Subject: Remicade-Avsola-Inflectra-Renflexis 2182-A SGM P2021a
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REMICADE
(infliximab)
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AVSOLA
(infliximab-axxq)
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INFLECTRA
(infliximab-dyyb)
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RENFLEXIS
(infliximab-abda)
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Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Adult patients with moderately to severely active Crohn’s disease (CD) and fistulizing CD
2. Pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease
3. Moderately to severely active ulcerative colitis (UC) in patients 6 years of age or older
4. Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
5. Active ankylosing spondylitis (AS)
6. Active psoriatic arthritis (PsA)
7. Chronic severe plaque psoriasis (PsO)
B. Compendial Uses
1. Axial spondyloarthritis
2. Behcet’s syndrome
3. Granulomatosis with polyangiitis (Wegener’s granulomatosis)
4. Hidradenitis suppurativa
5. Juvenile idiopathic arthritis
6. Pyoderma gangrenosum
7. Sarcoidosis
8. Takayasu’s arteritis
9. Uveitis
10. Reactive arthritis
11. Immune checkpoint inhibitor toxicity
12. Acute graft versus host disease
13. Moderate to severe plaque psoriasis
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. Crohn’s disease (CD)
1. Initial requests:
i. Chart notes, medical record documentation, or claims history supporting previous medications
tried (if applicable), including response to therapy. If therapy is not advisable, documentation of
clinical reason to avoid therapy.
ii. Chart notes or medical record documentation supporting diagnosis of fistulizing Crohn’s
disease (if applicable).
2. Continuation requests: Chart notes or medical record documentation supporting positive clinical
response to therapy or remission
B. Ulcerative colitis
1. Initial requests
i. Chart notes, medical record documentation, or claims history supporting previous medications
tried (if applicable), including response to therapy. If therapy is not advisable, documentation of
clinical reason to avoid therapy.
ii. Chart notes or medical record documentation of hospitalization due to acute, severe ulcerative
colitis (if applicable).
2. Continuation requests: Chart notes or medical record documentation supporting positive clinical
response to therapy or remission.
C. Rheumatoid arthritis (RA)
1. For initial requests:
i. Chart notes, medical record documentation, or claims history supporting previous
medications tried (if applicable), including response to therapy. If therapy is not advisable,
documentation of clinical reason to avoid therapy.
ii. Laboratory results, chart notes, or medical record documentation of biomarker testing
(i.e., rheumatoid factor [RF], anti-cyclic citrullinated peptide [anti-CCP], and C-reactive
protein [CRP] and/or erythrocyte sedimentation rate [ESR]) (if applicable).
2. For continuation requests: Chart notes or medical record documentation supporting positive clinical response.
D. Ankylosing spondylitis (AS), axial spondyloarthritis, juvenile idiopathic arthritis, and reactive arthritis:
1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous
medications tried (if applicable), including response to therapy. If therapy is not advisable,
documentation of clinical reason to avoid therapy.
2. Continuation requests: Chart notes or medical record documentation supporting positive
clinical response.
E. Psoriatic arthritis (PsA): For continuation requests: Chart notes or medical record documentation
supporting positive clinical response.
F. Plaque psoriasis
1. Initial requests:
i. Chart notes or medical record documentation of affected area(s) and body surface area (BSA)
affected (if applicable).
ii. Chart notes, medical record documentation, or claims history supporting previous medications
tried (if applicable), including response to therapy. If therapy is not advisable, documentation of
clinical reason to avoid therapy.
2. Continuation requests: Chart notes or medical record documentation of decreased body surface
area (BSA) affected and/or improvement in signs and symptoms.
G. Behcet’s disease (initial requests only): Chart notes, medical record documentation, or claims history
supporting previous medications tried, including response to therapy (if applicable).
H. Hidradenitis suppurativa
1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous
medications tried (if applicable), including response to therapy. If therapy is not advisable,
documentation of clinical reason to avoid therapy.
2. Continuation requests: Chart notes or medical record documentation supporting positive clinical
response to therapy.
