CurrentAetnaPolicy 0712

Ziconotide (Prialt) Clinical Policy Bulletin

Policy Summary

PayerAetna

PolicyZiconotide (Prialt) Clinical Policy Bulletin

Policy CodePolicy 0712

Change Typeclarified (references & policy history updated)

Effective Date09/09/2005

Next Review Date08/08/2024

Key ActionProvider must document that member has severe chronic pain and is intolerant of or refractory to other treatments and confirm absence of pre-existing psychosis or other contraindications prior to IT ziconotide.

SourceLink

POLICY UPDATE CHANGES

Last review dated 09/21/2023; effective date 09/09/2005; next review 08/08/2024.

1Covered indication (severe chronic pain with prior treatment failure)

3Main absolute contraindications listed

7Experimental/Investigational indications listed

40+References cited in Part 2

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.

Quick thresholds & stats

Initiation dose2.4 mcg/day titrated by day 21

Maximum dose19.2 mcg/day

Covered indication count1

Contraindications count3

Experimental indications count7

References count40+

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

Relevant Codes

Covered HCPCSHCPCSCovered

J2278

Injection, ziconotide, 1 mcg

Covered ICD-10 (indications, when selection criteria met)ICD-10Covered

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

Other related CPT codes (relevant to CPB procedures)CPT

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

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Other HCPCS / Equipment relatedHCPCS

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)

Related opioid HCPCS (listed)HCPCS

J2270	Injection, morphine sulfate, up to 10 mg
J2272	Injection, morphine sulfate (Fresenius Kabi), up to 10 mg
S0093	Injection, morphine sulfate, 500 mg (loading dose for infusion pump)

ICD-10 codes not covered for indications listed in the CPB (examples)ICD-10Not Covered

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)

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Provider Actions & Billing

Documentation Required

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

Documentation Required

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)

Billing Rule

Use J2278 for drug billing

Report ziconotide dosing using HCPCS code J2278 (Injection, ziconotide, 1 mcg) when selection criteria are met.

Report J2278 (Injection, ziconotide, 1 mcg) for ziconotide drug billing when selection criteria are met

Documentation Required

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

Documentation Required

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)

Note

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

Policy Summary

PayerAetna

PolicyZiconotide (Prialt) Clinical Policy Bulletin

Policy CodePolicy 0712

Change Typeclarified (references & policy history updated)

Effective Date09/09/2005

Next Review Date08/08/2024

SourceLink

On This Page

OpenPayer

Ziconotide (Prialt) Clinical Policy Bulletin

Coverage Summary

Medical Necessity & Exclusions

Relevant Codes

Provider Actions & Billing

Background & Evidence

Revision History