Implantable infusion pumps

Status: Decision completed

Policy context

Issues of efficacy, safety, and cost for permanent implantation of an Implantable Infusion Pump for drug administration to treat chronic noncancer pain were identified. Extreme concerns regarding Implantable Infusion Pump overdose, pump failure, and misuse.

Primary criteria ranking

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

Background

Implantable drug delivery systems deliver an active drug to a target organ or body compartment for prolonged periods of time. The pump is surgically implanted underneath the skin, operates by battery, and connects to a tube or catheter that is placed in the appropriate body area. For treatment of chronic noncancer pain, the catheter is usually placed intraspinally. Implantable infusion pumps have FDA approval for treatment of chronic noncancer pain when used to administer opioids (morphine) and an analgesic (ziconotide).

Implantable infusion pumps could potentially provide benefits of more effective pain control by administration directly to the target area; lower drug doses; and reduced side effects or toxicities of the drugs. However, potential harms include the surgical risks, device failures or complications, and drug overdose if inappropriately used or monitored. Primary concerns include safety concerns over the long term usage (patients generally have 20+ year life expectancy); FDA recalls and safety alerts; and invasive procedure risks and complications, and contraindications. Efficacy concerns include duration and degree pain control, and improvements in functional and quality of life outcomes. Finally, there are cost concerns related to the high initial costs for implantation and device, maintenance and costs of adverse events due related to the surgical placement of the device compared to alternatives, including no cost for delivery of oral medication.