Invivyd Receives Healthcare Common Procedure Coding System (HCPCS) Reimbursement Codes from the U.S. Centers for Medicare & Medicaid Services (CMS) Covering PEMGARDA

• Product-specific Q Code (Q0224) facilitates product reimbursement for PEMGARDA; corresponding M Code (M0224) defines reimbursement for product administration
• Reimbursement through Medicare/Medicaid represents approximately 50% of covered lives in target population

WALTHAM, Mass., April 15, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common Procedure Coding System (HCPCS) Q code (Q0224) covering product reimbursement for PEMGARDA. In addition, CMS issued a product specific M code (M0224) covering the administration of PEMGARDA. Both HCPCS codes are effective retroactively to March 22, 2024, the date of emergency use authorization (EUA) for PEMGARDA.

HCPCS is a group of standardized codes that represent medical procedures, supplies, products, and services. The codes are used to facilitate the processing of health insurance claims by Medicare and other insurers.

PEMGARDA (pemivibart) injection, for intravenous use, received EUA from the U.S. Food and Drug Administration for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

“CMS provides coverage for nearly half of the moderately to severely immunocompromised people at highest risk for severe COVID-19 whom we are targeting, and obtaining a Q code that secures PEMGARDA reimbursement for such a significant population marks another key milestone in our efforts to bring this important molecule to those individuals,” said Jeremy Gowler, Interim Chief Executive Officer at Invivyd. “While still in the very early days of the launch, we have already seen exciting initial interest in PEMGARDA from patients and prescribers, sold and shipped product, and engaged in constructive conversations with a range of commercial payors. Momentum is building, and I look forward to providing additional updates on our commercial progress in the months ahead.”