Find the enrollment forms you'll need to help patients access KADCYLA after it's been prescribed, including for coverage, reimbursement and financial assistance services. There are also tips for composing a letter of medical necessity and appeal letter.
To learn more about the resources available to help your practice, including information on benefits investigations and prior authorizations, go to Helpful Resources for Your Practice.
KADCYLA Access Solutions can help your patients better understand their coverage, find financial assistance options, learn how to get KADCYLA and know which specialty pharmacy their health insurance plan requires.
This form is used to collect the patient’s health insurance and treatment information for enrollment in KADCYLA Access Solutions.
This form is signed and dated by your patient, giving written permission for KADCYLA Access Solutions to discuss their health information with you and the patient's health insurance plan.
A version of the Patient Consent Form for your Spanish-speaking patients.
The Genentech Patient Foundation provides free KADCYLA to people who don’t have insurance coverage or who have financial concerns and meet eligibility criteria.
The following forms are needed for applying for assistance from the Genentech Patient Foundation. Learn more about the Genentech Patient Foundation and other resources programs.
Includes patient, insurance and prescription information. Page two must be completed and submitted by the prescriber.
This form is signed and dated by your patient, giving written permission for KADCYLA Access Solutions to discuss their health information with you and the patient's health insurance plan.
A version of the Patient Consent Form for your Spanish-speaking patients.
This guide provides tips to help you draft a letter of medical necessity. A sample letter is also included for your reference.
This guide provides tips to help you draft an appeal letter. A sample letter is also included for your reference.
Use the links below to find additional information to enclose in your letter of medical necessity or appeal letter:
Gianni L, et al. Lancet Oncol. 2016;17(6):791-800.
Gianni L, et al. Lancet Oncol. 2016;17(6):791-800.
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
Cortazar P, et al. Lancet. 2014;384(9938):164-172.
Cortazar P, et al. Lancet. 2014;384(9938):164-172.
KADCYLA Prescribing Information. Genentech, Inc. 2022.
KADCYLA Prescribing Information. Genentech, Inc. 2022.
Roche.com. FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer.
Roche.com. FDA approves Roche's Kadcyla (trastuzumab emtansine), the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer.
Verma S, Miles D, Gianni L, et al; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer [published correction appears in N Engl J Med. 2013;368:2442]. N Engl J Med. 2012;367:1783-1791 and Supplementary Appendix.
Verma S, Miles D, Gianni L, et al; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer [published correction appears in N Engl J Med. 2013;368:2442]. N Engl J Med. 2012;367:1783-1791 and Supplementary Appendix.
Junttila TT, Li G, Parsons K, Phillips GL, Sliwkowski MX. Trastuzumab-DM1 (T-DM1) retains all the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensitive breast cancer. Breast Cancer Res Treat. 2011;128:347-356.
Junttila TT, Li G, Parsons K, Phillips GL, Sliwkowski MX. Trastuzumab-DM1 (T-DM1) retains all the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensitive breast cancer. Breast Cancer Res Treat. 2011;128:347-356.
Staudecher AH, Brown MP. Antibody drug conjugates and bystander killing: is antigen-dependent internalisation required? Br J Cancer. 2017;117(12):1736-1742.
Staudecher AH, Brown MP. Antibody drug conjugates and bystander killing: is antigen-dependent internalisation required? Br J Cancer. 2017;117(12):1736-1742.
Lewis Phillips GD, Li G, Dugger DL, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68(22):9280-9290.
Lewis Phillips GD, Li G, Dugger DL, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68(22):9280-9290.
Nahta R, Esteva FJ. Herceptin: mechanisms of action and resistance. Cancer Lett. 2006; 232:123-138.
Nahta R, Esteva FJ. Herceptin: mechanisms of action and resistance. Cancer Lett. 2006; 232:123-138.
von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617-628.
von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617-628.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 28, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed March 28, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Denduluri N, Somerfield MR, Chavez-MacGregor M, et al. Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Guideline Update. J Clin Oncol. 2021;39(6):685-693.
Denduluri N, Somerfield MR, Chavez-MacGregor M, et al. Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Guideline Update. J Clin Oncol. 2021;39(6):685-693.
Loibl S, Mano MS, Untch M, et al. Phase III study of adjuvant ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis. Presented at: San Antonio Breast Cancer Symposium; December 5-9, 2023; San Antonio, TX. Accessed January 29, 2024.
Loibl S, Mano MS, Untch M, et al. Phase III study of adjuvant ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis. Presented at: San Antonio Breast Cancer Symposium; December 5-9, 2023; San Antonio, TX. Accessed January 29, 2024.
Geyer CE, et al. Phase III study of trastuzumab emtansine (T-DM1) vs trastuzumab as adjuvant therapy in patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy including trastuzumab: primary results from KATHERINE (NSABP B-50-I, GBG 77 and Roche BO27938). Presented at: San Antonio Breast Cancer Symposium; December 4-8, 2018.
