HCP Savings & Support | Jaypirca® (pirtobrutinib)

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Savings Card

Jaypirca Savings Card

Eligible, commercially insured patients pay as little as $0 a month.^*

Download Savings Card

Questions about savings? Call the Jaypirca Savings Card Support Line at 1-833-727-4589.

Terms and Conditions

By using the Jaypirca Savings Card ("Card"), you attest that you meet the eligibility criteria, and you agree to comply with the terms and conditions described below:

Card Eligibility:

You have been prescribed Jaypirca consistent with FDA approved product labeling
You are enrolled in a commercial drug insurance plan
You are not enrolled in any state, federal, or government funded healthcare program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA, TRICARE^®/CHAMPUS, or any state prescription drug assistance program.
You are a resident of the United States or Puerto Rico
You are 18 years of age or older

Card Terms and Conditions
For patients with commercial drug insurance coverage for Jaypirca: You must have commercial drug insurance that covers Jaypirca and a prescription consistent with FDA-approved product labeling to pay as little as $0 for a 1-month prescription fill of Jaypirca. Month is defined as 30-days. Card savings are subject to a maximum monthly savings of wholesale acquisition cost plus usual and customary pharmacy charges and separate maximum annual savings of up to $25,000 per calendar year. Subject to Lilly USA, LLC's ("Lilly") right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions which may occur at Lilly's sole discretion, without notice, and for any reason, Card expires and savings end on 12/31/2024.

Additional Program Terms and Conditions
If you have an insurance plan that is participating in an alternate funding program ("AFP") (examples include, but are not limited to, ImpaxRX, Payer Matrix, SHARx, Script Sourcing, and Paydhealth) that requires you to apply to the Jaypirca Savings Card Program or otherwise pursue specialty drug prescription coverage through an alternate funding vendor as a condition of, requirement for, or prerequisite to coverage of Jaypirca, you are not eligible for and are prohibited from using the Jaypirca Savings Card Program. AFPs include programs where coverage, reimbursement, or patient out of pocket costs for a product in some way vary based on the availability of a manufacturer co-pay program. AFPs may modify, delay, deny, restrict, or withhold insurance benefits or coverage from patients, or exclude Lilly products from coverage contingent upon a member's use of Jaypirca Savings Card Program. You agree to inform the Jaypirca Savings Card Program if you are or become a member of such an alternative funding program. You are responsible for any applicable taxes, fees, and any amount that exceeds the monthly or annual maximum Card savings. Monthly and annual maximum savings are set at Lilly's sole and absolute discretion and may be changed with or without notice at any time for any reason. At its sole discretion and with or without notice, Lilly may reduce, eliminate, or otherwise modify the Card savings for any reason, including but not limited to if your commercial drug insurance plan imposes additional requirements which limits or prevents you from receiving coverage for Jaypirca, only allows partial coverage for Jaypirca, removes coverage for Jaypirca and requires you to utilize the Card, does not provide a material level of financial assistance for the cost of Jaypirca, or does not apply Card payments to satisfy your co-payment, deductible, or coinsurance for Jaypirca. Card savings are not valid for: Massachusetts residents if an AB-rated generic equivalent is available; California residents if an FDA-approved therapeutic equivalent is available. You must meet the Card eligibility criteria, terms and conditions every time you use the Card. Card activation is required. No party may seek reimbursement from your health insurance, any third party, or any health savings, flexible spending, or other healthcare reimbursement accounts, for any amount of the savings received through the Card. By utilizing the Card, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you will notify your Insurance Carrier of your redemption of the Card. Card savings cannot be combined or utilized with any other program, discount, discount card, cash discount card, coupon, incentive, or similar offer involving Jaypirca. You agree that this Card savings is intended solely for the benefit of you, the patient, and that the Card benefits are nontransferable. It is prohibited for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade, or to counterfeit the Card. The Card is not insurance. Lilly has the sole right to interpret and apply Card eligibility criteria, and terms and conditions. Card eligibility, and terms and conditions may be terminated, rescinded, revoked, or amended by Lilly at any time without notice and for any reason. Eligibility criteria, and terms and conditions for the Jaypirca Savings Card Program may change from time to time; the most current version can be found at https://www.Jaypirca.com/savings-support. You may be required to obtain a new Card, including if any Card terms and conditions have been terminated, rescinded, revoked, or amended by Lilly. Card void where prohibited by law. Subject to Lilly's right to terminate, rescind, revoke or amend Card eligibility criteria and/or Card terms and conditions which may occur at Lilly's sole discretion, without notice, and for any reason, the Card expires and savings end on 12/31/2024.

