Blue Cross Blue Shield Iowa Parkinsons Coverage Update

Crexont (extended-release carbidopallevodopa) Initial Approval

Crexont (extended-release carbidopallevodopa) covered when ALL of the following are met:

Crexont initial approval: Member has a confirmed diagnosis of Parkinson's disease

Crexont prior therapy requirement: Member has experienced an inadequate response to a maximally tolerated dose or has documented intolerance, FDA labeled contraindication, or hypersensitivity to generic extended-release carbidopallevodopa

Approval will be granted for 12 months

Crexont Continuation

Crexont continuation criteria:

Crexont continuation: Meets initial criteria and is experiencing a noticeable symptomatic benefit demonstrated by a reduction in off episodes since initiating therapy with the requested medication

Approval of 12 months will be granted

Gocovri Initial Approval for Dyskinesia

Gocovri (extended-release amantadine) Initial Approval — dyskinesia when ALL of the following are met:

Diagnosis: Member has a confirmed diagnosis of Parkinson's disease and is experiencing dyskinesia despite receiving a stable dosage of carbidopallevodopa

Prior therapy requirement: Member has experienced an inadequate response to a maximally tolerated dose or has documented intolerance, FDA labeled contraindication, or hypersensitivity to generic immediate-release amantadine AND at least one agent in each of the following classes: MAO-B inhibitor and dopamine agonist (unless there is a clinical reason to avoid therapy)

UNLESS the member is currently receiving treatment with the requested product through insurance and experiencing a positive therapeutic outcome

Dosing adjunct note: Member will be using the requested medication as an adjunct to carbidopallevodopa when indicated

Initial approval will be granted for 6 months

Gocovri Initial Approval for 'Off' Episodes

Gocovri for 'off' episodes Initial Approval — when ALL of the following are met:

Diagnosis off episodes: Member has a confirmed diagnosis of Parkinson's disease and is experiencing 'off' episodes despite receiving a stable dosage of concurrent carbidopallevodopa

Prior therapy requirement off: Member has documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one agent in each of the following classes: MAO-B inhibitor (unless clinical reason to avoid), dopamine agonist, and COMT inhibitor; member will use the requested medication as an adjunct to carbidopallevodopa

Initial approval will be granted for 6 months; UNLESS the member is currently receiving treatment with the requested product through insurance and experiencing a positive therapeutic outcome

Gocovri Continuation

Gocovri continuation criteria:

Gocovri continuation: Meets initial criteria and is experiencing a noticeable symptomatic benefit

Approval of 12 months will be granted

Inbrija Initial Approval

Inbrija (inhaled levodopa) Initial Approval — covered when ALL of the following are met:

Diagnosis: Member has a confirmed diagnosis of Parkinson's disease and is experiencing intermittent 'off' episodes despite receiving a stable dosage of concurrent carbidopallevodopa

Prior therapy requirement: Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one agent in each of the following classes used in combination with carbidopallevodopa, including dopamine agonist and MAO-B inhibitor (unless clinical reason to avoid)

Member will be using the requested medication as an adjunct to carbidopallevodopa; initial approval will be granted for 6 months; UNLESS the member is currently receiving treatment with the requested product through insurance and experiencing a positive therapeutic outcome

Inbrija Continuation

Inbrija continuation criteria:

Inbrija continuation: Meets initial criteria and is experiencing a noticeable symptomatic benefit demonstrated by a reduction in off episodes since initiating therapy with the requested medication

Approval of 12 months will be granted

Neupro Initial and Continuation Criteria

Neupro (rotigotine patch) coverage:

Parkinson's disease indication: Patient ≥18 years with Parkinson's disease who have tried and failed extended-release ropinirole or pramipexole unless intolerance/contraindication/hypersensitivity or currently receiving product through insurance with positive outcome

Initial approval will be granted for 6 months; continuation approval of 12 months with symptomatic benefit

Restless legs syndrome indication: Patient ≥18 years with moderate to severe primary restless legs syndrome who have tried and failed extended-release ropinirole unless intolerance/contraindication/hypersensitivity or currently receiving product through insurance with positive outcome

