Dispensing of Oral Antiviral Drugs for Treatment of COVID-19 by Zip Code–Level Social Vulnerability — United States, December 23, 2021–May 21, 2022

United States, December 23, 2021-May 21, 2022

Jeremy A.W. Gold, MD; James Kelleher; Jake Magid, MEng; Brendan R. Jackson, MD; Meghan E. Pennini, PhD; Diana Kushner, MPH; Emily J. Weston, MPH; Bobby Rasulnia, PhD; Sachiko Kuwabara, PhD; Kelly Bennett, MPH; Barbara E. Mahon, MD; Anita Patel, PharmD; John Auerbach, MBA

Disclosures

Morbidity and Mortality Weekly Report. 2022;71(25):825-829. 

In This Article

Abstract and Introduction

Introduction

The COVID-19 pandemic has highlighted and exacerbated long-standing inequities in the social determinants of health.[1–3] Ensuring equitable access to effective COVID-19 therapies is essential to reducing health disparities. Molnupiravir (Lagevrio) and nirmatrelvir/ritonavir (Paxlovid) are oral antiviral agents effective at preventing hospitalization and death in patients with mild to moderate COVID-19 who are at high risk* for progression to severe COVID-19 when initiated within 5 days of symptom onset. These medications received Emergency Use Authorization from the Food and Drug Administration (FDA) in December 2021 and were made available at no cost to recipients through the U.S. Department of Health and Human Services (HHS) on December 23, 2021. Beginning March 7, 2022, a series of strategies was implemented to expand COVID-19 oral antiviral access, including the launch of the Test to Treat initiative.§ Data from December 23, 2021–May 21, 2022, were analyzed to describe oral antiviral prescription dispensing overall and by week, stratified by zip code social vulnerability. Zip codes represented areas classified as low, medium, or high social vulnerability; approximately 20% of U.S. residents live in low-, 31% in medium-, and 49% in high-social vulnerability zip codes. During December 23, 2021–May 21, 2022, a total of 1,076,762 oral antiviral prescriptions were dispensed (Lagevrio = 248,838; Paxlovid = 827,924). Most (70.3%) oral antivirals were dispensed during March 7–May 21, 2022. During March 6, 2022–May 21, 2022, the number of oral antivirals dispensed per 100,000 population increased from 3.3 to 77.4 in low-, from 4.5 to 70.0 in medium-, and from 7.8 to 35.7 in high-vulnerability zip codes. The number of oral antivirals dispensed rose substantially during the overall study period, coincident with the onset of initiatives to increase access. However, by the end of the study period, dispensing rates in high-vulnerability zip codes were approximately one half the rates in medium- and low-vulnerability zip codes. Additional public health, regulatory, and policy efforts might help decrease barriers to oral antiviral access, particularly in communities with high social vulnerability.

Nationwide oral antiviral dispensing data are reported to HHS daily through the HHS Health Partner Ordering Portal (HPOP)**; 85%–95% of oral antiviral sites report dispensing data to HHS. Information regarding the location of oral antiviral prescription dispensing and the number of active sites dispensing oral antivirals is geocoded to the zip code level. An active site dispensing oral antivirals was defined as any provider that had ordered oral antiviral courses during the previous 60 days or that reported inventory during the previous 14 days. For this analysis, zip codes were ranked according to the Equitable Distribution Index scale, a proxy for social vulnerability. Based on Equitable Distribution Index score, zip codes were classified as having low (0–0.33), medium (>0.33–0.66), or high (>0.66–1.00) social vulnerability.

Total numbers of Lagevrio and Paxlovid prescriptions dispensed and the number of dispensing sites during December 23, 2021–May 21, 2022, were tabulated and examined by week and zip code–level social vulnerability. Social vulnerability–stratified rates of oral antiviral prescription dispensing (prescriptions dispensed per 100,000 population) were calculated; the population denominators used for rate calculations were obtained from 2018 CDC and Agency for Toxic Substances and Disease Registry social vulnerability index (SVI) data.[4] This activity was reviewed by HHS and CDC and was conducted consistent with applicable federal law and CDC policy.††

During December 23, 2021–May 21, 2022, a total of 1,076,762 oral antiviral prescriptions (248,838 Lagevrio; 827,924 Paxlovid) were dispensed (Figure 1); overall, 70.3% (756,858) were dispensed during March 7–May 21, 2022. The weekly number of oral antiviral prescriptions dispensed initially peaked at 56,073 (30,636 Lagevrio; 25,437 Paxlovid) during the week ending February 12, 2022; declined to 14,925 (3,821 Lagevrio; 11,104 Paxlovid) during the week ending March 26, 2022; and increased to 179,728 (19,162 Lagevrio; 160,566 Paxlovid) during the week ending May 21, 2022. The number of dispensing sites increased from 49 during the week ending December 25, 2021, to 39,687 during the week ending May 21, 2022 (Figure 2).

Figure 1.

Weekly number of courses of oral COVID-19 antiviral therapy (Lagevrio* and Paxlovid) dispensed — United States, December 23, 2021–May 21, 2022
*Molnupiravir.
Nirmatrelvir/ritonavir.

Figure 2.

