CurrentUnitedHealthcarePolicy N/A

Cuvrior (trientine tetrahydrochloride) prior authorization

Prior authorization and medical necessity criteria for Cuvrior (trientine tetrahydrochloride) for treatment of adult patients with Wilson's disease; applicable to prescribers and pharmacy benefit management for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyCuvrior (trientine tetrahydrochloride) prior authorization

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

Key ActionObtain prior authorization showing diagnosis of Wilson's disease, de-coppered status (NCC 25–150 mcg/L), history of intolerance/failure to trientine hydrochloride, and that prescriber is a hepatologist.

SourceLink

POLICY UPDATE CHANGES

Updated background and references; annual review with no changes to coverage criteria.

12 monthsauthorization duration (initial and reauthorization)

25-150 mcg/Lde-coppered definition (NCC)

hepatologistrequired prescriber specialty

2/2024, 2/2025P&T approval dates

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This policy notes that Cuvrior is typically excluded from coverage. Plan-specific benefit documents may list Cuvrior as an exclusion and may impose tried/failed criteria or other step edits. Providers and pharmacy benefit administrators should refer to the member’s specific plan to confirm exclusion status and any applicable plan-level requirements before submitting a prior authorization request.

Definitions Used in This Policy

inv-11: De-coppered — Serum non-ceruloplasmin copper (NCC) level 3e= 25 and 3c= 150 mcg/L.

DefinitionDe-coppered = serum non-ceruloplasmin copper (NCC) level >= 25 and <= 150 mcg/L

Clinical relevanceEligibility requirement for maintenance treatment with Cuvrior in adults with Wilson's disease

Related requirementPatient must also be tolerant to penicillamine and prescribed by a hepatologist for coverage

Authorization durationAuthorizations issued for 12 months when criteria met

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required: initial approval only when ALL criteria are met including diagnosis of Wilson's disease, de-coppered status (NCC 25–150 mcg/L), tolerance to and discontinuation of penicillamine, history of intolerance/failure/contraindication to trientine hydrochloride, and prescription by a hepatologist. Authorization = 12 months.

Initial Authorization criteria: (a) Diagnosis of Wilson's disease; (b) Patient is de-coppered, defined as serum non-ceruloplasmin copper (NCC) ≥ 25 and ≤ 150 mcg/L; (c) Patient is tolerant to penicillamine; (d) Patient will discontinue penicillamine before starting Cuvrior; (e) History of intolerance, failure, or contraindication to trientine hydrochloride; (f) Prescribed by a hepatologist. All criteria must be met for approval.
Absence of documented Wilson's disease or failure to document NCC within the specified range (25–150 mcg/L) is a denial condition. Other denial reasons: not tolerant to penicillamine, no documentation of discontinuation of penicillamine prior to Cuvrior, lack of documented intolerance/failure/contraindication to trientine, or prescriber is not a hepatologist.
Reauthorization documentation: must include evidence of positive clinical response to Cuvrior (examples: increased 24-hour urinary copper excretion from baseline, normalization of serum free copper, prevention of or improvement in clinical symptoms) and the prescriber must be a hepatologist. Authorization for reauthorization = 12 months.
Plan-level step therapy/exclusion note: Cuvrior is typically excluded from coverage; tried/failed criteria may be required. Refer to the member-specific benefit plan and any applicable state mandates or federal requirements to determine exclusion status and additional utilization management rules.
Provider actions: submit supporting documentation with the prior authorization request — diagnosis of Wilson's disease, recent NCC lab result (25–150 mcg/L), documentation of penicillamine tolerance and plan to discontinue it prior to Cuvrior, documentation of trientine intolerance/failure/contraindication, evidence of prescriber specialty (hepatologist), and for reauthorization include objective measures of response (e.g., 24-hour urinary copper excretion, serum free copper, clinical symptom improvement).

Denial Risk

Denial Conditions / Return Reasons

Denial risk: absence of required documentation or failure to meet any Initial Authorization criteria will result in denial or return of the request. For reauthorization, lack of documented clinical response or non-hepatologist prescriber may result in denial.

Denial/return reasons include: no documented diagnosis of Wilson's disease; NCC outside the required 25–150 mcg/L range; no documentation of penicillamine tolerance or failure to discontinue penicillamine prior to Cuvrior initiation; no documented intolerance/failure/contraindication to trientine hydrochloride; prescriber not a hepatologist; for reauthorization, no objective evidence of clinical benefit.

Documentation Required

Documentation Requirements

Documentation guidance: acceptable evidence for initial and reauthorization requests and examples of objective measures of response to include with requests.

Acceptable documentation for initial authorization: clinical chart notes confirming diagnosis of Wilson's disease, laboratory report showing serum NCC between 25–150 mcg/L, documentation of penicillamine tolerance and plan to stop it prior to starting Cuvrior, documentation of intolerance/failure/contraindication to trientine, and prescriber specialty verification (hepatologist).
Acceptable documentation for reauthorization: objective measures demonstrating positive clinical response such as increased 24-hour urinary copper excretion from baseline, normalization of serum free copper, and clinical notes documenting prevention of or improvement in Wilson's disease-related symptoms.
Operational note: Authorizations (initial and reauthorization) are issued for 12 months. State mandates, federal requirements, and member-specific benefit plan coverage may further modify criteria or coverage. Always verify plan-specific exclusion/step-therapy status prior to submission.

Step Therapy

Plan-level Step Therapy / Exclusion Note

Step therapy / exclusion note: check member-specific plan for exclusion status and any tried/failed requirements; Cuvrior is often excluded.

Cuvrior is typically excluded from coverage and may have tried/failed criteria in place. Refer to the member-specific benefit plan to determine whether exclusions or step therapy requirements apply.

Plan-level step	Description	Action / Notes
1	Cuvrior (trientine tetrahydrochloride) is typically excluded from coverage	Tried/failed criteria may be required depending on the member-specific plan; refer to plan specifics to determine exclusion status and any step edits

Background and Indication

Cuvrior (trientine tetrahydrochloride) is a copper chelator indicated for the maintenance treatment of adult patients with Wilson’s disease who are de-coppered and tolerant to penicillamine. It is used as a maintenance therapy following initial de-coppering, consistent with standard chelation strategies for Wilson’s disease.

Policy Summary

PayerUnitedHealthcare

PolicyCuvrior (trientine tetrahydrochloride) prior authorization

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateMay 1, 2025

Next Review DateFeb 1, 2025

SourceLink

On This Page

OpenPayer

Cuvrior (trientine tetrahydrochloride) prior authorization

Coverage Criteria for Cuvrior (trientine tetrahydrochloride)

Key Clinical Coding and Lab Thresholds

Definitions Used in This Policy

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Provider Actions and Documentation Requirements

Step Therapy and Exclusion Notes

Background and Indication