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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).
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
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.
08/26/2015: Medical policy revised to add ICD-10 codes.
02/02/2016: Approved by Pharmacy & Therapeutics (P&T) Committee. Policy guidelines updated to add medically necessary and investigative definitions.
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.