IHS Test to Treat Initiative

Background:

On March 2, 2022, the Biden Administration released the National COVID-19 Preparedness Plan Exit Disclaimer: You Are Leaving www.ihs.gov , with four key goals including to Protect Against and Treat COVID-19. In coordination with this Plan, on March 4, 2022, the

U.S. Department of Health and Human Services (HHS) issued a COVID-19 Test to Treat Initiative Fact Sheet Exit Disclaimer: You Are Leaving www.ihs.gov  outlining rapid ‘on the spot’ access to lifesaving COVID treatments. Effective March 7, 2022, the HHS Coordination Operations and Response Element (HCORE) began distributing oral antiviral pills directly to participating Test to Treat pharmacy-based clinics. In addition to the current pro-rata jurisdictional allocation, HCORE plans to provide the Indian Health Service (IHS) with a supplemental allocation of the oral antivirals, Paxlovid® and molnupiravir, in support of an IHS COVID-19 Test to Treat Initiative.

Current Status & Indications:

On December 22, 2021, the U.S. Food and Drug Administration issued an emergency use authorization Exit Disclaimer: You Are Leaving www.ihs.gov (EUA) for Paxlovid^® (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to- moderate COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19 Exit Disclaimer: You Are Leaving www.ihs.gov , including hospitalization and death. On December 23, 2021, the U.S. Food and Drug Administration issued an emergency use authorization Exit Disclaimer: You Are Leaving www.ihs.gov  (EUA) for molnupiravir for the treatment of mild-to-moderate COVID-19 in certain adults who are at high risk for progression to severe COVID-19 Exit Disclaimer: You Are Leaving www.ihs.gov , including hospitalization and death.

Availability, Prioritization, Reporting, and Scalability:

Due to initial supply-chain limitations, I/T/U Test to Treat sites will be prioritized based on site readiness and factors that promote equity such as geographic region and facility size and type. Participating sites will be expected to regularly report inventory and utilization (e.g. HHS Health Partner Ordering Portal, IHS National Pharmacy & Therapeutics Committee Emerging Treatments Survey) in support of continuing distributions. As supply increases, the goal is to scale-up Test to Treat operations IHS-wide, including sharing of best practices by participating sites.

Criteria for Distribution to Test to Treat I/T/U sites:

1. Site requesting oral antivirals (Paxlovid^® and molnupiravir) as part of the IHS Test to Treat Initiative will undertake a self-assessment of readiness to administer the product (including current policies/procedures in place) before submitting a distribution At a minimum, elements of self- assessment shall include;
   • Adherence to all components of Emergency Use Authorization(s)
   • Access to COVID-19 testing and pharmacy services,
   • Testing logistics (order, result, reporting, prioritized case investigation & contact tracing Exit Disclaimer: You Are Leaving www.ihs.gov ),
   • Treatment logistics (provider order, cross-check for contraindications, pharmacy dispensing), &
   • Process for tracking & reporting Adverse Drug Events to MedWatch or in accordance with with EUA.
2. Attestation and completed request submitted in HHS Health Partner Ordering Portal (HPoP).
3. Site will participate in all storage, dispensing, utilization, inventory management, and other reporting requirements per HHS and IHS policy related to the Test to Treat Initiative.