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Spine Feature

Courtesy of Texas Back Institute and Jack Zigler, M.D. / Courtesy of Synthes Spine

Hanging Tough: Lumbar Disc Replacement Over Fusion

Robin Young • Thu, May 25th, 2017

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On August 14, 2006, the ProDisc-L Total Disc Replacement (TDR) was approved by the U.S. Food and Drug Administration to treat functionally disabling pain from lumbar degenerative disc disease.

Seventeen medical centers participated in the original 292 patient trial comparing lumbar total disc replacement (ProDisc-L, n = 160 patients) to lumbar fusion (circumferential, n = 80).

As a condition of approval, the FDA required ProDisc’s manufacturer (Synthes Spine, now a division of Johnson & Johnson) to conduct a five-year study assessing long term safety and efficacy.

That date passed in 2011.

Jack Zigler M.D., however, kept on tracking his old ProDisc patients—or at least as many as he could find.

Zigler was the principal investigator for the original IDE (investigational device exemption) study. He also performed the first ProDisc artificial disc replacement surgery in the United States on October 3, 2001. He is one of the partners at the Texas Back Institute.

From the podium at the May 12 FORE Castellvi Spine meeting he reported that he was able to track down 49 of his original 108 ProDisc patients and 5 of the original 15 fusion patients. The average time to follow up was a bit over 12 years (143 months).

Here is what he learned:


Mean ODI Scores:

ODI scores in both groups improved significantly and remained so through 10 year follow-up (p<0.05)


Mean VAS Pain Scores:

Pain scores in both groups improved significantly and remained so during 10 year follow-up (p<0.05)


Mean VAS Satisfaction Scores:

Satisfaction scores remain high throughout follow-up; no significant difference


 

Less OR Time, Less Blood Loss, Fewer Hospital Days

At the 3-year follow up, Zigler and his colleagues also documented that TDR operative time was 68% faster than fusion—that TDR blood lost was less than half that of fusion and they were able to safely discharge patients one full day earlier.

Zigler along with spine surgeons Barton L. Sachs, Ralph F.F. Rashbaum and Donna D. Ohnmeiss were able to track down 157 of the original IDE patient group at 3 years.

As the following three charts indicate, both ProDisc and fusion delivered statistically significant pain relief and improved satisfaction to those 3-year patients.


Mean ODI Scores:

Both groups improved significantly, the ProDisc scores were slightly better.


Mean VAS Pain Scores:

Both groups improved significantly, the ProDisc scores were slightly better.


Mean VAS Satisfaction Scores:

In terms of satisfaction, scores for both ProDisc and fusion were high.


 

Costs Less Than Fusion, Too

In 2010, Rick Delamarter, M.D., looked at the cost of ProDisc L versus circumferential fusion and found that it cut hospital service costs 49% (54% when instrumentation was included). What Delamarter did NOT take into account was the surgeon fee.

We asked Jack Zigler how much surgeons are paid to do a total disc replacement versus fusion and he said: “Less than half, and probably average is about 40% of what they'd get paid for a fusion.”

The Spine Journal tackled the issue of lumbar fusion costs in 2013 and again in 2016. In the 2013 study, the authors concluded that the mean cost of anterior-posterior circumferential fusion was $25,165[1]. In the 2016 study, authors concluded that the mean cost of a lumbar laminectomy plus fusion was $27,800.[2]

Taking the midpoint of those two studies as the cost of lumbar spine fusion ($26,500) and assuming that ADR can cut that roughly in half—reduced OR time, blood loss, days in the hospital and a 60% cut in the surgeon’s fee—then the theoretical savings available per case are somewhere north of $10,000.

Reimbursement: Cervical vs. Lumbar

ProDisc-L received FDA approval in 2006. The first cervical artificial disc replacement (Prestige) was approved in July 2007.

In August 2007 CMS (Centers for Medicare and Medicaid Services) issued a national non-coverage decision for lumbar artificial disc replacement (LADR), saying the surgery was not reasonable and necessary for the Medicare population over 60 years of age.

