Sole Source Justification - PreserVision_2-7-22.pdf

Department of Veterans Affairs Office of Acquisition and Logistics

National Acquisition Center, National Contract Service

Hines, Illinois 60141

Justification for Other than Full and Open Competition

(1) Identification of Agency and Contracting Activity and specific identification of the document:

Justification for other than full and open competition is provided by The Department of Veterans Affairs, Office of Acquisition and Logistics, National Acquisition Center.

This document sets forth the justification and approval for other than full and open competition for the acquisition described herein, under the authority of FAR 6.302-1

“only one responsible source and no other supplies or services will satisfy agency requirements”.

(2) Nature and/or description of the action being approved:

Preservision AREDS Lutein and AREDS2 Formula are branded medications with no generic alternative. Preservision AREDS Lutein and AREDS2 Formula is currently provided by Bausch Health US, LLC to VA and other government agencies through

National Contract VA797E-17-C-0043 for a five year period, 08/01/2017 - 07/31/2022, which was awarded and administered by the National Acquisition Center. The contemplated contract will have a base year with 4 one-year option periods. The VA National Contracts Service was recently informed of a novation with

Bausch that will take place within the next couple of months. Bausch & Lomb Merge, LLC was created, divided from Bausch Health US, LLC, then merged with Bausch & Lomb Americas, Inc. Bausch & Lomb Americas Inc. will be the entity that spins off and that name will remain. For the purposes of this procurement, the name of the contractor shall be named “Bausch” until the novation has been completed. The Government intends to enter into a sole source contract with Bausch for Preservision AREDS Lutein and AREDS2 Formula, a branded medication with no generic alternative.

(3) Description of the supplies or services required to meet the agency’s needs (including the estimated value)

Preservision AREDS Lutein and AREDS2 Formula must be made available for patients with macular degeneration. The Age-Related Eye Disease Study (AREDS) evaluated the effects of a high-dose vitamin supplement that contained Vitamin A

(as B-carotene), Vitamin E, Zinc oxide and copper. AREDS2 is a study that further investigated the addition of antioxidants (lutein + zeaxanthin) to the original AREDS vitamin formula as well as evaluated the effects of removing Vitamin A (B-carotene) and reducing zinc oxide content. These findings revealed that eliminating Vitamin A (B-carotene) did not have an apparent effect on vision. However, the presence of Vitamin A (B-carotene) did have potential harmful effects in patients considered to be smokers or former smokers. Because of these safety concerns and apparent lack of benefit, it is recommended that ocular vitamins with Vitamin A (B-carotene) not be used in the Veteran population. Preservision AREDS Lutein and AREDS2 Formula do not contain Vitamin A (B-carotene) which makes these appropriate supplements for Veterans. The exact formulation in Preservision AREDS lutein and AREDS2 formulas were used in the AREDS trial, and there is high quality clinical evidence to suggest safety and effectiveness for only this combination of ingredients

The contractor shall be required to provide the estimated requirements of Preservision AREDS Lutein and AREDS2 Formula listed in the table below to meet the agencies’ (VA, IHS, DOD, and BOP) needs.

The following branded products are required to meet the agencies’ needs.

NDC/UPC DESCRIPTION BRAND NAME

PACKAGE

SIZE

(BOTTLES)

TOTAL

ESTIMATED

ANNUAL USAGE

(BOTTLES)

TOTAL

ESTIMATED

ANNUAL

EXPENDITURES

24208-0632-11

MULTIVITAMIN/OPHTH

ANTIOXIDANT/LUTEIN

CAP/TAB

PRESERVISION

ARED WITH

LUTEIN 120 21,776 $443,359

24208-0697-62

MULTIVIT/OPHTH

AREDS2/LUTEIN/ZEAXANTHIN

CAP/TAB

PRESERVISION

ARED2 120 505,693 $11,059,506

$11,502,865

Base + 4 Option

Yrs $57,514,326

(4) Identification of the statutory authority permitting other than full and open competition:

The statutory authority permitting other than full and open competition is 41 U.S.C.

3304 (a) (1) as implemented by FAR 6.302-1, which authorizes, under certain conditions, contracting without providing for full and open competition when the agencies’ requirements can only be provided from one responsible source and no other supplies or services will satisfy agency requirements. AREDS is only available from one source, Bausch, due to patent exclusivity.

