Subject: Stelara 2010-A SGM P2022a
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. Moderate to severe plaque psoriasis (PsO) in patients 6
years or older who are candidates for phototherapy or
systemic therapy
2. Active psoriatic arthritis (PsA) in patients 6 years or older
3. Moderately to severely active Crohn’s disease (CD) in
adults
4. Moderately to severely active ulcerative colitis (UC) in
adults
B. Compendial Uses19
Immune checkpoint inhibitor-related toxicity
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. Plaque psoriasis
1. Initial requests:
i. Chart notes or medical record documentation of
affected area(s) and body surface area (BSA)
affected.
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.
B. Psoriatic 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.
C. 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.
D. 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.
E. Immune checkpoint inhibitor-related toxicity
Chart notes, medical record documentation, or claims
history supporting previous medications tried, including
response to therapy or intolerance to therapy. If therapy is
not advisable, documentation of clinical reason to avoid
therapy.
III. PRESCRIBER SPECIALTIES
The medication must be prescribed by or in consultation with
one of the following:
A. Plaque psoriasis: dermatologist
B. Psoriatic arthritis: rheumatologist or dermatologist
C. Crohn’s disease and ulcerative colitis: gastroenterologist
D. Immune checkpoint inhibitor-related toxicity: hematologist
or oncologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Plaque psoriasis (PsO)
1. Authorization of 12 months may be granted for members
6 years of age or older who previously received a
biologic or targeted synthetic drug (e.g., Sotyktu, Otezla)
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 6 years of age or older 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 A).
B. Psoriatic arthritis (PsA)
1. Authorization of 12 months may be granted for members
6 years of age or older who have previously received a
biologic or targeted synthetic drug (e.g., Rinvoq, Otezla)
indicated for active psoriatic arthritis.
2. Authorization of 12 months may be granted for members
6 years of age or older for treatment of active psoriatic
arthritis when either of the following criteria is met:
i. Member has mild to moderate disease and meets
one of the following criteria:
a. Member has had an inadequate response to
methotrexate, leflunomide, or another
conventional synthetic drug (e.g., sulfasalazine)
administered at an adequate dose and duration.
b. Member has an intolerance or contraindication
to methotrexate or leflunomide (see Appendix
B), or another conventional synthetic drug
(e.g., sulfasalazine).
c. Member has enthesitis or predominantly axial
disease.
ii. Member has severe disease.
C. Crohn’s disease (CD)
1. Authorization of 12 months may be granted for adult
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 adult
members for the 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 C).
3. Authorization of 12 months may be granted for adult
members for the treatment of fistulizing CD.
D. Ulcerative colitis (UC)
1. Authorization of 12 months may be granted for adult
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 adult
members 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 D).
3. Authorization of 12 months may be granted for adult
members who have ever been hospitalized for acute
severe UC (e.g., continuous bleeding, severe toxic
symptoms, including fever and anorexia).
E. Immune checkpoint inhibitor-related toxicity
Authorization of 1 month may be granted for the treatment
of immune checkpoint inhibitor-related diarrhea or colitis
when the member has experienced an inadequate response,
intolerance, or contraindication to infliximab or vedolizumab.
V. CONTINUATION OF THERAPY
A. Plaque psoriasis (PsO)
Authorization of 12 months may be granted for all members
6 years of age or older (including new members) who are
using the requested medication for moderate to severe
plaque psoriasis and who achieve or maintain 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)
B. Psoriatic arthritis (PsA)
Authorization of 12 months may be granted for all members
6 years of age or older (including new members) who are
using the requested medication for psoriatic arthritis and
who achieve or maintain 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. Axial disease
6. Skin and/or nail involvement
C. Crohn’s Disease (CD)
1. Authorization of 12 months may be granted for all adult
members (including new members) who are using the
requested medication for moderately to severely active
or fistulizing Crohn’s disease and who achieve or
maintain remission.
2. Authorization of 12 months may be granted for all adult
members (including new members) who are using the
requested medication for moderately to severely active
or fistulizing 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)
D. Ulcerative colitis
1. Authorization of 12 months may be granted for all adult
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 adult
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)
E. Immune checkpoint inhibitor-related toxicity
All members (including new members) requesting
authorization for continuation of therapy must meet all initial
authorization criteria.
VI. 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 drugs or targeted synthetic drugs 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 drug or
targeted synthetic drug.
Stelara for intravenous administration will only be authorized to
use for the treatment of Crohn’s disease, ulcerative colitis, and
immune checkpoint inhibitor-related toxicity.
VII. DOSAGE AND ADMINISTRATION
Approvals may be subject to dosing limits in accordance with
FDA-approved labeling, accepted compendia, and/or evidence-
based practice guidelines.
VIII. APPENDICES
Appendix A: 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
(e.g., liver or kidney disease, blood dyscrasias, uncontrolled
hypertension)
Appendix B: Examples of Contraindications to
Methotrexate or Leflunomide
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 C: 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:
Metronidazole ± ciprofloxacin, tacrolimus
6. Perianal and fistulizing disease – maintenance of remission:
a. Azathioprine, mercaptopurine
b. Alternative: methotrexate IM or SC
Appendix D: 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
Place of Service:
Outpatient
The above policy is based on the following references:
- Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; July 2022.
- 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,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.
- 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.
- 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.
- Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on June 15, 2022 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
- 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.
- Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroentrol. 2019;114:384-413.
- 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.
- 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.
- 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.
- Feuerstein JD, Ho EY, 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.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed June 09, 2022.
- Coates LC, Soriano ER, Corp N, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): updated treatment recommendations for psoriatic arthritis 2021. Nat Rev Rheumatol. 2022;18(8):465-479.
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.
March 28, 2023
