CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Apokyn Inj

Defines coverage criteria for apomorphine (Apokyn/Kynmobi) for acute, intermittent treatment of 'off' episodes in Parkinson's disease, including initial authorization (6 months) and continuation criteria (12 months). Excludes non-PD indications as experimental/investigational.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyApokyn Inj

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of ≥2 hours/day 'off' time, current carbidopa/levodopa, unsuccessful levodopa adjustments, and failure of carbidopa/levodopa plus one adjunctive therapy for initial 6‑month approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Covered Indication (PD 'off' episodes)

>=2 hrs/dayMinimum daily 'off' time

6 moInitial authorization

12 moContinuation authorization

Coverage Summary

Scope: Defines coverage criteria for apomorphine (Apokyn/Kynmobi) for the acute, intermittent treatment of 'off' episodes in Parkinson's disease, limited to the FDA‑approved indication and excluding non‑PD uses as experimental/investigational.

Coverage stance: covered_with_criteria. Authorization thresholds: members must have at least 2 hours per day of 'off' time. Initial authorization may be granted for 6 months when all initial criteria are met. Continuation authorization may be granted for 12 months when continuation criteria are met.

Key Summary

Covered Indication (Parkinson's disease 'off' episodes)Acute, intermittent treatment of 'off' episodes in Parkinson's disease (Apokyn, Kynmobi)

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

Initial authorization duration6 months

Continuation authorization duration12 months

Medical Necessity Criteria

Initial Authorization (6 months) - Parkinson's disease

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Member experiences at least 2 hours per day of 'off' time>= 2 hours per day
Member is currently being treated with carbidopa/levodopa
Attempts to manage 'off' episodes by adjusting the dosing or formulation of carbidopa/levodopa were ineffective
AND treatment with carbidopa/levodopa plus ONE of the following was ineffective
- Dopamine agonist (e.g., pramipexole, ropinirole) was ineffective
- Monoamine oxidase B (MAO-B) inhibitor (e.g., selegiline, rasagiline) was ineffective
- Catechol-O-methyl transferase (COMT) inhibitor (e.g., entacapone, tolcapone) was ineffective

Continuation of Therapy (12 months)

Authorization of 12 months may be granted for continued treatment when BOTH of the following are met:

ALL of the following

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)

Indications Not Covered

All other indications beyond FDA-approved and compendial uses are considered:

Experimental/investigational and not medically necessary

Provider Actions & Authorization Requirements

Prior Authorization

Authorization required for initial treatment

Prior authorization required for initial 6-month authorization; provider must document at least 2 hours/day 'off' time, current carbidopa/levodopa use, unsuccessful adjustments to levodopa dosing/formulation, and failure of carbidopa/levodopa plus one adjunctive therapy (dopamine agonist, MAO-B inhibitor, or COMT inhibitor).

>= 2 hours/day of 'off' time
Current carbidopa/levodopa therapy
Unsuccessful adjustments to levodopa dosing or formulation
Failure of carbidopa/levodopa plus one adjunctive therapy (dopamine agonist, MAO‑B inhibitor, or COMT inhibitor)

Prior Authorization

Authorization required for continuation

For 12-month continuation, provider must document ongoing carbidopa/levodopa therapy and clinical improvement with the apomorphine product (e.g., reduced daily 'off' time or improved motor function).

Ongoing carbidopa/levodopa therapy
Evidence of clinical improvement (reduced daily 'off' time or improved motor function)

Background & Evidence

Background: Apokyn (apomorphine) and Kynmobi are FDA‑approved for the acute, intermittent treatment of hypomobility/‘off’ episodes in patients with Parkinson's disease. The policy restricts coverage to members with significant daily 'off' time who have tried and failed optimization of carbidopa/levodopa dosing or formulation and have not responded to adjunctive therapies.

Definition — 'Off' episodes: Periods of hypomobility or decreased motor function experienced by patients with Parkinson's disease (episodes of 'end‑of‑dose wearing off' and unpredictable 'on/off' fluctuations).

Evidence: Referenced product labeling and guidance include Apokyn and Kynmobi package inserts and apomorphine labeling (2022), plus clinical guidance such as the American Academy of Neurology practice parameter and NICE guidance as listed in the references.