CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Apomorphine (Apokyn, Kynmobi) — Coverage Criteria for Acute 'Off' Episodes in Parkinson's Disease

Covers authorization criteria for apomorphine formulations (Apokyn injection, Kynmobi sublingual) for acute, intermittent treatment of '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) — Coverage Criteria for Acute 'Off' Episodes in Parkinson's Disease

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of ≥2 hours/day 'off' time, current carbidopa/levodopa therapy, and prior optimization/adjunct therapy trials.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 mocontinuation authorization duration

≥2 h/dayminimum daily 'off' time required

prior levodopaconcomitant therapy requirement

Coverage Criteria for Apomorphine (Apokyn, Kynmobi)

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inv-01: Initial Therapy (6 months)

Covered when ALL of the following are met for initial authorization (6 months):

Initial Authorization for Parkinson's disease: Member has a diagnosis of Parkinson's disease.

Initial Authorization for Parkinson's disease: Member experiences at least 2 hours per day of 'off' time.At least 2 hours per day

Initial Authorization for Parkinson's disease: Member is currently being treated with carbidopa/levodopa.

Initial Authorization for Parkinson's disease: Attempts to manage 'off' episodes by adjusting the dosing or formulation of carbidopa/levodopa were ineffective.

Initial Authorization for Parkinson's disease: Treatment with carbidopa/levodopa plus one of the following therapies was ineffective at managing 'off' episodes: 1) a dopamine agonist (e.g., pramipexole, ropinirole); 2) a MAO-B inhibitor (e.g., selegiline, rasagiline); 3) a COMT inhibitor (e.g., entacapone, tolcapone).

inv-02: Continuation Therapy (12 months)

Covered when BOTH of the following are met for continuation authorization (12 months):

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

Continuation Therapy: Member is experiencing improvement with the requested medication (for example, reduction in daily 'off' time or improvement in motor function after administration).

Coverage is limited to the FDA‑approved acute, intermittent treatment of hypomobility or "off" episodes in patients with Parkinson's disease. This includes treatment of "end‑of‑dose wearing off" and unpredictable on/off episodes as specified in the FDA indications for the apomorphine products.

Use of apomorphine for any indication other than the FDA‑approved acute, intermittent treatment of "off" episodes in Parkinson's disease is considered not medically necessary and is therefore excluded from coverage.

Coding and Quick Facts

Referenced Productsmixed

Apokyn	apomorphine hydrochloride injection (brand name reference)
Kynmobi	apomorphine hydrochloride sublingual film (brand name reference)

Referenced Products (alternate coding)mixed

apomorphine hydrochloride

apomorphine hydrochloride (generic name reference)

Minimum daily 'off' time

Minimum daily 'off' timeMember must experience at least 2 hours per day of 'off' time

Authorization contextRequired for initial authorization (up to 6 months) for Parkinson's disease acute, intermittent 'off' episodes

Documentation implicationClinical documentation should demonstrate duration of daily 'off' time (>=2 hours) as part of prior authorization

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals may be granted for up to 6 months; continuation approvals may be granted for up to 12 months. Requests must document that member meets the clinical prerequisites listed below.

Initial authorization: up to 6 months
Continuation authorization: up to 12 months

Step Therapy

Prior Therapy / Step Requirements

Step therapy/ prior treatment requirements must be documented before approval. The member must be currently treated with carbidopa/levodopa and have had inadequate control of 'off' episodes after medication adjustment and adjunctive therapies.

Member currently 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 was ineffective: dopamine agonist (e.g., pramipexole, ropinirole); MAO‑B inhibitor (e.g., selegiline, rasagiline); COMT inhibitor (e.g., entacapone, tolcapone)

Denial Risk

Indication Restrictions

Use is limited to the FDA‑approved indication: acute, intermittent treatment of 'off' episodes in patients with Parkinson's disease. Use for any other indication is considered experimental/investigational and not covered.

Covered indication: acute, intermittent treatment of 'off' episodes in Parkinson's disease (FDA‑approved)
Not covered: use for indications other than the FDA‑approved acute, intermittent 'off' episodes — considered experimental/investigational

Documentation Required

Documentation and Clinical Criteria — Grounds for Denial

Provide clinical documentation to support the request. Denial may occur if minimum clinical criteria are not met or required prior therapies/adjustments are not documented.

Document daily duration of 'off' time (must be at least 2 hours per day)
Confirm member is currently on carbidopa/levodopa and describe prior adjustments to dosing or formulation
Document prior adjunctive therapy trials and reason for discontinuation or lack of effectiveness (dopamine agonist, MAO‑B inhibitor, or COMT inhibitor)
For continuation requests, document member is on carbidopa/levodopa and experiencing clinical improvement with the requested medication (e.g., reduced daily 'off' time or improved motor function)
Clinical criteria not met — examples of grounds for denial: <2 hours/day of 'off' time; member not currently on carbidopa/levodopa; lack of documentation of prior dosing/formulation adjustments or adjunctive therapy trials