Clarissa Chan, PharmD
As pandemic uncertainty dissipates, COVID-19 therapeutics are transitioning from U.S. government–procured sources to the commercial market. Health care providers—and especially patients—will encounter changes in distribution, access, and affordability for COVID-19 medications such as Paxlovid and Lagevrio.
What problems may arise with the transition of COVID-19 therapeutics to the commercial market?
Transitioning to payment through a typical insurance model has its challenges for both pharmacists and patients.
“For pharmacists, [medications] may require prior authorization, such as confirmation of a positive COVID-19 test [result], which may be the same as now,” said Robert Popovian, founder of Conquest Advisors and chief science policy officer at Global Healthy Living Foundation. He said he thinks it’s unlikely PBMs will make it difficult either, considering it’s an infectious disease with significant mortality and morbidity consequences.
With the impacts on distribution, Popovian said patients may face an out-of-pocket cost requirement based on their benefit design.
How can pharmacists inform patients and other health care providers of the changes?
“Pharmacists can guide patients to use the enhanced COVID-19 medications locator created by HHS (www.treatments.hhs.gov) to find COVID-19 test-to-treat locations and locations that are participating in patient assistance programs,” said Morgan Howard, PharmD, senior manager of practice implementation at APhA.
There may be locations that offer outpatient COVID-19 medications and are not listed on this website. The locations displayed on this locator have reported availability of Paxlovid, Lagevrio, or Veklury within the last 60 days, she said.
Where should pharmacists look for the most recently updated information on commercial distribution?
Pharmacists should refer to reliable sources, such as official government health agencies, pharmaceutical companies, and professional organizations, for the most updated information on commercial distribution of Paxlovid and Lagevrio, said Howard.
“These sources can provide guidance on distribution timelines, allocation strategies, and availability in different regions,” said Howard. “The Administration for Strategic Preparedness & Response (ASPR) has created guides intended to provide direction as the U.S. government prepares to wind down the current distribution of government–procured COVID-19 therapeutics and transitions the COVID-19 oral antiviral treatments to the commercial market.”
Associations such as APhA and the National Alliance of State Pharmacy Associations have been directly engaged with ASPR in finding solutions by disseminating resources that provide guidance on distribution timelines, allocation strategies, and availability in different regions, Howard said.
Will Paxlovid and Lagevrio be affordable for patients?
Efforts are underway to ensure that Paxlovid and Lagevrio remain affordable for patients, particularly those facing financial barriers to accessing treatment.
This may include reimbursement programs for those who are uninsured or insured by Medicare and Medicaid, and patient assistance programs aimed at reducing out-of-pocket costs and improving affordability. These programs include Pfizer’s PAXCESS program and Merck Programs to Help Those in Need (merckhelps.com), said Howard.
How is FDA monitoring the safety and efficacy of Paxlovid and Lagevrio?
As part of the emergency use authorizations for Paxlovid and Lagevrio, FDA requires that both health care providers who prescribe the product and sponsors for each product report to FDA all serious adverse events and medication errors considered to be potentially related to the product.
Once FDA approves a product, health care providers are encouraged to report adverse events to either the drug company or FDA via the MedWatch program, said Charles Kohler, an FDA spokesperson.
FDA’s principal repository for drug safety information is the FDA Adverse Event Reporting System (FAERS) database, which contains adverse event reports, medication error reports, and product quality complaints resulting in adverse events that were submitted to FDA.
The database is designed to support FDA’s postmarketing safety surveillance program for drug and therapeutic biological products. It has also been used to conduct surveillance for all COVID-19 emergency use authorization products, Kohler said.
If a potential safety concern is identified, further evaluation using other data sources can be performed and may result in regulatory action such as updating a product’s labeling information, restricting the use of a drug, communicating new safety information to the public, or in rare cases removing the drug from market, according to Kohler. ■
Review the latest information on the sunsetting of the U.S. government’s COVID-19 Therapeutics Distribution Program: https://aspr.hhs.gov/COVID-19/Therapeutics/Pages/COVID19-Tx-Transition-Guide.aspx ■