HPOP Reporting Required
Reporting for all products, both administered (even if it is zero) and on-hand count, is required in HPOP. If a facility has inventory, reporting is required on Mondays and Thursdays.
When reporting, please enter:
- patient courses administered/dispensed and
- patient courses on-hand
Enter the courses administered/dispensed since last entry AND on hand. DO NOT enter cumulative totals that have already been reported.
If your site would like additional training on reporting, please contact HPOP-Therapeutics@hhs.gov.
Revised PAXLOVID Patients, Parents, and Caregivers Fact Sheet
Pfizer has become aware of reports of wrong-dose medication errors that have occurred with Paxlovid. These wrong-dose errors have occurred during prescribing, dispensing, and administration. Many of these errors have occurred during patient self-administration and generally involved patients incorrectly taking the wrong combination of nirmatrelvir tablets and ritonavir tablets from the blister card leading to wrong-dose medication errors.
Pfizer has revised the PAXLOVID Patients, Parents, and Caregivers Fact Sheet to address wrong dose medication errors that occur during patient self-administration. The revised Fact Sheet will show how the medication is labeled and inform the patient on how to correctly take Paxlovid. Each dispensed prescription for Paxlovid should include a Patients, Parents, and Caregivers Fact Sheet.
For more information, refer to the revised Fact Sheet for Patients, Parents, and Caregivers, the Fact Sheet for Healthcare Providers, and the DHCP Letter.
New: Paxlovid Shelf-Life Extension from 12 to 18 months
The FDA authorized extended expiration dates for the four lots of Paxlovid manufactured prior to the EUA issuance and labeled with a 9-month expiry. The expiration dates on these lots now reflect the 12-month product shelf-life (see Table), when stored according to the storage and handling conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization for Emergency Use Authorization (EUA) for Paxlovid.
Pfizer has also received approval for the expiry extension from 12 to 18 months. An HCP communication and updates to the ASPR and FDA websites are forthcoming and anticipated.
For more information, visit the FDA website.
Reminder: Shelf-Life Extensions
Several products have initial expiration dates approaching, but many COVID-19 therapeutics have received extensions. Please check with the manufacturer before removing any products from the proper storage conditions.
See links below for detailed expiry information:
Please find an addition listing of expiration extensions from the FDA here.
Maintain all monoclonal antibodies under proper refrigerated temperatures, even if they are not currently authorized for use. It is expected that will be authorized again in the future for use against new strains of SARS-COV2.
Eligibility for COVID-19 Outpatient Treatments
ASPR has published a new information sheet on Paxlovid Eligibility and Effectiveness. The information sheet summarizes current information about Paxlovid, offers resources about other COVID-19 therapeutics, and encourages the consideration of COVID-19 therapeutics for any SARS-CoV-2 patient who meets the eligibility criteria.
Who can receive the COVID-19 outpatient treatments?
There is strong scientific evidence that antiviral treatment of outpatients at risk for severe COVID-19 reduces their risk of hospitalization and death.
The antiviral drug Paxlovid (ritonavir-boosted nirmatrelvir), along with Veklury (remdesivir), are the preferred treatments for eligible adult and pediatric patients with positive results of SARS-CoV-2 testing and who are at risk for progression of severe COVID-19.
There is a sufficient supply of COVID-19 therapeutics. The oral antiviral medications, Paxlovid and Lagevrio, are allocated through DSHS (request in HPOP) and both Veklury and bebtelovimab are available for purchase.
Who is considered to have a risk factor for severe COVID-19?
Per the current CDC’s Interim Clinical Considerations for COVID-19 Treatment in Outpatient Guidelines, risk factors include:
Bebtelovimab Available for Purchase
Bebtelovimab will be available for purchase from the distributor AmerisourceBergen (ABC).
- The purchase cost per patient course of bebtelovimab will be $2,100.
- A commercial ABC account is required to purchase bebtelovimab. Contact asdaccountsetup@amerisourcebergen.com to set up an ABC account.
- For questions about purchasing bebtelovimab, contact c19therapies@amerisourcebergen.com.
- ABC will not take returns of purchased bebtelovimab for refunds.
- CMS reimbursement cost for the medication for Medicaid and Medicare patients is pending and will be posted here when it is available. See also CMS COVID-19 Monoclonal Antibodies.
- Reimbursement by private insurance companies will vary by plan
Existing USG Bebtelovimab
The United States Government (USG) requests that providers reserve the USG-purchased bebtelovimab for uninsured and underinsured patients that are not able to take or access Paxlovid or Veklury (remdesivir), the two recommended therapeutics.
Facilities must continue to report transfers, wastage, and administration and on-hand inventory of all USG-purchased bebtelovimab in HPOP on Mondays and Thursdays until this supply has been depleted.
Providers MAY NOT seek reimbursement for bebtelovimab that was distributed at no cost from the USG and should keep this stock separated from any product that is purchased. The batch numbers for bebtelovimab will be different for commercial bebtelovimab than the USG supply. Do not report commercially purchased bebtelovimab in HPOP.
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