January 5, 2022
Monoclonal status RED
LMH Health has received a limited allocation of monoclonal antibodies (with confirmation from our distributor) and will restart mAb infusions on 1/6/22 in a Red: (Tier 3) status allowing for 3 infusions per day through TPC. In keeping with the current Tier 3 resource state, patients must fulfill standard mAb criteria plus > 4 or more high risk factors. Infusions will continue to occur on a first come, first serve basis and request judicious ordering practices.
Recent communications from HHS and KDHE indicate eventual improvement in the mAb allocation supply chain later in January. Planned weekly updates will now occur Wednesday afternoons or Thursday mornings to minimize the risk of distributor related shortages that the KDHE may not be aware of at the time of mAb allocation to individual institutions. Urgent changes will be communicated as needed.
- Oral antivirals (Paxlovid and Molnupiravir) may provide an alternative option to mAb therapy in high-risk patients. For an overview of oral therapies, please click here.
- Oral therapies are currently available in limited supply at specific community pharmacies that can be found on the KDHE website here.
KDHE will continue to update their directory as changes occur. Unfortunately, there is not a “real-time” supply resource and prescriptions should be called in directly to the pharmacy on the list after verification of available medication. As with any new medication, please ensure critical drug interactions, contraindications and/or renal adjustment need are not present.
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 afternoon 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 Yellow or Tier 2 status and the patient does not meet the criteria, set forth below 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. Continue to monitor communications for updates.
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 on 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 1 week. The standard criteria plus 1 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 1 week. The standard criteria plus > 2 high risk factors.
5. Red: (Tier 3): We currently have less than 3 doses per day for 1 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.
Please visit lmh.org/mab for additional information.