Amendment 2 Questions 7.22.2021.pdf

Below are additional questions submitted by prospective vendors regarding the NPV GEN IV Solicitation SPE2DX-20-R-0001 (posted on June 3rd, 2021). DLA Troop Support has provided a response below each question.

Note: The answers to vendor questions provided in this attachment are provided solely for informational and clarification purposes only and do not change or alter any solicitation requirements. In the event of a discrepancy between the answers and the solicitation, the solicitation will take precedent. The answers provided are merely informational and not binding.

Emergency Orders: As follow-up to question 54 (regarding emergency orders), at the bidders conference DLA confirmed that products distributed through few distribution centers (typically specialty pharmaceuticals) would not have to meet this requirement. However, the agency's written answer states that the only exception is items to be drop shipped from the manufacturer.

It is not feasible to meet this requirement for all products. Will DLA reconsider its response to be consistent with that provided orally at the bidders conference?

During the preproposal conference, DLA used specialty pharmaceuticals as an example of a product that is typically drop shipped from a manufacturer or a specialty distribution channel. DLA will revise Statement of Work, Section 7, paragraph F(9). Order Placement/Delivery (page 41) in Amendment P0002 to reflect as such.

Can DLA advise on how it is interpreting the Trade Agreements Act since the Acetris decision?

The Acetris decision makes clear the Contracting Officer will explain how the contractor is determine TAA status. Specifically, it would be helpful to know if API is made in a non-TAA country and moved to a non-US, TAA-compliant country for final formulation/production, is it TAA compliant?

DLA does not provide legal opinions on the interpretation of the Acetris decision or any other related contractual matters to contractors.

The RFP provided volume for FY18, FY19 and FY20 that was purchased through Mail Order. It also provided a file of Specialty volume (per the DoD’s definition) with expected volume across both Mail Order and the new Specialty Pharmacies. Is there any volume expected from the Specialty Pharmacies that does not meet the DoD’s specialty definition, and has thus not yet been provided?

DLA is currently unaware of the exact utilization of the specialty pharmacies that will be included under NPV GENIV. As previously noted, volume is only estimated as specialty pharmacy locations will be new to GENIV and are not known yet at this time.

A product is required to meet 4 of 6 criteria as laid out in the RFP. Per DoD response, criteria 5 is only for REMS products. However, REMS is also listed in criteria 3 as “special handling”.

In the DLA’s response, REM’s products were used as an example of pharmaceuticals that would meet criteria 3 or criteria 5. REMS products are not the only type of pharmaceutical that would meet criteria 5. Any pharmaceutical that can be proven to require unique distribution would be eligible to meet criteria 5.

As to Criterion #5 (non-traditional channel) for the specialty pharmaceutical definition, please confirm that consistent with industry standards products distributed to a specialty pharmacy would meet this criterion.

DLA agrees that consistent with industry standard, a majority of products distributed to a specialty pharmacy would be considered as a non-traditional channel.

With two criteria centered around REMS and special handling, there is structurally no room for any oral products to meet the majority of the criteria. This is outside the norm for market definitions (see attached IQVIA and HDA definitions) and causes products that are widely accepted as specialty to not be included on the list. This includes Hep C and HIV products which only meet 3 of the 6 DoD criteria (1,4, and 6), but the majority of IQVIA and HDA criteria.

DLA disagrees that any of the 6 criteria are solely focused on REMS products. As previously noted, REMS products were merely used as an example when describing some of the criteria. DLA however, does acknowledge that criteria 6 “requires extensive monitoring of therapy and/or patient counseling or requires reimbursement assistance” was inadvertently combined and should be separated. This will be revised in Amendment P0002.

As a follow-up to Question #12, the DOD stated that “Specialty drugs would be taken out of the contract all together. The NPV would be notified of this decision 60 days prior to the start of a contract period if this decision were made.” Since Specialty products are estimated by the DOD to be 20% of the total spend, this scenario would result in a significant change in product mix and could pose significant business risk to the NPV. When the DOD notifies the NPV of this decision, will DoD agree to adjust the pricing for the remaining business?

DLA Troop Support does not intend to renegotiate distribution fees in the event specialty pharmaceuticals are removed from the NPV GENIV contract. In accordance with the Statement of Work Section 1(E) Specialty Pharmaceuticals, DLA Troop Support reserves the right to reevaluate and remove specific specialty pharmaceuticals from the NPV contract. Notification will be provided to the NPV at least 60 days prior to the removal of any specialty pharmaceutical. In addition, if it is determined that the requirement for replenishing specialty pharmaceuticals is no longer needed, the Government reserves the right to remove all specialty pharmaceuticals from the NPV contract. Notification will be provided at least 60 days prior to the start of the next option period if the Government expects to exclude specialty replenishment from the contract.