Support & Resources

TRODELVY Logo

TRODELVY ACCESS SERVICES 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 Savings Program*
  • Immunomedics Patient Assistance Program (PAP)
  • Referrals to independent third-party assistance organizations

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

* Patients must not be enrolled in a government-sponsored program and must meet certain other eligibility criteria to qualify for this program. If approved, the patient pays $0, with a maximum benefit of $25,000 per year.

Immunomedics 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 verify patient’s coverage for TRODELVY. If co-pay assistance needs are identified, the Case Manager 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 will contact the patient directly regarding the application process.

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

For further information, please contact TRODELVY ACCESS SERVICES:

TRODELVY SAVINGS PROGRAM

TRODELVY

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.§

Reimbursement process

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

Submit reimbursement claim and attachments via mail or fax.

Mail: TRODELVY ACCESS SERVICES

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. Immunomedics 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.

Immunomedics Patient Assistance Program

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

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

TRODELVY ACCESS SERVICES

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 SERVICES at 1-844-TRODELVY (1-844-876-3358).

Third-party Assistance Referrals

TRODELVY ACCESS SERVICES 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.

ORDERING INFORMATION
TRODELVY (180 mg) is supplied as a sterile lyophilized powder in individually-boxed single-use vials (NDC: 55135-132-01).

Download the Ordering Information Sheet for complete TRODELVY ordering 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.

Downloadable Resources
The following tools and resources are available to help you learn more about TRODELVY

Get a comprehensive overview of the clinical trial, including study design, efficacy results, and how TRODELVY is thought to work


Download the full TRODELVY Prescribing Information, including the Patient Information


Use this form to enroll your patients in TRODELVY ACCESS SERVICES


Ensure accurate submission of the CMS-1500 Claim Form for TRODELVY claims


Ensure accurate submission of the CMS-1450 Claim Form for TRODELVY claims


Certify that TRODELVY is a medically necessary therapy for your patient


Download a helpful checklist for ensuring complete and accurate TRODELVY claims submissions

INDICATION

TRODELVY™ (sacituzumab govitecan-hziy) is indicated for the treatment of adult patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION
WARNING: NEUTROPENIA AND DIARRHEA

Severe 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

TRODELVY is contraindicated in patients who have experienced a severe hypersensitivity reaction to TRODELVY.

Hypersensitivity

TRODELVY can cause severe and life-threatening hypersensitivity. Anaphylactic reactions have been observed in clinical trials with TRODELVY.

Hypersensitivity reactions within 24 hours of dosing occurred in 37% (151/408) of patients treated with TRODELVY. Grade 3-4 hypersensitivity occurred in 1% (6/408) of patients treated with TRODELVY. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 1% (3/408).

Pre-infusion medication for patients receiving TRODELVY is recommended. Observe patients closely for infusion-related reactions during each TRODELVY 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.

Nausea and Vomiting

TRODELVY is emetogenic. Nausea occurred in 69% (74/108) of patients with mTNBC and 69% (281/408) of all patients treated with TRODELVY. Grade 3 nausea occurred in 6% (7/108) and 5% (22/408) of these populations, respectively.

Vomiting occurred in 49% (53/108) of patients with mTNBC and 45% (183/408) of all patients treated with TRODELVY. Grade 3 vomiting occurred in 6% (7/108) and 4% (16/408) of these patients, respectively.

Premedicate with a two or three drug combination regimen (e.g. dexamethasone with either a 5-HT3 receptor antagonist or an NK-1 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 at the time of scheduled treatment administration 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.

Use in Patients with Reduced UGT1A1 Activity

Individuals who are homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia and may be at increased risk for other adverse reactions following initiation of TRODELVY treatment.

In 84% (343/408) of patients who received TRODELVY (up to 10 mg/kg on Days 1 and 8 of a 21-day cycle) and had retrospective UGT1A1 genotype results available, the incidence of Grade 4 neutropenia was 26% (10/39) in patients homozygous for the UGT1A1*28 allele, 13% (20/155) in patients heterozygous for the UGT1A1*28 allele and 11% (16/149) in patients homozygous for the wild-type allele.

Closely monitor patients with reduced UGT1A1 activity for severe neutropenia. The appropriate dose for patients who are homozygous for UGT1A1*28 is not known and should be considered based on individual patient tolerance to treatment.

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.

Lactation

There is no information regarding the presence of sacituzumab govitecan-hziy or SN-38 in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY.

Adverse Reactions

Most common adverse reactions (incidence ≥25%) in patients with mTNBC are nausea (69%), neutropenia (64%), diarrhea (63%), fatigue (57%), anemia (52%), vomiting (49%), alopecia (38%), constipation (34%), rash (31%), decreased appetite (30%), abdominal pain (26%), and respiratory infection (26%).

Please see full Prescribing Information, including boxed Warning, and Patient Information.