Market Snapshot

2011 Update on Vertebroplasty: The Comeback Kid

Maria Shepherd

Data Decision Group

In August 2009, the outcomes of two randomized controlled trials were published in the New England Journal of Medicine (NEJM).1,2 The studies compared outcomes for osteoporotic vertebral compression fracture (VCF) treated with vertebroplasty or a sham procedure and demonstrated similar improvements in pain for patients in both arms of the trials. Results from the two studies indicated that the vertebroplasty procedure provided no patient benefit and that any benefits demonstrated in other studies were probably due to the “placebo effect.”

This caused an explosion of controversy from interventional radiologists and spine surgeons. In some commentaries, the study design of the two trials was challenged. In others, experienced surgeons with successful outcomes in vertebroplasty wondered how this dichotomy was created.

The negative commercial impact of these two studies was immediate but ultimately was not sustainable. In 2010, according to one report, vertebroplasty and vertebral augmentation procedures (including kyphoplasty), dropped by 10 percent following the two August 2009 NEJM publications.3 These reports concluded that the drop in procedure volumes was due to a significant decline in patient referrals.

Why This is Important

Global estimates place the number of people suffering from VCF at approximately 1.4 million.4 In the United States, it is reported that out of the 750,000 VCF estimated annually, approximately one-third receive treatment.5 Most VCF 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 patients routinely were referred for surgery.There is a high cost of treatment and annual spend for osteoporotic fractures in the United States was estimated to range from $12 billion to $18 billion in 2002.2

The Fallout

In 2007, it was estimated that there were more than 140,000 percutaneous VCF procedures, and it was forecasted that this number would rise to more than 180,000 by 2009, at a compound annual growth rate of 13 percent. Another recent editorial, titled “How CER Could Pay for Itself: Insights from Vertebral Fracture Treatments” in the NEJM cited statements by payers that they were in process of deciding if they should limit or withdraw coverage for these procedures.6 In the fourth quarter of last year, Blue Cross Blue Shield announced that kyphoplasty and vertebroplasty no longer met its effectiveness criteria.7

The fallout from the NEJM studies placed intense scrutiny on vertebroplasty and kyphoplasty procedures. The most recent article also examined VCF procedure costs and payer reimbursement patterns. It is no surprise that private payers reimbursed a lower percentage of VCF procedures; the majority patient segment share treated for VCF falls into the elderly demographic that is eligible for Medicare.8

In addition, the data showed a significant preference for kyphoplasty over vertebroplasty (Chart 2), most probably due to clinical study outcomes documenting lower complication rates (Chart 3).10

In a Market Snapshot column titled “An Update on the Controversy in Vertebroplasty,” published in the May/June 2010 issue of Orthopedic Design & Technology, we predicted that the effort to restore physician confidence in vertebroplasty would require a significant investment in research and development, clinical studies, sales and marketing at companies that provide devices for VCF. Reports stated that the commercial impact of the two NEJM studies continued throughout 2009 and that U.S. VCF device sales generated only $75 million in 1Q10.13

The Comeback

Since last year’s report, new technologies gained growth and share in the VCF market and are supported by data from non-commercial sources. Study results published in Lancet last year compared conservative management to kyphoplasty for patients suffering from VCF and found an improved quality of life increase (SF-36 PCS score, p<0.0001) for patients who had kyphoplasty.14 Yet another study—also published in Lancet in 2010—found that osteoporotic VCF patients treated with vertebroplasty showed significantly greater pain relief for up to one year compared with medical management.15 In addition, a significant improvement in pain relief was seenearlier and in a greater number of patients with vertebroplasty than with medical management.

Comparing the NEJM to the Lancet articles demonstrates the extreme difference patient selection and appropriate controls may play in clinical outcomes. Additional studies are needed, but it is clear from the articles were published in the Lancet that vertebroplasty and kyphoplasty may have the ability to provide greater pain relief and quality of life improvement over medical management.

The VCF market is one with a vast base of underserved patients. Even with the contradictory results of the two sets of studies from NEJM and Lancet, the opportunity for innovators in this industry is enormous.

References:

1. Kalmes, et.al, “A randomized trial of Vertebroplasty for osteoporotic spinal fractures,” NEJM, 2009; 361:569-579.

2. Buchbinder, et al, “A randomized trial of Vertebroplasty for painful osteoporotic vertebral fractures,” NEJM, 2009; 557-568.

3. MRG, Dec. 9, 2009.

4. Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporosis Int 2006;17:1726-33.

5. Carmona RH, Office of the Surgeon General. Bone Health and Osteoporosis: A Report of the Surgeon General. Rockville, MD: U.S. Department of Health and Human Services, 2004.

6. Perspective, Elshaug, et al, N ENGL J MED 364;15.

7. www.bcbs.com/blueresources/tec/vols/ 24/percutaneous-vertebroplasty.html.

8. Lad S., et al, “National trends in vertebral augmentation procedures for the treatment of vertebral compression fractures,” Surg Neurol. May 29, 2008.

9. http://hcupnet.ahrq.gov/.

10. Eck JC, et al, Spine J, 2007.

11. Osteo News, Winter 2009 – Issue No. 21.

12. http://hcupnet.ahrq.gov/.

13. MRG, Press Release May 6, 2010.

14. Wardlaw D, Van Meirhaeghe, “Another chapter for vertebral compression fractures” Lancet 2010; DOI: 10.1016/S0140- 6736(10)61162-2.

15. Klazen C, et al, “Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomized trial” Lancet 2010; DOI: 10.1016/S0140-6736(10)60954-3.

Maria Shepherd, founder of Data Decision Group, has 20 years of leadership experience in medical device/life-sciences marketing in small startups and top-tier companies. The firm quantitatively and qualitatively sizes opportunities, evaluates new technologies, and assesses prospective acquisitions. Shepherd can be reached at (617) 548-9892or at [email protected] or www.ddecisiongroup.com.