Commercialization of COVID Therapeutics

Amanda Applegate • Nov 08, 2023

Use government stock for un/underinsured patients; transition to commercial products for insured

tl;dr:

  • Order commercial stock of molnupiravir and Paxlovid
  • Use up the molnupiravir you have in stock for Medi/Medi + uninsured
  • Return EUA labeled Paxlovid that expires Dec 2023 or later before 12/31/23


Ordering of HHS-procured Lagevrio (molnupiravir) closes at 3 p.m., Friday, November 10, 2023, for everyone other than federal entities partners (eg prisons, IHS). Ordering molnupiravir through wholesalers started November 1. Wholesalers anticipate having commercial orders filled within 1-2 weeks.


The Merck Patient Assistance Program intends to provide Lagevrio free of charge to eligible patients who, without assistance, could not otherwise afford the product. This program is expected to start in mid-November. HHS-distributed molnupiravir should continue to be used for all eligible patients, including Medicare, Medicaid, uninsured and underinsured patients, until HHS-distributed supply is depleted or reaches expiration. Please ensure providers have sufficient USG inventory on hand to meet demand while patient assistance programs ramp up.


Ordering of  HHS-procured Paxlovid will close on December 15, 2023, at 3 p.m. ET except for all federal entity partners. Ordering through wholesalers also opened for Paxlovid on November 1. Ordering of HHS-distributed Paxlovid and reduced dose Paxlovid will transition from ordering against thresholds to ordering using the out-of-cycle request process on November 27, 2023.


Returns of the EUA-labeled Paxlovid with an expiry of December 2023 or later will be accepted through December 31, 2023; for each returned EUA-labeled Paxlovid, Pfizer will provide a credit to the government for use in the U.S. government Prescription Assistance Program (USG PAP). We encourage all providers to maximize use of the USG-distributed supply, particularly to ensure distribution channels, payment systems, and the USG PAP operated by Pfizer are fully operational before returning EUA-labeled Paxlovid.


Please see Sunsetting the U.S. Government COVID-19 Therapeutics Distribution Program for more details on the transition to traditional commercial distribution.

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