Apomorphine

POLICY NUMBER

L.5.01.406

Apokyn (apomorphine)

Onapgo (apomorphine)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Apomorphine is a non-ergoline dopamine agonist that 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 apomorphine is a good therapeutic option for rapid rescue from disabling “off” episodes in patients with unpredictable or suboptimal effects from levodopa.

Apokyn (apomorphine) is indicated for acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) in patients with advanced Parkinson’s disease. Apokyn (apomorphine) is available as a subcutaneous pen for intermittent use.

Onapgo (apomorphine) is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease and is administered via continuous subcutaneous infusion.

POLICY

Prior authorization is required.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

Initial Criteria

Apokyn (apomorphine) may be considered medically necessary when ALL of the following criteria are met:

1. The individual is ≥18 years of age;

2. The individual has a documented diagnosis of advanced Parkinson’s disease as determined by a board certified neurologist;

3. The individual has documented acute, intermittent hypomobility, “off” episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes);

4. The individual is currently on levodopa AND at least one other agent for symptom management of Parkinson’s disease (i.e., amantadine, entacapone, selegiline, or tolcapone);

5. The individual is not taking concomitant drugs of the 5HT3 antagonist class (i.e., ondansetron, granisetron, dolasetron, palonosetron, and alosetron);

6. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

7. The prescribed dosage is within the program quantity limits based on FDA-approved labeled dosage.

Length of Approval: 6 months

Renewal Criteria

Apokyn (apomorphine) may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has previously been approved for therapy through BCBSMS PA process;

2. The individual has documented clinical improvement in acute, intermittent hypomobility, “off’’ episodes;

3. The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND

4. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.

Length of Approval: 12 months

Onapgo (apomorphine) is considered not medically necessary as there are other options covered by the Plan for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

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

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 Mental Health Disorders, 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 medical necessity, “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.

POLICY HISTORY

10/1/2004: 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.

05/26/2016: Policy number L.5.01.406 added.

02/07/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

02/06/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

05/30/2018: Deleted outdated references from the Sources section.

02/05/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy description updated with minor wording change. Added statement that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Added policy statement regarding dosing recommendations for Apokyn. Added 12 month length of approval. Effective 01/01/2019.

11/01/2020: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug name to the top of the policy. Policy description updated to remove contraindications. Medically necessary policy statement revised to list additional criteria. Added renewal criteria. Policy Exceptions updated regarding State Health Plan members. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders." Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

09/28/2023: Code Reference section updated to add new ICD-10 diagnosis codes G20.A1, G20.A2, G20.B1, G20.B2, and G20.C, effective 10/01/2023.

01/15/2025: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Apokyn (apomorphine hydrochloride)" to "Apokyn (apomorphine)." Policy description updated to remove the brand name, Apokyn. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Policy statements updated to remove Apokyn from the coverage criteria. Medically necessary policy statement updated for clarification and to add the following criteria: 1) The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; and 2) The prescribed dosage is within the program quantity limits based on FDA-approved labeled dosage. Renewal criteria updated regarding FDA-labeled contraindications and dose requirements. Sources updated. Code Reference section updated to revise description for HCPCS code J0364 and to remove deleted ICD-10 diagnosis code G20.

09/01/2025: Policy title changed from "Apokyn (apomorphine)" to "Apomorphine." Policy description updated regarding Apokyn (apomorphine) and indications for Onapgo (apomorphine). Initial and renewal criteria updated to change "Apomorphine" to "Apokyn (apomorphine)." Added the following policy statements: 1) Onapgo (apomorphine) is considered not medically necessary as there are other options covered by the Plan for the treatment of motor fluctuations in adults with advanced Parkinson's disease. 2) Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary. Sources updated.

12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Sources updated.

SOURCE(S)

1. Apokyn prescribing information. MDD US Operations, LLC. October 2024. Last accessed September 2025.

2. Onapgo prescribing information. MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc. August 2025. Last accessed September 2025.

3. 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 Standard.

CODE REFERENCE

This 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.

Covered Codes

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