(5) Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited:

All Preservision AREDS Lutein and AREDS2 Formula are manufactured in a non- TAA country and subject to Public Law 102-585, and are unique to the manufacturer. Bausch is currently the only manufacturer of Preservision AREDS

Lutein and AREDS2 Formula. VHA indicates that a need exists for this type of formula based on the attached Clinical Justification. No other source can meet the government’s needs for the Preservision AREDS Lutein and AREDS2 Formula over the contemplated contract period (Base plus 4 Option Years) because Bausch currently holds a patent and thus market exclusivity. Although the composition patent has recently expired, the method of use patent won’t expire until 2026. As of now, there are no comparable products available in the market.

(6) Description of the efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and , if not, which exception under 5.202 applies:

For the reasons stated above Bausch is the only potential source of Preservision AREDS Lutein and AREDS2 Formula. The proposed action will be publicized on the Federal Business Opportunities website at beta.sam.gov with the Government’s intent to sole source these formulas. The Justification for Other than Full and Open Competition also will be made available at beta.sam.gov

(7) A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable:

A determination of fair and reasonable price will be made prior to award based on the analysis of current commercial market prices. Pursuant to Public Law 102-585, Veterans Health Care Act of 1992, Section 603, pricing for covered drugs is capped at no greater than 76% of the non-Federal Average Manufacturer Price (non-FAMP) for VA, IHS, DOD and the BOP. Therefore, under this contract, VA, IHS, DOD and BOP (participants under this contract) will receive at least a 24% discount from the net prices wholesalers pay to manufacturers for covered drugs. This is commonly known as the Federal Ceiling Price (FCP). The FCP is calculated and established annually by the VA. VA, DOD, FHCC, and IHS will pay no more than the calculated FCP for Preservision AREDS. BOP is not part of the Big4. If different prices are proposed for BOP, the determination that the prices are fair and reasonable will be made on a comparison of previous FSS prices awarded for BOP and a comparison of prices offered to the Big4.

(8) A description of the market research conducted, the results or a statement of the reason market research was not conducted.

The program office identified one possible vendor (Bausch) for the AREDS Lutein and AREDS2 Formula. The Contracting Officer performed both a Veteran Information Pages (VIP) search and a Dynamic Small Business Search (DSBS), but did not identify any additional potential sources that may be able to provide this http://www.fbo.gov/ http://www.fbo.gov/ product. A search through Orangebook and Dailymed websites, further concluded that there is only one known manufacturer (Bausch) of Preservision AREDS Lutein and AREDS2 Formula that will meet the Government’s requirement for the Age-

Related Eye Disease Study (AREDS) recommended slowing progression to advanced macular degeneration.

(9) Other facts supporting the use of other than full and open competition:

The intended procurement will be applicable only to branded pharmaceuticals, subject to Public Law 102-585, Section 603. These items, unique to each manufacturer, are available only from one source.

(10) List of sources, if any, that expressed, in writing, an interest in the acquisition:

Despite conducting extensive market research, Bausch was the only company that expressed, in writing, an interest in the acquisition. In accordance with FAR 6.302- 1(c)(1)(ii)(c) & 6.305(c) this justification will be posted with the government’s solicitation. However, for the reasons stated above, there is no expectation that any other source will be able to participate in this procurement.

(11) Statement of actions the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required:

Bausch is currently the sole manufacturer of the branded drugs Preservision AREDS Lutein and AREDS2 Formula that will meet the Government’s requirement for the

Age-Related Eye Disease Study (AREDS) recommended to slow progression to advanced macular degeneration for the Base plus 4 Option Years. The procurement of this drug will be made under competitive, negotiated procedures once its patent expires in 2026. If the medications become available in the generic form the contract will be reviewed to determine if prices are fair and reasonable.

TECHNICAL AND REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this justification and which form a basis for this justification are complete and accurate.

__ _______________________ 01/10/2022

Date Sue Patterson VHA Pharmacy Benefits Management

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge and belief.

1/10/2022 Diana Martinez, Contracting Officer Date VA National Acquisition Center, Hines, Illinois

LEGAL REVIEW

Concur as to the formalities and requirements In FAR 6.302-1 only.

CONTRACTING ACTIVITY COMPETITION ADVOCATE

REVIEW AND APPROVAL

Approval of this action is granted based on the above Justification and Certifications from Pharmacy Benefits Management and the Contracting Officer.

Craig Robinson, Associate Executive Director Date VA National Acquisition Center, Hines, Illinois