I. Uveitis
1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous
medications tried (if applicable), including response to therapy. If therapy is not advisable,
documentation of clinical reason to avoid therapy.
2. Continuation requests: Chart notes or medical record documentation supporting positive clinical
response to therapy.
J. Granulomatosis with polyangiitis (Wegener’s granulomatosis), pyoderma gangrenosum, sarcoidosis,
Takayasu’s arteritis, immune checkpoint inhibitor toxicity, and acute graft versus host disease (initial
requests only): Chart notes, medical record documentation, or claims history supporting previous
medications tried (if applicable). If therapy is not advisable, documentation of clinical reason to
avoid therapy.
III. CRITERIA FOR INITIAL APPROVAL
A. Moderately to severely active Crohn’s disease (CD)
1. Authorization of 12 months may be granted for members who have previously received a biologic
indicated for the treatment of moderately to severely active Crohn’s disease.
2. Authorization of 12 months may be granted for the treatment of moderately to severely active
Crohn’s disease when the member has had an inadequate response, intolerance or contraindication
to at least one conventional therapy option (See Appendix A).
3. Authorization of 12 months may be granted for the treatment of fistulizing CD.
4. Authorization of 12 months may be granted when the member is less than 18 years of age.
B. Moderately to severely active ulcerative colitis (UC)
1. Authorization of 12 months may be granted for members who have previously received a biologic or
targeted synthetic drug (e.g., Xeljanz) indicated for moderately to severely active ulcerative colitis.
2. Authorization of 12 months may be granted for the treatment of moderately to severely active
UC when the member has had an inadequate response, intolerance or contraindication to at least
one conventional therapy option (See Appendix B).
3. Authorization of 12 months may be granted for members who have been hospitalized for acute
severe UC (e.g., continuous bleeding, severe toxic symptoms, including fever and anorexia).
C. Moderately to severely active rheumatoid arthritis (RA)
1. Authorization of 12 months may be granted for members who have previously received a biologic or
targeted synthetic DMARD (e.g., Rinvoq, Xeljanz) indicated for moderately to severely active
rheumatoid arthritis. The requested medication must be prescribed in combination with methotrexate
or leflunomide unless the member has a clinical reason not to use methotrexate (see Appendix C)
or leflunomide.
2. Authorization of 12 months may be granted for treatment of moderately to severely active RA
when all of the following criteria are met:
i. Member meets either of the following criteria:
a. Member has been tested for either of the following biomarkers and the test was positive:
1. Rheumatoid factor (RF)
2. Anti-cyclic citrullinated peptide (anti-CCP)
b. Member has been tested for ALL of the following biomarkers:
1. RF
2. Anti-CCP
3. C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)
ii. Member is prescribed the requested medication in combination with methotrexate or
leflunomide, or has a clinical reason not to use methotrexate (see Appendix C) or leflunomide.
iii. Member meets any of the following criteria:
a. Member has experienced an inadequate response to at least a 3-month trial of methotrexate
despite adequate dosing (i.e., titrated to at least 15 mg/week).
b. Member has an intolerance or contraindication to methotrexate (see Appendix C).
D. Active ankylosing spondylitis (AS) and active axial spondyloarthritis
1. Authorization of 12 months may be granted for members who have previously received a biologic
indicated for active ankylosing spondylitis or active axial spondyloarthritis.
2. Authorization of 12 months may be granted for treatment of active ankylosing spondylitis
or active axial spondyloarthritis when any of the following criteria is met:
i. Member has experienced an inadequate response to at least two non-steroidal
anti-inflammatory drugs (NSAIDs).
ii. Member has an intolerance or contraindication to two or more NSAIDs.
E. Active psoriatic arthritis (PsA)
Authorization of 12 months may be granted for treatment of active psoriatic arthritis (PsA).
F. Moderate to severe plaque psoriasis
1. Authorization of 12 months may be granted for members who have previously received Otezla
or a biologic indicated for the treatment of moderate to severe plaque psoriasis.
