Gallium-68 gozetotide (PSMA-11)
Gallium-68 PSMA-11 was the first PSMA PET tracer approved in the US (2020), and is made on site from a generator or cyclotron.
UCLA/UCSF academic NDA (2020) established PSMA PET; Telix's Illuccix (kit, 2021) and Gozellix (2025, longer shelf-life), Novartis' Locametz (2022, companion for Pluvicto). Competes with 18F agents (Pylarify, Posluma) that offer central distribution.
- Medicare
- Part B (clinician-administered)
Diagnostic radiopharmaceutical billed with the PET/CT scan under Part B. Since 2025, Medicare's hospital outpatient system pays separately for diagnostic radiopharmaceuticals whose per-day cost exceeds a threshold, which covers PSMA agents. Medicare Administrative Contractors decide PET coverage for prostate cancer; all now cover PSMA PET for initial staging of unfavourable risk disease and biochemical recurrence.
- Commercial insurance
- covered with prior authorisation
PSMA PET is covered by most commercial plans for staging and recurrence with prior authorisation for the imaging procedure; radiology benefit managers apply appropriateness criteria.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Diagnostic non-laboratory tests (imaging). Not medical or financial advice; verify with your plan.
- Appraised for
- PSMA PET-CT for prostate cancer staging and recurrence
- Notes
- Radiopharmaceuticals are not appraised as TAs. PSMA PET-CT is commissioned by NHS England (clinical commissioning policy) for biochemical recurrence and high-risk staging, and is required to select patients for Pluvicto. Locametz and Illuccix are MHRA-licensed kits.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE search: gallium-68 PSMA-11 PET. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2020 | PSMA PET (UCLA/UCSF NDA); kits 2021-2022 |
Trials
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Latest papers
topQuery for this drug: (TITLE:"Gallium-68 gozetotide" OR ABSTRACT:"Gallium-68 gozetotide" OR TITLE:"PSMA-11" OR ABSTRACT:"PSMA-11" OR TITLE:"Illuccix" OR ABSTRACT:"Illuccix" OR TITLE:"Gozellix" OR ABSTRACT:"Gozellix" OR TITLE:"Locametz" OR ABSTRACT:"Locametz") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gallium-68 gozetotide (PSMA-11), not a curated reading list.
Pages like this
not linked directly; found by shared links- PersonJeremie Calais
Shares UCLA Jonsson Comprehensive Cancer Center, PSMA, PSMA PET, Prostate cancer.
- PersonThomas A. Hope
Shares UCSF Helen Diller Family Comprehensive Cancer Center, PSMA, PSMA PET, Prostate cancer.
- PersonJohannes Czernin
Shares UCLA Jonsson Comprehensive Cancer Center, PSMA, PSMA PET, Prostate cancer.
- PersonRahul Aggarwal
Shares UCSF Helen Diller Family Comprehensive Cancer Center, PSMA, PSMA PET, Prostate cancer.
- CompanyClarity Pharmaceuticals
Shares PSMA, PSMA PET, Prostate cancer.
- ProductFlotufolastat F-18
Shares PSMA, PSMA PET, Prostate cancer.
- PersonPeter Bartenstein
Shares PSMA, PSMA PET, Prostate cancer.
- PersonOwen N. Witte
Shares UCLA Jonsson Comprehensive Cancer Center, PSMA, Prostate cancer.