TRICARE^® is a registered trademark of the Department of Defense (DoD), DHA.

Patient Support

Support tailored to your eligible patient's Jaypirca treatment journey^†

Enroll your patients

To enroll your eligible patients in all or any of these support programs,^† please call the Lilly Oncology Support Center at 1-866-472-8663, Monday–Friday, 8 am—10 pm ET.

Jaypirca Interim Access Program

The Jaypirca Interim Access Program may provide a temporary supply of Jaypirca at no cost to insured, eligible patients who have been prescribed Jaypirca for the first time and are experiencing a delay in their insurance coverage decision.^*

^*TERMS AND CONDITIONS: The Jaypirca Interim Access Program (or "Program") provides a 15-day supply of Jaypirca at no charge for eligible, insured patients who are: 1) prescribed Jaypirca for the first time, 2) experiencing a minimum 5-business-day delay in insurance coverage determination, 3) prescribed Jaypirca for an FDA-approved indication or an indication medically supported by CMS-recognized compendia, 4) enrolled in the Lilly Oncology Support Center, and 5) residents of the United States or Puerto Rico. May not be combined with any other offer. Not available to patients whose insurers have made a final determination to deny the patient coverage for Jaypirca. If a denial is received after the initial 5 business days have passed and appeal rights are being pursued, or if there is a persistent coverage delay, the patient, under appropriate circumstances, may be eligible for up to 3 additional 15-day supplies of Jaypirca. Product provided through the Program is only available through the Program non-commercial specialty pharmacy. Product is provided free of charge and may not be sold, bartered, or returned for credit. Reimbursement cannot be sought from any third party for product provided under the program. Patients enrolled in Medicare Part D are prohibited from counting any portion of the cost of the product provided under the Program towards true out-of-pocket ("TrOOP") costs for prescription drug calculations. No purchase contingency or other obligation accompanies program participation. This Program is not health insurance and does not guarantee coverage. Lilly reserves the right to change or end the program at any time. Benefits under the program are not transferable.

Insurance and Coverage Assistance^†

Benefits investigation

Helps eligible enrolled Jaypirca patients understand their coverage options, locate the appropriate specialty pharmacy, and identify their lowest possible out-of-pocket cost

Field Reimbursement Manager (FRM) support

FRMs help patients access prescribed Lilly FDA-approved medicines and educate HCPs and their staff on the complex access and reimbursement landscape to help patients receive and start Jaypirca

Jaypirca Ongoing Support^†

The Lilly Oncology Support Center can help eligible Jaypirca patients by:

Connecting patients to relevant resources, based upon questions or needs
Reiterating treatment information when taking Jaypirca^‡

^†Jaypirca support programs and offerings are not a guarantee of coverage. Terms and conditions apply for all programs. See Jaypirca enrollment form for details.
^‡The Lilly Oncology Support Center does not replace a trained healthcare provider; when medical questions arise, your patients will always be directed back to your office.

Download enrollment form

MyRightDose: A Dose Exchange Program^§

With MyRightDose, your patients can continue their Jaypirca therapy at the appropriate dose for them, without the hassle of delays or additional co-pays.

^§Additional terms and conditions apply. See the MyRightDose enrollment form for details.

