PBS delay forces halt to drug program enrolments

THE manufacturers of dabigatran (Pradaxa) have halted enrolment in a patient familiarisation program for the drug six weeks early following a government decision to delay PBS listing of the drug and review anticoagulant therapies.

The announcement comes a week after the TGA warned that adverse bleeding events have increased since dabigatran received approval for patients with non-valvular atrial fibrillation in April this year.

Boehringer Ingelheim announced in a statement today that the patient enrolment period for the Pradaxa (dabigatran) Start Up Product Familiarisation Program would close tomorrow in light of uncertainty surrounding 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 statement from the company said.