NICE draft guidance recommends apalutamide for treating prostate cancer

The positive recommendations follow an improved discount to the price of apalutamide offered by the company.

The draft guidance looks at apalutamide plus ADT for treating prostate cancer in adults which either:

• No longer responds to hormone therapy (hormone-relapsed prostate cancer) in people who are at high risk of the cancer spreading to other parts of their body, or
• Is still sensitive to hormone therapy (hormone-sensitive prostate cancer) but has already spread.

Apalutamide is a type of drug called an androgen receptor inhibitor which works by blocking the effect of testosterone on prostate cancer cells.

Current treatment for hormone-relapsed non-metastatic prostate cancer is ADT (treatments which stop testosterone from reaching the cancer cells), alone or with darolutamide (another androgen receptor inhibitor). Current treatment for hormone-sensitive metastatic prostate cancer is docetaxel (a chemotherapy drug) plus ADT or ADT alone for people who cannot take docetaxel. NICE recently recommended the androgen receptor inhibitor enzalutamide plus ADT as an option as this stage of the treatment pathway.

For both types of prostate cancer the clinical trial results suggest that, compared with placebo plus ADT, apalutamide plus ADT increases the time until the disease gets worse and how long people with these types of prostate cancer live.

As this appraisal considered 2 different types of prostate cancer, 2 recommendations were made. For people with hormone-relapsed prostate cancer at high risk of spreading, the cost-effectiveness estimates are within what NICE considers to be an effective use of NHS resources.

For people with hormone-sensitive metastatic prostate cancer, apalutamide plus ADT is not cost effective compared with docetaxel. However, many people cannot or should not take docetaxel, because of its adverse effects, and for these people the most appropriate comparator is ADT alone. Compared with ADT alone, the cost-effectiveness estimates for apalutamide plus ADT are within what NICE considers to be an effective us of NHS resources. Therefore, apalutamide plus ADT is recommended for people with hormone-sensitive metastatic prostate cancer, but only if docetaxel is not suitable or cannot be tolerated.

It is estimated that around 8,000 people with hormone-sensitive or hormone-relapsed prostate cancer will now be eligible for treatment with apalutamide.

Meindert Boysen, NICE deputy chief executive and director of the Centre for Health Technology Evaluation, said: “We are very pleased that Janssen has been able to work with us to address the uncertainties in the evidence identified by the committee in the previous draft guidance. This means that we are able to produce final draft guidance recommending apalutamide as an effective and valuable additional treatment option for people with these types of prostate cancer.”

ENDS