1.1 Padeliporfin is not recommended, within its marketing authorisation, for untreated, unilateral, low-risk prostate cancer in adults.
1.2 This recommendation is not intended to affect treatment with padeliporfin 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
Current treatments for low-risk prostate cancer include active surveillance and, for people whose disease has progressed (usually beyond low-risk disease), radical therapies such as surgery and radiotherapy. Focal therapies such as cryotherapy and high-intensity focused ultrasound can also be used, but are not routinely available.
Professional organisations and NHS England say that there is a growing trend for people with low-risk disease to have active surveillance rather than radical therapy. This is because long-term studies show that people with low-risk disease live as long whichever they have, but radical therapies are associated with long-term, severe side effects. Also, improvements in diagnostic tests mean that low-risk disease can be more accurately identified.
The company proposes padeliporfin as an option for people with low-risk disease who choose not to have active surveillance and so would otherwise have radical therapies. There is no clinical evidence on how effective padeliporfin is at slowing the disease compared with radical therapies. Also, there is no evidence to support the company's assumption that the length of time people live with padeliporfin is the same as with radical therapies.
Clinical trial evidence comparing padeliporfin with active surveillance does show that, at 2 years, it is more effective at slowing prostate cancer. However, it is unclear whether the benefit seen at 2 years leads to people living longer. Also, it is unclear whether some of the people in the trial would have had intermediate-risk prostate cancer.
Professional organisations and NHS England do not support using padeliporfin for low-risk prostate cancer because, like radical therapies, it is associated with long-term side effects, without supporting evidence of long-term clinical benefit.
The company's cost-effectiveness analyses compare padeliporfin with radical therapies. However, because there is no clinical-effectiveness evidence comparing padeliporfin and radical therapies, it is not possible to consider these analyses. Therefore, padeliporfin cannot be recommended for untreated, unilateral, low-risk prostate cancer.