UK pharma AstraZeneca's heart drug Brilique is the first medicine to be evaluated under the new pricing process in Germany.
IHS Global Insight Perspective | |
Significance | Germany's Institute for Quality and Efficiency in Health Care (IQWiG) has concluded that Brilique (ticagrelor) brings significant patient-related outcomes in patients with non ST-elevation myocardial infarction (NSTEMI) or unstable angina but fails to demonstrate an additional benefit in patients with STEMI. |
Implications | IQWiG came to this conclusion after comparing Brilique with the appropriate comparators in four patient populations. The innovation score assigned to Brilique for each patient population will inform the upcoming price negotiations. |
Outlook | The positive preliminary results are set to qualify Brilique for price negotiations with the statutory health insurance. |
Germany's Institute for Quality and Efficiency in Health Care (IQWiG) has issued a positive opinion on UK pharma AstraZeneca's oral antiplatelet treatment Brilique (ticagrelor) after completion of its early benefit assessment. The cost-effectiveness watchdog concluded that Brilique (ticagrelor) brings significant patient-related outcomes in patients with non ST-elevation myocardial infarction (NSTEMI) or unstable angina (UA), but fails to demonstrate an additional benefit in patients with STEMI. IQWiG evaluated Brilique's clinical benefit in adult patients with acute coronary syndromes (ACS) in a total of four patient sub-populations. The summary of the report, in German, is available here.
Brilique's Innovation Scores in Treatment of ACS | |||
Patient Population | Appropriate Comparator | Data Provided | Innovation Score |
NSTEMI/UA | Clopidogrel + aspirin | PLATO study, direct comparison: ticagrelor + aspirin versus clopidogrel + aspirin | Important additional benefit (rating of 2) |
STEMI/Percutaneous Coronary Intervention (PCI) | Prasugrel + aspirin | Indirect comparison of results from PLATO (ticagrelor + aspirin versus clopidogrel + aspirin) and TRITON (prasugrel + aspirin versus clopidogrel + aspirin) | No additional benefit proven (rating of 5) |
STEMI/Coronary Artery Bypass Graft (CABG) | Aspirin monotherapy | No comparison of ticagrelor versus aspirin monotherapy | No additional benefit proven (rating of 5) |
STEMI medically managed | Clopidogrel + aspirin | No data submitted | No additional benefit proven (rating of 5) |
Source: IQWiG | |||
Insufficient data were presented for the STEMI medically managed and STEMI/CABG patient sub-groups. In the STEMI/PCI sub-group, the indirect comparison of results from the PLATO and TRITON studies was insufficient to convince IQWiG of an additional benefit compared with prasugrel plus aspirin. On the positive side, IQWiG recognised an important additional benefit for patients with NSTEMI/UA, which represent 72% of the ACS patient population in Germany.
Outlook and Implications
Outcomes of the early benefit assessment of Brilique are overall very positive for AstraZeneca. Within three months, the G-BA will issue an opinion on whether Brilique qualifies for price negotiations with the statutory health insurance or for reference pricing. In light of its very good innovation score in patients with NSTEMI or UA, Brilique is expected to be subject to price negotiations, starting in January 2012. For now, Brilique is available at a retail price of EUR1.69 (USD2.24) or EUR1.77 per 90-mg tablet, depending on the package size (source: IHS Global Insight's POLI database). The drug will remain freely priced during its first year of commercialisation if the Federal Joint Committee (G-BA) decides to proceed with price negotiations; in light of the results of the early benefit assessment, this is the most plausible hypothesis. But if the G-BA eventually chooses to reference price the drug, Brilique will receive a reference price during the first quarter of 2012.
In Europe, Brilique was recently recommended by the United Kingdom's National Institute for Health and Clinical Excellence (NICE) for use in the National Health Service (NHS; see United Kingdom: 30 June 2011: NICE's ERG Finds Brilique Cost Effective in Comparison with Plavix for UA and NSTEMI Patients with ACS). The drug was found to be cost-effective in combination with aspirin, compared with clopidogrel (Plavix; Sanofi, France) in combination with aspirin for the treatment of UA and NSTEMI patients with ACS.
The results of this first early benefit assessment underline the stringent criteria of the G-BA/IQWiG when it comes to comparative data against appropriate comparators. Under the new pricing process, direct comparisons will be preferred, while indirect ones will have to be very solid to convince the drug watchdog of an additional clinical benefit.