Access Resources

Jaypirca is available through:

Contracted specialty pharmacies^¶

Hospital and health system practices

In-office dispensing practices (IODs)

Jaypirca is available through contracted specialty pharmacies and can be purchased through authorized distributors.

See a list of specialty pharmacies

^¶Eligible pharmacies can purchase Jaypirca through authorized distribution partners. A list of authorized distributors can be found at lillytrade.com.

Here are some helpful resources to help you and your patients with common access issues

Jaypirca access, reimbursement, and distribution

The access and reimbursement landscape can be complex and cumbersome. Information within the guide can help you navigate the complexities of the reimbursement landscape.

Download distribution guide

Coverage authorization appeals letter

If an initial claim or coverage authorization request letter is denied, the payer may require a coverage authorization appeals letter.

Download sample

Letter of medical necessity (LMN)

Many health plans require that an LMN accompany a coverage authorization appeals letter.

Download sample

Enrollment form

Enroll your patients to gain access to the Jaypirca support offerings.

Download enrollment form

EHR Resources - Electronic Order Sets

Easy-to-use, step-by-step downloadable instructions to develop Jaypirca electronic order sets in your EHR system.

Download the appropriate instructions for your system from the table below

Epic	Order Set Instructions
Cerner	Order Set Instructions
OncoEMR	Order Set Instructions
iKnowmed	Order Set Instructions

If your system is not listed, please download the Treatment Plan Guide to help develop Jaypirca electronic order sets

Download treatment plan guide

Important Safety Information

Infections: Fatal and serious infections (including bacterial, viral, fungal) and opportunistic infections occurred in Jaypirca-treated patients. In a clinical trial, Grade ≥3 infections occurred in 24% of patients with hematologic malignancies, most commonly pneumonia (14%); fatal infections occurred in 4.4%. Sepsis (6%) and febrile neutropenia (4%) occurred. In patients with CLL/SLL, Grade ≥3 infections occurred (32%), with fatal infections occurring in 8%. Opportunistic infections included Pneumocystis jirovecii pneumonia and fungal infection. Consider prophylaxis, including vaccinations and antimicrobial prophylaxis, in patients at increased risk for infection, including opportunistic infections. Monitor patients for signs and symptoms, evaluate promptly, and treat appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Hemorrhage: Fatal and serious hemorrhage has occurred with Jaypirca. Major hemorrhage (Grade ≥3 bleeding or any central nervous system bleeding) occurred in 3% of patients, including gastrointestinal hemorrhage; fatal hemorrhage occurred (0.3%). Bleeding of any grade, excluding bruising and petechiae, occurred in 17%. Major hemorrhage occurred in patients taking Jaypirca with (0.7%) and without (2.3%) antithrombotic agents. Consider risks/benefits of co-administering antithrombotic agents with Jaypirca. Monitor patients for signs of bleeding. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca. Consider benefit/risk of withholding Jaypirca 3-7 days pre- and post-surgery depending on type of surgery and bleeding risk.

Cytopenias: Jaypirca can cause cytopenias, including neutropenia, thrombocytopenia, and anemia. In a clinical trial, Grade 3 or 4 cytopenias, including decreased neutrophils (26%), decreased platelets (12%), and decreased hemoglobin (12%), developed in Jaypirca-treated patients. Grade 4 decreased neutrophils (14%) and Grade 4 decreased platelets (6%) developed. Monitor complete blood counts regularly during treatment. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Cardiac Arrhythmias: Cardiac arrhythmias occurred in patients who received Jaypirca. In a clinical trial of patients with hematologic malignancies, atrial fibrillation or flutter were reported in 3.2% of Jaypirca-treated patients, with Grade 3 or 4 atrial fibrillation or flutter in 1.5%. Other serious cardiac arrhythmias such as supraventricular tachycardia and cardiac arrest occurred (0.5%). Patients with cardiac risk factors such as hypertension or previous arrhythmias may be at increased risk. Monitor for signs and symptoms of arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea) and manage appropriately. Based on severity, reduce dose, temporarily withhold, or permanently discontinue Jaypirca.

