Special Authority Criteria - Prasugrel

Generic Name / Strength / Form

prasugrel

Special Authority Criteria Approval Period

To be taken in combination with ASA in patients with an ST elevation myocardial infarction (STEMI) AND after revascularization with Percutaneous Coronary Intervention (PCI) AND failure on optimal clopidogrel and ASA therapy as defined by one of the following:

Definite stent thrombosis1

OR

Recurrent myocardial infarction (MI).

Notes:

  1. Definite stent thrombosis, according to the Academic Research Consortium, is a total occlusion originating in or within 5 mm of the stent or is a visible thrombus within the stent or is within 5 mm of the stent in the presence of an acute ischemic clinical syndrome within 48 hours. Definite stent thrombosis must be confirmed by angiography or by pathologic evidence of acute thrombosis.

Up to 12 months

Practitioner Exemptions

  • None

Special Notes

  • 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).
  • The TRITON-TIMI 38 trial suggests that patients with unstable angina or non-ST elevation myocardial infarction experience a statistically significant increase in major bleeds with prasugrel compared with clopidogrel.
  • 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.

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