J1305 — Injection, evinacumab-dgnb, 5mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Diagnosis of HoFH by, or in consultation with, a lipid specialist (e.g., cardiologist, endocrinologist, lipid specialist/lipidologist) experienced in the management of HoFH.
- Submission of medical records (e.g., chart notes, laboratory values) confirming genetic confirmation of biallelic pathogenic/likely pathogenic variants on different chromosomes at the LDLR, APOB, PCSK9, or LDLRAP1 genes or ≥ 2 such variants at different loci; OR documentation of BOTH: untreated LDL-C > 400 mg/dL AND one of: xanthoma before 10 years of age; OR evidence of familial hypercholesterolemia in at least one parent.
- If using the LDL-C / clinical criteria pathway: laboratory documentation of untreated LDL-C > 400 mg/dL and clinical documentation of xanthoma before age 10 and/or family history consistent with FH in a parent, as described above.
Key Coverage Criteria
- Evkeeza (evinacumab-dgnb) is proven and medically necessary for the treatment of homozygous familial hypercholesterolemia (HoFH) patients who meet all of the following criteria:
- For initial therapy, all of the following: Diagnosis of HoFH by, or in consultation with, a lipid specialist (e.g., cardiologist, endocrinologist, lipid specialist/lipidologist); and Confirmation of the HoFH diagnosis based on one of the following: (a) Submission of medical records (e.g., chart notes, laboratory values) confirming genetic confirmation of biallelic pathogenic/likely pathogenic variants on different chromosomes at the low-density lipoprotein receptor (LDLR), apolipoprotein B (APOB [...]
- For continuation of therapy, all of the following: Documentation of a positive clinical response to Evkeeza therapy; and Evkeeza will not be used in combination with Juxtapid (lomitapide); and Evkeeza dosing is in accordance with the United States Food and Drug Administration approved labeling; and reauthorization will be for no more than 12 months.
- FDA indication (informational): Evkeeza is indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 5 years and older, with homozygous familial hypercholesterolemia (HoFH).
- Authorization of hospital outpatient facility infusion services (place of service codes 19 and 22) for specialty medications and IVIG/SCIG when outpatient hospital facility-based administration is medically necessary and the member meets at least one of the criteria below.
- Patient is medically unstable and is at risk of requiring medical services and equipment available only in an outpatient hospital setting (e.g., endotracheal tube, chest tube insertion equipment, cricothyroidotomy set, mechanical ventilator) during administration of the requested drug.
14 Active Policies
UHC-POL-evkeeza — Evkeeza (Evinacumab-Dgnb)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-evkeeza — Evkeeza (Evinacumab-Dgnb)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-evkeeza — Evkeeza (Evinacumab-Dgnb)
Related Codes
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