November 30, 2021

mAb Direct Ordering

To: Members of the LMH Health Medical Staff

From: Dr. Christopher Brychel, Dr. Christopher Penn, Dr. Jennifer Schrimsher, Caitlin Johnston, APRN

Dear Providers,

This correspondence is to inform you of a significant change in referrals for monoclonal antibody (mAb) infusions for the treatment of mild-to-moderate COVID-19 disease in patients at risk for progression to severe COVID-19 illness. Beginning December 6, 2021, mAb will no longer require a referral and will become directly orderable by each provider. In addition, our staff will no longer be reviewing positive tests, so it is up to each individual provider to order mAb, if applicable. It is our hope that this change will increase efficiency and ease in the treatment process, as well as allow a sustainable workflow as the pandemic continues.

• Before December 6, it is critical that prescribing providers familiarize themselves with the three Emergency Use Authorizations for:
  • Bamlanivimab/Etesevimab
  • Casirivimab/Imdevimab
  • Sotrovimab, with a focus on authorization criteria and counseling points
• http://pi.lilly.com/eua/bam-and-ete-eua-factsheet-hcp.pdf
• https://www.regeneron.com/downloads/treatment-covid19-eua-fact-sheet-for-hcp.pdf
• https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Sotrovimab/pdf/SOTROVIMAB-EUA.PDF#nameddest=HCPFS

Monoclonal Antibody Workflow beginning December 6, 2021:

1. Identification of mAb candidate by EUA criteria (see attached) by provider.

a. LMH Providers: utilize SharePoint document

b. Non-LMH Providers: please make copy of the attached.

i. Updates to order sets will be sent by an LMH representative.

2. Ordering provider will contact the patient to review EUA consent directly.

3. Fully completed order sheet (attached) and a copy of the positive test result will be faxed to Treatment and Procedure Center (TPC)

a. TPC Fax: 785-505-5253

b. TPC Phone: 785-505-2860 (You are strongly encouraged to call and verify receipt of order.)

4. TPC staff will review and, if patient fulfills mAb criteria, contact the patient to arrange for mAb infusion appointment and provide appointment instructions.

5. Ordering providers external to LMH will be notified directly by TPC staff once mAb infusion is complete.

a. Verification within chart/Cerner will be present for LMH providers.

6. Further management and follow-up will be the responsibility of the ordering provider.

Important Notes:

1. TPC Staff will not:

a. Review/consent EUA with patient

b. Retrieve missing or partial information (e.g. test result)

c. Schedule patients that are not mAb candidates

d. Schedule those whose order forms are not complete

2. Monoclonal referral order within Cerner will be deactivated.

3. The Monoclonal referral voicemail (785-505-5182) will be reviewed during the first month of this process in case questions or problems arise.

4. Appointments will be filled on a first come, first serve basis with regard to TPC capacity and staffing.

5. Pharmacy will determine which monoclonal product will be dispensed based on allocations and availability. Pharmacy will routinely consult ID to ensure EUA criteria (i.e. variants) is met.

a. Current EUA mAb products in the U.S. are:

i. Bamlanivimab/Etesevimab

ii. Casirivimab/Imdevimab

iii. Sotrovimab

b. Please see the attached script for suggestions regarding general mAb EUA consent for the referring provider.

6. DO NOT REFER PATIENTS TO THE EMERGENCY DEPARTMENT FOR mAb THERAPY.

Please feel free to contact us at 785-505-5182 if you have questions or concerns.