Nerlynx - NC Standard

Restricted Product(s)

• Nerlynx® (neratinib)

FDA Approved Use

• For extended adjuvant treatment of adult patients with early stage HER2-overexpessed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. 
• In combination with capecitabine for the treatment of adults with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

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 an over expression of HER2 (medical record documentation required); AND 
5. The patient has been diagnosed with early stage (I-III) breast cancer; AND 
   1. The patient has been on adjuvant therapy with trastuzumab (e.g., Herceptin, trastuzumab biosimilar products) prior to initiating therapy with Nerlynx; AND 
   2. Nerlynx will be used as a part of extended adjuvant therapy; AND 
   3. Nerlynx will not be taken for more than a year; OR 
6. The patient has been diagnosed with advanced or metastatic breast cancer; AND 
   1. The patient has previously received 2 or more anti-HER2 based regimens; AND 
   2. Nerlynx will be used in combination with capecitabine; AND 
7. 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 
8. 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

January 2023: Criteria update: Criteria review and formatting changes. Updated criteria point regarding adjuvant therapy with trastuzumab to allow for biosimilars.

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

Mar 2020: Criteria update: Added new indication of advanced or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2-based regimens in metastatic setting in combination with capecitabine.

Aug 2017: original utilization management criteria issued