Distribution from the Strategic National Stockpile, Pre-Positioning, and Contingency Supplies

TPOXX (Tecovirimat) Operational Planning Guide — Information for Providing Therapeutics for Persons with Mpox

Distribution of TPOXX through Enrollment in STOMP

Providers are encouraged to inform eligible patients about the Study of Tecovirimat for Human Mpox Virus (STOMP). For details, providers should visit the STOMP website or call the STOMP call center at 1-855-876-9997. 

Orders for immediate patient use  

Health care providers should contact CDC in conjunction with their jurisdictional health departments when attending to patients who: 

• are ineligible for STOMP
  
• decline enrollment (while also meeting treatment eligibility criteria outlines in the revised CDC EA-IND)

Approved order requests initiated through the health department to the CDC Emergency Operations Center (EOC) at (770-488-7100) are fulfilled by the Strategic National Stockpile (SNS). (Note: The email box is monitored from 9 a.m. – 4 p.m. U.S. Eastern time on non-holiday weekdays. For urgent issues, contacting the on-call clinician via the EOC is preferred.)

Typically, TPOXX from the SNS is delivered within 24 hours of order placement. However, some orders may arrive within 48 hours due to the time the order was placed, shipping routes and/or other logistical factors. 

Pre-positioning and continued availability of pre-positioned TPOXX

As part of the U.S. government's response to the mpox outbreak, nearly 40,000 treatment courses of oral TPOXX were pre-positioned throughout the country. This inventory can be used for the treatment of patients in accordance with the CDC-held EA-IND protocol and  CDC's Guidance for Tecovirimat Use.

Pre-positioning of additional oral TPOXX was paused on February 27, 2023. This was decision was based on several epidemiological factors and the current outbreak trajectory, including significant declines in the rolling seven-day average for new cases. ASPR, in consultation with its federal partners, continues to assess the need for pre-positioning and will notify jurisdictions if the program resumes.

Contingency planning / limited pre-positioned supply

Beginning in June of 2023, as an additional contingency measure for rapid initiation of treatment for critically ill patients with mpox who are eligible for treatment under the EA-IND, any jurisdiction can place a one-time order for up to 20 bottles of oral TPOXX using the HPOP ordering system for pre-positioning (see “Ordering" for additional information on how to place an order using HPOP). Additional supply beyond the 20 bottles may be considered under certain circumstances and will be determined on a case-by-case basis.

Data Reporting

The data reporting requirements are not impacted by the PHE and therefore remain unchanged. 

• Health departments, as the central depot responsible for TPOXX distribution within their jurisdictions, are responsible for communicating the reporting requirements on TPOXX use under the EA-IND with the appropriate persons. 
• Treating facilities, hospitals, medical centers, and providers (private or affiliated with these facilities) need to ensure EA-IND paperwork is completed and submitted for each patient treated in accordance with FDA and HHS guidance (as noted below). 
• For jurisdictions with pre-positioned oral TPOXX, jurisdictions will be required to attest to reporting doses on-hand and doses dispensed or administered, on a weekly cadence or as directed by HHS.   

For details regarding TPOXX use under CDC’s EA-IND and requisite documentation to enable access to TPOXX outside the STOMP trial, please visit the Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Mpox website for up-to-date tecovirimat EA-IND protocol and requirements.