Review Finds That More Work is Needed on New Anticoagulant Medicines
A report into anticoagulation therapies released today by the Minister for Health Tanya Plibersek found more work was needed before new oral anticoagulants (NOACs) such as dabigatran (PradaxaŽ) could be listed on the PBS.
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18 December 2012
A report into anticoagulation therapies released today by the Minister for Health Tanya Plibersek found more work was needed before new oral anticoagulants (NOACs) such as dabigatran (PradaxaŽ) could be listed on the PBS.
This review has highlighted that there are differences between the outcomes from clinical trials and how the medicine is used in the real world.
Some use of dabigatran in real world settings has been different to the clinical trial evidence presented to the Pharmaceutical Benefits Advisory Committee (PBAC) in March 2011, including the
- average age of patients who are likely to use it,
- dose that people are likely to use, and
- treatment that patients would otherwise be receiving.
Ms Plibersek said that the emerging use of this drug in practice needs to be reflected in assessing its cost-effectiveness compared with existing treatments.
“Australia is a world leader in health technology assessment and 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.”
In light of the latest clinical information, the Review concluded that ‘the net benefit of NOACs in clinical practice and the subsequent impact on cost-effectiveness is uncertain at this stage and the PBAC should review its March 2011 advice to list, dabigatran on the Pharmaceutical Benefits Schedule’.
The Minister also said that as a result of the safety questions raised in the Report, she had asked the Therapeutic Goods Administration (TGA) to review the safety information for dabigatran and to continue doing so regularly.
Since the previous 2011 PBAC recommendation, the TGA has issued two safety advisories for dabigatran relating to increased risk of bleeding especially for people over 75 years, and the need to monitor kidney function. This highlights the need for caution in prescribing this drug for some patients – specifically the elderly and those with reduced kidney function.
“All drugs have both risks and benefits associated with their use. Dabigatran and the other newer anticoagulants are no different, and as relatively new drugs, it's important to stay on top of the evidence as it emerges to ensure patient safety.”
The Report also found that patients would benefit greatly if barriers to the use of existing therapies such as warfarin were dealt with and that Australians needed to be made more aware of a potentially fatal heart condition known as atrial fibrillation.
“I am keen to give patients and clinicians certainty about how these newer anticoagulants fit into treatment, so I had the matter considered by the PBAC at the first opportunity, on 13 December 2012,” Ms Plibersek said.
“The Committee has advised me that based on the new information that has arisen about this drug’s use in clinical practice, it is now concerned about whether dabigatran represents value for money at the price offered by the company.
“Because of this, the PBAC has now advised me that it is of a mind to rescind its March 2011 recommendation for dabigatran.
“The PBAC feels there is an appropriate place in clinical treatment for the newer anticoagulant medicines, but would like to see further economic modelling to show the value of these new anticoagulants, in light of the additional information now available,” Ms Plibersek said.
“Mindful of the need to finalise its recommendation as soon as possible, the Committee will allow the sponsor of dabigatran and the sponsors of other new oral anticoagulants to make a late submission to the March 2013 meeting.”
“It’s important the companies have the opportunity to respond to the Committee’s comments, and provide the data and economic modelling it requested.
“This comprehensive report will help guide future policy and health service planning for the care of patients with atrial fibrillation,” Ms Plibersek said.
Up to 300,000 Australians, mainly older people, are affected by atrial fibrillation—a common form of cardiac arrhythmia, or irregular heartbeat—which can put sufferers at risk of a stroke at any time. Many have no symptoms and could be unaware of the risk.
The report was undertaken by Emeritus Professor Lloyd Sansom AO, former chair of the Pharmaceutical Benefits Advisory Committee.
The full report is available at the PBS website.
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