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Prior Authorization Protocol
APOKYNR (apomorphine)

HNCA
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:
    • Acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinsons disease.
  2. Health Net Approved Indications and Usage Guidelines:
    • Patient is experiencing hypomobility episodes at the end of the dosing interval or is experiencing unpredictable hypomobility ("on/off") episodes
  3. Coverage is Not Authorized For:
    • Patients who are taking a drug of the 5-HT3 antagonist class (i.e., ZofranR (ondansetron), KytrilR (granisetron), AnzemetR (dolasetron), AloxiR (palonosetron), and LotronexR (alosetron)).
    • 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:
    • Based on reports of profound hypotension and loss of consciousness when apomorphine was given to patients receiving ondansetron, the concomitant use of apomorphine with drugs of the 5-HT-3 antagonist class is contraindicated. These drugs should not be used to prevent or treat apomorphine-induced nausea and vomiting.
    • Apomorphine induces nausea and vomiting. Patients should be pretreated with trimethobenzamide 300 mg orally three times a day for three days prior to beginning apomorphine therapy. The manufacturer recommends continuing trimethobenzamide for the first two months of apomorphine therapy. However, the length of concomitant therapy in trials varied.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    entacapone (ComtanR)
    Catechol-O-methyltransferase (COMT) inhibitor

    200 mg PO with each dose of carbidopa/levodopa

    1600 mg/day

    AzilectR (rasagiline)
    MAO B inhibitor

    0.5-1 mg PO QD

    1 mg/day

    selegiline (EldeprylR)
    MAO B inhibitor

    5 mg PO BID

    10 mg/day

    carbidopa/levodopa-extented release (SinemetR CR)
    Dopaminergics

    25 mg/100 mg PO BID; 50 mg/200 mg PO BID
    12 tablets/day
    carbidopa/levodopa-immediate release (SinemetR, ParcopaR)
    Dopaminergics
    10 mg/100 mg PO TID to QID; 25 mg/100 mg PO TID

    carbidopa 200 mg/day

    ropinirole (RequipR, Requip XLTM)
    Dopaminergics

    0.25 mg PO TID titrate weekly to 3-9 mg PO TID

    24 mg/day

    pramipexole (MirapexR)
    Dopaminergics

    0.375 mg PO TID in divided doses increase every 5 to 7 days as needed.

    1.5 - 4.5 mg/ day

    carbidopa, levodopa and entacapone (StalevoR)
    Antiparkinson combination Agent

    Conversion of treatment regimen already stabilized on equivalent doses of carbidopa-levodopa and Comtan:

    Carbidopa/ levodopaComtanStalevo
    1/2 tablet (25/100 mg)200 mg50
    1 tablet (25/100 mg)200 mg100
    1 1/2 tablet (25/100 mg)200 mg150

    Conversion from tx without Comtan:

    > 600 mg of levodopa/day< 600 mg w/o dyskinesia
    Titrate with individual agents (carbidopa/ levodopa and Comtan)Consult Prescribing information to convert to Stalevo

    1600 mg/day (of entacapone)

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Apokyn

    0.2 ml SC initial test dose.
    If patient tolerates and responds,
    starting dose should be 0.2 ml used on an as
    needed basis to treat "on/off" episodes.

    If needed, may increase dose by
    0.1 ml (1 mg) increments every few days.
    Maximum single dose is 0.6 ml.

    Dose
    Number of Doses including priming in each vial
    0.2 ml
    9
    0.4 ml
    5
    0.6 ml
    3

    HNCA: 6 months

  7. Product Availability:
    Solution for injection: 10 mg/ml (3-ml cartridges, 5 cartridges per carton)
  8. References:
    1. Apokyn [package insert]. Louisville, KY: US WorldMeds, LLC. July 2014 .
    2. Pahwa R, Factor SA, Lyons KE, et al. Practice Parameter: Treatment of Parkinson disease with motor fluctuations and dyskinesia (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006; 66:983-995.
    3. Apokyn. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current. Accessed June 1, 2015.
    4. DRUGDEXR System [Internet database]. Greenwood Villlage, Colo:Thomson
    Healthcare. Updated periodically. Accessed June 1, 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.