2. Authorization of 12 months may be granted for treatment of moderate to severe plaque
psoriasis in members when any of the following criteria is met:
i. Crucial body areas (e.g., hands, feet, face, neck, scalp, genitals/groin, intertriginous areas)
are affected.
ii. At least 10% of the body surface area (BSA) is affected
iii. At least 3% of body surface area (BSA) is affected and the member meets any of the following criteria:
a. Member has had an inadequate response or intolerance to either phototherapy
(e.g., UVB, PUVA) or pharmacologic treatment with methotrexate, cyclosporine, or acitretin.
b. Member has a clinical reason to avoid pharmacologic treatment with methotrexate,
cyclosporine, and acitretin (see Appendix D).
G. Behcet’s disease
1. Authorization of 12 months may be granted for members who have previously received Otezla
or a biologic indicated for the treatment of Behcet’s disease.
2. Authorization of 12 months may be granted for the treatment of Behcet’s disease when the
member has had an inadequate response to at least one nonbiologic medication for Behcet’s
disease (e.g., apremilast, colchicine, systemic glucocorticoids, azathioprine).
H. Granulomatosis with polyangiitis (Wegener’s granulomatosis)
Authorization of 12 months may be granted for treatment of granulomatosis with polyangiitis when
either of the following criteria is met:
1. Member has experienced an inadequate response to corticosteroids or immunosuppressive
therapy (e.g., cyclophosphamide, azathioprine, methotrexate, or mycophenolate mofetil).
2. Member has an intolerance or contraindication to corticosteroids and immunosuppressive
therapy (e.g., cyclophosphamide, azathioprine, methotrexate, or mycophenolate mofetil).
I. Hidradenitis suppurativa
1. Authorization of 12 months may be granted for members who have previously received a
biologic indicated for the treatment of severe, refractory hidradenitis suppurativa.
2. Authorization of 12 months may be granted for treatment of severe, refractory hidradenitis
suppurativa when either of the following is met:
i. Member has experienced an inadequate response to oral antibiotics for at least 90 days.
ii. Member has an intolerance or contraindication to oral antibiotics.
J. Juvenile Idiopathic arthritis (JIA)
1. Authorization of 12 months may be granted for members who have previously received a
biologic or targeted synthetic DMARD indicated for juvenile idiopathic arthritis.
2. Authorization of 12 months may be granted for the treatment of JIA when any of the following
criteria is met:
i. Member has an inadequate response to at least a 1-month trial of NSAIDs.
ii. Member has an inadequate response to at least a 2-week trial of corticosteroids.
iii. Member has an inadequate response to at least a 3-month trial of methotrexate or leflunomide.
K. Pyoderma gangrenosum
1. Authorization of 12 months may be granted for members who have previously received a biologic
indicated for pyoderma gangrenosum.
2. Authorization of 12 months may be granted for treatment of pyoderma gangrenosum when
either of the following is met:
i. Member has experienced an inadequate response to corticosteroids or immunosuppressive
therapy (e.g., cyclosporine or mycophenolate mofetil).
ii. Member has an intolerance or contraindication to corticosteroids and immunosuppressive
therapy (e.g. cyclosporine, mycophenolate mofetil).
L. Sarcoidosis
Authorization of 12 months may be granted for treatment of sarcoidosis in members when any of the
following criteria is met:
1. Member has experienced an inadequate response to corticosteroids or immunosuppressive therapy.
2. Member has an intolerance or contraindication to corticosteroids and immunosuppressive therapy.
M. Takayasu’s arteritis
Authorization of 12 months may be granted for treatment of refractory Takayasu’s arteritis when any
of the follow criteria is met:
1. Member has experienced an inadequate response to corticosteroids or immunosuppressive therapy
(e.g., methotrexate, azathioprine, or mycophenolate mofetil).
2. Member has an intolerance or contraindication to corticosteroids and immunosuppressive therapy
(e.g., methotrexate, azathioprine, or mycophenolate mofetil).
