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State Issues New Request Process for Monoclonal Antibody Therapies

The Department of Health (DOH) issued Guidance to Providers on How to Request COVID-19 Monoclonal Antibody (mAb) Therapeutics this week providing a new process to obtain supply of the therapies.

On Sept. 13th, the U.S. Department of Health and Human Services (HHS) changed the distribution system for mAb therapeutics. HHS transitioned from a direct requesting process whereby providers requested directly from the distributor, AmerisourceBergen, to a state/territory-coordinated distribution system.

Each state/territorial health department will now determine where mAb product goes within their jurisdiction. States and territories will be assigned a weekly allotment of mAb product by HHS. The amount will be based on COVID-19 case burden and mAb therapeutic utilization.

DOH has issued a form that providers should use to request supply. At this time, only providers who have an active account from AmerisourceBergen can submit a request to obtain supply. DOH will notify all other providers interested in obtaining mAb therapeutics when an option for them to request these products becomes available.

The mAb therapeutics affected are:

  1. Bamlanivimab/etesevimab (Lilly)
  2. Etesevimab (Lilly – to pair with bamlanivimab already on hand)
  3. Casirivimab/imdevimab, i.e., REGEN-COV (Regeneron)

The distribution of these therapeutics will remain with AmerisourceBergen. The Department will inform AmerisourceBergen of each provider’s request and how much of the request should be filled. As the State will be allotted a finite amount of mAb product each week, providers may not receive the total amount of product they requested. The Department will determine how much product each provider receives based on the supply allotted to the State by HHS.

The guidance sets forth the information to be provided in an Excel spreadsheet to make a request for supply. All requests must be received by the Department by Monday at 5 p.m. Providers should submit the spreadsheet to the Department at COVID19therapeutics@health.ny.gov with the subject line “Therapeutic Request for my Site.”

Requests will be reviewed that same week and entered in the AmerisourceBergen portal by the Friday deadline for each weekly cycle. DOH has confirmed that requests are for projected supply amounts needed. Please consider this lag time when you are ordering supply.

The Department is working on creating an online form to collect requests. In the meantime, providers will email the Department their requests using the Excel spreadsheet provided in the guidance. The Department will notify providers when the request process will be switched to the online form.

Members should reach out to LeadingAge NY if they have concerns or questions about the new ordering process. Members not yet offering mAb but interested in doing so may reach out to our office to learn more from members already engaged in offering this treatment.

Contact: Meg Everett, meverett@leadingageny.org, 518-929-9342