BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes.

THE THEMIS TRIAL

In High-Risk Patients With CAD and T2D Without a History of MI or Stroke

STUDY DESIGN

The THEMIS trial was a Phase 3b, randomized, double-blind, placebo-controlled trial comparing BRILINTA 60 mg twice daily versus aspirin for the prevention of CV events in patients with coronary artery disease (CAD), who also had type 2 diabetes (T2D) and no history of MI or stroke, at high risk for such events (N=19,220). All patients received low-dose aspirin 75–150 mg once daily, unless contraindicated or not tolerated.1,2

Primary efficacy end point1:

Composite of CV death, MI, or stroke

VIEW THE DATA

Primary safety end point1:

TIMI major bleeding

VIEW THE DATA
Key Inclusion Criteria

KEY INCLUSION CRITERIA1

  • CAD defined as history of PCI/CABG or ≥50% lumen stenosis confirmed by angiography
  • Age ≥50
  • T2D (glucose lowering medication for ≥6 months)
Key Exclusion Criteria

KEY EXCLUSION CRITERIA2

  • History of previous MI or stroke
  • Planned revascularization
Median Follow Up

MEDIAN FOLLOW-UP 33 MONTHS AND UP TO 58 MONTHS1

SELECT BASELINE RISK FACTORS1

Baseline Characteristics
  • Median age: 66 years; male 69%
  • More than half (58%) of patients had PCI in the past (median time since most recent PCI: 3.3 years)2

PRIMARY EFFICACY1,2

IN HIGH-RISK PATIENTS WITH CAD WHO HAVE T2D AND NO HISTORY OF MI OR STROKE,

BRILINTA 60 MG + ASPIRIN SIGNIFICANTLY REDUCED THE COMPOSITE PRIMARY END POINT AT 36 MONTHS VS ASPIRIN

THEMIS PRIMARY EFFICACY END POINT: COMPOSITE OF CV DEATH, MI, OR STROKE

Chart showing superior reduction in CV events with BRILINTA 60 mg plus aspirin vs aspirin at 36 months in THEMIS.
  • Events per 1000 patient years 24 vs 27 for BRILINTA 60 mg plus aspirin vs aspirin, respectively
  • The composite efficacy end point was driven by MI and stroke
  • BRILINTA is indicated to reduce the risk of first MI or stroke in patients with CAD without a history of MI or stroke who are at high risk
  • BRILINTA is not indicated to reduce the risk of CV death in patients with CAD without a history of MI or stroke who are at high risk

*Hazard ratio derived from a Cox proportional-hazards model on data from the primary and secondary end points.2

THEMIS: BLEEDING OUTCOMES

IN HIGH-RISK PATIENTS WITH CAD WHO HAVE T2D AND NO HISTORY OF MI OR STROKE

BRILINTA + ASPIRIN (N=9562) ASPIRIN (N=9531)
EVENTS/
1000 patient years 		EVENTS/
1000 patient years
TIMI major 9 4
TIMI major or minor 12 5
TIMI major, minor, or requiring medical attention 46 18
Fatal bleeding 1 0
Intracranial hemorrhage 3 2

TIMI Major: Fatal bleeding or any intracranial bleeding, or clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL, or a fall in hematocrit of ≥15%; if CABG related: fatal bleeding or perioperative intracranial bleeding or reoperation following closure of the sternotomy incision for the purpose of controlling bleeding or transfusion of ≥5 units of whole blood or PRBCs within a 48-hour period (cell saver transfusion will not be counted in calculations of blood products) or chest tube input >2 L within a 24-hour period. TIMI minor: Clinically overt with 3-5 g/dL decrease in hemoglobin or ≥10% to <15% decrease in hematocrit. Medical attention: Any overt sign of hemorrhage that meets one of the following criteria and does not meet criteria of TIMI major or minor event: requiring intervention; leading to hospitalization, prompting evaluation. Fatal bleeding: Bleeding that directly results in death within 7 days.2

DOSING & ADMINISTRATION1

Initiate and continue in high-risk patients with CAD, without history of MI or stroke

BRILINTA 60 mg twice daily + low-dose aspirin once daily
Image of 2 BRILINTA tablets and an aspirin tablet

One 60-mg tablet of BRILINTA twice daily

Aspirin Tablet

81 mg of aspirin once daily

Tablet images are not actual size.

