CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Cmp_Onpattro_20250514 1

Covers use, dosing, approval and renewal criteria, and billing codes for Onpattro (patisiran) for Medicaid, Commercial, and Medicare-Medicaid Plan members per Neighborhood Health Plan of Rhode Island policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_Onpattro_20250514 1

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 10, 2019

Next Review Date

Key ActionPrescriber must document definitive diagnosis, objective baseline strength/weakness measure, exclusion of other neuropathy causes, and that vitamin A supplementation is in place; MMP members with prior receipt within 365 days are exempt from step therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

6 monthsInitial Authorization Length

300 unitsMax Dose per 3 weeks

>=18Age Requirement (years)

1Covered ICD-10 Diagnosis (count)

Coverage Summary

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage stance: covered_with_criteria for Onpattro (patisiran) IV for hATTR polyneuropathy. Scope: Medicaid, Commercial, and Medicare-Medicaid Plan members. Subject: Onpattro (patisiran) IV for hATTR polyneuropathy. Effective date: 04/10/2019. Last review: 05/14/2025.

Initial Authorization Length: 6 months.

Max Dose per 3 weeks: 300 billable units (30 mg) every 3 weeks.

Age Requirement: >=18 years.

Covered ICD-10 Diagnosis: E85.1 (Neuropathic heredofamilial amyloidosis).

Provider Actions

Prior Authorization

Prior authorization required with documentation

Prescriber must document definitive diagnosis (tissue biopsy with amyloid deposition and identification of a pathogenic TTR variant by molecular genetic testing), objective baseline strength/weakness measure, exclusion of other causes of neuropathy, confirmation that the member is receiving vitamin A supplementation at the recommended daily allowance, and note that MMP members with prior receipt within 365 days are exempt from step therapy.

J0222
E85.1

Documentation Required

Specialist prescribing/consult requirement

Must be prescribed by or in consultation with a neurologist or physician specializing in the treatment of amyloidosis related to hATTR; include documentation of the specialist consultation with the request.

Billing Rule

Dose reporting and unit conversion

Report HCPCS code J0222 with 1 billable unit = 0.1 mg; convert dosing to units accordingly.

Maximum per dose = 30 mg (300 units) every 3 weeks

Denial Risk

Exclusion conditions

Claims will be denied if the patient has any of the following exclusion conditions.

Prior or planned liver transplant
Severe renal impairment or end-stage renal disease
New York Heart Association (NYHA) heart failure classification >2
Other known causes of neuropathy (e.g., uncontrolled diabetes, sensorimotor or autonomic neuropathy not related to hATTR amyloidosis)
Primary or leptomeningeal amyloidosis
Cardiomyopathy hATTR (hATTR-CM)
Reference diagnosis code: E85.1

Documentation Required

Renewal documentation

For renewal, provide evidence of continued benefit and absence of unacceptable toxicity; include documentation demonstrating stabilization or improvement in symptoms or objective clinical scores compared to baseline.

Objective scores: MRC muscle strength, mNIS+7, Norfolk QoL-DN
Examples of symptom stabilization/improvement: improved ambulation, reduced neurologic symptom burden, improved activities of daily living

Clinical Evidence

mNIS+7APOLLO: significant improvement in modified Neuropathy Impairment Score+7 vs placebo

mBMIAPOLLO: improvement / weight stabilization (mBMI) vs placebo

safetyFavorable safety profile — adverse events generally mild to moderate and manageable

Pivotal trial: APOLLO demonstrated significant improvement in mNIS+7 and mBMI vs placebo.

Package insert: Alnylam Onpattro package insert, January 2023.

Background: Onpattro (patisiran) is FDA-approved for hereditary transthyretin-mediated amyloidosis with polyneuropathy; clinical trials (APOLLO) demonstrated improvement in neuropathy scores and mBMI with an acceptable safety profile.

Background

Onpattro (patisiran) is an RNA interference (RNAi) therapeutic FDA-approved for hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN). The high-level indication is treatment of hATTR polyneuropathy.

Mechanism/summary: patisiran is an RNAi therapeutic that reduces transthyretin production, leading to clinical benefit in hATTR-PN; the pivotal APOLLO trial showed significant improvement in neuropathy measures and modified body mass index (mBMI) versus placebo and a favorable/acceptable safety profile.

Key trial findings (APOLLO): improvement in modified Neuropathy Impairment Score +7 (mNIS+7) and mBMI compared to placebo, indicating slowed neuropathy progression and weight stabilization.

Definitions: MMP = Medicare-Medicaid Plan.

Definitions: mNIS+7 = modified Neuropathy Impairment Score +7 composite score.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCmp_Onpattro_20250514 1

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 10, 2019

Next Review Date

SourceLink

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OpenPayer

Cmp_Onpattro_20250514 1

Coverage Summary

Initial Therapy Criteria

Continuation / Renewal Criteria

Provider Actions

Applicable Codes

Clinical Evidence

Background

Revision History