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.
Quick Links
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.
-
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:
Early Breast Cancer
PERJETA® (pertuzumab) is indicated for use in combination with Herceptin® (trastuzumab) and chemotherapy for
- the neoadjuvant treatment of patients 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 patients with HER2-positive early breast cancer (EBC) at high risk of recurrence
Metastatic Breast Cancer
PERJETA® (pertuzumab) is indicated for use in combination with Herceptin® (trastuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
BOXED WARNINGS: Left Ventricular Dysfunction and Embryo-Fetal Toxicity
- PERJETA can result in 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 result in embryo-fetal death and birth defects. Advise patients of these risks and the need for effective contraception
- 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. In an animal reproduction study, administration of pertuzumab to pregnant cynomolgus monkeys during the period of organogenesis resulted in oligohydramnios, delayed fetal kidney development, and embryo-fetal death at exposures 2.5 to 20 times the exposure in humans at the recommended dose, based on Cmax
- 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
Additional Important Safety Information
PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients
Left Ventricular Dysfunction (LVD)
- Assess LVEF prior to initiation of PERJETA and at regular intervals during treatment to ensure that LVEF is within normal limits. If LVEF declines and has not improved, or has declined further at the subsequent assessment, discontinuation of PERJETA and trastuzumab should be strongly considered
- In the CLEOPATRA study, for patients with MBC, PERJETA in combination with trastuzumab and docetaxel was not associated with increases in the incidence of symptomatic left ventricular systolic dysfunction (LVSD) or decreases in LVEF compared to placebo in combination with trastuzumab and docetaxel. LVD occurred in 4% of patients in the PERJETA-treated group and in 8% of patients in the placebo-treated group. Symptomatic LVSD (CHF) occurred in 1% of patients in the PERJETA-treated group and in 2% of patients in the placebo-treated group
- Patients who have received prior anthracyclines or prior radiotherapy to the chest area may be at higher risk of decreased LVEF
- In the NeoSphere study, for patients treated in the neoadjuvant setting, the incidence of LVSD was higher in the PERJETA-treated groups compared to the trastuzumab and docetaxel–treated group. An increased incidence of LVEF declines was observed in patients treated with PERJETA in combination with trastuzumab and docetaxel. In the overall treatment period, LVEF decline >10% and a drop to <50% occurred in 2% of patients treated with neoadjuvant trastuzumab and docetaxel as compared to 8% of patients treated with neoadjuvant PERJETA in combination with trastuzumab and docetaxel. LVD occurred in 0.9% of patients treated with neoadjuvant trastuzumab and docetaxel as compared to 3% of patients treated with neoadjuvant PERJETA in combination with trastuzumab and docetaxel. Symptomatic LVSD occurred in 0.9% of patients treated with neoadjuvant PERJETA in combination with trastuzumab and in no patients in the other 3 arms. LVEF recovered to ≥50% in all patients
- In the TRYPHAENA study, for patients treated in the neoadjuvant setting, in the overall treatment period, LVEF decline ˃10% and a drop to <50% occurred in 7% of patients treated with PERJETA plus trastuzumab and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by PERJETA plus trastuzumab and docetaxel; in 16% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC; and in 11% of patients treated with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH). LVD occurred in 6% of patients treated with PERJETA plus trastuzumab and FEC, followed by PERJETA plus trastuzumab and docetaxel; in 4% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC; and in 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, in 1% of patients treated with PERJETA in combination with TCH, and in 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 the BERENICE study, 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 dose-dense doxorubicin and cyclophosphamide (ddAC), and in 2% of patients treated with PERJETA plus trastuzumab and docetaxel following FEC. Ejection fraction decrease (asymptomatic LVD) occurred in 7% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and in 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 CHF) occurred in 2% of patients treated with PERJETA plus trastuzumab and paclitaxel following ddAC and in none of the patients treated with PERJETA plus trastuzumab and docetaxel following FEC in the neoadjuvant period
- In the APHINITY study, for patients treated in the adjuvant setting, the incidence of symptomatic heart failure (NYHA Class III/IV) with a LVEF decline ≥10% and a drop to <50% was <1% (0.6% of PERJETA-treated patients vs 0.2% of placebo-treated patients). Of the patients who experienced symptomatic heart failure, 47% of PERJETA-treated patients and 67% of placebo-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 and 3% of placebo-treated patients, of whom 80% of PERJETA-treated patients and 81% of placebo-treated patients recovered at the data cutoff
Infusion-Related Reactions
- PERJETA has been associated with infusion reactions, including fatal events