Second Primary Malignancies: Second primary malignancies, including non-skin carcinomas, developed in 9% of Jaypirca-treated patients. The most frequent malignancy was non-melanoma skin cancer (4.6%). Other second primary malignancies included solid tumors (including genitourinary and breast cancers) and melanoma. Advise patients to use sun protection and monitor for development of second primary malignancies.

Embryo-Fetal Toxicity: Jaypirca can cause fetal harm in pregnant women. Administration of pirtobrutinib to pregnant rats during organogenesis caused embryo-fetal toxicity, including embryo-fetal mortality and malformations at maternal exposures (AUC) approximately 3-times the recommended 200 mg/day dose. Advise pregnant women of potential fetal risk and females of reproductive potential to use effective contraception during treatment and for one week after last dose.

Adverse Reactions (ARs) in Patients Who Received Jaypirca

The most common (≥20%) ARs in the BRUIN pooled safety population of patients with hematologic malignancies (n=593) were decreased neutrophil count (46%), decreased hemoglobin (39%), fatigue (32%), decreased lymphocyte count (31%), musculoskeletal pain (30%), decreased platelet count (29%), diarrhea (24%), COVID-19 (22%), bruising (21%), cough (20%).

Mantle Cell Lymphoma

Serious ARs occurred in 38% of patients. Serious ARs occurring in ≥2% of patients were pneumonia (14%), COVID-19 (4.7%), musculoskeletal pain (3.9%), hemorrhage (2.3%), pleural effusion (2.3%), and sepsis (2.3%). Fatal ARs within 28 days of last Jaypirca dose occurred in 7% of patients, most commonly due to infections (4.7%), including COVID-19 (3.1% of all patients).

Dose Modifications and Discontinuations: ARs led to dose reductions in 4.7%, treatment interruption in 32%, and permanent discontinuation of Jaypirca in 9% of patients. ARs resulting in dosage modification in >5% of patients included pneumonia and neutropenia. ARs resulting in permanent discontinuation in >1% of patients included pneumonia.

ARs (all Grades %; Grade 3-4 %) in ≥10% of Patients: fatigue (29; 1.6), musculoskeletal pain (27; 3.9), diarrhea (19; -), edema (18; 0.8), dyspnea (17; 2.3), pneumonia (16; 14), bruising (16; -), peripheral neuropathy (14; 0.8), cough (14; -), rash (14; -), fever (13; -), constipation (13; -), arthritis/arthralgia (12; 0.8), hemorrhage (11; 3.1), abdominal pain (11; 0.8), nausea (11; -), upper respiratory tract infections (10; 0.8), dizziness (10; -).

Select Laboratory Abnormalities (all Grades %; Grade 3 or 4 %) that Worsened from Baseline in ≥10% of Patients: hemoglobin decreased (42; 9), platelet count decreased (39; 14), neutrophil count decreased (36; 16), lymphocyte count decreased (32; 15), creatinine increased (30; 1.6), calcium decreased (19; 1.6), AST increased (17; 1.6), potassium decreased (13; 1.6), sodium decreased (13; -), lipase increased (12; 4.4), alkaline phosphatase increased (11; -), ALT increased (11; 1.6), potassium increased (11; 0.8). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (10), platelets decreased (7), lymphocytes decreased (6).

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Serious ARs occurred in 56% of patients. Serious ARs occurring in ≥5% of patients were pneumonia (18%), COVID-19 (9%), sepsis (7%), and febrile neutropenia (7%). Fatal ARs within 28 days of last Jaypirca dose occurred in 11% of patients, most commonly due to infections (10%), including sepsis (5%) and COVID-19 (2.7%).

