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First-line Advanced RCC
Overview
Efficacy Measures: OS, PFS, & ORR
Safety & Tolerability Profile
Dosing
Therapy Management Strategies
MOAs – INLYTA and pembrolizumab
NCCN Recommendation
Publications
Health Care Provider Videos
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Second-line Advanced RCC
Overview
Efficacy Measures: PFS, ORR, OS, & Subset
Analyses
Safety & Tolerability Profile
Patient Characteristics & Treatment
Considerations
Oral Dosing
VEGFR Pathway & INLYTA® (axitinib) MOA
NCCN Recommendation
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Pfizer Oncology Together
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Events
Materials
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Patient Financial Support & Resources
Making your patients’ support needs a priority. Together.
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At Pfizer Oncology Together™, patient support is at the core of everything we do. We’ve gathered resources and developed tools to help patients and their loved ones throughout INLYTA® (axitinib) treatment. From helping to identify financial assistance options to connecting patients to resources for emotional support, your patients’ needs are our priority.
Patient Financial Assistance
Pfizer Oncology Together can help patients understand their insurance benefits and connect them with financial assistance resources, regardless of their insurance coverage.
COMMERCIALLY INSURED
Resources for eligible patients with commercial, private, employer, and state health insurance marketplace coverage:
Co-pay assistance: Eligible, commercially insured patients may pay as little as $0 per month for INLYTA. Limits, terms, and conditions apply*
For more information, see your Pfizer Oncology representative or visit PfizerOncologyTogether.com.
*Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico. Patients may receive up to $25,000 per product in savings annually. The offer will be accepted only at participating pharmacies. This offer is not health insurance. No membership fees apply. Pfizer reserves the right to rescind, revoke, or amend this offer without notice. For full Terms and Conditions, please see PfizerOncologyTogether.com/terms. For any questions, please call 1-877-744-5675, visit PfizerOncologyTogether.com/terms or write: Pfizer Oncology Together Co-Pay Savings Program, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560.
MEDICARE/GOVERNMENT INSURED
Help identifying resources for eligible patients with Medicare/Medicare Part D, Medicaid, and other government insurance plans:
- Assistance for patients with searching for financial support that may be available from independent charitable foundations. These foundations exist independently of Pfizer and have their own eligibility criteria and application processes. Availability of support from the foundations is determined solely by the foundations
- Financial assistance through Extra Help, a Medicare Part D Low-Income Subsidy (LIS) program
- Free medication†
UNINSURED
Help identifying resources for eligible patients without any form of healthcare coverage:
- Help finding coverage
- Free medication through the Pfizer Patient Assistance Program, or at a savings through the Pfizer Savings Program‡
†If support from independent charitable foundations or Medicare Extra Help is not available, Pfizer Oncology Together will provide eligible patients with medication for free through the Pfizer Patient Assistance Program. The Pfizer Patient Assistance Program is a joint program of Pfizer Inc. and the Pfizer Patient Assistance Foundation™. The Pfizer Patient Assistance Foundation is a separate legal entity from Pfizer Inc. with distinct legal restrictions.
‡The Pfizer Savings Program is not health insurance. For more information, call the toll-free number 1-877-744-5675. There are no membership fees to participate in this program. Estimated savings are 50% and depend on such factors as the particular drug purchased, amount purchased, and the pharmacy where purchased.
NEED INLYTA STARTER SAMPLES?
CONTACT YOUR PFIZER SALES REPRESENTATIVE
Access & Reimbursement Support
If patients prescribed INLYTA need access or reimbursement support, Pfizer Oncology Together is here to help with:
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Benefits verification:
We can help determine a patient’s coverage and out-of-pocket costs -
Prior authorization (PA) assistance:
We can coordinate with a patient’s insurer to determine the PA requirements. After your office submits a PA request, we’ll follow up with the payer until a final outcome is determined -
Appeals assistance:
We can review the reasons for a denied claim and provide information on payer requirements. After your office submits an appeal, we’ll follow up with the payer until a final outcome is determined -
Specialty pharmacy coordination:
To help your patients access the medication you’ve prescribed, we can identify specialty pharmacy options. If you prefer, you and your staff can also continue to work directly with specialty pharmacies -
Dedicated local support:
Pfizer Oncology Account Specialists can provide detailed information on Pfizer Oncology medications and access resources. In addition, they can help you and your office staff contact a Pfizer Oncology Field Reimbursement Manager (FRM) in your area
FRMs are trained to help address specific access issues—in person or over the phone. They can help educate your staff on our access and reimbursement resources and help address challenging or urgent Pfizer Oncology patient cases you have sent to Pfizer Oncology Together.
