of JIA (see Table 1)
3. Psoriatic Arthritis (PsA)
When a benefit, coverage of Orencia SC may be approved for PsA when one (1) of the following criteria is met (a., b., or c.):
a. Spinal or axial PsA (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
b. PsA without spinal or axial disease (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
c. Enthesitis and/or dactylitis associated PsA (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA
iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
B. Reauthorization
When a benefit, reauthorization of Orencia SC may be approved when the following criterion is met (1.):
1. Clinical documentation of disease stability or improvement must be provided.
C. Quantity Limitations
When prior authorization is approved, Orencia SC may be authorized in quantities as follows:
|
Diagnosis
|
Induction Therapy
|
Maintenance Therapy
|
|
RA, JIA, PsA
|
Four (4) prefilled syringes within the first four (4) weeks of therapy
|
Four (4) prefilled syringes every four (4) weeks
|
X. Otezla (apremilast)
A. Initial Authorization
1. Psoriatic Arthritis (PsA)
When a benefit, coverage of Otezla may be approved for PsA when one (1) of the following criteria is met (a., b., or c.):
a. Spinal or axial PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
b. PsA without spinal or axial disease (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
c. Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA
iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
2. Plaque Psoriasis (PsO)
When a benefit, coverage of Otezla may be approved for PsO when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
3. Oral Ulcers associated with Behçet’s Disease
When a benefit, coverage of Otezla may be approved for oral ulcers associated with Behçet’s Disease when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of oral ulcers associated with Behçet’s Disease.
c. The member has experienced therapeutic failure or intolerance to at least one (1) topical triamcinolone product for acute flare-up of oral ulcers.
d. The member has experienced therapeutic failure or intolerance to colchicine for prevention of recurrent oral ulcers.
B. Reauthorization
When a benefit, reauthorization of Otezla may be approved when the following criterion is met (1.):
1. Clinical documentation of disease stability or improvement must be provided.
XI. Rinvoq (upadacitinib)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Rinvoq may be approved for RA when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe RA.
c. The member has experienced therapeutic failure, intolerance or contraindication to methotrexate.
B. Reauthorization
When a benefit, reauthorization of Rinvoq may be approved when the following criterion is met (1.):
1. Clinical documentation of disease stability or improvement must be provided.
XII. Siliq (brodalumab)
A. Initial Authorization
1. Plaque Psoriasis (PsO)
Initiation (0 to < 4 months previous therapy for Siliq)
When a benefit, initiation of Siliq may be approved for PsO when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsO (see Table 1).
Maintenance (≥ 4 months previous therapy for Siliq)
When a benefit, maintenance of Siliq may be approved for PsO when all of the following criteria are met (a. through e.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsO (see Table 1).
e. 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
|
|
PsO
|
Three (3) prefilled syringes within the first two (2) weeks of therapy
|
Two (2) prefilled syringes every four (4) weeks
|
XIII. Simponi (golimumab)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Simponi SC 50 mg may be approved for RA when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe
c. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all nonbiologic DMARDs are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of RA (see Table 1).
2. Ankylosing Spondylitis (AS)
When a benefit, coverage of Simponi SC 50 mg may be approved for AS when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of AS.
c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of AS (see Table 1).
3. Psoriatic Arthritis (PsA)
When a benefit, coverage of Simponi SC 50 mg may be approved for PsA when one of the following criteria is met (a., b., or c.):
a. Spinal or axial PsA (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
b. PsA without spinal or axial disease (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
c. Enthesitis and/or dactylitis associated PsA (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA
iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
4. Ulcerative Colitis (UC)
When a benefit, coverage of Simponi SC may be approved for UC when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate or severe UC.
c. The member has experienced therapeutic failure or intolerance to preferred biologic product (Humira) for the treatment of UC (see Table 1).
