COVID-19 Antibody Allocation & Transparency
Lilly is working with global regulators to make bamlanivimab and etesevimab (authorized to be administered together) available for emergency use in countries around the world. Global allocation will be made based on Lilly’s guiding principles that aim to ensure access for patients with high unmet need, no matter where they live.
To guide decisions on where to send the medicine, we’re taking a data-driven approach while relying on key principles that are rooted in the values that have guided our company since 1876. These principles are:
Allocation: Treatment will be allocated based on unmet medical needs globally. This applies to countries with an active product order/request and with either a regulatory or donation pathway to receive that product.
Patient cost: Our goal is for patients to have no out-of-pocket costs for our antibody treatments, wherever possible.
Pricing to health systems: Equitable government pricing will be tiered based on a country’s ability to pay.
Lilly routinely monitors both supply and demand. Lilly’s monthly process to allocate materials globally is as follows:
Determine eligible countries: Countries are eligible for an allocation if they issued a regulatory authorization and have a purchase agreement by the 15th of the prior month. In addition, Lilly donates treatment to Direct Relief for use in countries which qualify as low- and lower-middle-income.
Calculate treatment quantities: When supply exceeds demand, orders are filled when received. When demand exceeds supply, treatment quantities available to each country may be calculated based on available supply and the country’s disease burden as calculated from trusted research centers such as the Johns Hopkins University Coronavirus Resource Center and international health authorities such as the World Health Organization.
Acceptance of quantities: Lilly informs the eligible country of the quantity available to them. Each country confirms the quantity it will accept. Any quantities not accepted by a country are reallocated via step 2 above and offered to other eligible countries.
Shipment and distribution: The following month, Lilly ships the agreed-upon quantities to receiving countries where local government then directs distribution of the treatment. In the case of donations, Lilly ships to an intermediary, Direct Relief, who in turn ships to receiving countries where local government then directs distribution of the treatment.
Bamlanivimab and etesevimab have not been approved, but have only been authorized for emergency use by FDA to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Bamlanivimab and etesevimab are authorized to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com.
Bamlanivimab and etesevimab are not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%, as determined by FDA. A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available on the following FDA website: https://www.fda.gov/media/151719/download
Lilly Cautionary Statement Regarding Forward-Looking Statements
Contained within are forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab and etesevimab together as a potential treatment for patients with COVID-19, and the supply, distribution and orders/contracts with governments and other parties relating to these therapies, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that bamlanivimab and etesevimab together will prove to be safe and effective treatments or successful preventative therapies for COVID-19, that bamlanivimab and etesevimab together will receive regulatory approvals or additional authorizations, that patients will volunteer to participate in clinical trials or achieve positive outcomes, that Lilly will obtain any additional purchase orders or supply contracts, or that Lilly can provide an adequate supply of bamlanivimab, etesevimab or both therapies together in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.