Skip To Main Content
For Patients and Caregivers

Helpful Resources for Your Practice

Herceptin HYLECTA Access Solutions offers a range of access and reimbursement resources for your patients and practice after Herceptin HYLECTA is prescribed, including help with benefits investigations (BIs), resources for prior authorizations (PAs), sample billing and coding information, resources for denials and appeals, information about distribution and referrals to potential financial assistance options.

Quick Links

Help with Coverage (BIs and PAs)
Reimbursement (Billing, Coding and Appeals)
Online Patient Enrollment
Herceptin HYLECTA Distribution

Coverage

Get help understanding insurance benefits and coverage, such as with benefits investigations and prior authorization resources.

Benefits Investigations

Herceptin HYLECTA Access Solutions can conduct a benefits investigation (BI) which can determine:

  • If treatment is covered
  • If treatment is denied
  • If a prior authorization or pre-determination is required*
  • If your patient's insurance plan has a mandated or preferred specialty pharmacy

*If your patient’s request for a prior authorization is not granted, your Herceptin HYLECTA Access Solutions specialist can work with you to determine your next steps.

Get started with enrollment by following the steps below.

Option 1: Submit online

If your practice has a registered account for My Patient Solutions, you can get started by logging into your account.

Don't have an account?

Your patient is required to complete the Patient Consent Form. You can either upload their Patient Consent Form as part of your application or have your patient submit the form via fax, text or e-submit.

  • An online tool to help you enroll patients in Herceptin HYLECTA Access Solutions and manage your service requests at your convenience.

Option 2: Print & fax or text

Step 1: Print one of the Patient Consent Forms below for your patient to complete.

Step 2: Print and complete the Prescriber Service Form below.

Step 3: Submit the completed forms via fax or text.

Both forms are required. We must have both the Patient Consent Form and the Prescriber Service Form before we can help you.

What to expect next:

  • The request will be processed within five business days upon receipt of both required forms.
  • Your office will be contacted to discuss any next steps.

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and healthcare provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.

Herceptin HYLECTA Case Managers

A Case Manager may assist during your patient's treatment with access, reimbursement, and helping your patient get their prescribed medicine.

Learn more about Herceptin HYLECTA Case Managers

Reimbursement

Sample coding information and resources for denials and appeals

Herceptin HYLECTA Sample Coding

This coding information may assist you as you complete the payer forms for Herceptin HYLECTA. These tables are provided for informational purposes only. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding.

Sample Coding: Adjuvant Breast Cancer & Metastatic Breast Cancer

Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

Appeals

If your patient’s health insurance plan has issued a denial, your Herceptin HYLECTA Access Solutions specialist can provide resources as you prepare an appeal submission, as per your patient’s plan requirements. 

If a plan issues a denial: 

  1. The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
  2. Your Herceptin HYLECTA Access Solutions specialist has local payer coverage expertise and can help you determine specific requirements for your patient.

A sample appeal letter and additional considerations are available on the Practice Forms & Documents page.

Appeals cannot be completed or submitted by Genentech on your behalf.

Online Patient Enrollment

My Patient Solutions is an online tool to help you enroll patients in Herceptin HYLECTA Access Solutions and manage your service requests, all through one portal. It allows you the flexibility to work with Herceptin HYLECTA Access Solutions when it’s convenient for you.

With My Patient Solutions, you can:

  • Enroll and re-enroll patients in Herceptin HYLECTA Access Solutions and/or the Genentech Patient Foundation
  • View Genentech Patient Foundation eligibility and coordinate shipment
  • Communicate with your Herceptin HYLECTA Access Solutions specialist
  • Easily identify next steps for service requests
  • View Benefits Investigation reports for all your enrolled patients
  • Follow up on prior authorizations or appeals

How to register

Account registration can be completed by one person for the entire practice and for multiple practice locations. For help with registration or if you have questions, call us at 877-GENENTECH (877-436-3683) (6AM-5PM PST, Monday through Friday).

Register for My Patient Solutions

Herceptin HYLECTA Distribution

Genentech has contracted with authorized specialty distributors and specialty pharmacies (SPs) to service practices choosing to prescribe Herceptin HYLECTA. 

These partners have made a commitment to product integrity and have agreed to distribute only products purchased directly from Genentech and not to distribute Herceptin HYLECTA through secondary channels.

Authorized Distributors

For a full list of authorized distributors, please visit the Genentech Access Solutions website or contact Herceptin HYLECTA Access Solutions at 888-249-4918.

About Buy and Bill

With Buy and Bill, the practice purchases the medication in advance, then bills the patient's health insurance plan for reimbursement. The practice is responsible for storing and handling the drug as well as collecting the patient's co-pay for both the drug and its administration. With Buy and Bill, practices can maintain a stock of the drug, giving them the flexibility to treat patients when clinically appropriate.

About Specialty Pharmacies

Herceptin HYLECTA Access Solutions works with specialty pharmacies (SPs) to help patients receive their prescribed Genentech medicines.

In addition to distributing medicines, an SP may provide the following services:

  • Reimbursement resources
  • Clinical services to support patients throughout their treatment
  • The ability to manage the specialty handling and shipping needs linked with many specialty therapies

You can work with your preferred SP or contact Herceptin HYLECTA Access Solutions to learn which SP the patient’s health insurance plan mandates or prefers.

For a full list of in-network specialty pharmacies, please visit the Genentech Access Solutions website or contact Herceptin HYLECTA Access Solutions at 888-249-4918.

Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item. For any product-specific distribution questions, call Herceptin HYLECTA Access Solutions at 888-249-4918 (6AM-5PM PST, Monday through Friday).

Product Issues

We are serious about patient safety. If your Genentech product is spoiled, expired or damaged, we may be able to help you replace it.

Need more help? Click here to find the latest information.

Please contact Genentech Customer Service at 800-551-2231 for any order or return-related questions.

Contact Us

Need more help? Contact Herceptin HYLECTA Access Solutions

Call 888-249-4918 (Mon.–Fri., 6AM–5PM PST).

Financial support

Financial Support

Find the right financial resources option for your patients.

Explore options
NEXT: Practice Forms & Documents

  • We are open from 6AM-5PM PST, Mon. through Fri., except for the following holidays:

    • New Year’s Day
    • Martin Luther King, Jr. Day
    • Memorial Day
    • Juneteenth
    • Independence Day
    • Labor Day
    • Thanksgiving Holiday (Thursday and Friday)
    • Christmas Day

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

Adjuvant Breast Cancer
Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) is indicated for adjuvant treatment of adults with HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion diagnostic 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 is indicated in adults:

  • In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab

BOXED WARNINGS and Additional Important Safety Information

Cardiomyopathy

  • Herceptin HYLECTA administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin HYLECTA with anthracycline-containing chemotherapy regimens.
  • Evaluate left ventricular function in all patients prior to and during treatment with Herceptin HYLECTA. Discontinue Herceptin HYLECTA treatment in patients receiving adjuvant therapy and withhold Herceptin HYLECTA in patients with metastatic disease for clinically significant decrease in left ventricular function

Pulmonary Toxicity

  • Herceptin HYLECTA administration can result in serious and fatal pulmonary toxicity. Symptoms usually occur during or within 24 hours of Herceptin HYLECTA administration. Discontinue Herceptin HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Monitor patients until symptoms completely resolve

Embryo-Fetal Toxicity

  • Exposure to Herceptin HYLECTA during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception

Cardiomyopathy

  • Herceptin HYLECTA administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin HYLECTA with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant breast cancer trial of intravenous trastuzumab, one patient who developed CHF died of cardiomyopathy
  • Herceptin HYLECTA can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death
  • Herceptin HYLECTA can also cause asymptomatic decline in LVEF
  • Discontinue Herceptin HYLECTA treatment in patients receiving adjuvant breast cancer therapy and withhold Herceptin HYLECTA in patients with metastatic disease for clinically significant decrease in left ventricular function

Cardiac Monitoring

  • Evaluate cardiac function prior to and during treatment
  • Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
  • Monitor frequently for decreased left ventricular function during and after Herceptin HYLECTA treatment
  • Monitor more frequently if Herceptin HYLECTA is withheld for significant left ventricular cardiac dysfunction

Embryo-Fetal Toxicity

  • Exposure to Herceptin HYLECTA during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
  • Verify the pregnancy status of females of reproductive potential prior to the initiation of Herceptin HYLECTA
  • Advise pregnant women and females of reproductive potential that exposure to Herceptin HYLECTA during pregnancy or within 7 months prior to conception can result in fetal harm 
  • Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of Herceptin HYLECTA
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Herceptin HYLECTA treatment and any potential adverse effects on the breastfed child from Herceptin HYLECTA or from the underlying maternal condition
  • If Herceptin HYLECTA is administered during pregnancy, or if a patient becomes pregnant while receiving Herceptin HYLECTA or within 7 months following the last dose of Herceptin HYLECTA, health care providers and patients should immediately report Herceptin HYLECTA exposure to Genentech at 1‑888‑835‑2555

Pulmonary Toxicity

  • Herceptin HYLECTA administration can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. 
  • Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity
  • Discontinue Herceptin HYLECTA in patients experiencing pulmonary toxicity

Exacerbation of Chemotherapy-Induced Neutropenia

  • In randomized, controlled clinical trials with intravenous trastuzumab, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not

Hypersensitivity and Administration-Related Reactions

  • Severe administration-related reactions (ARRs), including hypersensitivity and anaphylaxis, have been reported with Herceptin HYLECTA. Patients experiencing dyspnea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of a severe or of a fatal ARR.
  • In the HannaH and SafeHER trials, 9% and 4.2% of patients experienced Grade 1-4 hypersensitivity and anaphylaxis, respectively.  Grade 3-4 hypersensitivity and anaphylactic reactions occurred in 1% and <1% of the patients treated with Herceptin HYLECTA, respectively. In the SafeHER trial, 2 patients required permanent treatment discontinuation with Herceptin HYLECTA; 1 patient due to a hypersensitivity reaction and 1 patient due to anaphylaxis.  Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products
  • Closely monitor patients for systemic hypersensitivity reactions, especially during the first administration. Permanently discontinue Herceptin HYLECTA in patients who experience anaphylaxis or severe hypersensitivity reactions.
Medications to treat such reactions, as well as emergency equipment, should be available for immediate use.  For patients experiencing reversible Grade 1 or 2 hypersensitivity reactions, consider pre-medication with an analgesic, antipyretic, or an antihistamine prior to re-administration of Herceptin HYLECTA

Most Common Adverse Reactions
Adjuvant Breast Cancer

  • Most common adverse reactions for Herceptin HYLECTA are fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and pain in extremity.

Metastatic Breast Cancer (based on intravenous trastuzumab)

  • Most common adverse reactions are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.

You may report side effects to the FDA at (800) FDA‑1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835‑2555.

Please see additional select Important Safety Information throughout, and the accompanying full Prescribing Information, including BOXED WARNINGS.