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'.
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 and retreatment with taxanes (for example, cabazitaxel). Some people may be eligible for radium‑223 dichloride, but no evidence was submitted comparing lutetium‑177 vipivotide tetraxetan with radium‑223 dichloride, so this comparison could not be considered.
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 also evidence from a trial directly comparing lutetium‑177 vipivotide tetraxetan with cabazitaxel, but this has limitations. Indirect comparisons suggest that lutetium‑177 vipivotide tetraxetan may work better than cabazitaxel. But these also have limitations. So, the evidence for lutetium‑177 vipivotide tetraxetan compared with cabazitaxel is uncertain.
When compared with best supportive care, lutetium‑177 vipivotide tetraxetan meets NICE's criteria for a life-extending treatment at the end of life. It is unclear whether this is the case when it is compared with cabazitaxel because of the uncertainty in the clinical evidence. The most likely cost-effectiveness estimates for lutetium‑177 vipivotide tetraxetan compared with best supportive care and cabazitaxel are higher than what NICE normally considers an acceptable use of NHS resources, even when taking the end of life criteria into consideration. So, it is not recommended for routine use.
Because of the high cost-effectiveness estimates and a lack of new data comparing lutetium‑177 vipivotide tetraxetan with relevant medicines, it cannot be recommended for use in the Cancer Drugs Fund.