X.42 BIOLOGICS FOR RHEUMATIC DISORDERS AND HIDRADENITIS SUPPURATIVE
BIOLOGICS FOR RHEUMATIC DISORDERS AND HIDRADENITIS SUPPURATIVE
X.42
X.42 BIOLOGICS FOR RHEUMATIC DISORDERS AND HIDRADENITIS SUPPURATIVE
Policy
CRITERIA FOR USE
Initial Evaluation
**Use of Olumiant in the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) is not covered under the pharmacy benefit.**
I. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or has consulted with a specialist in the area of the patient’s diagnosis AND
II. The patient will NOT be using the requested agent in combination with another biologic immunomodulator and/or Otezla AND
III. The patient does not have any FDA labeled contraindications to the requested agent AND
IV. The requested dosage is within FDA approved dosage guidelines AND
V. The patient has been tested for latent tuberculosis (TB) when required by the prescribing information for the requested agent AND if positive the patient has begun therapy for latent TB AND
VI. The patient has ONE of the following diagnoses:
A. The patient has diagnosis of moderately to severely active rheumatoid arthritis (RA) and BOTH of the following:
1. ONE of the following:
a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the last 90 days OR
b.The patient has tried and had inadequate response to maximally tolerated methotrexate (e.g., titrated 25mg weekly) for at least 3-months OR
c. The patient has tried and had an inadequate response to another conventional agent (i.e., hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA for at least 3-months OR
d. The patient has intolerance or hypersensitivity to ONE of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA OR
e. The patient has an FDA labeled contraindication to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in the treatment of RA OR
f. The patient’s medication history indicated use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of RA AND
2. ONE of the following:
a. The request is for preferred biologic agent (see table) OR
b. The request is for non-preferred biologic agent and patient has failure of pre-requisite agent(s) outlined in table AND
3. If the request is for Simponi, the ONE of the following:
a. The patient will be using methotrexate in combination with the requested agent OR
b. The patient has an intolerance, hypersensitivity, or FDA labeled contraindication to methotrexate OR
B. The patient has diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) OR active systemic juvenile idiopathic arthritis (SJIA) and BOTH of the following:
1. ONE of the following:
a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the last 90 days OR
b. The patient has tried and had an inadequate response to ONE conventional agent (i.e., methotrexate, leflunomide) used in the treatment of PJIA after at least a 3-month duration of therapy OR
c. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of PJIA OR
d. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PJIA OR
e. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of PJIA AND
2. ONE of the following:
a. The request is for preferred biologic agent (see table) OR
b. The request is for non-preferred biologic agent and patient has failure of pre-requisite agent(s) outlined in table OR
C. The patient has diagnosis of active psoriatic arthritis (PsA) and BOTH of the following:
1. ONE of the following:
a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the last 90 days OR
b. The patient has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA after at least a 3-month duration of therapy OR
c. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of PsA OR
d. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of PsA OR
e. The patient has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) OR
f. The patient has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) OR
g. The patient’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in compendia for the treatment of PsA AND
2. ONE of the following:
a. The request is for preferred biologic agent (see table) OR
b. The request is for non-preferred biologic agent and patient has failure of pre-requisite agent(s) outlined in table OR
D. The patient has diagnosis of active ankylosing spondylitis (AS) or active non-radiographic axial spondyloarthritis (nr-axSpA) and BOTH of the following:
1. ONE of the following:
a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the last 90 days OR
b. The patient has tried and had an inadequate response to TWO different NSAIDs used in the treatment of AS or nr-axSpA after at least a 4-week total trial OR
c. The patient has an intolerance or hypersensitivity to TWO different NSAIDs used in the treatment of AS or nr-axSpA OR
d. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of AS or nr-axSpA OR
e. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of AS AND
2. ONE of the following:
a. The request is for preferred biologic agent (see table) OR
b. The request is for non-preferred biologic agent and patient has failure of pre-requisite agent(s) outlined in table OR
E. The patient has diagnosis of hidradenitis suppurativa (HS) and BOTH of the following:
1. ONE of the following:
a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the last 90 days OR
b. The patient has tried and had an inadequate response to ONE conventional agent (i.e., oral tetracyclines [doxycycline, minocycline, tetracycline]; oral contraceptives [females only]; metformin [females only]; finasteride [females only]; spironolactone [females only]; intralesional corticosteroids [triamcinolone]; clindamycin in combination with rifampin; combination of rifampin, moxifloxacin, and metronidazole; cyclosporine; oral retinoids) used in the treatment of HS after at least a 3-month duration of therapy OR
c. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of HS OR
d. The patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of HS OR
e. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of HS AND
2. ONE of the following:
a. The request is for preferred biologic agent (see table) OR
b. The request is for non-preferred biologic agent and patient has failure of pre-requisite agent(s) outlined in table OR
F. The patient has diagnosis of uveitis and ALL of the following:
1. ONE of the following:
a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the last 90 days OR
2. Both of the following:
a. ONE of the following:
i. The patient has tried and had an inadequate response to oral corticosteroids used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis after at least a 2-week duration of therapy OR
ii. The patient has tried and had an inadequate response to periocular or intravitreal corticosteroid injections in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis OR
iii. The patient has an intolerance or hypersensitivity to oral corticosteroids OR periocular or intravitreal corticosteroid injections used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis OR
iv. The patient has an FDA labeled contraindication to BOTH oral corticosteroids and periocular/intravitreal corticosteroids AND
b. ONE of the following:
i. The patient has tried and had an inadequate response to ONE conventional systemic agent (i.e., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus) used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis after at least a 3-month duration of therapy OR
