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The United Kingdom’s National Institute of Health and Care Excellence has recommended apalutamide for use in combination with androgen deprivation therapy in patients with high-risk hormone-relapsed nonmetastatic prostate cancer and in those with hormone-sensitive metastatic prostate cancer if docetaxel is not suitable or cannot be tolerated.
The United Kingdom’s National Institute of Health and Care Excellence (NICE) has recommended apalutamide (Erleada) for use in combination with androgen deprivation therapy (ADT) in patients with high-risk hormone-relapsed nonmetastatic prostate cancer and in those with hormone-sensitive metastatic prostate cancer if docetaxel is not suitable or cannot be tolerated.1,2
The decision is supported by evidence from clinical trials that have indicated that apalutamide plus ADT prolongs survival and the time until the disease spreads vs ADT alone. Although apalutamide/ADT is not cost-effective vs docetaxel, the cost-effectiveness estimates for the combination fall within what NICE considers to be an acceptable use of National Health Service (NHS) resources.
“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has been able to work with us to address the uncertainties in the evidence identified by the committee in the previous draft guidance,” Meindert Boysen, NICE deputy chief executive and director of the Centre for Health Technology Evaluation, stated in the press release.3 “This means that we are able to produce final draft guidance recommending apalutamide as an effective and valuable additional treatment option for people with these types of prostate cancer.”
Data from the phase 3 SPARTAN trial (NCT01946204), which evaluated the safety and effectiveness of apalutamide/ADT (n = 806) vs placebo/ADT (n = 401) in patients with hormone-relapsed nonmetastatic prostate cancer who were at high risk of metastasis, demonstrated that the median metastasis-free survival (MFS) in these arms was 40.5 months vs 15.7 months, respectively (HR, 0.30; 95% CI, 0.24-0.36).
Moreover, the median overall survival (OS) in the investigative and control arms was 73.9 months and 59.9 months, respectively (HR, 0.78; 95% CI, 0.64-0.96). The second progression-free survival (PFS2) in these arms was 55.6 months and 41.2 months, respectively.
The mean change in EQ-5D-3L visual analogue score demonstrated improvements with apalutamide plus ADT vs placebo plus ADT at treatment cycles 21 (mean difference, 3.03) and 25 (mean difference, 3.28; P < .05).
Findings from the phase 3 TITAN trial (NCT02489318), which examined apalutamide/ADT (n = 525) vs placebo/ADT (n = 527) in patients with hormone-sensitive metastatic prostate cancer, showed that the median radiographic progression-free survival was not reached in the investigative arm vs 22.1 months in the control arm (HR, 0.50; 95% CI, 0.4-0.6).
Moreover, the mean change in EQ-5D-5L visual analogue score demonstrated no differences between the investigative and control arms for all treatment cycles. At cycle 21, the mean change with apalutamide/ADT was 2.50 vs 2.04 with placebo/ADT, with a difference of -0.46 (P = .7678).
Regarding safety, clinical experts concluded that the combination of apalutamide and ADT is well tolerated. Although rash and hypothyroidism have been reported with the regimen, these effects are manageable.
“The company further increased its discount for apalutamide. The committee considered that the incremental cost-effectiveness ratio that most closely reflected its preferred assumptions was below the middle range of £20,000 to £30,000 per quality-adjusted life-year gained,” according to the final appraisal document. “Therefore, apalutamide is recommended as a cost-effective use of NHS resources for treating hormone-relapsed non-metastatic prostate cancer.”