Subject: Humira 2008-A SGM P2021a
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. 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
RA.
2. Reducing signs and symptoms of
moderately to severely active polyarticular
JIA in patients 2 years of age and older.
3. Reducing signs and symptoms, inhibiting
the progression of structural damage, and
improving physical function in adult
patients with active PsA.
4. Reducing signs and symptoms in adult
patients with active AS.
5. The treatment of moderately to severely
active Crohn’s disease in adult and
pediatric patients 6 years of age and older.
6. The treatment of moderately to severely
active ulcerative colitis in adults and
pediatric patients 5 years of age and older.
Limitations of Use: The effectiveness of
Humira has not been established in
patients who have lost response to or were
intolerant to TNF blockers.
7. 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.
8. The treatment of moderate to severe
hidradenitis suppurativa in patients 12
years of age and older.
9. The treatment of non-infectious
intermediate, posterior, and panuveitis in
adults and pediatric patients 2 years of age
and older.
B. Compendial Uses
Axial spondyloarthritis
Behcet's disease
Pyoderma gangrenosum
Oligoarticular juvenile idiopathic arthritis
Immunotherapy-related inflammatory arthritis
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. 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.
B. Articular juvenile idiopathic arthritis,
ankylosing spondylitis (AS) and active axial
spondyloarthritis:
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.
C. Psoriatic arthritis (PsA): For continuation
requests: Chart notes or medical record
documentation supporting positive clinical
response.
D. Crohn’s disease
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.
E. 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.
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. 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.
H. Uveitis (non-infectious intermediate, posterior
and panuveitis)
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. Behcet’s disease (initial requests only): Chart
notes, medical record documentation, or claims
history supporting previous medications tried,
including response to therapy (if applicable).
J. Pyoderma gangrenosum and immunotherapy-
related inflammatory arthritis (initial requests
only): 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
III. CRITERIA FOR INITIAL APPROVAL
A. 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.
2. Authorization of 12 months may be
granted for treatment of moderately to
severely active RA when all of the
following are 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 meets either 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 A).
B. Moderately to severely active articular
juvenile idiopathic arthritis
1. Authorization of 12 months may be granted
for members who have previously received
a biologic or targeted synthetic DMARD
indicated for moderately to severely active
articular juvenile idiopathic arthritis.
2. Authorization of 12 months may be granted
for treatment of moderately to severely
active articular juvenile idiopathic arthritis
when any of the following criteria is met:
i. The member has had an inadequate
response to methotrexate or another
non-biologic DMARD administered at an
adequate dose and duration.
ii. The member has risk factors (See
Appendix E) and the member also
meets one of the following:
a. High-risk joints are involved (e.g.,
cervical spine, wrist, or hip).
b. High disease activity.
c. Are judged to be at high risk for
disabling joint disease.
C. Active psoriatic arthritis (PsA)
Authorization of 12 months may be granted for
treatment of active psoriatic arthritis (PsA).
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 treatment of active
ankylosing spondylitis or active axial
spondyloarthritis.
2. Authorization of 12 months may be granted
for treatment of active ankylosing
spondylitis and 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. 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 treatment of Crohn’s
disease.
2. Authorization of 12 months may be granted
for treatment of moderately to severely
active CD 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 treatment of fistulizing CD.
4. Authorization of 12 months may be granted
when the member is less than 18 years of
age.
F. 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 treatment of
moderately to severely active ulcerative
colitis.
2. Authorization of 12 months may be granted
for 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
C).
3. Authorization of 12 months may be granted
for members who have ever been
hospitalized for acute severe UC (e.g.,
continuous bleeding, severe toxic
symptoms, including fever and anorexia).
G. Moderate to severe plaque psoriasis
(PsO)
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).
H. Moderate to severe hidradenitis
suppurativa
1. Authorization of 12 months may be granted
for members who have previously received
a biologic indicated for treatment of
moderate to severe hidradenitis
suppurativa.
2. Authorization of 12 months may be granted
for treatment of moderate to severe
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.
