inclisiran
Marketed as LEQVIO.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| NDA214012 | LEQVIO | 2021-12-22 | NOVARTIS |
Manufacturers
NOVARTIS
Common denial patterns
- Step therapy requiring statin + ezetimibe + PCSK9 mAb trial first
- LDL-C threshold requirements
- FH-only restriction despite FDA labeling for ASCVD
Specific notes
Brand: Leqvio. siRNA targeting PCSK9 — twice-yearly subQ dosing. Approved for primary hyperlipidemia including HeFH and clinical ASCVD requiring additional LDL-C lowering.
Novartis Patient Assistance Foundation: https://www.leqvio.com
Frequently asked questions
Why does insurance commonly deny inclisiran?
Step therapy requiring statin + ezetimibe + PCSK9 mAb trial first; LDL-C threshold requirements; FH-only restriction despite FDA labeling for ASCVD.
When was inclisiran FDA approved?
Earliest FDA approval on record: 2021-12-22.
What brand names are sold as inclisiran?
LEQVIO.
Is there a patient assistance program for inclisiran?
Yes — Novartis Patient Assistance Foundation at https://www.leqvio.com.
What's specific to inclisiran?
Brand: Leqvio. siRNA targeting PCSK9 — twice-yearly subQ dosing. Approved for primary hyperlipidemia including HeFH and clinical ASCVD requiring additional LDL-C lowering.
Sources
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