BRILINTA IS MORE AFFORDABLE THAN YOU MAY THINK3

BRILINTA FOR FIVE

>90% of commercially insured patients can get BRILINTA for $5 per month, every month, for as long as you prescribe, with the BRILINTA Savings Card*†ǂ

WITH THE BRILINTA SAVINGS CARD, PATIENTS CAN:

  • Pay as low as $5*† for a 30-day supply
  • Save each time they refill
  • Maintain the benefit for as long as they’re prescribed BRILINTA
BRILINTA® (ticagrelor) Savings Coupon

Individual costs and benefit design may vary. Please consult with individual plans for specific information. AstraZeneca does not endorse any individual Commercial, Medicare Part D, or Medicaid plan or plans.

*Eligible patients will pay as low as $5 for a 30-day supply subject to a maximum savings of $200 per 30-day supply. Patients who remain eligible are automatically re-enrolled each year. See eligibility rules and restrictions.

†Subject to eligibility rules; restrictions apply.

ǂ“Patients” means covered lives (EGWP, Medicare MA, Medicare PDP, Medicare SN, Medi-Medi, PACE) at tiers 1-7 Nationwide as calculated by Fingertip Formulary® 7/11/20.

Connect your eligible patients to savings today

3 ways to get the savings card:

Download a BRILINTA Savings Card

Every download will have a different number, so please don't make duplicates of the same card.

E-mail a Savings Card to your patient

Tell patients to text SAVE6 to 997989

A coupon code will be sent to their phone; message and data rates may apply

Mail order rebate: Another way to save:

Download the rebate form

If your patients fill their prescription through mail order, they can fill out this form or call 1-888-512-7454

E-mail the rebate form to your patients

Please note: If you are a health care professional affiliated with an employer, institution, or committee, or practicing in a state that restricts what items you may receive from manufacturers, we ask that you not accept or download any restricted items from this site. If you are a health care provider practicing in Vermont, we are required by state law to deny you permission to download any items made available on this site.

ELIGIBILITY REQUIREMENTS AND INFORMATION

Commercially insured patients and cash-paying patients

Eligibility: You may be eligible for this offer if you are insured by commercial insurance and your insurance does not cover the full cost of your prescription, or you are not insured and are responsible for the cost of your prescriptions.

Patients who are enrolled in a state or federally funded prescription insurance program are not eligible for this offer. This includes patients enrolled in Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DOD) programs or TriCare, and patients who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees.

If you are enrolled in a state-or federally-funded prescription insurance program, you may not use this Savings Card even if you elect to be processed as an uninsured (cash-paying) patient.

This offer is not insurance, is restricted to the United States and Puerto Rico, and to patients over 18 years of age.

Terms of Use: Eligible commercially insured patients with a valid prescription for BRILINTA® (ticagrelor) tablets who present this savings card at participating pharmacies will pay as low as $5 per 30-day supply. $200 maximum savings limit applies; patient’s out-of-pocket expense may vary. If you pay cash for your prescription, AstraZeneca will pay up to the first $100, and you will be responsible for any remaining balance, for each monthly prescription. Other restrictions may apply. Patient is responsible for applicable taxes, if any. Nontransferable, limited to one per person, cannot be combined with any other offer. Void where prohibited by law, taxed or restricted. Patients, pharmacists, and prescribers cannot seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this offer. AstraZeneca reserves the right to rescind, revoke, or amend this offer, eligibility and terms of use at any time without notice. This offer is not conditioned on any past, present or future purchase, including refills. Offer must be presented along with a valid prescription at the time of purchase. For additional details about this offer, please visit www.brilinta.com. If you have any questions regarding this offer, please call 1-800-422-5604.

BY USING THIS CARD, YOU AND YOUR PHARMACIST UNDERSTAND AND AGREE TO COMPLY WITH THESE ELIGIBILITY REQUIREMENTS AND TERMS OF USE.

Program Managed by ConnectiveRx, on behalf of Astrazeneca.

Pharmacist Instructions for a Patient with an Eligible Third Party:

For Commercially Insured/Covered Patients: Submit the claim to the primary Third-Party Payer first, then submit the balance due to Change Healthcare as a Secondary Payer COB with patient responsibility amount and a valid Other Coverage Code of 8. The patient is responsible for the first $5 and the card pays up to the next $200 per 30-day supply; patient’s out-of-pocket expenses may vary. Reimbursement will be received from Change Healthcare.

Pharmacist Instructions for a Cash-Paying Patient: Submit this claim to Change Healthcare. A valid Other Coverage Code (eg, 1) is required. The card will cover up to $100 per 30-day supply. Reimbursement will be received from Change Healthcare. Patients enrolled in a state or federally funded prescription insurance program may not use this savings card.

Valid Other Coverage Code required. For any questions regarding Change Healthcare online processing, please call the Help Desk 1-800-422-5604.

