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

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