C-code for ONPATTRO™ (patisiran) lipid complex injection
- December 5, 2018
- No responses
We are sending this communication on behalf of Alnylam Pharmaceuticals, Inc., to announce the assignment of a product‐specific temporary C-code for ONPATTRO™ (patisiran) lipid complex injection, for intravenous use. The Centers for Medicare & Medicaid Services (CMS) released the 2019 Alpha-Numeric HCPCS File, which included the designation of C9036, Injection, patisiran, 0.1 mg for ONPATTRO with the effective date of January 1, 2019.1
|Trade Name||HCPCS Code||Strength||NDC2||CMS Long Descriptor||Effective Date|
|ONPATTRO||C9036 Injection, patisiran||10 mg/5 mL
(2 mg/mL) in a single-dose vial
|January 1, 2019|
*Note that the product’s NDC code has been “zero‐filled” to ensure creation of an 11‐digit code that meets HIPAA standards.
The zero‐fill location is indicated in bold. HCPCS=Healthcare Common Procedure Coding System; NDC=National Drug Code.
ONPATTRO was approved by the US Food and Drug Administration on August 10, 2018.3 ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.4
Please see Important Safety Information below, and full Prescribing Information for ONPATTRO.
IMPORTANT SAFETY INFORMATION
Infusion-related reactions (IRRs) have been observed in patients treated with ONPATTRO. In a controlled clinical study, 19% of ONPATTRO-treated patients experienced IRRs, compared to 9% of placebo-treated patients. The most common symptoms of IRRs with ONPATTRO were flushing, back pain, nausea, abdominal pain, dyspnea, and headache.
To reduce the risk of IRRs, patients should receive premedication with a corticosteroid, acetaminophen, and antihistamines (H1 and H2 blockers) at least 60 minutes prior to ONPATTRO infusion. Monitor patients during the infusion for signs and symptoms of IRRs. If an IRR occurs, consider slowing or interrupting the infusion and instituting medical management as clinically indicated. If the infusion is interrupted, consider resuming at a slower infusion rate only if symptoms have resolved. In the case of a serious or life-threatening IRR, the infusion should be discontinued and not resumed.
Reduced Serum Vitamin A Levels and Recommended Supplementation
ONPATTRO treatment leads to a decrease in serum vitamin A levels. Supplementation at the recommended daily allowance (RDA) of vitamin A is advised for patients taking ONPATTRO. Higher doses than the RDA should not be given to try to achieve normal serum vitamin A levels during treatment with ONPATTRO, as serum levels do not reflect the total vitamin A in the body.
Patients should be referred to an ophthalmologist if they develop ocular symptoms suggestive of vitamin A deficiency (e.g. night blindness).
The most common adverse reactions that occurred in patients treated with ONPATTRO were upper respiratory tract infections (29%) and infusion‑related reactions (19%).
For additional information about ONPATTRO, please see the full Prescribing Information.
- Centers for Medicare & Medicaid Services. 2019 Alpha-Numeric HCPCS File.https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2019-Alpha-Numeric-HCPCS-File.html. Accessed 11/06/2018.
- US Food and Drug Administration.National Drug Code Background Information.
https://www.fda.gov/drugs/developmentapprovalprocess/ucm070829. Accessed 11/06/2018.
- US Food and Drug Administration.ONPATTRO™ (patisiran) Approval Announcement. https://www.fda.gov/NewsEvents/%20Newsroom/PressAnnouncements/ucm616518.htm. Accessed 08/10/2018.
- 4.ONPATTRO [package insert]. Cambridge, MA: Alnylam Pharmaceuticals, Inc; 2018.