ii. The patient has an intolerance or hypersensitivity to ONE conventional systemic agent used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis OR
iii. The patient has an FDA labeled contraindication to ALL conventional systemic agents used in the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis OR
3. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of non-infectious intermediate uveitis, posterior uveitis, or panuveitis AND
4. ONE of the following:
i. The request is for preferred biologic agent (see table) OR
ii. The request is for non-preferred biologic agents and patient has failure of pre-requisite agent(s) outlined in table OR
G. The patient has diagnosis of giant cell arteritis (GCA) and BOTH of the following:
1. ONE of the following:
a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the last 90 days OR
b. The patient has tried and had an inadequate response to systemic corticosteroids (e.g., prednisone, methylprednisolone) used in the treatment of GCA after at least a 7-10 day duration of therapy OR
c. The patient has an intolerance or hypersensitivity to systemic corticosteroids used in the treatment of GCA OR
d. The patient has an FDA labeled contraindication to ALL systemic corticosteroids OR
e. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of GCA AND
2. ONE of the following:
a. The request is for preferred biologic agent (see table) OR
b. The request is for non-preferred biologic agent and patient has failure of pre-requisite agent(s) outlined in table OR
H. The patient has diagnosis of enthesitis related arthritis (ERA) and BOTH of the following:
1. ONE of the following:
a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the last 90 days OR
b. The patient has tried and had an inadequate response to TWO different NSAIDs used in the treatment of ERA after at least a 4-week total trial OR
c. The patient has an intolerance or hypersensitivity to TWO different NSAIDs used in the treatment of ERA OR
d. The patient has an FDA labeled contraindication to ALL NSAIDs used in the treatment of ERA OR
e. The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of ERA AND
2. ONE of the following:
a. The request is for preferred biologic agent (see table) OR
b. The request is for non-preferred biologic agent and patient has failure of pre-requisite agent(s) outlined in table AND
I. The patient has diagnosis of polymyalgia rheumatica and BOTH of the following:
1. ONE of the following:
a. Information has been provided that indicates the patient has been treated with the requested agent (starting on samples is not approvable) within the last 90 days OR
b. The patient has tried and had an inadequate response to systemic corticosteroids at a dose equivalent to at least 7.5 mg/day of prednisone used in the treatment of PMR after at least an 8-week duration of therapy OR
c. The patient is currently treated with systemic corticosteroids at a dose equivalent to at least 7.5 mg/day of prednisone and cannot tolerate a corticosteroid taper OR
2. ONE of the following:
a. The request is for preferred biologic agent (see table) OR
b. The request is for non-preferred biologic agent and patient has failure of pre-requisite agent(s) outlined in table.
**All other used not addressed in this policy for adalimumab, etanercept, anakinra, abatacept, certolizumab, golimumab, tocilizumab, tofacitinib, canakinumab, secukinumab, infliximab, upadacitinib, ixekizumab, sarilumab are considered investigational**
Renewal Evaluation
I. Renewal of Target Agent(s) may be considered medically necessary when
A. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
B. The patient has had clinical benefit with requested agent (e.g. symptom improvement, improved physical function, inhibition of structural damage progression) AND
C. The patient has no FDA approved contraindication to use of requested medication AND
D. The requested medication is not being used in combination with another biologic immunomodulator listed in this policy AND
E. The requested dose is within FDA approved dosage limits
Length of Approval: 12 months
Dates
-
Original Effective
01-15-2014
-
Last Review
11-05-2025
-
Next Review
11-10-2026
Guidelines
Self Administered Preferred Agent Step Table
|
Disease State |
Step 1a (preferred) |
Step 1b (Directed to ONE preferred TNF inhibitor-Step 1a) |
Step 2 (non-preferred, directed to ONE step 1 agents) |
Step 3a (non-preferred, directed to TWO agents step 1 agents) |
Step 3b (non-preferred, directed to TWO agents from step 1 and/or step 2) |
Step 3c (non-preferred, directed to THREE step 1 agents) |
|
Rheumatoid Disorders |
||||||
|
Ankylosing Spondylitis |
SQ: Cosentyx, Enbrel, **See adalimumab table for preferred products.** |
Oral: Rinvoq, Xeljanz, Xeljanz XR |
N/A |
SQ: Bimzelx,Cimzia, Simponi, Taltz |
N/A |
SQ: **See adalimumab table for preferred products.** |
|
Nonradigraphic axial spondyloarthritis (nr-axSpA) |
SQ: Cimzia, Cosentyx |
Oral: Rinvoq |
N/A |
SQ: Taltz, Bimzelx |
N/A |
N/A |
|
Polyarticular Juvenile Idiopathic Arthritis (PJIA) |
SQ: Enbrel, **See adalimumab table for preferred products.** |
Oral: Rinvoq, Rinvoq LQ Xeljanz |
SQ: Tyenne (preferred adalimumab biosimilar or Humira is required Step 1 agent |
SQ: Cimzia |
SQ: Orencia, Actemra (preferred adalimumab product AND Tyenne are required Step agents) |
SQ: Kevzara, **See adalimumab table for preferred products.** |
|
Psoriatic Arthritis |
SQ: Cosentyx, Enbrel, Skyrizi, Tremfya, **See adalimumab and ustekinumab table for preferred products.**
Oral: Otezla, Otezla XR |
Oral: Rinvoq, Rinvoq LQ Xeljanz, Xeljanz XR |
N/A |
SQ: Bimzelx, Cimzia, Orencia, Simponi, Taltz |
N/A |
SQ: **See adalimumab and ustekinumab table for preferred products.** |
|
Rheumatoid Arthritis |
SQ: Enbrel, **See adalimumab table for preferred products.** |
Oral: Rinvoq, Xeljanz, Xeljanz XR |
SQ: Tyenne (formulary adalimumab biosimilar or Humira is required Step 1 agent) |
Oral: Olumiant
SQ: Cimzia, Kevzara, Orencia, Simponi |
SQ: Actemra (a preferred adalimumab product AND Tyenne are required Step agents) |
SQ: Kineret, **See adalimumab table for preferred products.** |
|
Dermatologic disorders |
||||||
|
Hidradenitis Suppurativa |
SQ: Cosentyx, **See adalimumab table for preferred products.** |
N/A |
N/A |
SQ: Bimzelx |
N/A |
SQ: **See adalimumab table for preferred products.** |
|
OTHER |
||||||
|
Uveitis |
SQ: **See adalimumab table for preferred products.** |
N/A |
N/A |
N/A |
N/A |
SQ: **See adalimumab table for preferred products.** |
|
Indications without prerequisite biologic Immunomodulators required |
||||||
|
Enthesitis related arthritis (ERA) |
SQ: Cosentyx |
|
|
|
|
|
|
Giant Cell Arteritis (GCA) |
SC: Tyenne
Oral: Rinvoq |
|
SC: Actemra |
|
|
|
|
Neonatal-Onset Multisystem inflammatory disease (NOMID) |
|
|
|
|
|
|
|
Polymyalgia Rheumatica (PMR) |
SQ: Kevzara |
|
|
|
|
|
|
Systemic Juvenile Idiopathic Arthritis (SJIA) |
SQ: Tyenne |
|
SQ: Actemra
|
|
|
|
|
Systemic-Sclerosis-associated interstitial lung disease (SSc-ILD) |
|
|
|
|
|
|
*Note: A trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as ONE product.
**For infliximab under the medical benefit, BCBSNE requires the use of a preferred infliximab product as listed below. There are no benefits available for non-preferred infliximab biosimilar products.**
|
Preferred Agent(s) |
Non-preferred Agent(s) |
|
Avsola (infliximab-axxq) Inflectra (infliximab-dyyb) |
Renflexis (infliximab-abda) Remicade (infliximab) Infliximab |
**Humira (adalimumab biosimilars)**
|
Formulary |
Preferred adalimumab products (Step 1a) |
Non-preferred adalimumab products (Step 3c) |
|
PDL10 |
Brand Humira, adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Julio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
NetResults Select (PDL20) |
Brand Humira, adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
PDL25 |
adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Brand Humira, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
NetResults Balaned (PDL30) |
Brand Humira, adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
NetResults Performance (PDL40) |
Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
PDL50 |
adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Brand Humira, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
PDL66 |
Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
TraditionalRXList (Ind ACA 6-tier) (PDL68) |
Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
Value RXList (Ind ACA 4-tier (PDL69) |
Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
BluePride RXChoices (90) |
Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
|
BluePride RXChoices (91) |
Adalimumab-aaty, adalimumab-adaz, Hadlima, Simlandi |
Brand Humira, Abrilada, adalimumab-aacf, adalimumab-adbm, adalimumab-fkjp, adalimumab-ryvk, Cyltezo, Hulio, Idacio, Hyrimoz, Amjevita, Yuflyma, Yusimry |
| Formulary | Preferred ustekinumab product (step 1a) | Non-preferred ustekinumab product (step 3c) |
| PDL10 | Steqeyma, Yesintek, Selarsdi, Brand Stelara | Wezlana |
| PDL20 | Steqeyma, Yesintek, Selarsdi, Brand Stelara | Wezlana |
| PDL30 | Steqeyma, Yesintek, Selarsdi, Brand Stelara | Wezlana |
| PDL40 | Steqeyma, Yesintek, Selarsdi | Brand Stelara, Wezlana |
| PDL68 | Steqeyma, Yesintek, Selarsdi | Brand Stelara, Wezlana |
| PDL69 | Steqeyma, Yesintek, Selarsdi | Brand Stelara, Wezlana |
| PDL90 | Steqeyma, Yesintek, Selarsdi | Brand Stelara, Wezlana |
| PDL91 | Steqeyma, Yesintek, Selarsdi | Brand Stelara, Wezlana |
| PDL25 | Steqeyma, Yesintek, Selarsdi | Brand Stelara, Wezlana |
Description
Target Agents and FDA approved indications:
Actemra® (tocilizumab) is FDA approved for the following:
· the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
· the treatment of giant cell arteritis (GCA) in adult patients.
· for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease.
· for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.
· for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
· for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older.
· for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adult patients who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Bimzelx® (bimekizumab) is FDA approved for the following:
· the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy
· the treatment of adult patients with active psoriatic arthritis
· for the treatment of adult patients with active non-radiographic axial spondyloarthritis with obejective signs of inflammation
· for the treatment of adult patients with active ankylosing spondylitis
· for the treatment of adult patients with moderate to severe hidradenitis suppurativa
Cimzia® (certolizumab) is FDA approved for the following:
· for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
· for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).
· for the treatment of adult patients with active psoriatic arthritis (PsA).
· for the treatment of adults with active ankylosing spondylitis (AS).
· for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
· for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
· for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older
Cosentyx® (secukinumab) is FDA approved for the following:
· for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.
· for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.
· for the treatment of adult patients with active ankylosing spondylitis (AS).
· for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
· for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.
· for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS).
Enbrel® (etanercept) is FDA approved for the following:
· for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA). Enbrel can be initiated in combination with methotrexate (MTX) or used alone.
· for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ages 2 and older.
· for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis (PsA). Enbrel can be used with or without methotrexate.
· for reducing signs and symptoms in patients with active ankylosing spondylitis (AS).
· for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
Humira® (adalimumab) is FDA approved for the following:
· for 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. HUMIRA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
· for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. HUMIRA can be used alone or in combination with methotrexate.
· for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. HUMIRA can be used alone or in combination with non-biologic DMARDs.
· for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
· for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
· for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.
· for 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.
· for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.
· for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.
Kevzara® (sarilumab) is FDA approved for the following:
· for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
· for treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
· for treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients who weigh 63kg or greater.
Kineret® (anakinra) is FDA approved for the following:
· for the reduction in 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 1 or more disease modifying antirheumatic drugs. (DMARDs). KINERET can be used alone or in combination with DMARDs other than Tumor Necrosis Factor (TNF) blocking agents.
· for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID).
· for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA).
Olumiant® (baricitinib) is FDA approved for the following:
· for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
· for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
· for the treatment of adult patients with severe alopecia areata.
Orencia® (abatacept) is FDA approved for the following:
· for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
· for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis.
· for the treatment of adult patients with active psoriatic arthritis (PsA).
· for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor.
Rinvoq® (upadacitinib) is FDA approved for the following:
· for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
· for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.
· for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an inadequate response or intolerance to one or more TNF blockers.
Rinvoq LQ® (upadacitinib) is FDA approved for the following:
· for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) who have had an inadequate response or intolerance to one or more TNF blockers.
