Cost Effectiveness Analysis-Cryopreserved Amniotic Membrane?s (cAM) Use in Lumbar Micro Discectomy-A Modeling of the Costs and Outcomes from a Randomized Controlled Trial

Objective: Few studies have evaluated the cost effectiveness associated with lumbar microdiscectomy. The outcome data used in this analysis was from a prior randomized controlled trial (RCT) demonstrating that the use of a cryopreserved amniotic membrane (cAM) reduced the incidence of repeat procedures and improved outcomes vs. the standard of care (SOC). The purpose of this analysis was to cost out the procedural data associated with the outcomes from this RCT for cAM and then to evaluate the cost effectiveness of this alternative compared to every day practice. Methods: The direct costs of care for patients undergoing lumbar microdiscectomy were modeled using Medicare 2017 national average reimbursement. TreeAge Pro 2018 software was used for the decision tree analysis over a 2 year period. The assumed cost of cAM was $500 US. The probabilities of events were derived from the published literature, including repeat surgery from recurrent disc herniation. The effectiveness outcome evaluated was the Ostwestry Disability Index, as evaluated in the RCT and from published literature. One-way sensitivity analysis was conducted along with Monte Carlo simulation. Results: The use of cAM was the least costly alternative over 2 years by $343 vs. SOC ($12,417 vs. $12,760). One-way sensitivity analyses found the following variables had the greatest effect on the decision to use SOC vs. cAM (based on costs alone): incidence of revision surgery due to recurrent disc herniation for cAM (>6.8%) and SOC ( $843); cost of an inpatient repeat procedure of <$8,408. In Monte Carlo simulation, cAM dominated 53% of the time. Conclusion: Based on a lower incidence of repeat procedures and an improved ODI, cAM can be a cost effective alternative when compared to SOC. In today’s environment of US value based reimbursement, the use of cAM may hold promise.