05.19.10
Data Decision Group
Vertebral compression fractures (VCF) are common. A VCF occurs when the bones of the spine become broken due to trauma. The bones of the spine are strong and great force usually is needed to break them, but in certain patient populations, (the elderly, cancer patients), the bones of the spine can break with little or no trauma. The incidence of VCF is highly correlated with a diagnosis of osteoporosis (abnormal loss of bony tissue resulting in fragile porous bones) and the vertebrae most commonly broken are those in the lower back.Annual estimates place the incidence of VCF at greater than 700,000 per year in the United States. Most resolve over time with conventional treatment (bed rest, bracing, analgesics), but some patients do not recover well, and experience debilitating pain. In the past, these patientsroutinely were referred for surgery.
In August, 2009, the outcomes of two randomized controlled trials were published in the New England Journal of Medicine. These studies compared outcomes for osteoporotic VCF treated with either vertebroplasty or a sham procedure and demonstrated similar improvements in pain for patients in both arms of the trials. This caused an explosion of controversy from interventional radiologists and spine surgeons. The implication drawn was that the vertebroplasty procedure provided no patient benefit and that any benefits demonstrated in other studies most likely were due to the “placebo effect.” In some commentaries, the study design of these two trials was challenged; in others, experienced surgeons with successful outcomes in vertebroplasty wondered how this dichotomy was created.
Study Impact
The commercial impact of these two studies was immediate. According to one report, vertebroplasty and vertebral augmentation procedures (including kyphoplasty), dropped by 10 percent following the two August 2009 NEJM publications. The same report stated that the drop in procedure volumes was due to a decline in patient referrals. It also said that based on a survey of 245 U.S. physicians, 70 percent of surgeons who perform VCF disagreed with the NEJM study results, compared with 30 percent of referring physicians. The report concluded that while there is consensus among doctors that the NEJM findings identify the need for more robust clinical trials, there also is a need and an opportunity for industry to restore physicians’ confidence to help the market recover.
Restoring physicians’ confidence is a challenge, because multiple medical specialists perform VCF; (interventional radiologists, orthopedic surgeons, spine surgeons and neurosurgeons). This makes the target market performing VCF diverse and large. In addition, the procedure is performed at multiple sites of care (see Table 1 below). The effort to restore doctors’ confidence will require a significant investment in sales and marketing at companies that provide devices for VCF. The complexity of this market will add complexity and cost to sales and commercialization activities.
Reports state that the commercial impact of the two NEJM studies continues and that U.S. VCF device sales generated only $75 million in the first quarter of 2010. However, new technologies continue to gain share in theVCF market.
Trends in this industry include devices that will:
• Allow controlled or adjustable height restoration;
• Decrease the potential for leakage of cement;
• Control cement viscosity;
• Allow lower pressure injection;
• Reduce the risk for adjacent level fractures; and
• Reduce the incidence of osteoporosis related fractures.
The VCF market is one with a vast base of under-served patients. Even with the damaging results of the two NEJM studies, the opportunity for innovators in industry
is enormous.
References:
1. Einhorn, TA. Vertebroplasty: an opportunity to do something really good for patients. Spine. 2000. 25(9): 1051-1052
2. Kalmes, et.al, A randomized trial of Vertebroplasty for osteoporotic spinal fractures, NEJM, 2009; 361:569-579
3. Buchbinder, et. al, A randomized trial of Vertebroplasty for painful osteoporotic vertebral fractures, NEJM, 2009; 557-568
4. MRG, December 9, 2009
5. Menze, M. Pearl Diver, February 3, 2009
6.MRG, Press Release May, 6, 2010
7. Menze, M. Pearl Diver, February 3, 2009
Maria Shepherd is president at Data Decision Group, a medical device and life sciences strategic marketing, market research and mergers and acquisitions support firm.