News

# Australian MPs demand more data on dabigatran for atrial fibrillation

BMJ 2013; 346 (Published 15 January 2013) Cite this as: BMJ 2013;346:f303
1. David Brill
1. 1Sydney

Australia is standing firm on its refusal to fund the high profile new anticoagulant dabigatran (marketed as Pradaxa) for preventing strokes in people with atrial fibrillation.

A long anticipated report from the Department of Health and Ageing, published last month,1 urged the federal government to again postpone a decision on whether taxpayers should fund the new generation anticoagulants until further data were available.

The government followed the recommendation, defying considerable pressure from the public and the manufacturer, Boehringer Ingelheim, in a saga spanning almost two years.

The government has asked the company to gather more data, redo its economic analyses, and restate its case to a March meeting of the Pharmaceutical Benefits Advisory Committee, the expert group advising the health minister, Tanya Plibersek, on which drugs to subsidise.

Plibersek said that dabigatran had been used differently in the real world than in clinical trials and that its net benefit and cost effectiveness in clinical practice remained uncertain.

“We make no apology for thoroughly assessing the effectiveness and cost effectiveness of new drugs, balancing access to new medicines while also protecting public safety,” she said.

Dabigatran’s story has taken several unusual twists since the Pharmaceutical Benefits Advisory Committee originally recommended it for public funding back in March 2011. A positive committee verdict of a drug usually ensures smooth passage into the national Pharmaceutical Benefits Scheme, but dabigatran became politicised when the then health minister, Nicola Roxon, stalled its progress. Although the committee had found that dabigatran would prove cost effective, the initial outlay was huge: Roxon said that it was predicted to cost more than $A1bn (£0.7bn; €0.8bn;$US1.1bn) over four years.

The drug was left in limbo for a time, until the government commissioned a comprehensive review of anticoagulation in atrial fibrillation. This took another 15 months.

Meanwhile, matters have been complicated by the fact that 24 000 Australians are already receiving the drug free from Boehringer Ingelheim under a “product familiarisation” scheme, thought to be the country’s largest ever.

The programme, which was launched shortly after the committee’s positive verdict, is fully permitted under Medicines Australia’s code of conduct but has divided the medical community.

Many of the anticoagulation review’s 64 submissions called for dabigatran to be funded, including several from patients in the familiarisation programme.

Savithri Rao, a GP in Sydney, said that her four patients who were taking dabigatran had tolerated it well and found it easy to take, with minimal side effects. “Patients are very happy with it,” she told the BMJ.

Others, however, have strongly criticised the programme. Among them is the Royal Australian College of General Practitioners, which questioned whether companies should be allowed to roll out new drugs in general practice, where infrastructure is often lacking to systematically monitor patient safety.

There have been anecdotal reports of emergency departments being unsure how to handle bleeding in patients on dabigatran. The Therapeutic Goods Administration issued two “safety advisories” in late 2011 urging caution over the risk of bleeding and advising close monitoring of renal function.

Controversy was further fuelled by a Boehringer Ingelheim campaign urging Australians to sign an online petition to “demand 21st century stroke prevention.” This drew over 1000 signatures but was later deemed to breach Medicines Australia’s code on advertising drugs to the general public, landing the company a \$A125 000 fine.

With so much attention on dabigatran, and with the rivals rivaroxaban (Xarelto) and apixaban (Eliquis) now making forays into Australia, the anticoagulation review surprised many by shifting the emphasis back on to the old, off-patent warfarin.

The 153 page final anticoagulation report made sweeping recommendations to improve warfarin use for the estimated 240 000 to 400 000 Australians with atrial fibrillation, including new national guidelines, education campaigns, a shared care model, and financial incentives for warfarin care.

Richmond Jeremy, a Sydney cardiologist and president of the Cardiac Society of Australia and New Zealand, said that the report was comprehensive and pragmatic.

“The newer anticoagulants at this point in time appear to represent a viable alternative for people who have poor warfarin control or, for whatever reason, should not be warfarinised,” he said. “However, there are risks and benefits of all anticoagulant treatment . . . and it remains to be seen how patient compliance with newer agents will compare with that of warfarin.”

## Notes

Cite this as: BMJ 2013;346:f303

## Footnotes

• bmj.com Observations: From rags to riches: the atrial fibrillation story (BMJ 2012;344:e3871, doi:10.1136/bmj.e3871); Editorial: Cost of dabigatran for atrial fibrillation (BMJ 2011;343:d6980, doi:10.1136/bmj.d6980); Research: Dabigatran etexilate versus warfarin in management of non-valvular atrial fibrillation in UK context (BMJ 2011;343:d6333, doi:10.1136/bmj.d6333).

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