Future US Purchases Of Lilly’s Bamlanivimab Will Depend On Success Of Outpatient Infusion Process
HHS reverses course on cost sharing for the antibody and says patients will not have to pay. Operation Warp Speed will watch ‘extremely carefully’ to see if the health care system is able to adapt its practices to safely administer to the drug for COVID-19, officials say at a media briefing. FDA-authorized dose of the drug is not too low, Woodcock says.
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The doses of bamlanivimab and etesevimab authorized for use in combination are a fraction of those shown to be effective in the Phase III BLAZE-1 trial; however, Phase II data, PK/PD modeling and in vitro data suggest the lower doses will have the same clinical impact as the higher-dose regimen, the FDA said.
The bamlanivimab/etesevimab combo, filed for US emergency authorization in November, shows ability to reduce risk of hospitalization or death in COVID-19 patients. Lilly also sees prevention role for bamlanivimab.
Unused supply for the Lilly and Regeneron therapies has policymakers considering Medicare payment changes for providers managing outpatient infusion, but those may require legislation. National Academies of Sciences, Engineering and Medicine committee considers the ‘paradox of unused supply with a relatively scarce product’ and tries to dissect the challenges that may be contributing to the unexpected lack of take-up for the mABs.