Siliq® (brodalumab) is FDA approved for the following:
· for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.
Simponi® (golimumab) is FDA approved for the following:
· in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
· alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis.
· for the treatment of adult patients with active ankylosing spondylitis.
· in adult patients with moderately to severely active ulcerative colitis 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.
Skyrizi® (risankizumab) is FDA approved for the following:
· for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
· for the treatment of active psoriatic arthritis in adults.
· for the treatment of moderately to severely active Crohn's disease in adults.
Stelara® (ustenkinumab) is FDA approved for the following:
· for the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
· for the treatment of patients 6 years or older with active psoriatic arthritis.
· for the treatment of adult patients with moderately to severely active Crohn's disease.
· for the treatment of adult patients with moderately to severely active ulcerative colitis.
Taltz® (ixekizumab) is FDA approved for the following:
· for the treatment of patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
· for the treatment of adult patients with active psoriatic arthritis.
· for the treatment of adult patients with active ankylosing spondylitis.
· for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
Tremfya® (guselkumab) is FDA approved for the following:
· for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
· for the treatment of adult and pediatric patients 6 years of age and older who also weigh at least 40kg with active psoriatic arthritis.
· for the treatment of adult patients with moderately to severely active ulcerative colitis
· for the treatment of adult patients with moderately to severely active Crohn's Disease
Xeljanz solution® (tofacitinib) is FDA approved for the following:
· for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adult and pediatric patients 2 years of age and older with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers.
Xeljanz tablet® (tofacitinib) is FDA approved for the following:
· for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adult and pediatric patients 2 years of age and older with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.
Xeljanz XR tablet® (tofacitinib) is FDA approved for the following:
· for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more TNF blockers.
· for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers.
**There are no other preferred products under the medical benefit, therefore, healthcare administered products (i.e. lyophilized powder certolizumab, etc.) are not subject to trial and failure of a medical or self-inject product.**
FDA Approved Dosage/QL Reference
|
Brand (generic) |
Indication |
DOSE |
||
|
|
|
IV |
SQ |
ORAL |
|
Actemra |
Rheumatoid arthritis |
4mg/kg every 4 weeks, may increase to 8mg/kg every 4 weeks |
-Patients less than 100kg weight: 162mg every other week, followed by increase to weekly depending on response -Patients at or above 100kg weight: 162mg every week |
n/a |
|
|
Giant Cell Arteritis |
6mg/kg every 4 weeks (Not to exceed 600mg per infusion) |
162mg every week |
n/a |
|
|
Systemic Sclerosis-Associated Interstitial Lung Disease |
n/a |
162mg every week |
n/a |
|
|
Juvenile Idiopathic Arthritis |
-Patients less than 30kg weight: 10mg/kg every 4 weeks -Patients at or above 30kg weight: 8mg/kg every 4 weeks |
-Patients less than 30kg weight: 162mg every 3 weeks -Patients at or above 30kg weight: 162mg every 2 weeks |
n/a |
|
|
Systemic Juvenile Idiopathic Arthritis |
-Patients less than 30kg weight: 12mg/kg every 2 weeks -Patients at or above 30kg weight: 8mg/kg every 2 weeks |
-Patients less than 30kg weight: 162mg every 2 weeks -Patients at or above 30kg weight: 162mg every week |
n/a |
|
Cimzia |
Crohns Disease |
|
400mg at wk 0,2,4, then 400mg every 4 weeks |
n/a |
|
|
Rhematoid Arthritis |
|
400mg at wk 0,2,4, then 200mg every other week (400mg every 4 weeks may be considered) |
n/a |
|
|
Psoriatic Arthritis |
|
400mg at wk 0,2,4, then 200mg every other week (400mg every 4 weeks may be considered) |
n/a |
|
|
Ankylosing Spondylitis |
|
400mg at wk 0,2,4, then 200mg every 2 weeks or 400mg every 4 weeks |
n/a |
|
|
Non-radiographic Axial Spondyloarthritis |
|
400mg at wk 0,2,4, then 200mg every other week or 400mg every 4 weeks |
n/a |
|
|
Plaque Psoriasis |
|
400mg every other week. |
n/a |
|
Cosentyx |
Plaque Psoriasis |
|
Adult: 300mg at wk 0,1,2,3,4, then 300mg every 4 weeks Pediatric (age 6 and up): -Patients less than 50kg weight: 75mg at wk 0,1,2,3,4, then 75mg every 4 weeks -Patients at or above 50kg weight: 150mg at wk 0,1,2,3,4, then 150mg every 4 weeks |
n/a |
|
|
Psoriatic Arthritis |
1.75mg/kg every 4 weeks (with or without 6mg/kg loading dose at wk 0) |
150mg every 4 weeks (with or without loading doses of 150mg at wk 0,1,2,3,4). Dose may be increased to 300mg every 4 weeks based on response |
n/a |
|
|
Juvenile Psoriatic Arthritis (2 years of age and older) |
|
-Patients ≥15kg and <50kg: 75mg at wk 0,1,2,3,4, then 75mg every 4 weeks -Patients ≥50kg: 150mg at wk 0,1,2,3,4, then 150mg every 4 weeks |
n/a |
|
|
Anklyosing Spondylitis |
1.75mg/kg every 4 weeks (with or without 6mg/kg loading dose at wk 0)*Not to exceed 300mg per infusion* |
150mg every 4 weeks (with or without loading doses of 150mg at wk 0,1,2,3,4). Dose may be increased to 300mg every 4 weeks based on response |
n/a |
|
|