Dose Modifications and Discontinuations: ARs led to dose reductions in 3.6%, treatment interruption in 42%, and permanent discontinuation of Jaypirca in 9% of patients. ARs resulting in dose reductions in >1% included neutropenia; treatment interruptions in >5% of patients included pneumonia, neutropenia, febrile neutropenia, and COVID-19; permanent discontinuation in >1% of patients included second primary malignancy, COVID-19, and sepsis.

ARs (all Grades %; Grade 3-4 %) in ≥10% of Patients: fatigue (36; 2.7), bruising (36; -), cough (33; -), musculoskeletal pain (32; 0.9), COVID-19 (28; 7), pneumonia (27; 16), diarrhea (26; -), abdominal pain (25; 2.7), dyspnea (22; 2.7), hemorrhage (22; 2.7), edema (21; -), nausea (21; -), pyrexia (20; 2.7), headache (20; 0.9), arthritis/arthralgia (19; 1.8), rash (19; 0.9), peripheral neuropathy (16; 3.6), dizziness (15; -), fall (14; 0.9), constipation (14; -), insomnia (14; -), upper respiratory tract infections (13; 2.7), second primary malignancy (13; 2.7), renal insufficiency (12; 6), hypertension (12; 5), neurological changes (12; 2.7), mucositis (12; 0.9), decreased appetite (12; -), respiratory tract infection (11; 1.8), supraventricular tachycardia (10; 5).

Select Laboratory Abnormalities (all Grades %; Grade 3 or 4 %) that Worsened from Baseline in ≥20% of Patients: neutrophil count decreased (63; 45), hemoglobin decreased (48; 19), calcium decreased (40; 2.8), platelet count decreased (30; 15), sodium decreased (30; -), lymphocyte count decreased (23; 8), ALT increased (23; 2.8), AST increased (23; 1.9), creatinine increased (23; -), lipase increased (21; 7), alkaline phosphatase increased (21; -). Grade 4 laboratory abnormalities in >5% of patients included neutrophils decreased (23).

Drug Interactions

Strong CYP3A Inhibitors: Concomitant use with Jaypirca increased pirtobrutinib systemic exposure, which may increase risk of Jaypirca ARs. Avoid use of strong CYP3A inhibitors with Jaypirca. If concomitant use is unavoidable, reduce Jaypirca dosage according to approved labeling.

Strong or Moderate CYP3A Inducers: Concomitant use with Jaypirca decreased pirtobrutinib systemic exposure, which may reduce Jaypirca efficacy. Avoid concomitant use of Jaypirca with strong or moderate CYP3A inducers. If concomitant use with moderate CYP3A inducers is unavoidable, increase Jaypirca dosage according to approved labeling.

Sensitive CYP2C8, CYP2C19, CYP3A, P-gp, or BCRP Substrates: Concomitant use with Jaypirca increased their plasma concentrations, which may increase risk of adverse reactions related to these substrates for drugs that are sensitive to minimal concentration changes. Follow recommendations for these sensitive substrates in their approved labeling.

Use in Special Populations

Pregnancy and Lactation: Due to potential for Jaypirca to cause fetal harm, verify pregnancy status in females of reproductive potential prior to starting Jaypirca and advise use of effective contraception during treatment and for one week after last dose. Presence of pirtobrutinib in human milk is unknown. Advise women not to breastfeed while taking Jaypirca and for one week after last dose.

Geriatric Use: In the pooled safety population of patients with hematologic malignancies, patients aged ≥65 years experienced higher rates of Grade ≥3 ARs and serious ARs compared to patients <65 years of age.

Renal Impairment: Severe renal impairment increases pirtobrutinib exposure. Reduce Jaypirca dosage in patients with severe renal impairment according to approved labeling.

PT HCP ISI COMBO DEC2023

Please see full Prescribing Information and Patient Information for Jaypirca.

Indications

Jaypirca is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

Jaypirca is also indicated for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.

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

Savings & Support