CurrentHap Caresource MI Coordinated HealthPolicy N/A

Amyloidosis - Onpattro Utilization Management Medical Policy

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This policy governs prior authorization and medical-benefit coverage of Onpattro (patisiran intravenous infusion) for adults with symptomatic polyneuropathy caused by hereditary transthyretin-mediated amyloidosis. It defines clinical eligibility, specialist prescribing requirements, dosing limits, and circumstances in which coverage is not recommended.

Policy Summary

PayerHap Caresource MI Coordinated Health

PolicyAmyloidosis - Onpattro Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeMaterial clinical and coverage changes

Effective DateN/A

Last ReviewDec 10, 2025

Next Review DateN/A

Key ActionObtain prior authorization for medical-benefit coverage of Onpattro and document that all eligibility and dosing requirements are met.

SourceLink

POLICY UPDATE CHANGES

A history of liver transplantation was added as a condition that excludes approval for Onpattro.

Wainua and Attruby were added to the examples of medications whose concurrent use with Onpattro is not recommended.

The genetic diagnosis criterion was revised to require confirmation of a transthyretin pathogenic variant rather than using the term mutation.

≥18 yearsMinimum patient age

1 yearApproval duration

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CurrentHap Caresource MI Coordinated HealthPolicy N/A

Amyloidosis - Onpattro Utilization Management Medical Policy

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Sign up for all hap_caresource_mi_coordinated_health policy alerts

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Policy Summary

PayerHap Caresource MI Coordinated Health

PolicyAmyloidosis - Onpattro Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeMaterial clinical and coverage changes

Effective DateN/A

Last ReviewDec 10, 2025

Next Review DateN/A

Key ActionObtain prior authorization for medical-benefit coverage of Onpattro and document that all eligibility and dosing requirements are met.

SourceLink

POLICY UPDATE CHANGES

A history of liver transplantation was added as a condition that excludes approval for Onpattro.

Wainua and Attruby were added to the examples of medications whose concurrent use with Onpattro is not recommended.

The genetic diagnosis criterion was revised to require confirmation of a transthyretin pathogenic variant rather than using the term mutation.

≥18 yearsMinimum patient age

1 yearApproval duration

0.3 mg/kg; 30 mg max

Every 3 weeksAdministration frequency

No liver transplant historyRequired exclusion

Recommended Authorization Criteria

FDA-approved indication: hATTR polyneuropathy

Approve for 1 year if the patient meets ALL of the following criteria.

Patient eligibility

Age: Patient is at least 18 years of age.≥18 years
Genetic confirmation: Patient has a transthyretin pathogenic variant confirmed by genetic testing.Confirmed by genetic testing
Clinical disease: Patient has symptomatic polyneuropathy.
Examples include reduced motor strength or coordination and impaired sensation; assessments may include history and clinical examination, electromyography, or nerve conduction velocity testing.
Transplant history: Patient does not have a history of liver transplantation.No history of liver transplantation
Specialist involvement: Medication is prescribed by or in consultation with a neurologist, geneticist, or physician who specializes in treatment of amyloidosis.

Approved dosing

Approve dosing only when both dosing requirements are met.

Dosing criteria

Dose amount: Dose is up to 0.3 mg/kg given intravenously, with a maximum dose of 30 mg.≤0.3 mg/kg and ≤30 mg
Frequency: Dose is administered not more frequently than once every 3 weeks.No more often than once every 3 weeks

Concurrent use of Onpattro with other medications indicated for hereditary transthyretin-mediated amyloidosis polyneuropathy or transthyretin-mediated amyloidosis-cardiomyopathy is not recommended. Examples include Amvuttra (vutrisiran), Attruby (acoramidis), Tegsedi (inotersen), Wainua (eplontersen), and tafamidis products. Combination therapy is generally not recommended because controlled clinical trial data supporting additive efficacy are lacking.

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. The criteria may be updated as new published data become available.

Initial Approval

Initial approval

Approve for 1 year when all eligibility criteria are met.

Initial therapy: Adult patient has genetically confirmed hATTR, symptomatic polyneuropathy, no history of liver transplantation, and appropriate specialist prescribing or consultation.Age ≥18 years; dose ≤0.3 mg/kg and ≤30 mg IV; no more often than every 3 weeks

Provider Requirements and Review Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical-benefit coverage of Onpattro. Approval is recommended only when the applicable indication criteria and dosing requirements are met.

