Ninlaro - NC Standard

Restricted Product(s)

• Ninlaro® (ixazomib)

FDA Approved Use

• Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Criteria for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 18 years of age or older; AND 
3. The patient is being managed by or in consultation with an oncologist; AND 
4. The patient has a confirmed diagnosis of multiple myeloma; AND 
   1. The patient has received at least one prior therapy for treatment of multiple myeloma; AND 
5. The patient will be treated concomitantly with Ninlaro in combination with lenalidomide and dexamethasone; AND 
6. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. [Medical records and references / evidence must be provided]; AND 
7. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

February 2023: Criteria update: Criteria review and formatting changes.

August 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic (if available).

February 2020: Criteria change: Reformatted criteria. Allow for approval if currently taking for a cancer diagnosis.

October 2018: Annual review; No change.

April 2017: Quantity limits added

January 2017: Reviewed for ASO Net Results and Essential formularies

December 2015: Original utilization management criteria issued.