Committed to Helping You Get Your Genentech Medicine
Knowing what to expect can make all the difference. We can help you
through each step of getting your Genentech medicine.
Frequently Asked Questions
About Herceptin Hylecta Access Solutions
What is Herceptin Hylecta Access Solutions?
Herceptin Hylecta Access Solutions is a resource for people who take
a Genentech medicine. We connect you to the medicine you need.
I Am Concerned About Paying for Herceptin Hylecta
My co-pays for Herceptin Hylecta are too high. How can you help me?
There may be options to help you get the Genentech medicine your doctor has prescribed. Herceptin Hylecta Access Solutions can refer you to patient assistance options.
Where can I find information about the Genentech® Access to Care Foundation (GATCF)?
Getting My Medicine
How long will it take to get my medicine?
You might not be able to get your Genentech medicine right away. First, your doctor’s office or specialty pharmacy will have to check to make sure your health insurance plan covers your medicine. This is called a “benefits investigation.” They also might have to send some more information before your plan covers your medicine. This is called a “prior authorization.”
Enrolling in Herceptin Hylecta Access Solutions
How do I enroll in Herceptin Hylecta Access Solutions?
- You fill out the Patient Consent Form.
- Your doctor fills out the Prescriber Service Form. You do not have to fill out anything on this form.
- Your doctor sends both of these forms to Herceptin Hylecta Access Solutions.
There are 3 ways to send us the Patient Consent Form:
- Complete it online at Genentech-Access.com/PatientConsent
- Fill out a paper copy and fax or mail it to us (or give it to your doctor to do so)
- Text a picture of the completed form to (650) 877-1111
Why do I need to sign the Patient Consent Form?
The PAN form lets us discuss your health information with your doctor
and your health insurance plan. We can’t work with you without a
I submitted the Patient Consent Form online or gave the signed Patient Consent Form to my doctor. Is there anything else I need to do to enroll?
You do not need to do anything else, but your doctor does. He or she needs to submit a form called the Prescriber Service Form. This form tells us your doctor wants to treat you with Herceptin Hylecta. Make sure your doctor has sent us the Prescriber Service Form so you get help from us.
You do not need to fill out anything on the Prescriber Service Form.
I already submitted a PAN form. Do I also need to fill out the Patient Consent Form?
The Patient Consent Form replaces the PAN. The PAN and the Patient Consent Form are valid for 3 years in all states (except Maryland, where it is valid for 1 year).
If your PAN is still valid, you do not need to fill out the Patient Consent Form yet.
My Health Plan Denied Coverage for Herceptin Hylecta
My health insurance plan will not cover Herceptin Hylecta. What do I do?
If your health insurance plan will not cover your Genentech medicine, you and your doctor’s office can file an appeal. Contact your doctor to ask if you should file an appeal.
We have resources to help you and your doctor file an appeal.
Does Herceptin Hylecta Access Solutions send the appeal to my health insurance plan?
We have resources to help you and your doctor file an appeal. You or
your doctor’s office has to file the appeal directly with your health
How long does an appeal take?
This depends on your health insurance plan. You should ask your plan directly about its process. Sometimes the appeals process is quick. However, it can take several months if you have to appeal several times.
My Insurance Might Change
I am enrolled in Herceptin Hylecta Access Solutions and my health insurance plan has changed. What do I do next?
If your insurance changes while you’re taking your Genentech
medicine, call us. We can help you understand your new coverage.
I no longer have a health insurance plan. What should I do?
The Genentech Patient Foundation gives free Genentech medicine to
people who don't have insurance coverage or who have financial
concerns and to people who meet certain income criteria.
It is your and your doctor's responsibility to complete and submit
all required paperwork to your health insurance plan. Genentech
cannot guarantee your plan will cover any treatments.
PAN=Patient Authorization and Notice of Request
for Transmission of Health Information to Genentech Access Solutions
and Genentech® Access to Care Foundation.
Important Safety Information & Indication
What it treats
Adjuvant Breast Cancer
HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) is approved for the treatment of adults with early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* HERCEPTIN HYLECTA can be used in several different ways:
- As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC→TH”
- With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH”
- Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin) based therapy (a type of chemotherapy)
Patients are selected for therapy based on an FDA-approved test for trastuzumab.
*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.
Metastatic Breast Cancer
HERCEPTIN HYLECTA has 2 approved uses in adults with metastatic breast cancer:
- HERCEPTIN HYLECTA in combination with the chemotherapy drug paclitaxel is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer
- HERCEPTIN HYLECTA alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease
Patients are selected for therapy based on an FDA-approved test for trastuzumab.
Important Patient Safety Information
Possible Serious Side Effects With HERCEPTIN HYLECTA
Not all people have serious side effects, but side effects with HERCEPTIN HYLECTA therapy are common.
Although some people may have a life-threatening side effect, most do not.
Your doctor will stop treatment if any serious side effects occur.
HERCEPTIN HYLECTA is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:
These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both HERCEPTIN HYLECTA and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with HERCEPTIN HYLECTA.
Contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness.
SEVERE LUNG PROBLEMS including:
- Severe shortness of breath
- Scarring of the lungs
- Fluid in or around the lungs
- Weakening of the valve between the heart and the lungs
- Not enough oxygen in the body
- Swelling of the lungs
Your doctor may check for signs of severe lung problems when he or she examines you.
These signs usually happen within 24 hours after receiving HERCEPTIN HYLECTA.
BE SURE TO CONTACT YOUR DOCTOR IF YOU:
ARE A WOMAN WHO COULD BECOME PREGNANT, OR MAY BE PREGNANT
HERCEPTIN HYLECTA may result in the death of an unborn baby or birth defects. Contraception should be used while receiving HERCEPTIN HYLECTA and for 7 months after your last dose of HERCEPTIN HYLECTA. If you are or become pregnant while receiving HERCEPTIN HYLECTA or within 7 months after your last dose of HERCEPTIN HYLECTA, you are encouraged to report HERCEPTIN HYLECTA exposure to Genentech at 1-888-835-2555.
Have LOW WHITE BLOOD CELL COUNTS
Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving intravenous trastuzumab plus chemotherapy than in patients receiving chemotherapy alone.
Your doctor may check for signs of low white blood cell counts when he or she examines you.
Experience HYPERSENSITIVITY AND ADMINISTRATION-RELATED REACTIONS, which have been reported with HERCEPTIN HYLECTA. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products. Your doctor will monitor you for signs of these reactions. Contact your healthcare provider immediately if you experience any symptoms of hypersensitivity and administration-related reactions, including dizziness, nausea, chills, fever, vomiting, diarrhea, hives, swelling under the skin, breathing problems, or chest pain.
SIDE EFFECTS SEEN MOST OFTEN
The most common side effects seen in treatment of adjuvant breast cancer with HERCEPTIN HYLECTA were tiredness, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough, and pain in extremity.
The most common side effects seen in treatment of metastatic breast cancer (based on intravenous trastuzumab) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.
You should contact your doctor immediately if you have any of the side effects listed above.
You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
You may also report side effects to Genentech at 1-888-835-2555.
Please see the HERCEPTIN HYLECTA full Prescribing Information for additional Important Safety Information, including most serious side effects.