The Centers for Medicare and Medicaid Services (CMS) has called this MEDCAC to consider the evidence on the impact of radiotherapy for the treatment of localized prostate cancer on health outcomes. CMS understands that there are other treatment options available for the treatment of localized prostate cancer, such as surgical interventions, cryoablation, ultrasound, etc.; however, a review of all available treatment options would be too wide in scope to accomplish at a single MEDCAC meeting. Therefore, the scope of this MEDCAC is limited to radiotherapy for the treatment of localized prostate cancer with comparisons to watchful waiting.
With the advent of the prostate-specific antigen (PSA) test in the 1990s, the lifetime risk of being diagnosed with prostate cancer in the United States has nearly doubled to twenty percent. However, the risk of dying of prostate cancer remains at approximately three percent. Once prostate cancer has been diagnosed, the decision on the best course of treatment can be complex. Numerous factors can influence the decision on how to proceed, including that some prostate cancers grow so slowly they would likely never cause significant problems during a patient’s lifetime. The adverse effects of the available interventions and how they affect quality of life must also be considered.
As with any item or service, CMS asks whether or not it improves health outcomes, i.e., its overall benefits and harms for patients. We ask the panel to address this question as it pertains to radiotherapy for the treatment of localized prostate cancer. The outcomes of greatest interest for CMS include mortality and morbidity. Mortality may be measured by adjusted rates or survival time from diagnosis. Survival time from diagnosis may be influenced by lead and length time bias, which may be of particular relevance for slowly progressing conditions such as prostate cancer. Morbidity includes functional outcomes such as urinary incontinence, fecal incontinence, sexual dysfunction and adverse events from treatment such as rectal fistula, radiation burns and infections.
CMS looks forward to the Panel’s careful consideration of the evidence and its evidence based conclusions surrounding this topic. The following voting and discussion questions identify for the Panel the issues of most interest to CMS regarding this complex topic.