Lenvima - NC Standard

Restricted Product(s)

• Lenvima® (lenvatinib)

FDA Approved Use

• For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). 
• In combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior antiangiogenic therapy. 
• In combination with pembrolizumab, for the first line treatment of adult patients with advanced renal cell carcinoma (RCC). 
• For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). 
• In combination with pembrolizumab, for the treatment of patients with advanced endometrial carcinoma (EC) that is mismatch repair proficient (pMMR), as determined by an FDA-approved test, or not microsatellite instability-high (MSI-H), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

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 of older; AND 
3. The patient is being managed by or in consultation with an oncologist; AND 
4. ONE of the following: 
   1. The patient has been diagnosed with locally recurrent or metastatic, progressive, or radioactive iodine-refractory differentiated thyroid cancer (DTC); AND 
      1. Lenvima will be used as a single agent; OR 
   2. The patient has been diagnosed with advanced renal cell carcinoma (RCC); AND 
      1. Lenvima will be used in combination with everolimus; AND 
         1. The patient has tried and failed one prior anti-angiogenic therapy; OR 
      2. Lenvima will be used in combination with pembrolizumab; AND 
         1. Lenvima will be used as first-line treatment; OR 
   3. The patient has been diagnosed with unresectable hepatocellular carcinoma (HCC); AND 
      1. Lenvima will be used as first-line treatment; OR 
   4. The patient has been diagnosed with advanced endometrial carcinoma (EC); AND
      1. Lenvima will be used in combination with pembrolizumab; AND 
      2. ONE of the following: 
         1. The patient has mismatch repair proficient (pMMR) carcinoma; OR 
         2. The patient does not have microsatellite instability-high (MSI-H) carcinoma; AND 
      3. The patient has had disease progression following prior systemic therapy; AND 
      4. The patient is not a candidate for curative surgery or radiation; AND 
5. 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). 
6. 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

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

September 2023: Criteria change: Criteria review and formatting changes. Rewording of FDA indication per package insert. Added duration of approval to quantity limit exception criteria.

Aug 2021: Criteria update: New indication for RCC in combination with pembrolizumab.

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

Oct 2019: Criteria update: Corrected Lenvima 4mg daily dose therapy pack to 5 capsules per card.

Sept 2019: Criteria update: New indication for endometrial carcinoma

Nov 2018: Added expanded indication for hepatocellular carcinoma

May 2018: Clarified quantity limitations on 8 mg and 18 mg therapy packs.

Jan 2017: Original utilization management criteria issued.