Prostate Cancer UK criticises decision to reject hormone therapy

Prostate Cancer UK has criticised the National Institute for Health and Care Excellence (Nice) over its interim decision to reject the use of a hormone therapy for men with the disease.

The charity warned the rejection of apalutamide could leave thousands of men each year without access to a life-extending treatment.

It said this is the second rejection in six months of a new treatment that could help men newly diagnosed with advanced prostate cancer.

According to the charity, the new treatments are particularly important for patients who cannot receive the standard treatment of docetaxel chemotherapy.

This is more likely to affect older men and those with other health conditions and will also affect anyone whose cancer has progressed from localised disease.

These men would be left with limited treatment options and face missing out on months of additional life, the charity said.

Nice also reviewed apalutamide as a treatment for men with localised disease that has stopped responding to standard hormone therapies.

While these men have alternative treatments available, Prostate Cancer UK believes they should be offered the choice of apalutamide if it can be made available to the NHS at a price it can afford.

The charity is calling for Nice and the pharmaceutical companies involved to do everything they can to make sure a suitable treatment is approved for men who are not able to receive chemotherapy.

The initial rejections of apalutamide and abiraterone make it even more essential that enzalutamide is approved when updated guidance is published next month, it said.

Angela Culhane, chief executive at Prostate Cancer UK, said: “For the second time in six months, Nice has rejected a treatment which could have given thousands of men more valuable time with their families.

“This is particularly concerning for men who can’t have chemotherapy, who face being left with no real alternative.

“It is now vital that Nice and the pharmaceutical companies involved act urgently to make sure these men have access to an effective treatment.”

Nice said trial results suggest that, compared with placebo plus ADT, apalutamide plus ADT increases the time until the disease gets worse and how long people live.

However, this evidence is uncertain because in the trial some people could switch to other treatments, and some people could receive treatments not available with the NHS.

In addition, estimates are uncertain for how long it took until people’s disease got worse after the clinical trial had ended and how long people lived.

The cost-effectiveness estimates in the analyses which best reflect the committee’s preferred assumptions are above what Nice considers an acceptable use of NHS resources.

Therefore, apalutamide plus ADT has not been recommended for adults with hormone-relapsed non-metastatic prostate cancer, or with hormone-sensitive metastatic prostate cancer.

A Nice spokesman said: “Nice understands that today’s announcement will be disappointing for some people with prostate cancer.

“However, this is not Nice’s final guidance on apalutamide and the recommendations may change after public consultation.

“After consultation the independent appraisal committee will meet again to consider the evidence, this appraisal consultation document and comments from the consultees, including the company and patient groups, as well as from people who are not consultees.

“We would therefore urge anyone with an interest in this appraisal to submit their comments ahead of the 11 June deadline.”