VENCLEXTA PATIENT SUPPORT SERVICES

Transcription

1 VENCLEXTA PATIENT SUPPORT SERVICES Models shown are not actual patients or health care professionals. Indication VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. a This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Select Important Safety Information Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during ramp-up is contraindicated. Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in previously treated CLL patients with high tumor burden when treated with VENCLEXTA. Patients should be assessed for TLS risk, including evaluation of tumor burden and comorbidities, and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricemics. Reduced renal function (CrCl <80 ml/min) further increases the risk. Monitor blood chemistries and manage abnormalities promptly. Employ more intensive measures (IV hydration, frequent monitoring, hospitalization) as overall risk increases. Avoid concomitant use of moderate CYP3A inhibitors or P-gp inhibitors. Concomitant use with strong or moderate CYP3A inhibitors and P-gp inhibitors may increase the risk of TLS at initiation and during ramp-up, and may require dose adjustment due to increases in VENCLEXTA exposure. Grade 3 or 4 neutropenia occurred in patients treated with VENCLEXTA. Do not administer live attenuated vaccines prior to, during, or after treatment until B-cell recovery occurs. VENCLEXTA may cause embryo-fetal harm. Advise females of reproductive potential to avoid pregnancy during treatment. Please see Important Safety Information on pages

2 WELCOME AbbVie and Genentech are dedicated to providing VENCLEXTA TM support to patients who qualify. The programs described in this brochure are intended to support patients as they begin treatment and throughout their time on therapy. 2 Please see Important Safety Information on pages

3 TABLE OF CONTENTS BioOncology Co-pay Card for VENCLEXTA Helps qualified commercially insured patients with out-of-pocket costs. The VENCLEXTA SureStart Program Provides VENCLEXTA while eligible patients await coverage decisions. Dedicated VENCLEXTA support from oncology nurses. Coordinates access and reimbursement services. How VENCLEXTA is supplied How and where to get VENCLEXTA. 3

4 BIOONCOLOGY CO-PAY CARD FOR VENCLEXTA The BioOncology Co-pay Card for VENCLEXTA can help qualified commercially insured patients with the out-of-pocket costs associated with their VENCLEXTA prescription. Out-of-pocket costs include co-pays and co-insurance. WHICH PATIENTS ARE ELIGIBLE?* Eligible Covered by commercial or private insurance Treatment is consistent with the FDA-approved use of VENCLEXTA Age 18 years or older Live and receive treatment in US or Puerto Rico Not eligible Participating in Medicare, Medicaid, Medigap, VA, DoD, TRICARE, or any other state or federal government-funded health plan Uninsured or currently participating in Genentech Access to Care Foundation (GATCF) HOW IT WORKS Each patient pays a $5 co-pay per prescription No income requirements Annual benefit limit of co-pay card is $25,000 Physician or patient newly prescribed VENCLEXTA must request benefit within 120 days of receiving the product for new program participants No physical card needed; patients simply need their ID code Patient eligibility must be re-verified every 12 months *Other eligibility criteria and requirements may apply. If you want to enroll your patients or have any questions, call (855) MY-COPAY/(855) from 9 AM to 8 PM ET, Monday through Friday, or visit 4 Please see Important Safety Information on pages

5 THE VENCLEXTA SURESTART PROGRAM If your patient faces a coverage delay, the VENCLEXTA SureStart Program can help your patient start his or her VENCLEXTA therapy while waiting for a coverage decision. Co-pay and SureStart ELIGIBILITY CRITERIA Eligible Not eligible Prescribed VENCLEXTA tablets for a labeled indication No initial prior authorization (PA) or coverage decision for VENCLEXTA received within 5 business days Uninsured HOW IT WORKS Shipments begin after there has been a delay in coverage decision for VENCLEXTA Shipments can continue for up to 90 days for clinically appropriate patients if a coverage decision is still pending Once coverage has been determined, the patient no longer qualifies for VENCLEXTA SureStart Program Other eligibility criteria and requirements may apply. To get started, submit the completed Statement of Medical Necessity (SMN) and Patient Authorization and Notice of Release of Information (PAN) to Access Solutions. These forms can be downloaded at 5

