AstraZeneca makes major commitment to help patients with acute coronary syndrome have BRILINTA (ticagrelor) available in their local communities

Tuesday, 4 December 2012

Agreements with national, regional and independent pharmacies represent greater consistency to help with continuity of care as patients transition from hospital to home 

For immediate release: December 4, 2012

WILMINGTON, Del. - AstraZeneca (NYSE: AZN) today announced a new program with more than 26,000 national, regional and independent pharmacies to broaden stocking of BRILINTA® (ticagrelor) tablets, greatly enhancing its retail availability in the United States. This new pharmacy program is another investment by AstraZeneca to help patients with acute coronary syndrome (ACS) and healthcare providers maintain continuity of care throughout the course of treatment. AstraZeneca is working with payers as well as pharmacies to assist patients in filling their prescriptions for BRILINTA in a timely manner once they leave the hospital.

Participating pharmacy chains in this unique program include Walmart, Rite Aid, Kmart, Sam’s Club, Publix, Kerr Drug, Wegmans, Giant Eagle, Tops Markets, Kinney Drug, Bartell Drug, Bi-Lo, and Winn-Dixie. These participating retail chains are not exclusive distributors and BRILINTA may be available at other retail pharmacy chains and independent pharmacies. For additional information, please call 1-888-512-7454 (1-888-51-BRILINTA).

“Our pharmacy program is one of many initiatives we have in place to help ensure that patients with ACS have widespread access to BRILINTA, an important medication indicated to reduce their risk for thrombotic cardiovascular events,” said James Ferguson, MD, Executive Director, Medical Affairs and Strategic Development, U.S., and Vice President for Global Medical Affairs at AstraZeneca. “When a treating physician prescribes BRILINTA, it is critical that their patients start and finish the entire course of treatment without unnecessary disruptions, particularly when transitioning from the hospital to home. We believe this program will truly help patients to get access to a medication that is now part of multiple guidelines' recommended treatment following an ACS event.”

“Our efforts to help improve continuity of care are important for patients prescribed BRILINTA and pharmacies are key partners for us,” said Suzanne Delaney, Executive Director, Commercial Brand Leader at AstraZeneca. “It’s gratifying for us to see such robust support from wholesalers, retailers and payers, indicating positive momentum in the market.”

BRILINTA is indicated to reduce the rate of thrombotic cardiovascular (CV) events in patients with ACS (unstable angina [UA], non–ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). In PLATO, BRILINTA has been shown to reduce the rate of a combined end point of CV death, myocardial infarction (MI), or stroke compared to clopidogrel. In PLATO, the difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with an artery-opening procedure known as percutaneous coronary intervention (PCI), BRILINTA reduces the rate of stent thrombosis.

BRILINTA has been studied in ACS in combination with aspirin. Maintenance doses of aspirin above 100 mg decreased the effectiveness of BRILINTA. Avoid maintenance doses of aspirin above 100 mg daily.

BRILINTA payer access continues to grow, with more than 100 leading U.S. payers providing “preferred” access to this medication. Overall, access is currently 82% of covered lives with 70% having unrestricted access. In addition, BRILINTA is now on formulary at 81% (324) of the top 400 hospitals throughout the United States as identified by AstraZeneca. A full list of available formularies that include BRILINTA can be found on Fingertip Formulary, a website that offers formulary drug status on the most commonly prescribed drugs across a comprehensive list of health plans.

Another important support resource now available is Access My BRILINTA, which provides time-saving prescription access and affordability information to patients and healthcare providers. Access My BRILINTA is available by calling 1-888-512-7454 (1-888-51-BRILINTA) or visiting BRILINTA.com.

For patients that require BRILINTA beyond their hospital stay, a savings card program is available based on eligibility. Commercially insured and cash-paying patients may be eligible for one free 30-day prescription and can save up to $825 per year on their next 11 refills. For each refill (a 30-day supply of up to 60 tablets), savings may apply after the first $18 spent by a patient, up to a $75 savings limit. Patients covered through Medicare, Medicaid or similar federal or state programs may be eligible for one month free prescription. Patients can find out more at www.BRILINTAtouchpoints.com or by calling 1-888-412-7454.

IMPORTANT SAFETY INFORMATION ABOUT BRILINTA

WARNING: 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 planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery
  • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA
  • If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events

WARNING: ASPIRIN DOSE AND BRILINTA EFFECTIVENESS

  • Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75 mg - 100 mg per day

CONTRAINDICATIONS
BRILINTA is contraindicated in patients with a history of intracranial hemorrhage and active pathological bleeding such as peptic ulcer or intracranial hemorrhage. BRILINTA is also contraindicated in patients with severe hepatic impairment because of a probable increase in exposure; it has not been studied in these patients. Severe hepatic impairment increases the risk of bleeding because of reduced synthesis of coagulation proteins.

