April 8, 2022
Limited infusion-based regimens available due to revocation of Sotrovimab EUA
Due to reduced efficacy and BA.2 dominance, the FDA recently revoked the EUA for Sotrovimab eliminating it as a treatment option for COVID-19 infections in patients at high-risk for progression to severe COVID-19 disease. This will limit our available infusion-based regimens for COVID-19 treatment to Bebtelovimab. Unfortunately, due to clinical trial limitations, Bebtelovimab is not considered a first-line therapy and this should be considered while weighing treatment options for each patient. Barring new clinical data, it is our recommendation that Bebtelovimab only be considered in individuals unable to receive Paxlovid (ritonavir-boosted nirmatrelvir).
Paxlovid availability can be found on HHS/ASPR therapeutics locator website, included below. The most common reason for Paxlovid contraindication is drug-drug interaction and before prescribing Paxlovid, would strongly recommend ensuring a critical drug interaction does not exist. EMR drug interaction checkers may not be optimized for this purpose and an independent interaction checker can be found at https://www.covid19-druginteractions.org/ or a member of the LMH Health pharmacy team can be contacted to assist. This PDF provides an excellent overview of Paxlovid, including stratification of drug interactions. Please note that Paxlovid needs to be started within 5 days of symptom onset.
In summary, all monoclonal therapy referrals will result in utilization of Bebtelovimab with an understanding that the referring provider is aware of treatment guidelines. Updated order sets are forthcoming.
Please note that Molnupiravir is placed within a similar tier as Bebtelovimab and determination on utilization is based upon provider preference and informed decision making with the patient.
We will have a town hall meeting on April 11 and will be happy to answer questions. Thank you for the flexibility and effort that every provider has contributed to throughout the pandemic.
Treatment guideline links: