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INDICATION

PRIALT® (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

Connect with a reimbursement specialist

Get connected with an ESTEVE Reimbursement Specialist, who can:

  • Provide educational information to you and your staff about the payer reimbursement landscape for PRIALT, access programs, and other general reimbursement topics
  • Answer questions about coding and coverage
  • Review common billing and coding errors
  • Provide an overview of ESTEVE Together, as well as the PRIALT Assurance program and Patient Assistance Program
  • Offer publicly available coverage information
  • Review redacted claims to understand reasons for denied or underpaid claims

Contact a specialist

Contact an ESTEVE Reimbursement Specialist at reimbursement@esteve.com.

Reimbursement Guide

Access the Reimbursement Guide for help with billing and coding.

Download Reimbursement Guide

Get your patients started on PRIALT

ESTEVE Together is committed to helping appropriate patients get access to PRIALT. Several different options are available for eligible patients based on personal needs.

ESTEVE Together can provide assistance to eligible patients to help minimize out-of-pocket costs for a PRIALT prescription. Eligible, commercially insured patients may pay as little as $20 for their PRIALT prescription.*

ESTEVE Together may be able to help your patients understand their existing insurance coverage.

Uninsured patients who are in need of financial assistance can apply for the Patient Assistance Program.

*ESTEVE Together can provide assistance to eligible, commercially insured patients to help reduce out-of-pocket costs for a PRIALT prescription. Eligible patients may pay as little as $20 for their PRIALT prescription, subject to an annual limit. Customers are not eligible if prescriptions are paid for by any state or other federally funded programs, including, but not limited to, Medicare or Medicaid, Medigap, VA or DOD or TRICARE, or where prohibited by law. ESTEVE Pharmaceuticals, S.A. reserves the right to rescind, revoke, or amend this offer at any time. Terms and conditions apply.

Coverage Support and Savings Program Form

Download form

Patient Assistance Enrollment ⁠Form

Download form

It starts with enrolling your patient. Enrollment in the support program does not guarantee coverage, and individual results may vary. For more information, contact ESTEVE Together for PRIALT at 1-833-ESTEVE-1 (1-833-378-3831).

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Choose how you order PRIALT

Interested in buy-and-bill? Learn more about the PRIALT Assurance program

PRIALT Assurance program form PRIALT Assurance program form
Download form

PRESCRIBING PRIALT

How to start your patients on PRIALT

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RESOURCES for your patients

Explore resources for your patients

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connect with a rep

Get dedicated assistance from your local representative

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Important Safety Information and Indication

BOXED WARNING: Neuropsychiatric Adverse Reactions

  • PRIALT is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or psychiatric signs or symptoms.

Contraindications

PRIALT is contraindicated in patients with:

  • A known hypersensitivity to ziconotide or any of its formulation components.
  • A medical condition that would render intrathecal administration hazardous to the use of intrathecal analgesia such as the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of cerebrospinal fluid (CSF).
  • A pre-existing history of psychosis.

Additional Important Safety Information

Cognitive and Neuropsychiatric Adverse Reactions (see BOXED WARNING)

  • PRIALT may cause or worsen depression, with the risk of suicide in susceptible patients.
  • Patients with pretreatment for psychiatric disorders may be at an increased risk of psychiatric disturbances.
  • Cognitive impairment such as confusion (particularly in the elderly ≥65 years), memory impairment, speech disorder, aphasia, thinking abnormal, and amnesia, along with decreased alertness/unresponsiveness, may appear gradually after several weeks of treatment. Reduce the dose of PRIALT or discontinue the use of PRIALT if signs or symptoms of cognitive impairment develop but consider other contributing causes. The cognitive effects of PRIALT are generally reversible within 2 weeks after drug discontinuation.
  • PRIALT therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms.
  • Concomitant use of central nervous system (CNS) depressants with PRIALT may have additive effects and require dosage adjustments.

Reduced Level of Consciousness and Driving, Operating Machinery

  • In clinical trials, 2% of PRIALT-treated patients became unresponsive or stuporous. Patients are at higher risk for depressed levels of consciousness with concomitant use of antiepileptics, neuroleptics, sedatives, or diuretics.
  • PRIALT has been associated with cognitive impairment and decreased alertness/unresponsiveness. Caution patients against engaging in hazardous activities that require complete mental alertness or motor coordination.
  • If reduced levels of consciousness occur, discontinue PRIALT until the event resolves, consider other etiologies (e.g., meningitis), and discontinue other CNS-depressant drugs as clinically appropriate.

