Jurisdictions can pre-position supply of TPOXX to further improve access in communities disproportionately affected by mpox.
HHS will provide an ordering threshold for each jurisdiction using a formula based 75% on the number of cases in their jurisdiction and 25% on the number of individuals who have the highest risk of contracting the virus, including individuals who have HIV or other immunocompromising conditions. The threshold will be re-evaluated regularly and adjusted as the outbreak evolves. Jurisdiction can order against that threshold based on their need. Thresholds are listed on the
TPOXX Thresholds by Jurisdiction page.
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. In addition, 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). Please note, that ordering of additional supply once a jurisdiction’s initial threshold amount has been fully ordered against is contingent on how much product is used, including reporting of product used in HPOP and submitting EA-IND Patient Intake Form (Form A) to CDC. Health departments, serving as the central depot responsible for TPOXX distribution within their jurisdictions are responsible for communicating reporting on TPOXX use under the EA-IND with the appropriate end-user.
CDC holds an EA-IND protocol to allow access to and use of TPOXX for treatment of mpox. The EA-IND provides umbrella regulatory coverage to clinicians and facilities so that they do not need to request and obtain their own INDs. The EA-IND also provides liability coverage under the Public Readiness and Emergency Preparedness (PREP) Act for healthcare providers prescribing, administering, or dispending the drug, and the ability for patients to seek compensation if they are seriously injured by the medication (Countermeasures Injury Compensation Program). If there are no contraindications to treatment, treatment may begin once informed consent is obtained, with completion of the remaining required EA-IND paperwork soon after treatment starts.
To ensure appropriate monitoring of patient safety and clinical outcomes for anyone receiving TPOXX,
healthcare providers are required to complete and submit to CDC the following documentation into an online registry (CDC began collecting
electronic forms starting on October 28, 2022)9 10:
Informed Consent Form (or
short form): Obtain prior to treatment
- Patient Intake Form: Submitted within 7 days of starting treatment
- FDA Form 1572: One form per facility for all TPOXX treatments administered at the same facility, submitted within 7 days of starting treatment
- Serious Adverse Events: Report life-threatening or serious adverse events associated with TPOXX by completing a
PDF MedWatch Form and returning it to CDC within 72 hours of awareness or sooner, if possible. The PDF MedWatch Form can also be downloaded from the
Healthcare providers may also provide the Clinical Outcome Form (progress information during and post treatment; optional submission 3 -14 days after last patient follow-up)
All submissions can be made via email (email@example.com) or uploading to ShareFile
Jurisdictions can receive additional TPOXX supply to meet the threshold only when,
- There is documented
use of 80% of their current TPOXX inventory as reported in HPOP AND
- There is documented
submission to the CDC of required regulatory forms (Patient Intake Form, at minimum) for 90% of
- Please note, all reporting on inventory and dispensing data for oral TPOXX is in bottles, not patient courses11
9 Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Monkeypox | Monkeypox | Poxvirus | CDC
10 Online TPOXX registry
11 Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Mpox