Initial approval 6 months; continuation 12 months with clinical benefit (quality of life, daytime functioning, or sleep)

Nourianz Initial and Continuation Criteria

Nourianz (istradefylline) Initial Approval — covered when ALL of the following are met:

Diagnosis and symptom: Member has a confirmed diagnosis of Parkinson's disease and is experiencing 'off' episodes despite receiving a stable dosage of concurrent carbidopallevodopa

Prior therapy requirement: Member has experienced an inadequate response to a maximally tolerated dose or has a documented intolerance, FDA labeled contraindication, or hypersensitivity to at least one agent in each of the following classes: dopamine agonist, COMT inhibitor, and MAO-B inhibitor (unless clinical reason to avoid); member will use as adjunct to carbidopallevodopa

Initial approval will be granted for 6 months; continuation 12 months with noticeable symptomatic benefit

Nourianz (istradefylline) — Initial Approval

Covered when ALL of the following are met

Nourianz initial: Member is ≥18 with confirmed Parkinson's disease and experiencing "off" episodes despite stable carbidopa/levodopa; inadequate response or intolerance/contraindication/hypersensitivity to at least one agent in each required class (dopamine agonist, COMT inhibitor, MAO-B inhibitor) unless clinical reason to avoid; will be used as an adjunct to carbidopa/levodopa; exception if currently receiving product through insurance with positive therapeutic outcome.

Initial approval will be granted for 6 months

Nourianz — Continuation

Covered when ALL of the following are met

Nourianz continuation: Member met initial criteria and is experiencing noticeable symptomatic benefit demonstrated by reduction in off episodes since initiating therapy.

Approval of 12 months will be granted

Onapgo — Initial Approval

Covered when ALL of the following are met

Onapgo initial: Member is levodopa responsive with clearly defined 'on' periods; has had an inadequate response or intolerable adverse event with oral carbidopa/levodopa and one additional anti-Parkinson agent; member has 'off' periods of at least 2.5 hours per day despite optimization efforts; prior trial or intolerance to a dopamine agonist, COMT inhibitor, or MAO-B inhibitor.≥ 2.5 hours/day off time

Initial approval will be granted for 6 months

Onapgo — Continuation

Onapgo continuation: Member is experiencing a noticeable symptomatic benefit as demonstrated by reduction in off episodes since initiating therapy with the requested medication.

Approval of 12 months will be granted

Ongentys — Initial Approval

Covered when ALL of the following are met

Ongentys initial: Member has confirmed Parkinson's disease with intermittent off episodes despite stable carbidopallevodopa; experienced inadequate response or intolerance to at least one agent in each of the following classes (MAO-B inhibitor, dopamine agonist, another COMT inhibitor) unless clinical reason to avoid; will be used as adjunct to carbidopallevodopa; exception if currently receiving product through insurance with positive therapeutic outcome.

Initial approval will be granted for 6 months

Ongentys — Continuation

Ongentys continuation: Member meets initial criteria and is experiencing noticeable symptomatic benefit demonstrated by reduction in off episodes.

Approval of 12 months will be granted

Osmolex (amantadine) — Initial Approval for Parkinsonism and Extrapyramidal Reactions

Covered when ALL of the following are met

Osmolex initial PD: Member experienced inadequate response to a maximally tolerated dose or has documented intolerance, FDA labeled contraindication, or hypersensitivity to generic immediate-release amantadine AND at least one agent in dopamine agonist and MAO-B inhibitor classes; will be used adjunctively with carbidopallevodopa where applicable; exception if currently receiving product through insurance with positive therapeutic outcome.

Initial approval will be granted for 6 months

Osmolex initial extrapyramidal: For drug-induced extrapyramidal reactions in adults: inadequate response/intolerance to generic immediate-release amantadine and prescriber has assessed and adjusted medications known to cause extrapyramidal symptoms; exception if currently receiving product through insurance with positive therapeutic outcome.

Initial approval will be granted for 6 months

Osmolex — Continuation

Osmolex continuation: Member meets initial criteria and is experiencing a noticeable symptomatic benefit.

