First G-BA decision to assess the additional benefit of a new drug
15.12.2011 18:45
The Federal Joint Committee (G-BA) completed the first procedure for an early benefit assessment for drugs with new active ingredients, as required by law for drugs approved after January 1, 2011, in Berlin in mid-December. It's about the additional benefit of ticagrelor, an active ingredient used to treat certain cardiovascular diseases (acute coronary syndrome).
The decision, which was taken by consensus between the G-BA sponsors and the patient representatives, represents a considerable additional benefit for ticagrelor for patients with unstable angina pectoris (IA) as well as for patients with myocardial infarction without ST-segment elevation (NSTEMI, ST-segment is a curve section of the electrocardiogram). The appropriate comparator therapy defined by the G-BA here is clopidogrel plus ASA.
For patients with myocardial infarction with ST-segment elevation and percutaneous coronary intervention (cardiac catheter-assisted treatment of narrowed or blocked coronary arteries), the G-BA finds no additional benefit compared to therapy with prasugrel plus aspirin. Excluded from this are patient groups for whom the G-BA sees evidence of a non-quantifiable additional benefit. These are patients over 75 years of age who, after an individual risk-benefit assessment, are not eligible for treatment with prasugrel plus ASA, as well as patients whose medical history includes an ischemic stroke or a transient ischemic attack (circulatory disorder in the body). brain, which causes neurological deficits).
The G-BA found no additional benefit of this active ingredient for two other patient groups for which ticagrelor is approved. These are patients with ST-segment elevation myocardial infarction who were treated with the comparator therapy clopidogrel plus aspirin as well as patients with ST-segment elevation myocardial infarction and aortocoronary bypass surgery who received only aspirin.
The resolution was prepared on the basis of the benefit assessment by the Institute for Quality and Efficiency (IQWiG) and takes into account the results of the written and oral comment process. The G-BA assessed the extent of the additional benefit in accordance with the criteria set out in the Rules of Procedure (Chapter 5, Section 5 Para. 7 VerfO). The next step will be for the National Association of Statutory Health Insurance Funds to conduct price negotiations with the pharmaceutical company AstraZeneca on the basis of the G-BA decision.
Around 20 additional active ingredients are currently in the early benefit assessment process.
The G-BA's decision will be submitted to the Federal Ministry of Health for review and, if there are no objections, will come into force after it is announced in the Federal Gazette. The text of the resolution is now available on the following website:
http://www.g-ba.de/informationen/beschluesse/zum-aufgabenbereich/54/