6 Providing support for patients taking VENCLEXTATM This program is intended to support your patients taking VENCLEXTA for an approved use during the ramp-up phase and throughout their therapy. VENCOMPASS Nurses have experience in cancer care and are dedicated to Helping patients throughout their treatment journey with VENCLEXTA Communicating with your patients about VENCLEXTA Informing you when your patients enroll in the program Patients will be matched with a dedicated VENCOMPASS Nurse VENCOMPASS is not intended to replace your medical advice. All information to be provided will be based on full Prescribing Information and Medication Guide. 6 Please see Important Safety Information on pages

7 VENCOMPASS Nurses can provide support through Weekly laboratory reminders Hydration reminders Recognizing potential treatment issues Answering productspecific questions VENCOMPASS Dosing reminders Directing patients to organizations that can provide additional support Frequency of calls is determined based on your patient s preference Please visit or call (844) 9-COMPASS/(844) for more information. 7

8 VENCOMPASS Nurse assistance, education, and support Welcome call Once enrolled, a VENCOMPASS Nurse will reach out to your patient. During this call, the VENCOMPASS Nurse will Understand your patient s needs regarding VENCLEXTA TM therapy using the full Prescribing Information and Medication Guide Understand your patient s questions about CLL Review next steps in their VENCLEXTA therapy After the call, a VENCOMPASS welcome letter will be sent to your patients, and a patient enrollment notification will be sent to your office. Initiating treatment A VENCOMPASS Nurse calls your patient prior to his or her first dose of VENCLEXTA. During this call, the VENCOMPASS Nurse will Follow up on delivery of VENCLEXTA to patient home or site of care Review the ramp-up dosing protocol and remind your patient to reach out to you prior to initiating his or her therapy Customize your patient s calls to meet his or her preferences and schedule VENCOMPASS Nurses provide product information and support based upon patient needs. All information to be provided will be based on full Prescribing Information and Medication Guide. 8 Please see Important Safety Information on pages

9 Dose ramp-up calls The VENCOMPASS Nurse will perform check-in and reminder calls, as requested by your patient, during the 5-week ramp-up period. During these calls, the VENCOMPASS Nurse will Remind your patients about doctor and laboratory appointments Remind your patient about the importance of hydration during this phase of treatment Pre-schedule check-in calls Commitment to therapy With the patient s permission, the VENCOMPASS Nurse will continue to provide VENCLEXTA support to your patient. During these calls, the VENCOMPASS Nurse will Discuss topics such as Dosing Refill reminders Importance of taking VENCLEXTA exactly as prescribed Product-related questions Communicate with your patient as a resource at a frequency specified by the patient Provide VENCLEXTA support to your patient using the full Prescribing Information and Medication Guide Customize and schedule your patient s calls to meet his or her preferences Please visit or call (844) 9-COMPASS/(844) for more information. 9

10 VENCLEXTA Access Solutions provides reliable, effective access and reimbursement services to assist your patients and practice. We can help you address the needs of each patient s coverage scenario: Full benefits investigations (BIs) Guidance with denials and appeals Prior authorization (PA) support Referrals to patient assistance services Sample billing and coding information To get started, submit the completed SMN and PAN. These forms can be downloaded at To learn more about our programs and services, visit or call (888) Please see Important Safety Information on pages

