The U.K.’s National Institute for Health and Clinical Excellence (NICE) has issued its final guidance materials for ticagrelor (Brilique, AstraZeneca). The institute has endorsed the drug as a treatment option in combination with low-dose aspirin for up to 12 months in acute coronary syndromes (ACS) patients.
The European Commission gave AstraZeneca permission to market ticagrelor across the 27 member states within the European Union last December. And, after months of waiting, the FDA approved the drug for the same indications this June.
NICE has endorsed use of the drug in the following patient populations:
- Patients with STEMI;
- Patients with non-STEMI; and
- Patients who are admitted to the hospital with unstable angina defined as ST or T wave changes on electrocardiogram suggestive of ischemia plus one other characteristic associated with cardiovascular disease.
While the drug was previously approved by the European Union for marketing across the member states, the NICE guidelines allow for the marketing of the drug throughout England and Wales, among other countries.
“The independent Appraisal Committee concluded from the evidence that ticagrelor plus aspirin significantly reduces MI and death from cardiovascular causes – by 16 percent and 21 percent respectively – compared with clopidogrel plus aspirin. This draft guidance recognizes the potential of ticagrelor in providing the NHS in England and Wales with another valuable tool to enable it to deal more effectively with the long-term management of ACS,” Carole Longson, MD, director of the NICE health technology evaluation center, said in a statement.
Consultees will have now until Sept. 30 to appeal. If no appeals are received, final guidance materials are expected to be published Oct. 26, according to NICE.