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.
The GAVRETO SureStart Program provides eligible patients who have experienced an insurance coverage delay of 30 days with one free 30-day supply of GAVRETO. If a coverage delay persists, a patient may be eligible for one 30-day refill of GAVRETO. There is no obligation to purchase any future product and receipt of free product is not contingent on any future purchase. Requests for the GAVRETO SureStart Program cannot be processed without a completed and signed 1) GAVRETO Prescriber Service Form and 2) Patient Consent Form. Patients must be prescribed GAVRETO for an FDA-approved indication. Neither the prescriber, the pharmacy, nor any patient receiving free product via the GAVRETO SureStart Program may seek reimbursement or credit for any part of the benefit received by the patient through this offer from any insurer, health plan, or government program.
The GAVRETO SureStart Program cannot be counted towards any out-of-pocket costs under any plan (such as true out-of-pocket cost under a Medicare Part D prescription drug plan). The GAVRETO SureStart Program enrollment team may notify the patient’s insurer that the patient is receiving a free supply of product from the program. Prescribers may not advertise or otherwise use the program as a means of promoting their services or Genentech’s products to patients. This program is void where prohibited by law and may not be used in or by residents of restricted states, where applicable. The free supply may not be sold, purchased or traded or offered for sale, purchase or trade. This program is not a benefit plan. Genentech reserves the right to rescind, revoke or amend the program without notice at any time.
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.
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.
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
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.