Number of active provider sites for oral antiviral therapy against COVID-19, by week and zip code social vulnerability score* — United States, December 23, 2021–May 21, 2022
*Zip codes were classified as having low, medium, or high social vulnerability based on ranking within the lower, middle, and upper tertiles of the Equitable Distribution Index score.

As of May 21, 2022, the largest number of dispensing sites was located in high-vulnerability zip codes (18,844; 47.5%), approximately one third (13,072; 32.9%) were in medium-vulnerability zip codes, and approximately one fifth (7,771; 19.6%) were in low-vulnerability zip codes. Overall, during December 23, 2021–May 21, 2022, the highest rates of oral antiviral prescriptions dispensed were in low-vulnerability zip codes (373.3 per 100,000), followed by medium- (359.5) and high- (287.4) vulnerability zip codes. During December 23, 2021–March 5, 2022, the rates of oral antiviral courses dispensed ranged from 0.2 to 27.0 per 100,000 in high-, 0.2 to 13.4 in medium-, and 0.1 to 8.6 in low-vulnerability zip codes (Figure 3). During March 6, 2022–May 21, 2022, the rates of oral antivirals dispensed increased from 3.3 to 77.4 per 100,000 and from 4.5 to 70.0 in low- and medium-vulnerability zip codes, respectively; rates in high-vulnerability zip codes increased from 7.8 to 35.7, reaching approximately one half the rate in low- and medium-vulnerability zip codes. At the end of the study period, (May 21, 2022), COVID-19 continued to cause an average of 291 deaths and 3,833 new hospitalizations per day.§§

Figure 3.

Courses of oral COVID-19 antiviral therapy dispensed per 100,000 persons, by week and zip code social vulnerability level — United States, December 26, 2021–May 21, 2022*
*The week ending December 25, 2021, is not shown because no oral antiviral dispensing was reported during that week. Zip codes were classified as having low, medium, or high social vulnerability based on ranking within the lower, middle, and upper tertiles of the Equitable Distribution Index score.

*Groups at high risk include persons aged ≥65 years and those with certain medical conditions. https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
Lagevrio and Paxlovid are oral antiviral therapies indicated for the treatment of patients with mild to moderate COVID-19 who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progression to severe COVID-19. Lagevrio is indicated for the treatment of adults aged ≥18 years for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically indicated. Paxlovid is indicated for persons aged ≥12 years who weigh at least 88 lbs (40 kg). https://www.fda.gov/media/155050/download; https://www.fda.gov/media/155054/download
§Strategies implemented included the Test to Treat initiative, increased communication to providers and patients, and direct distribution to Federal Retail Pharmacy Therapeutic Partners, enabling expansion of the number of dispensing sites. A program of HHS, Test to Treat is a federal initiative designed to provide rapid access to lifesaving COVID-19 treatments at no cost to recipients. https://aspr.hhs.gov/TestToTreat/Pages/default.aspx The launch of this program garnered media attention and heightened the visibility of oral antivirals to health care providers and the public. At Test to Treat sites, patients can receive COVID-19 testing, obtain assessment by a qualified health care provider who can prescribe antivirals, and receive oral antiviral treatment. Providing these services at a single location ensures rapid and convenient access to treatment. Test to Treat program sites accounted for 6% of all oral antiviral dispensing sites and dispensed 17% of all prescriptions.
Zip code–level social vulnerability was classified according to the equitable distribution index (EDI) score. EDI is used by the federal COVID-19 response because zip code–level data offer a more detailed characterization of population vulnerability than do county level–data, while providing sufficient geographic granularity to accomplish operational goals not achievable using U.S. Census Bureau tract–level data. Similar to the CDC SVI (https://www.atsdr.cdc.gov/placeandhealth/svi/index.html), which produces county-level and U.S. Census Bureau tract–level estimates of social vulnerability, EDI uses 15 indicators categorized into four themes: 1) socioeconomic status, 2) household composition and disability, 3) racial and ethnic minority status and language, and 4) housing type and transportation. EDI includes all 15 indicators as a composite measure, and a final score is ranked from lowest (0) to highest (1) vulnerability. A percent rank function is used, such that an equal number of geographic components are in each percentile of the index. To map U.S. Census Bureau tracts to zip codes, EDI uses a crosswalk file published by the U.S. Department of Housing and Urban Development. https://www.huduser.gov/portal/datasets/usps_crosswalk.html EDI is not generated for zip codes where any of the 15 components are suppressed within the American Community Survey (this represents <1% of all zip codes mapped to U.S. Census Bureau tract data).
**HPOP is used by oral antiviral partners to order oral antivirals cost-free to recipients and to report inventory and product use. HPOP oral antiviral partners include all U.S. states and other jurisdictions, Federal Retail Pharmacy Therapeutics Partners, and federal entities (e.g., Indian Health Service, Bureau of Prisons, and U.S. Department of State). https://aspr.hhs.gov/COVID-19/Therapeutics/Distribution/Pages/process-for-ordering.aspx
††45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect. 552a; 44 U.S.C. Sect. 3501 et seq.
§§The number of COVID-19 deaths and new COVID-19 hospitalizations presented are the 7-day moving averages on May 21, 2022. https://covid.cdc.gov/covid-data-tracker/#datatracker-home (Accessed June 2, 2022).

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