– Midwest CEPAC’s vote on value reflects uncertainty around duration of treatment with antiandrogens –
Boston – October 4, 2018 – The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance on three antiandrogen therapies for the treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC): abiraterone acetate (Zytiga®, Janssen Biotech, Inc; a separate formulation [Yonsa®, Sun Pharma] was not evaluated), enzalutamide (Xtandi®, Astellas Pharma, Inc.), and apalutamide (Erleada™, Janssen Biotech, Inc.).
ICER’s report was reviewed at a September 2018 public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), one of ICER’s three independent evidence appraisal committees. During the meeting, the Council found evidence sufficient to show a net health benefit of treating nmCRPC with either apalutamide or enzalumatide, compared to androgen deprivation therapy (ADT) alone. However, the Council found evidence insufficient to show a net health benefit for treating with abiraterone acetate.
During the deliberation, Council members weighed the therapies’ other benefits and contextual considerations and noted the high burden of illness for men with prostate cancer. The Council commented on the need for robust head-to-head trials of these treatments, and the majority of Council members voted that significant uncertainty remains regarding the long-term benefits of the treatments.
Despite the recognized net health benefit for both apalutamide and enzalumatide in treating earlier stage disease, the Council voted that both treatments only represent an intermediate long-term value for money due to existing uncertainties around how the duration of benefit was captured in the clinical trials.
“Reflecting the Council’s concerns, for this Final Report ICER conducted additional economic analyses showing that the long-term value for money of antiandrogen therapies is sensitive to the duration of treatment,” said David Rind, MD, ICER’s Chief Medical Officer. “Longer term data on duration of treatment and overall survival should further clarify the cost-effectiveness of these therapies.”
Key Policy Recommendations
Throughout the public meeting – during the presentation of the clinical evidence and economic model, the public comments, and the Council’s deliberation – participants discussed the implications of the evidence for policy and practice. Key recommendations stemming from the meeting include:
- Since price appears to be aligned with the added benefits from early treatment, payers should work to design and implement benefit designs that would cover antiandrogen therapy in a way that reduces financial toxicity for patients.
- If apalutamide and enzalutamide are considered for treatment of men with nmCRPC and longer prostate specific androgen (PSA) doubling times, clinicians should practice shared decision-making with their patients and make them aware that the clinical trials only examined men with PSA levels that doubled in 10 months or less.
- Manufacturers and researchers should collaborate to ensure that future clinical trials of treatments for men with nonmetastatic or metastatic forms of the disease use identical endpoints to allow for clear comparison of drug effectiveness.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit 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.
ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.