Saturday, June 27, 2015

Who Will Pay for All the New DBS Implants?

Recently, Science and Nature had news features on big BRAIN funding for the development of deep brain stimulation technologies. The ultimate aim of this research is to treat and correct malfunctioning neural circuits in psychiatric and neurological disorders. Both pieces raised ethical issues, focused on device manufacturers and potential military applications, respectively.

A different ethical concern, not mentioned in either article, is who will have access to these new devices, and who is going to pay the medical costs once they hit the market. DBS for movement disorders is a test case, because Medicare (U.S.) approved coverage for Parkinson's disease (PD) and essential tremor in 2003. Which is good, given that unilateral surgery costs about $50,000.

Willis et al. (2014) examined Medicare records for 657,000 PD patients and found striking racial disparities. The odds of receiving DBS in white PD patients were five times higher than for African Americans, and 1.8 times higher than for Asians. And living in a neighborhood with high socioeconomic status was associated with 1.4-fold higher odds of receiving DBS. Out-of-pocket costs for Medicare patients receiving DBS are over $2,000 per year, which is quite a lot of money for low-income senior citizens.

Aaron Saenz raised a similar issue regarding the cost of the DEKA prosthetic arm (aka "Luke"):
But if you're not a veteran, neither DARPA project may really help you much. The Luke Arm is slated to cost $100,000+.... That's well beyond the means of most amputees if they do not have the insurance coverage provided by the Veteran's Administration. ... As most amputees are not veterans, I think that the Luke Arm has a good chance of being priced out of a large market share.

The availability of qualified neurosurgeons, even in affluent areas, will be another problem once future indications are FDA-approved (or even trialed).

The situation in one Canadian province (British Columbia, with a population of 4.6 million) is instructive. An article in the Vancouver Sun noted that in March 2013, only one neurosurgeon was qualified to perform DBS surgeries for Parkinson's disease (or for dystonia). This resulted in a three year waiting list. Imagine, all these eligible patients with Parkinson's have to endure their current condition (and worse) for years longer, instead of having a vastly improved quality of life.
Funding, doctors needed if brain stimulation surgery to expand in B.C.:

... “But here’s the problem: We already have a waiting list of almost three years, from the time family doctors first put in the referral to the DBS clinic. And I’m the only one in B.C. doing this. So we really aren’t able to do more than 40 cases a year,” [Dr. Christopher Honey] said.
. . .
...The health authority allocates funding of $1.1 million annually, which includes the cost of the $20,000 devices, and $14,000 for each battery replacement. On average, batteries need to be replaced every three years.
. . .
To reduce wait times, the budget would have to increase and a Honey clone would have to be trained and hired.

Back in the U.S., Rossi et al. (2014) called out Medicare for curbing medical progress:
Devices for DBS have been approved by the FDA for use in treating Parkinson disease, essential tremor, obsessive-compulsive disorder, and dystonia,2 but expanding DBS use to include new indications has proven difficult—specifically because of the high cost of DBS devices and generally because of disincentives for device manufacturers to sponsor studies when disease populations are small and the potential for a return on investment is not clear. In many of these cases, Medicare coverage will determine whether a study will proceed. ... Ultimately, uncertain Medicare coverage coupled with the lack of economic incentives for industry sponsorship could limit investigators’ freedom of inquiry and ability to conduct clinical trials for new uses of DBS therapy.

But the question remains, where is all this health care money supposed to come from?

The device manufacturers aren't off the hook, either, but BRAIN is trying to reel them in. NIH recently sponsored a two-day workshop, BRAIN Initiative Program for Industry Partnerships to Facilitate Early Access Neuromodulation and Recording Devices for Human Clinical Studies [agenda PDF]. The purpose was to:
  • Bring together stakeholders and interested parties to disseminate information on opportunities for research using latest-generation devices for CNS neuromodulation and interfacing with the brain in humans.
  • Describe the proposed NIH framework for facilitating and lowering the cost of new studies using these devices.
  • Discuss regulatory and intellectual property considerations.
  • Solicit recommendations for data coordination and access.

The Program Goals [PDF]:
...we hope to spur human research bridging the “valley of death” that has been a barrier to translating pre-clinical research into therapeutic outcomes. We expect the new framework will allow academic researchers to test innovative ideas for new therapies, or to address scientific unknowns regarding mechanisms of disease or device action, which will facilitate the creation of solid business cases by industry and venture capital for the larger clinical trials required to take these ideas to market.

To advance these goals, NIH is pursuing general agreements (Memoranda of Understanding, MOUs) with device manufacturers to set up a framework for this funding program. In the MOUs, we expect each company to specify the capabilities of their devices, along with information, support and any other concessions they are willing to provide to researchers.

In other words, it's a public/private partnership to advance the goal of having all depressed Americans implanted with the CyberNeuroTron WritBit device by 2035 (just kidding!!).

But seriously... before touting the impending clinical relevance of a study in rodents, basic scientists and bureaucrats alike should listen to patients with the current generation of DBS devices. Participants in the halted BROADEN Trial for refractory depression reported outcomes ranging from “...the side effects caused by the device were, at times, worse than the depression itself” to “I feel like I have a second chance at life.”

What do you do with a medical device that causes great physical harm to one person but is a godsend for another? What are the factors involved? Sloppy patient selection criteria? Surgeon ineptitude? Anatomical variation? All of the above and more are likely to contribute to the wildly divergent outcomes.

One anonymous commenter on a previous post recently said that the study sponsor had abandoned them:
The BROADEN study isn't continuing the 4 year follow-up study. I'm in it and just got a phone call. They'll put in a rechargeable device for those of us enrolled and will not follow up with us. The FDA approved it just for us who had the surgery. It looks like St. Judes isn't going foe FDA approval anymore. I have no public reference for this but it was what I was just told over the phone. It has helped me and I don't know what I'm going to do about follow-up care except with my psychiatrist who doesn't have DBS experience. Scary.

Why isn't the manufacturer providing medical care for the study participants? Because they don't have to! In her Science piece, Emily Underwood reported:
Recent failures of several large clinical trials of deep brain stimulation for depression loomed large over the meeting. In the United States, companies or institutions sponsoring research are rarely, if ever, required to pay medical costs that trial subjects incur as a result of their participation, [Hank] Greely points out. “Many people who work in research ethics, including me, think this is wrong,” he says. 

Hopefully the workshop attendees considered not only how to lower the cost of new DBS studies, but also how to provide equitable circuit-based health care in the future.

Further Reading (and viewing)

Watch the NIH videocast: Day 1 and Day 2.

BROADEN Trial of DBS for Treatment-Resistant Depression

Update on the BROADEN Trial of DBS for Treatment-Resistant Depression


Rossi, P., Machado, A., & Okun, M. (2014). Medicare Coverage of Investigational Devices. JAMA Neurology, 71 (5) DOI: 10.1001/jamaneurol.2013.6042

Willis, A., Schootman, M., Kung, N., Wang, X., Perlmutter, J., & Racette, B. (2014). Disparities in deep brain stimulation surgery among insured elders with Parkinson disease. Neurology, 82 (2), 163-171 DOI: 10.1212/WNL.0000000000000017

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