11 Committed to patient access, regardless of their ability to pay Patient assistance is available for eligible patients with commercial insurance, public insurance, or no insurance. VENCLEXTA Access Solutions offers the following options to help patients with their out-of-pocket costs. Each has its own eligibility criteria that must be met for patients to receive assistance. COMMERCIALLY INSURED PATIENTS PUBLICLY INSURED PATIENTS UNINSURED PATIENTS VENCLEXTA ACCESS SOLUTIONS REFERRALS TO PATIENT ASSISTANCE SERVICES REFERRALS TO CO-PAY ASSISTANCE FOUNDATIONS* THE GENENTECH ACCESS TO CARE FOUNDATION (GATCF) Referrals to co-pay assistance foundations* VENCLEXTA Access Solutions If commercially or publicly insured patients have difficulty paying for their medicine s co-pay, co-insurance, or other out-of-pocket costs, Access Solutions can refer eligible patients to a co-pay assistance foundation supporting their disease state. Visit to see an updated list of co-pay assistance foundations with available funding. The Genentech Access to Care Foundation (GATCF) GATCF provides free medicine to eligible patients who are uninsured, rendered uninsured by payer denial, or underinsured. To qualify, patients must meet specific financial and medical criteria. * AbbVie and Genentech do not influence or control the operations of these co-pay assistance foundations, but Access Solutions can make an appropriate referral to assist patients seeking co-pay assistance. We cannot guarantee co-pay assistance once a patient has been referred by Access Solutions. The foundations to which we refer patients each have their own criteria for patient eligibility, including financial eligibility. To be eligible for free medicine from GATCF, insured patients must have exhausted all other forms of patient assistance (including brand-specific co-pay cards and support from co-pay assistance foundations supporting the patient s disease state) and meet additional financial and medical criteria. 11

12 HOW VENCLEXTATM IS SUPPLIED To order any of the below, please contact one of the specialty pharmacies (SP) or distributors listed on the following page STANDARD SUPPLY The starting pack provides the first 4 weeks of VENCLEXTA according to the ramp-up schedule. NDC # The recommended daily dose of 400 mg is supplied as 100-mg tablets (qty 120). 100-mg bottle: NDC # mg and 50-mg wallets are available if dose holds should occur. 10-mg wallet: NDC # mg wallet: NDC # Unit doses. 10-mg unit dose (x2): NDC # mg unit dose: NDC # mg unit dose: NDC # Please see Important Safety Information on pages

13 SPECIALTY PHARMACIES AND DISTRIBUTORS The following network of SPs and distributors are authorized to dispense VENCLEXTA. This network will assist providers and patients in obtaining VENCLEXTA. SPs may be able to provide services such as prior authorization assistance and identifying co-pay support options for eligible patients. Avella Specialty Pharmacy Website: Phone: (877) Fax: (877) Biologics Website: Phone: (800) Fax: (800) Diplomat Specialty Pharmacy Website: Phone: (877) Fax: (800) SPECIALTY PHARMACIES Onco360 Website: Phone: (877) Fax: (877) SPECIALTY DISTRIBUTORS McKesson Specialty Health Website: Phone, Oncology: (800) Phone, Multispecialty: (855) Fax: (800) Oncology Supply Website: Phone: (800) Fax: (800) ASD Healthcare Website: Phone: (800) Fax: (800) McKesson Plasma & Biologics Website: Phone: (877) Fax: (888) How VENCLEXTA Is Supplied Cardinal Health Website: Phone, Hospitals: (866) Phone, Oncology: (877) Fax: (877) These lists are subject to change; for the most up-to-date information, please visit 13

