Introduction
Clinical Implementation Guide Objectives
COVID-19 Therapeutics under Emergency Use Authorization (EUA)
COVID-19 Therapeutics: Resources for Health Care Professionals and Public Health Officials
Module 1: COVID-19 Outpatient Therapeutics Overview
COVID-19 Outpatient Therapeutics Overview
Who Is At Risk for Severe COVID-19?
Summary of COVID-19 Preventative Agents/Treatments
NIH Guidelines For Treatment of Mild to Moderate COVID-19 in Non-hospitalized Adults Who Are at High Risk of Progressing to Severe COVID-19
Recommendation for Special Populations: Immunocompromised & Pediatrics
Module 2: Products for Treatment of Mild-to-Moderate COVID-19
Products for Treatment of Mild-to-Moderate COVID-19
Paxlovid
Veklury
Lagevrio
Module 3: Oral Antiviral Administration
Oral Antiviral Administration
Patient Flow for Antiviral Oral Therapies
Test to Treat: About the Program
Treatments Locator
Module 4: Facilitating Patient Access
Facilitating Patient Access
Access to Oral Antivirals (OAVs)
Continued Access to Paxlovid
Continued Access to Lagevrio
Module 5: Reimbursement
Reimbursement
CMS Guidance for Oral Antivirals
CMS Resources: Veklury Billing
CMS Resources
Module 6: Product Returns
Product Returns
Inventory and Disposal Management for Transition to Traditional Commercial Distribution
Data Reporting Requirements
Guidelines for Product Return/Disposal
On Site Destruction of Expired or Unauthorized Product
Module 7: Additional Resources
Additional Resources
COVID-19 Vaccination after mAb Administration
For USG Procurement Reporting Guidance
Opting in to the Treatments Locator
Voluntary Reporting of Commercial Therapeutics
COVID-19 Therapeutic Resources
Module 8: Appendices
Appendices
Appendix A: Outpatient Infusion Site Resources
Appendix B: COVID-19 Convalescent Plasma
Appendix C: Formerly-Authorized Products