Invivyd Receives Healthcare Common Procedure Coding System (HCPCS) Reimbursement Codes from the U.S. Centers for Medicare & Medicaid Services (CMS) Covering PEMGARDA™
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Insights
With CMS assigning HCPCS codes for Invivyd's PEMGARDA, this represents a pivotal juncture for both the company and the healthcare system at large. The Q0224 and M0224 codes grant vital reimbursement pathways, important for Invivyd's product's market penetration. Given Medicare and Medicaid's extensive coverage, reaching approximately 50% of the target population, the financial implications are substantial.
The challenge, however, lies in the intricate dynamics of biopharmaceutical reimbursements. The codes must be widely recognized by other insurers to ensure comprehensive access. Thus, while Invivyd may anticipate a surge in demand, actual sales will also depend on the broader insurance landscape's alignment with CMS's adoption of the HCPCS codes.
Moreover, the retroactive effective date to the EUA presents an operational hurdle. Invivyd must swiftly adapt its billing operations to process claims from March 22, 2024, onwards. This period will be critical for Invivyd's near-term revenue recognition and cash flows.
From a market perspective, the HCPCS coding for PEMGARDA can be seen as a bellwether for both Invivyd's stock performance and its competitive positioning. As a drug aimed at a specific, high-risk demographic, the company’s foray into this niche market is now backed by a stronger assurance of return on investment, due to the CMS reimbursement codes.
However, uptake is not solely dependent on reimbursement; it is also a function of the drug's perceived value versus alternative treatments and prophylaxes. The 'initial interest' as reported by the CEO indicates a favorable market reception, but the true determinant of success will be long-term utilization and outcomes data.
In assessing the stock market reaction, investors will closely scrutinize prescription trends and payer adoption beyond Medicare and Medicaid. Any indication of hesitation from private insurers might temper market enthusiasm despite the positive CMS decision.
The issuance of HCPCS codes by CMS is a strategic lever that can shift the cost-effectiveness trajectory for PEMGARDA. By securing reimbursement, Invivyd improves the treatment's accessibility, potentially improving health outcomes for the immunocompromised cohort it serves.
Yet, the economic impact of PEMGARDA extends beyond immediate revenue. It's poised to possibly reduce the burden of COVID-19 among vulnerable populations, potentially translating into lower overall healthcare costs associated with severe cases. This preventative approach aligns with broader public health objectives, presenting a dual benefit scenario: mitigating the societal costs of untreated COVID-19 and driving revenue for Invivyd.
Longer-term, the sustainable incorporation of PEMGARDA into treatment guidelines will depend on ongoing studies and data on effectiveness and cost-benefit analyses. These will inform future policy decisions and insurer behaviors, which are as critical as the CMS codes themselves.
- 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.”
PEMGARDA is available by prescription through a network of authorized specialty distributors. Healthcare professionals seeking to obtain PEMGARDA for their patients should contact their primary vendor for ordering information or contact Invivyd at 1-800-890-3385 for more information. For additional information about PEMGARDA, please see the full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.
About PEMGARDA
PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in a global Phase 2/3 clinical trial for the prevention of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity in pseudotyped virus-like particle and authentic virus neutralization assays against major SARS-CoV-2 variants, including JN.1, the dominant variant in the U.S. currently according to estimates from the Centers for Disease Control and Prevention. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA 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. PEMGARDA is not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19. Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse events (all grades, incidence ≥
To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Additionally, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a commercial-stage company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. The company’s proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to keep pace with evolving viral threats. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first mAb in a planned series of innovative antibody candidates. Visit https://invivyd.com/ to learn more.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kg) with moderate-to-severe immune compromise; the company’s plans and expectations related to the commercialization of PEMGARDA; the company’s ongoing research and clinical development efforts; the company’s mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2; the design of the company’s INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to keep pace with evolving viral threats; the company’s expectation that PEMGARDA is the first mAb in a planned series of innovative antibody candidates; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether the EUA is revoked or revised by the FDA; the company’s ability to build and maintain sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; changes in expected or existing competition; the timing and progress of the company’s discovery, preclinical and clinical development activities; the uncertainties and timing of the regulatory authorization or approval process, and available development and regulatory pathways for authorization or approval of the company’s product candidates; changes in the regulatory environment; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of PEMGARDA or any other product candidate following regulatory authorization or approval; the predictability of clinical success of the company’s product candidates based on neutralizing activity in preclinical studies; the risk that results of preclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; the company’s reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical trials; variability of results in models used to predict activity against SARS-CoV-2 variants; whether PEMGARDA or any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the complexities of manufacturing mAb therapies; the company’s dependence on third parties to manufacture, label, package, store and distribute clinical and commercial supplies of its product candidates; whether the company is able to provide sufficient commercial supply of PEMGARDA to meet market demand; whether the company can obtain and maintain third-party coverage and adequate reimbursement for PEMGARDA or any other product candidate; the company’s ability to leverage its INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to keep pace with evolving viral threats; any litigation and other proceedings or government investigations relating to the company; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
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Contacts:
Media Relations
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FAQ
What are the HCPCS reimbursement codes received by Invivyd (IVVD) from CMS for PEMGARDA?
What percentage of the target population is represented by Medicare/Medicaid for reimbursement of PEMGARDA?
What is the purpose of the Q code (Q0224) and M code (M0224) granted by CMS for PEMGARDA?
What is the emergency use authorization (EUA) date for PEMGARDA?
How can healthcare professionals obtain PEMGARDA for their patients?
