Recent Updates on Paxlovid’s Transition to Market & Why Access Matters

13 May, 2024

The Issue of Low Uptake of Proven Antivirals

The anti-COVID antiviral combination ritonavir-boosted nirmatrelvir (Paxlovid) has had low uptake in the United States (Hunter, February 2024). This is despite generating early global enthusiasm based on its ability to lower the risk of severe disease or death by 51% to 89% (Shah, November 2022; Hammond, February 2022). Even in settings like long-term care or skilled nursing facilities, which had a rate of COVID-19–related hospitalizations higher than any other population, only 18% of cases of COVID-19 in residents received treatment with an oral antiviral or monoclonal antibody (McGarry, August 2023). Bizarre patterns of clinical use have been observed in Medicare claims data, wherein the highest risk individuals receive the fewest prescriptions. By contrast, skilled nursing facilities with patients that are predominantly White, better staffed and with higher star ratings received access to more COVID-19 prescription treatments each year (Wilcock, January 2024).

The top reasons cited for Paxlovid underuse by Medicare patients are perceived or real cost barriers, poor reimbursement from commercial insurers that makes community pharmacies hesitant to stock medications, and concerns from patients and providers about drug-drug interactions and viral rebound phenomenon. However, just as most deaths from COVID-19 are preventable, most barriers to antiviral use can be circumvented to save lives. Importantly, the efficacy of antivirals against COVID-19 has not substantially waned over time (unlike the efficacy of monoclonal antibodies), despite ongoing and dramatic viral variant evolution. This is notable because it is not true of many antivirals in other disease contexts (von Delft, May 2023).

The Commercialization of Paxlovid: What’s Special About March 8, 2024?

On May 25, 2023, the U.S. Food & Drug Administration approved a new drug application for Paxlovid for the treatment of mild-to-moderate symptomatic COVID-19 (FDA, March 2024). This was followed by a transition period in which both EUA-labeled Paxlovid and NDA-labeled Paxlovid were in circulation and could be used.

In late January of 2024, FDA revised the December 2021 EUA letter for Paxlovid (FDA, March 2024). The revisions stated that any Paxlovid manufactured and labeled according to the EUA would still be authorized for use through the expiration date or through March 8, 2024, whichever came earlier. After that date, EUA-labeled Paxlovid was not authorized for use, and all patients prescribed Paxlovid would receive the NDA-labeled drug. While the EUA initially continued to authorize use of Paxlovid in children ages 12 to <18 years of age with COVID-19 and risk factors for progressive disease, these pediatric patients now receive NDA-labeled Paxlovid.

This commercialization of Paxlovid may increase public perception of barriers to its use and provides additional reasoning to revisit tools to reduce barriers to access.

Cost Considerations & Access to Paxlovid in the Post-Licensing Period

The Institute for Clinical and Economic Review has provided an analysis of value-based pricing of Paxlovid. Based on evolving viral epidemiology, increasing vaccination rates and relative effectiveness of various treatments, it estimated that Paxlovid will be cost effective at a “reasonable threshold” if each treatment course is priced at between $563 and $906. This is lower than the initial benchmark that was set for health benefit/cost effectiveness because of both lower hospitalization risk for people infected with currently dominant variants and lower relative risk reduction of hospitalization from Paxlovid treatment (ICER, December 2022). The price that HHS paid throughout the pandemic for a single 5-day course of Paxlovid was $530 (Mole, October 2023). As of February 2024, Paxlovid is priced at $1,390 for a 5-day course (Mole, October 2023).

Efforts have been made in both public and private sectors to lessen disparities in Paxlovid access and increase low-cost access. Pfizer, the manufacturer of the drug, issued a press release on Oct. 13, 2023, announcing a revised supply agreement with HHS. The new agreement stated that HHS would return 8 million EUA-labeled treatment courses of Paxlovid in exchange for guaranteed access to the same number of future NDA-labeled courses of Paxlovid.

Other facets of the October 2023 agreement between HHS and Pfizer were designed to increase overall patient access to Paxlovid, including Pfizer allowing people on Medicaid or Medicare to access free Paxlovid treatment via a patient assistance program through the end of 2024. The company also agreed to supply free Paxlovid to uninsured or underinsured patients through the end of 2028, replacing any expired product with fresh batches. Lastly, they agreed to give the U.S. government 1 million treatment courses to add to the Strategic National Stockpile. In return, HHS agreed to “ensure a smooth and predictable transition to the commercial market over the next few months.”

The Real Bottom Line

Paxlovid is effective and accessible for most patients, and there are strong equity arguments for providers to close gaps in antiviral access and uptake. Most importantly, with the steady death toll from COVID-19 still mounting, and tens of thousands of vulnerable individuals continually hospitalized from COVID-19 each week, there is still ample reason to reach for the tools that we have to save more lives. Use the chart below to find more information on accessing free or low-cost COVID-19 antivirals.

Infographic: High-Yield Paxlovid Resources

PDF with information on:

  • Access to COVID-19 antivirals;
  • Treatment guidelines;
  • Drug-drug interactions; and
  • Links to other public health resources.
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