B. Reauthorization
When a benefit, reauthorization of Simponi SC may be approved when the following criterion is met (1.):
1. 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
|
|
RA, AS, PsA
|
One (1) 50 mg syringe/ autoinjector within the first four (4) weeks of therapy
|
One (1) 50 mg syringe/ autoinjector every four (4) weeks
|
|
UC
|
Three (3) 100 mg syringes/ autoinjector within the first four (4) weeks of therapy
|
One (1) 100 mg syringe/ autoinjector every four (4) weeks
|
XIV. Skyrizi (risankizumab)
A. Initial Authorization
1. Plaque Psoriasis (PsO)
When a benefit, coverage of Skyrizi may be approved for PsO when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
B. Reauthorization
When a benefit, reauthorization of Skyrizi 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, Skyrizi may be authorized in quantities as follows:
|
Diagnosis
|
Induction Therapy
|
Maintenance Therapy
|
|
PsO
|
Four (4) prefilled syringes (75 mg/0.83 mL) per 28 days
|
Two (2) prefilled syringes per 84 days
|
XV. Stelara (ustekinumab)
A. Initial Authorization
1. Psoriatic Arthritis (PsA)
When a benefit, coverage of Stelara may be approved for PsA when one of the following criteria is met (a., b., or c.):
a. Spinal or axial PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. Treatment with at least one (1) NSAID was ineffective or not tolerated, or all NSAIDs are contraindicated.
b. PsA without spinal or axial disease (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. Treatment with at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine) was ineffective or not tolerated, or all nonbiologic DMARDs are contraindicated.
c. Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA.
ii. When treatment with (1. or 2.):
1. At least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated.
2. All NSAIDs and all local glucocorticoid injections are contraindicated.
2. Plaque Psoriasis (PsO)
When a benefit, coverage of Stelara may be approved for PsO when all of the following criteria are met (a., b., and c.):
a. The member is 12 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
3. Crohn’s Disease (CD)
When a benefit, coverage of Stelara may be approved for adult CD when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe CD.
c. The member received a single induction dose of Stelara IV within 2 months of initiating therapy with Stelara SC and achieved clinical response or remission.
d. The member meets one (1) of the following criteria (i., ii., or iii.):
i. The member is currently pregnant.
ii. The member has experienced therapeutic failure or intolerance to at least two (2) immunosuppressants (e.g. corticosteroids, azathioprine, 6-mercaptopurine, or methotrexate), or immunosuppressants are contraindicated.
iii. 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 (1) of the following (1. or 2.):
1. Demyelinating disease
2. Heart failure
4. Ulcerative Colitis (UC)
When a benefit, coverage of Stelara may be approved for UC when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate or severe UC.
c. The member received a single induction dose of Stelara IV within 2 months of initiating therapy with Stelara SC and achieved clinical response or remission.
d. The member has experienced therapeutic failure or intolerance to preferred product Humira for the treatment of UC. Note: A trial of an infliximab product (e.g., Remicade, Inflectra, Renflexis) or Simponi SC also counts.
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.
. Ulcerative Colitis
a. Following a weight-based intravenous dose, the recommended dose is 90 mg 8 weeks following the intravenous dose, then every 8 weeks thereafter.
C. Quantity Limitations
When prior authorization is approved, Stelara SC may be authorized in quantities as follows:
|
Diagnosis
|
Induction Therapy
|
Maintenance Therapy
|
|
PsA, PsO
|
Two (2) prefilled syringes within the first four (4) weeks of therapy
|
One (1) syringe every eighty four (84) days (12 weeks)
|
|
CD, UC
|
N/A
|
One (1) syringe every fifty-six (56) days (8 weeks)
|
N/A=Not Applicable
- *Patients diagnosed with Crohn’s disease or ulcerative colitis may receive every 8-week dosing of Stelara. Patient Level Authorization (PLA) input - One (1) prefilled syringe every 42 days.
XVI. Taltz (ixekizumab)
A. Initial Authorization
1. Psoriatic Arthritis (PsA)
When a benefit, coverage of Taltz may be approved for PsA when one of the following criteria are met (a., b., or c.):
a. Spinal or axial PsA (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
b. PsA without spinal or axial disease (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
c. Enthesitis and/or dactylitis associated PsA (i. through iv.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA
iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
iv. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of PsA (see Table 1).
2. Plaque Psoriasis (PsO)
When a benefit, coverage of Taltz may be approved for PsO when all of the following criteria are met (a. through d.):
a. The member is 6 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
d. If the member is 18 years of age or older, the member has experienced therapeutic failure or intolerance to at least three (3) preferred biologic products for the treatment of PsO (see Table 1).
3. Ankylosing Spondylitis (AS)
When a benefit, coverage of Taltz may be approved for AS when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of AS.
c. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
d. The member has experienced therapeutic failure or intolerance to at least two (2) preferred biologic products for the treatment of AS (see Table 1).
4. Non-radiographic Axial Spondyloarthritis (nr-axSpA)
When a benefit, coverage of Taltz may be approved for nr-axSpA when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of nr-axSpA.
c. The member has experienced therapeutic failure or intolerance to at least two (2) nonsteroidal anti-inflammatory drugs (NSAIDs), or all NSAIDs are contraindicated.
B. Reauthorization
When a benefit, reauthorization of 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
|
|
PsO with or without PsA
|
Eight (8) autoinjector/prefilled syringes within the first twelve (12) weeks of therapy
|
One (1) autoinjector/prefilled syringe every four (4) weeks
|
|
PsA, AS
|
Two (2) autoinjector/prefilled syringes within the first four (4) weeks of therapy
|
One (1) autoinjector/prefilled syringe every four (4) weeks
|
|
nr-axSpA
|
N/A
|
One (1) autoinjector/prefilled syringe every four (4) weeks
|
N/A=Not Applicable
XVII. Tremfya (guselkumab)
A. Initial Authorization
1. Plaque Psoriasis (PsO)
When a benefit, coverage of Tremfya may be approved for PsO when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe PsO.
c. The member meets one (1) of the following criteria (i. or ii.):
i. The member has experienced therapeutic failure or intolerance to phototherapy (e.g. PUVA, UVB). If member is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), the member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
ii. The member has experienced therapeutic failure or intolerance to at least one (1) systemic therapy (e.g. methotrexate, cyclosporine), or all systemic therapies are contraindicated.
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
|
|
PsO
|
Two (2) prefilled syringes (100 mg/mL) per 28 days
|
One (1) prefilled syringe per 56 days
|
XVIII. Xeljanz (tofacitinib)
A. Initial Authorization
1. Rheumatoid Arthritis (RA)
When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for RA when all of the following criteria are met (a., b., and c.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate to severe RA.
c. The member has experienced therapeutic failure or intolerance to methotrexate.
2. Psoriatic Arthritis (PsA)
When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for PsA when one (1) of the following criteria are met (a., b., or c.):
a. Spinal or axial PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of spinal or axial PsA.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) nonsteroidal anti-inflammatory drug (NSAID), or all NSAIDs are contraindicated.
b. PsA without spinal or axial disease (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of PsA without spinal disease.
iii. The member has experienced therapeutic failure or intolerance to at least one (1) non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, cyclosporine), or all non-biologic DMARDs are contraindicated.
c. Enthesitis and/or dactylitis associated PsA (i., ii., and iii.):
i. The member is 18 years of age or older.
ii. The member has a diagnosis of enthesitis and/or dactylitis associated with PsA
iii. The member has experienced therapeutic failure or intolerance to at least one (1) NSAID or a local glucocorticoid injection, or all NSAIDs and all local glucocorticoid injections are contraindicated.
3. Ulcerative Colitis (UC)
When a benefit, coverage of Xeljanz or Xeljanz XR may be approved for UC when all of the following criteria are met (a. through d.):
a. The member is 18 years of age or older.
b. The member has a diagnosis of moderate or severe UC.
c. The dose requested is not greater than 20 mg per day.
d. Treatment with preferred biologic product (Humira) for the treatment of UC was ineffective or not tolerated (see Table 1).
B. Reauthorization
When a benefit, reauthorization of Xeljanz or Xeljanz XR may be approved when the following criterion is met (1.):
1. Clinical documentation of disease stability or improvement must be provided.
XIX. 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.
XX. An exception to some or all of the criteria above may be granted for select members and/or circumstances based on state and/or federal regulations.