WASHINGTON – Pharmacy groups praised the U.S. Food and Drug Administration on the revised 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 National Association of Chain Drug Stores (NACDS) president and CEO Steven 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.
The National Community Pharmacists Association also issued the following statement from CEO B. Douglas Hoey:
“Pharmacists are the drug therapy and drug interaction experts. This move opening up their ability to assess the need for and prescribe Paxlovid will improve patients’ timely access to treatments that will help keep them out of the hospital and alive.
“We’re grateful to the FDA for engaging with us on this issue and appreciate the agency’s course correction. But to further support a successful COVID-19 oral antiviral program, the Biden administration and payers also must ensure appropriate payment for the pharmacist assessing the patients, performing drug and disease interaction checks, and working with physician colleagues on proper prescribing.”
“APhA thanks FDA for recognizing the expertise of pharmacists as critical providers of care for important COVID-19 treatments,” added Ilisa BG Bernstein, APhA interim executive vice president and CEO. “Opening the door for pharmacists as prescribers will open the door to equitable access at pharmacies in communities across the country.”