WARNINGS AND PRECAUTIONS

  • Moderate Hepatic Impairment: Consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor
  • Premature discontinuation increases the risk of MI, stent thrombosis, and death
  • Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients taking clopidogrel. Dyspnea resulting from BRILINTA is self-limiting. Rule out other causes
  • BRILINTA is metabolized by CYP3A4/5. Avoid use with strong CYP3A inhibitors and potent CYP3A inducers. Avoid simvastatin and lovastatin doses >40 mg
  • Monitor digoxin levels with initiation of, or any change in, BRILINTA therapy

ADVERSE REACTIONS

  • The most commonly observed adverse reactions associated with the use of BRILINTA vs clopidogrel were Total Major Bleeding (11.6% vs 11.2%) and dyspnea (14% vs 8%)
  • In clinical studies, BRILINTA has been shown to increase the occurrence of Holter-detected bradyarrhythmias. PLATO excluded patients at increased risk of bradycardic events. Consider the risks and benefits of treatment

Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide. This information can be found at www.brilintatouchpoints.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch.

AstraZeneca also offers a US patient assistance program for BRILINTA through its AZ&METM Prescription Savings Program. To determine eligibility, patients can visit www.AZandMe.com or call 1-800-AZandMe (292-6363).

NOTES TO EDITOR

"Preferred" formulary status means placement of BRILINTA on Tier 2 or the formulary tier designated by the managed care organization as having the lowest co-pay for branded products.

About BRILINTA® (ticagrelor) tablets

BRILINTA is an oral antiplatelet treatment for ACS. BRILINTA is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclopentyltriazolopyrimidines (CPTPs). BRILINTA works by inhibiting platelet activation and has been shown to reduce the rate of thrombotic CV events, such as a heart attack or CV death, in patients with ACS.

BRILINTA is available in 90-mg tablets to be administered with a single 180-mg oral loading dose (two 90-mg tablets) followed by a twice daily, 90-mg maintenance dose. Following an initial loading dose of aspirin, BRILINTA should be used with a maintenance dose of 75 mg - 100 mg aspirin once daily, 81-mg aspirin dose in the US.

BRILINTA is a registered trademark of the AstraZeneca group of companies.

About PLATO

PLATO (PLATelet Inhibition and Patient Outcomes) was a large (18,624 patients in 43 countries), head-to-head patient outcomes study of BRILINTA vs clopidogrel, both given in combination with aspirin and other standard therapy. The study was designed to establish whether BRILINTA could achieve a clinically meaningful reduction in cardiovascular (CV) events in acute coronary syndrome (ACS) patients, above and beyond that afforded by clopidogrel. Patients were treated for at least 6 months and up to 12 months.

PLATO demonstrated that treatment with BRILINTA led to a significantly greater reduction in the primary end point – a composite of CV death, MI, or stroke – compared to patients who received clopidogrel (9.8% vs 11.7% at 12 months; 1.9% absolute risk reduction [ARR]; 16% relative risk reduction [RRR]; 95% CI, 0.77 to 0.92; P<0.001). The difference in treatments was driven by CV death and MI with no difference in stroke. In PLATO, the absolute difference in treatment benefit vs clopidogrel was seen at 30 days and the Kaplan-Meier survival curves continued to diverge throughout the 12-month treatment period.

The PLATO study also demonstrated that treatment with BRILINTA for 12 months was associated with a 21% RRR in CV death (4% vs 5.1%; 1.1% ARR; P=0.001) and a 16% RRR in MI compared to clopidogrel at 12 months (5.8% vs 6.9%; 1.1% ARR; P<0.005).

The primary safety end point in the PLATO study was Total Major Bleeding (11.6% for BRILINTA and 11.2% for clopidogrel). In PLATO, non-CABG major + minor bleeding events were more common with BRILINTA vs clopidogrel (8.7% vs 7% respectively). The rate of non-CABG-related major bleeding was higher for BRILINTA (4.5%) vs clopidogrel (3.8%).

Dyspnea was reported in 14% of patients treated with BRILINTA and in 8% of patients treated with clopidogrel. Dyspnea was usually mild to moderate in intensity and often resolved during continued treatment.

About Acute Coronary Syndrome (ACS)

ACS is an umbrella term for conditions that result from insufficient blood supply to the heart muscle. These conditions range from unstable angina (UA), non–ST-elevation myocardial infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI).

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

CONTACTS

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