ModifiedHealth NetPolicy CP PHAR.488

Apomorphine (Apokyn, Apokyn NXT, Onapgo)

Clinical policy detailing medical necessity criteria, initial and continuation approval criteria, dosing limits, contraindications, prior authorization requirements, formulation-specific limits, and coding implications for apomorphine products (Apokyn, Apokyn NXT, Onapgo) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyApomorphine (Apokyn, Apokyn NXT, Onapgo)

Policy CodePolicy CP PHAR.488

Change TypeFormulation updatesstep therapy bypass (IL HIM)coding additionsremoval of Kynmobi

Effective DateSep 1, 2020

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria when requesting apomorphine.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395 (effective 01/01/2026 noted in policy body; entry dated 06.27.25).

Added formulations Apokyn NXT and Onapgo to policy and added requirement to use generic apomorphine for Apokyn/Apokyn NXT unless contraindicated.

Removed Kynmobi (sublingual apomorphine) formulation from policy due to market withdrawal by manufacturer.

Added HCPCS codes J3490 and C9399 to coding implications.

3Formulations covered (Apokyn, Apokyn NXT, Onapgo)

>=2Required prior anti-Parkinson agent classes tried

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Onapgo max daily dose (mg)

2Approval duration (Medicaid/HIM vs Commercial)

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Clinical policy detailing medical necessity criteria, initial and continuation approval criteria, dosing limits, contraindications, prior authorization requirements, formulation-specific limits, and coding implications for apomorphine products (Apokyn, Apokyn NXT, Onapgo) across Commercial, HIM, and Medicaid lines of business. Subject: Apomorphine (Apokyn, Apokyn NXT, Onapgo). Formulations covered: Apokyn, Apokyn NXT, Onapgo (3 formulations).

Initial Therapy Criteria

Initial Approval Criteria

Apomorphine (Apokyn, Apokyn NXT, Onapgo) is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of Parkinson's disease
Prescribed by or in consultation with a neurologist
Member is experiencing hypomobility episodes at the end of the dosing interval or unpredictable hypomobility (on/off) episodes (see Appendix D)
Prescribed in combination with levodopa/carbidopa
Failure of at least two anti-Parkinson agents from different therapeutic classes
- MAO-B inhibitor (example: rasagiline)
- COMT inhibitor (examples: entacapone, tolcapone)
- Dopamine agonist (examples: ropinirole/ropinirole ER, pramipexole/pramipexole ER)
Member must use generic apomorphine for Apokyn or Apokyn NXT requests, unless contraindicated or clinically significant adverse effects are experienced
Dose does not exceed
- Apokyn, Apokyn NXT: 0.6 mL (6 mg) per injection; up to 5 injections per day; maximum 2 mL (20 mg) per day
  i.e., max 6 mg/injection, max 5 injections/day, total max 20 mg/day
- Onapgo: 98 mg (1 cartridge) per day
  Onapgo total daily max 98 mg

ref

Continuation Therapy Criteria

Continued Therapy Criteria

For members on therapy or requesting renewal, ALL of the following must be met:

ALL of the following

Continuity of care or prior approval
- Member is currently receiving medication via Centene benefit
- Member has previously met initial approval criteria
- Member is enrolled in a state and product with continuity of care regulations (refer to state specific addendums)
Member is responding positively to therapy

Unapproved Indications / Exclusions

Diagnoses/Indications NOT Authorized

Coverage not authorized for:

Non-FDA approved indications that are not addressed in this policy, unless sufficient documentation of efficacy and safety according to applicable off-label use policies (CP.CPA.09 commercial, HIM.PA.154 marketplace, CP.PMN.53 Medicaid) or evidence of coverage documents

Contraindication note: Concomitant use of apomorphine with 5-HT3 antagonists (including ondansetron, granisetron, dolasetron, palonosetron) is contraindicated due to reports of profound hypotension and loss of consciousness. Manufacturer recommends pretreatment with trimethobenzamide 300 mg orally three times daily for three days prior to initiating apomorphine to reduce nausea, and continuing as needed generally no longer than two months.

Applicable Codes

HCPCS / Drug Codes referenced (informational only)HCPCS

J0364	Injection, apomorphine hydrochloride, 1 mg
J3490	Unclassified drugs
C9399	Unclassified drugs or biologicals

Provider Actions & Requirements

Prior Authorization

Documentation Submission

Provider must submit documentation supporting that the member has met all approval criteria. Please include office chart notes, relevant lab results, prior medication trials, and any other clinical information that documents diagnosis, symptom history, and treatment response.

