Last week’s unanimous FDA panel vote backing Inspire Medical Systems’ neurostimulator for obstructive sleep apnoea was good news for patients who cannot tolerate the unwieldy ventilation technologies currently used to treat the disease.
But the makers of continuous positive airway pressure (CPAP) systems are facing another challenge – one from which Inspire stands to gain. Changes to the way Medicare reimburses CPAP machines are in the offing, and if bundled payments are introduced, the cost-cutting measures CPAP manufacturers will have to adopt could make even more patients candidates for Inspire’s device.
The strength of feeling the advisory committee showed for the Inspire II neurostimulator was impressive, particularly considering that it is an unorthodox application for this type of technology. The device is implanted in the patient’s chest and senses when breathing is impaired, upon which it sends an impulse causing the tongue to move an clear the airway. The patient does not awaken (Event – Panel to assess whether Inspire’s neurostimulation can send patients to sleep, January 28, 2014).
But there is a clear need for innovation in this space. CPAP systems work by forcing air in through the patient’s nose and/or mouth through a mask which must be strapped to the the head each night. Many patients find the mask uncomfortable or the sensation of air flow unpleasant, and compliance with CPAP is poor.
While the panel vote does not assure US approval of the Inspire II, a 12-nil decision, albeit with one abstention, is a pretty good omen.
The panel proposed contraindications that would limit uptake of the device, recommending against its use in obese patients, those with other implantable devices and those who will need MRI, among other groups. Sleep apnoea correlates closely with obesity, so a large group of patients have been ruled out.
But there could be a major positive too. The adcom recommended that the product be approved for three groups of patients with moderate to severe sleep apnoea: those whose apnoea hypopnea index – a measure of pauses in breathing or of shallow breathing – remains below a certain level despite CPAP; those who cannot use CPAP for more than four hours a night at least five nights a week; and those who are simply unwilling to use CPAP.
This last group in particular could be set to expand. The Centers for Medicare & Medicaid has been ratcheting down coverage of CPAP machines through a competitive bidding programme under which suppliers submit bids that undercut current Medicare prices. The CMS then uses these bids to set the amount it will pay for the machines, and the company with the winning bid is contracted as the Medicare suppliers.
The CMS is also evaluating potential methods of providing reimbursement, and is considering bundled payments. At present, it makes a one-off payment for the air pump system and pays for consumables such as the masks on demand. A bundled arrangement would instead see the supplier receive a monthly payment to cover the cost of the system, consumables and other services.
If such a model is implemented, CPAP manufacturers such as Resmed, Fisher & Paykel Healthcare and Philips’ Respironics unit may well move to minimise mask replacement, for example, as a way to save costs.
And it is not hard to see that if patients no longer receive replacement masks when they want them, they will become less likely to use their CPAP equipment. If Inspire’s neurostimulator is approved in the US with the indication suggested by the panel, a growing population of CPAP refuseniks will be a boon.