CurrentUnitedHealthcarePolicy Program Number 2025 P 1173-12

Ninlaro (ixazomib) prior authorization criteria

UnitedHealthcare prior authorization/notification criteria for coverage of Ninlaro (ixazomib) for specified hematologic malignancies and conditions; applies to pharmacy benefit members nationally unless superseded by state mandates. Pediatric prescriptions (<19) auto-process without review.

Policy Summary

PayerUnitedHealthcare

PolicyNinlaro (ixazomib) prior authorization criteria

Policy CodePolicy Program Number 2025 P 1173-12

Change TypeClarification (no material coverage change)

Effective DateSep 1, 2025

Next Review Date

Key ActionSubmit prior authorization requests showing the specified diagnosis-based criteria; for reauthorization provide documentation (or claims logic) that the patient has no evidence of progressive disease while on therapy.

SourceLink

POLICY UPDATE CHANGES

Multiple myeloma criteria updated to require only diagnosis (June 2024 update noted; annual reviews with no change to coverage criteria in 2025).

12authorization duration (typical initial and reauthorization)

<19pediatric prescriptions auto-approved

≥1 priorlabel indication requirement for multiple myeloma

1/2A/2BNCCN recognized regimens referenced

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Ninlaro (ixazomib) — Coverage Rules

General coverage and pediatrics

Coverage is provided when the following program-level rules are met:

ANY of the following

Member is less than 19 years of age
Prescriptions for members under 19 automatically process without coverage review; authorization issued for 12 months.
ALL of the following
- Member meets one of the approved indications listed below (Multiple Myeloma; relapsed or refractory systemic light chain amyloidosis; Waldenström macroglobulinemia/lymphoplasmacytic lymphoma)
  Some state mandates may supersede criteria for off-label uses.
- Authorization duration and reauthorization rules are met (see indication-specific nodes).

ANY of the following

Member is less than 19 years of age
Prescriptions for members under 19 automatically process without coverage review; authorization issued for 12 months.
ALL of the following
- Member meets one of the approved indications listed below (Multiple Myeloma; relapsed or refractory systemic light chain amyloidosis; Waldenström macroglobulinemia/lymphoplasmacytic lymphoma)
  Some state mandates may supersede criteria for off-label uses.
- Authorization duration and reauthorization rules are met (see indication-specific nodes).

Multiple myeloma — Initial authorization

Initial authorization will be approved when ALL of the following are met:

ALL of the following

Diagnosis of multiple myeloma
Per FDA label: indicated in combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy.

Multiple myeloma — Reauthorization

Reauthorization will be approved when ALL of the following are met:

ALL of the following

Patient does not show evidence of progressive disease while on Ninlaro therapy
Authorization will be issued for 12 months.

Relapsed or refractory systemic light chain (AL) amyloidosis — Initial authorization

Initial authorization will be approved when ALL of the following are met:

ALL of the following

Diagnosis of relapsed or refractory systemic light chain amyloidosis

Relapsed or refractory systemic light chain (AL) amyloidosis — Reauthorization

Reauthorization will be approved when ALL of the following are met:

ALL of the following

Patient does not show evidence of progressive disease while on Ninlaro therapy
Authorization will be issued for 12 months.

Waldenström macroglobulinemia / lymphoplasmacytic lymphoma — Initial authorization

Initial authorization will be approved when BOTH of the following are met:

ALL of the following

Diagnosis of Waldenström macroglobulinemia/lymphoplasmacytic lymphoma
Used in combination with rituximab (Rituxan) and dexamethasone

Waldenström macroglobulinemia / lymphoplasmacytic lymphoma — Reauthorization

Reauthorization will be approved when ALL of the following are met:

ALL of the following

Patient does not show evidence of progressive disease while on Ninlaro therapy
Authorization will be issued for 12 months.

NCCN recommended regimens

Coverage may be granted where the regimen is recognized by the NCCN Drugs & Biologics Compendium with Category of Evidence and Consensus 1, 2A, or 2B:

ALL of the following

Regimen for the diagnosis is listed in NCCN with category 1, 2A, or 2B
Authorization will be issued for 12 months. State mandates and member benefit plans may modify application.

Referenced Code Systems

ICD-10 diagnosis codes (referenced generically)ICD-10

Document references use of diagnosis codes (ICD-10) for automated approvals; specific ICD-10 codes not listed in policy text.

What Providers Must Do

Prior Authorization

Prior authorization required

Prior authorization is required; members must meet the specified diagnosis-based criteria for approval. UnitedHealthcare may also approve initial authorizations or reauthorizations automatically based on prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic.

Automated approval/re-approval may occur using prior claims, medication history, and diagnosis codes.
Pediatric prescriptions (age <19) automatically process without a coverage review; authorization issued for 12 months when applicable.

Documentation Required

Documentation required for reauthorization

For reauthorization, the provider must document (or rely on claims-based logic) that the patient does not show evidence of progressive disease while on Ninlaro therapy. Typical authorization and reauthorization durations are issued for 12 months.

Documentation of absence of progressive disease is required for reauthorization decisions.

Clinical and Administrative Background

Ninlaro (ixazomib) is an oral proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

The manufacturer does not recommend Ninlaro for use in the maintenance setting or for newly diagnosed multiple myeloma outside of controlled clinical trials.

The National Comprehensive Cancer Network (NCCN) also recognizes additional uses for ixazomib, including as primary or maintenance therapy for multiple myeloma, for treatment of relapsed or refractory systemic light chain (AL) amyloidosis, and for treatment of Waldenström macroglobulinemia/lymphoplasmacytic lymphoma when used in combination regimens (for example, with rituximab and dexamethasone).

Defined Terms

Definitions

AuthorizationApproval to dispense and reimburse Ninlaro under the member's benefit; typical duration is 12 months unless otherwise noted.

Progressive diseaseClinical or radiographic evidence of disease progression while on therapy (as used for reauthorization decisions); specific criteria not detailed in policy.

NCCN recognized regimenA regimen listed in the NCCN Drugs & Biologics Compendium with Category of Evidence and Consensus 1, 2A, or 2B.

Policy Changes

2016-01-01program_creation

Program created as a prior authorization/notification policy for Ninlaro (ixazomib).

2016-04-01criteria_update

Removed Revlimid & dexamethasone requirement from coverage criteria per NCCN; updated background and references.

2017-03-01annual_review

Annual review with updates to background information and criteria to include NCCN recommendation for primary use in combination with lenalidomide and dexamethasone.

Ninlaro (ixazomib) prior authorization criteria

Ninlaro (ixazomib) — Coverage Rules

Referenced Code Systems

What Providers Must Do

Clinical and Administrative Background

Defined Terms

Policy Changes

Other Policies to Review