Onpattro (patisiran lipid complex) (Intravenous) coverage
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This policy defines prior authorization, dosing, renewal, and medical necessity criteria for intravenous Onpattro (patisiran lipid complex) for treatment of hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy for members covered by eocco.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-01: Initial Therapy — Covered when ALL of the following are met
Covered when ALL of the following are met:
Weight-based dosing specified separately.
inv-02: Renewal (Continuation) Therapy — Renewal prior authorization may be approved when ALL of the following are met
Renewal prior authorization may be approved when ALL of the following are met:
Renewals authorized every 12 months per policy.
Coverage is not permitted in combination with other transthyretin (TTR)–reducing or stabilizing agents. Specifically, concomitant use with agents such as tafamidis, acoramidis, inotersen, vutrisiran, or eplontersen is excluded. Providers must document that the member is receiving vitamin A supplementation at the recommended daily allowance (RDA) prior to and during therapy.
This therapy is limited to the treatment of polyneuropathy due to hereditary transthyretin‑mediated (hATTR) amyloidosis as defined by the policy. Coverage requires a definitive diagnosis of hATTR documented by supportive imaging or histopathology and identification of a heterozygous pathogenic or likely pathogenic TTR variant by molecular genetic testing. In addition, polyneuropathy must be demonstrated by at least two of the following: subjective neuropathy symptoms, abnormal nerve conduction studies consistent with polyneuropathy, or an abnormal neurologic examination suggestive of neuropathy. Other causes of peripheral neuropathy must be excluded, baseline strength/weakness must be documented with an objective clinical tool (e.g., MRC), and the member must not have received an orthotopic liver transplant (OLT).
Initial Therapy Criteria
inv-17: Initial Therapy Criteria — nested initial coverage criteria and dosing
Initial coverage criteria and dosing
Maximum billing: 300 HCPCS billable units per 3-week dosing interval (1 unit = 0.1 mg).
Continuation / Renewal Criteria
inv-18: Continuation Therapy — renewal requirements and clinical follow-up
Renewal requirements
Renewals authorized every 12 months per policy.
Coding and Billing
| 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 Actions and Requirements
Prior authorization duration
Prior authorization is required. Initial approvals are provided for 6 months (180 days); renewals may be authorized every 12 months (365 days).
Step therapy not required
No step therapy is specified in this policy.
Required clinical documentation
Document the definitive diagnosis and supportive testing: a documented hATTR diagnosis in a proband with suggestive imaging or histopathology plus identification of a heterozygous pathogenic (or likely pathogenic) TTR variant by molecular genetic testing; objective baseline strength/weakness measurement (e.g., MRC); nerve conduction studies or neurologic exam consistent with polyneuropathy; and documentation that other causes of neuropathy have been excluded.
- Definitive diagnosis: imaging or histopathology findings of amyloidosis AND heterozygous pathogenic/likely pathogenic TTR variant by molecular genetic testing
- At least two of: subjective neuropathy symptoms; abnormal nerve conduction studies; abnormal neurologic exam
- Baseline strength/weakness documented with objective tool (e.g., MRC)
- Documentation excluding other causes of neuropathy
- Record that member has not received orthotopic liver transplant
Vitamin A supplementation documentation
Provide documentation that the member is receiving vitamin A supplementation at the recommended daily allowance (RDA).
Denial risk: clinical eligibility not met
Denial may be triggered if the member does not meet the definitive diagnostic and clinical criteria for hATTR-related polyneuropathy, including lack of molecular genetic confirmation of a heterozygous pathogenic TTR variant, failure to demonstrate polyneuropathy by the required findings, failure to exclude other causes of neuropathy, absence of baseline objective strength/weakness documentation, or history of orthotopic liver transplant.
- No heterozygous pathogenic or likely pathogenic TTR variant identified
- Polyneuropathy not demonstrated by at least two required findings
- Other causes of neuropathy not excluded
- No baseline objective strength/weakness measurement documented
- Member has received orthotopic liver transplant
Denial risk: concomitant TTR therapies
Denial may be triggered if the member is receiving concomitant transthyretin (TTR)–reducing or stabilizing agents such as tafamidis, acoramidis, inotersen, vutrisiran, or eplontersen.
Site of Care
Site-of-care program requirements for infusion centers
For groups in scope for the Site of Care specialty infusion program, the provider must meet all Site of Care program requirements for infusion center administration.
Quantity Limits
Step Therapy Assessment
| Step | Requirement | Notes |
|---|---|---|
| 1 | Prior authorization considered due to drug cost as part of the NQTL assessment | Appendix A NQTL checklist indicates 'Cost of drug' was concluded: Consider for PA |
Background
Hereditary transthyretin‑mediated (hATTR) amyloidosis is an inherited, orphan disorder caused by pathogenic variants in the TTR gene that promote misfolding and amyloid deposition. The disease can produce a progressive polyneuropathy that impairs motor, sensory, and autonomic function. Patisiran (Onpattro) is an RNA interference therapeutic indicated for treatment of polyneuropathy due to hATTR; it is administered intravenously on a weight‑based schedule and requires documentation of a definitive hATTR diagnosis and baseline neurologic assessment prior to initiation. Per policy, members must also receive vitamin A supplementation at RDA and must not be treated concurrently with other TTR‑targeting therapies.
Definitions
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