I. Uveitis (non-infectious intermediate,
posterior and panuveitis)
1. Authorization of 12 months may be granted
for members who have previously received
a biologic indicated for non-infectious
intermediate, posterior, and panuveitis.
2. Authorization of 12 months may be granted
for treatment of non-infectious
intermediate, posterior and panuveitis when
either of the following is met:
i. Member has experienced an inadequate
response with corticosteroids or
immunosuppressive therapy (e.g.,
azathioprine, cyclosporine,
methotrexate).
ii. Member has an intolerance or
contraindication to corticosteroids and
immunosuppressive therapy (e.g.,
azathioprine, cyclosporine,
methotrexate).
J. 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).
K. Pyoderma gangrenosum
1. Authorization of 12 months may be granted
for members who have previously received
a biologic indicated for treatment of
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. Immunotherapy-related inflammatory
arthritis
Authorization of 12 months may be granted for
treatment of severe/refractory
immunotherapy-related inflammatory arthritis
that is not responding to corticosteroids and
anti-inflammatory agents.
IV. CONTINUATION OF THERAPY
A. 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.
B. Moderately to severely active articular
juvenile idiopathic arthritis
Authorization of 12 months may be granted for
all members (including new members) who are
using the requested medication for moderately
to severely active articular 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
C. 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
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
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. Moderately to severely active Crohn’s
disease
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)
F. Moderately to severely active ulcerative
colitis
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)
G. 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)
H. Moderate to severe hidradenitis
suppurativa
Authorization of 12 months may be granted
for all members (including new members) who
are using the requested medication for
moderate to severe 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
I. Uveitis (non-infectious intermediate,
posterior and panuveitis)
Authorization of 12 months may be granted
for all members (including new members) who are using the requested medication for non-
infectious intermediate, posterior, and panuveitis 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 disease flares
compared to baseline
2. Stability or improvement in anterior
chamber (AC) cell grade compared to
baseline
3. Stability or improvement in vitreous haze
(VH) grade compared to baseline
4. Stability or improvement in visual acuity
compared to baseline
5. Reduction in glucocorticoid requirements
from baseline
6. No new active inflammatory chorioretinal
and/or inflammatory retinal vascular
lesions relative to baseline
J. Immunotherapy-related inflammatory
arthritis
All members (including new members)
requesting authorization for continuation of
therapy must meet all initial authorization
criteria.
K. 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 a 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. For rheumatoid arthritis, member
must initiate treatment with every other week
dosing.
VII. APPENDICES
Appendix A: 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 B: 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
intravenous (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 C: Examples of Conventional
Therapy Options for UC
1. Mild to moderate disease – induction of
remission:
a. Oral mesalamine (e.g., 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 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)
APPENDIX E: Risk factors for Articular
Juvenile Idiopathic Arthritis
1. Positive rheumatoid factor
2. Positive anti-cyclic citrullinated peptide
antibodies
3. Pre-existing joint damage
Place of Service:
Outpatient
The above policy is based on the following references:
- Humira [package insert]. North Chicago, IL: AbbVie 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.
- Sieper J, van der Heijde D, Dougados M, et al. Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1). Ann Rheum Dis. 2013;72(6):815-22.
- Smolen JS, Landewé R, Billsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;0:1-18.
- 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.
- 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.
- Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care Res. 2019;71(6):717-734. doi:10.1002/acr.23870.
- Gossec L, Baraliakos X, Kerschbaumer A, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies; 2019 update. Ann Rheum Dis. 2020;79(6):700-712.
- 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].
- 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.
- 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.
- 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.
- 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.
- 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.
- Hatemi G, Christensen R, Bodaghi, et al. 2018 update of the EULAR recommendations for the management of Behcet’s syndrome. Ann Rheum Dis. 2018.; 77: 808-818.
- 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.
- Tuberculosis (TB). TB risk factors. Centers for Disease Control and Prevention. Retrieved on 15 November 2021 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
- 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.
- 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.
- Micromedex® (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed August 12, 2021.
- Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroentrol. 2019;114:384-413.
- 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.
- The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed August 12, 2021.
- 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. 2021; 160:2496-2508.
- 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.
- 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