Approval of 12 months will be granted

Extended-release ropinirole (Requip XL) and pramipexole (Mirapex ER) — Initial Approval

Covered when ALL of the following are met

ER dopamine agonists initial: Age ≥18 with idiopathic Parkinson's disease who have tried and failed immediate-release formulations of ropinirole or pramipexole; for ropinirole also indicated for restless legs syndrome when IR failed

Approval granted for 12 months; Extended-release formulations are not medically necessary if IR not tried/failed

ER dopamine agonists — Continuation

ER agonists continuation: Member meets initial criteria and is experiencing a noticeable symptomatic benefit.

Approval of 12 months will be granted

Rytary (extended-release carbidopa/levodopa) — Initial and Continuation

Initial covered when ALL of the following are met

Rytary initial: Member has a confirmed diagnosis of Parkinson's disease and has experienced an inadequate response to a maximally tolerated dose or has documented intolerance, FDA labeled contraindication, or hypersensitivity to generic extended-release carbidopallevodopa

Initial approval will be granted for 12 months

Rytary continuation: Member meets initial criteria and has a noticeable symptomatic benefit demonstrated by reduction in off episodes since initiating therapy with the requested medication

Approval of 12 months will be granted

Tolcapone (Tasmar) — Initial and Continuation

Initial covered when ALL of the following are met

Tolcapone initial: Member has a confirmed diagnosis of idiopathic Parkinson's disease; inadequate response or intolerance to at least one agent in dopamine agonist and MAO-B inhibitor classes and another COMT inhibitor; will be used adjunctively with carbidopa/levodopa; exception if currently receiving product through insurance with positive therapeutic outcome.

Initial approval will be granted for 1 month

Tolcapone continuation: Member meets initial criteria, is experiencing a noticeable symptomatic benefit, and has been evaluated with no signs of hepatic injury

Approval of 12 months will be granted; hepatic monitoring required

Vyalev (foscarbidopa/foslevodopa) — Initial and Continuation

Covered when ALL of the following are met

Vyalev initial: Member is levodopa responsive with clearly defined on periods; inadequate response or intolerable adverse event with oral carbidopa/levodopa and one additional anti-Parkinson agent; off periods ≥2.5 hours/day despite optimization efforts; prior trial or intolerance to dopamine agonist, COMT inhibitor, and MAO-B inhibitor.≥ 2.5 hours/day off time

Initial approval will be granted for 6 months

Vyalev continuation: Member is experiencing a noticeable symptomatic benefit demonstrated by reduction in off episodes since initiating therapy with the requested medication

Approval of 12 months will be granted

Initial Approval (general adjunctive agents)

Covered when ALL of the following are met

Initial approval general: Member is levodopa responsive with clearly defined 'on' periods; inadequate response or intolerable adverse event with oral carbidopa-levodopa and one of the listed anti-Parkinson agents; member has 'off' periods of at least 2.5 hours per day despite optimization efforts.

Continuation Approval (general)

Covered when ALL of the following are met

Continuation general: Member is experiencing a noticeable symptomatic benefit as demonstrated by a reduction in off episodes since initiating therapy with the requested medication.

Xadago (safinamide) Initial Approval

Covered when ALL of the following are met

Xadago initial: Confirmed Parkinson's disease diagnosis; experiencing off episodes despite stable carbidopa-levodopa dosage; inadequate response or intolerance/contraindication/hypersensitivity to at least one agent in required classes (including another MAO-B inhibitor) unless currently receiving the product through insurance with positive outcome; will be used as adjunct to carbidopa-levodopa.

Xadago Continuation

Covered when ALL of the following are met

Xadago continuation: Meets all initial criteria and is experiencing a noticeable symptomatic benefit.

Zelapar (selegiline ODT) Initial Approval

Covered when ALL of the following are met

Zelapar initial: Confirmed Parkinson's disease diagnosis and deterioration in response quality to carbidopallevodopa despite optimized stable dosing; inadequate response or intolerance to selegiline capsules/tablets and at least one agent in required classes (including another MAO-B inhibitor) unless currently receiving the product through insurance with positive therapeutic outcome; will be used as adjunct to carbidopallevodopa.

Zelapar Continuation

Covered when ALL of the following are met

Zelapar continuation: Meets all initial criteria and is experiencing a noticeable symptomatic benefit.

