SEPTEMBER 2010 VOL 1 NO 4
www.ValueBasedCancer.com
Cost-Effectiveness in the New REMS Regulation Provokes Anger Comparative Effectiveness Landscape in Provider Community After some setbacks, now what? By Cherie Dewar Boston, MA—Cost-effectiveness can still add value in the comparative effectiveness landscape without it becoming woven into the politically caustic concept of healthcare allocation, according to 4 experts from academia, industry, and governmental agencies. The future of cost-effectiveness in the larger universe of comparative effectiveness research in a post–healthcare reform world was debated during a roundtable discussion at the AcademyHealth conference in Boston. A Suddenly Toxic Methodology Steven Pearson, MD, president and founder of the Institute for Clinical and
Public FDA meeting addresses concerns Economic Review, Harvard Medical School, Boston, MA, noted the restrictions placed on the use of costeffectiveness during the healthcare reform debate. “Wow, cost-effectiveness really took an arrow to the heart,” Dr Pearson said. As stated by the new independent, nongovernmental Patient-Centered Outcomes Research Institute, healthcare policy cannot “develop or use dollars per quality-adjusted life-year as a threshold to establish what type of healthcare is cost-effective or recommended.” Continued on page 20
Comparative Effectiveness Research in Oncology Is High Priority Goal is to reflect care in real-world setting By Wayne Kuznar Chicago, IL—Oncology has been identified as a high-priority area for comparative effectiveness research (CER), given the accelerating pace of diagnostic and therapeutic interventions and the often high costs attached to these interventions. CER in oncology was the subject of a well-attended symposium at the 2010 ASCO meeting. The goal of CER is to reflect care in the real-world setting, said Gary H. Lyman, MD, professor of medicine and
director of health services, effectiveness, and outcomes research in oncology, Duke Comprehensive Cancer Center, Durham, NC. This means going beyond the confines of study populations to the broader context of real-life clinical practice. The toolbox for comparative effectiveness contains randomized controlled trials (RCTs), which are considered the gold standard of CER, as well as systematic reviews and meta-analyses of RCTs. However, because most clinical questions in oncology have not Continued on page 5
By Margot J. Fromer Silver Spring, MD—Risk Evaluation and Mitigation Strategies (REMS) are required from some drug manufacturers as part of a new US Food and Drug Administration (FDA) regulation designed to draw the attention of sponsors, providers, and patients to the likelihood of severe adverse events accompanying certain drugs and biologic agents. Going beyond the usual drug label, REMS are required for certain drugs, depending on: • Number of persons likely to use a drug • Severity of the disease for which the drug is intended • Expected benefit of a drug weighed against its possible adverse effects • Duration of treatment
• Seriousness of side effects • When new safety data are available • If the drug or biologic agent is a new Janet Woodcock, MD molecular entity. Although the cancer community is affected by REMS to the greatest extent, no one is pleased to be further entangled in government red tape. Negative reactions to REMS have been many and loud; therefore, the FDA held a meeting to address questions and concerns on July 27 and 28 at its Silver Spring, MD, headquarters. The 250 attendees represented a wide range of those affected—drug manufacturers (also called “sponsors” under the legislation), providers, professional societies, and patient advocacy groups. The consensus was that Continued on page 12
Fostering Clinical Research in the Community Setting By Charles Bankhead Chicago, IL—Taking part in clinical research poses administrative, logistic, and financial challenges to community oncology practices, but also presents these organizations with opportunities for a more active role in shaping patient care. Therefore, community practices that venture into clinical research should strive to follow emerging guidelines aimed at establishing exemplary clinical trial sites, according to speakers at an American Society of Clinical Oncology To read the VBCC Perspective on this story, please turn to page 9.
(ASCO) education program. Considerations involved in developing an exemplary research site in- Robin Zon, MD clude the following: • Structuring and marketing a program for success • Organizing a team that recognizes its critical role in the program’s success • Knowing the costs to budget effectively and negotiate contracts. Community oncology practices have a vested interest in participating in clinical research, according to Robin Zon, MD, a Continued on page 8
IN THIS ISSUE Jayson Slotnik explains preventive services rule changes .................... 14 Comparing VHA and fee-for-service cancer care ................................... 20 Continuing education on value-based benefit design ............................ 22 Reviewing new therapies for prostate cancer......................................... 25 ©2010 Engage Healthcare Communications, LLC