Pradaxa PBS delay halts enrolments in free program

THE manufacturer of dabigatran (Pradaxa) last week halted enrolment in a patient familiarisation program following a government decision to delay PBS listing of the drug and review anticoagulant therapies.

The announcement followed a TGA warning that adverse bleeding events have increased since dabigatran received approval in April this year for patients with non-valvular atrial fibrillation.

Boehringer Ingelheim said patient enrolment for the Pradaxa Start Up Product Familiarisation Program had closed in light of uncertainty about its PBS listing.

“The closure of patient enrolments, while regrettable, is the most responsible decision the company could make in light of the government’s move to further delay the reimbursement of Pradaxa by referring it for further review,” a company statement said.

A spokesperson said at least 25,000 patients were already enrolled in the program, and the drug would continue to be provided free of charge to them until 1 June 2012 or PBS listing “whichever comes first”.