CurrentCignaPolicy N/A

Oncology (Oral -Proteasome Inhibitor) -Ninlaro Prior Authorization Policy

Prior authorization policy describing coverage criteria for Ninlaro (ixazomib capsules) for FDA-approved and supported off-label indications (multiple myeloma, systemic light chain amyloidosis, Waldenström macroglobulinemia/lymphoplasmacytic lymphoma), including age, prior therapy, regimen combination, transplant status, approval duration, and not-covered uses.

Policy Summary

PayerCigna

PolicyOncology (Oral -Proteasome Inhibitor) -Ninlaro Prior Authorization Policy

Policy CodePolicy N/A

Change TypeCriteria revisions and additions

Effective Date

Next Review Date

Key ActionPrior authorization is required; document age, prior regimens, transplant status, prescriber attestation if not candidate for bortezomib or carfilzomib, and combination regimen details to meet criteria.

SourceLink

POLICY UPDATE CHANGES

Policy name changed to 'Oncology (Oral - Proteasome Inhibitor) - Ninlaro PA Policy' on 04/11/2025.

An option for approval was added allowing approval when prescriber attests patient is not a candidate for bortezomib or carfilzomib and patient is not a transplant candidate.

Multiple Myeloma criterion changed from 'following autologous stem cell transplantation (ASCT)' to 'following hematopoietic stem cell transplantation.'

In multiple myeloma regimen examples, 'cyclophosphamide' was added as an option in combination therapy.

Systemic Light Chain Amyloidosis note updated to add daratumumab (IV and subcutaneous) and carfilzomib as example agents used in other regimens.

3Covered Indications

1 yearApproval Duration per Indication

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Coverage Summary & Criteria

This prior authorization policy covers Ninlaro (ixazomib capsules) with a covered_with_criteria stance for FDA‑approved and supported off‑label uses. Approvals are provided for 1 year when the applicable clinical criteria are met. The policy applies to adults with a minimum age of ≥18 years and describes requirements related to prior therapy, combination regimen (e.g., lenalidomide or cyclophosphamide plus dexamethasone), and transplant status for multiple myeloma, as well as criteria for systemic light chain amyloidosis and Waldenström macroglobulinemia/lymphoplasmacytic lymphoma.

Not Covered

Considered not medically necessary for any other use(s).

Any indication not specified in the FDA-approved indication or Other Uses with Supportive Evidence

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of Ninlaro (ixazomib). Approvals are provided for the duration noted in the policy: 1 year for the listed indications.

Documentation Required

Clinical documentation of prior therapy or regimen

Providers must document the following to meet policy criteria: patient age (≥ 18 years); prior regimens when required by the indication (e.g., at least one prior regimen for multiple myeloma or tried at least one other regimen for systemic light chain amyloidosis); transplant status or use following hematopoietic stem cell transplantation; a prescriber statement/attestation if the prescriber indicates the patient is not a candidate for bortezomib or carfilzomib (where that alternative pathway is used); and details of the planned combination regimen (e.g., combination with lenalidomide or cyclophosphamide and dexamethasone, or use with rituximab and dexamethasone for Waldenström).

Patient age (≥ 18 years)
Prior regimens when required (e.g., ≥1 prior regimen for multiple myeloma; tried ≥1 other regimen for systemic light chain amyloidosis)
Transplant status or use following hematopoietic stem cell transplantation
Prescriber attestation if patient is not a candidate for bortezomib or carfilzomib (for the alternative approval pathway)
Combination regimen details (e.g., lenalidomide or cyclophosphamide + dexamethasone; rituximab + dexamethasone for Waldenström)

Applicable Codes

DrugNDCCovered

No codes listed

Background, Definitions, and Clinical Evidence

Ninlaro (ixazomib) is an oral proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for multiple myeloma in patients who have received at least one prior therapy; it is not recommended for maintenance or in newly diagnosed disease outside clinical trials. NCCN guidelines list Ninlaro‑containing regimens across multiple myeloma, systemic light chain amyloidosis, and Waldenström macroglobulinemia: for multiple myeloma (NCCN Multiple Myeloma v2.2025) Ninlaro combinations are included for primary therapy, maintenance in certain circumstances, and for previously treated disease (including Ninlaro/lenalidomide/dexamethasone and Ninlaro/cyclophosphamide/dexamethasone). For systemic light chain amyloidosis (NCCN Amyloidosis v2.2025) and Waldenström macroglobulinemia (NCCN Waldenström v3.2025) Ninlaro‑based regimens are listed among treatment options.

Ninlaro: Brand name for ixazomib capsules (oral proteasome inhibitor).

Evidence sources include the Ninlaro prescribing information (Takeda Ninlaro prescribing information, March 2024) and NCCN clinical practice guidelines: Multiple Myeloma (v2.2025), Systemic Light Chain Amyloidosis (v2.2025), and Waldenström Macroglobulinemia/Lymphoplasmacytic Lymphoma (v3.2025). These guideline versions and dates are cited in the policy references.

Policy Changes

04/12/2023non-material_revision

Multiple Myeloma: added 'or cyclophosphamide' to Ninlaro combination therapy examples (cosmetic to example list/combination agents).

04/24/2024no_material_change_note

Annual revision: No criteria changes.

04/09/2025material_revision

Multiple Myeloma: criterion changed from 'following autologous stem cell transplantation (ASCT)' to 'following hematopoietic stem cell transplantation.'; Systemic Light Chain Amyloidosis: added Darzalex (daratumumab IV), Darzalex Faspro (daratumumab + hyaluronidase SC), and Kyprolis (carfilzomib IV) as example agents used in other regimens.