Statement on the Prioritization for the Use of Anti-SARS-CoV-2 (COVID-19) Monoclonal Antibodies and Antiviral Agents in the Outpatient Setting in the Setting of Limited Supply

Dallas County Public Health Committee; Dallas County Medical Society 
January 18, 2021 

The SARS-CoV-2 Omicron variant is currently the dominant variant of concern in the United States.  The SARS-CoV-2 vaccine is now available for those five years and older (including boosters in those 12 years of age and older) and is the primary strategy to prevent severe COVID-19 infection and hospitalizations.  However, those who are immunocompromised or have certain underlying medical conditions may still be vulnerable following vaccination.

Based on recently published clinical trials, several anti-SARS-CoV-2 therapeutics have been recently approved and distributed:
monoclonal antibodies 
• Evusheld [tixagevimab/cilgavimab] and 
• Sotrovimab 

new antivirals 
• Molnupiravir and 
• Paxlovid 

These therapeutics either help prevent COVID-19 infection (Evusheld)(ref. 1,2,3) or decrease the risk of complications (Sotrovimab, Molnupiravir and Paxlovid)(ref. 3,4) have received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for patients with certain well-defined medical co-morbid conditions in the outpatient settings(ref. 1,3,4.) For treatment, Sotrovimab, Molnupiravir and Paxlovid are currently available for high-risk individuals with mild to moderate COVID-19 infection who are at risk of developing complications or being hospitalized. Both the National Institutes of Health (NIH) and the Infectious Diseases Society of America (IDSA) define the severity of COVID-19 infection and the high-risk medical conditions that increase the patient’s risk of complications(ref. 1,3,4.) To be most beneficial, these must be administered within a specific time from symptom onset. Currently, these novel agents are in very limited supply in the State of Texas and the DFW region. For these reasons while the supply of these agents is constrained, we encourage following the NIH and IDSA frameworks to:

1. urge providers to prioritize patients who will benefit the most (highest risk patients who will not develop immunity) from these treatments.  
2. encourage providers to assure that patients are early in the course of illness (meet the time criteria), have more and significant comorbidities given these agents are in short supply.  
3. promote prioritization of the highest tier of at-risk patients using the NIH COVID-19 Treatment Guidelines(ref. 1).
Furthermore, it is our goal to recommend these agents be distributed equitably to the residents of Dallas County. We strongly encourage institutions use an ethical framework in order to promote the common good, maximize the public health, enhance economic and social benefits, assuring that people are treated fairly and with equity.   

References: 
NIH guidance: 
1. The COVID-19 Treatment Guidelines Panel’s Interim Statement on Patient Prioritization for Outpatient Anti-SARS-CoV-2 Therapies or Preventive Strategies When There Are Logistical or Supply Constraints
2. Anti-SARS-CoV-2 Antibody Products / The COVID-19 Treatment Guidelines Panel's Statement on Therapies for High-Risk, Nonhospitalized Patients With Mild to Moderate COVID-19

3. Using Therapeutics to Prevent and Treat COVID-19
4. Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Providers / Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States

IDSA guidance: 
1. IDSA Guidelines on the Treatment and Management of Patients with COVID-19 - Recommendation 17-18 / IDSA Guidelines on the Treatment and Management of Patients with COVID-19 - Recommendation 19-20
 
Texas and Other State guidance:
Ethical Framework for Allocation of Monoclonal Antibodies during the COVID-19 Pandemic
Interim-DOH Guidance on Prioritization for Use of AntiSARS-CoV-2 Monoclonal Antibodies
Prioritization of Anti-SARS-CoV-2 Monoclonal Antibodies and Oral Antivirals for the Treatment of COVID-19 During Times of Resource Limitations
Texas DSHS COVID-19 Therapeutics Information
Texas DSHS Update on Monoclonal Antibodies and the Omicron Variant, January 3, 2022

Links to information about these agents:
Evusheld
Molnupiravir
Paxlovid
Soltrovimab / Fact sheet for healthcare providers emergency use authorization (EUA) of Sotrovimab / Fact sheet for patients, parents, and caregiver’s emergency use authorization (EUA) of Sotrovimab for the treatment of coronavirus disease 2019 (COVID-19)

Drug availability:
Molnupiravir (DSHS)
Paxlovid (DSHS)
Molnupiravir, Paxlovid, EVUSHELD (HealthData.gov)
Regional Mab infusion clinics