CPAP: A Market Primed for Disruption

Approximately 50% of the 90 million Americans who snore have obstructive sleep apnea (OSA), a condition that disrupts breathing and often goes undiagnosed.¹ The issue is widespread and dangerous, associated with a higher risk of stroke, heart failure, and dementia. CPAP is the gold standard treatment, is highly effective, and is commonly covered by insurance.
There are many steps to getting a CPAP, including a sleep test in an overnight lab (how OSA is typically diagnosed). Unfortunately, recent recalls of some brands of CPAP devices have created confusion among OSA patients about the choice of using a CPAP at all.

For mild OSA cases, some patients can use oral devices, lose weight, or avoid sleeping face up to address the issue. For patients with moderate to severe sleep OSA, however, the standard treatment is CPAP.¹ In spite of this, a study found that three months after starting CPAP, almost 30% of people don’t consistently use the device.²

In the study, telemonitoring data from a CPAP manufacturer database assessed compliance in patients initiating CPAP therapy. The study was restricted to U.S. patients aged 18 to 90 years old and the findings revealed adherence to CPAP among study participants varied from 17% to 71%.² In another study, a systematic review over 20 years reported mean CPAP usage across studies of 4.5 hrs/night.³ This is important because in 2008, CMS established a policy denying long-term coverage for CPAP if patients do not meet an adherence level of ≥4 hours of use on 70% of nights in a consecutive 30-day period within the first 90 days. The CMS policy has been adopted by most private U.S. insurers, leading DME providers to start extensive telemonitoring of CPAP adherence with early troubleshooting to reach the CMS thresholds. The telemonitoring and troubleshooting programs have worked and data from a large clinical cohort now show almost 75% of patients started on CPAP meet CMS adherence criteria.²

According to the National Council on Aging, approximately 39 million adults in the U.S. have OSA (although only 33 million are thought to use a CPAP), while 936 million adults globally are estimated to have mild to severe OSA (Table 1).⁴ This means the U.S. market is saturated and a shift in market share requires a disruptive device that addresses unmet needs for the patient, clinician, healthcare system, or all three.

Why This Is Important

Inspire, a disruptive technology to treat OSA, was launched in 2014, and experienced rapid growth in subsequent years (Table 2).⁵ Inspire isn’t indicated for all OSA patients, but several competitors are following rapidly and this will be an interesting market to watch.


Unlike CPAP devices, which require a mask to push air into the airway, Inspire is an implantable upper airway stimulation device that stabilizes the patient’s throat during sleep to prevent OSA. While it is presently the only FDA-approved implant for OSA, another device is currently undergoing clinical trials.⁵

The perceived patient benefit of Inspire is obvious: pressing a button on the Inspire remote before falling asleep is much easier than setting up a CPAP, putting on a mask, and trying to go to sleep. For patients who fit the inclusion criteria, physicians claim the Inspire device substantially improves OSA symptoms.

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READ MORE: FDA OKs Inspire Medical’s Next-Gen Sleep Apnea Neurostimulation

The downside of Inspire is that it is implanted via surgery. CPAP devices are far less invasive, and if patients do not fit the eligibility criteria exactly, there may be no benefit to implanting Inspire for treating OSA. The ads for Inspire are charming—“No mask. No hose. Just sleep.” However, patients report there are two sides to this coin. Inspire makes traveling more convenient, but the implant procedure is performed under general anesthesia (always a red flag for me) and the recovery can be painful.

Clinicians report it takes approximately one month to activate the device after implantation, and several months more for the physician to find the ideal settings. Physicians wait one month after the implant procedure before turning the Inspire device on the first time, giving the patient time to heal. The device is modified based on feedback from the patient and device data.

Patients report the nightly process can be frustrating. The patient activates the device before going to sleep with the Inspire remote. There is a pulse, and then an interval—which can be programmed, but has a 30-minute default—to give the patient time to fall asleep before the Inspire stimulation starts. According to the University of Kansas Health System, the stimulation feels like a tickling or a slight contraction on the tongue. If the patient is still awake when the stimulation starts, it is recommended to restart the cycle. Patients who routinely experience insomnia must initiate this process repeatedly, which can be a source of frustration.

When the Inspire device’s battery is running low, it will need to be replaced in an outpatient surgical procedure. Inspire reports the battery has been designed to last from nine to 11 years and its longevity varies according to use. One patient reported airport security hasn’t been a problem with the Inspire implantable and the device has not been an issue when getting an MRI.

Inspire is indicated for adults 18 to 80 years old with moderate to severe sleep apnea and a BMI of 32 or lower. Patients also need to demonstrate poor tolerance or non-compliance to CPAP or similar devices and most need to have tried another therapy like CPAP for at least three months to be considered a candidate. Prospective Inspire users will also need to go through a diagnostic procedure called a drug-induced sleep endoscopy. During this procedure, patients are mildly sedated so a surgeon can assess their throat as it collapses.⁶ Certain types of throat collapse prevent prospective patients from qualifying for an Inspire implant.

As promising as it sounds, Inspire is not a fix for every OSA patient. Even after the rigorous screening process, the probability of a positive outcome with the Inspire implant is not 100%. In one study, funded by Inspire, 68% of patients who received the implant had sleep apnea events reduced by at least 50% at 12 months,⁷ and the typical sleep apnea score fell from moderate into the mild range.⁸ It was important to note that one-third of participants did not see that level of improvement.

The Medi-Vantage Perspective

Disrupt, disrupt, disrupt. Most patients (and their spouses) don’t like traditional CPAP. Voice of the customer (VOC) research can help CPAP manufacturers understand these unmet needs. Physicians are another important VOC segment to explain the trends in the treatment of OSA, to help medtech manufacturers understand the unmet needs of the entire space, and to develop a leapfrog device that will lead the market and capture market share. Further, don’t forget reimbursement! There is a reason 33 million U.S. patients out of 39 million patients (85%) diagnosed with OSA are using CPAP and reimbursement is one of them. 

References

1. tinyurl.com/mpo240901
2. tinyurl.com/mpo240902
3. tinyurl.com/mpo240903
4. tinyurl.com/mpo240904
5. tinyurl.com/mpo240905
6. tinyurl.com/mpo240906
7. tinyurl.com/mpo240907
8. tinyurl.com/mpo240908

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MORE FROM THIS AUTHOR: What’s So Great About the Boston Medtech Ecosystem?

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Maria Shepherd has more than 20 years of experience in marketing in small startups and top-tier companies. She founded Medi-Vantage, which provides marketing and business strategy for the medtech industry. She can be reached at [email protected]. Visit her website at www.medi-vantage.com.