Tykerb - NC Standard

Restricted Product(s)

Restriction applies to brand and generic products • ykerb® (lapatinib)

FDA Approved Use

• In combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. 
• In combination with letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 receptor for whom hormonal therapy is indicated.

Limitations of Use

Patients should have disease progression on trastuzumab prior to initiation of treatment with Tykerb in combination with capecitabine.

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. If the request is for brand Tykerb, 
   1. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic lapatinib (medical record documentation required); AND 
5. One of the following: 
   1. The patient has been diagnosed with advanced or metastatic breast cancer; AND 
      1. The patient has an over expression of HER2 (medical record documentation required); AND 
      2. The patient has received prior therapy including an anthracycline, a taxane, and trastuzumab; AND 
      3. Tykerb will be used in combination with capecitabine; AND 
      4. The patient experienced disease progression on traztuzumab prior to initiating therapy with Tykerb; OR 
   2. The patient has been diagnosed with hormone receptor-positive metastatic breast cancer; AND 
      1. The patient has an over expression of HER2 (medical record documentation required); AND 
      2. The patient is postmenopausal; AND 
      3. Tykerb will be used in combination with letrozole; 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

July 2022: Criteria change: Require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication. 
March 2020: Criteria change: Reformatted criteria & added Limitations of Use. Allow for approval if currently taking for a cancer diagnosis and utilizing the generic product (if available).
October 2018: Annual review; No change.
April 2017: Original utilization management criteria issued.