Revlimid - NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Revlimid® (lenalidomide)

FDA Approved Use

For the treatment of adult patients with:

• Multiple myeloma (MM), in combination with dexamethasone. 
• Multiple myeloma (MM), as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). 
• Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. 
• Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
•  Previously treated follicular lymphoma (FL), in combination with a rituximab product. 
• Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

Limitations of Use

• Revlimid is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Criteria for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; 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 diagnosis of multiple myeloma; AND 
   1. The requested medication is being used for treatment in combination with dexamethasone; OR 
   2. The requested medication is being used for maintenance treatment following autologous hematopoietic stem cell transplantation; OR 
5. The patient is being treated for transfusion-dependent anemia due to low or intermediate-1-risk myelodysplastic syndrome with confirmation of 5-q deletion; OR
6. The patient has a diagnosis of mantle cell lymphoma; AND 
   1. The patient’s disease has either relapsed or progressed after two prior therapies, one of which includes Velcade (bortezomib); OR 
7. The patient has a diagnosis of follicular lymphoma (FL) or marginal zone lymphoma (MZL); AND 
   1. The patient’s disease was previously treated; AND 
   2. The requested medication is being used in combination with a rituximab product; OR 
8. 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 record documentation and references / evidence must be provided; AND 
9. 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

March 2022: Criteria change: Addition of new to market lenalidomide (generic Revlimid) to the policy.
June 2020: Criteria update: Corrected diagnosis requirements for multiple myeloma. Allow for approval if currently taking for cancer diagnosis and utilizing generic formulation (if available).
August 2019: Criteria update: Reformatted criteria, Updated indications, & Limitations of Use added.
October 2018: Annual review; No change.
April 2017: Quantity limits added
January 2017: Reviewed for ASO Net Results and Essential formularies
May 2015: Historical revision
July 2011: Original utilization management criteria issued.