UK’s NICE favors restricted approval for prasugrel

Prasugrel should be made available in the UK, but only to a limited number of patients, according to preliminary guidance from the National Institute for Health and Clinical Excellence (NICE).

The document recommends that prasugrel, in combination with aspirin, should be “an option for preventing atherothrombotic events in people with acute coronary syndromes having percutaneous coronary intervention” only when immediate PCI for STEMI is “necessary” or when “stent thrombosis has occurred during clopidogrel treatment.” In addition, patients already receiving prasugrel for other indications “should have the option to continue therapy until they and their clinicians consider it appropriate to stop.”

The appraisal committee is now accepting comments on its document, and is not expected to issue a final recommendation until the fall.

You can read more about this an article about this in an article by Selina McKee in PharmaTimes.

Here is a CardioBrief chronology of the prasugrel controversy.

Here is the text of the NICE appraisal committee’s preliminary recommmendations:

Appraisal Committee’s preliminary recommendations

1.1  Prasugrel in combination with aspirin, within its marketing authorisation, is recommended as an option for preventing atherothrombotic events in people with acute coronary syndromes having percutaneous coronary intervention, only when:

  • immediate primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction is necessary, or
  • stent thrombosis has occurred during clopidogrel treatment.

1.2  People currently receiving prasugrel for treatment of acute coronary syndromes whose circumstances do not meet the criteria in 1.1 should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

Comments

  1. concerned says

    serious blow for prasugrel that wanted to take the whole PCI market.

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