As 2020 draws to a close, it has been a year like no other, KMC Health Care would like to look ahead to 2021 and take time to consider what it will bring…..
PUBLIC SUMMARY DOCUMENTS
Transparency will be the theme of PSDs moving into 2021. We’ve seen glimpses of the new redaction criteria and the narrower published ICER ranges, but with the compulsory implementation impacting all PSDs from the November 2020 PBAC meeting, their release in the first quarter of 2021 will be viewed with great interest. Will it change the use of post hoc clinical information provided to support submissions? Will companies be concerned about the narrowing of ICER ranges and the risk of international pricing impacts? The PSDs are an area to watch closely as they may well impact the industry’s ability for successful submissions.
Some are proposed, some are confirmed, but the changes impacting the PBAC and its processes are bound to impact the sponsor environment – the linking of major and minor submission deadlines, new categories for initial submissions (1, 2, 3 and 4), new categories for resubmission pathways (early re-entry, standard re-entry, early resolution and facilitated resolution including workshop) and their cost recovery impacts, increased features of the HPP, more co-dependent submissions, new technologies and different funding streams. The PBAC processes of a few years ago will be well and truly exiled to the history books.
Whilst not due to expire until mid-2022, it has been reported that Medicines Australia (and other industry associations) have committed to finalising the next industry agreements before the Federal Government budget in May 2021. But what will this new agreement look like – changes to statutory price reductions, industry representatives on government committees, what does “guaranteed” PBS funding actually mean? Only time will tell what these agreements actually entail and the impact across the industry
Inquiry into Approval Processes for New Drugs and Novel Medical Technologies in Australia and the National Medicines Policy Review
At the time of publication there have been 197 submissions to the “Zimmerman” inquiry from government departments and agencies, sponsors, industry associations, patient advocacy groups and individuals. There has been one day of public hearings with no more currently scheduled. As for the National Medicines Policy Review, announced in 2019 but delayed due to COVID-19, there have been industry calls to not rush this review but to take the time necessary to ensure a complete and comprehensive review takes place. What will come of this inquiry and review? Will it shape future government policy? Will they be linked?
2021 AND BEYOND……
These are just some of the changes that may impact our environment and industry as we move into 2021. KMC Health Care keep abreast and are involved in these and many other changes, and are always available to provide insights, information and can assist as you navigate the changing environment and all your Market Access, Reimbursement and Commercialisation needs.