Limited Coverage Drugs - Special Authority Criteria

In combination with ASA in patients with an ST elevation myocardial infarction (STEMI) AND prior revascularization via percutaneous coronary intervention with  a bare metal or drug eluting stent(s), AND one of the following while on optimal clopidogrel and ASA therapy:

1. definite stent thrombosis OR
2. recurrent myocardial infarction (MI).

Notes: 

• Definite stent thrombosis as defined by the Academic Research Consortium: when confirmed by angiography or by pathologic confirmation of acute thrombosis; is defined as a total occlusion originating in or within 5 mm of the stent or a visible thrombus within the stent or within 5 mm of the stent in the presence of an acute ischemic clinical syndrome within 48 hours.
• The TRITON-TIMI 38 trial suggests that patients with unstable angina or non ST elevation myocardial infarction (UA/NSTEMI) experience a statistically significant increase in major bleeds with prasugrel compared with clopidogrel.
• As per the product monograph, prasugrel is contraindicated in patients with a known history of transient ischemic attack or stroke; those with active pathological bleeding such as peptic ulcer or intracranial hemorrhage; and those with severe hepatic impairment (Child-Pugh Class C).
• As per the product monograph, prasugrel is not recommended in patients > 75 years of age because of the increase risk of fatal and intracranial bleeding; or those with body weight <60 kg because of increased risk of major bleeding due to an increase in exposure to the active metabolite of prasugrel.