Monday, November 19, 2012

Federal Government criticised over delay of new heart and stroke drug Pradaxa (Australia)

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The Federal Government is under pressure to subsidise a blood-thinning drug.

THOUSANDS of patients are at risk of a stroke or heart attack as the Government continues to delay subsidising a new blood-thinning medication its own experts recommended 18 months ago.

The $100-a-month treatment Pradaxa can be used by an estimated 100,000 Australian patients who can't or won't use the current treatment Warfarin, which requires regular blood tests and interacts with food and other medicines. The Pharmaceutical Benefits Advisory Committee recommended Pradaxa be subsidised in March 2011 but the Government failed to approve the subsidy within the required six months.

Instead, it asked the chair of the PBAC to review his own decision in a new inquiry that was meant to report in July this year. The outcome of that inquiry has still not been made public and there are growing concerns the Government is trying to delay subsidising the drug, at a cost of about $250 million a year, so it can balance its Budget. Greens health spokesman Senator Richard Di Natale has expressed concerns about increasing delays in listing drugs once they have been approved by the PBAC. "The PBAC approval process is one of the few areas of public policy that involves establishing a rigorous evidence base and it needs to be protected from all forms of interference," he said. "While some approved medications might appear to be expensive, it needs to be remembered that an independent expert assessment has shown them to be cost-effective over the long term and that decision must be respected,'' he told pharmaceutical journal Daily Dispatch.

Pradaxa is used in New Zealand and is widely available across the world. Boehringer Ingelheim, which makes the medicine, says it is receiving 50-60 phone calls a day from patients worried about the status of Pradaxa. "We believe the Government understands the need for further treatment options to prevent stroke for thousands of senior Australians with atrial fibrillation and is in a position to act swiftly," the managing director of Boehringer Ingelheim Wes Cook said.

Canberra cardiologist Libby Anderson says Pradaxa is a safer drug as "very simply from the patient's point of view it doesn't require blood tests at least once a month". She says 10 per cent of the population aged over 70 have an irregular heartbeat and the condition is responsible for one in five strokes. Self-funded retiree Shirley Savell is receiving Pradaxa under a special free-access program funded by Boehringer Ingelheim and says when she was using Warfarin she needed a fasting blood test every three days to make sure her dose was correct and couldn't eat green vegetables.

She accused the Government of "playing games" by delaying the subsidy. The provision of the Pradaxa review to the Government "is imminent", said a spokesman for Health Minster Tanya Plibersek and it would then "consider what further action is required".


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