following a full submission assessed under the end of life and orphan equivalent medicine process:
lutetium (177Lu) vipivotide tetraxetan (Pluvicto®) is not recommended for use within NHSScotland.
Indication under review: Treatment of adult patients with prostate specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.
177Lu vipivotide tetraxetan, compared with cabazitaxel, increased prostate specific antigen (PSA) response rate in adults with mCRPC previously treated with docetaxel. The addition of 177Lu vipivotide tetraxetan to standard of care increased progression free and overall survival in adults with mCRPC previously treated with at least one androgen receptor pathway inhibitor (ARPI) and one or two taxane regimens.
The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present sufficiently robust clinical and economic analyses to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
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Medicine details
- Medicine name:
- lutetium (177Lu) vipivotide tetraxetan (Pluvicto)
- SMC ID:
- SMC2517
- Indication:
Treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.
- Pharmaceutical company
- Advanced Accelerator Applications
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 09 October 2023