Photo: Jeff Lagasse/Healthcare Finance News
The U.S. Food and Drug Administration on Wednesday revised the Emergency Use Authorization for Pfizer’s antiviral COVID-19 treatment Paxlovid, allowing pharmacists to prescribe the treatment, with limitations.
Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years old and older who are at high risk for progression to severe COVID-19, including hospitalization or death.
According to the FDA, Paxlovid must be taken within five days of symptom onset in order for it to be effective. Because of that small window, the agency said authorizing state-licensed pharmacists to prescribe the drug could expand access to more people in the eligible population.
Patients who report a positive home test result from a rapid antigen diagnostic test or PCR test to their provider are eligible for Paxlovid under the EUA.
Under the limitations outlined in the authorization, a state-licensed pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs if certain criteria apply.
Among the criteria: not enough information available to assess renal and hepatic function; not enough information to assess for a potential drug interaction; or the need to modify other medications due to a potential drug interaction.
Patients looking to determine their eligibility for receiving Paxlovid prescriptions from state-licensed pharmacists are encouraged to bring 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. They should also bring a list of all medications they’re taking, including over-the-counter medications.
WHAT’S THE IMPACT: REACTION
Medications such as Paxlovid have been developed to not only mitigate COVID-19 among patients, but to ease the burden on healthcare systems and facilities that have buckled under the weight of rising case counts at times during the pandemic.
While data still shows it can reduce the risk of severe disease, Paxlovid’s goal of halting virus transmission altogether has failed, meaning hospitals won’t be able to count on it putting the brakes on an illness that has sent volumes soaring and eroded profit margins and worker morale.
The FDA’s decision received pushback from American Medical Association President Dr. Jack Resneck, who said via statement that while Paxlovid can be beneficial, “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.”
“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,” said Resneck. “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 LARGER TREND
The FDA originally issued an EUA for Paxlovid just before Christmas 2021. Importantly, the drug is not authorized for the prevention of COVID-19, or for treating those already requiring hospitalization due to severe or critical COVID-19. It’s also not a substitute for vaccination in those for whom the shot and a booster dose are recommended.
The Biden White House in November secured 10 million treatment courses of Paxlovid at a cost of about $5 billion, contingent on EUA or approval from the FDA.
Yet, in May, Pfizer’s own internal data showed Paxlovid proved ineffective at preventing coronavirus infection among people living in the same house as an infected person. While there were risk reductions of 32% and 37% in adults who had received Paxlovid for five and 10 days, respectively, the results were not statistically significant. It’s a disappointing finding for a drug that initially sought to prevent infection from a household contact.
While the finding is not what Pfizer had hoped, the company said the results don’t impact the strong efficacy and safety data observed in an earlier trial that tested the drug’s effect in preventing severe illness, and pointed out that use of Paxlovid is on the rise globally.