Personalized Patient Support
When your patients need support for their day-to-day challenges, we want to be a place they can turn to for help. At Pfizer Oncology Together, our Care Champions, who have social work experience, can connect patients prescribed INLYTA to resources that may help with some of their daily needs.§
- Emotional Support We can connect patients to diagnosis-specific support groups, an independent organization that offers short-term counseling, and a free app, developed by Pfizer Oncology, to help patients connect with loved ones and ask for the support they need
- Educational Support To help support patients’ overall health and well-being, we’ve created resources about physical and mental health, as well as nutritional tips and healthy recipes developed in partnership with dietitians who specialize in oncology nutrition. We can also provide patients with information to help them understand their prescribed INLYTA
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Practical Support If patients need assistance with transportation or lodging for treatment-related appointments, we’ll connect them to independent organizations that offer these services for free to qualifying patients
And if your patients are leaving work for a period of time during treatment, or preparing to return to work, we can send them information to help make the transition easier.
For live, personalized support
Call 1-877-744-5675 (Monday-Friday 8 AM-8 PM ET)
§Some services are provided through third-party organizations that operate independently and are not controlled by Pfizer. Availability of services and eligibility requirements are determined solely by these organizations.
Pfizer Oncology Together Co-Pay Savings Program
Terms and Conditions
By using this co-pay card, you acknowledge that you currently meet the eligibility criteria and will comply with the Terms and Conditions described below:
- Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
- Patient must have private insurance. Offer is not valid for cash-paying patients.
- With this card, eligible patients will pay a $0 co-pay per eligible monthly prescription, subject to a maximum amount of $25,000 per product per calendar year. The amount of any benefit is the difference between your co-pay and $0. After the annual maximum of $25,000 per product is reached, you will be responsible for the remaining monthly out-of-pocket costs. This card may not be redeemed more than once per 30 days.
- This co-pay card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
- You must deduct the value of this co-pay card from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf.
- You are responsible for reporting use of the co-pay card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the co-pay card, as may be required. You should not use the co-pay card if your insurer or health plan prohibits use of manufacturer co-pay cards.
- This co-pay card is not valid where prohibited by law.
- Card cannot be combined with any other savings, free trial, or similar offer for the specified prescription.
- Card will be accepted only at participating pharmacies.
- This card is not health insurance.
- Offer good only in the U.S. and Puerto Rico.
- Card is limited to 1 per person during this offering period and is not transferable.
- No other purchase is necessary.
- Data related to your redemption of the co-pay card may be collected, analyzed, and shared with Pfizer for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other co-pay card redemptions and will not identify you.
- Pfizer reserves the right to rescind, revoke, or amend this offer without notice.
- Offer expires 12/31/2022.
- If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer. Mail a copy of the patient’s pharmacy receipt indicating patient name, name of medication purchased, price paid, and date purchased, along with a copy of the patient’s Pfizer Oncology Together Co-Pay Savings Card, to:
Pfizer Oncology Together Co-Pay Savings Program
2250 Perimeter Park Drive, Suite 300
Morrisville, NC 27560
BAVENCIO is a registered trademark of Merck KGaA, Darmstadt, Germany. All other trademarks are property of their respective owners.
Patient Support and Resources
- Pfizer Oncology Together
Vouchers Events Materials Videos
Arterial and venous thrombotic events have been observed and can be fatal. Use with caution in patients who are at increased risk for, or who have a history of, these events.
Hemorrhagic events, including fatal events, have been reported. INLYTA has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. If any bleeding requires medical intervention, temporarily interrupt the INLYTA dose.
Cardiac failure has been observed and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with INLYTA. Management of cardiac failure may require permanent discontinuation of INLYTA.
Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula. Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment.
Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiation of, and periodically throughout, treatment.
INLYTA has the potential to adversely affect wound healing. Withhold INLYTA for at least 2 days prior to elective surgery. Do not administer INLYTA for at least 2 weeks following major surgery and until adequate wound healing. The safety of resuming INLYTA after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed. If signs or symptoms occur, permanently discontinue treatment.
Monitor for proteinuria before initiation of, and periodically throughout, treatment. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with INLYTA.
