Boston, Mass. August 11, 2015 – The Institute for Clinical and Economic Review (ICER) has posted the final report Controversies in Obesity Management and an accompanying action guide to the California Technology Assessment Forum (CTAF) website. The report evaluates the evidence on the comparative clinical effectiveness and value of multiple surgical, device, and pharmacological treatment approaches for people who are overweight or obese. The report also provides recommendations on how to apply the evidence to clinical practice and medical policies that were derived from a Policy Roundtable discussion held during the July 14 CTAF public meeting.
Among the key votes at the public meeting, the CTAF Panel found the evidence inadequate to distinguish the clinical effectiveness of four different weight-loss drugs. The vote was split nearly evenly on whether the evidence was adequate to demonstrate that the vBloc device was better than usual care. But for patients with class I obesity (BMI between 30 and 35) who also have type 2 diabetes, the CTAF Panel voted unanimously that the evidence is adequate to demonstrate the superiority of bariatric surgery over conventional weight-loss management. Bariatric surgery has historically been limited to patients with a BMI of 35 or higher; the CTAF Panel’s vote reflects the growing body of evidence that surgery may not only reduce weight but also improve or resolve type 2 diabetes for patients with a class I obesity.
“Patients and clinicians are eager for effective options to treat obesity,” said Steven D. Pearson, MD, MSc, President of ICER. “The evidence with which to judge the long-term clinical effectiveness of many treatment options is still limited, and it is even more difficult to distinguish the comparative clinical effectiveness of drugs, devices, and different surgical options. Nonetheless, the final report highlights that a variety of options have been shown to be superior to usual care. Using this information, clinicians and patients should work together to identify the most appropriate treatment for each individual from the range of treatment alternatives.”
As part of its deliberation, the CTAF Panel considered economic analyses of the long-term cost-effectiveness and short-term potential budget impact of different treatment options. For patients with class I obesity and type 2 diabetes, the majority of the CTAF Panel concluded that bariatric surgery represents an intermediate to high “health system value” using an ICER-developed framework to assess the value of medical interventions.
The CTAF Panel’s deliberation was informed by discussion with a Policy Roundtable of subject matter experts that included clinicians, representatives from public and private payers, and a patient advocate who had undergone bariatric surgery.
The final report examines the evidence on four bariatric procedures, three types of devices, and four medications, as shown below:
- Roux-en-Y gastric bypass
- laparoscopic adjustable gastric banding
- vertical sleeve gastrectomy
- biliopancreatic diversion (with or without duodenal switch)
- temporary intragastric balloon systems (e.g., Silimed®, ReShape®)
- vagus nerve block devices (Maestro®)
- duodenal-jejunal bypass liner (Endobarrier®)
- naltrexone/bupropion sustained-release (Contrave®)
- phentermine/topiramate extended-release (Qsymia®)
- lorcaserin (BELVIQ®)
- liraglutide (Saxenda®)
ICER also released an action guide, available on the CTAF website, which pairs the recommendations derived from the public meeting with tools to help clinicians discuss and manage patient weight, resources to help individuals in their efforts to lose weight, information on alternative payment arrangements for payers, and population health management resources for policymakers.