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Prior Authorization Protocol
RYTARYTM (carbidopa/levodopa)

NATL

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • For the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication
  2. Health Net Approved Indications and Usage Guidelines:
    • Diagnosis of Parkinson's disease
    AND
    • Failure or clinically significant adverse effects to generic carbidopa/levodopa tablets
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    This field intentionally left blank.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    carbidopa/levodopa extended release (Sinemet CR)

    25 mg/100 mg PO BID; 50 mg/200 mg PO BID

    12 tablets/day

    carbidopa/levodopa immediate release (Sinemet, Parcopa)
    10 mg/100 mg PO TID to QID; 25 mg/100 mg PO TID
    carbidopa 200 mg/day
    carbidopa/levodopa/entacapone (Stalevo)

    Individualized based on therapeutic response

    6 tablets/day of Stalevo 200; 8 tablets/day of Stalevo 50, 75, 100, 125, 150
    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Rytary

    Levodopa-naive patients
    Starting dose 23.75 mg/95 mg PO TID; may increase to 36.25 mg/145 mg PO TID on the fourth day of treatment.
    Based on clinical response and tolerability, dose may be increase to a maximum of 97.5 mg/390 mg PO TID
    Converting patients taking carbidopa/levodopa IR products:
    Refer to dosing table in prescribing information.

    Dosages of other carbidopa and levodopa products are not interchangeable with Rytary.

    Length of Benefit

  7. Product Availability:
    Extended-release capsules: carbidopa and levodopa 23.75 mg / 95 mg, 36.25 mg / 145 mg, 48.75 mg / 195 mg, 61.25 mg / 245 mg
  8. References:
    1. Rytary [Prescribing Information]. Hayward, CA: Impax Pharmaceuticals; January 2015.
The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.