Liver enzyme elevation has occurred during treatment with INLYTA as a single agent. INLYTA in combination with pembrolizumab can cause hepatotoxicity with higher than expected frequencies of Grades 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Monitor ALT, AST, and bilirubin before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used for monotherapy. Consider withholding INLYTA and/or pembrolizumab, initiating corticosteroid therapy, and/or permanently discontinuing the combination for severe or life-threatening hepatotoxicity.
For patients with moderate hepatic impairment, the starting dose of INLYTA should be decreased. INLYTA has not been studied in patients with severe hepatic impairment.
INLYTA can cause fetal harm. Advise patients of the potential risk to the fetus and to use effective contraception. When INLYTA is used in combination with pembrolizumab, refer to the full Prescribing Information of pembrolizumab for pregnancy and contraception information.
Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose of INLYTA. Grapefruit or grapefruit juice may also increase INLYTA plasma concentrations and should be avoided.
Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate CYP3A4/5 inducers.
Fatal adverse reactions (ARs) occurred in 3.3% of patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC. These included 3 cases of cardiac arrest, 2 cases of pulmonary embolism, and 1 case each of cardiac failure, death due to unknown cause, myasthenia gravis, myocarditis, Fournier’s gangrene, plasma cell myeloma, pleural effusion, pneumonitis, and respiratory failure.
The most common (≥20%) ARs (all grades, vs sunitinib) occurring in patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC were diarrhea (56% vs 45%), fatigue/asthenia (52% vs 51%), hypertension (48% vs 48%), hepatotoxicity (39% vs 25%), nausea (28% vs 32%), constipation (21% vs 15%), hypothyroidism (35% vs 32%), decreased appetite (30% vs 29%), palmar-plantar erythrodysesthesia (28% vs 40%), stomatitis/mucosal inflammation (27% vs 41%), rash (25% vs 21%), dysphonia (25% vs 3.3%), and cough (21% vs 14%).
The most common (≥20%) Grade 3/4 ARs (vs sunitinib) occurring in patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC were hypertension (24% vs 20%) and hepatotoxicity (20% vs 4.9%).
The most common (≥20%) lab abnormalities (all grades, vs sunitinib) occurring in patients receiving INLYTA in combination with pembrolizumab as first-line treatment for advanced RCC included hyperglycemia (62% vs 54%), increased ALT (60% vs 44%), increased AST (57% vs 56%), increased creatinine (43% vs 40%), hyponatremia (35% vs 29%), hyperkalemia (34% vs 22%), hypoalbuminemia (32% vs 34%), hypercalcemia (27% vs 15%), hypophosphatemia (26% vs 49%), increased alkaline phosphatase (26% vs 30%), hypocalcemia (22% vs 29%), increased blood bilirubin (22% vs 21%), prolonged activated partial thromboplastin time (22% vs 14%), lymphopenia (33% vs 46%), anemia (29% vs 65%), and thrombocytopenia (27% vs 78%).
The most common (≥20%) ARs (all grades, vs sorafenib) in patients receiving INLYTA as second-line treatment for advanced RCC were diarrhea (55% vs 53%), hypertension (40% vs 29%), fatigue (39% vs 32%), decreased appetite (34% vs 29%), nausea (32% vs 22%), dysphonia (31% vs 14%), palmar-plantar erythrodysesthesia syndrome (27% vs 51%), weight decreased (25% vs 21%), vomiting (24% vs 17%), asthenia (21% vs 14%), and constipation (20% vs 20%).
The most common (≥10%) Grade 3/4 ARs (vs sorafenib) occurring in patients receiving INLYTA as second-line treatment for advanced RCC were hypertension (16% vs 11%), diarrhea (11% vs 7%), and fatigue (11% vs 5%).
The most common (≥20%) lab abnormalities (all grades, vs sorafenib) occurring in patients receiving INLYTA as second-line treatment for advanced RCC included increased creatinine (55% vs 41%), decreased bicarbonate (44% vs 43%), hypocalcemia (39% vs 59%), decreased hemoglobin (35% vs 52%), decreased lymphocytes (absolute) (33% vs 36%), increased ALP (30% vs 34%), hyperglycemia (28% vs 23%), increased lipase (27% vs 46%), increased amylase (25% vs 33%), increased ALT (22% vs 22%), and increased AST (20% vs 25%).
INLYTA® (axitinib) in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
INDICATIONS
INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.
Please see full Prescribing Information.
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