Forms and Documents

We've made enrollment simpler, faster and more intuitive with some key changes to our forms. The Prescriber Service Form and the Patient Consent Form are required for enrollment in Genentech Access Solutions. These forms replace the Statement of Medical Necessity (SMN) and the Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation (PAN).

 

KADCYLA Access Solutions Enrollment Forms

 

Other Important Documents

Considerations for Composing a Letter of Medical Necessity

This guide provides tips to help you draft a letter of medical necessity. A sample letter is also included for your reference. Use the links below to find additional information to enclose in your letter.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for KADCYLA

 

Sample Appeal Letter – KADCYLA for eBC

This sample appeal letter may be used if a patient's health insurance plan denies coverage of KADCYLA for early breast cancer.

 

Considerations for Composing a Sample Appeal Letter

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.

FDA approval letter (Follow this link and search by the drug name)

Prescribing Information

Sample coding for KADCYLA

 

Enrolling in the Genentech Patient Foundation

The Genentech Patient Foundation gives free medicine to people who don't have insurance coverage or who have financial concerns and to people who meet certain income criteria.

 

Fax Cover Letter

Use this cover sheet when faxing documents to KADCYLA Access Solutions.

Important Safety Information & Indication

Indication

KADCYLA® (ado-trastuzumab emtansine), as a single agent, is indicated for the treatment of patients with HER2-positive (HER2+), metastatic breast cancer (MBC) 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

Important Safety Information

Boxed WARNINGS: HEPATOTOXICITY, CARDIAC TOXICITY, EMBRYO-FETAL TOXICITY

  • Do not substitute KADCYLA for or with trastuzumab
  • Hepatotoxicity: Serious hepatotoxicity has been reported, including liver failure and death in patients treated with KADCYLA. Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. Reduce dose or discontinue KADCYLA as appropriate in cases of increased serum transaminases or total bilirubin
  • Cardiac toxicity: KADCYLA administration may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate left ventricular function in all patients prior to and during treatment with KADCYLA. Withhold treatment for clinically significant decrease in left ventricular function
  • Embryo-fetal toxicity: Exposure to KADCYLA during pregnancy can result in embryo-fetal harm. Advise patients of these risks and the need for effective contraception

The following additional serious adverse reactions have been reported in clinical trials with KADCYLA:

  • Interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or fatality: KADCYLA should be permanently discontinued in patients diagnosed with ILD or pneumonitis
  • Infusion-related reactions (IRR), hypersensitivity: KADCYLA treatment should be interrupted in patients with severe IRR and permanently discontinued in the event of a life-threatening IRR
  • Thrombocytopenia: Monitor platelet counts prior to initiation of KADCYLA and prior to each dose. Institute dose modifications as appropriate
  • Hemorrhage: Fatal cases of hemorrhage occurred in clinical trials among patients with no known identified risk factors, as well as among patients with thrombocytopenia and those receiving anticoagulation and antiplatelet therapy
  • Peripheral neuropathy: KADCYLA should be temporarily discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until resolution to ≤Grade 2
  • Reactions secondary to extravasation: The infusion site should be closely monitored for possible subcutaneous infiltration during drug administration

Additional Important Safety Information:

  • Detection of HER2 protein overexpression or gene amplification is necessary for selection of patients appropriate for KADCYLA therapy
  • Nursing mothers: Discontinue nursing or discontinue KADCYLA, taking into consideration the importance of the drug to the mother
  • The most common adverse drug reactions (frequency >25%) across clinical trials with KADCYLA were fatigue, nausea, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, increased transaminases, constipation, and epistaxis

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1-888-835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Please see additional Important Safety Information and accompanying full Prescribing Information, including Boxed WARNINGS.