NICE rejects Janssen’s prostate cancer drug Erleada
pharmafile | May 21, 2021 | News story | Medical Communications |
NICE has published has published draft guidance rejecting Janssen’s Erleada (apalutamide) with androgen deprivation therapy (ADT) for treating prostate cancer.
The draft guidance considers Erleada for treating hormone-relapsed prostate cancer in adults who are at high risk of the cancer spreading, or hormone-sensitive prostate cancer that has already metastasised.
Erleada is 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, 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.
Although the trial suggested Erleada paired with ADT increased survival, NICE did not consider the evidence certain as some people in the trial could switch to other treatments, and some could receive treatments not available in the NHS.
NICE also stated that estimates were uncertain of how long it took for the disease to worsen after the clinical trial had ended, and how long people lived.
NICE could therefore not recommend Erleada as an acceptable use of NHS resources based on the cost-effectiveness analysis.
Janssen has agreed a confidential discount to the list price of £2,735 per pack of 112 tablets – but NICE said that the drug is too expensive for the NHS in England and Wales.
In a statement, Janssen said it is “disappointed” with the decision but remains “committed to working with NICE throughout the subsequent stages of this appraisal” to “enable routine access” to Erleada.
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