AoI A006 Clarification Questions_Answers.docx

1. Agreement with distributor – is the pharmacy expected to incur additional costs or is the ‘last mile’ funded by the program?

The pharmacy is expected to incur additional costs related to 'last mile' (e.g., delivery) and is encouraged to reflect the anticipated cost in their response (i.e., reflect in FFP estimate).

A) All dispensing costs, to include “last mile”, will be reimbursed

1. What volume will be allocated and at what frequency?

To date the USG has agreed to procure 1.7 million patient courses of the Merck oral antiviral molnupiravir. How and at what schedule this will be allocated, is to be determined following response to this AoI and subsequent review of all full proposals.

A) TBD – Will be based on solution brief responses and negotiated awards.

1. How will ‘equitable distribution’ be measured and how should this be balanced against ensuring availability in ‘hot-spots’?

Equitable distribution will be accessed, in part, via the data Offerors submit (i.e., zipcodes of pharmacy locations, mail order or courier delivery within 24 hours). Offerors should address in their response how they are prepared to provide the therapeutics to anyone residing within the US states and territories, regardless of their ability to pay, ability to come to the physical location, and with ability to respond to surges in local areas.

A) TBD – Will be based on solution brief responses and negotiated awards.

1. What is the intake process/patient journey for the scripts? Is there a manufacturer hub to triage the scripts from physician/patient to the selected pharmacies and how is that determined?

Not sure how much we can disclose (Sheila to comment), but the general therapeutics journey is: Manufacturer -> Distributor -> Pharmacy -> Patient.

1. No cost to patient or third party – will this all be billed directly to HHS eg no commercial payors involved?

A) At this time, all reimbursement is expected to come directly from the Federal Government.

A) TBD – Will be based on solution brief responses and negotiated awards.

1. How will patient outreach be measured?

How we will measure patient outreach will be determined after we evaluate the proposed means by which Offerors propose to conduct outreach.

A) TBD – Will be based on solution brief responses and negotiated awards.

1. What additional FDA provisions are there?

A) We will not know the specifics of FDA requirements until (and if) they issue the EUA and associated Fact Sheets.

1. Confirm the product and handling characteristics?

NOTE TO CHRIS – DEFER TO YOU HOW TO ADDRESS. However, we want them to think agnostically about what would be involved in dispensing an oral drug product. All that is public now is Merck’s molnupiravir. Per this morning’s discussions, it’s possible (likely) that other products will become available and dispensed through these pharmacies. You can share that we do not anticipate any special handling (e.g., cold chain, refrigeration) for these products.

A) Product cannot be confirmed at this time. Can only share that it is not anticipated that any special handling (e.g., cold chain, refrigeration) for these products.

1. Weekly reporting – signal when 75% of funds are expended; what are these funds for and how will they be distributed?

The funds are to cover the cost of dispensing and potentially delivering the therapeutics to patients. Not sure how to respond to the “how will they be distributed.” Does distributed mean reimbursed, or allocated across the compliment of offerors? If the former, defer to contracting folks. If the latter, I think the answer is that’s TBD on responses and eventual contracts.

1. Can you provide more detail on how the offer will be marketed Not sure the “offer” to which they are referring.

1. Will there be an opportunity for cost recovery on O/H?

It is expect the offerors will include any cost recovery and is encouraged to reflect the anticipated cost in their response (i.e., reflect in FFP estimate).