Bristol-Myers Squibb Company, B-294944.2, January 18, 2005

B-294944.2 Jan 18, 2005 Jump To VIEW DECISION DOWNLOADS RELATED PAGES GAO CONTACTS Highlights Bristol-Myers Squibb Company (BMS) protests the terms of request for proposals (RFP) No. RFP-797-NC-04-0016, issued by the Department of Veterans Affairs (VA) for Angiotensin II Receptor Antagonists, also known as Angiotensin II Receptor Blockers (or ARBs), for the treatment of patients with both hypertension and type 2 diabetes mellitus with nephropathy. The ARB selected in this procurement will be the only ARB designated on the VA's National Formulary for treatment of the condition described above. BMS argues that the RFP's price evaluation approach will not identify the proposal that will provide the actual lowest price to the government. We deny the protest. View Decision B-294944.2, Bristol-Myers Squibb Company, January 18, 2005 Decision Matter of: Bristol-Myers Squibb Company File: B-294944.2 Date: January 18, 2005 Alex D. Tomaszczuk, Esq., and Jack Y. Chu, Esq., Shaw Pittman, for the protester. Melbourne A. Noel, Jr., and Philip S. Kauffman, Esq., Department of Veterans Affairs, for the agency. [1] Ralph O. White, Esq., and Christine S. Melody, Esq., Office of the General Counsel, GAO, participated in the preparation of the decision. DIGEST Agency's use of a price evaluation scheme in a pharmaceutical procurement that compares prices for two drugs on a per-tablet basis is unobjectionable where the record shows that the optimal dosing level for both drugs is a single pill taken once daily, and where the agency has no valid data for estimating other dosing levels of these drugs, and does not expect other dosing levels to be ordered in significant quantities. DECISION Bristol-Myers Squibb Company (BMS) protests the terms of request for proposals (RFP) No. RFP-797-NC-04-0016, issued by the Department of Veterans Affairs (VA) for Angiotensin II Receptor Antagonists, also known as Angiotensin II Receptor Blockers (or ARBs), for the treatment of patients with both hypertension and type 2 diabetes mellitus with nephropathy. The ARB selected in this procurement will be the only ARB designated on the VA's National Formulary for treatment of the condition described above. BMS argues that the RFP's price evaluation approach will not identify the proposal that will provide the actual lowest price to the government. We deny the protest. BACKGROUND The RFP here was released on August 23, 2004, and anticipates award of a fixedprice, indefinite-quantity contract for a base period of 1 year, with up to four 1year options. On its face, the RFP limited this competition to two ARBs--Irbesartan (manufactured by BMS and Sanofi, marketed as Avapro) and Losartan (manufactured by Merck, marketed as Cozaar). As indicated above, the RFP also advised that these drugs were being purchased for the treatment of hypertension and type 2 diabetes mellitus with nephropathy, and that the successful offeror's drug would be the only ARB listed on the formulary for treatment of this condition. [3] Prior to the release of the RFP here, doctors from the VA's Pharmacy Benefits Management (PBM) Section, together with the VA's Medical Advisory Panel (MAP)--a panel of 13 physicians throughout the VA and the Department of Defense--prepared a Drug Class Review of all available ARBs. Agency Report (AR) at 2. This Drug Class Review was first completed in 2003, was revised in June 2004, and is appended to the RFP (as Attachment C). Id. Using the findings of the Drug Class Review, the VA's PBM and MAP doctors prepared a second document explaining the VA's purchasing approach for ARBs. This document--also appended to the RFP (as Attachment D)--is entitled, "Medical Determination of Minimum Needs for VA National Formulary Selection of an [ARB]," hereinafter the "Medical Needs Determination." The VA's Medical Needs Determination reflects several decisions related to the dispute in this protest. Specifically, the document explains that ARBs are not the VA's preferred method of treating simple hypertension-- i.e. , hypertension not accompanied by complications such as heart failure or diabetic nephropathy. See Medical Needs Determination at 1, 3. In fact, the Determination advises that there are four different classes of antihypertensive medications, several of which should be tried prior to prescribing an ARB for simple hypertension. Id . at 3; see also AR, Tab 4 (e-mail from PBM Section to the CO, and others, dated Sept. 16, 2004, explaining the hierarchy of treatment for simple hypertension). [4] As a result, while the VA concedes there may be some usage of ARBs to treat patients with simple hypertension, that is not the purpose of this procurement. Instead, the VA has decided to purchase ARBs for two discrete conditions: (1)hypertension with diabetic nephropathy (the instant procurement), and (2) heart failure (which is being procured simultaneously via a different RFP). Medical Needs Determination at 1.