One of the most challenging (and often rewarding) tasks we undertake in Technology Insights is helping hospitals manage physician preference item (PPI) spend. To this end, we provide analytical technology investment and physician negotiation support for hospitals. A common question we receive during these engagements is how much will comparative effectiveness research impact orthopedic and cardiovascular PPI spend in the coming years. Clearly, there's no question that comparative effectiveness research is needed to better understand and justify the money we spend on tests and therapies.
Much is still to be determined as to how this research will be organized, funded, and used in the near- and long-term, not the least of which is the role that industry will play in shaping new legislative bodies charged with devising and executing comparative effectiveness research. A recent article in the New England Journal of Medicine elevates these issues to the forefront of reform discussion. In the article, the author warns of the presence of industry on government comparative effectiveness committees and the potential implication: parties with commercial interest in legislative outcomes shaping future research priorities and methodologies.
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Today, the FDA approved Thoratec's HeartMate II ventricular assist device for a destination therapy (DT) indication.This is the first continuous flow left-ventricular assist device (LVAD) with such an indication; the HeartMate XVE, a bulkier pulsatile pump, was previously the only VAD with DT approval. That distinction is a huge step forward for late-stage heart failure patients that are not eligible for a heart transplant, a patient population that may be as high as 50,000 individuals.
Previously indicated as a "bridge to transplant" device, this new indication comes after the completion of a 200-patient trial that randomized patients to receive either a HeartMate II or Thoratec's first-generation HeartMate XVE pulsatile pump. The positive outcome of that study (Of the 134 patients randomized to HeartMate II, 62 survived at least two years on the device stroke-free, next to only seven of the 66 patients randomized to the HeartMate XVE that survived two years without a stroke or surgery to repair or replace their device) paved the way for this decision.
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Earlier this week the New York Times (NYT) ran an article on the rising interest in total ankle replacement. Ankle replacement has been performed on a limited basis for over thirty years. However, the technical challenges of the surgery, coupled with a lack of enabling technologies, have left the majority of patients experiencing ankle arthritis to either live with the pain or opt for an ankle fusion--a procedure that significantly limits ankle mobility. Yet, despite its limitations, fusion of the ankle joint (arthrodesis) remains the gold standard for treating acute ankle arthritis. Fusion remains technically simpler and is plagued by fewer intraoperative and post-operative complications than ankle replacement.
The NYT notes that one of the keys to successful total ankle replacement is effective patient selection. Age, for instance, is an important predictor of ankle replacement failure rates. Older patients tend to have fewer revisions and replacement failures. Also, because of the precise bone alignment and healing process necessary for a successful ankle replacement, any indication of ankle misalignment or bone weakness (advanced osteoporosis, morbid obesity, etc) increases the risk of post-operative complications.
Several vendors market total ankle replacement implants including Wright Medical and DePuy. Beyond implants, however, this may be one area where the precision of robotic surgery could function as an enabler. Though NYT doesn't allude to this, I blogged last week on the potential impact of robotics within orthopedics, and ankle replacement is one area where robotic guidance could help alleviate surgeons' lack of comfort with operating in such a tight space. Still, with hip and knee replacement volumes growing at rapid rates and predicted shortages of orthopedic specialists emerging over the next decade, it's unlikely ankles will become a major part of the joint replacement playbook anytime soon.
The NYT article offers a quick look at total ankle replacement and I'd encourage you to read it if you have a little extra time. But, given that the current market for ankle fusion in the US is under 30,000 patients and that ankle replacement remains among the most technically challenging surgeries for orthopedic surgeons to perform in the US, I'm not exactly sure why NYT is covering the procedure.
Officials from the National Association of Children's Hospitals and Related Institutions (NACHRI) briefed members of a congressional caucus on pediatric health care on Wednesday, January 13th and discussed findings emerging from a December 2009 survey of 44 children's hospitals entitled the Pediatric Subspecialty Physician Survey of Children's Hospitals. While members of Congress aim to push health care reform legislation through Washington, survey results seem to bolster the argument that further initiatives to improve the supply of pediatric specialists are needed.