N. Uveitis
1. Authorization of 12 months may be granted for members who have previous received a biologic
indicated for uveitis.
2. Authorization of 12 months may be granted for treatment of uveitis when any of the following
criteria is met:
i. Member has experienced an inadequate response to corticosteroids or immunosuppressive
therapy (e.g., methotrexate, azathioprine, or mycophenolate mofetil).
ii. Member has an intolerance or contraindication to corticosteroids and immunosuppressive
therapy (e.g., methotrexate, azathioprine, or mycophenolate mofetil).
O. Reactive arthritis
1. Authorization of 12 months may be granted for members who have previously received a biologic
indicated for reactive arthritis.
2. Authorization of 12 months may be granted for treatment of reactive arthritis when any of the
following criteria is met:
i. Member has experienced an inadequate response to at least a 3-month trial of methotrexate
despite adequate dosing (i.e., titrated to at least 15 mg/week).
ii. Member has an intolerance or contraindication to methotrexate (see Appendix C).
P. Immune checkpoint inhibitor toxicity
Authorization of 1 month may be granted for the treatment of immune checkpoint inhibitor
(e.g., CTLA-4, PD-L1 inhibitor) toxicity when any of the following is met:
1. Member has had an inadequate response, intolerance, or contraindication to corticosteroids.
2. Member has cardiac toxicity.
3. Member has moderate or severe diarrhea or colitis.
Q. Acute graft versus host disease
Authorization of 12 months may be granted for treatment of acute graft versus host disease
when either of the following criteria is met:
1. Member has experienced an inadequate response to systemic corticosteroids.
2. Member has an intolerance or contraindication to corticosteroids.
IV. CONTINUATION OF THERAPY
A. Moderately to severely active Crohn’s disease (CD)
1. Authorization of 12 months may be granted for all members (including new members) who are
using the requested medication for moderately to severely active Crohn’s disease and who
achieve or maintain remission.
2. Authorization of 12 months may be granted for all members (including new members) who are
using the requested medication for moderately to severely active Crohn’s disease and who achieve
or maintain a positive clinical response as evidenced by low disease activity or improvement in
signs and symptoms of the condition when there is improvement in any of the following from baseline:
i. Abdominal pain or tenderness
ii. Diarrhea
iii. Body weight
iv. Abdominal mass
v. Hematocrit
vi. Endoscopic appearance of the mucosa
vii. Improvement on a disease activity scoring tool (e.g., Crohn’s Disease Activity Index [CDAI] score)
B. Moderately to severely active ulcerative colitis (UC)
1. Authorization of 12 months may be granted for all members (including new members) who are using the
requested medication for moderately to severely active ulcerative colitis and who achieve or
maintain remission.
2. Authorization of 12 months may be granted for all members (including new members) who are
using the requested medication for moderately to severely active ulcerative colitis and who achieve
or maintain a positive clinical response as evidenced by low disease activity or improvement in signs
and symptoms of the condition when there is improvement in any of the following from baseline:
i. Stool frequency
ii. Rectal bleeding
iii. Urgency of defecation
iv. C-reactive protein (CRP)
v. Fecal calprotectin (FC)
vi. Endoscopic appearance of the mucosa
vii. Improvement on a disease activity scoring tool (e.g., Ulcerative Colitis Endoscopic Index of
Severity [UCEIS], Mayo score)
C. Moderately to severely active rheumatoid arthritis (RA)
Authorization of 12 months may be granted for all members (including new members) who are using
the requested medication for moderately to severely active rheumatoid arthritis and who achieve or
maintain a positive clinical response as evidenced by disease activity improvement of at least 20%
from baseline in tender joint count, swollen joint count, pain, or disability.
