'Game-changing' anti-clotting treatment funded

PHARMAC is funding an innovative form of anti-blood clotting treatment that will significantly change the way anticoagulation is managed in New Zealand.

Dabigatran (Pradaxa) is a direct thrombin inhibitor, a new type of oral anticoagulant which helps prevent blood clotting. This is essential treatment for people who have the heart rhythm disorder atrial fibrillation, which increases their risk of having a stroke. Dabigatran can also be used to prevent clots following total hip or knee replacements.

Dabigatran will be funded from 1 July 2011 and PHARMAC is believed to be one of the first public funders in the world to fund it without restriction.

PHARMAC Medical Director Dr Peter Moodie says the current standard anticoagulant treatment in atrial fibrillation is warfarin, which has significant risks for patients and requires close patient monitoring including regular blood tests and associated dose adjustments.

“Warfarin has been the standard treatment for many years and, though it is effective, it is difficult to tolerate for some people and is associated with risks of strokes or bleeding if not closely managed,” says Dr Moodie. “Warfarin also has the added difficulty of its levels being affected by food intake such as broccoli, whereas dabigatran is not.

“Funding dabigatran is an exciting step forward for anticoagulation treatment in this country. It is literally a game-changer and demonstrates PHARMAC’s desire to move relatively swiftly to fund genuinely innovative medicines.”

“Although the advice from our clinical committees is that dabigatran may be no more effective than warfarin, we anticipate that it will potentially be better tolerated by some patients as it comes without the need for the intensive patient management that warfarin requires. Because not all patients needing warfarin can tolerate the treatment, some have to be treated using low-dose aspirin, which is not optimal. It is likely that most of those patients will now change to dabigatran.”

“This will mean that anticoagulation treatment will be far more convenient for patients and clinicians, and removes the need for testing which is a significant financial and administrative cost to DHBs and clinicians.”

Warfarin will continue to be funded; however, Dr Moodie says he expects dabigatran to eventually replace warfarin as standard anticoagulant treatment for the indications described above. PHARMAC also recently agreed to fund another anti-clotting agent, rivaroxaban, for clot prevention following major orthopaedic surgery.

Funding dabigatran is likely to be PHARMAC’s largest-value investment this year. Overall, dabigatran could cost as much as $155 million over five years but this cost will be reduced through confidential rebates. PHARMAC estimates about 30,000 to 40,000 people are currently being treated for atrial fibrillation using either warfarin or aspirin, and they could potentially shift to dabigatran.

Dabigatran will have no restrictions on listing, which means it will be able to be prescribed by any clinician for any indication; although it is only currently registered in New Zealand for the treatment of atrial fibrillation and clot prevention following total hip and knee replacements.

Dr Moodie says that, given the shift that is about to occur in anticoagulation treatment, PHARMAC will be supporting the funding decision with wide-spread information and training for clinicians.

“Dabigatran is a comparatively new technology and we want to ensure that clinicians are aware of the risks and how to manage them,” he says. Unlike warfarin which is taken once daily, dabigatran is taken twice a day.

PHARMAC has been working with the Haematology Society of Australia and New Zealand to develop clinical guidelines for managing bleeding side-effects from dabigatran. These guidelines will be made available and sent to hospitals before funding begins.

PHARMAC-funded bpacnz, which produces evidence-based information and guidance for clinicians, is also including information about dabigatran in its regular publication, the Best Practice Journal, to clinicians, practice nurses and pharmacists.