Ziconotide (Prialt®) is FDA approved as an intrathecal infusion for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant or refractory to other treatment, such as systemic analgesics, adjunctive therapies or intrathecal morphine.

Ziconotide will be covered when all the following criteria are met:

1. Members must have a documented diagnosis of a chronic pain condition;
2. Members must be under the supervision of a pain specialist (e.g., neurologist, anesthesiologist);
3. Members must have tried and failed at least 3 different oral opioid therapies or have tried and failed intrathecal morphine.

Ziconotide is not a substitute for opioids. If opiate withdrawal is required, patients must be withdrawn slowly from opiates when initiating therapy.

Ziconotide will not be covered in combination with any other intrathecal medication, due to the lack of safety, efficacy, and long-term drug product stability in these situations.

Ziconotide will not be covered for the treatment of acute pain conditions because of the lack of data in the published literature to support this use.

Severe psychiatric symptoms and neurological impairment may occur during treatment with ziconotide.  Patients with a pre-existing history of psychosis should not be treated with ziconotide. All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness.

The use of ziconotide for any other diagnosis not listed in the coverage criteria above is considered experimental/investigational, and therefore, not covered.  A participating, preferred, or network provider can bill the member for the denied service.

Description

Ziconotide is a synthetic equivalent of a naturally occurring conopeptide (venom) found in the piscivorous marine snail. Ziconotide acts by blocking calcium from binding to calcium channels involved with nociceptive processing and is thought to exhibit its pharmacological effects by preventing pain signals from reaching the brain. Ziconotide is not an opioid and does not bind to opioid receptors.

See Medical Policy Bulletin S-40 for information on the implantable infusion pump.

Coverage for ziconotide is determined according to individual or group customer benefits. Ziconotide is not reimbursable under the prescription drug benefit.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious life-threatening condition and when medically necessary and appropriate for the patient’s condition.

PRN References

08/2005,  Ziconotide eligible for chronic pain conditions

Prialt® (Ziconotide intrathecal infusion) package insert; Elan Pharmaceutical, Inc., San Diego, CA, 12/2004

Intrathecal Ziconotide in the Treatment of Refractory Pain in Patients with Cancer or AIDS, Journal of American Medical Association, Vol. 291, No. 1, 01/2004

Intrathecal Ziconotide for Chronic Pain, Journal of American Medical Association, Vol. 292, No. 14, 10/2004