Radiation Therapy for Localized Prostate Cancer

CMS evidence review | evidence_type=MEDCAC Meeting | record_type=medcac_meeting | document_id=54 | meeting_date=2010-04-21

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.

Actions Taken: November 13, 2009 Announced meeting. March 2, 2010 Posted Federal Register notice announcing meeting. March 8, 2010 Posted questions to panel. April 16, 2010 Posted technology assessment April 20, 2010 Posted agenda , roster and speaker list . April 26, 2010 Posted presentations and scoresheet [PDF, 134KB] from meeting. October 20, 2010 Posted transcript [PDF, 378KB] and minutes [PDF, 114KB] from meeting. Agenda: Federal Register Notice Agenda Medicare Evidence Development & Coverage Advisory Committee April 21, 2010 7:30 AM - 4:30 PM CMS Auditorium Clifford Goodman, PhD, Chair Saty Satya-Murti, MD, Vice Chair Marcel Salive, MD, Director, Division of Medical & Surgical Services, CAG Maria Ellis, Executive Secretary 7:30 - 8:00 AM Registration 8:00 - 8:15 AM Opening Remarks— Maria Ellis/Marcel Salive, MD/Clifford Goodman, PhD 8:15 - 8:25 AM CMS Presentation of Voting Questions - Deirdre O’Connor 8:25 - 9:10 AM TA Presentation: Thomas Dvorak, MD , Clinical Instructor, Department of Radiation Oncology; Stanley Ip, MD , Assistant Director, Evidence-based Practice Center; Raveendhara R. Bannuru, MD , Senior Research Associate, Evidence-based Practice Center, Tufts Medical Center, Boston, MA 9:10 - 10:00 AM Scheduled Public Comments - Part 1 (Refer to Speaker List) 10:00 - 10:15 AM BREAK 10:15 - 11:00 AM Scheduled Public Comments - Part 2 (Referto Speaker List) Public attendees, who have contacted the executive secretary prior to the meeting, will address the panel and present information relevant to the agenda. Speakers are asked to state whether or not they have any financial involvement with manufacturers of any products being discussed or with their competitors and who funded their travel to this meeting. 11:00 - 11:15 AM Open Public Comments Public Attendees who wish to address the panel will be given that opportunity 11:15 - 12:00 PM Questions to Presenters 12:00 - 1:00 PM LUNCH (on your own) 1:00 - 2:00 PM Initial Open Panel Discussion: Dr. Goodman 2:00 - 3:00 PM Formal Remarks and Voting Questions The Chairperson will ask each panel member to state his or her position on the voting questions 3:00 - 4:00 PM Final Open Panel Discussion: Dr. Goodman 4:00 - 4:30 PM Closing Remarks/Adjournment: Dr. Salive & Dr. Goodman Issue: 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. Minutes: Download meeting minutes [PDF, 114KB]. Other Material: Transcript 1 CMS Presentation TA Presentation Panel Voting Questions: For the following voting questions, use the following scale identifying level of confidence - with 1 being the lowest or no confidence and 5 representing a high level of confidence. 1 — 2 — 3 — 4 — 5 Low Intermediate High Confidence Confidence Confidence For the purpose of questions 1 thru 4, the outcomes of interest are defined as: Mortality – survival and death rate Functional outcomes – erectile dysfunction, urinary incontinence, fecal incontinence Adverse events – rectal fistula, radiation burns, infection. How confident are you that there is adequate evidence to determine if radiation therapy for the treatment of localized prostate cancer affects each of the following health outcomes? Mortality Functional outcomes Adverse events How confident are you that the evidence is adequate to conclude that the use of external beam radiation therapy improves each of the health outcomes listed below as compared to a therapeutic strategy of watchful waiting? Mortality Functional outcomes Adverse events How confident are you that the evidence is adequate to conclude that the use of brachytherapy improves each of the health outcomes listed below as compared to a therapeutic strategy of watchful waiting? Mortality Functional outcomes Adverse events How confident are you that the evidence is adequate to conclude that the use of each of the modalities identified below improves each of the health outcomes listed, over the identified comparator? Stereotactic body radiation therapy (SBRT, including CyberKnife therapy) compared