Mail-Order Rebate for Commercially Insured and Cash-Paying Patients:

ELIGIBILITY: You may be eligible for this offer if you are insured by commercial insurance and your insurance does not cover the full cost of your prescription, or you are not insured and are responsible for the cost of your prescriptions. Patients who are enrolled in a state or federally funded prescription insurance program are not eligible for this offer. This includes patients enrolled in Medicare Part D, Medicaid, Medigap, Veterans Affairs (VA), Department of Defense (DOD) programs or TriCare, and patients who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees. If you are enrolled in a state-or federally-funded prescription insurance program, you may not use this savings card even if you elect to be processed as an uninsured (cash-paying) patient. This offer is not insurance, is restricted to the United States and Puerto Rico, and to patients over 18 years of age.

Terms of Use: Eligible commercially insured patients with a valid prescription for BRILINTA® (ticagrelor) tablets who present this savings card at participating pharmacies will pay as low as $5 per 30-day supply. $200 maximum savings limit applies; patient’s out-of-pocket expense may vary. If you pay cash for your prescription, AstraZeneca will pay up to the first $100, and you will be responsible for any remaining balance, for each monthly prescription. Other restrictions may apply. Patient is responsible for applicable taxes, if any. Nontransferable, limited to one per person, cannot be combined with any other offer. Void where prohibited by law, taxed or restricted. Patients, pharmacists, and prescribers cannot seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this offer. AstraZeneca reserves the right to rescind, revoke, or amend this offer, eligibility and terms of use at any time without notice. This offer is not conditioned on any past, present or future purchase, including refills. Offer must be presented along with a valid prescription at the time of purchase. For additional details about this offer, please visit www.brilinta.com. If you have any questions regarding this offer, please call 1-800-422-5604.

BY USING THIS CARD, YOU AND YOUR PHARMACIST UNDERSTAND AND AGREE TO COMPLY WITH THESE ELIGIBILITY REQUIREMENTS AND TERMS OF USE.

Program Managed by ConnectiveRx, on behalf of Astrazeneca.

Medicare or Medicaid Patients

Eligibility for Free Trial Offer for Medicare or Medicaid Patients: This offer is good for eligible patients purchasing up to a 30-day supply (up to 60 tablets) of BRILINTA® (ticagrelor) tablets and may not be used for any other product. This offer is good for the purchase of BRILINTA® manufactured for AstraZeneca Pharmaceuticals LP and lawfully purchased from an authorized retailer or distributor in the United States or its territories. This offer may be used by eligible patients who participate in Medicaid, Medicare, or similar federal or state programs, or by patients who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees. This offer is not insurance and is not valid for mail order, or for patients under 18 years of age. Offer not valid where prohibited by law, taxed, or restricted. Offer is not transferable, is limited to one per person, and may not be combined with any other offer. Offer must be presented along with a valid prescription for BRILINTA® at the time of purchase.

Medicaid or Medicare Patients: You will receive one 30-day prescription free. If you have any questions regarding this offer, please call 1-800-422-5604. AstraZeneca reserves the right to change or discontinue this offer at any time without notice. No claim for payment can be made to ANY Third-Party Payer for product dispensed pursuant to this offer. Not valid if reproduced.

Pharmacist instructions for Commercially Insured/Covered Patients: Submit the claim to the primary Third-Party Payer first, then submit the balance due to Change Healthcare as a Secondary Payer COB with patient responsibility amount and a valid Other Coverage Code (eg, 8). The patient is responsible for $0.00. Reimbursement will be received from Change Healthcare.

Pharmacist instructions for Medicare or Medicaid Patients: Submit this claim to Change Healthcare. The information printed below should be used when submitting for reimbursement. No claim for payment can be made to ANY Third-Party Payer for product dispensed pursuant to this offer. Not valid if reproduced.

For any questions regarding Change Healthcare online processing, please call the Help Desk 1-800-422-5604.

