| Effective Date:10/01/2019 |
Title:Evenity (romosozumab-aggg)
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| Revision Date:
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Document:BI625:00
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| CPT Code(s):J3111
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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)
Evenity
(romosozumab-aqqg) requires prior authorization.
2)
Evenity is used to treat
osteoporosis in postmenopausal women at high risk for fracture.
3)
Evenity is a specialty
injection covered under the medical benefit.
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Medical Statement
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Evenity (romosozumab-aqqg) is considered medically necessary for patients
meeting the following criteria:
1)
Patient is 18 years of
age or older AND
2)
Patient is a
postmenopausal female AND
3)
Patient has a diagnosis
of osteoporosis AND
4)
Patient has not had a
myocardial infarction or stroke within the past 12 months AND
5)
Patient meets one of the
following criteria:
a.
Prescribed by or in
consultation with one of the following specialists: a gynecologist,
endocrinologist, rheumatologist, geriatrician, orthopedist, or physiatrist; OR
b.
Failure of a 12-month
trial of a bisphosphonate (alendronate is preferred) at up to maximally
indicated doses, unless contraindicated or clinically significant adverse
effects are experienced
AND
6)
Dose does not exceed
210mg per month AND
7)
Patient has not received
a total of 12 monthly doses.
Codes
Used In This BI:
J3111 Injection,
romosozumab-aqqg, 1mg
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Limits
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Evenity is limited to a maximum of 12 monthly doses in a lifetime per the
FDA-approved labeling.
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Reference
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1)
Evenity Prescribing
Information. Thousand Oaks, CA. Amgen. April 2019.
2)
Camacho PM, Petak SM,
Binkley N, et al. American Association of Clinical Endocrinologists and American
College of Endocrinology clinical practice guidelines for the diagnosis and
treatment of postmenopausal osteoporosis – 2016 – executive summary. Endocr
Prac. 2016 Sep;22(9):1111-18.
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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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