AstraZeneca announced that the German reimbursement body, the Federal Joint Committee (G-BA), has published the Institute for Quality and Efficiency in Healthcare (IQWiG) preliminary assessment report regarding the medical benefit of Brilique (ticagrelor). AstraZeneca is pleased with this preliminary assessment as we seek to help ensure ACS patients continue to have access to this innovative medicine in Germany.

AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) is a new law that became effective 1 January 2011 for the mandatory pricing and reimbursement assessment for newly introduced drugs in the German healthcare system. Brilique is the first product to be evaluated under this process.

As part of the process, the G-BA performs a benefit assessment based on the manufacturer’s value dossier and assigns ratings per indication to inform the price negotiations. Ratings range from 1 – 6, with 1 representing “major additional benefit” and 6 representing “less benefit than comparator”. For the Brilique assessment, IQWiG has defined four patient populations with the following comparators: NSTEMI/UA (Non ST-Elevation Myocardial Infarction/Unstable Angina): Clopidogrel + aspirin, STEMI/PCI (ST-Elevation Myocardial Infarction/Percutaneous Coronary Intervention): Prasugrel +aspirin, STEMI/CABG (ST-Elevation Myocardial Infarction Coronary Artery Bypass Graft): aspirin monotherapy and STEMI Medically Managed: Clopidogrel + aspirin.

It is estimated that NSTEMI/UA represents 72 per cent of the acute coronary syndromes (ACS) patient population in Germany. In its preliminary assessment, IQWiG assigned the following ratings: “Important additional benefit” (rating of 2) for NSTEMI/UA and “No additional benefit proven” (rating of 5) for the three STEMI patient sub-populations.

AstraZeneca looks forward to the next step in the process and will respond to the G-BA regarding the assessment in the coming weeks. This will be followed by the final benefit assessment, which is anticipated at the beginning of 2012, after which AstraZeneca will begin pricing discussions 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.

This assessment follows the recent final draft recommendation from the National Institute for Health and Clinical Excellence (NICE), who recommended the use of Brilique by the National Health Service (NHS) in England and Wales. In its Final Appraisal Determination (FAD), NICE concluded that ticagrelor, in combination with low dose aspirin, is a cost-effective treatment option in adult patients with ACS, which includes heart attack and unstable angina.

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: major additional benefit (e.g. cure of disease, significant extension of survival), important additional benefit (e.g. moderate extension of survival), some additional benefit (e.g. reduction in side effects), additional benefit but not quantifiable, no additional benefit proven and less benefit than comparator.

Brilique is an oral antiplatelet treatment for ACS. It is a direct-acting P2Y12 receptor antagonist in a new chemical class called cyclopentyltriazolopyrimidines (CPTPs). Brilique is the first reversibly-binding oral ADP receptor antagonist to be approved for use in ACS.

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 compared to prasugrel or aspirin monotherapy in ACS patients.

Brilique has received price approvals in 20 countries and reimbursement authorizations in nine. The product is approved in 45 countries, including in the European Union under the trade name Brilique and in the US, Brazil, Canada, and Australia, under the trade name Brilinta.

Brilinta and Brilique are trademarks of the AstraZeneca group of companies.

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.