IMPORTANT SAFETY INFORMATION FOR BRILINTA® (ticagrelor) 60-MG AND 90-MG TABLETS

WARNINGS:

A. BLEEDING RISK

  • BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding
  • Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage
  • Do not start BRILINTA in patients undergoing urgent coronary artery bypass graft surgery
  • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events

B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

  • Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided

CONTRAINDICATIONS

  • BRILINTA is contraindicated in patients with a history of intracranial hemorrhage or active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with hypersensitivity (eg, angioedema) to ticagrelor or any component of the product

WARNINGS AND PRECAUTIONS

  • Dyspnea was reported more frequently with BRILINTA than in patients treated with control agents. Dyspnea from BRILINTA is often self-limiting
  • Discontinuation of BRILINTA will increase the risk of MI, stroke, and death. When possible, interrupt therapy with BRILINTA for 5 days prior to surgery that has a major risk of bleeding. If BRILINTA must be temporarily discontinued, restart as soon as possible
  • Ticagrelor can cause ventricular pauses. Bradyarrhythmias including AV block have been reported in the post-marketing setting. Clinical trials excluded patients at increased risk of bradyarrhythmias not protected by a pacemaker, and they may be at increased risk of developing bradyarrhythmias
  • Avoid use of BRILINTA in patients with severe hepatic impairment. Severe hepatic impairment is likely to increase serum concentration of ticagrelor and there are no studies of BRILINTA in these patients
  • In patients with Heparin Induced Thrombocytopenia (HIT): False negative results for HIT-related platelet functional tests, including the heparin-induced platelet aggregation (HIPA) assay, have been reported with BRILINTA. BRILINTA is not expected to impact PF4 antibody testing for HIT

ADVERSE REACTIONS

  • The most common adverse reactions (>5%) associated with the use of BRILINTA included bleeding and dyspnea

DRUG INTERACTIONS

  • Avoid use with strong CYP3A inhibitors and strong CYP3A inducers. BRILINTA is metabolized by CYP3A4/5. Strong inhibitors substantially increase ticagrelor exposure and so increase the risk of adverse events. Strong inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor
  • As with other oral P2Y12 inhibitors, co-administration of opioid agonists delay and reduce the absorption of ticagrelor. Consider use of a parenteral anti-platelet in ACS patients requiring co-administration
  • Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse events
  • Monitor digoxin levels with initiation of, or change in, BRILINTA therapy

SPECIAL POPULATIONS

  • Lactation: Breastfeeding not recommended

INDICATIONS

BRILINTA is indicated to reduce the risk of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel. BRILINTA also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS.

BRILINTA is indicated to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes.

DOSING

In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily.

In patients with CAD but no prior stroke or MI, administer 60 mg twice daily.

Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.

Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

References: 1. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Wallentin L, Becker RC, Budaj A, et al; for the PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045-1057 and Supplementary Appendix. 3. Sahlén A, Varenhorst C, Lagerqvist B, et al. Outcomes in patients treated with ticagrelor or clopidogrel after acute myocardial infarction: experiences from SWEDEHEART registry. Eur Heart J. 2016;37(44):3335-3342. 4. Bonaca MP, Bhatt DL, Cohen M, et al, for the PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015;372:1791-1800. 5. Steg PG, Bhatt DL, Simon T, et al; for the THEMIS Steering Committee and Investigators. Ticagrelor in patients with stable coronary disease and diabetes. N Engl J Med. 2019;381(14):1309-1320.

References: 1. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Wallentin L, Becker RC, Budaj A, et al; for the PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009;361(11):1045-1057 and Supplementary Appendix. 3. Sahlén A, Varenhorst C, Lagerqvist B, et al. Outcomes in patients treated with ticagrelor or clopidogrel after acute myocardial infarction: experiences from SWEDEHEART registry. Eur Heart J. 2016;37(44):3335-3342. 4. Bonaca MP, Bhatt DL, Cohen M, et al, for the PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015;372:1791-1800.

References: 1. BRILINTA® (ticagrelor) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020. 2. Steg PG, Bhatt DL, Simon T, et al; for the THEMIS Steering Committee and Investigators. Ticagrelor in patients with stable coronary disease and diabetes. N Engl J Med. 2019;381(14):1309-1320. 3. Fingertip Formulary.® July 11, 2020.

ACS=acute coronary syndrome; CV=cardiovascular; MI=myocardial infarction; PEGASUS=Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin; PLATO=PLATelet inhibition and patient Outcomes; SWEDEHEART=Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies; THEMIS=Effect of Ticagrelor on Health Outcomes in DiabEtes Mellitus Patients Intervention Study; T2D=type 2 diabetes.

ACS=acute coronary syndrome; CV=cardiovascular; MI=myocardial infarction; PEGASUS=Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin; PLATO=PLATelet inhibition and patient Outcomes; SWEDEHEART=Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies.

ACS=acute coronary syndrome; ARR=absolute risk reduction; ARI=absolute risk increase; CABG=coronary artery bypass graft; CI=confidence interval; Hb=hemoglobin; Hct=hematocrit; HR= hazard ratio; K-M=Kaplan-Meier; PLATO=PLATelet inhibition and patient Outcomes; RRR=relative risk reduction.