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Lutetium-177 vipivotide tetraxetan for treating PSMA-positive hormone-relapsed metastatic prostate cancer after 2 or more treatments

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1 Recommendations

1.1 Lutetium-177 vipivotide tetraxetan is not recommended, within its marketing authorisation, for treating prostate-specific membrane antigen (PSMA) positive hormone-relapsed metastatic prostate cancer in adults:

  • after taxane-based chemotherapy and an anti-androgen or

  • when taxanes are medically unsuitable.

1.2 This recommendation is not intended to affect treatment with lutetium-177 vipivotide tetraxetan that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Treatments for hormone-relapsed metastatic prostate cancer that has progressed after taxane-based chemotherapy and an anti-androgen include best supportive care, radium‑223 dichloride and retreatment with taxanes (for example, cabazitaxel).

Evidence from a clinical trial shows that lutetium-177 vipivotide tetraxetan increases the time before the cancer gets worse and how long people live compared with best supportive care. There is no evidence from a direct comparison with cabazitaxel. Indirect comparisons suggest that lutetium-177 vipivotide tetraxetan may be more effective than cabazitaxel. But they all have limitations, so the results are uncertain. Radium‑223 dichloride may be a comparator for a few people. But no evidence was submitted for this comparison, so it could not be considered.

Lutetium-177 vipivotide tetraxetan meets NICE's criteria for a life-extending treatment at the end of life compared with best supportive care. It is unclear whether this is the case when it is compared with cabazitaxel because of the uncertainty in the clinical evidence. But, for both comparisons, the most likely cost-effectiveness estimates for lutetium-177 vipivotide tetraxetan are much higher than what NICE normally considers an acceptable use of NHS resources. So, it is not recommended.