Onapgo (apomorphine) and Vyalev (foscarbidopa/foslevodopa) - Prior Authorization
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Prior authorization policy for coverage of Onapgo (apomorphine hydrochloride) and Vyalev (foscarbidopa/foslevodopa) for adults with advanced Parkinson's disease under Harvard Pilgrim and affiliated Tufts commercial and specified public products.
Added coverage criteria for Onapgo (apomorphine).
Template updated to remove CareLink from the Medical Necessity Guideline template and updated plan name references.
Coverage Criteria for Onapgo and Vyalev
Onapgo Initial Coverage
Covered when ALL of the following are met:
Onapgo initial coverage
- Diagnosis: Patient has a diagnosis of advanced Parkinson's Disease
- Off time: Member experiences at least 2.5 hours of 'off' time per day>=2.5 hours/day
- Prescriber: Medication is prescribed by, or in consultation with, a neurologist
- Optimized therapy: Physician attests patient has persistent motor fluctuations despite optimized carbidopa/levodopa therapy
- Prior trials: Trial and failure, inadequate response, intolerance, or contraindication to TWO agents from two different classes (dopamine agonist; COMT inhibitor; MAO-B inhibitor)2 agents from 2 classes
Examples: pramipexole, ropinirole; entacapone; rasagiline, selegiline
Vyalev Initial Coverage
Covered when ALL of the following are met:
Vyalev initial coverage
- Diagnosis: Patient has a diagnosis of advanced Parkinson's Disease
- Off time: Member experiences at least 2.5 hours of 'off' time per day>=2.5 hours/day
- Prescriber: Medication is prescribed by, or in consultation with, a neurologist
- Optimized therapy: Physician attests patient has persistent motor fluctuations despite optimized carbidopa/levodopa therapy
- Prior trials: Trial and failure, inadequate response, intolerance, or contraindication to TWO agents from two different classes (dopamine agonist; COMT inhibitor; MAO-B inhibitor)2 agents from 2 classes
Examples: pramipexole, ropinirole; entacapone; rasagiline, selegiline
Reauthorization Criteria (both drugs)
Reauthorization may be granted when ALL of the following are met:
Initial approval duration and reauthorization duration each 12 months per Limitations
General coverage decision process
Coverage is determined using medical necessity guidelines in coordination with the member's benefit document and treating physician.
Treating providers are responsible for medical advice and treatment; the guideline is not a guarantee of payment and claims adjudication is subject to eligibility, benefits, and required authorizations.
Samples, free goods, or similar offerings of the requested medication do not qualify as evidence of an established clinical response and will not be considered for prior authorization.
For self-insured plans, coverage may vary depending on the terms of the member's benefit document; if a discrepancy exists between this Medical Necessity Guideline and a self-insured member's benefit document, the benefit document governs. For Tufts Health Together (Medicaid), coverage may be available beyond these guidelines for pediatric members under age 21 under EPSDT with prior authorization.
This section does not specify additional conditions classified as not medically necessary beyond the limits and exclusions already noted (for example, exclusion of samples/free goods).
Within the excerpted guideline there are no explicit additional statements listing specific services or uses of these medications as not medically necessary beyond standard adjudication caveats; final coverage determination is made in coordination with the member's benefit document and treating physician.
Coding and Clinical Thresholds
| J7356 | INJECTION, FOSCARBIDOPA 0.25 MG/FOSLEVODOPA 5 MG |
| J7356 | INJECTION, FOSCARBIDOPA 0.25 MG/FOSLEVODOPA 5 MG |
Provider Actions, Prior Authorization, and Documentation
Prior authorization required for Onapgo and Vyalev (HCPCS J7356 for Vyalev)
Prior authorization is required for Onapgo and Vyalev when the listed clinical criteria are met. The policy lists HCPCS code J7356 for foscarbidopa/foslevodopa (Vyalev).
- Prior authorization must be obtained before coverage is approved when the clinical criteria in the guideline apply.
- HCPCS J7356 corresponds to foscarbidopa/foslevodopa (Vyalev) injection and is listed in the policy coding table.
