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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
Metastases
Decision
Recommended
Indication
Apalutamide plus androgen deprivation therapy (ADT) is recommended as an option for treating hormone-sensitive metastatic prostate cancer in adults.
Decision Detail
It is recommended only if: • docetaxel is not suitable • the company provides apalutamide according to the commercial arrangement (simple discount patient access scheme). This recommendation is not intended to affect treatment with apalutamide plus ADT 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.
Summary
Clinical trial evidence comes from TITAN which was a phase 3, randomised, multicentre trial comparing apalutamide plus ADT (n=525) with placebo plus ADT (n=527) for hormone-sensitive metastatic prostate cancer. The trial population had adenocarcinoma of the prostate that had metastasised but was still sensitive to treatment with hormone therapy. The trial included people with Eastern Cooperative Oncology Group [ECOG] scores of 0, 1 or 2 and excluded people with severe haematological, hepatic or renal dysfunction. In TITAN, the median radiographic progression-free survival was not reached for people randomised to apalutamide plus ADT and 22.1 months for people randomised to placebo plus ADT. The median overall survival and median progression-free survival on first subsequent treatment (PFS2) for people randomised to apalutamide plus ADT and for people randomised to placebo plus ADT are academic-in-confidence and cannot be reported here. The mean change in EQ-5D-5L visual analogue score showed no differences between the apalutamide plus ADT and placebo plus ADT treatment arms for all treatment cycles. The committee understood that no evidence was available for people who cannot have docetaxel as they were likely excluded from the TITAN trial. The committee concluded that apalutamide plus ADT extended radiographic progression-free survival, overall survival and PFS2 when compared with placebo plus ADT. However, there was no clinical evidence for a subgroup who cannot have docetaxel. Because of confidential commercial arrangements for apalutamide and subsequent treatments, the cost-effectiveness estimates cannot be reported here. The committee agreed that the cost-effectiveness estimates for apalutamide plus ADT compared with docetaxel plus ADT were well above the range normally considered a cost-effective use of NHS resources. So, it concluded that apalutamide could not be recommended as a cost-effective use of NHS resources for treating hormone-sensitive metastatic prostate cancer. The committee considered the population who cannot have docetaxel, for whom apalutamide plus ADT would be a clinically and cost-effective option. The committee was aware that docetaxel was not a relevant comparator for them or a treatment they would have when their disease became resistant to hormone treatment. The relevant comparator was ADT alone. The committee was aware that it had no direct relevant evidence with which to consider the cost effectiveness of apalutamide plus ADT compared with ADT alone for people who cannot have docetaxel. The committee concluded that, in the absence of evidence directly addressing the population of interest, this increased the uncertainty in the cost effectiveness results. Nonetheless, when taking into account the company's increased discount and the uncertainty, the committee considered that the incremental cost-effectiveness ratio (ICER) most closely reflecting its preferred assumptions is within a cost-effective use of NHS resources. So, the committee recommended apalutamide plus ADT as an effective use of NHS resources for treating hormone-sensitive metastatic prostate cancer for people who cannot have docetaxel.