Flash back to 1st January 2011 and the Department of Health introduced a unique market access route for innovative medicines to be listed on the PBS: the Managed Entry Scheme.
The original framework for the introduction of a PBS Managed Entry Scheme outlined that this mechanism would be applicable when:
- There was a clinical need for the intervention; and
- When the PBAC would not otherwise recommend the listing of the drug at the proposed price because the extent or value of the clinical effect is uncertain.
It also specified a future price cannot be specified or guaranteed at the time of the initial listing, but that the PBAC would reconsider a Managed Entry resubmission and a price change in the event that identified uncertainties are resolved by the additional data.
Have the aspirations of Managed Entry Schemes been met?
The PBS Managed Entry Scheme provides an opportunity for new medicines to gain PBS listing earlier than previously possible. Whilst this opportunity sounds good, as suggested by the absence of references to Managed Entry Scheme proposals in PBAC meeting agendas and Public Summary Documents, it appears that there is a reluctance to pursue a Managed Entry route to market from industry.
Reluctance to pursue market entry under a Managed Entry Scheme may be due to a range of regulatory and commercial issues affecting when and how a new product is brought to market. However, a gap in the original framework for Managed Entry Schemes was the high degree of uncertainty about the mechanism(s) for sponsors to be able renegotiate a price that reflects the overall value of their product when mature evidence addressing areas of PBAC uncertainty was available.
Whilst overall industry experience with the PBS Managed Entry Scheme appears to be limited, two positive recommendations under a Managed Entry Scheme were outlined in the November 2014 outcomes of the PBAC meeting (crizotinib [Xalkori®, Pfizer] and trametinib [Mekinist®, GSK].
In both cases the PBAC outlined that there would be no opportunity for sponsors to seek a higher price upon the presentation of more mature evidence, a position seemingly in conflict with the framework for Managed Entry Schemes published by the Department of Health.
In making these recommendations under a Managed Entry Scheme the PBAC has ruled out the option for sponsors to renegotiate price when more robust evidence is available. Further, the PBAC outlined conditions upon which a future price reduction may be sought, as well as the potential need for sponsors to rebate the Australian Commonwealth Government, with interest at a rate deemed appropriate by the Commonwealth. Such conditions are not detailed in, and appear to be in conflict with, the description of the Managed Entry Scheme framework published by the Department in 2011.
Managed Entry Schemes going forward
The punitive scenario under which the PBAC has recommended crizotinib and trametinib be listed on the PBS under a Managed Entry Scheme serves as a further deterrent for sponsors to consider proposing a Managed Entry Scheme under the current framework. Thus, the precedent set by the PBAC in November 2014 may be counter-productive in achieving one of the principles underpinning the development of the Managed Entry Framework: namely providing a mechanism for Australian patients to have early access innovative medicines when there is an unmet clinical need. This would be a disappointing outcome for all parties.
Perhaps reflecting the reluctance of industry to pursue Managed Entry Schemes, the PBAC is set to consider a draft ‘Managed Access Programme’ framework at the March 2015 meeting. Whether or not this programme will represent a pragmatic evolution of the Managed Entry Scheme will be determined over the course of 2015.
In the interests of all stakeholders, let’s hope so.
This article was written by Toby Gould from our Market Access team.