NACDS today welcomed the announcement by the U.S. Food and Drug Administration (FDA) that it revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), “to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.”
“The FDA’s action is an extremely important revision for patient access and for equity in the use of COVID-19 antivirals,” said NACDS President & CEO Steven C. Anderson. “The fact that there is a pharmacy within five miles of 90 percent of Americans led to remarkable effectiveness on behalf of the American people in the COVID-19 vaccination effort. This action on COVID-19 antivirals is a crucial step forward, and one for which NACDS has advocated in the best interest of patients throughout the nation. Now, to make better access for the public a reality, we encourage the federal government to take the necessary next steps to support pharmacy-based assessments that guide the use of this lifesaving therapy.”
NACDS consistently has urged FDA to support pharmacist prescribing of COVID-19 antivirals to improve access and foster equity, in alignment with authorizations granted to pharmacists by the Department of Health and Human Services through the Public Readiness and Emergency Preparedness (PREP) Act in September of last year. A recent poll conducted by Morning Consult and commissioned by NACDS found that a majority of American adults said that pharmacists’ prescribing of antivirals would have a mostly positive impact on each of the following: COVID hospitalizations, ability to find care for COVID symptoms, health equity, convenience of receiving care for COVID, and correct use of COVID antiviral medications.
However, NACDS is asking that outstanding reimbursement challenges be immediately addressed to help effectively support pharmacist prescribing of COVID-19 antivirals to enhance public access and foster equity. NACDS is encouraging lawmakers, the Centers for Medicare & Medicaid Services, and commercial payers, to immediately support coverage for the pharmacy-based assessments that inform the appropriate prescribing of this lifesaving therapy.
In the longer term, the Equitable Community Access to Pharmacist Services Act (H.R. 7213), would provide coverage under Medicare Part B for pharmacist services including treatment for certain conditions, such as COVID-19. More information on this important legislation is available at pharmacycare.org
Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research, noted the importance of pharmacists for enhancing timely access to this treatment for COVID-19. Dr. Cavazzoni stated: “The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic. Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.”
More information is available at NACDS.org/COVID-19.