- In the CLEOPATRA study, on the first day, when only PERJETA was administered, the overall frequency of infusion reactions was 13% in the PERJETA-treated group and 10% in the placebo-treated group. Less than 1% were Grade 3 or 4. The most common infusion reactions (≥1.0%) 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 (≥1.0%) were fatigue, dysgeusia, hypersensitivity, myalgia, and vomiting
- In the NeoSphere, TRYPHAENA, and APHINITY studies, PERJETA was administered on the same day as the other study treatment drugs. For APHINITY, infusion-related reactions occurred in 21% of patients on the first day of PERJETA administration (in combination with trastuzumab and chemotherapy) and in 18% of patients in the placebo arm. The incidence of Grades 3-4 National Cancer Institute–Common Terminology Criteria for Adverse Events (NCI-CTCAE v4.0) reactions was 1% for the PERJETA arm and 0.7% for the placebo arm
- Observe patients closely for 60 minutes after the first infusion and for 30 minutes after subsequent infusions of PERJETA. If a significant infusion 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
- In the CLEOPATRA study, the overall frequency of hypersensitivity reaction/anaphylaxis was 11% in the PERJETA-treated group and 9% in the placebo-treated group. The incidence of Grades 3-4 hypersensitivity reaction/anaphylaxis was 2% in the PERJETA-treated group and 3% in the placebo-treated group according to NCI-CTCAE v3.0. Overall, 4 patients in the PERJETA-treated group and 2 patients in the placebo-treated group experienced anaphylaxis
- In the NeoSphere, TRYPHAENA, BERENICE, and APHINITY studies, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA. In NeoSphere, 2 patients in the PERJETA and docetaxel–treated group experienced anaphylaxis. In APHINITY, the overall frequency of hypersensitivity/anaphylaxis was 5% in the PERJETA-treated group vs 4% in the placebo-treated group. The incidence was highest in the PERJETA plus TCH–treated group (8%), of which 1% were NCI-CTCAE (v4.0) Grades 3-4
- Patients should be observed 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 PERJETA is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients
Most Common Adverse Reactions
Neoadjuvant Treatment of Breast Cancer
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 4 cycles were alopecia, neutropenia, diarrhea, and nausea. The most common NCI-CTCAE v3.0 Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, leukopenia, and diarrhea
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 3 cycles following 3 cycles of FEC were diarrhea, nausea, alopecia, neutropenia, vomiting, and fatigue. The most common NCI-CTCAE v3.0 Grades 3-4 adverse reactions (>2%) were neutropenia, leukopenia, febrile neutropenia, diarrhea, left ventricular dysfunction, anemia, dyspnea, nausea, and vomiting
- The most common adverse reactions (>30%) with PERJETA in combination with TCH administered for 6 cycles were diarrhea, alopecia, neutropenia, nausea, fatigue, vomiting, anemia, and thrombocytopenia. The most common NCI-CTCAE v3.0 Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, anemia, leukopenia, diarrhea, thrombocytopenia, vomiting, fatigue, alanine aminotransferase (ALT) increased, hypokalemia, and hypersensitivity
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and paclitaxel administered for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache. The most common Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, neutrophil count decreased, white blood cell count decreased, anemia, diarrhea, peripheral neuropathy, ALT increased, and nausea
- The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel administered for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia. The most common Grades 3-4 adverse reactions (>2%) were febrile neutropenia, diarrhea, neutropenia, neutrophil count decreased, stomatitis, fatigue, vomiting, mucosal inflammation, neutropenic sepsis, 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. The most common Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, diarrhea, neutrophil count decreased, anemia, white blood cell count decreased, leukopenia, fatigue, nausea, and stomatitis
- The incidence of diarrhea, all Grades, was higher when chemotherapy was administered with targeted therapy (61% in the PERJETA-treated group vs 34% in the placebo-treated group) and was higher when administered with non–anthracycline-based therapy (85% in the PERJETA-treated group vs 62% in the placebo-treated group) than with anthracycline-based therapy (67% in the PERJETA-treated group vs 41% in the placebo-treated group). The incidence of diarrhea during the period that targeted therapy was administered without chemotherapy was 18% in the PERJETA-treated group vs 9% in the placebo-treated group. The median duration of all Grades diarrhea was 8 days for the PERJETA-treated group vs. 6 days for the placebo-treated group. The median duration of Grade ≥3 diarrhea was 20 days for the PERJETA-treated group vs. 8 days for the placebo-treated group. More patients required hospitalization for diarrhea as a serious adverse event in the PERJETA-treated group (2.4%) than in the placebo-treated group (0.7%)
Metastatic Breast Cancer
- The most common adverse reactions (>30%) seen with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. The most common NCI-CTCAE v3.0 Grades 3-4 adverse reactions (>2%) were neutropenia, febrile neutropenia, leukopenia, diarrhea, peripheral neuropathy, anemia, asthenia, and fatigue
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 full Prescribing Information for additional Important Safety Information, including BOXED WARNINGS.