Non-coverage means, of course, no reimbursement. Private insurers quickly adopted that same general approach to patients under 60 years of age.

Cervical did not get a non-coverage decision. For the last decade that decision dramatically affected sales of lumbar ADR vs cervical ADR.

Rick Phillips of Spinemarket, Inc. estimates that lumbar ADR is about half the level in the above table. Here is his estimate:

Source: Rick Phillips: Spinemarket, Inc.

Reimburser Animus to Lumbar TDR Has Cost U.S. Healthcare $11 Billion

Every year approximately 720,000 of the estimated 31 million Americans who experience back pain have spine surgery.

Total disc replacement, whether cervical or lumbar, represents 2% of spine surgery. Before CMS’ non-coverage decision, most analysts expected TDR’s to eventually capture 15-25% of the spine surgery market (depending on the analyst).

Had TDR, in fact, captured 15% of the spine surgery market, the number of procedures would be around 108,000 per year.

In terms of savings, that would have theoretically lowered spine surgery costs by $1.08 billion annually or $11 billion cumulatively since 2007.

Final Thoughts

As recently as May 1, 2017 the largest private health insurer in the United States, United Healthcare wrote the following about lumbar artificial discs:

“Lumbar artificial total disc replacement is unproven and not medically necessary for treating single or multiple level degenerative disc disease in skeletally mature patients. The long-term clinical outcome of lumbar disc replacement is unclear.”[3]

So we repeat…two decades and hundreds of clinical studies including several level 1 clinical trials, steady improvement in instruments, implants and patient selection and published support from two major spine surgeon societies begs three questions:

  1. Why do major health insurance carriers in the U.S. continue to describe lumbar disc arthroplasty as an experimental treatment and therefore refuse to provide reimbursement for lumbar disc arthroplasty even in patients who meet strict selection criteria?
  2. Why are payers denying an effective and well documented treatment for millions of Americans with chronic and debilitating lumbar or cervical degenerative disc disease?
  3. Why, finally, are major health insurers wasting so much money when they could be saving approximately $10k per case with LADR?

 


Selection of NEW Disc Arthroplasty Studies Published in 2016

Source: RRY Publications and public documents

Cost analysis of anterior-posterior circumferential fusionand transforaminal lumbar interbody fusionTate M. Andres, BS*, Justin J. Park, MD, Pedro A. Ricart Hoffiz, MD, Brian J. McHugh, MD,Daniel T. Warren, MD, Thomas J. Errico, MDDivision of Spine Surgery, Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases, 301 East 17th St, New York, NY 10003, USAReceived 17 January 2012; revised 25 September 2012; accepted 17 November 2012

Cost analysis of anterior-posterior circumferential fusion and transforaminal lumbar interbody fusion (PDF Download Available). Available from: https://www.researchgate.net/publication/235375117_Cost_analysis_of_anterior-posterior_circumferential_fusion_and_transforaminal_lumbar_interbody_fusion [accessed May 23, 2017].

Determining the Drivers of Cost for Elective Laminectomy and Fusion for Lumbar Degenerative Disease Chotai, Silky et al. The Spine Journal, Volume 16, Issue 10, S141


[1] Cost analysis of anterior-posterior circumferential fusion and transforaminal lumbar interbody fusion Tate M. Andres, BS*, Justin J. Park, MD, Pedro A. Ricart Hoffiz, MD, Brian J. McHugh, MD, Daniel T. Warren, MD, Thomas J. Errico, MD Division of Spine Surgery, Department of Orthopaedic Surgery, NYU Hospital for Joint Diseases, 301 East 17th St, New York, NY 10003, USAReceived 17 January 2012; revised 25 September 2012; accepted 17 November 2012
[2] Determining the Drivers of Cost for Elective Laminectomy and Fusion for Lumbar Degenerative Disease Chotai, Silky et al. The Spine Journal , Volume 16 , Issue 10 , S141
[3] https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/Medical%20Policies/Medical%20Policies/Artificial_Total_Disc_Replacement_for_the_Spine.pdf

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