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CMS panel confident in short-, mid-term bariatric therapy outcomes
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An advisory panel recently convened to advise CMS on the risks and benefits of bariatric surgery and endoscopic bariatric therapies in the Medicare population, and while some members worried the evidence on long-term outcomes was insufficient, the average votes indicated the panel’s overall confidence in the short- to mid-term benefits of these obesity therapies, according to a guest speaker.
“The average votes, at least through both the short- and mid-term outcomes, were definitely positive,” said Shelby Sullivan, MD, of the division of gastroenterology at University of Colorado Denver, who was a guest speaker representing the ASGE at the Medicare Evidence Development & Coverage Advisory Committee meeting.
On a 1 through 5 scale indicating their confidence that the benefits of both surgical and endoscopic therapies outweigh the harms, the average panel votes were 4.23 for 2-year weight loss and 3.69 for 2- to 5-year weight loss. When also factoring in postoperative complications, diabetes and metabolic outcomes, the average vote was 3.69 for 2-year outcomes and 3.15 for 2- to 5-year outcomes.
However, average votes did not exceed the median 2.5 threshold for confidence in predictors of success.
Recipients of these therapies
The fact that the panel evaluated bariatric surgery and endoscopic bariatric therapies altogether was particularly interesting, according to Sullivan. Also of note, she said, one speaker shared data revealing that younger, disabled Medicare beneficiaries were receiving these treatments more often than older beneficiaries.
“As it turns out, even though all of the data evaluated for the panel was based on the older adult population aged 65 years and older, the reality is that most of the Medicare patients who underwent bariatric surgery or endoscopic bariatric procedures were the dual eligible population, and the average age was significantly younger than 65 years,” Sullivan told Healio Gastroenterology and Liver Disease.
Young and disabled patients were not included in the pivotal trials for endoscopic bariatric therapies, she noted. “Most of the patients included in those trials were pretty healthy,” and it is therefore unknown whether the dual eligible Medicare population are the same as the older adult bariatric population, she said.
Outcomes, adverse events
During her presentation, Sullivan shared data on cardiovascular outcomes, the most costly medical complications for CMS. Data from a post hoc analysis of the LookAhead trial showed a greater reduction in CV outcomes when patients who received intensive lifestyle therapy achieved more than 10% total body weight loss vs. controls, she said.
“This demonstrates that the percent total body weight loss is likely to be important, and that 10% or more weight loss is most likely to be associated with reduction in risk in these outcomes, which are really costing Medicare money and are causing a lot of morbidity in their population,” she said. “We don’t have a lot of data on risk reduction in terms of CV mortality with these procedures.”
Additionally, she shared data on adverse events that occurred during pivotal trials of intragastric balloons.
“Although we did see a severe adverse event rate of about 10% with both Reshape and Orbera, most of those are related to nausea and vomiting causing dehydration requiring IV fluids in a hospital setting, and we’ve now become much better at being able to manage these symptoms and prevent those from happening, so we don’t see this level of complications in clinical practice,” she said.
She also discussed a unique aspect of endoscopic bariatric therapies, in that significantly more weight loss occurs in clinical practice vs. clinical trials.
“With other medications, devices and procedures, typically you see the highest effect in a study setting, and you’ll see less effect in the clinical setting, but the exact opposite is true for the endoscopic bariatric therapies,” she said.
One reason for this is that patients struggling with weight loss may receive a more intensive lifestyle therapy in the clinical setting vs. a study setting, as investigators are aiming to identify the isolated effects of devices in trials, she said. Another reason is that in randomized sham controlled trials, the sham control can have a significant effect on weight loss, by between 30% and 40%, she explained.
“We saw a 40% increase in weight loss with the POSE procedure in the Essential trial in patients that knew they had the procedure, and there was no other difference between our lead-in patients and our randomized patients in the active arm, other than the lead-in patients knew they had the procedure and the active randomized patients didn’t,” she said.
Similarly, when comparing the open-label Orbera study with the randomized sham controlled Obalon and Reshape studies, patients lost 30% to 40% more weight when they knew they had the procedure compared with those who did not.
Long-term outcomes, funding
She recommended that the development of a registry to attain more long-term outcomes data in this population.
“There is no funding mechanism to attain more data in this population, so I recommended that CMS should change their National Coverage Determination on balloons, which are currently not covered,” she said. “Medicare should cover these devices and aspiration therapy and develop a registry. That is the quickest way to get data on this population.”
While it is uncertain how CMS will respond to the panel, Sullivan said the major GI societies — of whom the ASGE, AGA and ACG were represented at the meeting — will continue to advocate for their patients with obesity.
“All of the major GI societies are interested in further work with CMS to make sure that we are adequately treating patients with procedures and devices that have level 1 evidence for benefit and that would treat disease that clearly affects this population, both in disabled and older adult population,” she said. “It’s unclear from this panel how CMS will respond, but based on the voting we are hopeful that CMS will be responding positively in terms of the importance of continuing to cover bariatric surgery and starting to cover the endoscopic bariatric therapies to give our patients more options.” – by Adam Leitenberger
Reference:
CMS. MEDCAC Meeting 8/30/2017 - Health Outcomes After Bariatric Surgical Therapies in the Medicare Population. Accessed September 18, 2017. https://www.cms.gov/medicare-coverage-database/details/medcac-meeting-details.aspx?MEDCACId=74
Disclosures: Sullivan reports financial relationships with Allurion, Aspire Bariatrics, Baranova, GI Dynamics, Elira Therapeutics, Spatz, Reshape, USGI Medical, Obalon and Takeda.