NEW: Walgreens Expands Home Delivery to include Lagevrio
On Dec. 27, 2022, Walgreens expanded the oral antiviral free prescription delivery service to include Lagevrio which delivers COVID-19 medications directly to the doorsteps of Americans. Previously, this program was only for Paxlovid.
Patients with a prescription for Lagevrio or Paxlovid that is filled at Walgreens in a socially vulnerable community, based on the Centers for Disease Control and Prevention (CDC) Social Vulnerability Index, will be able to have their Lagevrio or Paxlovid prescription delivered to their home at no cost via Walgreens.com and the Walgreens app.
NEW: Legislative Provision to Allow Part D payment of EUA oral antivirals if commercialized while under EUA
H.R. 2617 enacted to include EUA oral antivirals as covered Part D drugs. HR2617 Bill has the following impact:
- NO CHANGE to the current payment structure
- Allows coverage of COVID-19 oral antivirals (Paxlovid, Lagevrio) by Medicare Part D plans if a product is commercialized while under EUA (prior to change, a product available only under EUA would not have met statutory definition of a covered Part D drug)
- COVID-19 oral antivirals continue to be provided by HHS free of charge; no payment can be sought for USG procured medications
- CMS is already able to cover fully approved oral antivirals under Part D
- There remains ample supply of USG procured product to facilitate continued distribution of free product
NEW: FDA Labeling Supplement for Veklury
On December 16th, FDA approved a labeling supplement modifying the indication for Veklury as shown below; a positive result of a COVID test is no longer required.
VEKLURY is a severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) nucleotide analog RNA polymerase inhibitor indicated for the treatment of coronavirus disease 2019 (COVID 19) in adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS CoV 2 viral testing, who are:
- Hospitalized, or
- Not hospitalized and have mild to moderate COVID 19 and are at high risk for progression to severe COVID 19, including hospitalization or death
How to order Velkury:
Hospitals can place orders with any of the following distributors by calling directly:
- AmerisourceBergen Specialty Distribution: 800-746-6273
- Cardinal Specialty: 855-855-0708
- McKesson Plasma and Specialty: 877-625-2566
Non-hospitals can contact these two distributors:
Eligible non-hospitals include:
- Infusion centers
- Long term care
- Skilled nursing facilities
- Dialysis care
- Clinics
- Acute/urgent care
- Retail and Specialty pharmacies that serve Long-term care or skilled nursing facilities
New and Updated Resources: Lagevrio Information Sheet, Digital Toolkit, and CDC Webpages
ASPR has added a new Lagevrio Information Sheet and updated their Digital Toolkit with Test to Treat social media content.
CDC has also updated the Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19 for Healthcare Professionals. This update highlights Age being the strongest risk factor for severe COVID-19 outcomes.
Reminder: Evusheld and Omicron Variants
The Evusheld Fact Sheet has been updated to reflect in-vitro neutralizing data for several Omicron subvariants.
- Over 90% of circulating variants are projected to be resistant to Evusheld.
- Breakthrough infections are possible. Advise patients to have a treatment plan in place and to seek timely medical attention if symptoms occur
- This is important messaging to both patients that received Evusheld previously and patients getting first dose
NIH Guidelines update (Dec 1) notes the prevalence of Omicron subvariants that are resistant to Evusheld is rapidly increasing. However, Evusheld is the only agent FDA authorized for SARS-CoV-2 PrEP in people who are not expected to mount an adequate immune response to COVID-19 vaccination or those with contraindications for COVID-19 vaccines. Therefore, the Panel continues to recommend the use of tixagevimab plus cilgavimab as PrEP for eligible individuals. This recommendation may change if the prevalence of resistant subvariants increases.
Refer to FDA releases important information about risk of COVID-19 due to certain variants not neutralized by EVUSHELD
Reminder: Shelf-Life Extensions
NIH has implemented a new initiative called Make My Test Count that helps public health teams determine how fast the SARS CoV 2 virus is spreading or where surges are happening.
Individuals can easily and quickly notify NIH of their COVID 19 test results in one click. The data from Make My Test Count can help public health teams monitor the COVID 19 environment while keeping your personal test results private and anonymous.
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