Washington, D.C.—The federal COVID-19 therapeutics program distributed about 16 million COVID-19 antiviral treatment courses through August 2022.

Efforts to ensure equitable access to antivirals have been hampered, however. One of the reasons is that pharmacy prescribing has not been widely implemented because of unresolved issues related to the reimbursement structure for Paxlovid.

"Equitable access to COVID-19 therapeutics is a critical aspect of the distribution program led by the U.S. Department of Health and Human Services (HHS)," according to a recent communication published in the Morbidity & Mortality Weekly Report.

The communication pointed out that two oral antiviral products—nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio)—received Emergency Use Authorizations (EUAs) from the FDA in December 2021 to reduce the risk for COVID-19-associated hospitalization and death for infected patients. The antivirals are intended for patients with mild-to-moderate COVID-19 who are at higher risk for severe illness.

The authors noted that the United States Department of Health and Human Services (HHS) has been distributing these medications at no cost to recipients since their authorization. "Data collected from provider sites during December 23, 2021-May 21, 2022, indicated substantial disparities in the population-adjusted dispensing rates in high social vulnerability (high-vulnerability) zip codes compared with those in medium- and low-vulnerability zip codes," the authors added. "Specifically, dispensing rates for the 4-week period during April 24-May 21, 2022, were 122 per 100,000 residents (19% of overall population-adjusted dispensing rates) in high-vulnerability zip codes compared with 247 (42%) in medium-vulnerability and 274 (39%) in low-vulnerability zip codes."

The new report updated the analysis of dispensing rates by zip code–level social vulnerability. The HHS authors pointed out that data on how many COVID-19 oral antiviral treatment courses are dispensed are collected twice a week from each provider site receiving medications. The HHS Health Partner Ordering Portal is used by oral antiviral provider partners, including those in all U.S. states and jurisdictions, the Federal Retail Pharmacy Therapeutics Program, and federal agencies to order oral antivirals at no cost and to report inventory and product use.

The latest analysis found that, in 2022:

• Overall, dispensing of oral antivirals increased 57% from 643 per 100,000 persons during April 24-May 21, to 1,012 during July 31-August 28
• Compared with data collected during April 24-May 21, dispensing during the most recent 4-week period (July 31-August 28) increased to 315 per 100,000 persons (31% of overall population-adjusted dispensing rates) in high-vulnerability zip codes, 367 (36%) in medium-vulnerability zip codes, and 331 (33%) in low-vulnerability zip codes
• That represented increases in dispensing rates of 159% in high-vulnerability areas, 48% in medium-vulnerability areas, and 21% in low-vulnerability areas.

"These data indicate a narrowing of the dispensing gap among high-vulnerability and medium-and low-vulnerability zip codes; at the same time, overall dispensing increased," the authors wrote.

"HHS worked closely with states and territories to improve equitable dispensing, with a focus on increasing education and awareness and enhancing distribution efforts, including COVID-19–focused teleprescribing programs, mobile test-to-treat sites, prepositioning of oral antivirals at provider sites in high-vulnerability zip codes, and increased distribution to federally qualified health centers," the report advised. "These efforts were designed to reduce barriers to access by making it easier to satisfy the requirements necessary to receive a clinical assessment to obtain a prescription and begin oral antiviral medication within 5 days of symptom onset."

Some of the efforts to improve distribution to areas with high need did not work as well, the authors wrote. "Although both oral antivirals continue to be prescribed primarily by physicians or advanced practice providers, on July 6, 2022, FDA updated the Paxlovid EUA to allow state-licensed pharmacists to prescribe it for an individual patient under certain conditions, including having sufficient data on the patient's medical history and use of other medications. However, pharmacy prescribing of Paxlovid has not yet been widely implemented because of these limitations on prescribing and unclear reimbursement structure for pharmacists to prescribe."

The American Pharmacists Association advises that while pharmacists now have the authority to prescribe Paxlovid for the treatment of mild-to-moderate COVID-19 disease under certain conditions, there is no current federal policy providing coverage for the associated clinical services required for pharmacist prescribing.

In a July 2022 letter to Medicare and Medicaid officials, the American Society of Health-System Pharmacists (ASHP) wrote, "However, absent a reimbursement mechanism for clinical assessment and counseling of patients seeking the medication, this service may prove financially infeasible for many pharmacies and pharmacists, particularly those working in rural and underserved areas."

The ASHP recommended that the Center for Medicare and Medicaid Services issue guidance confirming that pharmacists are eligible to use standard evaluation and management billing codes when prescribing Paxlovid and providing related care. It also asked the agency to use its emergency and demonstration project authorities to assure pharmacists' eligibility to be reimbursed for Paxlovid-related services under Medicare and other federal health programs.

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