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New HTA Decisions in England
October 2021
Drug name
ERLEADA® (apalutamide)
Company
Janssen
Decision date
08/09/2021
Therapeutic area
Cancer
Therapeutic sub area
Prostate cancer
Decision
Recommended
Indication
Apalutamide plus androgen deprivation therapy (ADT) is recommended as an option for treating hormone‑relapsed non‑metastatic prostate cancer that is at high risk of metastasising in adults. High risk is defined as a blood prostate-specific antigen (PSA) level that has doubled in 10 months or less on continuous ADT.
Decision Detail
The company has a commercial arrangement (simple discount patient access scheme).
Summary
Clinical trial evidence came from SPARTAN which was a phase 3, randomised, multicentre trial comparing apalutamide plus ADT (n=806) with placebo plus ADT (n=401) for hormone-relapsed non-metastatic prostate cancer. The trial population had adenocarcinoma of the prostate that was hormone relapsed and at high risk of metastasis. High risk was defined as a blood prostate specific antigen (PSA) doubling time of 10 months or less during continuous ADT before randomisation. In SPARTAN, the median metastases-free survival was 40.5 months for people randomised to apalutamide plus ADT and 15.7 months for people randomised to placebo plus ADT. The median overall survival was 73.9 months for people randomised to apalutamide plus ADT and 59.9 months for people randomised to placebo plus ADT. The median progression-free survival on the first subsequent treatment taken for metastatic disease (PFS2) was 55.6 months for people randomised to apalutamide plus ADT and 41.2 months for people randomised to placebo plus ADT. The mean change in EQ-5D-3L visual analogue score showed improvements in the apalutamide plus ADT arm compared with the placebo plus ADT arm at cycles 21 (mean difference 3.03) and 25 (mean difference 3.28), p<0.05. The committee concluded that apalutamide plus ADT extended metastases-free survival, overall survival, PFS2 and health-related quality of life when compared with placebo plus ADT, and was clinically effective. Because of confidential commercial arrangements for apalutamide and other treatments in the pathway, the cost-effectiveness estimates cannot be reported here. However, the committee considered that the incremental cost effectiveness ratio (ICER) that most closely reflected its preferred assumptions was below the middle of the range of £20,000 to £30,000 per QALY gained. Therefore, apalutamide is recommended as a cost-effective use of NHS resources for treating hormone-relapsed non-metastatic prostate cancer.