Ziconotide (Prialt) Clinical Policy Bulletin
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Defines Aetna's medical necessity, contraindications, experimental/investigational uses, dosing recommendations, and applicable billing/coding for intrathecal ziconotide (Prialt) for severe chronic pain.
Last review dated 09/21/2023; effective date 09/09/2005; next review 08/08/2024.
Coverage Summary
Defines Aetna's medical necessity, contraindications, experimental/investigational uses, dosing recommendations, and applicable billing/coding for intrathecal ziconotide (Prialt) for severe chronic pain. Aetna considers intrathecal (IT) administration of ziconotide medically necessary for adults with severe chronic pain when IT therapy is warranted and the pain is intolerant of or refractory to other treatments (e.g., systemic analgesics, adjunctive therapies, or IT morphine).
Aetna highlights that ziconotide is delivered via an intrathecal infusion/pump, has a narrow therapeutic window requiring slow titration and careful monitoring, and is contraindicated in patients with a pre-existing history of psychosis or other contraindications to IT analgesia. The policy includes dosing thresholds, billing/coding guidance, and requirements for documentation and monitoring of neuropsychiatric adverse events.
Medical Necessity & Exclusions
Medically Necessary
Aetna considers intrathecal administration of ziconotide medically necessary when ALL of the following are met:
ALL of the following
- Member has severe chronic pain
- Intrathecal therapy is warranted
- Pain is intolerant of or refractory to other treatments such as systemic analgesics, adjunctive therapies, or intrathecal morphine
Not Medically Necessary (Contraindications)
Ziconotide intrathecal infusion is considered not medically necessary if ANY of the following contraindications are present:
ANY of the following
- Contraindications to intrathecal (IT) analgesia include ONE of:: Pre-existing history of psychosis
- Contraindications to intrathecal (IT) analgesia include ONE of:: Infection at the microinfusion injection site
- Contraindications to intrathecal (IT) analgesia include ONE of:: Uncontrolled bleeding diathesis
- Contraindications to intrathecal (IT) analgesia include ONE of:: Spinal canal obstruction
Experimental and Investigational (Not Covered)
Intrathecal administration (or other routes) of ziconotide is considered experimental and investigational for the following indications because effectiveness has not been established:
ANY of the following
- Autism
- Epilepsy
- Irukandji syndrome
- Migraines
- Primary lateral sclerosis
- Stroke
- Intrathecal combination of ziconotide, morphine, and levobupivacaine for treatment of cancer-related refractory pain
Relevant Codes
| J2278 | Injection, ziconotide, 1 mcg |
| G89.0 | Pain, not elsewhere classified |
| G89.1 | Acute pain |
| G89.2 | Chronic pain, not elsewhere classified |
| G89.3 | Neoplasm related pain (acute) (chronic) |
| G89.4 | Chronic pain syndrome |
| 62320 | Injection(s), diagnostic or therapeutic substance(s), interlaminar epidural or subarachnoid, cervical or thoracic, lumbar or sacral (caudal), without imaging guidance |
| 62321 | with imaging guidance |
| 62322 | Injection(s) including needle or catheter placement, continuous infusion or intermittent bolus, interlaminar epidural or subarachnoid, without imaging guidance |
| 62323 | with imaging guidance |
| 62324 | Injection(s) including indwelling catheter placement, continuous infusion or intermittent bolus, interlaminar epidural or subarachnoid, cervical or thoracic, without imaging guidance |
| 62325 | with imaging guidance |
| 62326 | Injection(s) including indwelling catheter placement, continuous infusion or intermittent bolus, lumbar or sacral (caudal), without imaging guidance |
| 62327 | with imaging guidance |
| 62350 | Implantation, revision or repositioning of tunneled intrathecal or epidural catheter |
| 62351 | with laminectomy |
| E0779 | Ambulatory infusion pump, mechanical, reusable, for infusion 8 hours or greater |
| E0780 | Ambulatory infusion pump, mechanical, reusable, for infusion less than 8 hours |
| E0781 | Ambulatory infusion pump, single or multiple channels, electric or battery operated, with administrative equipment, worn by patient |
| E0783 | Infusion pump system, implantable, programmable (includes all components) |
| E0785 | Implantable intraspinal catheter used with implantable infusion pump, replacement |
| E0786 | Implantable programmable infusion pump, replacement (excludes catheter) |
| C72.0 | Malignant neoplasm of spinal cord (spinal canal obstruction) |
| D33.4 | Benign neoplasm of spinal cord (spinal canal obstruction) |
| D69.9 | Hemorrhagic condition, unspecified (uncontrolled bleeding diathesis) |
| F23 | Brief psychotic disorder |
| F24 | Shared psychotic disorder |
| F28 | Other psychotic disorder not due to a substance or known physiological condition |
| F29 | Unspecified psychosis not due to a substance or known physiological condition |
| F84.0 | Autistic disorder |
| G12.23 | Primary lateral sclerosis |
| G40.001 | Epilepsy and recurrent seizures (range begins) |
Provider Actions & Billing
Document prior treatment failures
Provider must document that member has severe chronic pain and is intolerant of or refractory to other treatments such as systemic analgesics, adjunctive therapies, or intrathecal morphine.