to classically fractionated external beam radiation therapy (EBRT, including 3D-conformal radiation therapy, intensity modulated radiation therapy, and particle therapy) Mortality Functional outcomes Adverse events SBRT compared to high dose rate brachytherapy (HDR). Mortality Functional outcomes Adverse events SBRT compared to low dose rate brachytherapy (LDR). Mortality Functional outcomes Adverse events How confident are you that these conclusions are generalizable to: the Medicare patient population? community based settings? Discussion Questions What type of additional evidence on the impact of radiotherapy on prostate cancer outcomes is needed to improve decision making in the approach to treating localized prostate cancer? How can the medical research and provider community address the evidentiary gaps that may contribute to health disparities that exist in the diagnosis, treatment and outcomes for localized prostate cancer? Download scoresheet [PDF, 134KB]. Roster: Clifford Goodman, PhD Chair Senior Vice President The Lewin Group Saty Satya-Murti, MD, FAAN Vice Chair Health Policy Consultant Charles S. Carignan, MD Executive Vice President Chief Medical Officer Novasys Medical, Inc. Roger Dmochowski, MD Department of Urology Vanderbilt University Josef E. Fischer, MD Harvard Medical School William V. McDermott Professor of Surgery Renaissance Building James M. Hevezi, PhD, FACR/FAAPM ACR Board of Chancellors Chair, Commission on Medical Physics Director of Medical Physics CyberKnife Center of Miami Jeffrey G. Jarvik, MD, MPH Professor Radiology & Neurosurgery Department of Radiology University of Washington Roger D. Klein, MD, JD Medical Director Molecular Oncology BloodCentr of Wisconsin Barbara McNeil, MD, PhD Professor Department of Health Care Policy Harvard Medical School Curtis A. Mock, MD, MBA National Medical Director VP Medicare Advantage Ovations UnitedHealthcare Louis Potters, MD, FACR Chairman Department of Radiation Medicine North Shore Long Island Jewish Health David J. Samson, MS Blue Cross and Blue Shield Association Sanford J. Schwartz, MD Professor of Medicine, Health Management & Economics University of Pennsylvania Robert L. Steinbrook, MD Adjunct Associate Professor of Medicine and Community and Family Medicine Dartmouth Medical School Craig Umscheid, MD, MSCE University of Pennsylvania School of Medicine Industry Representative G. Gregory Raab, PhD Health Policy Consultant Raab Associates CMS Liaison Marcel Salive, MD Director Division of Medical & Surgical Services Coverage and Analysis Group Executive Secretary Maria A. Ellis Speaker List: Medicare Evidence Development & Coverage Advisory Committee April 21, 2010 SPEAKER LIST * 7 MINUTES PER SPEAKER* Peter Grimm, DO, Executive Director, Prostate Cancer Treatment Center Seattle Jonathan Briers, MD, Vice President, Medical Affairs, Nucletron Howard Sandler, MD, MS, Ronald H. Bloom, Chair in Cancer Therapeutics, Professor and Chair, Department of Radiology Oncology, Cedars-Sinai Medical Center Luther W. Brady, MD, Distinguish University Professor, Hylda Cohn/American Cancer Society, Professor of Clinical Oncology, Professor Department of Radiation Oncology, Drexel University College of Medicine Albert Blumberg, MD, Representing: American College of Radiology (ACR) Sean P. Collins, MD, PhD, Department of Radiation Medicine, Georgetown University Hospital, Lombardi Comprehensive Cancer Center Carl Olsson, MD, John K. Lattimer Professor and Chairman, Department of Urology at the College of Physicians and Surgeons of Columbia University and Chief of the Squier Urological Clinic of the Presbyterian Hospital in New York City Representing: American Urological Association Andrew K. Lee, MD, MPH, Associate Professor, Radiation Oncology, MD Anderson Cancer Center Gregory S. Merrick, MD, Schiffler Cancer Center and Wheeling Jesuit University, Wheeling, WV Chrissie Kotwica, RN, BSN, CyberKnife Coalition Member, CyberKnife Centers of Miami and Palm Beach Alan Katz, MD, Associate Professor of Radiation Oncology, Medical Directory, Department of Radiation Oncology, University of Rochester Medical Center Anthony Zietman, MD, Representing: American Society for Radiation Oncology (ASTRO)