G-BA issues positive final medical benefit assessment for BRILIQUE in Germany

AstraZeneca today announced that the German assessment body, the Federal Joint Committee (G-BA), has issued its final decision regarding the medical benefit of BRILIQUE (ticagrelor). This positive decision is in line with the preliminary assessment published by the Institute for Quality and Efficiency in Healthcare (IQWiG) in October, with the addition of a new ST-Elevation Myocardial Infarction/Percutaneous Coronary Intervention (STEMI/PCI) sub-group for patients over 75 years or patients with prior stroke or transient ischemic attack (TIA).

The G-BA announced its final assessment of BRILIQUE as follows:

• “Important additional benefit” (rating of 2) for Non ST-Elevation Myocardial Infarction/Unstable Angina (NSTEMI/UA); comparator: Clopidogrel + aspirin
• “Additional benefit but not quantifiable” (rating of 4) for STEMI/PCI patients over 75 years or those patients with prior stroke or TIA; comparator: Prasugrel + aspirin
• “No additional benefit proven” (rating of 5) for the three following STEMI patient sub-populations: •STEMI/PCI (separate from the above); comparator: Prasugrel +aspirin
• STEMI/CABG (ST-Elevation Myocardial Infarction Coronary Artery Bypass Graft); comparator: aspirin monotherapy
• STEMI Medically Managed; comparator: Clopidogrel + aspirin

In the PLATO study (PLATelet Inhibition and Patient Outcomes), BRILIQUE demonstrated superior efficacy versus clopidogrel across a broad spectrum of acute coronary syndromes (ACS) patients, including both NSTEMI/UA and STEMI. The GBA’s final assessment acknowledges the additional benefit that BRILIQUE provides approximately 80% of the ACS patient population in Germany.

This outcome represents the first decision by the G-BA under AMNOG (Arzneimittelmarkt-Neuordnungsgesetz), the new law that became effective 1 January 2011 for the mandatory pricing assessment for newly introduced drugs in the German healthcare system. BRILIQUE is the first product to be evaluated under this process.

While the G-BA decision informs pricing negotiations, it is important to note that BRILIQUE will remain reimbursed in Germany for the full ACS patient population.

AstraZeneca will begin pricing discussions in January with the GKV-SV, the Federal Association of Statutory Health Insurance Funds.

BRILIQUE is already available in Germany for healthcare professionals to prescribe in accordance with local guidance. On 6 December 2010, the European Commission approved BRILIQUE for the prevention of atherothrombotic events in adult patients with ACS (unstable angina, NSTEMI, or STEMI). In August 2011, BRILIQUE was placed in a first line position ahead of clopidogrel in the revised treatment guidelines for Non ST-Elevation Myocardial Infarction (NSTEMI)/Unstable Angina patients issued by the European Society of Cardiology.