Spine surgeons see real upside in the newer biologics, from faster fusion to fewer failures and less hardware lucency, but the long-term evidence behind many of these products has not kept pace with their adoption.
The osteobiologics category now accounts for billions in annual spend, yet much of it still rests on low-certainty data, leaving surgeons to weigh clinical results, cost and reimbursement realities case by case.
Becker’s asked three spine surgeons how they are navigating that tension between newer biologics and the limited long-term evidence behind them.
Editor’s note: Responses were lightly edited for clarity and length.
Question: How are you navigating the tension between adopting newer biologics and the still-limited long-term evidence behind many of them?
Krishna Satyan, MD. Neurosurgeon at Dallas Neurosurgical & Spine (Plano, Texas): This is a very good question. We see the benefits of the newer biologics in how patients are fusing, with fewer fusion failures, less pseudarthrosis, and less lucency around hardware. That said, we can’t ignore the gaps in the evidence, so I base my decisions on whether there’s at least some data to support a product, and where there is, the results justify the use. The bigger issue is that oftentimes insurance companies are blocking biologics regardless of that data. They classify these as something other than implants, so they don’t have to pay, which forces surgeons back to older methods. The older versions can work, but we’ve also seen decreased fusion rates and increased hardware failure with them in comparison to newer technologies.
Christian Zimmerman, MD. Spinal Neurosurgeon, Saint Alphonsus Health System, SAHS Neuroscience Institute (Boise, Idaho): The gold standard of autologous bone grafting and the historical of apprehension of additional complexity (especially added pain) surrounding further surgical interventions, can be allayed by local bone harvesting. Bone dust and its fragments are effortlessly salvaged with the use of suction traps or direct collection. The use of biologics in their many forms remains discontented, mostly due to limited evidence, methodological differences, and unresolved safety concerns. Arguably, the use of blood derivatives for soft tissue healing shows some promise when surgical alternatives are opposing. Recent and repeated inquiry about hip grafting is routinely addressed and assured as the alternatives are explained.
The proper use of demineralized bone matrix, combined and supplemented with the patient’s bone, is a safer alternative. Not so much tension per se, but disquieted apprehension on behalf of practitioners, especially serving the more venerable patients with comorbidities and soundness. Fusion rates amongst these folks remains formable and rightly anent. The keen eye and a sharper perception endure.
Philip K. Louie, MD. Spine Surgeon, Medical Director of Research and Academics, Center for Neurosciences and Spine, Virginia Mason Franciscan Health: For me, this is as much of an evidence question and as it is a ‘value’ question these days. When most products in the osteobiologics category sit at low-to-very-low GRADE certainty across 43 randomized controlled trials (with $3-5 billion annual spend), the issue is whether we have the right framework to even think through which biologics to apply. That framework has to weigh comparative evidence, total episode cost including revision risk, the patient population, and the regulatory reality of the product itself. The tangible next step is for the field to demand three things: standardized fusion definitions across studies, comparative trials funded outside of industry, and episode-level cost transparency.
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