Information for providers about therapeutic treatments for COVID-19

Overview

In early 2022, when demand for COVID therapeutics was very high and supply was very limited, the federal government partnered with states to ensure an equitable distribution to providers serving those most at risk for severe disease. Providers in Connecticut were enrolled in the Health Partner Ordering Portal (HPOP). 

The federal government has also partnered with national and independent pharmacy networks. Pharmacies enrolled in the Federal Retail Pharmacy Therapeutics Program (FRPTP) program receive a distribution directly from the federal government. Information and a list of FRPTP partners can be found at this link: FRPTP Fact Sheet | HHS/ASPR

As the supply of COVID Therapeutics is no longer constrained, many of the Connecticut Health Partner Ordering Portal (HPOP) enrolled providers have transitioned back to their commercial distributors. A limited number of HPOP enrolled providers are supported through DPH’s weekly allocation and can place orders that are reviewed and approved on a weekly basis. Utilization and quantity on hand must be entered in HPOP every Monday and Thursday. For any questions, providers should email DPH at COVIDmeds.DPH@ct.gov.

News, Updates, and Resources for Health Care Professionals

At this time, Paxlovid (nirmatrelvir co-packaged with ritonavir) and Veklury (remdesivir) for adults (ages 18 and older) are approved therapeutics. Paxlovid for pediatric patients (ages 12-17) and Lagevrio are available under a U.S. Food and Drug Administration’s Emergency Use Authorization.

 

HHS/ASPR purchased supplies of COVID-19 therapeutic products for outpatient use. As these products transition to commercial market, HHS is working with state health departments as well as national health care and medical organizations and associations to maximize access to COVID-19 treatments.

On November 1, 2023, Lagevrio and Paxlovid became commercially available. To learn more about continuing HHS distribution timelines of HHS-procured inventory, please see Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program.

COVID-19 Therapeutics | HHS/ASPR

Follow this link to a list of Frequently Asked Questions on the COVID-19 Therapeutic Transition to Commercial Distribution: COVID-19 Therapeutics Transition to Commercial Distribution: Frequently Asked Questions | HHS/ASPR

Current Treatments

The Food and Drug Administration (FDA) has approved or issued emergency use authorizations (EUA) for therapeutics for treatment of early mild-to-moderate COVID-19 in high-risk patients:

  • The preferred option at this time is the oral antiviral Paxlovid which should be administered within 5 days of onset. 

  • Similar effectiveness can be achieved with the intravenous antiviral remdesivir (VEKLURY) which required infusion on 3 consecutive days and must be started within 7 days of symptom onset. 

  • If neither of these therapeutics are available or appropriate, the oral medication Lagevrio (molnupiravir) may be given starting within 5 days of symptom onset.

  • For hospitalized patients, the FDA has authorized the emergency use of Gohibic, for individuals placed on mechanical ventilation.

Five previously authorized monoclonal antibodies are no longer authorized due to the presence of variants that reduce their effectiveness: Casirivimab/imdevimab (REGEN-COV), Bamlanivimab/etesevimab, Sotrovimab, Bebtelovimab, and Evusheld

FDA Shelf-life Extension

There have been recent changes in shelf-life extension for several therapeutics.

In most cases, the packaging labels do not represent the most current expiration date for that product.

Please visit the ASPR webpage for a complete list of up-to-date extensions

COVID-19 Therapeutic Product Expiration (hhs.gov)

Guidance

PAXLOVID

LAGEVRIO (molnupiriavir)

REMDESIVIR (Veklury)

 

Previously Available Products

Throughout the pandemic, the FDA has paused emergency use authorization (EUA) for therapeutics to help combat COVID-19. Previously authorized therapeutic products may prove to be effective in treating future COVID-19 variants. Therefore, the HHS recommends that sites retain any stockpiles of paused or discontinued products. Additional information can be found at COVID-19 Paused and Discontinued Products | HHS/ASPR

Evusheld- On January 26, 2023, the FDA withdrew the EUA approval

Bebtelovimab- On November 30, 2022, the FDA withdrew the EUA approval

Sotrovimab- On April 5, 2022, the FDA withdrew EUA approval

Bamlanivimab/etesevimab and REGEN- COV - On January 24th, 2022, the FDA revised the EUA fact sheets noting these two COVID-19 treatments are no longer authorized for use. 

COVID-19 Test to Treat Program

Test to Treat is a nationwide initiative where people will be able to get tested and if they are positive, access treatments all in one location. These “One-Stop Test to Treat” locations will be available at hundreds of locations nationwide, follow the link below. People can also be tested and treated by their own health care providers who can appropriately prescribe oral antivirals.

Locator Sites

The HHS COVID-19 Therapeutics Locator is continually adding locations and the map does not include all the sites with COVID-19 Therapeutics. If you are a provider with questions on where to go for COVID-19 Therapeutics please send an email to covidmeds.DPH@ct.gov and we will connect you with a location that is offering them. Patients should coordinate with their respective physician or care provider before contacting a location to receive treatment.

Health Partner Ordering Platform

The Health Partner Ordering Platform (HPOP) is an ordering portal for allocating and/or requesting therapeutic products. 

Health Partner Ordering Platform Sign-In

HHS HPOP Help Desk Information for Users

  • For password resets, please use the “I forgot my password” link on the sign-in screen
  • For any issues with using the HPOP portal, please email HPOP-Therapeutics@hhs.gov


HPOP Provider Resources