CARBIDOPA/ LEVODOPA SUSP,INTESTINAL
Clinical Criteria Summary
Exclusion Criteria
- Currently taking or taken within 14 days a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine)
- Patient is not an appropriate candidate for PEG J placement
- Patient has not demonstrated a response to prior levodopa use
Inclusion Criteria
- Diagnosis of Idiopathic Parkinson’s disease
- Patient is under the care of a VA or VA Community Care neurologist
- Motor fluctuations (“wearing off”) that require dosing of dopaminergic medications at intervals every 4 hours or less
- Either combination of carbidopa/levodopa controlled-release (CR) and immediate-release (IR) tablet formulations or carbidopa/levodopa extended-release (ER) capsules throughout the day have not adequately resolved OFF periods
- Contraindication, intolerance, or inadequate therapeutic response to at least one agent from two of the following classes: dopamine agonist, catechol-O methyl transferase [COMT] inhibitor, monoamine oxidase type B [MAO B] inhibitor
Documentation & Clinical Management Requirements
- Discussion with patient/caregiver/family regarding realistic efficacy expectations, device management, and potential device-related complications should be documented in the patient’s medical record
- Recommended dosing should be determined based on the patient’s current carbidopa/levodopa dose and other Parkinson’s disease therapies per product prescribing information
Device Placement Considerations
- Absolute contraindications to J-tube placement include: known or suspected intestinal obstruction, serious coagulation disorders, sepsis or active peritonitis
- Relative contraindications include: ascites and neoplastic, inflammatory and infiltrative disease of the gastric and abdominal walls