Interventions of interest, May 2015:

Devices

  • Temporary intragastric balloon systems (e.g., Silimed®, ReShape®)
  • Vagus nerve block devices (e.g., Maestro® system)
  • Duodenal-jejunal bypass liner (EndoBarrier®)

Medications

  • Naltrexone/bupropion sustained-release (Contrave®)
  • Phentermine/topiramate extended-release (Qsymia®)
  • Lorcaserin (Belviq®)
  • Liraglutide (Saxenda®)

Intervention of interest, April 2015:

  • Roux-en-Y gastric bypass (RYGB)
  • Biliopancreatic diversion/duodenal switch (BPD/DS)
  • Laparoscopic adjustable gastric banding (LAGB)
  • Vertical sleeve gastrectomy (VSG)

It is estimated that more than one-third of American adults and about 17% of adolescents are obese. The health effects of obesity are myriad and include the development of type 2 diabetes, hypertension, cardiovascular disease, cancer, high blood pressure, and sleep apnea. Obesity and its sequelae are estimated to generate $147 billion in health care costs in the US alone. The complexity involved in managing obesity may affect both patient candidacy for certain treatment options as well as adherence to lifestyle changes necessary to sustain weight loss and improve health outcomes. Clinical interest is therefore high in treatments that may be used for patients at multiple levels of obesity, as well as in interventions that promote better adherence to lifestyle change.

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.

For questions or additional information, please contact info@icer.org.

Final Documents

Below you will find the final documents from the assessment review process:

Public Comments on Draft Evidence ReportDownload
Response to Comments on Draft Evidence ReportDownload
Final Evidence Report and Meeting SummaryDownload

ICER’s President Steve Pearson, MD, MSc stated:

“Patients and clinicians are eager for effective options to treat obesity. 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.”