Eli Lilly’s investigational monoclonal antibody (mAb) bamlanivimab, which recently was issued emergency use authorization (EUA) by the FDA for Covid-19, is unlikely to face payer pushback, despite its broad label, GlobalData reports.
The data and analytics company notes that drug prices have been closely examined during the Covid-19 pandemic, but, citing feedback from EUA experts, given bamlanivimab’s potential benefit in curtailing hospitalizations, it and other mAbs under FDA review may offer pricing value. Manasi Vaidya of GlobalData said, “If bamlanivimab and other similar monoclonal antibodies can reduce hospitalization risk, they could be prevent [ing] anxiety and loss of income that would have resulted otherwise, and thus be cost-effective.”
Earlier this month, FDA granted bamlanivimab EUA to treat mild-to-moderate Covid-19 patients who are at high risk for progressing to severe infection and/or hospitalization. Specifically, this includes adults 65 years or older, and/or those with certain chronic medical conditions. Lilly will be supplying 300,000 vials of 700 mg bamlanivimab at a cost of $1,250 per vial.
Vaidya points out that distribution channels are different today from pre-pandemic times and uncertainty on demand coupled with specialized manufacturing requirements for mAbs could create their own barriers to access.
“Unlike situations where payers may require additional documentation or restrict use to a narrower patient population for a newly approved biologic, with COVID-19, a physician determination for bamlanivimab’s need may be adequate for coverage,” she said.