Non-Radiographic Axial Spondyloarthritis |
1.75mg/kg every 4 weeks (with or without 6mg/kg loading dose at wk 0)*Not to exceed 300mg per infusion* |
150mg every 4 weeks (with or without loading doses of 150mg at wk 0,1,2,3,4) |
n/a |
|
|
Enthesitis-Related Arthritis |
n/a |
-Patients ≥15kg and <50kg: 75mg at wk 0,1,2,3,4, then 75mg every 4 weeks -Patients ≥50kg: 150mg at wk 0,1,2,3,4, then 150mg every 4 weeks |
n/a |
|
|
Hidradenitis Suppurativa |
n/a |
300mg at week 0,1,2,3,4, then every 4 weeks. Dose may be increased to 300mg every 2 weeks if patient does have adequate response to 4 week dosing. |
n/a |
|
Enbrel |
Rheumatoid Arthritis |
n/a |
50mg weekly |
n/a |
|
|
Polyarticular Juvenile Idiopathic Arthritis |
n/a |
-Patients 63kg or more weight: 50mg weekly -Patients less than 63kg weight: 0.8mg/kg weekly |
n/a |
|
|
Psoriatic Arthritis |
n/a |
50mg weekly |
n/a |
|
|
Ankylosing Spondylitis |
n/a |
50mg weekly |
n/a |
|
|
Plaque Psoriasis |
n/a |
Adult: 50mg twice weekly for 3 weeks, then 50mg once weekly Pediatric: -Patients 63kg or more weight: 50mg weekly -Patients less than 63kg weight: 0.8mg/kg weekly |
n/a |
|
|
Juvenile Psoriatic Arthritis |
n/a |
-Patients 63kg or more weight: 50mg weekly -Patients less than 63kg weight: 0.8mg/kg weekly |
n/a |
|
Humira |
Rheumatoid Arthritis |
n/a |
40mg every other week *Some patients not taking concomitant MTX may derive additional benefit from 40mg weekly or 80mg every other week |
n/a |
|
|
Juvenile Idiopathic Arthritis (age 2 years and up) |
n/a |
-Patients 10kg to less than 15kg: 10mg every other week -Patients 15kg to less than 30kg: 20mg evey other week -Patients 30kg or greater: 40mg every other week |
n/a |
|
|
Psoriatic Arthritis |
n/a |
40mg every other week |
n/a |
|
|
Ankylosing Spondylitis |
n/a |
40mg every other week |
n/a |
|
|
Crohn’s Disease |
n/a |
Adults: 160mg on day 1, then 80mg on day 15, then 40mg every other week starting day 29 Pediatric (6yrs old and older): -Patients 17kg to less than 40kg weight: 80mg on day 1, 40mg on day 15, then 20mg every other week starting day 29 -Patients 40kg and greater: 160mg on day 1, 80mg on day 15, then 40mg every other week starting day 29 |
n/a |
|
|
Ulcerative Colitis |
n/a |
Adults: 160mg on day 1, then 80mg on day 15, then 40mg every other week starting day 29 Pediatrics (5yrs old and older): -Patients 20kg to less than 40kg: 80mg on day 1, 40mg on day 8 and day 15, then 40mg every other week OR 20mg weekly starting day 29 -Patients 40kg and greater: 160mg on day 1, 80mg on day 8 and 15, then 80mg every other week or 40mg weekly starting day 29 *Discontinue Humira in adult patients without evidence of clinical remission by eight weeks of therapy. |
n/a |
|
|
Plaque Psoriasis |
n/a |
80mg on day 1, then 40mg every other week starting day 8 |
n/a |
|
|
Hidradenitis Suppurativa |
n/a |
Adults: 160mg on day 1, then 80mg on day 15, then 40mg weekly or 80mg every other week starting day 29 Pediatrics (12yrs of age and older): -Patients 30kg to less than 60kg: 80mg on day 1, then 40mg every other week starting day 8 -Patients 60kg and greater: 160mg on day 1, then 80mg on day 15, then 40mg every week or 80mg every other week starting day 29. |
n/a |
|
|
Uveitis |
n/a |
Adult: 80mg on day 1, then 40mg every other week starting day 8 Pediatrics (2yrs old and older): -Patients 10kg to less than 15kg: 10mg every other week -Patients 15kg to less than 30kg: 20mg evey other week -Patients 30kg or greater: 40mg every other week |
n/a |
|
Kevzara |
Rheumatoid Arthritis (RA) |
n/a |
200mg every 2 weeks |
n/a |
|
|
Polymyalgia Rheumatica (PMR) |
n/a |
200mg every 2 weeks |
n/a |
|
Kineret |
Rheumatoid Arthritis |
n/a |
100mg daily |
n/a |
|
|
Cryopyrin-Associated Periodic Syndromes (CAPS) |
n/a |
1-2mg/kg daily, with adjustments done to maximum daily dose of 8mg/kg daily |
n/a |
|
|
Deficiency of Interleukin-1 receptor antagonist (DIRA) |
n/a |
1-2mg/kg daily, with adjustments done to maximum daily dose of 8mg/kg daily |
n/a |
|
Olumiant |
Rheumatoid Arthritis |
n/a |
n/a |
2mg once daily |
|
|
Alopecia Areata |
n/a |
n/a |
2mg once daily, may increase to 4mg daily to achieve adequate response, but then decrease back to 2mg daily |
|
Orencia |
Rheumatoid arthritis |
-Patients less than 60kg weight: 500mg at wk 0,2,4 then every 4 weeks -Patients 60-100kg weight: 750mg at wk 0,2,4 then every 4weeks -Patients more than 100kg: 1000mg at wk 0,2,4 then every 4 weeks |
125mg once weekly |
n/a |
|
|
Polyarticular Juvenile Idiopathic Arthritis |
Age 6yrs and up -Patients less than 75kg: 10mg/kg at wk 0,2,4 then every 4 weeks -Patients 75kg weight or more: 750-1000mg at wk 0,2,4 then every 4 weeks |
Age 2yrs and up -Patients 10-25kg: 50mg weekly -Patients 25-50kg: 87.5mg weekly -Patients 50kg or more: 125mg weekly |
n/a |
|
|
Psoriatic Arthritis |
-Patients less than 60kg weight: 500mg at wk 0,2,4 then every 4 weeks -Patients 60-100kg weight: 750mg at wk 0,2,4 then every 4weeks -Patients more than 100kg: 1000mg at wk 0,2,4 then every 4 weeks |
Adults 125mg weekly Pediatrics (2yrs and up) -Patients 10-25kg: 50mg weekly -Patients 25-50kg: 87.5mg weekly -Patients 50kg or more: 125mg weekly |
n/a |
|
Rinvoq |
Rheumatoid arthritis |
n/a |
n/a |
15mg once daily |
|
|
Psoriatic arthritis |
n/a |
n/a |
15mg once daily |
|
|
Atopic Dermatitis |
n/a |
n/a |
Adults 15mg once daily Pediatrics (12yrs and up, weighing at least 40kg) 15mg once daily |
|
|
Ulcerative Colitis |
n/a |
n/a |
45mg once daily for 8 weeks, then 15mg once daily (30mg daily may be considered for patients with severe or refractory disease) |
