COVID-19 Monoclonal Antibody Therapy and Other HERC Updates

Ariel Smits, MD, MPH August 5, 2021 COVID-19 Monoclonal Antibody Therapy

Drug Setting Route Indications

Out In IV Sub- Mild to moderate Post- pt pt Q COVID-19 in high exposure risk pts prophylaxis Sotrovimab* X X X Casirivimab and X X X X X imdevimab Bamlanivimab & X X X etesevimab** Tocilizumab*** X X X

*FDA EUA 5/26/21 **FDA EUA 6/24/21 ***Distribution paused 6/25/21

2 COVID-19 Monoclonal Antibody Therapy •Treatment of Infection

• Confirmed COVID-10 infection by PCR or antigen test • Treatment within 10 days of symptom onset • Not on oxygen therapy if outpatient • High risk patients: – Age ≥ 65 – Obese/overweight – Pregnant – Chronic kidney disease – Diabetes – Immunosuppressed – Children and adults under age 65 with chronic lung, heart or neurodevelopmental disorder

3 COVID-19 Monoclonal Antibody Therapy •Treatment of Infection

• Shown to prevent progression of disease – Reduce hospitalization by up to 30% • Reduce hospital burden – Decrease viral load • Reduce spread – Reduce medical visits

4 COVID-19 Monoclonal Antibody Therapy •Post Exposure Prophylaxis

• New indication for casirivimab/imdevimab (REGEN- COV) • Eligible patients – Ages 12 and older – Not fully vaccinated or immunocompromised vaccinated patients – Close exposure to confirmed infected individual or in same institutional setting as an infected individual (eg SNF or prison)

5 Counts of Services Provided, by month 2021 Plan January February March April May June FFS 0 1 0 3 4 1 CCO 13 7 8 14 20 5 Total 13 8 8 17 24 6

Counts by Medication, by month 2021 Procedure Code January February March April May June Bamlanivimab 1 13 8 8 5 - - Casirivimab and 0 0 0 1 5 5 imdevimab Bamlanivimab and 0 0 0 11 19 1 etesevimab 2 Sotrovimab3 - - - - 0 0 Toclilizumab4 - - - - - 0

1 EUA revoked 4/16/21 2 Distribution paused 6/25/21 3 EUA 5/26/21 4 FDA EUA 6/24/21

6 Barriers?

• Provider issues: – Lack of provider knowledge/perceived effectiveness • Patient issues: – Lack of willingness to undergo treatment – Waiting too long to get COVID tested • Drug issues – Trouble obtaining or storing drug • Administration issues – Ability to bring in COVID positive patients to infusion center • System issues – Difficulty obtaining COVID test results in timely manner – Difficulty with scheduling patients/coordinating testing and care

7 COVID-19 Monoclonal Antibody Therapy

• Questions – What other barriers are there? – How can HERC or OHA address these barriers to increase utilization?

8 Other HERC updates

• Move thrush to “above the line”

• Opening PET scans and MRI for Alzheimer’s patients being considered for or treated with aducanumab (Aduhelm)

• Question – What is your coverage of OTC medications?

9 Your feedback or questions

• [email protected] • [email protected]

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