Coverage, prior authorization, and adjudication process
Coverage decisions use the Medical Necessity Guidelines together with the member's benefit document and are made in coordination with the member's treating physician; prior authorization and referral/authorization checks may be required as part of adjudication.
- Decisions are made case-by-case using the guideline plus the Member's benefit document and treating physician input.
- Claims may require prior authorization, referral/authorization, and other utilization management steps during adjudication.
Step therapy: trial and failure of two agents from two classes required
Prior to approval, the patient must have trialed and had failure, inadequate response, intolerance, or contraindication to TWO agents from two different classes: dopamine agonist; COMT inhibitor; and MAO-B inhibitor.
- Examples provided: dopamine agonists (e.g., pramipexole, ropinirole); COMT inhibitor (e.g., entacapone); MAO-B inhibitors (e.g., rasagiline, selegiline).
- The two agents must be from two different classes.
No other explicit step-therapy rules specified in excerpt
The excerpt does not specify additional, separate step therapy rules beyond the two-agent requirement; the revision history notes that Onapgo coverage criteria were added but no separate step-therapy table is listed here.
- No other explicit step therapy sequences or prior authorization step rules are listed in this excerpt.
- Onapgo criteria were added in the revision history but explicit alternate step-therapy rules are not provided.
Required clinical documentation: diagnosis, ≥2.5 hours 'off' time, and optimized therapy attestation
Physician attestation or documentation must state that the patient has advanced Parkinson's disease, experiences at least 2.5 hours of 'off' time per day, and has persistent motor fluctuations despite optimized carbidopa/levodopa therapy.
- Documentation must confirm the >= 2.5 hours/day 'off' time threshold.
- Physician must attest that motor fluctuations persist despite optimized carbidopa/levodopa.
Prescriber requirement: neurologist prescribing or consultation required
The medication must be prescribed by, or in consultation with, a neurologist as part of the initial coverage criteria for both Onapgo and Vyalev.
- Prescriber requirement appears as a numbered criterion in both Onapgo and Vyalev initial coverage lists.
Documentation and payment caveats: guideline not a guarantee of payment
Treating providers remain responsible for the member's medical care; use of this guideline does not guarantee payment and claims adjudication depends on member eligibility, benefits, and required authorizations or referrals.
- Coverage is governed by the Medical Necessity Guideline plus the Member's benefit document; discrepancies for self‑insured plans are resolved by the benefit document.
- Payment is subject to eligibility on date of service, coordination of benefits, referral/authorization, utilization management, and claims editing logic.
Ineligible evidence for prior authorization: samples/free goods excluded
Samples, free goods, or similar offerings of the requested medication do not qualify as evidence of an established clinical response and will not be considered for prior authorization.
- Providers should not submit sample or free product use as proof of prior therapeutic response.
Denial triggers and adjudication conditions: eligibility, benefits, referrals, utilization management
Claims payment and prior authorization decisions are subject to member eligibility and benefits on the date of service, coordination of benefits, referral/authorization requirements, utilization management guidelines, and plan policies and claims editing logic—failure to meet these conditions may result in denial.
- Adjudication may deny payment if eligibility, benefits, referral/authorization, or utilization review requirements are not met.
- Providers should verify eligible benefits and obtain required authorizations prior to treatment to reduce denial risk.
Background
Onapgo (apomorphine hydrochloride) and Vyalev (foscarbidopa/foslevodopa) are FDA-approved products used to treat motor fluctuations in adults with advanced Parkinson's disease. The guideline states coverage is determined using these medical necessity criteria together with the member's benefit document and treating physician input. Vyalev is referenced in the guideline and package insert materials; HCPCS coding and product references for foscarbidopa/foslevodopa are provided in the document references.
Definitions and Key Terms
Revision History and Policy Changes
Administrative template language updated: CareLink removed and Tufts Health Together plan name wording revised in the Medical Necessity Guideline template.
Coverage criteria for Onapgo (apomorphine) were added when the existing Vyalev guideline was renamed to Advanced Parkinson's Disease Medications.
Reviewed by the Pharmacy and Therapeutics Committee (P&T).
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