Modifiedharvard pilgrim health carePolicy N/A

Advanced Parkinson’s Disease Medications

Prior authorization guideline governing coverage of Vyalev (foscarbidopa/foslevodopa) and Onapgo (apomorphine hydrochloride) for treatment of motor fluctuations in adults with advanced Parkinson's disease across specified Harvard Pilgrim / Tufts product lines.

Policy Summary

Payerharvard pilgrim health care

PolicyAdvanced Parkinson’s Disease Medications

Policy CodePolicy N/A

Change TypeAdded coverage criteria for Onapgo; renamed policy

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization requests with documentation supporting all Initial Coverage Criteria including diagnosis, hours of off time, neurologist prescribing/consultation, attestation of persistent motor fluctuations despite optimized carbidopa/levodopa, and trials of two different medication classes.

SourceLink

POLICY UPDATE CHANGES

Updated name of existing MNG from Vyalev (foscarbidopa/foslevodopa) to Advanced Parkinson's Disease Medications.

2Medications covered (named)

2Required medication-class trials

12 monthsInitial approval duration

Coverage Summary

Coverage stance: covered_with_criteria. This prior authorization guideline governs coverage of Vyalev (foscarbidopa/foslevodopa) and Onapgo (apomorphine hydrochloride) for treatment of motor fluctuations in adults with advanced Parkinson's disease across specified Harvard Pilgrim and Tufts product lines. Effective date: September 1, 2025. Status: MODIFIED.

Initial Therapy Criteria — Onapgo (apomorphine hydrochloride)

Initial Coverage Criteria - Onapgo (apomorphine hydrochloride)

The Plan may cover Onapgo when ALL the following clinical criteria is met:

ALL of the following

The patient has a diagnosis of advanced Parkinson's Disease
The member experiences at least 2.5 hours of 'off' time per day>= 2.5 hours/day
The medication is prescribed by, or in consultation with, a neurologist
There is physician attestation or documentation that the patient is experiencing persistent motor fluctuations despite optimized carbidopa/levodopa therapy
Trial and failure of TWO different classes
- Dopamine agonist (e.g., pramipexole, ropinirole)
- Catechol-o-methyl transferase (COMT) inhibitor (e.g., entacapone)
- Monoamine oxidase (MAO) B inhibitor (e.g., rasagiline, selegiline)

Reauthorization Criteria — Onapgo

Reauthorization Criteria - Onapgo

Reauthorization may be granted when ALL of the following clinical criteria are met:

ALL of the following

The patient continues to exhibit disease stability

Prior Authorization

Initial and reauthorization durations

Initial approval duration: 12 months. Reauthorization duration: 12 months.

Initial Therapy Criteria — Vyalev (foscarbidopa/foslevodopa)

Initial Coverage Criteria - Vyalev (foscarbidopa/foslevodopa)

The Plan may cover Vyalev when ALL the following clinical criteria is met:

ALL of the following

The patient has a diagnosis of advanced Parkinson's Disease
The member experiences at least 2.5 hours of 'off' time per day>= 2.5 hours/day
The medication is prescribed by, or in consultation with, a neurologist
There is physician attestation or documentation that the patient is experiencing persistent motor fluctuations despite optimized carbidopa/levodopa therapy
Trial and failure of TWO different classes
- Dopamine agonist (e.g., pramipexole, ropinirole)
- Catechol-o-methyl transferase (COMT) inhibitor (e.g., entacapone)
- Monoamine oxidase (MAO) B inhibitor (e.g., rasagiline, selegiline)

Reauthorization Criteria — Vyalev

Reauthorization Criteria - Vyalev

Reauthorization may be granted when ALL of the following clinical criteria are met:

ALL of the following

The patient continues to exhibit disease stability

Exclusions and Non‑Covered Conditions

Samples, free goods, or similar offerings do not qualify as evidence of an established clinical response and will not be considered for prior authorization. Documentation supporting prior authorization must include trials, documented inadequate response, intolerance, or contraindication to required therapies; samples or promotional free products will not satisfy these requirements.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required. Requests must include documentation supporting all initial coverage criteria: diagnosis of advanced Parkinson's disease; documentation of at least 2.5 hours per day of "off" time; prescription by or consultation with a neurologist; physician attestation/documentation of persistent motor fluctuations despite optimized carbidopa/levodopa; and documentation of trials of two different medication classes (see Trial documentation). Affected code: J7356.

Diagnosis of advanced Parkinson's Disease
At least 2.5 hours/day of "off" time
Prescribed by or in consultation with a neurologist
Attestation/documentation of persistent motor fluctuations despite optimized carbidopa/levodopa
Trials of two different medication classes (see documentation)

Documentation Required

Trial documentation

Documented trial and failure, inadequate response, intolerance, or contraindication to two medications from two different classes is required.

At least two medications from two different classes must be tried and documented as failed/inadequate/intolerant/contraindicated
Classes: dopamine agonist; COMT inhibitor; MAO-B inhibitor

Denial Risk

Samples not acceptable for response

Samples, free goods, or similar offerings do not qualify as evidence of an established clinical response and will not be considered for prior authorization; relying on such samples risks denial.

Prior Authorization

Initial and reauthorization durations

Initial approval duration will be for 12 months; reauthorizations will be for an additional 12 months.

Clinical Evidence & References

FDA indications: Onapgo — treatment of motor fluctuations in adults with advanced Parkinson's disease; Vyalev — treatment of motor fluctuations in adults with advanced Parkinson's disease.

Key guideline references: NICE guideline NG71 (2017) and AAN 2021 dopaminergic therapy guideline.

Background

This Medical Necessity Guideline defines prior authorization criteria for select medications indicated for motor fluctuations in adults with advanced Parkinson's disease (Vyalev and Onapgo). Coverage determinations are made using the guideline together with the member's benefit document and in consultation with the member's physician(s).

Definition — Advanced Parkinson's Disease: As referenced in FDA indications and this guideline; patient with motor fluctuations and at least >= 2.5 hours off time per day as specified in the criteria.

Revision History

2025-06-10last_review

Reviewed by Pharmacy and Therapeutics Committee (P&T).

2025-09-01material_changeLatest

Added coverage criteria for Onapgo (apomorphine). Effective September 1, 2025.

2025-09-01renamingLatest

Updated name of existing MNG from Vyalev (foscarbidopa/foslevodopa) to Advanced Parkinson's Disease Medications.

Policy Summary

Payerharvard pilgrim health care

PolicyAdvanced Parkinson’s Disease Medications

Policy CodePolicy N/A

Change TypeAdded coverage criteria for Onapgo; renamed policy

Effective DateSep 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Advanced Parkinson’s Disease Medications

Coverage Summary

Initial Therapy Criteria — Onapgo (apomorphine hydrochloride)

Reauthorization Criteria — Onapgo

Initial Therapy Criteria — Vyalev (foscarbidopa/foslevodopa)

Reauthorization Criteria — Vyalev

Exclusions and Non‑Covered Conditions

Applicable Codes

Provider Actions & Prior Authorization

Clinical Evidence & References

Background

Revision History