Ado-trastuzumab (Kadcyla)

These services may or may not be covered by all CoOportunity Health plans. Please see your plan documents for your own coverage information. If there is a difference between this general information and your plan documents, your plan will be used to determine your coverage.

Administrative process

Requires prior authorization from Pharmacy Administration.

Kadcyla (trastuzumab emtansine) is generally covered when used in the treatment of:

1. Patients with HER2-positive, metastatic breast cancer, and
2. Previously received trastuzumab and a taxane, separately or in combination, and
3. Received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. 

Kadcyla (trastuzumab emtansine) is a HER2-targeted antibody-drug conjugate of Herceptin (trastuzumab) and DM1, a microtubule inhibitor. DM1 is too toxic to deliver directly into the bloodstream. The Herceptin component of Kadcyla targets and delivers DM1 directly into cancer cells, sparing noncancerous cells.

Kadcyla (trastuzumab emtansine) is indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either:

• Received prior therapy for metastatic disease, or
• Developed disease recurrence during or within six months of completing adjuvant therapy.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.

HCPCS codes

J9354 – Injection, ado-trastuzumab emtansine, 1 mg

NDC Codes

50242008801 – 100mg single-use vial
50242008701 – 160mg single-use vial

References

1. Kadcyla Prescribing Information. South San Francisco, CA: Genentech, Inc.; February 2013.
2. Verma S, Miles D, Gianni L, et al. Trastuzumab Emtansine for HER2-Positive Advanced
3. Breast Cancer. N Engl J Med 2012;367:1783-91.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology : Breast Cancer. Version 1.2013. Available at: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf [Accessed March 4, 2013]
5. American Cancer Society. Breast Cancer Detailed Guide. Available at: http://www.cancer.org/cancer/breastcancer [Accessed March 4, 2013]
6. A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer (MARIANNE). Available at: http://clinicaltrials.gov/show/NCT01120184 [Accessed March 4, 2013]
7. A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Patients With HER2-Positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-Directed Therapy (TH3RESA). Available at: http://clinicaltrials.gov/show/NCT01419197 [Accessed March 4, 2013]
8. A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE). Available at: http://clinicaltrials.gov/ct2/show/NCT01772472 [Accessed March 4, 2013]
9. A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer. Available at: http://clinicaltrials.gov/ct2/show/NCT01641939 [Accessed March 4, 2013]

This information is for most, but not all, CoOportunity Health plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

CoOportunity Health has contracted with HealthPartners Administrators, Inc. to provide claims processing, medical management and certain other administrative services.