Sleep apnea, comparative effectiveness and the future

The need for comparative effectiveness research follows from a recognition that we, as a country, don't have unlimited resources to expend on the delivery of healthcare; particularly as it relates to medical devices.

It makes sense for healthcare payors to pay for what works and not what doesn't. That said, there is very little incentive for innovation if the hurdle of effectiveness is so high that medical device manufacturers are reluctant to spend the money in research and development.

For those using Positive Airway Pressure therapy to treat obstructive sleep apnea, the question of comparative effectiveness can be an concern, especially when there is innovative technology available to make treatment more effective or more comfortable.

Recently I attended a breakfast meeting hosted by the publishers of Health Affairs. Their October issue of the publication was dedicated to the question of comparative effectiveness. While the entire issue is worth reviewing there was one article of particular interest to me.

Steven Pearson and Peter Bach considered a way to incorporate comparative effectiveness into the reimbursement scheme for Medicare. Quoting from the article: "Upon making a new coverage decision, Medicare would assign the service (added - heath care item) to one of three payment categories based on the evidence of comparative clinical effectiveness. After an initial three-year period, if services with insufficient evidence do not provide additional evidence demonstrating superior clinical effectiveness, payment would drop to reference pricing levels."

This strategy allows for companies introducing new technology to get three years of "dynamic pricing" and to allow for the manufacturers and clinicians to perform research to demonstrate superior effectiveness of existing therapies.

The recently published draft comparative effectiveness review on the diagnosis and treatment of obstructive sleep apnea in adults did not find compelling research to show the superiority of other PAP therapy over traditional CPAP.

How this report is used could make it harder for device manufacturers to realize a higher rate of reimbursement for more sophisticated technology. But using the scheme proposed by Pearson and Bach there could be some additional benefit pending the clinical outcome data to justify a high reimbursement.

Dr. Berwick, if you are listening... I think incorporating comparative effectiveness model proposed in Health Affairs into what Medicare will reimburse and at what rate makes a lot of sense, particularly when it comes to therapies (PAP and OAT)for the treatment of Obstructive Sleep Apnea.

ASAA Comment to AHRQ CER on Sleep Apnea

Readers of this blog know that I am concerned about comparative effectiveness research and the impact it will have on the delivery of healthcare to those with sleep apnea. The Agency for Health Research and Quality (AHRQ), the federal agency within the Department of Health and Human Services charged with comparative effectiveness research commissioned a comparative effectiveness review on diagnosis and treatment of obstructive sleep apnea in adults.

Below is our comment on the review. I have some other thoughts on comparative effectiveness and I will be back with those over the Thanksgiving holiday.

The American Sleep Apnea Association (AASA) thanks the Agency for Health Research and Quality (AHRQ) for undertaking a Comparative Effectiveness Review (CER) of diagnostic and treatment modalities for Obstructive Sleep Apnea (OSA) in adults.

Given the prevalence of the condition and the health consequences associated with leaving the condition untreated and its progressive nature, it is appropriate that an analysis be done to determine the relative effectiveness of various diagnostic tools and treatment options.

The ASAA is encouraged by the attention that has been given to sleep apnea and the recognition that the questions addressed by this review are important for the public health. It is unfortunate that, at the present time, so many of the answers are not supported by clear data, and that the AHRQ report finds most of the key questions to have low or insufficient evidence to answer. These results should be used to encourage obtaining data, and not be interpreted as there being no answer or that the question is not important.

Those preparing the review indicated a significant lack of clinical outcome data to support anything but “all cause mortality” in the patients with the severest forms of the condition. Issues such as improvement in quality of life or neuro-cognitive functioning, both very important outcomes, are supported by little evidence.

Both with respect to Positive Air Pressure (PAP) and Mandibular Advancement Devices (MAD) there was an insufficiency of evidence to address, which patients might benefit most from treatment.

The insufficiency of the evidence extends to evaluating the comparative effectiveness, the purpose of the study of the three different treatment modalities – PAP, MAD and surgery.

Despite these negative results there is confirmation of certain aspects of OSA diagnosis and treatment –

· Type III and IV “limited” channel studies are generally accurate to diagnose OSA;

· An Apnea Hypopnea Index (AHI) greater than 30 events/hr is an independent predictor of all cause mortality;

· Given the large magnitude of effect on the important immediate outcomes, such as AHI there is moderate evidence to show that PAP is an effective treatment for OSA,

· The same is true of MAD with respect to OSA in patients without co morbidities or excessive sleepiness.

The ASAA agrees with the conclusions of the CER that additional research needs to be done if the benefits of treatment using the various therapies are to be fully understood.

Given the prevalence and the health-related consequences of untreated OSA, financial resources available through the National Institutes of Health should be committed to address the future research conclusions listed in the report.