Competition to supply free oral anticoagulants

DESPITE a pending government-ordered report on new oral anticoagulants, sponsors are pushing ahead with marketing their products with a second product familiarisation program (PFP) set to roll out.

Bayer announced last week it would offer free rivaroxaban (Xarelto) to selected patients under a PFP, while Boehringer Ingelheim (BI) said its first-to-market rival drug dabigatran (Pradaxa), was set to extend its PFP for another three months.

But the National Prescribing Service (NPS) has urged GPs to be cautious in switching to the warfarin alternatives.

“It would be useful if the PFPs were rolled out when we know that the product will be subsidised by the PBS and when we have a time frame for that decision,” NPS CEO Dr Lynn Weekes told MO.

“We are advising doctors that if they have patients who are stable on warfarin and tolerating it well, they should not be switched to another anticoagulant at the moment.

“Patients who have been on dabigatran as part of the PFP should remain on that treatment, provided they are not experiencing adverse effects.”

In a submission to the Sansom review into anticoagulant therapies for atrial fibrillation (AF), the NPS warned that better monitoring and GP support was needed when PFPs were implemented in primary care.The RACGP also criticised precipitate marketing of dabigatran.

But Dr Evan Ackermann, the chair of the RACGP national standing committee on quality care said last week that GPs should continue to prescribe anticoagulants in patients with AF according to stroke risk.

“GPs should use the CHADS2 score,” he said. 

Bayer said last week that rivaroxaban would be available to selected patients from May through to December 2013 for PBS reimbursement, whichever came first. 

Rivaroxaban was approved for the prevention of stroke and systemic embolism in patients with non-valvular AF and at least one additional stroke risk factor, and for the treatment of DVT and prevention of recurrent DVT and PE. 

At its March meeting the PBAC gave rivaroxaban a positive recommendation for the latter but rejected Bayer’s submission for listing on the AF indication. A Bayer spokesperson said another submission would be made. 

Meanwhile BI backflipped on its previous decision to end the free supply of dabigatran to 25,000 AF patients enrolled in their PFP on 1 June 2012, announcing last week that it would extend the program until 1 October 2012.