ResMed to AHRQ: Look at the real world

SAN DIEGO – ResMed says a draft technology assessment that shows published studies mostly do not support that CPAP therapy affects long-term clinical health outcomes bypasses “a generation of data in real-world evidence.” 

The company submitted comments on the 155-page assessment, presenting peer-reviewed and published data that show CPAP therapy improves quality of life, reduces health care costs and even reduces mortality. The data show a reduction in the incidences of heart attacks, a reduction in hypertension and a reduction in the incidences of solid cell cancer tumors, says CEO Mick Farrell. 

“These data prove that in partnership with our physician and provider colleagues in the market, we are saving lives and saving money for the health care system through our medical technology,” Farrell during a conference call to discuss the company’s most recent financial results. 

CMS requested that the Agency for Healthcare Research and Quality evaluate the evidence on the improvement of long-term clinical health outcomes with CPAP treatment, as well as the validity of criteria used as surrogate outcomes, and seek comments. 

Farrell also highlighted recent decisions by the health ministries in France, Germany and Japan to reimburse for digital health to treat OSA and recently published draft guidelines from the National Institute of Clinical Effectiveness (NICE) in the U.K. recommending that CPAP therapy, along with telemonitoring, is the frontline treatment option for patients with mild OSA. 

“That would be an expansion of coverage in the U.K. and also an expansion of the use of digital health technology in that market,” he said. 

It’s this kind of real-world evidence that needs to be incorporated into the assessment, says David Pendarvis, chief administrative officer and global general counsel. 

“We believe AHRQ is taking a very narrow perspective on looking at the clinical literature, looking only at randomized controlled trials done under certain very careful criteria,” he said. “While traditionally that has been the hallmark of the gold standard of trials, we think, particularly in this industry, you’ve got a massive amount of real-world evidence and a lot of other longitudinal trials that clearly demonstrates benefits. All of that evidence ought to be used to come to a conclusion.” 

Farrell pointed out that there are randomized controlled trials, or RCTs, that show CPAP therapy does affect outcomes, but they weren’t included in the assessment. 

“So, if you’re just looking at RCTs even, you need to include some of those RCTs which were very positive,” he said, “and the AHRQ just looked at some neutral RCTs and said, well, neutral means no benefit. There’s all these other proponents of evidence and RCTs that are positive.” 

Farrell continued: “We are optimistic that the final report, when issued, will reflect the preponderance of real-world evidence and broader RCTs showing both the clinical and economic benefits of treating sleep apnea with positive airway pressure.”