Artificial Disc Replacements Must Reach Insurance Payers' StandardsTwo companies are now selling the new artificial disc replacements (ADRs) in the United States. The first approved was the CharitÃ© ADR. More recently, the ProDisc-L won FDA approval and has entered the marketplace.
Even though the FDA has approved their sale and use, insurance companies want proof they work better than current treatment. They say they won't pay for this treatment until independent researchers prove the ADRs are safe and cost effective.
Other countries are asking for larger studies with higher standards. Clear evidence is needed before these motion-sparing implants will become the gold standard for chronic disc pain. And there needs to be a better way to reliably identify patients who do have pain from disc problems.
Surgeons using ADRs predict the trend away from fusion will continue. There will always be some patients who still need spinal fusion. They say that nonfusion treatment with motion sparing technology is the wave of the future.
Insurance companies (private and government backed) are asking for objective proof that ADRs are better than fusion or other methods. The problem is: what is the best definition of success? How is it measured?
The FDA wants trials to measure success based on a mathematical formula. Critics of this method say it doesn't take into account patients' satisfaction or improvement in quality of life.
Suggestions have been made for future studies. Patients who want spinal fusion should be compared to patients who want an ADR. Results may be different if patients are randomly assigned to one of those two groups if some patients were hoping to be in one group and got placed in the other.
And the ADR must be compared to lumbar fusion using a variety of different fusion methods since not all fusions are done the same way. Long-term studies over 10, 20, or 30 years are needed. But will third party payers refuse to pay (reimburse) for ADRs until then? Stay tuned -- we'll keep you posted!
ProDisc Enters the U.S. Marketplace -- But Will Major Payers Continue to Resist the Motion Revolution? In The Back Letter. November 2006. Vol. 21. No. 11. Pp. 121, 128-130.
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