Documentation Required

Specialist Prescribing Requirement

Because evaluation, diagnosis, monitoring for adverse events, and assessment of long-term efficacy require specialized skills, Onpattro must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior Authorization

Out-of-Policy Dosing Review

Requests for doses outside the established policy dosing may be considered on a case-by-case basis by a clinician, such as a Medical Director or Pharmacist. Standard dosing is up to 0.3 mg/kg intravenously, not exceeding 30 mg, and no more frequently than once every 3 weeks.

Onpattro Dosing Limits

Quantity Limits

MedicationOnpattro (patisiran)

RouteIntravenous administration

Maximum doseUp to 0.3 mg/kg, not to exceed 30 mg

Quantity Limits

MedicationOnpattro (patisiran)

Administration intervalIntravenous administration

Maximum frequencyNot more frequently than once every 3 weeks

Clinical Definitions

Definitions

ConditionHereditary transthyretin-mediated amyloidosis (hATTR)

Disease courseA progressive hereditary disease

CauseMutations or pathogenic variants in the transthyretin (TTR) gene

Systemic effectsAssociated with multisystem organ dysfunction

Definitions

ConditionSymptomatic polyneuropathy

Motor symptomsReduced motor strength or coordination

Clinical Background

Onpattro (patisiran) is a lipid nanoparticle-formulated RNA interference therapeutic indicated for adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR). hATTR results from pathogenic variants in the transthyretin gene and may cause progressive multisystem disease, including sensorimotor and autonomic neuropathy. This policy supports use for symptomatic hATTR polyneuropathy and does not recommend combination therapy with other drugs indicated for hATTR polyneuropathy or transthyretin-mediated cardiomyopathy.

Policy Summary

PayerHap Caresource MI Coordinated Health

PolicyAmyloidosis - Onpattro Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeMaterial clinical and coverage changes

Effective DateN/A

Last ReviewDec 10, 2025

Next Review DateN/A

Key ActionObtain prior authorization for medical-benefit coverage of Onpattro and document that all eligibility and dosing requirements are met.

SourceLink

On This Page

Documentation Required

Clinical Eligibility Documentation

Document all clinical eligibility requirements for hereditary transthyretin-mediated amyloidosis polyneuropathy (hATTR), including age, genetic confirmation, symptomatic disease, liver-transplant history, and qualified specialist involvement.

Patient is 18 years of age or older.
Genetic testing confirms a transthyretin pathogenic variant.
The patient has symptomatic polyneuropathy.
The patient has no history of liver transplantation.
Onpattro is prescribed by or in consultation with a neurologist, geneticist, or physician specializing in amyloidosis treatment.

Documentation Required

Polyneuropathy Assessment

Support the diagnosis of symptomatic polyneuropathy with appropriate clinical assessment. Documentation may include the patient's history and clinical examination, electromyography, or nerve conduction velocity testing.

Examples of symptoms include reduced motor strength or coordination and impaired sensation, including pain, temperature, vibration, or touch.
Examples of supporting assessments include history and clinical examination, electromyography, or nerve conduction velocity testing.

Documentation Required

Specialist Involvement

Identify the prescribing physician or consultant and document appropriate specialist qualifications for treatment of the patient's condition.

Acceptable specialist involvement includes a neurologist, geneticist, or physician who specializes in the treatment of amyloidosis.
Specialist involvement may be by prescription or consultation.

Denial Risk

Failure to Meet hATTR Polyneuropathy Criteria

Approval is not recommended when the patient does not meet all hATTR polyneuropathy eligibility requirements.

Patient is younger than 18 years of age.
A transthyretin pathogenic variant is not confirmed by genetic testing.
Symptomatic polyneuropathy is not documented.
The patient has a history of liver transplantation.
Required specialist prescribing or consultation is not documented.

Denial Risk

Concurrent Amyloidosis Therapy

Coverage is not recommended for concurrent use with another medication indicated for hATTR polyneuropathy or transthyretin-mediated amyloidosis-cardiomyopathy. Combination therapy is generally not recommended because controlled clinical trial data supporting additive efficacy are lacking.

Examples include Amvuttra (vutrisiran), Attruby (acoramidis), Tegsedi (inotersen), Wainua (eplontersen), or a tafamidis product.

Denial Risk

Circumstances Outside Criteria

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria may be updated as new published data become available.

Sensory impairmentImpaired pain, temperature, vibration, or touch sensation

Assessment methodsHistory and clinical examination, electromyography, or nerve conduction velocity testing