Subject: Tremfya 2156-A SGM P2023
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.
FDA-Approved Indications
A. Treatment of adult patients with moderate to severe plaque
psoriasis (PsO) who are candidates for systemic therapy or
phototherapy
B. Treatment of adult patients with active psoriatic arthritis
(PsA)
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.
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with
one of the following:
A. Plaque psoriasis: dermatologist
B. Psoriatic arthritis: rheumatologist or dermatologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Plaque psoriasis (PsO)
1. Authorization of 12 months may be granted for adult
members who have 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 adult
members 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 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).
B. Psoriatic arthritis (PsA)
1. Authorization of 12 months may be granted for adult
members 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 adult
members 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 or predominantly axial
disease.
ii. Member has severe disease.
V. CONTINUATION OF THERAPY
A. Plaque psoriasis (PsO)
Authorization of 12 months may be granted for all adult
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
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 adult
members (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. Axial disease
6. Skin and/or nail involvement
V. OTHER
For all indications: Member has had a documented negative
tuberculosis (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.
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:
- Tremfya [package insert]. Horsham, PA: Janssen Biotech, Inc.; July 2020.
- Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 4: Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61:451-485.
- 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.
- Reich K, Armstrong, AW, Foley P, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator–controlled VOYAGE 2 trial. Am J Clin Dermatol. 2017;76(3):418-431.
- Blauvelt A, Papp KA, Griffiths, CEM, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. Am J Clin Dermatol. 2017;76(3):405-417.
- 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 January 6, 2023 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
- Gossec L, Baraliakos X, Kerschbaumer A, et al. European League Against Rheumatism (EULAR) recommendations for themanagement of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020;79(6):700-712.
- Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheum. 2018;71:5-32.
- 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.
- Menter A, Gelfand JM, Connor C, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies. J Am Acad Dermatol. 2020;82(6):1445-1486.
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.
June 11, 2023
