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DESCRIPTIONApokyn® (apomorphine hydrochloride) stands out for its potency at overcoming “off” states associated with advanced Parkinson’s Disease that can be unresponsive even to continuous levodopa infusion. Subcutaneous administration of Apokyn® (Apomorphine Hydrochloride) is a good therapeutic option for rapid rescue from disabling “off” episodes in patients with unpredictable or suboptimal effects from levodopa. Improvement in Parkinson’s symptoms becomes evident within about 7—14 minutes following the subcutaneous injection, with a duration of action up to 2 hours.
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.
POLICYPrior authorization is required.
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).
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.
POLICY HISTORY10/1/2004: Code Reference section completed
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.
03/27/2014: Policy reviewed; no changes.
SOURCE(S)Drug Facts & Comparisons website. Available at: http://www.efactsweb.com/ Accessed on July 26, 2004.
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.
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.