D. Active ankylosing spondylitis (AS) and active axial spondyloarthritis
Authorization of 12 months may be granted for all members (including new members) who are
using the requested medication for active ankylosing spondylitis or active axial spondyloarthritis and
who achieve or maintain a positive clinical response with the requested medication as evidenced by low
disease activity or improvement in signs and symptoms of the condition when there is improvement in any
of the following from baseline:
1. Functional status
2. Total spinal pain
3. Inflammation (e.g., morning stiffness)
E. Active psoriatic arthritis (PsA)
Authorization of 12 months may be granted for all members (including new members) who are using
the requested medication for active psoriatic arthritis and who achieve or maintain a positive clinical
response as evidenced by low disease activity or improvement in signs and symptoms of the condition
when there is improvement in any of the following from baseline:
1. Number of swollen joints
2. Number of tender joints
3. Dactylitis
4. Enthesitis
5. Skin and/or nail involvement
F. Moderate to severe plaque psoriasis
Authorization of 12 months may be granted for all members (including new members) who are
using the requested medication for moderate to severe plaque psoriasis and who achieve or
maintain a positive clinical response as evidenced by low disease activity or improvement in
signs and symptoms of the condition when any of the following is met:
1. Reduction in body surface area (BSA) affected from baseline
2. Improvement in signs and symptoms from baseline (e.g., itching, redness, flaking, scaling,
burning, cracking, pain)
G. Hidradenitis suppurativa
Authorization of 12 months may be granted for all members (including new members) who are using
the requested medication for severe, refractory hidradenitis suppurativa and who achieve or maintain a
positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of
the condition when any of the following is met:
1. Reduction in abscess and inflammatory nodule count from baseline
2. Reduced formation of new sinus tracts and scarring
3. Decrease in frequency of inflammatory lesions from baseline
4. Reduction in pain from baseline
5. Reduction in suppuration from baseline
6. Improvement in frequency of relapses from baseline
7. Improvement in quality of life from baseline
8. Improvement on a disease severity assessment tool from baseline
H. Juvenile idiopathic arthritis (JIA)
Authorization of 12 months may be granted for all members (including new members) who are
using the requested medication for juvenile idiopathic arthritis and who achieve or maintain a
positive clinical response as evidenced by low disease activity or improvement in signs and symptoms
of the condition when there is improvement in any of the following from baseline:
1. Number of joints with active arthritis (e.g., swelling, pain, limitation of motion)
2. Number of joints with limitation of movement
3. Functional ability
I. Uveitis
Authorization of 12 months may be granted for all members (including new members) who are using
the requested medication for uveitis and who achieve or maintain a positive clinical response as
evidenced by low disease activity or improvement in signs and symptoms of the condition when the
patient meets any of the following:
1. Reduced frequency of recurrence compared to baseline
2. Zero anterior chamber inflammation or reduction in anterior chamber inflammation compared
to baseline
3. Decreased reliance on topical corticosteroids
J. Reactive arthritis
Authorization of 12 months may be granted for all members (including new members) who are using
the requested medication for reactive arthritis and who achieve or maintain a positive clinical response as
evidenced by low disease activity or improvement in signs and symptoms of the condition (e.g., tender
joint count, swollen joint count, or pain).
K. Immune checkpoint inhibitor toxicity and acute graft versus host disease
All members (including new members) requesting authorization for continuation of therapy must
meet all initial authorization criteria.
L. All other indications
Authorization of 12 months may be granted for all members (including new members) who are using
the requested medication for an indication outlined in Section III and who achieve or maintain positive
clinical response with the requested medication as evidenced by low disease activity or improvement in
signs and symptoms of the condition.
V. OTHER
For all indications: Member has had a documented negative TB test (which can include a tuberculosis skin test [PPD], an interferon-release assay [IGRA], or a chest x-ray)* within 6 months of initiating therapy for persons who are naïve to biologic DMARDs or targeted synthetic DMARDs associated with an increased risk of TB.
* If the screening testing for TB is positive, there must be further testing to confirm there is no active disease. Do not administer the requested medication to members with active TB infection. If there is latent disease, TB treatment must be started before initiation of the requested medication.
For all indications: Member cannot use the requested medication concomitantly with any other biologic DMARD or targeted synthetic DMARD.
VI. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.