|
|
Crohns Disease |
n/a |
n/a |
45mg once daily for 12 weeks, then 15mg once daily (30mg daily may be considered for patients with severe or refractory disease) |
|
|
Ankylosing Spondylitis |
n/a |
n/a |
15mg once daily |
|
|
Non-radiographic Axial Spondyloarthritis |
n/a |
n/a |
15mg once daily |
|
|
|
|
|
|
|
Rinvoq LQ |
Polyarticular juvenile idiopathic arthritis |
n/a |
n/a |
Adult 6mg twice daily Pediatric (age 2yr-18 yr) -10kg-<20kg: 3mg twice daily -20kg-<30kg: 4mg twice daily -30kg and greater: 6mg twice daily |
|
|
Psoriatic arthritis |
n/a |
n/a |
Adult 6mg twice daily Pediatric (age 2yr-18 yr) -10kg-<20kg: 3mg twice daily -20kg-<30kg: 4mg twice daily -30kg and greater: 6mg twice daily |
|
|
|
|
|
|
|
Siliq |
Plaque psoriasis |
210mg at week 0,1,2, then 210mg every 2 weeks |
n/a |
n/a |
|
|
|
|
|
|
|
Simponi |
Rheumatoid arthritis |
n/a |
50mg once every month |
n/a |
|
|
Psoriatic arthritis |
n/a |
50mg once every month |
n/a |
|
|
Ankylosing Spondylitis |
n/a |
50mg once every month |
n/a |
|
|
Ulcerative colitis |
n/a |
200mg at week 0, 100mg at week 2, then 100mg every 4 weeks |
n/a |
|
Simponi Aria |
Rheumatoid arthritis |
2mg/kg at wk 0 &4 then every 8 weeks |
n/a |
n/a |
|
|
Psoriatic arthritis |
2mg/kg at wk 0 &4 then every 8 weeks |
n/a |
n/a |
|
|
Ankylosing spondylitis |
2mg/kg at wk 0 &4 then every 8 weeks |
n/a |
n/a |
|
|
Polyarticular Juvenile Idiopathic arthritis |
80mg/m2 at wk 0&4, then every 8 weeks |
n/a |
n/a |
|
Skyrizi |
Plaque Psoriasis |
n/a |
150mg at wk 0&4, then every 12 weeks |
n/a |
|
|
Psoriatic arthritis |
n/a |
150mg at wk 0&4, then every 12 weeks |
n/a |
|
|
Crohn’s Disease |
600mg IV induction only at wk 0, 4, 8 |
180mg or 360mg at week 12, then every 8 weeks |
n/a |
|
Stelara |
Psoriasis |
n/a |
Adult -Patients weighing 100kg or less: 45mg at wk 0&4, then every 12 weeks -Patients weighing more than 100kg: 90mg at wk 0&4, then every 12 weeks Pediatric (6-17 yrs old) -Patients less than 60kg weight: 0.75mg/kg wk 0&4, then every 12 weeks -Patients 60kg-100kg: 45mg at wk 0&4, then every 12 weeks -Patients more than 100kg: 90mg at wk 0&4, then every 12 weeks |
n/a |
|
|
Psoriatic arthritis |
n/a |
Adult 45mg at wk0&4, then every 12 weeks *For patients with co-existent plaque psoriasis and weigh more than 100kg, dose of 90mg at wk 0&4, then every 12 weeks may be used* Pediatric (6-17 yrs of age) -Patients less than 60kg weight: 0.75mg/kg wk 0&4, then every 12 weeks -Patients 60kg or more: 45mg at wk 0&4, then every 12 weeks -Patients more than 100kg with co-existent plaque psoriasis: 90mg at wk 0&4, then every 12 weeks |
n/a |
|
|
Crohn’s Disease |
IV induction dose -Patients less than 55kg: 260mg once -Patients more than 55kg-85kg: 390mg once -Patients more than 85kg: 520mg once |
90mg every 8 weeks starting 8 weeks after IV loading dose |
n/a |
|
|
Ulcerative Colitis |
IV induction dose -Patients less than 55kg: 260mg once -Patients more than 55kg-85kg: 390mg once -Patients more than 85kg: 520mg once |
90mg every 8 weeks starting 8 weeks after IV loading dose |
n/a |
|
Taltz |
Plaque psoriasis |
n/a |
Adult 160mg at wk 0, then 80mg at wk 2,4,6,8,10, and 12, then 80mg every 4 weeks Pediatric -Patients greater than 50kg: 160mg at wk 0, then 80mg every 4 weeks -Patients 25-50kg: 80mg at wk 0, then 40mg every 4 weeks -Patients less than 25kg: 40mg at wk 0, then 20mg every 4 weeks |
n/a |
|
|
Psoriatic arthritis |
n/a |
160mg at week 0, then 80mg every 4 weeks |
n/a |
|
|
Ankylosing spondylitis |
n/a |
160mg at wk 0, then 80mg ever 4 weeks |
n/a |
|
|
Non-radiographic Axial Spondyloarthritis |
n/a |
80mg every 4 weeks |
n/a |
|
Tremfya |
Plaque psoriasis |
n/a |
100mg at wk 0 and 4, then 100mg every 8 weeks |
n/a |
|
|
Psoriatic arthritis |
n/a |
100mg at wk 0 and 4, then 100mg every 8 weeks |
n/a |
|
|
Crohns |
200mg IV at week 0,4,8 for induction only |
400mg SQ at wk 0,4,8, then 100mg at wk 16, then every 8 weeks OR
200mg at wk 12, then every 4 weeks |
|
|
|
Ulcerative Colitis |
200mg IV at week 0,4,8 for induction only |
400mg SQ at wk 0,4,8, then 100mg at wk 16, then every 8 weeks OR
200mg at wk 12, then every 4 weeks |
|
|
Xeljanz |
Rheumatoid arthritis |
n/a |
n/a |
Xeljanz: 5mg twice daily Xeljanz XR: 11mg once daily |
|
|
Psoriatic arthritis |
n/a |
n/a |
Xeljanz: 5mg twice daily Xeljanz XR: 11mg once daily |
|
|
Ankylosing spondylitis |
n/a |
n/a |
Xeljanz: 5mg twice daily Xeljanz XR: 11mg once daily |
|
|
Ulcerative colitis |
n/a |
n/a |
Xeljanz: 10mg twice daily for 8 weeks, then 5mg twice daily (10mg twice daily may be continued up to 16 weeks) Xeljanz XR: 22mg once daily for 8 weeks, then 11mg once daily (22mg once daily may be continued up to 16 weeks) |
|
|
Polyarticular Course Juvenile Idiopathic Arthritis |
n/a |
n/a |
Xeljanz tablet or oral solution: -10kg to less than 20kg: 3.2mg twice daily -20kg to less than 40kg 4mg twice daily -Weight greater than 40kg: 5mg twice daily |
|
|
|
|
|
|
|
Remicade (Avsola and Inflectra biosimilars) |
Crohn’s Disease |
5mg/kg at wk 0,2,6 then every 8 weeks; dose may be escalated up to 10mg/kg every 8 weeks
|
|
n/a |
|
|
Pediatric Crohn’s Disease |
Pediatric 6yrs of age and up 5mg/kg at wk 0,2,6 then every 8 weeks
|
n/a |
n/a |
|
|
Ulcerative Colitis |
5mg/kg at wk 0,2,6 then every 8 weeks |
n/a |
n/a |
|
|
Pediatric Ulcerative Colitis |
Pediatric 6yrs of age and up 5mg/kg at wk 0,2,6 then every 8 weeks
|
n/a |
n/a |
|
|
Rheumatoid Arthritis |
3mg/kg at wk 0,2,6, then every 8 weeks; dose may be escalated up to 10mg/kg every 8 weeks |
n/a |
n/a |
|
|
Ankylosing Spondylitis |
