For Patients and Caregivers

Financial Assistance Options

No matter what type of health insurance your patients have, and even if they have none at all, there may be financial assistance options available.

Quick Links

Genentech Oncology Co-pay Assistance Program
Independent Co-pay Assistance Foundations
Genentech Patient Foundation

Use our financial assistance tool to see which programs may be right for your patient. If you would rather talk through some potential options, call us at 888-249-4918 (Mon.–Fri., 6AM–5PM PST).

Get Started

If your patient has insurance coverage and needs help affording ROZLYTREK, these programs may help:

Genentech Oncology Co-pay Assistance Program

Co-pay Card Assistance

With the Genentech Oncology Co-pay Assistance Program, eligible patients with commercial insurance could pay as little as $5 per treatment for ROZLYTREK. Co-pay assistance of up to $25,000 is provided per calendar year.

Patients may be eligible if they:

  • Are taking ROZLYTREK for an FDA-approved use
  • Are 18 years of age or older or have a Legally Authorized Person over the age of 18 to manage the program
  • Have commercial (private or non-governmental) insurance. This includes plans available through state and federal health insurance exchanges
  • Live and receive treatment in the United States or U.S. Territories
  • Are not receiving assistance through the Genentech Patient Foundation or any other charitable organization for the same expenses covered by the program
  • Do not use a state or federal healthcare plan to pay for your medication. This includes, but is not limited to, Medicare, Medicaid and TRICARE

This Genentech Oncology Co-pay Assistance Program is valid ONLY for patients with commercial insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid or any other federal or state government program to pay for their medications are not eligible.

Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all remaining out-of-pocket expenses. The amount of the program benefit cannot exceed the patients’ out-of-pocket expenses for the cost associated with ROZLYTREK.

All participants are responsible for reporting the receipt of all program benefits as required by any insurer or by law. No party may seek reimbursement for all or any part of the benefit received through this Program. The program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. The patient, guardian, prescriber, hospital and any other person using the program agree not to seek reimbursement for all or any part of the benefit received by the patient through the offer of this program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time. Additional terms and conditions apply.

View full TERMS AND CONDITIONS.

Apply for the Genentech Oncology Co-pay Assistance Program

  • Commercial insurance: An insurance plan you get from a private health insurance company. This can be insurance from your job, from a plan you bought yourself or from a Health Insurance Marketplace (for example, from HealthCare.gov). Medicare and Medicaid are not considered commercial insurance. 

Independent Co-pay Assistance Foundations

Independent Co-pay Assistance

An independent co-pay assistance foundation is a charitable organization providing financial assistance to patients with specific disease states, regardless of treatment. Patients who are commercially or publicly insured, including those covered by Medicare and Medicaid, can contact the foundations directly to request assistance. Eligibility requirements, all aspects of the application process, turnaround times and the type or amount of assistance available (if any) can vary by foundation.

These foundations may be able to help. Please check their websites for up-to-date information.

Advise your patient that these organizations are independent of Genentech and may require the patient to provide personal or financial information directly to the organization to enroll in their respective programs. Genentech cannot share any information the patient has provided to us.

Independent co-pay assistance foundations have their own rules for eligibility. We have no involvement or influence in independent foundation decision-making or eligibility criteria and do not know if a foundation will be able to help your patient. We can only refer your patient to a foundation that supports their disease state. This information is provided as a resource for you. We do not endorse or show preference for any particular foundation. The foundations in this list may not be the only ones that might be able to help your patient.

The financial assistance tool can help your patient to find out if this option may be right for them. Get started.

If your patient has financial difficulty or does not have insurance coverage and needs help affording ROZLYTREK, this program may help:

Genentech Patient Foundation

Genentech Patient Foundation

The Genentech Patient Foundation gives free ROZLYTREK to people who have been prescribed this medicine and don’t have insurance or that have financial concerns and meet certain eligibility criteria.

Your patient may be eligible if their insurance coverage and income match one of these situations:

  • Uninsured patients with incomes under $150,000
  • Insured patients without coverage for ROZLYTREK with incomes under $150,000
  • Insured patients with coverage for a Genentech medicine:
    • With unaffordable out-of-pocket costs
    • Who have pursued other forms of financial assistance
    • With household size and income within certain guidelines

If you have any questions about the criteria or wish to discuss your options, please contact a Foundation Specialist at 888-941-3331 (Mon.–Fri., 6AM–5PM PST).

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 ROZLYTREK 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 Foundation Form below.

Step 3: Submit the completed forms via fax or text.

Both forms are required. We must have both the Patient Consent Form and the Prescriber Foundation 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.

If you have any questions about the criteria, please contact a Foundation Specialist at 888-941-3331 (Mon.–Fri., 6AM–5PM PST).

