PERJETA Access Solutions offers a range of access and reimbursement resources for your patients and practice after PERJETA 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.
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Coverage
Get help understanding insurance benefits and coverage, such as with benefits investigations and prior authorization resources.
Benefits investigations
PERJETA 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 SP
*If your patient’s request for a prior authorization is not granted, your PERJETA Access Solutions Specialist can work with you to determine your next steps.
Get started with enrollment by following the steps below.
Option 1: Submit forms 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.
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An online tool to help you enroll patients in PERJETA Access Solutions and manage your service requests at your convenience.
Option 2: Print forms and 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.
- Send via fax to 888-249-4919
- Text a photo of the form to 650-877-1111
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 the application outcome and any next steps.
Genentech reserves the right to modify or discontinue the program at any time and to verify the accuracy of information submitted.
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.
PERJETA Benefits Reverification
When a medical treatment is authorized by the patient’s insurance plan for a limited period of time, it will generally require reverification of coverage for continued treatment. PERJETA Access Solutions can help you obtain reverification for your patients.
If the patient’s health insurance plan denies the request for reverification, your practice may file an appeal on behalf of your patient.
Reimbursement
Sample coding information and resources for denials and appeals
PERJETA Sample Coding
This coding information may assist you as you complete the payer forms for PERJETA. 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.
Download sample coding and the important safety information for PERJETA below.
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 PERJETA 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:
- The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
- Your PERJETA 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 and 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 PERJETA Access Solutions and manage your service requests, all through one portal. It allows you the flexibility to work with PERJETA Access Solutions when it’s convenient for you.
With My Patient Solutions, you can:
- Enroll and re-enroll patients in financial assistance programs entirely online
- Communicate with your PERJETA 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
- View co-pay assistance outcomes and referral information
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).
PERJETA Distribution
Genentech has contracted with a network of authorized specialty distributors and specialty pharmacies (SPs) to service practices choosing to prescribe PERJETA.
These partners have made a commitment to product integrity and have agreed to distribute only products purchased directly from Genentech and not to distribute PERJETA through secondary channels.
Authorized Distributors and Specialty Pharmacies
For a full list of authorized distributors and in-network specialty pharmacies, please visit the Genentech Access Solutions website or contact PERJETA 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
PERJETA 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 PERJETA Access Solutions to learn which SP the patient’s health insurance plan mandates or prefers.
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 PERJETA 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.
Please contact Genentech Customer Service at (800) 551-2231 for any order or return-related questions.
Questions? Contact PERJETA Access Solutions
Call 888-249-4918 (Mon.–Fri., 6AM–5PM PST)
Indications:
PERJETA® (pertuzumab) is indicated for use in combination with trastuzumab and chemotherapy for:
- the neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer (EBC)
- the adjuvant treatment of adults with HER2-positive early breast cancer (EBC) at high risk of recurrence
PERJETA® (pertuzumab) is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
Important Safety Information
BOXED WARNINGS: Left Ventricular Dysfunction and Embryo-Fetal Toxicity
- PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased left ventricular ejection fraction (LVEF) and congestive heart failure (CHF). Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function
- Exposure to PERJETA can cause embryo-fetal death and birth defects. 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 PERJETA. Advise pregnant women and females of reproductive potential that exposure to PERJETA in combination with trastuzumab during pregnancy or within 7 months prior to conception can result in fetal harm, including embryo-fetal death or birth defects. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of PERJETA in combination with trastuzumab
- There is a pregnancy pharmacovigilance program for PERJETA. If PERJETA is administered during pregnancy, or if a patient becomes pregnant while receiving PERJETA or within 7 months following the last dose of PERJETA in combination with trastuzumab, healthcare providers and patients should immediately report PERJETA exposure to Genentech at 1-888-835-2555
Contraindications
PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients.
