Bone morphogenic proteins for use in spinal fusion

Status: Decision completed

Policy context

There have been recent concerns about safety due to adverse event reports and questions about clinical trial methodology and reporting of potential adverse events.  Questions were raised about the safety of Bone morphogenic proteins (BMP) based on observed effects including excess bone growth (heterotopic bone formation), and other adverse events including possible increased rates of retrograde ejaculation (RE) in men. Publication in June 2011 of a series of papers addressed these concerns, as well as, concerns about the methods used to determine rates of adverse effects in the original trials designed to test the safety of the then new products. Therefore, significant questions remain about the safety, efficacy and effectiveness, and cost effectiveness of recombinant bone morphogenic proteins when used in spinal surgery. 

Primary criteria ranking

  • Safety = Medium
  • Efficacy = Medium
  • Cost = High
Documents

Assessment timeline

  • Draft report published: January 12, 2012
  • Public comment period: January 12 to 30, 2012
  • Final report published: February 14, 2012
  • HTCC public meeting: March 16, 2012

Background

Bone morphogenic proteins (BMP) are naturally produced cell regulating proteins (TGF-B family) necessary for bone healing and regeneration, but also involved in other tissue configuration processes. Recombinant DNA methods have been used to produce higher quantities of bone morphogenic proteins than could be harvested from cadaver sources (due to minute naturally available amounts) for commercial application. Recombinant BMP products have been used since 2001 in procedures where bone healing or fusion is required; they are used in conjunction with collagen scaffolding materials and/or metallic cages.

BMP products provide the potential to avoid bone harvesting procedures necessary for use of autograft (self donated bone material), or to avoid allograft (use of bone from cadavers). Autograft requires bone harvesting, a separate surgical procedure that itself may result in pain and carries some risk related to the procedure and removal of bone, frequently from the iliac crest (hip). If BMP is a safe and effective alternative to autograft, patients may avoid a procedure and associated risk.