Non-Formulary Exception Coverage

Covered when ALL of the following are met in addition to Criteria for Approval

Non-formulary exception: Requested drug is used for an FDA-approved indication or an indication supported in current compendia; prescribed dose/quantity within FDA labeling or compendia dosing; all covered formulary alternatives are ineffective, less effective, or cause adverse effects with documentation of prior failure, contraindication, or adverse outcome

This policy may not apply to members covered under the Federal Employee Program (FEP). Benefit determinations for FEP members are governed by the Federal Employee Program, and Wellmark/Blue Cross Blue Shield will determine medical necessity only when the applicable contract provides the benefit and no contract exclusions apply. Providers must verify individual member benefits and applicable contract language prior to requesting coverage.

Extended‑release formulations of ropinirole (Requip XL) and pramipexole (Mirapex ER) are not considered medically necessary unless the member has first tried and failed the immediate‑release (IR) formulation of the requested product. The policy explicitly requires the patient to attempt the IR product prior to approval of the ER product; requests that do not document a trial and failure of the IR formulation may be denied.

Members who are currently receiving the requested medication as samples or through a manufacturer's patient assistance program must still meet the policy's initial approval criteria. Receipt of samples or participation in assistance programs does not provide automatic coverage or exempt the member from providing required documentation of diagnosis and prior therapy trials.

Determinations of medical necessity require confirmation that the service or drug is a covered benefit under the member's contract. Benefits must be verified and any exclusions, limitations, or exceptions in the applicable contract must be considered; Wellmark will only determine medical necessity when coverage exists and no contractual exclusions apply.

For approval of extended‑release ropinirole or pramipexole, documentation must explicitly show a trial and inadequate response or intolerance to the immediate‑release form of the same agent. If the member has not attempted or failed the IR formulation, the ER product is not medically necessary per policy and the request may be denied.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for the medications covered by this policy. Typical initial approval durations vary by agent (see individual agent criteria), and approvals are granted for a limited period (commonly 1–12 months) and may require reauthorization. Verify member benefits and contract exclusions before submitting an authorization request; coverage is determined by the member's contract and benefits at time of service.

Prior authorization required — duration varies by product (see agent-specific criteria).
Common initial approval durations: 1 month, 6 months, or 12 months depending on product and indication.
Verify member contract/benefits and exclusions prior to submitting a PA request.

Denial Risk

Prior Authorization Requirements and Denial Risks

Prior authorization will be denied if required prior therapy trials, intolerance, or contraindications are not documented. For agents that must be used as adjuncts to carbidopa-levodopa, documentation of stable concurrent carbidopa-levodopa dosing is required. Some products require the member to be levodopa responsive or to have a minimum amount of daily "off" time; absence of these will place the request at high risk for denial.

Denial risk if prior trials/intolerance not documented.
Document stable concurrent carbidopa-levodopa dosing when required by the agent.
Denial risk if member is not levodopa responsive or does not meet minimum "off" time thresholds where specified.

Note

Benefit Verification and Exclusions

Providers must confirm member benefits and any contract exclusions before requesting authorization. Wellmark (Blue Cross Blue Shield - Iowa) determines medical necessity only if the benefit exists and no contract exclusions apply. Members receiving samples or manufacturer assistance must still meet the criteria for initial approval to qualify for coverage.

Verify member contract and benefits prior to authorization.
Benefit existence and contract exclusions determine medical necessity review.
Members receiving samples or patient assistance still must meet initial approval criteria for coverage.

Step Therapy

Step Therapy / Trial Requirements

Step therapy requirements generally mandate documentation of inadequate response to, or intolerance of, less expensive or first-line therapies (often generic immediate-release agents) prior to approval of extended-release or branded products. Exceptions are considered when the member is already receiving the requested product through insurance with a documented positive therapeutic outcome.

Require inadequate response or intolerance to first-line/generic therapies before approval of higher-cost agents.
Existing insured use with documented positive outcome may waive step-therapy requirements.

