CurrentViva HealthPolicy IC-0379

Onpattro (patisiran lipid complex) (Intravenous)

Defines prior authorization, coverage criteria, dosing, renewal requirements, billing units, and covered diagnosis codes for Onpattro (patisiran) administered IV for hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy for members of Viva Health.

Policy Summary

PayerViva Health

PolicyOnpattro (patisiran lipid complex) (Intravenous)

Policy CodePolicy IC-0379

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProvide documentation of definitive hATTR diagnosis with molecular genetic testing showing a heterozygous pathogenic or likely pathogenic TTR variant, supportive imaging or histopathology, baseline objective measure of strength/weakness (e.g., MRC), and evidence that other causes of neuropathy have been excluded.

POLICY UPDATE CHANGES

No material changes

1Covered ICD-10 Diagnosis

300Max billable units

6 moInitial PA duration

AnnualRenewal interval

Coverage Summary

Coverage stance: covered_with_criteria for Onpattro (patisiran) for treatment of polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis. The policy aligns coverage to the FDA-approved indication and requires: genetic confirmation of a heterozygous pathogenic or likely pathogenic TTR variant and documentation of objective neuropathy assessment (e.g., abnormal nerve conduction studies or abnormal neurological examination) as part of the criteria for treatment.

Initial Approval Criteria

Coverage is provided when ALL of the following are met:

ALL of the following

Universal Criteria
- Age: Patient is at least 18 years of age
- Vitamin A supplementation: Patient is receiving supplementation with vitamin A at the recommended daily allowance
- Concomitant TTR agents: Must not be used in combination with other transthyretin (TTR) reducing or stabilizing agents (e.g., inotersen, tafamidis, vutrisiran, eplontersen, etc.)
hATTR polyneuropathy-specific criteria
- Definitive diagnosis: Patient has a definitive diagnosis of hATTR amyloidosis as documented in a proband with suggestive findings (including imaging or histopathology findings of amyloidosis) and a heterozygous pathogenic (or likely pathogenic) variant in TTR identified by molecular genetic testing
- Polyneuropathy evidence (at least 2)
  - Subjective symptoms: Subjective patient symptoms are suggestive of neuropathy
  - Nerve conduction studies: Abnormal nerve conduction studies are consistent with polyneuropathy
  - Neurological exam: Abnormal neurological examination is suggestive of neuropathy

Renewal / Continuation Criteria

Renewal Criteria

Approval may be renewed when ALL of the following are met:

ALL of the following

Continued criteria: Patient continues to meet the universal and other indication-specific relevant criteria identified in Initial Approval Criteria
Toxicity: Absence of unacceptable toxicity from the drug (examples include severe infusion-related reactions, ocular symptoms related to vitamin A deficiency such as night blindness)
Disease response
- Signs and symptoms of neuropathy
- MRC strength: MRC muscle strength

Concomitant Therapy & Exclusions

Exclusions: Onpattro must not be used in combination with other transthyretin (TTR) reducing or stabilizing agents (examples listed include inotersen, tafamidis, vutrisiran, eplontersen). The policy also requires that other causes of neuropathy be excluded before attributing peripheral neuropathy to hATTR, and treatment is not covered for patients who have received an orthotopic liver transplant (OLT).

Denial Risk

Concomitant TTR agent exclusion

Claims may be denied if Onpattro is used in combination with other TTR reducing or stabilizing agents (e.g., inotersen, tafamidis, vutrisiran, eplontersen).

Applicable Codes

Drug HCPCSHCPCSCovered

J0222

Injection, patisiran, 0.1 mg; 1 billable unit = 0.1 mg

NDCNDCCovered

71336-1000-xx

Onpattro 10 mg/5 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

E85.1

Neuropathic heredofamilial amyloidosis

Billing Rule

Dose and billing conversion

Bill J0222 where 1 billable unit = 0.1 mg; dosing per label and ensure total billed units do not exceed 300 units every 3 weeks.

J0222

Billing threshold

Maximum billing units300 billable units every 3 weeks (1 billable unit = 0.1 mg)

Provider Actions & Documentation

Prior Authorization

Prior authorization required

Initial prior authorization is valid for 6 months; renewal prior authorization may be renewed annually thereafter.

J0222

Documentation Required

Diagnostic and baseline documentation

Provide documentation of definitive hATTR diagnosis with molecular genetic testing showing a heterozygous pathogenic or likely pathogenic TTR variant, supportive imaging or histopathology, baseline objective measure of strength/weakness (e.g., MRC), and evidence that other causes of neuropathy have been excluded.

Documentation Required

Vitamin A supplementation

Document that patient is receiving vitamin A supplementation at the recommended daily allowance.

Documentation Required

Renewal response assessment

For renewal, document absence of unacceptable toxicity and objective evidence of stabilization or improvement in neuropathy signs/symptoms or MRC muscle strength compared to pre-treatment baseline.

Background

Background: Onpattro (patisiran) is an RNA interference (RNAi) therapeutic indicated for treatment of polyneuropathy of hATTR amyloidosis. This policy aligns coverage to the FDA-approved indication and requires genetic confirmation of a pathogenic or likely pathogenic TTR variant and objective assessment of neuropathy for approval.

Definitions:

Billable unit: For J0222, 1 billable unit = 0.1 mg patisiran.

hATTR amyloidosis definitive diagnosis: Proband with suggestive findings and a heterozygous pathogenic (or likely pathogenic) variant in TTR identified by molecular genetic testing.

Policy Summary

PayerViva Health

PolicyOnpattro (patisiran lipid complex) (Intravenous)

Policy CodePolicy IC-0379

Change TypeNo material change

Effective Date

Next Review Date

On This Page

OpenPayer

Onpattro (patisiran lipid complex) (Intravenous)

Coverage Summary

Initial Approval Criteria

Renewal / Continuation Criteria

Concomitant Therapy & Exclusions

Applicable Codes

Provider Actions & Documentation

Clinical Evidence

Background

Revision History