January 26, 2022

Monoclonal status YELLOW

Monoclonal allocations continue to fluctuate – currently our status is Tier 2/YELLOW, which means we currently have enough supply on hand to infuse 3-5 patients per day for one week. We ask that you continue to remain judicious on referrals to ensure the capacity of the Treatment and Procedure Center is not exceeded.

Please understand that due to the spread of the omicron variant, this continues to be a rapidly-evolving situation. You can also find this information at lmh.org/mab.

Monoclonal shortage plan 

Due to the rapidly changing nature of monoclonal allocations within the pandemic, we must prepare for shortages to optimize access for our highest risk patients. Unfortunately, we currently find ourselves within a shortage period and contingency criteria will need to be enacted. Updated information will be communicated every Wednesday evening or Thursday morning to inform what our current status will be for the upcoming week and will be listed as red, yellow, green or blue. We ask that providers adhere to the corresponding contingency state when ordering monoclonal therapy. For example, if we are in a Tier 2/YELLOW status and the patient does not meet the criteria set forth, we will not infuse.

The tiered approach is supported by the data below from the CDC. We recognize the complexity this adds to patient selection in an already challenging time. The following plan, approved by the Ethics committee, will proceed as follows:

1. Monoclonal antibodies will only be utilized for treatment of mild to moderate SARS-CoV-2.
2. We will infuse Douglas County residents or established LMH Health patients at this time. The rationale, approved by our Ethics committee, is that each state receives an allocation from the federal government based on the week’s previous use. The state then allocates to facilities across the state to care for patients in their region. Currently, we are being supplied at a rate that is slightly less than the demand of this facility and county. If supply and resources become more plentiful, Ethics will revisit. The quantity LMH Health is able to infuse is at the discretion of HHS & KDHE.
3. Green/Tier 1: We currently have enough supply on hand to infuse 6-10 patients per day for one week. The standard criteria plus one high risk factor as set forth in the EUA.
4. Yellow/Tier 2: We currently have enough supply on hand to infuse 3-5 patients per day for one week. The standard criteria plus >2 high risk factors.
5. Red/Tier 3: We currently have less than 3 doses per day for one week. The standard criteria plus >4 or more high risk factors.
6. Blue/Tier 4: We have no supply on hand OR the EUA has been revoked due to insufficient activity against the current dominant strain of SARS-CoV-2.

https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html