Forms and Documents
To enroll your patient in Herceptin® Access Solutions, please complete the forms described below. Then fax them to us at (888) 249-4919. Each form is an Adobe® Reader® PDF document. You may type in the form on your computer and print it out, or you may print it out and write in the needed information.
Statement of Medical Necessity (SMN)
The SMN is needed to refer your patient to Herceptin Access Solutions and the Genentech® Access to Care Foundation (GATCF). It may also be used to request a prior authorization if you are doing this with Herceptin Access Solutions. The physician must sign and date the SMN.
Patient Authorization and Notice of Release of Information (PAN)
The PAN is a form each patient signs for Herceptin Access Solutions or GATCF. The PAN lets Herceptin Access Solutions look at your patient's health records. We use this information for the purpose of helping with reimbursement, assisting with appeals or finding other help for eligible patients. The SMN must be faxed with the PAN for processing.
Medicare Appointment of Representative (AOR)
If your patient would like you to assist with an appeal, Medicare may require this form. This form needs to be completed by you and the patient.
Fax Cover Sheet
For your convenience, we have provided a fax cover sheet with the contact information already completed. You may use this when you are enrolling a patient in Herceptin Access Solutions or GATCF.
Herceptin (trastuzumab) Indications and Important Safety Information
Who is Herceptin for?
Herceptin is approved for the adjuvant treatment of HER2-overexpressing, node-positive or node-negative (ER/PR-negative or with one high-risk feature)* breast cancer. Herceptin can be used several different ways:
- As part of a treatment regimen including doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
- With docetaxel and carboplatin
- As a single agent following multi-modality anthracycline-based therapy
Herceptin in combination with paclitaxel is approved for the first-line treatment of HER2-overexpressing metastatic breast cancer. Herceptin as a single agent is approved for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
*High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
What important safety information should I know about Herceptin?
Herceptin treatment can result in heart problems, including those without symptoms (reduced heart function) and those with symptoms (congestive heart failure). The risk and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). Your doctor will stop or strongly consider stopping Herceptin if you have a significant drop in your heart function.
You should be monitored for decreased heart function before your first dose of Herceptin, and frequently during the time you are receiving Herceptin and after your last dose of Herceptin. If you must permanently or temporarily stop Herceptin due to heart problems, you should be monitored more frequently. In one study with Herceptin and certain types of chemotherapy, an inadequate blood supply to the heart occurred.
Some patients have had serious infusion reactions and lung problems; fatal infusion reactions have been reported. In most cases, these reactions occurred during or within 24 hours of receiving Herceptin. Your Herceptin infusion should be temporarily stopped if you have shortness of breath or very low blood pressure. Your doctor will monitor you until these symptoms go away. If you have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath, your doctor may need to completely stop your Herceptin treatment.
Worsening of low white blood cell counts associated with chemotherapy has also occurred.
Herceptin can cause low amniotic fluid levels and harm to the fetus when taken by a pregnant woman.
The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.
Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor.
Please see the Herceptin full Prescribing Information including Boxed WARNINGS and additional important safety information.
Herceptin® is a registered trademark and the Access Solutions logo and the Access Solutions Treatment made possible logo are trademarks of Genentech USA, Inc.
