Implantable Infusion Pumps for Non-Cancer Pain

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Implantable infusion pumps are battery powered devices that are surgically implanted to provide continuous drug delivery for pain management in patients with non-cancer pain. The pump, which has a fluid reservoir, is placed under the skin in the abdomen. The catheter is inserted into the intrathecal or epidural space of the spine, tunneled under the skin, and connected to the pump. The drug is delivered to the spinal cord where pain signals travel, interrupting pain signals before they reach the brain. The ability to deliver the drug directly into the spine provides pain relief with significantly smaller opioid doses, which can help to minimize side effects (e.g., drowsiness, dizziness, dry mouth, nausea, vomiting and constipation) that can accompany systemic pain medications that might be delivered orally, transdermally, or through an IV.

The New York State Department of Health currently covers implantable infusion pumps for patients with a cancer diagnosis. The Department will make a determination whether or not to expand coverage of this technology within the Medicaid benefit package.

Dossier sources of evidence already submitted:

The following evidence was recently submitted to the Department:

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  42. Rauck, RL, MS Wallace, MS Leonget al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. Journal of pain and symptom management. 2006;31(5):393-406.

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  48. Staats, PS, T Yearwood, SG Charapataet al. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or aids: A randomized controlled trial. Jama. 2004;291(1):63-70.

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  50. Turner, JA, JM Sears and JD Loeser. Programmable intrathecal opioid delivery systems for chronic noncancer pain: A systematic review of effectiveness and complications. The Clinical journal of pain. 2007;23(2):180-195.

  51. Tutak, U and DM Doleys. Intrathecal infusion systems for treatment of chronic low back and leg pain of noncancer origin. Southern medical journal. 1996;89(3):295-300.

  52. Wallace, MS, SG Charapata, R Fisheret al. Intrathecal ziconotide in the treatment of chronic nonmalignant pain: A randomized, double-blind, placebo-controlled clinical trial. Neuromodulation : journal of the International Neuromodulation Society. 2006;9(2):75-86.

  53. Wallace, MS, R Rauck, R Fisher, SG Charapata, D Ellis and S Dissanayake. Intrathecal ziconotide for severe chronic pain: Safety and tolerability results of an open-label, long-term trial. Anesthesia and analgesia. 2008;106(2):628-637.

  54. Wallace, MS, RL Rauck and T Deer. Ziconotide combination intrathecal therapy: Rationale and evidence. The Clinical journal of pain. 2010;26(7):635-644.

  55. Wesemann, K, RJ Coffey, Y Tan, S Broste, MS Wallace and A Buvanendran. Clinical accuracy and safety using the synchromed ii intrathecal drug infusion pump. Regional Anesthesia and Pain Medicine. 2014;39(4):341-346.

  56. Willis, KD and DM Doleys. The effects of long-term intraspinal infusion therapy with noncancer pain patients: Evaluation of patient, significant-other, and clinic staff appraisals. Neuromodulation : journal of the International Neuromodulation Society. 1999;2(4):241-253.