Genentech reserves the right to modify or discontinue the program at any time and to verify the accuracy of information submitted.

Not sure which programs may be able to help you? We'll walk you through some potential options with the financial assistance tool.

Get Started

  • Commercial insurance: An insurance plan you get from a private health insurance company. This can be insurance from your job, from a plan you bought yourself or from a Health Insurance Marketplace (for example, from HealthCare.gov). Medicare and Medicaid are not considered commercial insurance. 

  • Public insurance: A health insurance plan you get from the federal or state government. This includes Medicare, Medicaid, TRICARE and DoD/VA insurance.

  • For example, a household size of 1 with income of less than $75,000 may meet the criteria for assistance. Add $25,000 for each additional person in the household. There is no maximum number of people you may add.

INDICATIONS

ROS1-Positive Non-Small Cell Lung Cancer

ROZLYTREK is indicated for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

NTRK Gene Fusion-Positive Solid Tumors

ROZLYTREK is indicated for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:

  • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, as detected by an FDA-approved test without a known acquired resistance mutation,
  • are metastatic or where surgical resection is likely to result in severe morbidity, and
  • have either progressed following treatment or have no satisfactory alternative therapy.

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

WARNINGS and PRECAUTIONS

Congestive Heart Failure

  • Among the 355 patients who received ROZLYTREK across clinical trials, congestive heart failure (CHF) occurred in 12 patients (3.4%), including Grade 3 (2.3%). The median time to onset was 2 months (range: 11 days to 12 months). Of these 12 patients, ROZLYTREK was interrupted in 6 (50%) and discontinued in 2 (17%). CHF resolved in 6 patients (50%) following interruption or discontinuation of ROZLYTREK and institution of appropriate medical management. In addition, myocarditis in the absence of CHF was documented in 0.3% of patients
  • Assess left ventricular ejection fraction (LVEF) prior to initiation of ROZLYTREK in patients with symptoms or known risk factors for CHF. Monitor patients for clinical signs and symptoms of CHF, including shortness of breath and edema. For patients with myocarditis, with or without a decreased ejection fraction, MRI or cardiac biopsy may be required to make the diagnosis. For patients with new onset or worsening CHF, withhold ROZLYTREK, institute appropriate medical management, and reassess LVEF. Based on the severity of CHF or worsening LVEF, resume ROZLYTREK at a reduced dose upon recovery to baseline or permanently discontinue

Central Nervous System Effects

  • A broad spectrum of central nervous system (CNS) adverse reactions occurred in patients receiving ROZLYTREK, including cognitive impairment, mood disorders, dizziness, and sleep disturbances
  • Among the 355 patients who received ROZLYTREK across clinical trials, 96 (27%) experienced cognitive impairment; symptoms occurred within 3 months of starting ROZLYTREK in 74 (77%). Cognitive impairment included cognitive disorders (8%), confusional state (7%), disturbance in attention (4.8%), memory impairment (3.7%), amnesia (2.5%), aphasia (2.3%), mental status changes (2%), hallucinations (1.1%), and delirium (0.8%). Grade 3 cognitive adverse reactions occurred in 4.5% of patients. Of the 96 patients with cognitive impairment, 13% required a dose reduction, 18% required dose interruption, and 1% discontinued ROZLYTREK due to cognitive adverse reactions
  • Among the 355 patients who received ROZLYTREK across clinical trials, 36 (10%) experienced mood disorders. Median time to onset of mood disorders was 1 month (range: 1 day to 9 months). Mood disorders occurring in ≥1% of patients included anxiety (4.8%), depression (2.8%), and agitation (2%). Grade 3 mood disorders occurred in 0.6% of patients. One completed suicide was reported 11 days after treatment had ended. Among the 36 patients who experienced mood disorders, 6% required a dose reduction, 6% required dose interruption, and no patients discontinued ROZLYTREK due to mood disorders
  • Dizziness occurred in 136 (38%) of 355 patients. In patients who experienced dizziness, Grade 3 dizziness occurred in 2.2% of patients. Ten percent of patients required a dose reduction, 7% required dose interruption, and 0.7% discontinued ROZLYTREK due to dizziness
  • Among the 355 patients who received ROZLYTREK across clinical trials, 51 (14%) experienced sleep disturbances. Sleep disturbances included insomnia (7%), somnolence (7%), hypersomnia (1.1%), and sleep disorder (0.3%). Grade 3 sleep disturbances occurred in 0.6% of patients. Among the 51 patients who experienced sleep disturbances, 6% required a dose reduction and no patients discontinued ROZLYTREK due to sleep disturbances
  • Incidence of CNS adverse reactions was similar in patients with and without CNS metastases; however, the incidence of dizziness (38% vs 31%), headache (21% vs 13%), paresthesia (20% vs 6%), balance disorder (13% vs 4%), and confusional state (11% vs 2%) appeared to be increased in patients with CNS metastases who had received prior CNS irradiation (N=90) compared to those who did not (N=48)
  • Advise patients not to drive or operate hazardous machinery if they are experiencing CNS adverse reactions. Withhold and then resume at same or reduced dose upon improvement, or permanently discontinue ROZLYTREK based on severity

