Cost-Effectiveness of Implant for Sleep Apnea Uncertain

By Reuters Staff

August 29, 2019

NEW YORK (Reuters Health) - The Inspire II Upper Airway Stimulator, an implanted hypoglossal nerve stimulator (HGNS) for treatment of obstructive sleep apnea, works well in many, but fails to help a substantial proportion of patients, and others may require further surgery, according to new findings.

"A number of major insurers have recently issued positive coverage determinations for the device. However, the cost-effectiveness of the HGNS device remains uncertain," Dr. Vinay K. Rathi of Massachusetts Eye and Ear, in Boston, and colleagues note in JAMA Otolaryngology-Head and Neck Surgery, online August 22.

The implant is designed to open the airway during sleep by protruding the genioglossus muscle with inspiration. So far, it is the only HGNS device to have received approval from the U.S. Food and Drug Administration, which green-lighted it in 2014 for treating moderate to severe obstructive sleep apnea in people unable to tolerate continuous positive airway pressure.

Based on U.S. and European financial data, Dr. Rathi and colleagues found that between 2015 and 2018, global annual sales increased 6.3-fold and nearly 85% were sales in the U.S.

Since adoption, U.S. clinical-practice sales have totaled almost $90 million. In 2018, Medicare payments including both hospital and physician fees for HGNS device placement totaled more than $28,000 per procedure. Manufacturer markup, the researchers calculated, accounted for more than $18,000 - about two-thirds of the total Medicare payment.

"The device," they say "has shown great promise to date, with 5-year follow-up results in the phase 3 cohort revealing sustained improvements in patient-reported daytime somnolence and in disease-specific quality of life."

However, they add, more than a third of the patients did not respond and about 6% required further surgery.

The team concedes that the study has limitations, but "in the absence of definitive cost-effectiveness data, otolaryngologists contemplating adoption of the HGNS device should consider the available clinical evidence carefully."

Dr. Rathi did not respond to requests for comments.


JAMA Otolaryngol Head Neck Surg 2019.