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Apokyn® (apomorphine hydrochloride) is a non-narcotic derivative that acts as a potent dopaminergic agonist. This medication is available as a subcutaneous injection. Apomorphine can be derived from morphine, and can also be synthesized from other starting compounds. Apomorphine’s primary pharmacologic actions are derived from its polycyclic and tertiary amine structures that contain a moiety homologous with the dopamine receptors.

The use of Apokyn® (apomorphine hydrochloride) is contraindicated with concomitant use of drugs of the 5HT3 antagonist class, including ondansetron, granisetron, dolasetron, palonosetron, and alosetron. Patients who develop clinically significant orthostatic hypotension in response to the test dose of Apokyn® (apomorphine hydrochloride) should not be considered for continued treatment.

FDA APPROVED INDICATIONS

Apokyn® (apomorphine hydrochloride) is indicated for acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) associated with advanced Parkinson’s Disease.

The dose of Apokyn® (apomorphine hydrochloride) should be titrated based on effectiveness and tolerance.

• The recommended starting dose of Apokyn® (apomorphine hydrochloride) is 0.2 mL (2 mg).
• The recommended maximum dose of Apokyn® (apomorphine hydrochloride) is 0.6 mL (6 mg).
• If the patient tolerates the 0.2 mL (2 mg) dose and responds, use the staring dose of 0.2 mL (2 mg) on an as-needed basis to treat existing “off” episodes.
• The dose may be titrated on an as-needed basis by increasing the dose in increments of 0.1 mL (1mg) every few days on an outpatient basis.

IDENTIFICATION

Generic Name: Apomorphine Hydrochloride
Brand Name: Apokyn®

Apokyn® (apomorphine hydrochloride) is considered medically necessary for patients experiencing hypomobility, “off” episodes associated with advanced Parkinson’s disease as determined by a board certified neurologist.

In accordance with FDA dosing recommendations described in the product’s labeling, the frequency of dosing Apokyn® (apomorphine hydrochloride) should not exceed 5 times per day, a single dose should not exceed 0.6 mL (6mg), and the total daily dose should not exceed 2 mL (20mg).

None

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

11/2005:  Approved by Pharmacy & Therapeutics (P&T) Committee

12/7/2005:  Policy section updated; changed phone number for Accredo from 866-898-0104 to 1-866-240-3373; changed fax # from 866-898-0064 to 1-866-898-0069; Priority Healthcare information including phone number 888-927-6596 and fax # 888-704-3603 were removed.  CuraScript added with phone number 1-877-462-6211 and fax # 1-877-462-6234.

2/6/2006: Code Reference table updated; code S0167 added, code J3490 deleted

12/27/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions

3/5/2007: Code Reference section updated per quarterly HCPCS revisions

10/17/2007: CuraScript information removed from policy

01/01/2009: Accredo preferred provider information removed. BCBSMS information added.

04/24/2013: Policy reviewed; no changes to policy statement. Removed deleted HCPCS code S0167 from the Code Reference section. Deleted outdated references from the Sources section.

LeWitt, Peter A., MD. Subcutaneously administered apomorphine. Neurology. Vol. 62; 6. March 23, 2004. Available at: www.mdconsult.com. Accessed on July 26, 2004.

Apokyn package insert. Available at: http://www.apokyn.com/ Accessed on July 26, 2004.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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