Onpattro (patisiran) intravenous therapy for hATTR polyneuropathy
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Defines prior authorization, dosing, approval and renewal criteria, billing codes, and coverage conditions for Onpattro (patisiran) when used to treat polyneuropathy due to hereditary transthyretin-mediated (hATTR) amyloidosis for Viva Health members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Onpattro (patisiran)
Initial Therapy
Covered when ALL of the following are met for initial approval:
Derived from policy section III and Universal Criteria.
Continuation Therapy
Renewal permitted when ALL of the following are met:
From policy section IV.
Coverage is excluded when the member has received an orthotopic liver transplant (OLT) or when patisiran is administered concomitantly with other transthyretin (TTR) reducing or stabilizing agents. Examples of prohibited concomitant therapies include tafamidis, acoramidis, inotersen, vutrisiran, and eplontersen. Additionally, members must be receiving vitamin A supplementation at the recommended daily allowance as part of universal criteria for use.
Patisiran (Onpattro) is not covered for indications outside of treatment of polyneuropathy due to hereditary transthyretin-mediated (hATTR) amyloidosis. Coverage in this policy is specific to the polyneuropathy indication and requires documentation consistent with the policy’s diagnostic and clinical criteria.
Billing and Coding
| J0222 | Injection, patisiran, 0.1 mg; 1 billable unit = 0.1 mg |
| 71336-1000-xx | Onpattro 10 mg/5 mL single-dose vial |
| E85.1 | Neuropathic heredofamilial amyloidosis |
Provider Requirements, Prior Authorization, and Denial Triggers
Prior authorization validity and billing/dosing limit
Prior authorization is required. Initial authorization will be provided for 6 months (180 days); renewals may be approved every 12 months (365 days). Dosing/billing is limited to 300 billable HCPCS units every 3 weeks (1 unit = 0.1 mg, HCPCS J0222).
- Initial: 6 months (180 days).
- Renewal: every 12 months (365 days).
- Dosing limit: 300 billable units per 3 weeks.
Concomitant TTR therapy prohibited
Onpattro must not be used concomitantly with other transthyretin (TTR) reducing or stabilizing agents.
- Examples include tafamidis, acoramidis, inotersen, vutrisiran, eplontersen.
Required clinical documentation for prior authorization
Providers must supply documentation confirming a definitive diagnosis of hATTR amyloidosis and baseline clinical status prior to authorization.
- Documentation of definitive hATTR diagnosis: suggestive findings (imaging or histopathology) plus identification of a heterozygous pathogenic or likely pathogenic TTR variant by molecular genetic testing.
- Evidence polyneuropathy meets criteria: at least two of (subjective neuropathic symptoms; abnormal nerve conduction studies; abnormal neurologic exam).
- Documentation that peripheral neuropathy is attributed to hATTR with other causes excluded.
- Baseline objective muscle strength measurement (e.g., MRC).
- Documentation member is receiving vitamin A supplementation at the recommended daily allowance.
Triggers that may lead to denial
Cases may be denied if required diagnostic or clinical criteria are not met, if the member has had an orthotopic liver transplant, if Onpattro is used with another TTR-reducing/stabilizing agent, or if unacceptable toxicity is present.
- Lack of documented definitive hATTR diagnosis with heterozygous pathogenic/likely pathogenic TTR variant.
- Member has received an orthotopic liver transplant (OLT).
- Concomitant use with other TTR reducing or stabilizing agents (see examples).
- Unacceptable toxicity from the drug (e.g., severe infusion-related reactions, ocular symptoms related to vitamin A deficiency such as night blindness).
Background
Hereditary transthyretin-mediated (hATTR) amyloidosis is an inherited disorder in which a heterozygous pathogenic or likely pathogenic variant in the TTR gene leads to deposition of transthyretin amyloid and can cause progressive polyneuropathy. Patisiran (Onpattro) is an RNA interference therapeutic indicated for the treatment of polyneuropathy due to hATTR and is given intravenously. For coverage, the policy requires a definitive diagnosis of hATTR documented in a proband (supporting imaging or histopathology of amyloidosis plus molecular genetic testing identifying a heterozygous pathogenic or likely pathogenic TTR variant). Clinical evidence of polyneuropathy must be demonstrated by at least two findings (subjective neuropathic symptoms, abnormal nerve conduction studies consistent with polyneuropathy, or an abnormal neurological exam), other causes of neuropathy must be excluded, and baseline muscle strength must be documented with an objective tool (for example, Medical Research Council [MRC] muscle strength).
Definitions
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