CMS Grants Aponvie Pass Through Status

The Centers for Medicare & Medicaid Services (CMS) has granted transitional pass-through reimbursement status for Heron Therapeutics’ Aponvie (aprepitant) for intravenous use in adults for the prevention of postoperative nausea and vomiting. Effective April 1, 2023, and Aponvie will have a C-code C9145 and be reimbursed separately outside of the surgical bundle payment by Medicare at an average sales price +6% in both the hospital outpatient department and ambulatory surgery center settings of care. Aponvie recently blaunched with a wholesale acquisition cost of $58 per vial.

CMS grants pass-through status to certain new and innovative medical devices, drugs, and biological products. Drugs that are administered in the hospital-based outpatient department and ambulatory surgical center settings can have pass-through status. CMS collects utilization data during this pass-through period, and the agency uses this information when determining how to adjust the payment rate for the service using the product after transitional pass-through status expires.

For pass-through products used in a hospital setting, CMS reimburses 100% of the cost for Medicare Part B patients, and no copayment applies. When a pass-through drug or device is used in an ambulatory surgical center, however, the 20% copayment does apply.

The FDA approved Aponvie in September 2022 for the prevention of postoperative nausea and vomiting in adults. Aponvie is the first IV formulation of aprepitant. It is provided as single-dose vial that delivers the full 32 mg dose and reaches drug levels within five minutes and maintains therapeutic plasma concentrations for at least 48 hours.

Aponvie is the same formulation as Heron’s approved Cinvanti, which is an injectable emulsion formulation for prevention of chemotherapy-induced nausea and vomiting.

The approval is based on data demonstrating the bioequivalence of Aponvie 32 mg as a 30-second IV injection to oral aprepitant 40 mg. Results also showed Aponvie was well-tolerated with a similar safety profile compared with oral aprepitant. Because it is administered as an IV injection, Aponvie provides convenient, rapid, consistent, and reliable exposure in all patients and overcomes the need to take the oral formulation 1 to 3 hours before anesthesia.