Tukysa – NC Standard

Restricted Product(s)

• Tukysa™ (tucatinib)

FDA Approved Use

• Indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2- positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. 
• Indicated in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.

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 has a confirmed diagnosis of advanced unresectable or metastatic breast cancer; AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has human epidermal growth factor receptor 2 (HER2) positive breast cancer (medical record documentation required); AND 
   3. The patient will be treated concomitantly with trastuzumab and capecitabine; AND 
   4. The patient is taking Tukysa (tucatinib) after having received one or more anti-HER2-based regimens in the metastatic setting; OR 
3. The patient has a confirmed diagnosis of unresectable or metastatic colorectal cancer; AND 
   1. The patient is 18 years of age or older; AND 
   2. The patient has RAS wild-type HER2-positive colorectal cancer (medical record documentation required); AND 
   3. The patient will be treated concomitantly with trastuzumab; AND 
   4. The patient is taking Tukysa (tucatinib) following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; AND 
4. The patient is being managed by or in consultation with an oncologist; 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]; AND 
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

February 2023: Criteria change: Added new indication for unresectable or metastatic colorectal cancer. Criteria review and formatting changes. Added duration of approval to quantity limit exception criteria.

April 2020: Original utilization management criteria issued.