Consultation on the revised PBS Post-market Review (PMR) Framework

GSK Australia does not support removing the public consultation step on the draft Terms of Reference (ToR) for a Post Market Review (PMR). Although feedback provided to the PBAC by way of public consultation has made no material difference to the wording of the ToRs for PMRs, it does not mean that this feedback was of limited or no value, only that the feedback is not being implemented. Removing consultation steps is not necessarily required when the PBAC and department have been able to complete reviews within a twelve-month period previously, with all public consultation steps involved. Under the current process, The Review of Anticoagulation Therapies in Atrial Fibrillation in September 2011 and Review of Pharmaceutical Benefits Scheme Anti-dementia Drugs to Treat Alzheimers Disease in March 2012 were completed within ten months. This suggests the delays are not due to the public consultation process itself. Alternatively, GSK Australia supports the PBAC reviewing weighting given to stakeholder feedback in the review process and giving greater consideration into incorporating input received via public consultation which may lead to a more widely supported review.

GSK Australia recognises the importance of various perspectives being considered in this process, including clinical experts and patient groups. GSK Australia supports establishing a Review Reference Group when deemed appropriate by the PBAC, provided external, expert advice is sought independent of the PBAC and department including in instances where relevant expertise exists within the PBAC.

GSK Australia supports publishing the information on the Reference Group on the Post-Market Review webpage at the beginning of the Review.

GSK Australia supports the removal of references to internal working groups and other wording updates being created for each Post Market review.

GSK Australia supports keeping public consultation on the ToRs for PMRs. Removing consultation steps is not necessarily required when the PBAC and department have been able to complete reviews within a twelve-month period previously, with all public consultation steps involved.
Alternatively, GSK Australia supports the PBAC reviewing weighting given to stakeholder feedback in the review process and giving greater consideration into incorporating input received via public consultation. This may lead to a more widely supported review.
GSK Australia also recognises the importance of various perspectives being considered in the Review Reference Group including that of both clinical experts and patient groups, independent of the PBAC and department including in instances where relevant expertise exists within the PBAC. In many cases, these groups may not be aware of the opening of public consultation and therefore miss the opportunity to provide feedback. Even where a Review Reference Group has been formed, the consultation process should be strengthened to not so heavily rely on the PBACs input and be more proactive in attracting varied clinical expert and patient group input.
GSK Australia would like to see greater transparency in items being considered for Post Market Review, namely which are being presented to the PBAC and which of those are selected or rejected. This item list could be published along with the PBAC’s agenda, which would then invite stakeholder feedback through the normal public consultation process. This change would not require any more resource or greater process and may in turn result in fewer PMRs being carried forward and therefore reduce cost.