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ICER Report on Clinical Benefits and Value of Different Antiandrogen Therapies for Men With Nonmetastatic Castration-Resistant Prostate Cancer

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Key Points

  • Evidence shows a substantial net health benefit for both apalutamide and enzalutamide compared to treatment with ADT alone.
  • Due to a lack of direct comparisons, the evidence provides only moderate certainty that abiraterone acetate, used in combination with prednisone, achieves a small to substantial net health benefit over ADT alone.
  • Economic analyses assessed the long-term cost-effectiveness of apalutamide and enzalutamide, concluding that both therapies, when used to treat nonmetastatic disease, fall well within commonly accepted thresholds of $50,000–$150,000 per quality-adjusted life-year compared to ADT alone.

The Institute for Clinical and Economic Review (ICER) has released an evidence report assessing the comparative clinical effectiveness and value of antiandrogen therapies for the treatment of nonmetastatic castration-resistant prostate cancer. The report focuses on three antiandrogen therapies: abiraterone acetate (Zytiga), enzalutamide (Xtandi), and apalutamide (Erleada).

“While data on overall survival improvements are still immature, treating men with high-risk castration-resistant prostate cancer with antiandrogen therapies earlier, before metastatic disease is detected by conventional imaging, appears to improve outcomes,” noted David Rind, MD, MSc, ICER’s Chief Medical Officer. “Unfortunately, the lack of long-term survival data and the absence of head-to-head trials limits our ability to compare the effectiveness of enzalutamide with that of the newer drug apalutamide. For abiraterone, we have less certainty about its added benefits when used before cancer progression is detected, making it even more difficult to judge how its effectiveness matches up with the other treatment options. However, for all three drugs, while there are additional costs associated with earlier treatment, those costs appear to be aligned with the clinical benefits patients receive.”

ICER did not assess the therapies’ value for treating later-stage disease.

This evidence report will be the subject of an upcoming public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) in Chicago on September 13. A draft version of the report was previously open for a 4-week public comment period. The updated evidence report and voting questions reflect changes made based on comments received from patient groups, clinicians, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Report Findings

Evidence shows a substantial net health benefit for both apalutamide and enzalutamide compared to treatment with androgen-deprivation therapy (ADT) alone. However, due to a lack of direct comparisons, the evidence provides only moderate certainty that abiraterone acetate used in combination with prednisone achieves a small to substantial net health benefit over ADT alone.

Economic analyses assessed the long-term cost-effectiveness of apalutamide and enzalutamide, concluding that both therapies, when used to treat nonmetastatic disease, fall well within commonly accepted thresholds of $50,000 to $150,000 per quality-adjusted life-year compared to ADT alone. ICER did not calculate value-based prices for these drugs, since analyses compared earlier use of the drugs to later use of the same or other drugs.

The potential budget impact for expanded use of these therapies may raise affordability concerns for health systems, depending on how broadly they are used. The U.S. Food and Drug Administration labeled indication is for all men with nonmetastatic castration-resistant prostate cancer, although the clinical trials looked only at a higher risk subset. Clinicians may choose to focus on treating these higher-risk patients until further evidence becomes available.

At current net prices, accounting for typical rebates and discounts from wholesale acquisition cost, only about 19% of eligible patients (both high- and low-risk) could be treated with apalutamide at its net price before spending crossed ICER’s potential budget impact threshold of $991 million per year. About 18% of patients could be treated with enzalutamide at net price before reaching the threshold.

About ICER

ICER is an independent nonprofit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health-care system.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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