Subject: Kevzara 1957-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.
FDA-Approved Indications
A. Adult patients with moderately to severely active rheumatoid
arthritis (RA) who have had an inadequate response or
intolerance to one or more disease-modifying antirheumatic
drugs (DMARDs).
B. Adult patients with polymyalgia rheumatica (PMR) who have
had an inadequate response to corticosteroids or who cannot
tolerate corticosteroid taper.
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
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. 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. Continuation requests: Chart notes or medical record
documentation supporting positive clinical response.
B. Polymyalgia rheumatica
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 a
rheumatologist.
IV. CRITERIA FOR INITIAL APPROVAL
A. Rheumatoid arthritis (RA)
1. Authorization of 12 months may be granted for adult
members who have previously received a biologic or
targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated
for moderately to severely active rheumatoid arthritis.
2. Authorization of 12 months may be granted for adult
members 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 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).
B. Polymyalgia rheumatica (PMR)
Authorization of 12 months may be granted for adult
members for treatment of polymyalgia rheumatica (PMR)
when any of the following criteria is met:
1. Member has experienced an inadequate response to
systemic corticosteroids.
2. Member has experienced a disease flare during a taper
with systemic corticosteroids.
3. Member has experienced an inadequate response to
methotrexate.
4. Member has experienced an intolerance or
contraindication to both systemic corticosteroids and
methotrexate (see Appendix).
V. CONTINUATION OF THERAPY
A. Rheumatoid arthritis (RA)
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 RA
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. Polymyalgia rheumatica (PMR)
Authorization of 12 months may be granted for all adult
members (including new members) who are using the
requested medication for PMR 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. Morning stiffness
2. Hip or shoulder pain
3. Hip or shoulder range of motion
4. C-reactive protein (CRP) and/or erythrocyte
sedimentation rate (ESR)
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: Members 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 Contraindications to
Methotrexate
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:
- Kevzara [package insert]. Bridgewater, NJ: Sanofi-aventis, U.S. LLC /Regeneron Pharmaceuticals, Inc.; February 2023.
- Genovese MC, Fleischmann R, Kivitz AJ, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III study. Arthritis Rheumatol.June 2015;67(6):1424-37.
- StrandV, Reaney M, Chen C, et al. Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors. RMD Open. 2017; 3: doi: 10.1136/rmdopen-2016-000416.
- Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on June 15, 2022 from: https://www.cdc.gov/tb/topic/testing/tbtesttypes.htm.
- Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79:685-699.
- 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.
- 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.
- Dasgupta B, Cimmino MA, Kremers HM, et al. 2012 provisional classification criteria for polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative. Arthritis Rheum. 2012 Apr;64(4):943-54.
- 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
