CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Apomorphine (Apokyn, Kynmobi) for Parkinson's 'off' episodes — Coverage Criteria

Covers authorization and continuation criteria for apomorphine formulations (Apokyn injection, Kynmobi sublingual) for acute, intermittent treatment of 'off' episodes in Parkinson's disease patients when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyApomorphine (Apokyn, Kynmobi) for Parkinson's 'off' episodes — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis, baseline off time (≥1 hour/day), prior carbidopa/levodopa optimization and adjunctive therapy trials; initial approval may be for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthstypical initial authorization duration

12 monthscontinuation authorization duration

≥1 hr/dayrequired minimum daily 'off' time for eligibility

Apokyn, Kynmobidrugs referenced

Coverage Criteria for Apomorphine (Apokyn, Kynmobi)

Initial Therapy

Covered when ALL of the following are met

Initial Authorization Criteria: Member has Parkinson's disease.

Initial Authorization Criteria: Member experiences at least 1 hour per day of "off" time.>= 1 hour per day

Initial Authorization Criteria: Member is currently being treated with carbidopa/levodopa.

Initial Authorization Criteria: Attempts to manage "off" episodes by adjusting the dosing or formulation of carbidopa/levodopa were ineffective.

Initial Authorization Criteria: Treatment with carbidopa/levodopa plus one or more adjunctive therapies (e.g., MAO-B inhibitor such as selegiline or rasagiline, or a COMT inhibitor such as entacapone or tolcapone) was ineffective at managing "off" episodes.

Authorization of 6 months may be granted when all criteria are met.

Continuation Therapy

Covered when BOTH of the following are met

Continuation Criteria: Member is currently being treated with carbidopa/levodopa.

Continuation Criteria: Member is experiencing improvement with the requested medication (e.g., reduction in daily "off" time, improvement in motor function post-administration).

Authorization of 12 months may be granted when criteria are met.

This policy addresses coverage of apomorphine formulations (Apokyn injection and Kynmobi sublingual) specifically for the acute, intermittent treatment of 'off' episodes in Parkinson’s disease. Coverage is available when required authorization criteria are met for this FDA‑approved indication, including documented Parkinson’s disease, at least 1 hour per day of 'off' time, current carbidopa/levodopa therapy with unsuccessful optimization, and prior trial of adjunctive therapies unless contraindicated. All other uses outside the approved indication described above are not covered under this policy.

Use of apomorphine products is limited to the FDA‑approved indications and recognized compendial uses for the acute, intermittent treatment of 'off' episodes in Parkinson’s disease. Requests for apomorphine for indications beyond these approved or compendial uses are considered experimental/investigational and not medically necessary and therefore are not covered.

Prior Auth, Documentation, and Step Therapy Requirements

Prior Authorization

Prior authorization required; initial 6‑month, continuation 12‑month approvals

Prior authorization is required. When all initial authorization criteria are met, an initial approval may be granted for 6 months; continuation approvals may be granted for 12 months when continuation criteria are met and ongoing benefit is demonstrated.

Step Therapy

Step therapy: carbidopa/levodopa optimization and adjunctive therapy trials required

Trials of optimized carbidopa/levodopa (including adjustments of dosing or formulation) and treatment with carbidopa/levodopa plus one or more adjunctive therapies (e.g., MAO‑B inhibitor such as selegiline or rasagiline, or a COMT inhibitor such as entacapone or tolcapone) must have been ineffective before apomorphine is authorized.

Document attempts to manage "off" episodes by adjusting carbidopa/levodopa dosing or formulation
Document prior use of a MAO‑B inhibitor and/or a COMT inhibitor unless contraindicated

Documentation Required

Required clinical documentation: diagnosis, baseline off‑time, treatments and trial history

Provide clinical documentation showing a diagnosis of Parkinson's disease, baseline daily "off" time (at least 1 hour per day), current treatment with carbidopa/levodopa, documentation that adjustments of carbidopa/levodopa dosing or formulation were ineffective, and prior trial(s) of adjunctive therapies; for continuation, document clinical improvement (e.g., reduction in daily "off" time or improved motor function).

Diagnosis of Parkinson's disease
Baseline "off" time >= 1 hour per day
Current carbidopa/levodopa therapy and prior adjustments attempted
Prior trial(s) of adjunctive therapies (MAO‑B or COMT inhibitors) or rationale if contraindicated
For continuation: evidence of improvement with the requested medication (reduction in "off" time or improved motor function)

Denial Risk

Non‑approved indications considered experimental/investigational

Requests for uses outside the FDA‑approved or compendial indications (i.e., indications other than acute, intermittent treatment of "off" episodes in PD) are considered experimental/investigational and are not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyApomorphine (Apokyn, Kynmobi) for Parkinson's 'off' episodes — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

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Apomorphine (Apokyn, Kynmobi) for Parkinson's 'off' episodes — Coverage Criteria

Coverage Criteria for Apomorphine (Apokyn, Kynmobi)

Referenced Products, Codes, and Key Criteria

Prior Auth, Documentation, and Step Therapy Requirements

Key Definitions

Background

Apokyn	apomorphine hydrochloride injection (brand)
Kynmobi	apomorphine hydrochloride (sublingual brand)