TRODELVY ACCESS SUPPORT is a patient access and reimbursement support program. It will help you and your patient understand specific coverage and reimbursement guidelines for TRODELVY 180-mg single-dose vial.

Reimbursement support services include:
  • Coverage verification
  • Prior Authorization information
  • Claims status information
  • Billing and coding information
  • Alternate assistance options
Patient access support includes:

TRODELVY support may vary based on application criteria and is subject to change or discontinuation. Physician office must submit prior authorizations and appeals.

*TRODELVY Savings Program is not available to patients with any form of government insurance. Patients must meet certain eligibility criteria to qualify for this program. Once enrolled the patient pays $0 out-of-pocket for TRODELVY, with maximum benefit of $25,000 per year.

Gilead PAP provides TRODELVY free of charge for eligible patients who are uninsured or underinsured. To qualify for assistance, patients must meet certain eligibility criteria.

Patients with Medicare or other government insurance who need assistance with cost-share requirements for TRODELVY may be eligible for co-pay or co-insurance assistance through an independent co-pay assistance foundation. Case managers can help patients assess their high-level eligibility for possible coverage for TRODELVY through an independent co-pay assistance foundation. If co-pay assistance needs are identified, the case managers can provide information about any available foundations. The foundation will determine the patient’s eligibility for co-pay or co-insurance assistance based on their own criteria and, completely independent of Gilead and its agents, will contact the patient directly regarding the application process. Gilead and its agents make no guarantee regarding reimbursement for any service or item.

To enroll a patient into TRODELVY ACCESS SUPPORT, please complete the Enrollment Form with your patient and fax to 1-833-851-4344.

Patient Enrollment Form

For further information, please contact TRODELVY ACCESS SUPPORT:

Phone: 1-844-TRODELVY (1-844-876-3358)

Monday – Friday, 9 AM – 7 PM ET

Or fax inquiries to 1-833-851-4344


Trodelvy savings program

Savingscard

The TRODELVY Savings Program provides savings on out-of-pocket expenses for TRODELVY 180-mg single-dose vial, up to $25,000 annually for commercially or privately insured patients. Terms and conditions apply.§

  • Patients pay $0 out of pocket for TRODELVY, which includes co-pay and co-insurance up to $25,000 annually
  • The Program only assists with cost of TRODELVY; patient is responsible for cost-share of treatments and office visits
  • This Program does not support any claims covered, paid, or reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs
  • See Reimbursement Process below for simple steps to receive savings
  • For additional information, contact TRODELVY ACCESS SUPPORT at 1-844-TRODELVY (1-844-876-3358), option 4

Reimbursement process

Have your patient complete the Enrollment Form and attach the following:

An Explanation of Benefits or a dated pharmacy receipt indicating TRODELVY payment should be submitted, if available, within 120 days of the date of service to TRODELVY ACCESS SUPPORT.

Submit reimbursement claim and attachments via mail or fax.

MAIL: TRODELVY ACCESS SUPPORT

2730 S. Edmonds Ln.
Suite 300
Lewisville, TX 75067

Fax: 1-833-851-4344

Phone: 1-844-TRODELVY (1-844-876-3358), select option 4 for assistance.


§Terms & Conditions

Eligible patients receive up to a max benefit of $25,000 per year. This offer is not valid for prescriptions covered by or submitted for reimbursement, in whole or in part, under Medicare (including Medicare Part D), Medicaid, similar federal or state-funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), or where otherwise prohibited by law. No claims for reimbursement for TRODELVY units dispensed under the TRODELVY Savings Program may be submitted to any public payor (ie, Medicare, Medicaid, Medigap, Tricare, VA, and DoD). Product dispensed pursuant to program rules and federal and state laws. Gilead reserves the right to rescind, revoke, or amend this offer without notice at any time. Not valid if reproduced. This offer is valid in the United States. Void where prohibited by law.

Gilead Patient Assistance Program


Patients who are uninsured or underinsured may be eligible to obtain access to TRODELVY at no cost through the Gilead Patient Assistance Program (PAP). To qualify for assistance, patients must meet certain eligibility criteria.

  • To determine patient eligibility, fax a completed PAP Enrollment Form to 1-833-851-4344 or by mail:

    TRODELVY ACCESS SUPPORT

    2730 S. Edmonds Ln.
    Suite 300
    Lewisville, TX 75067

A Case Manager will contact your office with determination of patient’s eligibility.

For more information regarding the Patient Assistance Program, please contact TRODELVY ACCESS SUPPORT at 1-844-TRODELVY (1-844-876-3358).

Patient Assistance Program Enrollment Form

Third-party Assistance Referrals


TRODELVY ACCESS SUPPORT Case Managers can provide patients who are unable to afford their medication (including those with Medicare, Medicaid, or other government-sponsored insurance) with information about independent third-party organizations that may be able to help with the cost of treatment.

Your practice or your patients can call 1-844-TRODELVY (1-844-876-3358), option 4, for more information.

Reimbursement, billing, and coding

Coverage, coding, and billing requirements for TRODELVY may vary by plan and patient. Please download the resource guide below to assist you with proper coding to help optimize reimbursement support.

Reimbursement & Billing Guide

Indication

TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Important Safety Information

Boxed Warning: Neutropenia And Diarrhea
  • Severe or life-threatening neutropenia may occur. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
  • Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed. Administer atropine, if not contraindicated, for early diarrhea of any severity. At the onset of late diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS
  • Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may require dose modification. Neutropenia occurred in 61% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 47% of patients. Febrile neutropenia occurred in 7%. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever.

Diarrhea: Diarrhea occurred in 65% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 12% of patients. One patient had intestinal perforation following diarrhea. Neutropenic colitis occurred in 0.5% of patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening anaphylactic reactions have occurred with TRODELVY. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 37% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.3%. The incidence of anaphylactic reactions was 0.3%. Pre-infusion medication is recommended. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Medication to treat such reactions, as well as emergency equipment, should be available for immediate use. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: Nausea occurred in 66% of all patients treated with TRODELVY and Grade 3 nausea occurred in 4% of these patients. Vomiting occurred in 39% of patients and Grade 3-4 vomiting occurred in 3% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 67% in patients homozygous for the UGT1A1*28, 46% in patients heterozygous for the UGT1A1*28 allele and 46% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 25% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 11% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the ASCENT study (IMMU-132-05), the most common adverse reactions (incidence ≥25%) were fatigue, neutropenia, diarrhea, nausea, alopecia, anemia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

Please see full Prescribing Information, including BOXED WARNING.