Assistance options for your eligible patients

Several options are available to help eligible patients with the out-of-pocket (OOP) costs of GAVRETO® (pralsetinib).

Find out if your patients could be eligible using the Patient Assistance Tool.

  • Is your patient insured?

  • Does the patient's insurance cover his or her GAVRETO?

  • Does your patient have commercial insurance?

  • Has your patient already been referred to the Genentech Oncology Co-pay Assistance Program and is either ineligible or no longer receiving assistance?

  • Has your patient already been referred to an independent co-pay assistance foundation and is either ineligible or no longer receiving assistance?

  • Is the patient 18 years of age or older?

Your Patient Might Qualify for a Referral to the Genentech Oncology Co-pay Assistance Program

If eligible commercially insured patients need assistance with their out-of-pocket costs for GAVRETO, GAVRETO Access Solutions can refer them to the Genentech Oncology Co-pay Assistance Program.*

 

Learn More

 

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and or administration of their Genentech medication. Patient must be taking the Genentech medication for an FDA-approved indication. See full Terms and Conditions at CopayAssistanceNow.com.

Your Patient Might Qualify for a Referral to an Independent Co-pay Assistance Foundation

For eligible patients with commercial or public health insurance, GAVRETO Access Solutions offers referrals to independent co-pay assistance foundations.*

 

Learn More

 

*Advise your patient that these organizations are independent of Genentech or Blueprint Medicines and may require the patient to provide personal or financial information directly to the organization to enroll in their respective programs. Genentech and Blueprint Medicines 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.

Your Patient Might Qualify for a Referral to the Genentech Patient Foundation

The Genentech Patient Foundation provides free Genentech medicine to people who don't have insurance coverage or who have financial concerns and meet eligibility criteria.*

 

Learn More

 

*To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet a different set of income requirements.

Out of Pocket icon

Does Your Patient Have Commercial Insurance?

GAVRETO® Access Solutions can refer eligible patients to the Genentech Oncology Co-pay Assistance Program for help with the out-of-pocket costs associated with GAVRETO.*

Patient assistance services icon

Does Your Patient Have Insurance?

If eligible publicly or commercially insured patients have difficulty paying for their co-pay, co-insurance or other OOP costs, GAVRETO Access Solutions can refer them to an independent co-pay assistance foundation supporting their disease state.†

Genentect Patient Foundation icon

Does Your Patient Have No Insurance or Insurance Coverage, or High Out-of-Pocket Costs?

The Genentech Patient Foundation gives free Genentech medicine to people who don’t have insurance coverage or who have financial concerns and meet eligibility criteria.‡

Patient Coverage icon

Is Your Patient Awaiting Coverage Determination?

With the GAVRETO SureStart® Program, eligible patients taking GAVRETO may receive free medicine while awaiting an insurance coverage determination.

*Eligibility criteria apply. Not valid for patients using federal or state government programs to pay for their medications and/or administration of their Genentech medication. Patient must be taking the Genentech medication for an FDA-approved indication. See full Terms and Conditions at CopayAssistanceNow.com.
†Genentech and Blueprint Medicines do not influence or control the operations or eligibility criteria of any independent co-pay assistance foundation and cannot guarantee co-pay assistance after a referral from GAVRETO Access Solutions. The foundations to which we refer patients are not exhaustive or indicative of Genentech’s endorsement or financial support. There may be other foundations to support the patient's disease state.
‡To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine should try to pursue other forms of financial assistance, if available, and meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet a different set of income requirements.

GAVRETO Access Solutions provides reliable, effective access and reimbursement support to assist your patients and practice after GAVRETO is prescribed.

Learn how we help.

Determine which patient assistance option is right for your patient with the Patient Assistance Tool.

To enroll in Genentech patient support services, patients always complete the Patient Consent Form. Prescribers choose a form based on the specific patient needs: 

Each option has its own time period where your eligible patients will receive assistance. You can call us at (877) 436-3683 for more information.

To learn more about our programs and services:

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.

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      Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.3.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 18, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.

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