Pharmacy organizations, including the National Association of Chain Drug Stores and the National Community Pharmacists Association, were quick to applaud the Food and Drug Administration’s revision late Wednesday of the emergency use authorization for Paxlovid (nirmatrelvir and ritonavir).
This revision authorizes state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. However, the groups also are urging the federal government to take steps to address reimbursement challenges to support pharmacists in prescribing antivirals.
“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 and CEO Steve Anderson. “The fact that there is a pharmacy within 5 miles of 90% 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 noted that it consistently had urged the 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 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-19 hospitalizations, ability to find care for COVID-19 symptoms, health equity, the convenience of receiving care for COVID-19 and correct use of COVID-19 antiviral medications.
However, NACDS said that it 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. The organization is encouraging lawmakers, the Centers for Medicare & Medicaid Service and commercial payers to immediately support coverage for the pharmacy-based assessments that inform the appropriate prescribing of this lifesaving therapy.
NACDS said that 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 critical legislation is available online.
After months of advocacy by organizations, NCPA also praised the FDA's decision while urging that action be taken to address reimbursement to pharmacists.
"Pharmacists are the drug therapy and drug interaction experts," said NCPA CEO Douglas Hoey. "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."
Hoey added, “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.”
“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research. “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.”
The American Medical Association also reacted swiftly to the FDA's decision. A statement from AMA president Jack Resneck said: “Paxlovid is an important treatment and critical tool in the fight against COVID-19. While the majority of COVID-19 positive patients will benefit from Paxlovid, it is not for everyone and prescribing it requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving — requirements far beyond a pharmacist’s scope and training."
Resneck added, “In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams — teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one.”
The FDA said that when testing positive for COVID-19, patients should first consider seeking care from their regular healthcare provider or locating a Test-to-Treat site in their area. While this action allows state-licensed pharmacists to prescribe Paxlovid with certain limitations, community pharmacies not already participating as a Test-to-Treat site can decide if or how they will offer this service to patients, the FDA noted.
Patients who have tested positive for COVID-19 and are seeking to determine their eligibility for receiving Paxlovid at locations where prescribing by state-licensed pharmacists is available should bring the following information to ensure that the state-licensed pharmacist has sufficient information to determine their eligibility to receive Paxlovid:
- Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient’s healthcare provider; and
- A list of all medications patients are taking, including over-the-counter medications so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.
[Read more: Rite Aid offers COVID-19 oral antiviral medications]
Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (aged 12 years old and older weighing at least 40 k or about 88 lbs.), with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death.
Patients in the authorized population who report a positive home test result from a rapid antigen diagnostic test or a positive PCR test to their provider are eligible for Paxlovid under the EUA. Confirmation of a positive home rapid antigen diagnostic test with additional direct SARS-CoV-2 viral testing, such as a PCR, is not required. Antibody tests are not considered to be a direct SARS-CoV-2 viral test.