Warnings and Precautions
Left Ventricular Dysfunction
- PERJETA can cause left ventricular dysfunction, including symptomatic heart failure
- Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within normal limits. If the LVEF declines and has not improved, or has declined further at the subsequent assessment, consider permanent discontinuation of PERJETA and trastuzumab
- In the PERJETA-treated patients with MBC in CLEOPATRA, left ventricular dysfunction occurred in 4% of patients and symptomatic left ventricular systolic dysfunction (LVSD) (congestive heart failure) occurred in 1% of patients. Patients who received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of decreased LVEF or left ventricular dysfunction
- In patients receiving PERJETA as a neoadjuvant treatment in combination with trastuzumab and docetaxel in NeoSphere, LVEF decline >10% and a drop to <50% occurred in 8% of patients and left ventricular dysfunction occurred in 3% of patients. LVEF recovered to ≥50% in all these patients
- In patients receiving neoadjuvant PERJETA in TRYPHAENA, LVEF decline >10% and a drop to <50% occurred in 7% of patients treated with PERJETA plus trastuzumab and fluorouracil, epirubicin, and cyclophosphamide (FEC) followed by PERJETA plus trastuzumab and docetaxel, 16% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC, and 11% of patients treated with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH). Left ventricular dysfunction occurred in 6% of patients treated with PERJETA plus trastuzumab and FEC followed by PERJETA plus trastuzumab and docetaxel, 4% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC, and 3% of patients treated with PERJETA in combination with TCH. Symptomatic LVSD occurred in 4% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC, 1% of patients treated with PERJETA in combination with TCH, and none of the patients treated with PERJETA plus trastuzumab and FEC followed by PERJETA plus trastuzumab and docetaxel. LVEF recovered to ≥50% in all but 1 patient
- In patients receiving neoadjuvant PERJETA in BERENICE, in the neoadjuvant period, LVEF decline ≥10% and a drop to <50% as measured by ECHO/MUGA assessment occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC, and 2% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC. Ejection fraction decreased (asymptomatic LVD) occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following dose-dense doxorubicin and cyclophosphamide (ddAC) and 4% of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC in the neoadjuvant period. Symptomatic LVSD (New York Heart Association [NYHA] Class III/IV Congestive Heart Failure) occurred in 2% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and none of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC in the neoadjuvant period
- In patients receiving adjuvant PERJETA in APHINITY, the incidence of symptomatic heart failure (NYHA Class III/IV) with a LVEF decline ≥10% and a drop to <50% was 0.6%. Of the patients who experienced symptomatic heart failure, 47% of PERJETA-treated patients had recovered (defined as 2 consecutive LVEF measurements above 50%) at the data cutoff. The majority of the events (86%) were reported in anthracycline-treated patients. Asymptomatic or mildly symptomatic (NYHA Class II) declines in LVEF ≥10% and a drop to <50% were reported in 3% of PERJETA-treated patients, of whom 80% recovered at the data cutoff
- PERJETA has not been studied in patients with a pretreatment LVEF value of <50%, a prior history of CHF, decreases in LVEF to <50% during prior trastuzumab therapy, or conditions that could impair left ventricular function such as uncontrolled hypertension, recent myocardial infarction, serious cardiac arrhythmia requiring treatment, or a cumulative prior anthracycline exposure to >360 mg/m2 of doxorubicin or its equivalent
Embryo-Fetal Toxicity
- Based on its mechanism of action and findings in animal studies, PERJETA can cause fetal harm when administered to a pregnant woman. PERJETA is a HER2/neu receptor antagonist. Cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death have been reported with use of another HER2/neu receptor antagonist (trastuzumab) during pregnancy
Infusion-Related Reactions
- PERJETA can cause serious infusion reactions, including fatal events
- In CLEOPATRA, on the first day, when only PERJETA was administered, infusion-related reactions occurred in 13% of patients and <1% were Grade 3 or 4. The most common infusion reactions (≥1%) were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity, and vomiting. During the second cycle when all drugs were administered on the same day, the most common infusion reactions in the PERJETA-treated group (≥1%) were fatigue, dysgeusia, hypersensitivity, myalgia, and vomiting
- In APHINITY, when PERJETA was administered in combination with trastuzumab and chemotherapy on the same day, infusion-related reactions occurred in 21% of patients with <1% of patients experiencing Grade 3-4 events
- Observe patients closely for 60 minutes after the first infusion and for 30 minutes after subsequent infusions of PERJETA. If a significant infusion-related reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies. Monitor patients carefully until complete resolution of signs and symptoms. Consider permanent discontinuation in patients with severe infusion reactions
Hypersensitivity Reactions/Anaphylaxis
- PERJETA can cause hypersensitivity reactions, including anaphylaxis
- In CLEOPATRA, the overall frequency of hypersensitivity/anaphylaxis reactions was 11% in PERJETA-treated patients, with Grade 3-4 hypersensitivity reactions and anaphylaxis occurring in 2% of patients
- In NeoSphere, TRYPHAENA, BERENICE, and APHINITY, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA. In APHINITY, the overall frequency of hypersensitivity/anaphylaxis was 5% in the PERJETA-treated group. The incidence was highest in the PERJETA plus TCH treated group (8%) with 1% Grade 3-4 events
- Observe patients closely for hypersensitivity reactions. Severe hypersensitivity, including anaphylaxis and fatal events, have been observed in patients treated with PERJETA. Angioedema has been described in post-marketing reports. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use prior to administration of PERJETA
Most Common Adverse Reactions
Neoadjuvant Treatment of Breast Cancer
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia
- The most common adverse reactions (>30%) with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and paclitaxel when given for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel when given for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia
Adjuvant Treatment of Breast Cancer
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy, and vomiting
Treatment of Metastatic Breast Cancer
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
Please see the full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.