Office chart notes
Relevant lab results
Prior medication trials and dates
Neurology consultation notes (if applicable)

Prior Authorization

Prescriber Requirement

Apomorphine must be prescribed by, or in consultation with, a neurologist experienced in the management of Parkinson's disease.

Clinical Evidence & References

Primary prescribing information and key trials/guidelines: Onapgo Prescribing Information (February 2025); Apokyn Prescribing Information (January 2025); and clinical trial/guideline references including the TOLEDO trial (Lancet Neurology 2018) and American Academy of Neurology (AAN) practice parameters / evidence reviews.

Background

Apomorphine is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of hypomobility "off" episodes in advanced Parkinson's disease. The manufacturer recommends pretreatment with trimethobenzamide (300 mg orally three times daily for three days prior to starting apomorphine and continued as needed, generally no longer than two months) to reduce nausea. Concomitant use with 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron, palonosetron) is contraindicated because of reports of profound hypotension and loss of consciousness.

Definitions: Hypomobility (off) episodes — return of Parkinson's disease symptoms (bradykinesia, rest tremor, rigidity) when L-dopa treatment effect wears off after the dosing interval. MAO-B — monoamine oxidase type B. COMT — catechol-O-methyl transferase.

Revision History

06.27.25policy_revision

Added step therapy bypass for Illinois HIM requests per IL HB 5395 (effective 01/01/2026). Marked material.

02.13.25policy_revision

Added formulations Apokyn NXT and Onapgo to the policy and added requirement that Apokyn/Apokyn NXT requests use generic apomorphine unless contraindicated (generic-use requirement). Also revised concurrent therapy requirement to specify levodopa/carbidopa and added trial/failure of at least two anti-Parkinson agents from different classes. Marked material.

05.10.24policy_revision

Policy Summary

PayerHealth Net

PolicyApomorphine (Apokyn, Apokyn NXT, Onapgo)

Policy CodePolicy CP PHAR.488

Change TypeFormulation updatesstep therapy bypass (IL HIM)coding additionsremoval of Kynmobi

Effective DateSep 1, 2020

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria when requesting apomorphine.

SourceLink

On This Page

For Apokyn or Apokyn NXT requests, member must use generic apomorphine, unless contraindicated or clinically significant adverse effects are experienced

Dose limitations for continued therapy (must not exceed both limits as applicable)

Apokyn, Apokyn NXT: 0.6 mL (6 mg) per injection; up to 5 injections per day; maximum 2 mL (20 mg) per day
Onapgo: Continuous dosage up to 6 mg/hr over waking period (e.g., up to 16 hours) with total daily dosage including extra doses not exceeding 98 mg/day; no more than 3 extra doses over 16 hours with at least 3 hours between extra doses

Documentation Required

Therapy History Requirement

Document trial and failure of at least two anti-Parkinson agents from different therapeutic classes, unless contraindicated or clinically significant adverse effects occurred. Trials should include agents such as an MAO-B inhibitor, a COMT inhibitor, and/or a dopamine agonist as clinically appropriate.

Examples of therapeutic classes: MAO-B inhibitors (e.g., rasagiline)
COMT inhibitors (e.g., entacapone, tolcapone)
Dopamine agonists (e.g., ropinirole, pramipexole)

Billing Rule

Generic Substitution Requirement

For requests for Apokyn or Apokyn NXT, the member must use generic apomorphine if available unless the prescriber documents a contraindication or clinically significant adverse effects to the generic.

Prior Authorization

Concomitant Therapy Requirement

Apomorphine must be prescribed in combination with levodopa/carbidopa.

Denial Risk

Off‑label and Non‑FDA Uses

Requests for non–FDA-approved indications (off-label uses) not specifically addressed in this policy will be denied unless sufficient documentation is provided demonstrating efficacy and safety per the applicable off‑label/non‑formulary exception policies for the line of business.

Commercial: refer to CP.CPA.09
Health Insurance Marketplace: refer to HIM.PA.154
Medicaid: refer to CP.PMN.53

Removed Kynmobi (sublingual apomorphine) formulation from the policy due to market withdrawal by manufacturer (low utilization). Marked material.

06.27.25coding_updateLatest

Added HCPCS codes J3490 and C9399 to coding implications (informational). Marked non-material.