Wednesday, July 26, 2017

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A word from the PHSANZ President.
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PBS Update from the President of the PHSANZ.

The PHSANZ have been making representations to the PBS to have the reimbursement regulations for selective pulmonary dilators in Australia more closely reflecting of international guidelines- in particular the Nice 2013 guidelines. The approach included a meeting with the (then) PBAC chair (Dr. Suzanne Hill), a formal written response and a subsequent written submission to the PBS Drug Utilisation Sub Committee (DUSC) 
Although there was an apparent desire (by the PBS) if possible to match the reimbursement rules to international guidelines the wheels of government turn slowly, and where there may be an expenditure implication, at truly glacial speed.
What has now changed is that the definition of PAH now matches the Nice guideline- mean PAP ≥ 25mmHg and PCWP <15mmHg (no PVR is stated) at rest. Exercise PHT has been removed from the definition as per the Nice guidelines.
We were concerned to remove the blanket need for a trial of a non selective pulmonary dilator. The PHSANZ preferred approach, put to the PBS, was that (only) in the iPAH/fPAH/anorexogen induced PAH group (where the RAP is < 8mmHg at RHC and the patient is not FC IV and where the cardiac index is >2.5 l.min-1.m-2) an acute vasodilator response should be assessed and (only) if positive a trial of Ca  channel blockers should be undertaken.
In response the PBS requirement for those with RAP<8mmHg has been changed slightly to:
"Patient must have failed to respond to appropriate vasodilator treatment unless intolerance or contraindication to such treatment exists"
This I believe does allow us to avoid non selective vasodilator trials except as outlined above in greater concordance with the Nice guidelines.
We are still a long way from PBS funded drug combinations and the PBS have indicated this will require submissions from industry because of the cost implications. We will however continue discussions with industry to see if we can move forward on this important issue.
Trevor Williams
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