14 INDICATION AND IMPORTANT SAFETY INFORMATION Indication VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. a This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Important Safety Information Contraindication Concomitant use of VENCLEXTA with strong CYP3A inhibitors at initiation and during ramp-up phase is contraindicated. Tumor Lysis Syndrome Tumor lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in previously treated CLL patients with high tumor burden treated with VENCLEXTA. VENCLEXTA poses a risk for TLS in the initial 5-week ramp-up phase. Changes in blood chemistries consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLEXTA and at each dose increase. Patients should be assessed for TLS risk, including evaluation of tumor burden and comorbidities, and should receive appropriate prophylaxis for TLS, including hydration and anti-hyperuricemics. Reduced renal function (CrCl <80 ml/min) further increases the risk. Monitor blood chemistries and manage abnormalities promptly. Interrupt dosing if needed. Employ more intensive measures (IV hydration, frequent monitoring, hospitalization) as overall risk increases. Concomitant use of VENCLEXTA with strong or moderate CYP3A inhibitors and P-gp inhibitors may increase the risk of TLS at initiation and during the ramp-up phase, and may require dose adjustment due to increases in VENCLEXTA exposure. Neutropenia Grade 3 or 4 neutropenia occurred in 41% (98/240) of patients treated with VENCLEXTA. Monitor complete blood counts throughout treatment. Interrupt dosing or reduce dose for severe neutropenia. Consider supportive measures including antimicrobials for signs of infection and use of growth factors (e.g., G-CSF). 14 Immunization Do not administer live attenuated vaccines prior to, during, or after treatment with VENCLEXTA until B-cell recovery. Advise patients that vaccinations may be less effective.

15 Embryo-Fetal Toxicity VENCLEXTA may cause embryo-fetal harm when administered to a pregnant woman. Advise females of reproductive potential to avoid pregnancy during treatment. Adverse Reactions Serious adverse reactions were reported in 43.8% of patients. The most frequent serious adverse reactions ( 2%) were pneumonia (5%), febrile neutropenia (4.6%), pyrexia (3.3%), autoimmune hemolytic anemia (2.9%), anemia (2.1%), and TLS (2.1%). b The most common adverse reactions ( 20%) of any grade were neutropenia (45%), diarrhea (35%), nausea (33%), anemia (29%), upper respiratory tract infection (22%), thrombocytopenia (22%), and fatigue (21%). a Drug Interactions For patients who have completed the ramp-up phase and are on a steady daily dose of VENCLEXTA, reduce the dose by at least 75% when used concomitantly with strong CYP3A inhibitors. Resume the VENCLEXTA dose that was used prior to initiating the CYP3A inhibitor 2 to 3 days after discontinuation of the inhibitor. Avoid concomitant use of moderate CYP3A inhibitors or P-gp inhibitors. If an inhibitor must be used, reduce the VENCLEXTA dose by at least 50%. Monitor patients more closely for signs of VENCLEXTA toxicities. Resume the VENCLEXTA dose that was used prior to initiating the CYP3A inhibitor or P-gp inhibitor 2 to 3 days after discontinuation of the inhibitor. Patients should avoid grapefruit products, Seville oranges, and starfruit during treatment as they contain inhibitors of CYP3A. Avoid concomitant use of strong or moderate CYP3A inducers. Avoid concomitant use of narrow therapeutic index P-gp substrates. If these substrates must be used, they should be taken at least 6 hours before VENCLEXTA. Monitor international normalized ratio (INR) closely in patients receiving warfarin. Lactation Advise nursing women to discontinue breastfeeding during treatment with VENCLEXTA. Females and Males of Reproductive Potential Advise females of reproductive potential to use effective contraception during treatment with VENCLEXTA and for at least 30 days after the last dose. Based on findings in animals, male fertility may be compromised by treatment with VENCLEXTA. Important Safety Information a VENCLEXTA [package insert]. North Chicago, IL: AbbVie Inc. b Data on file, AbbVie Inc. ABVRRTI

16 VENCLEXTA PATIENT SUPPORT SERVICES IMPORTANT INFORMATION Dedicated VENCLEXTA support from oncology nurses (844) 9-COMPASS/(844) Reliable, effective access and reimbursement services (888) VENCLEXTA Please see Important Safety Information on pages VENCLEXTA is a trademark of AbbVie, Inc. BioOncology and the Access Solutions logo are registered trademarks of Genentech, Inc. Distributed and marketed by AbbVie, Inc., 1 North Waukegan Road, North Chicago, IL Marketed by Genentech USA, Inc. 1 DNA Way, South San Francisco, CA AbbVie, Inc. and Genentech USA, Inc /January 2018 Printed in USA