ModifiedCentenePolicy CP.PHAR.488

Apomorphine (Apokyn, Apokyn NXT, Onapgo) coverage

Defines medical necessity, prior authorization, dosing limits, and renewal durations for apomorphine products used to treat motor fluctuations ('off' episodes) in advanced Parkinson's disease for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyApomorphine (Apokyn, Apokyn NXT, Onapgo) coverage

Policy CodePolicy CP.PHAR.488

Change TypeMaterial clinical and operational updates

Effective DateSep 1, 2020

Next Review Date

Key ActionSubmit prior authorization with documentation of Parkinson's diagnosis, neurologist involvement, trials of at least two anti-Parkinson agents from different classes (unless contraindicated), concurrent levodopa/carbidopa use, and dosing within product limits.

SourceLink

POLICY UPDATE CHANGES

Added new formulations Apokyn NXT and Onapgo to policy and added generic apomorphine to policy requiring prior authorization.

Revised language to require apomorphine be prescribed concurrently with levodopa/carbidopa and added requirement for trial and failure of at least two anti-Parkinson agents from different therapeutic classes unless contraindicated or intolerant.

Removed Kynmobi formulation from policy due to market withdrawal by manufacturer.

Added HCPCS codes J3490 and C9399 and earlier added J0364 to coding list for informational purposes.

3named formulations

>=2required prior trials

6 mg/inj; 5/day

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Apomorphine

Initial Therapy

Covered when ALL of the following are met for Initial Approval (Parkinson's Disease):

Initial Approval - Parkinson's Disease: 1. Diagnosis of Parkinson's disease; 2. Prescribed by or in consultation with a neurologist; 3. Member is experiencing hypomobility episodes at the end of the dosing interval or unpredictable hypomobility ('on/off') episodes; 4. Failure of at least two anti-Parkinson agents from different therapeutic classes unless clinically significant adverse effects are experienced or all agents are contraindicated (examples: MAO-B inhibitor - rasagiline; COMT inhibitors - entacapone, tolcapone; dopamine agonists - ropinirole, pramipexole); 5. Prescribed in combination with levodopa/carbidopa; 6. For Apokyn or Apokyn NXT requests, member must use generic apomorphine unless contraindicated or clinically significant adverse effects are experienced; 7. Dose does not exceed product-specific limits: either (a) Apokyn/Apokyn NXT: 0.6 mL (6 mg) per injection, up to 5 injections per day, maximum 2 mL (20 mg) per day; or (b) Onapgo: 98 mg (1 cartridge) per day.

Initial approval applies per Approval duration section.

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy (Parkinson's Disease):

Continued Therapy - Parkinson's Disease: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. For Apokyn or Apokyn NXT requests, member must use generic apomorphine unless contraindicated or clinically significant adverse effects are experienced; 4. If request is for a dose increase, the new dose does not exceed product-specific limits: Apokyn/Apokyn NXT — 0.6 mL (6 mg) per injection, up to 5 injections/day, maximum 2 mL (20 mg)/day; Onapgo — 98 mg (1 cartridge) per day.

Continued approval durations differ by line of business.

Not Medically Necessary / Not Authorized Uses

Not authorized:

Not Authorized: Non‑FDA approved indications that are not addressed in this policy are not covered unless sufficient documentation of efficacy and safety is provided per applicable off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

Requests for non‑FDA indications should reference the off‑label policies listed.

Initial coverage criteria

Covered when ALL of the following are met

PA and formulation: Prior authorization is required for apomorphine products including Apokyn, Apokyn NXT, Onapgo, and generic apomorphine.

HCPCS codes J0364, J3490, C9399 are referenced for billing.

Concomitant therapy: Apomorphine must be prescribed concurrently with levodopa/carbidopa.

Policy language revised to clarify concurrent levodopa/carbidopa requirement.

Step therapy: Trial and failure of at least two anti‑Parkinson agents from different therapeutic classes is required prior to approval unless clinically significant adverse events occur or all are contraindicated.>=2 agents

Illinois‑specific step therapy bypass provisions may apply per IL HB 5395 (effective 1/1/2026 for Illinois HIM).

