Germany's Federal Joint Committee (G-BA) has delivered a positive opinion for AstraZeneca's antiplatelet therapy Brilique, the first drug to be assessed under new pricing assessment laws that came into effect on January 1, 2011.
Overall, the G-BA came down in favour of Brilique (ticagrelor) as a treatment for patients with acute coronary syndromes, allowing AstraZeneca to start pricing negotiations with the German health insurance system in the New Year.
"The G-BA's final assessment acknowledges the additional benefit that Brilique provides approximately 80 per cent of the ACS patient population in Germany," said AstraZeneca in a statement.
The company also pointed out that Brilique will remain reimbursed in Germany for all ACS patients, as the G-BA report is designed to inform pricing negotiations rather than clinical use or reimbursement policy for a new medicine.
The committee concluded that Brilique (ticagrelor) plus aspirin provided an "important additional benefit" as a treatment for a form of heart attack known as non-ST elevation myocardial infarction in patients with unstable angina (NSTEMI/UA) when compared to standard treatment with Sanofi's Plavix (clopidogrel) plus aspirin.
It also said Brilique was effective in ST-elevated MI patients (STEMI) in a subgroup of patients undergoing percutaneous coronary intervention (PCI) procedures such as angioplasty.
Specifically, the G-BA concluded that it conferred an "additional but not quantifiable" benefit in patients over 75 or those with prior stroke or transient ischaemic attacks (mini strokes), compared to therapy with Eli Lilly's Effient (prasugrel) plus aspirin. However, no additional benefit was seen in other STEMI/PCI patients, such as those undergoing bypass surgeries.
The recommendations are in line with the clinical assessment by Germany's Institute for Quality and Efficiency in Healthcare (IQWiG), which was published in October. Brilique was backed by NICE in the UK later the same month.
Ticagrelor has now been approved in 55 countries - including in the EU under the trade name Brilique and in the US, Canada, Australia and Brazil under the trade name Brilinta - and is reimbursed in 14. Sales have just started to build, with the drug bringing in $13m in the third quarter of 2011.