For Patients

Financial Frequently Asked Questions (FAQs)

Get answers to common questions about support and resources from Genentech for patients who have been prescribed GAVRETO.

Finding support FAQs

Regardless of the type of health insurance your patients have – and even if they don't have any – there may be options available to help them afford GAVRETO. 

Get details on potential programs.

You can check patient eligibility online. The financial assistance tool will guide the patient through some of their options and let them know which financial support programs may be right for them.

Here are a few things you or your patient may need on hand:

  • Patient information: full name, date of birth, mailing address, email, phone (home and/or mobile) and insurance information
  • Prescribing doctor's information: complete contact information, primary diagnosis code and prescription details
  • Patient's financial eligibility information: number of people in the patient's household (including patient) and annual net household income
Get started

Each program has its own time period in which eligible patients will receive assistance.

GAVRETO Access Solutions may be able to help patients understand how to get the medicine they need. GAVRETO Access Solutions can find out:

  • If the health insurance plan covers the GAVRETO medicine
  • How much the co-pay will be

Even with health insurance, there may be concerns about the cost of treatment. GAVRETO Access Solutions can refer patients to financial assistance options.

To learn more about potential financial assistance options, visit the Financial Assistance Options page.

Patients facing a coverage delay may be eligible for the SureStart Program while awaiting insurance verification. If you would like your patient considered for the SureStart Program, you can indicate that when enrolling in GAVRETO Access Solutions with the Prescriber Service Form. You will also need to have your patient complete the Patient Consent Form.

Eligible patients can receive a a 30-day supply of GAVRETO. Once coverage has been determined, the patient no longer qualifies for the SureStart Program.

Subject to eligibility requirements and terms and conditions. This program is void where prohibited by law and may not be used in or by residents of restricted states, if applicable.

View full TERMS AND CONDITIONS.

Contact Us

Questions? Contact GAVRETO Access Solutions

Call 888-249-4918 (Mon.–Fri., 6AM–5PM PST)

Insurance coverage FAQs

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

Review some of the potential options and get started.

GAVRETO Access Solutions is your resource for access and reimbursement support after GAVRETO is prescribed. You can:

No. If the patient's health insurance plan denied coverage for GAVRETO (after submission of a Prior Authorization, if required), the patient can apply for help from the Genentech Patient Foundation. The patient does not need to send proof of the appeal to get help.

Learn more about the Genentech Patient Foundation, including eligibility criteria and how to apply.

GAVRETO Access Solutions can help your patients better understand their coverage, find financial assistance options, learn how to get GAVRETO, understand which specialty pharmacy their health insurance plan requires, reverify coverage if needed and enroll in additional support options in the event of a coverage delay.

Important Safety Information & Indications

INDICATIONS

GAVRETO® (pralsetinib) is indicated for the treatment of:

  • Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
  • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Interstitial Lung Disease (ILD)/Pneumonitis occurred in 10% of patients who received GAVRETO, including 2.7% with Grade 3/4, and 0.5% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD.

Hypertension occurred in 29% of patients, including Grade 3 hypertension in 14% of patients. Overall, 7% had their dose interrupted and 3.2% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity.

Hepatotoxicity: Serious hepatic adverse reactions occurred in 2.1% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 69% of patients, including Grade 3/4 in 5% and increased alanine aminotransferase (ALT) occurred in 46% of patients, including Grade 3/4 in 6%. The median time to first onset for increased AST was 15 days (range: 5 days to 1.5 years) and increased ALT was 22 days (range: 7 days to 1.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity.

Grade ≥ 3 hemorrhagic events occurred in 2.5% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage.

Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated.

Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established.

Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the final dose. Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the final dose.

Common adverse reactions (≥25%) were constipation, hypertension, fatigue, musculoskeletal pain and diarrhea. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased calcium (corrected), decreased sodium, increased AST, increased ALT, decreased platelets and increased alkaline phosphatase.

Avoid coadministration of GAVRETO with strong CYP3A inhibitors or combined P-gp and strong CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose.

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 click here to see the full Prescribing Information for GAVRETO.