| Effective Date:06/01/2013 |
Title:Signifor (Pasireotide) & Signifor LAR
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| Revision Date:01/01/2016
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Document:BI411:00
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| CPT Code(s):None
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Public Statement
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Effective Date:
a)
This policy
will apply to all services performed on or after the above revision date which
will become the new effective date.
b)
For all
services referred to in this policy that were performed before the revision
date, contact customer service for the rules that would apply.
1)
Signifor
(Pasireotide) and Signifor LAR require prior authorization.
2)
Signifor is
used to treat Cushing’s disease.
3)
Signifor LAR
is used to treat acromegaly.
4)
Signifor is a
specialty drug and must be obtained through a contracted specialty pharmacy.
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Medical Statement
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Signifor is
considered medically necessary for members who meet the following criteria:
1)
Diagnosis of
Cushing’s Disease (E24.0) AND
2)
Pituitary
surgery has not been curative or surgery is not an option (provide rationale).
Signifor LAR
is considered medical necessary for members who meet the following criteria:
1)
Diagnosis of
acromegaly (E22.0) AND
2)
Had an
inadequate response to surgery or surgery is not an option (provide rationale).
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Limits
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1)
Signifor has
a quantity limit of 2 units per day for all strengths.
2)
Signifor LAR
is limited to one dose every 28 days.
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Reference
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1)
Signifor
prescribing information. Novartis. East Hanover, NJ. December 2012.
2)
Signifor LAR
prescribing information. Novartis. East Hanover, NJ. December 2014.
3)
Clinical
Pharmacology. Signifor. Accessed online May 2013.
4)
Colao A,
Petersenn S, Newell-Price J, et al. A 12-month Phase 3 study of Pasireotide in
Cushing’s disease. NEJM. March 2012 366;10:914-924.
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Application to Products
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This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
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Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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