Herceptin Hylecta Coverage

Benefits Investigations

Herceptin Hylecta Access Solutions can conduct a benefits investigation (BI) to help you determine if a Genentech medicine is covered, if prior authorizations (PAs) are required, which specialty pharmacy (SP) the health insurance plan prefers and if patient assistance might be needed.

Potential outcomes of a BI:

  • Treatment is covered
  • PA is required
  • Treatment is denied

Both the Prescriber Service Form and PAN must be received before Herceptin Hylecta Access Solutions can begin helping your patient.

These can be downloaded from Forms and Documents or submitted online via My Patient Solutions. 

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

Prior Authorization

Herceptin Hylecta Access Solutions can help you identify if a prior authorization (PA) is necessary and offer resources as you obtain it for your patient. Both the Prescriber Service Form and PAN must be received before Herceptin Hylecta Access Solutions can begin helping your patient.

If your patient’s request for a PA is not granted, your BioOncology Field Reimbursement Manager (BFRM) or Herceptin Hylecta Access Solutions Specialist can work with you to determine your next steps. You can find more tips like this in Forms and Documents.

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

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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

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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

IMPORTANT SAFETY INFORMATION

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
  • Exacerbation of chemotherapy-induced neutropenia has also occurred
  • Hypersensitivity and severe Administration-Related Reactions (ARRs) including anaphylaxis, have been reported with HERCEPTIN HYLECTA. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products

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): The 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 the HERCEPTIN HYLECTA full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.