CurrentmhnPolicy CP.PHAR.395

Clinical Policy: Patisiran (Onpattro)

Defines medical necessity guidance and coverage considerations for patisiran (Onpattro) therapy for members of the Health Plan; applies to providers submitting coverage requests and claims under the plan.

Policy Summary

Payermhn

PolicyClinical Policy: Patisiran (Onpattro)

Policy CodePolicy CP.PHAR.395

Change TypeConcurrent therapy restriction addedprior-treatment restriction removed

Effective DateSep 11, 2018

Next Review Date

Key ActionSubmit prior authorization with required clinical documentation per the Health Plan's process to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added Wainua to list of drugs that should not have been previously received or prescribed concurrently.

Removed criteria requiring member has not received prior treatment with Amvuttra, Tegsedi, or Wainua.

References reviewed and updated during annual reviews (4Q2023, 2Q2024, 2Q2025).

3annual review entries noted in this excerpt

Wainuadrug added to concurrent therapy exclusions

Medicaidstate Medicaid precedence

Coverage Criteria

The coverage criteria were revised to remove a prior-treatment exclusion that previously disallowed members who had received Amvuttra, Tegsedi, or Wainua from qualifying for patisiran. This change was made effective during the 2Q2025 review to permit alternative therapy following the market withdrawal of Tegsedi and after competitor analysis. Earlier operational changes had added Wainua to the list of drugs that should not be prescribed concurrently (2Q2024), but the current policy no longer requires that members be free of prior treatment with Amvuttra, Tegsedi, or Wainua. Providers should be aware that this is a material change to the policy's prior-agent restrictions and may affect prior authorization determinations.

Provider Actions and Requirements

Prior Authorization

Prior authorization required for coverage decisions

This clinical policy serves as the Health Plan's guide to medical necessity and is used to inform coverage decisions; providers must follow the Health Plan's prior authorization process and submit required documentation per the plan when requesting coverage for patisiran.

Step Therapy

Policy Summary

Payermhn

PolicyClinical Policy: Patisiran (Onpattro)

Policy CodePolicy CP.PHAR.395

Change TypeConcurrent therapy restriction addedprior-treatment restriction removed

Effective DateSep 11, 2018

Next Review Date

Key ActionSubmit prior authorization with required clinical documentation per the Health Plan's process to support medical necessity.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Background

This clinical policy provides guidance on medical necessity and coverage considerations for patisiran (Onpattro) therapy. The policy is developed from peer-reviewed literature, clinical standards, and specialist input and is intended to guide plan coverage and prior authorization decisions rather than dictate clinical care.

The document reflects periodic review and updates to references and operational criteria: annual reviews noted in 4Q2023, 2Q2024, and 2Q2025 resulted in reference updates and specific changes to concurrent-therapy and prior-treatment language. Providers should follow the Health Plan's prior authorization process and submit required documentation when requesting coverage in accordance with this policy.

This policy does not constitute medical advice; clinicians remain responsible for individual patient management while using this policy as the Health Plan's medical necessity framework.

Definitions

Clinical policy (as used here)

DefinitionA clinical policy is a document developed by experienced, licensed healthcare professionals that provides a guide to medical necessity and assists in coverage and benefit administration based on current standards, peer‑reviewed literature, guidelines, regulatory status, and expert input.

ScopeAdvisory to coverage decisions; does not constitute medical advice or dictate clinical practice; providers retain responsibility for treatment choices.

BasisBuilt from generally accepted standards of medical practice, peer‑reviewed literature, government approvals, evidence‑based guidelines, and practicing clinician views.

Legal/administrative noteCoverage decisions remain subject to plan contract terms, state and federal requirements, and Health Plan administrative policies; the Health Plan may change or withdraw the policy.

Effective date guidanceThe policy is effective as determined by the Health Plan; posted date may differ from effective date and legal/regulatory requirements govern if discrepancies exist.