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This article in The Economist really caught my eye this morning. Some pharmaceutical companies are beginning to bridge the gap between drugs and technology with so-called "smart pills" that are able to relay feedback after being swallowed. Once one of these pills hits the stomach, the acids activate the communication technology to send wireless signals through the body to another chip embedded in the skin. The skin patch can then wirelessly upload data to a smart phone or an internet site for physicians. Physicians can use the data to track whether the patient is taking the right meds at the right time and may also potentially track adverse reactions.
The Economist notes that some major pharmaceutical companies, like Novartis through their purchase of the start-up Proteus Biomedical, are pursuing this strategy to make up for the fact that many lucrative drugs have patents about to expire.
While this technology certainly is interesting by itself, I think it speaks volumes to where health care is headed. I've blogged a lot recently about how remote monitoring is beginning to play a larger role in the care of patients with chronic disease. While in TI our research focuses more on biotech than on pharmaceuticals, we do of course often track how advances in pharma may impact hospital-based business. As chronic disease management is often greatly concerned with adherence (or lack thereof) to pharmaceutical protocols, these "smart" pills may one day play a large role in the continuing management of these patients. There are obviously concerns, though, with a "big brother" type mentality associated with watching patient adherence to medical protocols. The article has a lot of interesting perspectives--I'd encourage anyone with a few extra minutes to read it.
Wednesday night I logged in to watch the live webcast of MAKO Surgical Corporation (MAKO) business update presented at the 28th Annual J.P. Morgan Healthcare Conference. Coming off of a 2009 year that saw a doubling of both the install base and the number of total procedures performed with the MAKO Rio System--a surgeon-guided robotic arm system designed to assist orthopedic surgeons with precision bone removal and implant placement during partial knee arthroplastyprocedures--MAKO executives are confident the company is well-positioned for continued growth in 2010.
In 2009, MAKO replaced all "TGS" systems (17) with the MAKO Rio System--a platform that improves upon the orginial model by allowing for development of new applications--and now the company has 36 systems placed across the US. Currently, 126 surgeons are trained to use the MAKO Rio System. Total procedure volumes grew 35 percent quarter over quarter in 2009, bringing the number of partial knee replacements completed with MAKO to 2,384 at the close of last year. Company executives estimate the existing platform can penetrate up to 50 percent of the existing knee replacement market (as many as 350,000 cases annually). As the orthopedic industry is slowly becoming more accepting of robotic technology, your institution may face the challenge of considering an investment in a high dollar technology with no incremental reimbursement and no guarantee of a positive financial return.
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Since it received FDA approval in 2003, Stereotaxis' Niobe magnetic catheter navigation system has attracted a great deal of attention within the world of electrophysiology (EP). With its ability to facilitate difficult and lengthy atrial fibrillation (AF) ablation cases, many centers have invested in the technology to distinguish themselves as premier AF ablation programs. Though the clinical and operational advantages of the Niobe system are far from established (especially given the $2-3M price tag), most physician champions assert that the system helps combat physician fatigue and back injury, while reducing radiation exposure. These selling points have also been noted by programs exploring additional applications beyond AF ablation.
The potential for Stereotaxis to be used beyond AF ablation has long been assumed, though the interest of physicians outside of EP has not been particularly strong. A recent article in the European Heart Journal may help shift some opinions or pique the interest of some physicians.
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The three major pillars of oncology treatment-surgery, radiation, and medicine-are often entangled in an intricate dance, with oncologists prescribing treatment courses that rely on time-sensitive collaboration between these approaches. When it comes to early-stage lung cancer, however, the historical gold standard for treatment of most early-stage cancer is surgery. Conventional wisdom holds that if you can cut it out, you probably should. And in the instance of stage I cancer in particular, many cases don't even require additional therapy beyond resection.
But as of fairly recently, there has been a growing debate over whether patients with early stage non-small cell lung cancer should receive the "newer" and non-invasive option of stereotactic radiosurgery (coined "SBRT"), or whether they should stick with the conventional approach of surgery. And although NCCN clinical practice guidelines - which still indicate that surgery is the recommended approach for these patients-carry immense weight in the way that patients are treated, in addition to physicians' recommendations, patient choice is a highly malleable variable that increasingly plays into these decisions. And I'd venture to guess that many of you reading this have noticed a billboard, commercial, or other advertisement highlighting the benefits of some advanced radiosurgery technology in your local market. This marketing force is fairly widespread across the country, and lung cancer is one of the fastest growing indications for this modality.
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