| Effective Date:06/01/2020 |
Title:Sarclisa
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| Revision Date:08/01/2022
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Document:BI655:00
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| CPT Code(s):J9227
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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)
Sarclisa (isatuximab)
requires prior authorization.
2)
Sarclisa is used to treat
multiple myeloma who have failed other treatments.
3)
Sarclisa is considered a
specialty drug and covered under the medical benefit.
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Medical Statement
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Sarclisa (isatuximab-irfc) is considered medically necessary for members 18
years of age or older who meet the following criteria:
1)
Diagnosis of multiple
myeloma;
2)
Have received at least
two other therapies, including Revlimid and a proteasome inhibitor (e.g.
Velcade, Ninlaro, Kyprolis) and will be used in combination with Pomalyst and
dexamethasone;
3)
Have received 1 to 3
prior lines of therapy and used in combination with carfilzomib and
dexamethasone for relapsed or refractory disease;
4)
Prescribed by or in
consultation with an oncologist.
Approval Duration: 6
months
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Limits
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Intentially left empty
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Reference
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1)
Sarclisa Prescribing
Information. Bridgewater, NJ: Sanofi-Aventis. March 2021.
2)
Clinical Pharmacology.
Accessed online 05-23-2022.
3)
NCCN Drugs & Biologics
Compendium. Accessed online 05-23-2022.
Addendum:
1)
Effective 10-01-2020:
Removed restriction if Darzalex previously used.
2)
Effective 08/01/2022:
Updated to add criteria for use with carfilzomib and dexamethasone
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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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