Non‑FDA approved indications for apomorphine that are not specifically addressed in this policy are not covered unless there is adequate supporting evidence. Providers seeking coverage for off‑label uses must submit documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or provide an applicable evidence of coverage document.

The transdermal/sublingual formulation Kynmobi has been removed from this policy following a manufacturer market withdrawal for low utilization. Kynmobi is no longer listed as a covered apomorphine formulation in this document.

Requests for apomorphine to treat conditions or indications that are not FDA‑approved and not described in this policy require support from the off‑label use process. Providers must supply sufficient clinical documentation per the referenced off‑label policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53) or an evidence of coverage document to justify medical necessity for non‑FDA indications.

Coding listed in this policy (HCPCS codes and descriptions) is provided for informational billing reference only. Inclusion or omission of a code in this document does not by itself guarantee coverage or payment; providers should confirm coding and reimbursement requirements with current professional coding resources prior to claim submission.

Billing and Coding

HCPCS Codes (informational)HCPCS

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

Apokyn / Apokyn NXT dosing limits

Per-injection limit0.6 mL (6 mg) per injection

Maximum injections per dayUp to 5 injections per day

Maximum total daily dose2 mL (20 mg) per day

Onapgo dosing limits

Total daily limit98 mg per day

Unit representationEquivalent to 1 Onapgo cartridge per day

AdministrationContinuous infusion with up to 3 extra doses over waking day as specified by product labeling

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for apomorphine products (including branded and generic formulations such as Apokyn, Apokyn NXT, and Onapgo). Providers must submit a prior authorization request and supporting clinical documentation demonstrating that the member meets all approval criteria for initial therapy (diagnosis, neurologist involvement, hypomobility episodes, required concomitant levodopa/carbidopa, dosing limits, and prior trial history).

Affected products: apomorphine (Apokyn, Apokyn NXT, Onapgo, generic apomorphine)
HCPCS references (informational): J0364 (apomorphine HCl 1 mg), J3490, C9399

Step Therapy

Step Therapy Requirement — Trials of ≥2 Anti‑Parkinson Agents

Step therapy: approval requires failure of at least two anti‑Parkinson agents from different therapeutic classes prior to initiation of apomorphine, unless the member experienced clinically significant adverse effects or all such agents are contraindicated. Examples of required class trials include at least two of the following classes: MAO‑B inhibitor (e.g., rasagiline), COMT inhibitor (e.g., entacapone, tolcapone), and dopamine agonist (e.g., ropinirole, pramipexole).

Definitions and Safety Notes

Off time / 'Off' episodes

DefinitionReturn of Parkinson's disease symptoms (bradykinesia, rest tremor, or rigidity) when the L-dopa treatment effect wears off after each dosing interval

Clinical contextRepresents motor fluctuations between 'on' time (symptom control) and 'off' time due to insufficient levodopa effect

Relevance to coveragePolicy requires presence of hypomobility ('off') episodes for initial and continued approval

Contraindicated concomitant medications

Contraindicated drug class5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron, palonosetron)

ReasonConcomitant use contraindicated due to reports of profound hypotension and loss of consciousness when combined with apomorphine

Background

Apomorphine is a non‑ergoline dopamine agonist approved for the acute, intermittent treatment of motor hypomobility ('off' episodes) in patients with advanced Parkinson's disease. 'Off' episodes refer to recurrence of bradykinesia, tremor, or rigidity when the effect of levodopa wanes between doses. Apomorphine provides a rapid onset option for these episodic motor fluctuations but carries notable adverse effect considerations such as nausea, vomiting and hypotension; antiemetic pretreatment (e.g., trimethobenzamide per product guidance) and monitoring are typically recommended. Product‑specific dosing limits and administration instructions (e.g., test dosing and per‑injection limits) apply and must be followed as part of prior authorization review.

Revision History

2025-06-27addedLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 and added HCPCS codes J3490 and C9399 to coding list; references reviewed and updated.

2025-02-13revised

Added new formulations Apokyn NXT and Onapgo; required prior authorization for generic apomorphine and clarified that Apokyn/Apokyn NXT must use generic apomorphine when available; revised concurrent therapy language to require levodopa/carbidopa and added requirement for trial and failure of at least two anti-Parkinson agents from different therapeutic classes unless contraindicated.