Geyer CE, et al. Phase III study of trastuzumab emtansine (T-DM1) vs trastuzumab as adjuvant therapy in patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy including trastuzumab: primary results from KATHERINE (NSABP B-50-I, GBG 77 and Roche BO27938). Presented at: San Antonio Breast Cancer Symposium; December 4-8, 2018.
This image shows the components of KADCYLA:
Trastuzumab–monoclonal antibody4
MCC–stable linker4,6
DM1–cytotoxic agent4,7
Overview
This image shows the trial design of KATHERINE.
Data
KATHERINE was a randomized, multicenter, open-label trial of 1,486 patients with HER2+ early breast cancer. Patients were required to have had residual invasive disease in the breast and/or axillary lymph nodes following neoadjuvant treatment with taxane + trastuzumab-based therapy. Patients were randomized to 3.6 mg/kg of KADCYLA or 6 mg/kg of Herceptin® (trastuzumab), with 743 patients in each arm.
Overview
This image shows a Kaplan-Meier curve of invasive disease-free survival (iDFS) in KATHERINE.
Data
Invasive disease-free survival, the primary end point, was significantly higher among patients who received KADCYLA than among those who received trastuzumab (hazard ratio, 0.54, 95% confidence interval [CI], 0.44-0.66; P<0.0001). 7-year iDFS was 80.8% in the KADCYLA group, compared to 67.1% in the trastuzumab group, representing a 46% reduction in the risk of recurrence
Overview
This image shows where KADCYLA fits in the HER2+ early breast cancer treatment plan and how many cycles of it to give.
Details
Following 3-6 cycles of neoadjuvant taxane + trastuzumab-based treatment, and surgery, give KADCYLA for 14 cycles, or until disease recurrence or unmanageable toxicity occurs.
Overview
This image shows the infusion schedule for KADCYLA in early breast cancer.
Details
The initial infusion of KADCYLA in EBC takes 90 minutes plus an observation time of at least 90 minutes to monitor for infusion-related reactions. If prior infusions were well tolerated, subsequent infusions take 30 minutes plus an observation time of at least 30 minutes.
Treat for a total of 14 cycles (every 3 weeks) unless there is disease recurrence or unmanageable toxicity.
Overview
This image shows the dose reduction schedule for adverse reactions to KADCYLA.
Details
The starting dose for KADCYLA is 3.6 mg/kg. The first dose reduction for KADCYLA is 3 mg/kg. The second dose reduction for KADCYLA is 2.4 mg/kg. After that, discontinue KADCYLA.
Overview
This image shows a Kaplan-Meier curve of overall survival (OS) in KATHERINE.
Data
Overall survival, the second interim endpoint, was significantly higher among patients who received KADCYLA than among those who received trastuzumab (hazard ratio, 0.66 (95% CI: 0.51-0.87; P=0.0027). 7-year OS was 89.1% in the KADCYLA group, compared to 84.4% in the trastuzumab group, representing a 34% reduction in the risk of death.
This image shows subgroup analysis of invasive disease-free survival, presented as a forest plot.
This image shows the 3-year subgroup analysis of invasive disease-free survival, presented as a forest plot.
This image shows the 7-year subgroup analysis of invasive disease-free survival, presented as a forest plot.
This image shows the components of KADCYLA:
Trastuzumab-monoclonal antibody1
MCC-stable linker1,3
DM1 cytotoxic agent1,4
Overview
This image shows the trial design of EMILIA.
Details
EMILIA was a randomized, open-label, international trial involving 991 patients with HER2+, unresectable, locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane (separately or in combination). Inclusion criteria included progression during or after the most recent treatment for locally advanced or metastatic disease or within 6 months after treatment for early-stage disease. Four hundred ninety-five patients were randomized to 21-day cycles of 3.6 mg/kg IV of KADCYLA on day 1. Four hundred ninety-six patients were randomized to 1,250 mg of lapatinib by mouth once daily, and 1,000 mg/m² of capecitabine by mouth twice daily on days 1-14. Treatment continued until disease progression or unacceptable toxicity.
Overview
This image shows the trial design of TH3RESA.
Details
TH3RESA was a phase 3, randomized, multicenter, open-label trial of 602 patients with HER2+ advanced breast cancer (ABC). Patients were required to have had disease progression after treatment with ≥2 prior HER2-directed therapies for ABC and prior treatment with trastuzumab, lapatinib, and a taxane. Patients were randomized to 3.6 mg/kg IV of KADCYLA or treatment of physician’s choice (TPC)* per local practice, with 404 patients in the KADCYLA arm and 198 patients in the TPC arm. Patients in the TPC arm who had disease progression had the option to cross over to the KADCYLA arm, and 93 patients did so.
