TPOXX Thresholds by Jurisdiction

On August 22, 2022, ASPR made 50,000 patient courses of TPOXX (100,000 bottles) available to jurisdictions to make the treatment more readily accessible for providers and patients. ASPR has distributed approximately 38,000 patient courses of TPOXX to help states and jurisdictions respond to the mpox outbreak.

TPOXX is not FDA-approved for mpox but is available under the Expanded Access Investigational New Drug (EA-IND) for treatment of people infected with mpox, particularly those with severe disease, or at risk for severe disease such as immunocompromised, and pediatric cases. A list of considerations can be found under Interim Clinical Guidance for the Treatment of Mpox.

Equitable distribution remains a priority, ensuring jurisdictions have the ability to access TPOXX when and where needed for eligible patients.

Jurisdiction health departments can order TPOXX capsules from thresholds. Thresholds are calculated based on a formula based 75% on the number of cases in their jurisdiction and 25% on the number of individuals who are at the highest risk of contracting the virus, including individuals who are living with HIV or who could benefit from HIV pre-exposure prophylaxis. Numbers for at-risk populations will be re-evaluated regularly and adjusted as needed.

Jurisdictions can receive additional TPOXX supplies to meet the threshold only when they have reported use of 80% of their current TPOXX supply through HPOP and have documented submission to the CDC of required regulatory forms (Patient Intake Form, at a minimum) for 90% of the used supply.

For the intravenous (IV) formulation of TPOXX, jurisdiction health departments should continue to contact the CDC directly. The IV formulation should only be considered when oral route is not possible, and patients should be converted to oral TPOXX as soon as they can tolerate swallowing capsules.

CDC holds the EA-IND protocol which allows access to and use of TPOXX for treatment of mpox. The EA-IND provides umbrella regulatory coverage to clinicians, so that facilities do not need to request and obtain their own INDs. The EA-IND also provides liability coverage under the PREP Act only when appropriate documentation is filed for each patient receiving treatment, and the drug is administered in accordance with the EA-IND. 

Appropriate monitoring of patient safety and clinical outcomes for anyone receiving TPOXX is required. Healthcare providers are required to complete the specific forms when initiating TPOXX treatment for a patient and return the forms to CDC. TPOXX distribution will be tracked by the number of bottles.

For additional ordering details, jurisdiction health departments and healthcare providers should see the TPOXX ordering in the operational planning guide. For pre-positioning purposes, we are estimating 2 bottles per patient course and will be tracking bottles for inventory purposes.