Special Notes:
VII. APPENDICES
Appendix A: Examples of Conventional Therapy Options for CD
1. Mild to moderate disease – induction of remission:
a. Oral budesonide
b. Alternatives: metronidazole, ciprofloxacin, rifaximin
2. Mild to moderate disease – maintenance of remission:
a. Azathioprine, mercaptopurine
B. Alternatives: oral budesonide, methotrexate intramuscular (IM) or subcutaneous (SC), sulfasalazine
3. Moderate to severe disease – induction of remission:
a. Prednisone, methylprednisolone intravenously (IV)
b. Alternatives: methotrexate IM or SC
4. Moderate to severe disease – maintenance of remission:
a. Azathioprine, mercaptopurine
B. Alternative: methotrexate IM or SC
5. Perianal and fistulizing disease – induction of remission
a. Metronidazole ± ciprofloxacin, tacrolimus
6. Perianal and fistulizing disease – maintenance of remission
a. Azathioprine, mercaptopurine
b. Alternative: methotrexate IM or SC
Appendix B: Examples of Conventional Therapy Options for UC
1. Mild to moderate disease – induction of remission:
a. Oral mesalamine (e.g., Apriso, Asacol, Asacol HD, Lialda, Pentasa), balsalazide, olsalazine
b. Rectal mesalamine (e.g., Canasa, Rowasa)
c. Rectal hydrocortisone (e.g., Colocort, Cortifoam)
d. Alternatives: prednisone, azathioprine, mercaptopurine, sulfasalazine
2. Mild to moderate disease – maintenance of remission:
a. Oral mesalamine, balsalazide, olsalazine, rectal mesalamine
b. Alternatives: azathioprine, mercaptopurine, sulfasalazine
3. Severe disease – induction of remission:
a. Prednisone, hydrocortisone IV, methylprednisolone IV
b. Alternatives: cyclosporine IV, tacrolimus, sulfasalazine
4. Severe disease – maintenance of remission:
a. Azathioprine, mercaptopurine
b. Alternative: sulfasalazine
Appendix C: Examples of Contraindications to Methotrexate
1. Clinical diagnosis of alcohol use disorder, alcoholic liver disease or other chronic liver disease
2. Breastfeeding
3. Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia)
4. Elevated liver transaminases
5. History of intolerance or adverse event
6. Hypersensitivity
7. Interstitial pneumonitis or clinically significant pulmonary fibrosis
8. Myelodysplasia
9. Pregnancy or currently planning pregnancy
10. Renal impairment
11. Significant drug interaction
Appendix D: Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Cyclosporine or Acitretin
1. Clinical diagnosis of alcohol use disorder, alcoholic liver disease or other chronic liver disease
2. Breastfeeding
3. Drug interaction
4. Cannot be used due to risk of treatment-related toxicity
5. Pregnancy or currently planning pregnancy
6. Significant comorbidity prohibits use of systemic agents (examples include liver or kidney
disease, blood dyscrasias, uncontrolled hypertension)
Place of Service:
Outpatient
The above policy is based on the following references:
- Remicade [package insert]. Horsham, PA: Janssen Biotech, Inc.; May 2020.
- Avsola [package insert]. Thousand Oaks, CA: Amgen; December 2019.
- Inflectra [package insert]. New York, NY: Pfizer Inc; June 2021.
- Renflexis [package insert]. Whitehouse Station, NJ. Merck & Co., Inc; February 2021.
- van der Heijde D, Ramiro S, Landewe R, et al. 2016 Update of the international ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;0:1-14.
- IBM Micromedex® DRUGDEX® System (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com/. Accessed August 16, 2021.
- Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
- Lichtenstein GR, Loftus Jr EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.
- Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59(6):762-784.
- Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79(6):685-699. doi:10.1136/annrheumdis-2019-216655.
- Singh JA,Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis 2016;68(1)1-26.
- Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1):137-174.
- Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies; 2015 update. Ann Rheum Dis. 2016;75(3):499-510.
- Gladman DD, Antoni C, P Mease, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 2005;64(Suppl II):ii14–ii17.