Skeletal Fractures

  • ROZLYTREK increases the risk of fractures. In an expanded safety population that included 338 adult patients and 30 pediatric patients who received ROZLYTREK across clinical trials, 5% of adult patients and 23% of pediatric patients experienced fractures. In adult patients, some fractures occurred in the setting of a fall or other trauma to the affected area, while in pediatric patients, all fractures occurred in patients with minimal or no trauma. In general, there was inadequate assessment for tumor involvement at the site of fracture; however, radiologic abnormalities, possibly indicative of tumor involvement, were reported in some patients
  • In both adult and pediatric patients, most fractures were hip or other lower extremity fractures (eg, femoral or tibial shaft). In a limited number of patients, bilateral femoral neck fractures occurred. The median time to fracture was 3.8 months (range: 0.3 to 18.5 months) in adults and 4.0 months (range: 1.8 months to 7.4 months) in pediatric patients. ROZLYTREK was interrupted in 41% of adults and 43% of pediatric patients due to fractures. No patients discontinued ROZLYTREK due to fractures
  • Promptly evaluate patients with signs or symptoms (eg, pain, changes in mobility, deformity) of fractures. There are no data on the effects of ROZLYTREK on healing of known fractures and risk of future fractures

Hepatotoxicity

  • Among the 355 patients who received ROZLYTREK, increased AST of any grade occurred in 42% of patients and increased ALT of any grade occurred in 36%. Grade 3–4 increased AST or ALT occurred in 2.5% and 2.8% of patients, respectively; the incidence may be underestimated as 4.5% of patients had no post-treatment liver function tests. Median time to onset of increased AST was 2 weeks (range: 1 day to 29.5 months). Median time to onset of increased ALT was 2 weeks (range: 1 day to 9.2 months). Increased AST or ALT leading to dose interruptions or reductions occurred in 0.8% and 0.8% of patients, respectively. ROZLYTREK was discontinued due to increased AST or ALT in 0.8% of patients
  • Monitor liver tests, including ALT and AST, every 2 weeks during the first month of treatment, then monthly thereafter and as clinically indicated. Withhold or permanently discontinue ROZLYTREK based on the severity. If withheld, resume ROZLYTREK at the same or reduced dose

Hyperuricemia

  • Among 355 patients who received ROZLYTREK across clinical trials, 32 patients (9%) experienced hyperuricemia reported as adverse reactions with symptoms, as well as elevated uric acid levels. Grade 4 hyperuricemia occurred in 1.7% of patients, including one patient who died due to tumor lysis syndrome. Among the 32 patients with hyperuricemic adverse reactions, 34% required urate-lowering medication to reduce uric acid levels, 6% required dose reduction, and 6% required dose interruption. Hyperuricemia resolved in 73% of patients following initiation of urate-lowering medication without interruption or dose reduction of ROZLYTREK. No patients discontinued ROZLYTREK due to hyperuricemia
  • Assess serum uric acid levels prior to initiating ROZLYTREK and periodically during treatment. Monitor patients for signs and symptoms of hyperuricemia. Initiate treatment with urate-lowering medications as clinically indicated and withhold ROZLYTREK for signs and symptoms of hyperuricemia. Resume ROZLYTREK at same or reduced dose upon improvement of signs or symptoms based on severity

QT Interval Prolongation

  • Among the 355 patients who received ROZLYTREK across the clinical trials, 3.1% of patients with at least one post-baseline ECG assessment experienced QTcF interval prolongation of >60 ms after starting ROZLYTREK and 0.6% had a QTcF interval >500 ms
  • Monitor patients who already have or who are at significant risk of developing QTc interval prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure, and those taking other medicinal products associated with QT prolongation. Assess QT interval and electrolytes at baseline and periodically during treatment, adjusting frequency based upon risk factors such as congestive heart failure, electrolyte abnormalities, or concomitant medications known to prolong the QTc interval. Based on the severity of QTc interval prolongation, withhold ROZLYTREK and then resume at same or reduced dose, or permanently discontinue

Vision Disorders

  • Among the 355 patients who received ROZLYTREK across clinical trials, vision changes occurred in 21% of patients, including Grade 1 (17%), Grade 2 (2.8%), and Grade 3 (0.8%). Vision disorders occurring in ≥1% included blurred vision (9%), photophobia (5%), diplopia (3.1%), visual impairment (2%), photopsia (1.1%), cataract (1.1%), and vitreous floaters (1.1%)
  • For patients with new visual changes or changes that interfere with activities of daily living, withhold ROZLYTREK until improvement or stabilization and conduct an ophthalmological evaluation as clinically appropriate. Upon improvement or stabilization, resume ROZLYTREK at same or reduced dose