- Documentation of severe chronic pain
- Records of prior therapies tried (systemic analgesics, adjunctive therapies, intrathecal morphine) and intolerance or refractory response
Screen for contraindications
Provider must document absence of pre-existing psychosis and absence of contraindications to intrathecal analgesia (infection at infusion site, uncontrolled bleeding diathesis, spinal canal obstruction) prior to treatment.
- Pre-existing history of psychosis (document absence)
- Infection at the microinfusion/infusion site (document absence)
- Uncontrolled bleeding diathesis (document absence)
- Spinal canal obstruction (document absence)
Monitoring for neuropsychiatric AEs
Providers should monitor patients frequently for cognitive impairment, hallucinations, or changes in mood or consciousness and interrupt or discontinue therapy if these occur.
- Frequent monitoring for cognitive/psychiatric signs (cognitive impairment, hallucinations, mood or consciousness changes)
- Interrupt or discontinue therapy if neuropsychiatric adverse events occur
Periodic laboratory monitoring
Periodic monitoring of serum creatine kinase is recommended due to potential elevation; evaluate patients for new neuromuscular symptoms.
- Periodic serum creatine kinase (CK) monitoring
- Evaluation for new neuromuscular symptoms (myalgias, muscle cramps, weakness, reduced activity)
Policy review and references available
Providers should reference the Clinical Policy Bulletin and supporting literature cited for clinical guidance and documentation supporting medical necessity determinations.
- Clinical Policy Bulletin (Number: 0712) and cited references available for guidance and documentation to support medical necessity
Background & Evidence
Ziconotide (Prialt) is a synthetic, non-opioid N-type calcium channel blocker approved by the FDA for the management of severe chronic pain in adults for whom intrathecal (IT) therapy is warranted and who are intolerant of or refractory to other treatments. It is administered intrathecally via continuous infusion or implanted pump/catheter. Because ziconotide has a narrow therapeutic window, conservative initiation and slow titration are recommended (initiation dose 2.4 mcg/day titrated by day 21; maximum 19.2 mcg/day). Ziconotide carries warnings for severe psychiatric symptoms and neuropsychiatric adverse events (e.g., cognitive impairment, hallucinations, mood or consciousness changes), and patients with a pre-existing history of psychosis should not be treated with Prialt.
Intrathecal (IT): Administration of medication into the spinal thecal (subarachnoid) space, typically via an implanted pump or catheter.
| Study / Source | Summary |
|---|---|
| Randomized trial (Staats et al. 2004) | Ziconotide provided statistically significant analgesia vs placebo in refractory pain (mean VASPI improvement 53.1% vs 18.1%, p < 0.001) |
| Pilot/other studies | Multiple small studies and case series report analgesic activity with notable adverse events; pilot bolus study showed ~25% mean VAS reduction and other observational/case reports support use in select refractory patients |
Revision History
Policy effective date established as 09/09/2005.
Last review dated 09/21/2023; Document Part 2 includes updated reference list and policy history entries.
Next scheduled review date set for 08/08/2024.
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