Overview
This image shows overall survival (OS) results for EMILIA.
Data
KADCYLA significantly increased median OS (30.9 months, vs 25.1 months with lapatinib + capecitabine—a nearly 6-month improvement in median OS; hazard ratio for death from any cause, 0.68; 95% confidence interval, 0.55 to 0.85; P=0.0006).
Overview
This image shows progression-free survival (PFS) results for EMILIA.
Data
Treatment with KADCYLA significantly improved PFS as assessed by independent review (median survival, 9.6 months, vs 6.4 months with lapatinib + capecitabine—a 50% improvement in median PFS; stratified hazard ratio for progression or death from any cause, 0.65; 95% confidence interval, 0.55 to 0.77; P<0.0001).
Overview
This image shows objective response rate (ORR) results for EMILIA.
Data
Patients treated with KADCYLA had a higher ORR (43.6%, vs 30.8% with lapatinib + capecitabine—a 12.7% improvement in ORR; 95% confidence interval, 6.0-19.4%).
Overview
This image shows duration of response (DoR) results for EMILIA.
Data
Treatment with KADCYLA significantly improved DoR (median DoR, 12.6 months, vs 6.5 months with lapatinib + capecitabine—nearly doubling DoR; 95% confidence interval, 8.4-20.8).
Overview
This image shows overall survival (OS) in patients with central nervous system (CNS) metastases at baseline in EMILIA.
Data
The estimated median OS was 26.8 months with KADCYLA vs 12.9 months with lapatinib + capecitabine.
Overview
This image shows progression-free survival (PFS) by independent review committee (IRC) in patients with central nervous system (CNS) metastases at baseline in EMILIA.
Data
The estimated median PFS was 5.9 months with KADCYLA vs 5.7 months with lapatinib + capecitabine.
Overview
This image shows progression-free survival (PFS) by investigator results for TH3RESA.
Data
Median PFS with KADCYLA was 6.2 months, vs 3.3 months with treatment of physician’s choice (TPC). Stratified HR=0.528; 95% confidence interval, 0.422 to 0.661; P<0.0001.
Overview
This image shows overall survival (OS) results for TH3RESA in the ITT population.
Data
Median OS with KADCYLA was 22.7 months, vs 15.8 months with treatment of physician’s choice (TPC). Stratified HR=0.68; 95% confidence interval, 0.54 to 0.85; P=0.0007.
Overview
This image shows the most common severe (Grade ≥3) adverse reactions in EMILIA.
Data
Numerical values presented on the image:
Grade ≥3 nausea seen in 0.8% of KADCYLA patients, compared to 2.5% of lapatinib + capecitabine patients
Grade ≥3 fatigue seen in 2.5% of KADCYLA patients, compared to 3.5% of lapatinib + capecitabine patients
Grade ≥3 thrombocytopenia seen in 15% of KADCYLA patients, compared to 0.4% of lapatinib + capecitabine patients
Grade ≥3 increased transaminases seen in 8.0% of KADCYLA patients, compared to 2.5% of lapatinib + capecitabine patients
Grade ≥3 diarrhea seen in 1.6% of KADCYLA patients, compared to 21% of lapatinib + capecitabine patients
Grade ≥3 peripheral neuropathy seen in 2.2% of KADCYLA patients, compared to 0.2% of lapatinib + capecitabine patients
Grade ≥3 vomiting seen in 0.8% of KADCYLA patients, compared to 4.5% of lapatinib + capecitabine patients
Grade ≥3 anemia seen in 4.1% of KADCYLA patients, compared to 2.5% of lapatinib + capecitabine patients
Grade ≥3 stomatitis seen in 0.2% of KADCYLA patients, compared to 2.5% of lapatinib + capecitabine patients
Grade ≥3 hypokalemia seen in 2.7% of KADCYLA patients, compared to 4.7% of lapatinib + capecitabine patients
Grade ≥3 neutropenia seen in 2.0% of KADCYLA patients, compared to 4.3% of lapatinib + capecitabine patients
This image shows recommended dosing for KADCYLA: 3.6 mg/kg every 3 weeks.
Overview
This image shows the infusion schedule for KADCYLA in metastatic breast cancer.
Details
The initial infusion of KADCYLA in EBC takes 90 minutes plus an observation time of at least 90 minutes to monitor for infusion-related reactions. If prior infusions were well tolerated, subsequent infusions take 30 minutes plus an observation time of at least 30 minutes.
Treat until disease progression or unmanageable toxicity.
Overview
This image shows the dose reduction schedule for adverse reactions to KADCYLA.
Details
The starting dose for KADCYLA is 3.6 mg/kg. The first dose reduction for KADCYLA is 3 mg/kg. The second dose reduction for KADCYLA is 2.4 mg/kg. After that, discontinue KADCYLA.
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