P03 - Pylarify FY 24 - Sole Source _ Post_Redacted.pdf

Effective Date: 02/01/2022 Page 2 of 4

( ) Public Interest

5. Demonstration that the C 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, F-18 Posluma, is available but does not perform exactly the same as Pylarify. As such, F-18 Posluma will suffer small differences in repeat exams.

6. 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).

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The offerer 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.

8. 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 currently under NAC contract 36F79719D0170, which is set to expire on 8/31/2024.

Lantheus is the only manufacturer and provider of Pylarify.

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

F18 Pylarify- the only acceptable choice for the Richmond VA Medical Center VA to maintain continuity of care.

F-18 Posluma-Different structure and binds differently in some organs (kidneys). Will suffer when compared 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 metastatic castration-resistant prostate cancer that has already been treated with other anticancer therapies. Richmond VA Medical Center community partners currently use Pylarify 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 isotope's half-life. Half-life governs the amount of time the PSMA agent is useful for, and with a 68-minute half-life, the dose becomes unusable shortly after the calibration time. F-18 has an additional 40 minutes of half-life, which allows more flexibility for patients who arrive late, cannot find parking, or cannot 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).