Embryo-Fetal Toxicity

  • Based on literature reports in humans with congenital mutations leading to changes in TRK signaling, findings from animal studies, and its mechanism of action, ROZLYTREK can cause fetal harm when administered to a pregnant woman. Administration of entrectinib to pregnant rats resulted in malformations at exposures approximately 2.7 times the human exposure at the 600 mg dose based on area under the curve (AUC)
  • Advise pregnant women of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with ROZLYTREK and for 5 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ROZLYTREK and for 3 months after the final dose

Most Common Adverse Reactions

  • The most common adverse reactions (≥20%) were fatigue (48%), constipation (46%), dysgeusia (44%), edema (40%), dizziness (38%), diarrhea (35%), nausea (34%), dysesthesia (34%), dyspnea (30%), myalgia (28%), cognitive impairment (27%), increased weight (25%), cough (24%), vomiting (24%), pyrexia (21%), arthralgia (21%), and vision disorders (21%)

DRUG INTERACTIONS

Effect of Other Drugs on ROZLYTREK

Moderate and Strong CYP3A Inhibitors

  • Adults and Pediatric Patients 12 Years and Older with BSA >1.50 m2. Coadministration of ROZLYTREK with a strong or moderate CYP3A inhibitor increases entrectinib plasma concentrations, which could increase the frequency or severity of adverse reactions. Avoid coadministration of strong or moderate CYP3A inhibitors
  • Pediatric Patients 12 Years and Older with BSA ≤1.50 m2. Avoid coadministration of ROZLYTREK with moderate or strong CYP3A inhibitors
  • Avoid grapefruit products during treatment with ROZLYTREK, as they contain inhibitors of CYP3A

Moderate and Strong CYP3A Inducers

  • Coadministration of ROZLYTREK with a strong or moderate CYP3A inducer decreases entrectinib plasma concentrations, which may reduce ROZLYTREK efficacy. Avoid coadministration of strong and moderate CYP3A inducers with ROZLYTREK

Drugs That Prolong QT Interval

  • QTc interval prolongation can occur with ROZLYTREK. Avoid coadministration of ROZLYTREK with other products with a known potential to prolong QT/QTc interval

ADDITIONAL IMPORTANT SAFETY INFORMATION

Lactation
Risk Summary

  • Because of the potential adverse reactions in breastfed children from ROZLYTREK, advise a lactating woman to discontinue breastfeeding during treatment with ROZLYTREK and for 7 days after the final dose

Pediatric Use

  • There is limited clinical experience with ROZLYTREK in pediatric patients. The safety of ROZLYTREK in pediatric patients 12 years of age and older was established based on extrapolation of data in adults and data from 30 pediatric patients enrolled in STARTRK-NG. Of these 30 patients, 7% were <2 years (n=2), 77% were 2 to <12 years (n=23), 17% were 12 to <18 years (n=5); 57% had metastatic disease (n=17), 44% had locally advanced disease (n=13), and all patients had received prior treatment for their cancer, including surgery, radiotherapy, or systemic therapy. The most common cancers were neuroblastoma (47%), primary CNS tumors (30%), and sarcoma (10%). The median duration of exposure for all pediatric patients was 4.2 months (range: 0.2 to 22.7 months)
  • Due to the small number of pediatric and adult patients, the single arm design of clinical studies of ROZLYTREK, and confounding factors such as differences in susceptibility to infections between pediatric and adult patients, it is not possible to determine whether the observed differences in the incidence of adverse reactions to ROZLYTREK are related to patient age or other factors. The Grade 3 or 4 adverse reactions and laboratory abnormalities that occurred more frequently (≥5%) in pediatric patients (n=30) compared with adults (n=338) were neutropenia (27% vs 2%), bone fractures (23% vs 5%), increased weight (20% vs 7%), thrombocytopenia (10% vs 0.3%), lymphopenia (7% vs 1%), increased gamma-glutamyl transferase (7% vs 0%), and device-related infection (7% vs 0.3%). Three pediatric patients discontinued ROZLYTREK due to an adverse reaction (Grade 4 pulmonary edema, Grade 3 dyspnea, and Grade 4 pancreatitis)
  • The safety and effectiveness of ROZLYTREK in pediatric patients <12 years of age with solid tumors who have an NTRK gene fusion have not been established
  • The safety and effectiveness of ROZLYTREK in pediatric patients with ROS1-positive NSCLC have not been established

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 additional Important Safety Information in the full Prescribing Information.

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