Reimbursement and regulatory plumbing caught up with PSMA PET this week: CMS granted transitional pass-through payment status to Lantheus’s PYLARIFY TruVu effective October 1, and the FDA handed Telix Fast Track designation for its pre-biopsy BiPASS program the same day. Paired with ASTRO data showing radioligand therapy matching hormone therapy’s progression-free survival benefit alongside SBRT, with fewer severe side effects, the pieces needed to scale PSMA-guided care are moving faster than practice billing workflows are.

CMS granted transitional pass-through payment status to Lantheus’s PYLARIFY TruVu (piflufolastat F 18), effective October 1, 2026, alongside a permanent HCPCS code for the PSMA PET imaging agent. The designation enables separate hospital-outpatient reimbursement during the product’s commercial launch window, removing one of the most common barriers new radiopharmaceuticals face — being bundled into a flat procedure payment that does not cover their cost. Lantheus Chief Commercial Officer Amanda Morgan called it an important milestone for the company’s PSMA PET franchise. The timing matters because it landed the same day the FDA gave Telix Fast Track status for a competing pre-biopsy PSMA PET pathway, signaling that both the payer and regulatory sides of the imaging ecosystem are moving in the same direction at once.

A UCLA-led three-arm analysis presented at ASTRO 2026 found that adding either 177Lu-PSMA radioligand therapy or hormone therapy to metastasis-directed SBRT delayed progression far beyond SBRT alone: a median of 19.4 months with radioligand therapy and 21.7 months with hormone therapy, versus 6 months with SBRT alone. The two active arms performed comparably on progression-free survival. Grade 3 or higher side effects occurred in 10% of patients on radioligand therapy versus 21% on the hormone-therapy combination, although the difference was not statistically significant. The authors conclude SBRT plus radioligand therapy appears to be an attractive hormone-sparing approach.

The phase 2 PSMAgRT trial’s five-year primary endpoint of failure-free survival did not reach statistical significance overall (66% vs. 62%), but PSMA-PET-guided radiotherapy intensification improved biochemical control specifically in high-risk and post-prostatectomy patients, with comparable grade 3 toxicity — results that support the phase III PATRON trial.

A head-to-head analysis presented at ASTRO 2026 examined how clinical factors affect detection with Blue Earth Diagnostics’ POSLUMA (flotufolastat F 18) and piflufolastat F 18 in men with biochemical recurrence at PSA levels of 0.5 ng/mL or below, the hardest range to distinguish true recurrence from background signal. Earlier results from the same study showed significantly lower urinary radioactivity with POSLUMA.

CMS’s grant of transitional pass-through status to PYLARIFY TruVu, paired with a permanent HCPCS code, both take effect October 1 and give Lantheus separate hospital-outpatient reimbursement as it prepares the product’s commercial launch.

The FDA’s Fast Track designation for Telix’s BiPASS program recognizes the imaging-first approach’s potential to cut unnecessary biopsies, since up to 75% of prostate biopsies come back negative, and supports Telix’s planned NDA submission.

Lantheus set an October 14 special shareholder meeting to vote on its $102.50-per-share-plus-CVR buyout by Curium, while the FTC’s restarted 30-day antitrust review runs toward an October 21 expiration.