CMS grants Transitional Pass-Through payment status to flotufolastat F 18

The Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through payment status for diagnostic radiopharmaceutical reimbursement of flotufolastat F 18 (formerly 18F-rhPSMA-7.3; trade name, Posluma) injection for patients with prostate cancer.¹

Flotufolastat F 18 was approved by the FDA in May 2023 for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level.

The high-affinity radiohybrid imaging agent was approved by the FDA in May 2023 for PET imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level.²

“We are very pleased that CMS has granted Pass-Through status for Posluma, as it increases patient access to our innovative product to inform patient management,” said Chief Executive Officer of Blue Earth Diagnostics David E. Gauden, DPhil, in a news release.¹

Gauden continued, “Posluma provides physicians with high-quality diagnostic information based on its diagnostic performance even at low PSA levels, high-affinity PSMA binding and potential for low urinary bladder activity. Blue Earth Diagnostics has a world-class franchise in prostate cancer imaging radiopharmaceuticals, with 2 FDA-approved, commercially available 18F-labeled PET imaging agents for prostate cancer. Blue Earth Diagnostics is strongly positioned to help physicians expand informed management and treatment options for men with prostate cancer across the care continuum.”

The reimbursement code for flotufolostat F 18 will be effective October 1, 2023.

Data supporting FDA approval of Flotufolastat F 18

The FDA approval of flotufolastat F 18 is based on findings from the phase 3 SPOTLIGHT and LIGHTHOUSE trials.

Updated data from the phase 3 SPOTLIGHT trial (NCT04186845) were presented at the American Urological Association 2023 Annual Meeting and showed that PET imaging with 18F-rhPSMA-7.3 frequently led to post-scan disease upstaging in men with prostate cancer recurrence compared with baseline conventional imaging.³

In total, 18F-rhPSMA-7.3 showed a correct detection rate (CDR) between 45% and 47% in 250 of 366 men who had negative baseline conventional imaging. CDR was defined as the percentage of patients scanned with at least 1 true positive PET finding compared with the Standard of Truth of histopathology or confirmatory conventional imaging. Upstaging results were found to vary depending on prior treatment and anatomical region.

Initial data from the phase 3 LIGHTHOUSE trial (NCT04186819) were presented at the 2022 Society of Urologic Oncology Annual Meeting and showed that use of 18F-rHPSMA-7.3 PET prior to prostatectomy was associated with positive disease detection.⁴

According to 3 readers, 7.8% to 13.0% of patients (n = 296) had an 18F-rHPSMA-7.3 PET–positive pelvic lymph node. Extrapelvic lesions were also identified in 16% to 28% of patients in an extended population (n = 352) that included those who received 18F-rHPSMA-7.3 PET regardless of surgery.

The safety of flotufolastat F 18 was evaluated in a population of 747 patients with initial or recurrent prostate cancer enrolled across clinical trials. The most commonly reported adverse events were diarrhea, an increase in blood pressure, and pain at the site of injection, which were reported in at least .4% of patients.

References

1. Blue Earth Diagnostics announces CMS Transitional Pass-Through payment reimbursement code for POSLUMA (Flotufolastat F 18) injection, effective October 1, 2023. News release. Blue Earth Diagnostics. Published online and accessed September 26, 2023. https://www.businesswire.com/news/home/20230926993373/en/Blue-Earth-Diagnostics-Announces-CMS-Transitional-Pass-Through-Payment-Reimbursement-Code-for-POSLUMA%C2%AE-Flotufolastat-F-18-Injection-Effective-October-1-2023

2. U.S. FDA approves Blue Earth Diagnostics’ Posluma (Flotufolastat F 18) injection, first radiohybrid PSMA-targeted PET imaging agent for prostate cancer. Accessed September 26, 2023. https://www.businesswire.com/news/home/20230530005180/en/U.S.-FDA-Approves-Blue-Earth-Diagnostics%E2%80%99-POSLUMA%C2%AE-Flotufolastat-F-18-Injection-First-Radiohybrid-PSMA-targeted-PET-Imaging-Agent-for-Prostate-Cancer

3. Schuster DM. Detection rate of 18F-rhPSMA-7.3 PET in patients with suspected prostate cancer recurrence: results from a phase 3, prospective, multicenter study (SPOTLIGHT). J Clin Oncol. 2022(suppl 6):9. doi:10.1200/JCO.2022.40.6_suppl.009

4. Chapin BF. Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in patients with newly diagnosed prostate cancer: results from a phase 3, prospective, multicenter study (LIGHTHOUSE). Poster presented at Society for Urologic Oncology (SUO) 23rd Annual Meeting; November 30-December 2, 2022; San Diego, CA. Poster 134