Following a full submission considered under the orphan equivalent process:
enzalutamide (Xtandi®) is not recommended for use within NHSScotland.
Indication under review: The treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC).
In a phase III study in men with high-risk non-metastatic CRPC enzalutamide was superior to placebo for metastasis-free survival. High-risk was defined as prostate specific antigen (PSA) doubling time ≤10 months and PSA ≥2 nanograms/mL. Both groups received on-going androgen-deprivation therapy or had undergone bilateral orchiectomy. Overall survival data are immature.
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 a sufficiently robust economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- enzalutamide (Xtandi)
- SMC ID:
- SMC2195
- Indication:
For the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). High-risk is defined as prostate specific antigen (PSA) doubling time (PSADT) ≤10 months and PSA ≥2 ng/mL.
- Pharmaceutical company
- Astellas Pharma Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 07 October 2019