- Peluso R, Lervolino S, Vitiello M, et al. Extra-articular manifestations in psoriatic arthritis patients. Clin Rheumatol. 2014 May 8. [Epub ahead of print].
- Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011;70:896–904.
- Beukelman T, Patkar NM, Saag KG, et al. 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res. 2011;63(4):465-482.
- Ringold S, Weiss PF, Beukelman T, et al. 2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis: Recommendations for the Medical Therapy of Children With Systemic Juvenile Idiopathic Arthritis and Tuberculosis Screening Among Children Receiving Biologic Medications. Arthritis & Rheumatism. 2013;65:2499-2512.
- Ward MM, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613. doi:10.1002/art.41042.
- Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
- Hatemi G, Christensen R, Bang D, et al. 2018 update of the EULAR recommendations for the management of Behcet’s syndrome. Ann Rheum Dis. 2018;77:808-818.
- Agarwal A, Andrews JM. Systematic review: IBD-associated pyoderma gangrenosum in the biologic era, the response to therapy. Aliment Pharmacol Ther. 2013;38(6):563-572.
- Arguelles-Arias F, Castro-Laria L, Lobaton T, et al. Characteristics and treatment of pyoderma gangrenosum in inflammatory bowel disease. Dig Dis Sci. 2013;58(10):2949-2954.
- Marzano AV, Ishak RS, Saibeni S, et al. Autoinflammatory skin disorders in inflammatory bowel diseases, pyoderma gangrenosum and Sweet's syndrome: A comprehensive review and disease classification criteria. Clin Rev Allergy Immunol. 2013;45(2):202-210.
- The NCCN Drugs & Biologics Compendium® © 2021 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed August 16, 2021.
- Tuberculosis (TB). TB risk factors. Centers for Disease Control and Prevention. Retrieved on November 15, 2021 from: https://www.cdc.gov/tb/topic/basics/risk.html.
- Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019;71(1):5-32. doi:10.1002/art.40726.
- Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology 2020; 158:1450.
- Flores D, Marquez J, Garza M, Espinoza LR. Reactive arthritis: newer developments. Rheum Dis Clin North Am. 2003;29(1):37-vi.
- AHFS DI (Adult and Pediatric) [database online]. Hudson, OH: Lexi-Comp, Inc.; http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed August 16, 2021.
- George, C, Deroide, F, Rustin, M. Pyoderma gangrenosum – a guide to diagnosis and management. Clin Med. 2019;19(3):224-8.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Hematopoietic Cell Transplantation (HCT): Pre-Transplant Recipient Evaluation and Management of Graft-Versus-Host Disease. Version 3.2021. https://www.nccn.org/professionals/physician_gls/pdf/hct.pdf. Accessed August 16, 2021.
- Menter, A, Cordero, KM, Davis, DM, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82(1):161-201.
- Menter, A, Gelfand, JM, Connor, C, et al. Joint AAD-NPF guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6): 1445-86.
- Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroentrol. 2019;114:384-413.
- Aletaha D, Neogi T, Silman, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-81.
- Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations Part I: Diagnosis, evaluation, and the use of complementary and procedural management. J Am Acad Dermatol. 2019; 81(1): 76-90.
- Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: A publication from the United States and Canadian Hidradenitis Suppurativa Foundations Part II: Topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019; 81(1): 91-101.
- Smolen JS, Aletaha D. Assessment of rheumatoid arthritis activity in clinical trials and clinical practice. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available with subscription. URL: www.uptodate.com. Accessed March 19, 2021.
- Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthrit Care Res. 2021;0:1-16.
- Feuerstein J, Ho E, Shmidt E, et al. AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease. Gastroenterology. 2021;160:2496-2508.
- Elmets C, Korman N, et al. Guidelines of Care for the Management and Treatment of Psoriasis with Topical Therapy and Alternative Medicine Modalities for Psoriasis Severity Measures. J Am Acad Dermatol. 2021;84:432-470.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
July 03, 2022