Step Therapy

Step Therapy Prior Trials

Specific step therapy prior trials required across the policy set frequently include trials (and inadequate response/intolerance documentation) in each of the following classes as applicable to the requested agent: dopamine agonist, MAO-B inhibitor, and COMT inhibitor. For some agents, immediate-release formulation failure is required before extended-release or ER agonists are approved.

Required prior trials often include: dopamine agonist; MAO-B inhibitor (rasagiline, safinamide, selegiline); COMT inhibitor (entacapone, tolcapone) as applicable.
ER ropinirole/pramipexole (Requip XL, Mirapex ER) require prior failure of the respective immediate-release product.

Step Therapy

Step Therapy Expectation

Policy expectations emphasize trial and inadequate response to less expensive immediate-release dopamine agonists before approving longer-acting or more costly formulations. Clinical rationale supports attempting generically available immediate-release agents first due to comparable efficacy in many settings.

Require trial and inadequate response to less expensive IR dopamine agonists before longer-acting agents.
Clinical rationale: IR generics are usually preferred prior to extended-release formulations.

Documentation Required

Required Clinical Documentation

Provide documentation confirming the diagnosis and the required prior inadequate response, intolerance, contraindication, or hypersensitivity to specified comparator agents. When the agent is indicated as adjunctive to carbidopa-levodopa, include evidence of a stable dosage of carbidopa-levodopa and that symptoms ("off" episodes or dyskinesia) persist despite that therapy.

Confirm diagnosis of Parkinson's disease (or idiopathic Parkinson's disease where specified).
Document inadequate response, intolerance, or contraindication to required comparator agents.
When adjunctive use is required, document stable carbidopa-levodopa dosing and persistent symptoms.

Documentation Required

Required Documentation for Prior Trials and Exceptions

When prior trials or exceptions are claimed, include chart notes or other documentation indicating prior treatment failure, severity of adverse events (if any), dosage and duration of prior treatment, and clinical rationale for exceptions (for example, contraindication or intolerance). Non-formulary exception requests must additionally show that all covered formulary alternatives would be ineffective or not tolerated.

Chart notes documenting prior trial details: dose, duration, and reason for discontinuation/failure.
Severity documentation for adverse events when intolerance is claimed.
For non-formulary exceptions, document that formulary alternatives are ineffective, not tolerated, or contraindicated.

Denial Risk

Agent-Specific Initial Approval Triggers

Some agents include agent-specific initial approval triggers. Examples include requirements that the member be levodopa responsive, have minimum daily "off" time (e.g., ≥ 2.5 hours per day for select agents), or have tried and failed specified classes of therapies. Failure to meet these agent-specific triggers places the request at high risk for denial.

Agent-specific triggers may include levodopa responsiveness and minimum daily "off" time thresholds.
Documented inadequate responses to required classes (e.g., MAO-B inhibitor, dopamine agonist, COMT inhibitor) are necessary when specified by the agent.

Prior Authorization

Initial Approval Triggers and Durations

Initial approval may be contingent on agent-specific criteria such as levodopa responsiveness, documented inadequate response to required comparators, and minimum "off" time. Examples from the policy: Crexont approvals are commonly 12 months when criteria met; many adjunctive agents (Nourianz, Ongentys, others) grant 6 months initial approval when all class trials and stable carbidopa-levodopa are documented; some agents (e.g., tolcapone) may have shorter initial approvals (e.g., 1 month) per criteria. Requests that do not document levodopa responsiveness, required prior failures, or minimum symptom thresholds should be expected to be denied.

Initial approval durations vary by product: common durations include 1 month, 6 months, or 12 months as specified in agent criteria.
Denial risk high if levodopa responsiveness, prior required failures, or symptom thresholds are not documented.

E0781	Vyafuser pump (Vyalev)
J3490	Unclassified drugs
J7356	Injection, foscarbidopa 0.25mg/foslevodopa 5mg
J3590	Unclassified biologics
J7799	Non-drug, other than inhalation drugs, administered through DME

OpenPayer

Parkinson's Disease Pharmacologic Agents — Coverage Criteria

Coverage Criteria for Parkinson's Disease Agents

Provider Requirements, Prior Authorization, and Documentation

Procedures, Codes, and Quantity Limits

Key Clinical Definitions

Background and Scope