6505--f-18 psma pylarify

Effective Date: 02/01/2022

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DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C246-24-AP-1230

Contracting Activity: Department of Veterans Affairs, VISN 6, Durham VA Medical Center, Station 558, 508 Fulton Street. Durham, NC 27705. 2237 number 558-24-3-241-0010,

Nature and/or Description of the Action Being Processed: This procurement is for F-18 Piflufolastat (Pylarify) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This action is for a new firm fixed price base plus 4 option year acquisition of a supply. The planned award date is June 15, 2024 with an estimated value of $747,005.04 from Jun 15 to Dec 31, 2024. The length of the award coincides with the medical centers need to provide uninterrupted imaging, staging, and treatment of prostate cancer. The proposed contractor is:

Name of Proposed Contractor: Lantheus

Street Address: 331 Treble Cove Rd.

City, State, Zip: N. Billerica, MA 01862

Phone: 1-800-362-2668

Description of Supplies/Services Required to Meet the Agency s Needs: The Durham VA Health Care System (DVAHCS) is currently using F-18 Pylarify. This solicitation requires F-18 Pylarify (Piflufolastat) in a 3cc syringe with a minimum volume of 0.5 ml, a prostate specific membrane antigen (PSMA) agent which allows for positron emission tomography (PET) imaging to be utilized in the diagnosis and treatment of prostate cancer. The estimated value of this requirement is

$866,092.80 for the following:

Products

Item#

Description/Part Number

Qty

Price per unit

Ext. Amount

NDC 71258-022-01

PYLARIFY Injection mfr Prod Number PYL-C base 6/15/24-12/31/24

207

$3,608.72

$747,005.04

Subtotal

207

$3,608.72

$747,005.04

Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(x ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement

( ) Authorized or Required by Statute ( ) National Security

( ) Public Interest

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; Pylarify injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate specific membrane antigen positive lesions in men with prostate cancer. PYLARIFY® can only be purchased through Lantheus, the manufacturer. A new F-18 based radiotracer is available F-18 Posluma, but it does not perform in exactly the same manner as Pylarify. As such, F-18 Posluma will suffer small differences in repeat exams.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: An intent to sole source will be posted in accordance with FAR 5.202(a)(13)(ii).

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The offeror has offered firm fixed pricing for the entire contract period without increases. The current pricing offer is the same as pricing previously negotiated by the government.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research demonstrated the required item is available only from Lantheus and is on NAC contract 36F79719D0170. Lantheus is the only manufacturer and provider of Pylarify.

There are currently four FDA approved prostate specific membrane antigen (PSMA) imaging agents.

F18 Pylarify- the only acceptable choice for the Durham VA to maintain continuity of care.

F-18 Posluma-Different structure and binds differently in some organs (kidneys). Will suffer when comparing to prior exams performed with Pylarify.

Ga-68 Locametz- Differences in imaging characteristics and half-life

Ga-68 Illucix- Differences in imaging characteristics and half-life

Pluvicto (Lutetium 177 vipivotide tetraxetan) is a radiopharmaceutical treatment for adults with advanced PSMA positive metatstatic castration-resistant prostate cancer that has already been treated with other anticancer treatments. Pylarify is currently used by Durham VA medical centers community partners to select patients for Pluvicto treatment and Pylarify is more structurally similar to Pluvicto than Posluma.

There are significant differences between F-18 and Ga-68. One of the most important differences between F-18 and Ga-68 is the half-life of the isotope. Half-life governs the amount of time the PSMA agent is useful for, with a 68-minute half-life, the dose becomes unusable a very short time after the calibration time. F-18 has an additional 40 minutes of half-life which allows more flexibility for patients that arrive late, cannot find parking, or are difficult to gain intravenous access. The opportunity to waste/lose a dose due to these issues must be avoided.

F-18 has been demonstrated to provide better spatial resolution than Ga-68 based on the different characteristics of each isotope. See Physical performance comparison of Ga-68 and F-18 in small animal PET system, Journal of Nuclear Medicine May 2010, Volume 51 Issue supplement titled: Physical performance comparison of Ga-68 and F-18 in small animal PET system | Journal of Nuclear Medicine (snmjournals.org).

Any Other Facts Supporting the Use of Other than Full and Open Competition: Radiologists familiar with the image appearance and biodistribution of Pylarify will be best served if the Durham VA continues to use the same tracer.

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Lantheus, 331 Treble Cove Rd., N. Billerica, MA 01862.

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions of this type to be competed. Awarded contract 36C24624P1326 to PROGENICS PHARMACEUTICALS INC for 747005.04000000 on 2024-06-07.