Specialty Pharmacy Clinical Policy Bulletins Aetna Non-Medicare Prescription Drug Plan
Subject: Stelara-Wezlana 2010-A SGM P2024
Drug
STELARA(ustekinumab)
WEZLANA(ustekinumab-auub)
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 and older who are candidates for phototherapy or systemic therapy 2. Active psoriatic arthritis (PsA) in patients 6 years and older 3. Moderately to severely active Crohn’s disease (CD) in adults 4. Moderately to severely active ulcerative colitis (UC) in adults B. Compendial Uses 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 (PsO) 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.
B. Psoriatic arthritis (PsA) 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 (CD) Continuation requests: Chart notes or medical record documentation supporting positive clinical response to therapy or remission.
D. Ulcerative colitis (UC) 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 (if applicable), including response 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: gastroenterologist, 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 and older who have previously received a biologic or targeted synthetic drug (e.g., Sotyktu, Otezla) indicated for treatment of moderate to severe plaque psoriasis.
2. Authorization of 12 months may be granted for members 6 years of age and older for treatment of moderate to severe plaque psoriasis 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 body surface area (BSA) is affected. iii. At least 3% of body surface area (BSA) is affected and the member meets either 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).
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), or another conventional synthetic drug (e.g., sulfasalazine). c. Member has enthesitis. ii. Member has severe disease.
C. Crohn’s disease (CD) Authorization of 12 months may be granted for adult members for treatment of moderately to severely active Crohn’s disease.
D. Ulcerative colitis (UC) Authorization of 12 months may be granted for adult members for treatment of moderately to severely active ulcerative colitis.
E. Immune checkpoint inhibitor-related toxicity Authorization of 6 months 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 and older (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 either 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 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 6. Functional status 7. C-reactive protein (CRP)
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 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 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. Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound 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. Appearance of the mucosa on endoscopy, computed tomography enterography (CTE), magnetic resonance enterography (MRE), or intestinal ultrasound 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 tuberculosis (TB) test (which can include a tuberculosis skin test [TST] or an interferon-release assay [IGRA])* 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 (e.g., chest x-ray). 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 for the same indication.
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. APPENDIX
Examples of Clinical Reasons to Avoid Pharmacologic Treatment with Methotrexate, Cyclosporine, Acitretin, or Leflunomide 1. Clinical diagnosis of alcohol use disorder, alcoholic liver disease, or other chronic liver disease 2. Drug interaction 3. Risk of treatment-related toxicity 4. Pregnancy or currently planning pregnancy 5. Breastfeeding 6. Significant comorbidity prohibits use of systemic agents (e.g., liver or kidney disease, blood dyscrasias, uncontrolled hypertension) 7. Hypersensitivity 8. History of intolerance or adverse event
Place of Service:
Outpatient
The above policy is based on the following references:
Stelara [package insert]. Horsham, PA: Janssen Biotech, Inc.; August 2022.
Wezlana [package insert]. Thousand Oaks, CA: Amgen Inc.; October 2023.
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, Mease P, 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.
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 Gastroenterol. 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. 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.
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.
NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®). Management of Immunotherapy-Related Toxicities. Version 1.2024. Available at: www.nccn.org. Accessed January 15, 2024.
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.
