CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Apomorphine (Apokyn, Kynmobi) for acute intermittent treatment of Parkinson's 'off' episodes — Coverage Criteria

Covers authorization criteria and continuation requirements for apomorphine products (Apokyn injection, Kynmobi sublingual) used to treat acute, intermittent 'off' episodes in patients with Parkinson's disease for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyApomorphine (Apokyn, Kynmobi) for acute intermittent treatment of Parkinson's 'off' episodes — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document Parkinson's diagnosis, ≥2 hours/day 'off' time, current carbidopa/levodopa use, prior adjunct therapy trials, and clinical improvement for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization duration

12 monthscontinuation authorization duration

>=2 hrs/dayminimum daily 'off' time required

FDA-onlycoverage scope

Coverage Criteria for Apomorphine

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inv-01: Initial therapy

Covered when ALL of the following are met:

Initial Authorization Criteria: Member has Parkinson's disease and experiences at least 2 hours per day of "off" time; member is currently being treated with carbidopa/levodopa; attempts to manage "off" episodes by adjusting the dosing or formulation of carbidopa/levodopa were ineffective; treatment with carbidopa/levodopa plus one of the following adjunct therapies was ineffective at managing "off" episodes: a MAO-B inhibitor (e.g., selegiline, rasagiline), a dopamine agonist (e.g., pramipexole, ropinirole), or a COMT inhibitor (e.g., entacapone, tolcapone); therapy is for an FDA-approved indication (acute, intermittent "off" episodes).6 months authorization

Authorization up to 6 months may be granted

inv-02: Continuation therapy

Covered when ALL of the following are met:

Continuation Authorization Criteria: Member is currently being treated with carbidopa/levodopa; member is experiencing improvement with the requested medication (e.g., reduction in daily "off" time, improvement in motor function post-administration).12 months authorization

Authorization up to 12 months may be granted

All uses of apomorphine products outside the FDA‑approved indications are considered experimental/investigational and are not medically necessary. The policy limits coverage to the labeled indication of acute, intermittent treatment of hypomobility ("off" episodes) in patients with Parkinson's disease; requests for non‑approved indications will be denied.

Use of apomorphine for indications other than the acute, intermittent treatment of "off" episodes in Parkinson's disease is not covered. The policy explicitly states that all other indications are considered experimental/investigational and not medically necessary.

Drug Products, Metrics, and Authorization Durations

Drug products referencedNDC

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

inv-06: Minimum daily 'off' time threshold

Minimum daily 'off' time>= 2 hours per day

Clinical basisRequirement reflects documented daily hypomobility despite optimization of therapy

MeasurementProvider must document quantified daily 'off' time in clinical notes or patient report

inv-07: Initial authorization duration (6 months)

Initial authorization durationUp to 6 months

Condition for grantMay be granted when all initial authorization criteria are met (member on carbidopa/levodopa, >=2 hrs/day 'off' time, unsuccessful adjustments and adjunct trials)

PurposeCovers initial acute, intermittent treatment of 'off' episodes

inv-08: Continuation authorization duration (12 months)

Continuation authorization durationUp to 12 months

Criteria for continuationMember is currently on carbidopa/levodopa and is experiencing improvement with the requested medication (e.g., reduced daily 'off' time or improved motor function)

DocumentationProvider must document clinical improvement on the medication for renewal

Provider Requirements and Authorization Notes

Prior Authorization

Initial authorization (6 months)

Initial authorization (6 months) — prior authorization may be granted when initial criteria met.

Member has a diagnosis of Parkinson's disease with at least 2 hours/day of documented "off" time
Member is currently being treated with carbidopa/levodopa
Attempts to manage "off" episodes by adjusting the dosing or formulation of carbidopa/levodopa were ineffective
Documented trial of carbidopa/levodopa plus at least one adjunct therapy was ineffective (examples: MAO-B inhibitor such as selegiline or rasagiline; dopamine agonist such as pramipexole or ropinirole; COMT inhibitor such as entacapone or tolcapone)

Prior Authorization

Continuation authorization (12 months)

Continuation authorization (12 months) — authorization for continuation when improvement and ongoing carbidopa/levodopa use documented.

Member demonstrates clinical improvement with the requested medication (e.g., reduction in daily "off" time or improved motor function after administration)
Member remains on carbidopa/levodopa therapy

Step Therapy

Step requirements

Step requirements — documented trials of carbidopa/levodopa optimization and adjunct therapies required.

Optimization trial: documented attempts to manage "off" episodes by adjusting dose or formulation of carbidopa/levodopa
Adjunct therapy trial: documented ineffective trial of carbidopa/levodopa plus one of the following classes/agents: MAO-B inhibitor (e.g., selegiline, rasagiline); dopamine agonist (e.g., pramipexole, ropinirole); COMT inhibitor (e.g., entacapone, tolcapone)

Documentation Required

Required clinical documentation

Required clinical documentation — supports PD diagnosis, quantified daily 'off' time (>=2 hours/day), current carbidopa/levodopa use, etc.

Documentation of Parkinson's disease diagnosis
Quantified daily "off" time (must be >= 2 hours per day)
Current carbidopa/levodopa treatment documented
Documentation of prior management attempts (dose/formulation adjustments) and adjunct therapy trials with outcomes

Denial Risk

Non‑approved indications

Non‑approved indications — use for non‑FDA or compendial indications is experimental/investigational and not covered.

Medications used for indications other than acute, intermittent treatment of "off" episodes in Parkinson's disease are considered not medically necessary

Denial Risk

Insufficient baseline criteria

Insufficient baseline criteria — requests missing baseline criteria (e.g., <2 hours/day 'off' time or not on carbidopa/levodopa) may be denied.

Requests lacking documented >= 2 hours/day of "off" time
Requests where member is not currently on carbidopa/levodopa
Requests without documentation of prior optimization or adjunct therapy trials

OpenPayer

Apomorphine (Apokyn, Kynmobi) for acute intermittent treatment of Parkinson's 'off' episodes — Coverage Criteria

Coverage Criteria for Apomorphine

Drug Products, Metrics, and Authorization Durations

Provider Requirements and Authorization Notes

Background

Definitions