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

Thursday, 15 December 2011

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.


About G-BA Rating System

The G-BA performs a benefit assessment based on the manufacturers’ value dossiers. Ratings are assigned per indication to inform the price negotiations, which are summarized as follows:

  • 1 = Major additional benefit (e.g. cure of disease, significant extension of survival)
  • 2 = Important additional benefit (e.g. moderate extension of survival)
  • 3 = Some additional benefit (e.g. reduction in side effects)
  • 4 = Additional benefit but not quantifiable
  • 5 = No additional benefit proven
  • 6 = Less benefit than comparator

About ACS Patient Population in Germany

It is estimated that NSTEMI/UA represents approximately 72% of the ACS patient population in Germany, and the newly defined STEMI/PCI sub-group represents an approximate further 8%.

About BRILIQUE (ticagrelor tablets)

BRILIQUE is an oral antiplatelet treatment for ACS. BRILIQUE is a direct-acting P2Y12 receptor antagonist in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs).

PLATO (A Study of PLATelet Inhibition and Patient Outcomes) was a large (18,624 patients in 43 countries) head-to-head patient outcomes study of ticagrelor versus clopidogrel in ACS patients, both given in combination with aspirin and other standard therapy. BRILIQUE has not been studied against prasugrel or aspirin monotherapy in ACS patients.

BRILIQUE is currently reimbursed in 14 countries. The product is approved in 55 countries, including in the European Union under the trade name BRILIQUE and in the US, Brazil, Canada, Australia and Russia, under the trade name BRILINTA.

BRILINTA and BRILIQUE are trademarks of the AstraZeneca group of companies. For detailed information regarding BRILINTA / BRILIQUE, please refer to the local Summary of Product Characteristics.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation 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 please visit: www.astrazeneca.com


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