Pressure is mounting on decisions to recommend and continue funding health technologies. Concerns around the rising cost of new medicines, an ageing population with greater resource utilisation, federal and state healthcare budgetary constraints, and an increasing dependency ratio (the ratio of individuals who are not in the labour force compared to those who are and paying tax) are significant contributors to that pressure.
As a developed country we are not alone facing the pressures of allocating increasingly limited resources to maximise health gains from our healthcare system. However debate in other countries with publically funded centralised healthcare systems has focused on refining how the value of new health technologies is assessed and translated into price. The premise of this has been to provide manufacturers with greater certainty around their investment and market access decisions.
Reforms in Australian healthcare policy have seemingly focused on the affordability of currently reimbursed products. The first of the 5% statutory price reductions began on April 1 2016 through the PBS Access and Sustainability Package for those molecules which have been in the F1 formulary for five years or more. This now adds a time component for which a molecule (irrespective of indication, timing of patent expiry or data exclusivity periods) can be listed before reductions in price are legislated, on top of price disclosure reductions legislated as the molecule shifts to the F2 formulary and generic medicines become available and compete for market share.
While policies that impact the affordability of medicines are applied post-listing, the initial benchmark assessment of value occurs during the submission phase. Demonstrating value to the PBS for new medicines is required throughout HTA processes, firstly through an assessment of the clinical effectiveness and safety of new medicines against a comparator in clinical trials. Then, depending upon these outcomes, the incremental clinical performance must be explained through a cost-minimisation or cost-effectiveness/utility analysis by considering health effects and healthcare resource implications.
Though attention has begun to turn to the inclusion of non-health attributes such as consumer experience/preference, it is not clear how these additional attributes will be incorporated into the decision making process. For example, whether they will be explicitly incorporated into a cost-effectiveness or cost-minimisation analysis or if they will be considered as additional criteria outside of the evaluation process. Perhaps there will be a standard framework for which information is assessed but how will that be standardised and communicated?
Similar issues arise in relation to existing consideration of life saving drugs and the role of the rule of rescue.
Over the next few months, the Guidelines Review Steering Committee will review the public consultation submissions issued in response to the new draft PBAC guidelines for the assessment of medicines. We can only hope that amongst their considerations they:
- Review whether deliberative decision making is appropriate for consistent and transparent outcomes, and
- Consider the array of decision making frameworks that fall under the umbrella of multi-criteria decision making (MCDA) which can be used to explicitly link different attributes, and effectively and transparently communicate outcomes.
As part of a broader process, it would be greatly advantageous to further consider, what relevant non-health attributes ought to be included; how they will be measured; how they will be valued; how the value of individual attributes will be aggregated and how this will be linked to an assessment of a medicines overall value.
The expertise and experience of the Commercial Eyes Market Access team is at your disposal to help you navigate the PBAC Guidelines for the assessment of medicines. Call us on +61 3 9251 0777.
This article was written by Peter Moore, our Health Economics and Market Access Manager.