Elevation of Serum Creatine Kinase

  • In clinical trials, 40% of patients had serum creatine kinase (CK) levels above the upper limit of normal (ULN) and 11% had CK levels >3 times the ULN. Monitor serum CK levels periodically. In the event of new neuromuscular symptoms, evaluate patients clinically and obtain CK measurements. If symptoms continue and CK levels remain elevated or continue to rise, reduce the dose, or discontinue the use of PRIALT.

Withdrawal From Opiates

  • PRIALT is not an opiate and cannot prevent or relieve the symptoms associated with the withdrawal of opiates.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥25%) in clinical trials were dizziness, nausea, confusional state, and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuations for adverse reactions.

Indication

PRIALT® (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch. You may also contact ESTEVE Pharmaceuticals, S.A. at 1‑888‑306‑6259 or drugsafety.us@esteve.com.

Please see accompanying Full Prescribing Information, including BOXED WARNING.

Important Safety Information and Indication

BOXED WARNING: Neuropsychiatric Adverse Reactions

  • PRIALT is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or psychiatric signs or symptoms.

Contraindications

PRIALT is contraindicated in patients with:

  • A known hypersensitivity to ziconotide or any of its formulation components.
  • A medical condition that would render intrathecal administration hazardous to the use of intrathecal analgesia such as the presence of infection at the microinfusion injection site, uncontrolled bleeding diathesis, and spinal canal obstruction that impairs circulation of cerebrospinal fluid (CSF).
  • A pre-existing history of psychosis.

Additional Important Safety Information

Cognitive and Neuropsychiatric Adverse Reactions (see BOXED WARNING)

  • PRIALT may cause or worsen depression, with the risk of suicide in susceptible patients.
  • Patients with pretreatment for psychiatric disorders may be at an increased risk of psychiatric disturbances.
  • Cognitive impairment such as confusion (particularly in the elderly ≥65 years), memory impairment, speech disorder, aphasia, thinking abnormal, and amnesia, along with decreased alertness/unresponsiveness, may appear gradually after several weeks of treatment. Reduce the dose of PRIALT or discontinue the use of PRIALT if signs or symptoms of cognitive impairment develop but consider other contributing causes. The cognitive effects of PRIALT are generally reversible within 2 weeks after drug discontinuation.
  • PRIALT therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms.
  • Concomitant use of central nervous system (CNS) depressants with PRIALT may have additive effects and require dosage adjustments.

Reduced Level of Consciousness and Driving, Operating Machinery

  • In clinical trials, 2% of PRIALT-treated patients became unresponsive or stuporous. Patients are at higher risk for depressed levels of consciousness with concomitant use of antiepileptics, neuroleptics, sedatives, or diuretics.
  • PRIALT has been associated with cognitive impairment and decreased alertness/unresponsiveness. Caution patients against engaging in hazardous activities that require complete mental alertness or motor coordination.
  • If reduced levels of consciousness occur, discontinue PRIALT until the event resolves, consider other etiologies (e.g., meningitis), and discontinue other CNS-depressant drugs as clinically appropriate.

Elevation of Serum Creatine Kinase

  • In clinical trials, 40% of patients had serum creatine kinase (CK) levels above the upper limit of normal (ULN) and 11% had CK levels >3 times the ULN. Monitor serum CK levels periodically. In the event of new neuromuscular symptoms, evaluate patients clinically and obtain CK measurements. If symptoms continue and CK levels remain elevated or continue to rise, reduce the dose, or discontinue the use of PRIALT.

Withdrawal From Opiates

  • PRIALT is not an opiate and cannot prevent or relieve the symptoms associated with the withdrawal of opiates.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥25%) in clinical trials were dizziness, nausea, confusional state, and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuations for adverse reactions.

Indication

PRIALT® (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1‑800‑FDA‑1088 or www.FDA.gov/medwatch. You may also contact ESTEVE Pharmaceuticals, S.A. at 1‑888‑306‑6259 or drugsafety.us@esteve.com.

Please see accompanying Full Prescribing Information, including BOXED WARNING.