5mg/kg at wk 0,2,6 then every 6 weeks |
n/a |
n/a |
|
|
Psoriatic arthritis |
5mg/kg at wk 0,2,6 then every 8 weeks |
n/a |
n/a |
|
|
Plaque psoriasis |
5mg/kg at wk 0,2,6 then every 8 weeks |
n/a |
n/a |
Quick Code Search
Procedure
Diagnosis
Codes
Injection, secukinumab, intravenous, 1 mg
INJECTION, RITUXIMAB AND HYALURONIDASE, 10 MG
Injection, abatacept, 10 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)
Injection, adalimumab, 20 mg
Injection, adalimumab, 1 mg
Injection, certolizumab pegol, 1 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)
Injection, etanercept, 25 mg (code may be used for medicare when drug administered under the direct supervision of a physician, not for use when drug is self administered)
Injection, golimumab, 1 mg, for intravenous use
Injection infliximab, 10 mg
Injection, infliximab-dyyb (zymfentra), 10 mg
Injection, secukinumab, intravenous, 1 mg
Injection, tocilizumab, 1 mg
Injection, ustekinumab, 1 mg
Ustekinumab, for intravenous injection, 1 mg
Unclassified drugs
Unclassified biologics
Injection, rituximab, 100 mg
Injection, rituximab 10 mg and hyaluronidase
Injection, rituximab, 10 mg
Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg
Injection, infliximab-abda, biosimilar, (renflexis), 10 mg
Inj rituximab-abbs bio 10 mg
Injection, infliximab-axxq, biosimilar, (avsola), 10 mg
Injection, rituximab-arrx, biosimilar, (riabni), 10 mg
Injection, adalimumab-aacf (idacio), biosimilar, 20 mg
Injection, tocilizumab-aazg (tyenne), biosimilar, 1 mg
Injection, adalimumab-fkjp, biosimilar, 1 mg
Injection, adalimumab-aaty, biosimilar, 1 mg
Injection, adalimumab-ryvk biosimilar, 1 mg
Injection, adalimumab-adbm, biosimilar, 1 mg
Injection, adalimumab-aacf (idacio), biosimilar, 1 mg
Injection, adalimumab-afzb (abrilada), biosimilar, 1 mg
Injection, trastuzumab-strf (hercessi), biosimilar, 10 mg
Injection, ustekinumab-ttwe (pyzchiva), subcutaneous, 1 mg
Injection, ustekinumab-ttwe (pyzchiva), intravenous, 1 mg
Injection, ustekinumab-aekn (selarsdi), 1 mg
Injection, ustekinumab-aauz (otulfi), biosimilar, 1 mg
References
|
2016
XeljanzTM (tofacitinib) [package insert]. New York, NY: Pfizer Labs, Feb 2016. |
|
2015
Baeten D, Sieper J, Braun J, et al. Seukinumab, an interleukin-17A inhibitor in ankylosing spondylitis. N Engl J Med 2015; 373:2534-2548. |
|
2015
Mease P.J, McInnes I.B, Kirkham B, et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med 2015;373:1329-1339. DOI: 10.1056/NEJMoa1412679 |
|
2015
McInnes I.B, Mease P.J, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2015;386:1137-1146. |
|
2015
Kimball AB, Zouboulis CC, Armstrong AW, etal. Safety and efficacy of adalimumab in patients with moderate to severe hidradenitis suppurativa: results from first 12 weeks of PIONEERI, a phase 3, randomized, placebo-controled trial. Poster or Paper presented at: 73rd Annual Meeting of the American Academy of Dermatology; March 20-24, 2015; San Francisco, CA. |
|
2015
Jemec GBE, Gottlieb A, Forman S, et al. Safety and efficacy of adalimumab in patients with moderate to severe hidradenitis suppurativa: results from first 12 weeks of PIONEERII, a phase 3, randomized, placebo-controled trial. Poster or Paper presented at: 73rd Annual Meeting of the American Academy of Dermatology; March 20-24, 2015; San Francisco, CA |
|
2015
Kimball AB, Jemec GBE, Armstrong AW, etal. Evaluating optimal medium-term dosing strategy for adalimumab in patients with moderate-to-severe hidradenitis suppurativa based on analysis of integrated results from the PIONEERI and II phase 3, randomized, placebo-controlled trials. Poster or Paper presented at: 73rd Annual Meeting of the American Academy of Dermatology; March 20-24, 2015; San Francisco, CA. |
|
2017
Kevzara Package Insert 2017 Regeneron Pharmaceuticals, Inc. / Sanofi-Aventis U.S. LLC
|
|
2017
Olumiant Package Insert 2018. Lilly USA, LLC |
|
2019
Rinvoq package insert. Abbvie Inc. August 2019
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Revisions
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06-24-2026
Updated FDA labeling for age for Xeljanz tablet and Xeljanz solution for treatment of PsA and criteria for use of Simponi in RA to match FDA labeling and trade requirements. |
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04-17-2026
Updated Xeljanz solution FDA labeled indications. |
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04-01-2026
Bimzelx moved from Step 3c to Step 3a for all indications per Prime trade contract. |
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01-27-2026
Addition of Otezla XR as preferred agent for diagnosis of psoriatic arthritis per trade contract. |
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01-01-2026
Updated preferred products for changes to brand Humira and brand Stelara. |
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12-02-2025
Updated diagnosis for use of Tremfya to include pediatric patients 6 years of age and up weighing at least 40kg. |
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07-30-2025
Addition of new indication for Rinvoq for GCA. |
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04-09-2025
Moved Cimzia to step 3a per trade contracts. |
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03-24-2025
Added new HCPC code for 04/01/2025: Q9999 |
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02-12-2025
Updated Tyenne (step 2 and 1a for shared indications with Actemra) and Actemra (non-pref Step 3b or 2) preferred status based on trade contracts; Addition of Stegeyma, Wezlana, and Yesintek as non-preferred products. |
