Subject: Signifor 2124-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 Indication
Signifor is indicated for the treatment of adult patients with
Cushing’s disease for whom pituitary surgery is not an option or
has not been curative.
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Cushing’s disease
Submission of the following information is necessary to initiate
the prior authorization review:
A. For initial requests, pretreatment cortisol level as measured
by one of the following tests:
1. Urinary free cortisol (UFC)
2. Late-night salivary cortisol (LNSC)
3. 1 mg overnight dexamethasone suppression test (DST)
4. Longer, low dose DST (2 mg per day for 48 hours
B. For continuation of therapy requests (if applicable),
laboratory report indicating current cortisol level has
decreased from baseline as measured by one of the following
tests:
1. Urinary free cortisol (UFC)
2. Late-night salivary cortisol (LNSC)
3. 1 mg overnight dexamethasone suppression test (DST)
4. Longer, low dose DST (2 mg per day for 48 hours)
III. CRITERIA FOR INITIAL APPROVAL
Cushing’s disease
Authorization of 6 months may be granted for the treatment of
Cushing’s disease in members who either have had surgery that
was not curative OR for members who are not candidates for
surgery.
IV. CONTINUATION OF THERAPY
Cushing’s disease
Authorization of 12 months may be granted for members that
meet one of the following criteria:
A. Lower cortisol levels since the start of therapy per one of the
following tests:
1. Urinary free cortisol (UFC)
2. Late-night salivary cortisol (LNSC)
3. 1 mg overnight dexamethasone suppression test (DST)
4. Longer, low dose DST (2 mg per day for 48 hours)
B. Improvement in signs or symptoms of the disease
Place of Service:
Outpatient
The above policy is based on the following references:
- Signifor [package insert]. Lebanon, NJ: Recordati Rare Diseases; March 2020.
- Nieman LK, Biller BM, Findling JW, et al. Treatment of Cushing’s Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(8):2807-2831. doi:10.1210/jc.2015-1818
- Fleseriu M, Auchus R, Bancos I, et al. Consensus on Diagnosis and Management of Cushing’s Disease: A Guideline Update. Lancet Diabetes Endocrinol. 2021;9(12):847-875. doi:10.1016/S2213-8587(21)00235-7
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.
August 13, 2023
