PBS update provides new options for people with CVD and leukaemia

UPDATED

High-risk patients with coronary artery disease (CAD) or peripheral artery disease (PAD) can now access the first non-vitamin K antagonist oral anticoagulant (NOAC) to be subsidised via the Pharmaceutical Benefits Scheme (PBS).
 
Rivaroxaban (sold as Xarelto) has been listed in combination with aspirin for the prevention of major cardiovascular events, and its use has been backed by the European Society of Cardiology and Vascular Medicine for the prevention of secondary heart attacks and strokes in this high-risk cohort.
 
There are more than one million people living in Australia with heart disease, who as a result are five to seven times more likely to have a secondary event and are twice as likely to die prematurely compared to the general population.
 
Associate Professor John Amerena, Cardiologist and Director of the Cardiology Research Department at University Hospital Geelong said despite ‘significant advances’ in treatment for cardiovascular disease (CVD), thousands of Australians are still dying annually from preventable secondary events.
 
‘We know from the Phase III COMPASS study, that despite the best available treatment, more can be done to prevent secondary cardiovascular events in these high-risk patients,’ he said.
 
‘GPs play a critical role in reviewing CAD and PAD patients, and working with specialists to consider the right secondary prevention measures.
 
‘It’s exciting that we now have a dual therapy option for the first time, marking a step change in how we can approach secondary prevention in cardiovascular disease.’
 
According to the Phase III COMPASS study, funded by the medication’s developer Bayer, rivaroxaban (2.5mg) twice daily plus aspirin (100mg) once daily reduces major cardiovascular events by 24%, compared to aspirin alone. The study also found that rivaroxaban plus aspirin reduces mortality rates by 18%, compared to aspirin alone, while there is no significant difference in intracranial or fatal bleeding between the two groups.
 
However, it did find a significantly higher risk of major bleeding in patients taking the rivaroxaban/aspirin regimen compared to aspirin alone (HR 1.70; 95% CI 1.40-2.05, P <0.001).
 
The latest round of changes also include the first PBS listing for blood cancer since the launch of the Australia’s Strategic Action Plan for Blood Cancers.
 
Eligible Australians with chronic lymphocytic leukaemia (CLL) are now able to access venetoclax (sold as Venclexta) in combination with obinutuzumab as a first line therapy via the PBS.
 
The combination therapy lasts 12 months and can be used with CLL patients who cannot be treated with standard chemotherapy-based treatments.
 
According to the medication’s manufacturer, AbbVie, venetoclax works by blocking a protein in the body (BCL-2) that helps to kill and reduce the number of these cancer cells.
 
Professor Stephen Opat, Director of Clinical Haematology at Monash Health Haematology, said the new listing means clinicians can now explore a range of options for patients.
 
‘Historically chemotherapy has been the most common starting point to treat blood cancer, but unfortunately there are several [groups of] patients that are unfit or can’t tolerate these agents due to side effects,’ he said.
 
‘Expanding the list of available treatments, especially targeted therapies, is now the focus area for healthcare.’
 
The medication was developed as part of a research collaboration between AbbVie, Genentech, and the Walter and Eliza Hall Institute.
 
Professor John Seymour, Director of Clinical Haematology at the Peter MacCallum Cancer Centre and Royal Melbourne Hospital, said the new listing is a positive development for cancer patients.
 
‘This reimbursement represents another important milestone for Australia,’ he said.
 
‘[Venetoclax] is the result of 30 years of research and collaboration. It is positive to see that this home-grown discovery has now evolved into a medicine that more Australians can have funded access to.’
 
While a host of new medications have been added to the PBS, the 1 December update has also seen a number of deletions – including the impending removal of subsidised access to 28 tablet packets of fluoxetine 20 mg tablet (sold as Prozac).
 
CORRECTION: This article previously stated that fluoxetine would be removed entirely from the PBS, when it is only 28 tablet packets of fluoxetine 20 mg tablet (sold as Prozac).

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cardiovascular disease chronic lymphocytic leukaemia fluoxetine PBS Pharmaceutical Benefits Scheme Prozac