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01-01-2025
Updated Kineret to Step 3c. Added biosimilar Tyenne to preferred product over branded Actemra. Updated preferred adalimumab products per formulary. |
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11-19-2024
Updated indications for Bimzelx and Cimzia; and preferred status for both. |
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09-12-2024
Added new HCPCS code effective 10/1/2024: Q5135 |
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07-05-2024
Updated all sections of the policy |
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06-26-2024
Added new 07/01/2024 HCPCS codes: J1748 and J3247 |
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05-16-2024
Addition of Cosentyx as preferred agent for treatement of hidradenitis suppurativa. |
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05-02-2024
Updated criteria for use of non-preferred infliximab product to require only failure of 1 preferred biosimilar product. |
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04-03-2024
Adding new 04/01/2024 code: C9166 |
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11-21-2023
Policy reviewed at Medical Policy Committee meeting on 11/8/2023 – no changes to policy |
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09-29-2023
Addition of criteria for use of Kevzara for diagnosis of polymyalgia rheumatica. |
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07-06-2023
Updated preferred criteria for addition of biosimilars, Cyltezo, Hadlima, Hulio, Idacio, Yuflyma, Yusimry. |
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07-01-2023
Updated preferred infliximab products and addition of Amjevita as preferred biosimilar. |
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06-28-2023
Added new code for 07/01/2023: Q5131 |
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11-08-2022
Addition of Rinvoq as Step 1b preferred agent for treatment of nr-axSpA. |
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09-01-2022
Addition of statement that Olumiant for treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) is not covered under pharmacy benefit. |
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07-15-2022
Updated Oral agent status from Step 2 to Step 1A. |
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03-12-2022
Updated preferred status of JAK inhibitors based on FDA labeling. |
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03-09-2022
Added table of preferred/non-preferred infliximab products. |
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03-03-2022
Updated Rinvoq preferred status for ankylosing spondylitis and psoriatic arthritis; Added Skyrizi for diagnosis of psoriatic arthritis. |
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12-16-2021
Addition of inflixmiab and rituximab biosimilars and preferred status. |
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06-25-2021
Added new code for 07/01/2021: Q5123 |
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05-18-2021
Updated preferred products for treatment of nonradiographic axial spondyloarthris (nr-axSpA) |
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04-08-2021
Addition of Cosentyx as preferred product for nonradiographic ankylosing spondylitis. |
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07-01-2020
Added new 07/01/2020 HCPC code: Q5121 |
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11-13-2019
Adding Rinvoq as preferred and updated 2nd level agents. |
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07-01-2019
Added preferred infliximab product of Remicade |
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06-26-2019
Added new 07/01/2019 code: Q5115. New version created |
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05-10-2019
Added clarification for Rituxan under Rheumatoid Arthritis |
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02-12-2018
Added new guidelines for Preferred Agents |
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12-21-2017
Added new code J3358 for 01/01/2018 |
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11-22-2017
Added Sarilumab to policy |
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11-02-2017
Added Q9989 to policy |
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08-29-2017
Added Rituxan Hycela as investigational for rheumatoid arthritis. |
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08-08-2017
Added Q5102 to policy as a new code from 01/01/2017 |
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01-04-2017
Added criteria for humira and removed apremilast which now has its own policy X.73. |
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09-07-2016
Added a new indication for humira for Hidradenitis Suppurative with critiera |
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06-14-2016
Added indications to which infliximab are considered investigative. |
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05-20-2016
Added new code for 07/01/2016 Q5102 |
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03-11-2016
Added Cosentyx and Ilaris to the policy |
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07-01-2015
Added golimumab and ustekinumab to policy section and guideline section as a medication that can be tried and failed. |
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01-15-2015
added Otezla and Stelara
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07-25-2014
Added Simponi Aria
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