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Special Projects for Equitable and Efficient Distribution (SPEED) –

Dear State Primary Care Association Representative and Health Center Leadership,

Information from HHS Office of the Assistant Secretary for Preparedness and Response (ASPR):

The U.S. Government (USG) seeks to increase the availability of COVID-19 monoclonal antibody (mAb) therapies authorized under U.S. Food and Drug Administration (FDA) Emergency Use Authorization for the treatment of mild to moderate COVID-19 infection in outpatients who are at high risk of disease progression or hospitalization.

These therapies aid the body’s immune response to fight the infection. The FDA has granted EUA for two therapies to date – bamlanivimab (Eli Lilly and Company) and casirivimab/imdevimab (Regeneron Pharmaceuticals, Inc.) – based on their potential to decrease hospitalization in high risk patients.  The USG has purchased both products, and the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) currently oversees the allocation and distribution of the therapies free of charge to approved healthcare facilities.

To enhance allocation to priority settings that care for populations at high risk for hospitalization, including Federally Qualified Health Centers (FQHCs), the USG established the Special Projects for Equitable and Efficient Distribution (SPEED) program, a component of the COVID-19 Monoclonal Antibody Therapeutics program. SPEED is separate and complementary to the state-based allocation system and provides direct federal allocation of mAbs to participating sites. Any FQHC or look-alike facility with the capacity and capability to administer mAbs to their patients are eligible to participate in SPEED. FQHCs that do not have on-site capabilities to administer mAbs may partner with local hospitals or community infusion centers to receive SPEED allocations approved for designated use with FQHC patients only.

We are seeking your help to disseminate information about SPEED to FQHCs in your state and through any additional channels you may have access to that will amplify the reach of this information. We invite you to share this message and the attached SPEED Enrollment Guide for Federally Qualified Health Centers, which provides high-level information about the program and resources for FQHCs to review and familiarize themselves with the mAb therapeutics and assess their readiness to administer them.

Thank you in advance for your continued efforts responding to the COVID-19 pandemic and sharing this resource with facilities in your state.

If you have any questions about COVID-19 monoclonal antibody therapeutics or need further assistance, please reference the attached COVID-19 Monoclonal Therapeutics SPEED FQHC Enrollment Guide and other fact sheets or contact us by email at [email protected].

Sincerely,

LCDR Tiffany Pfundt, PharmD, PMP

FQHC Lead for SPEED Program, COVID-19 Monoclonal Antibody Therapeutics Team
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services

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