In this Industry Update KMC Health Care analyse the March 2021 PBAC Meeting Outcomes, including the resultant new resubmission categories, and provide Cost Recovery and Health Products Portal development updates. A brief overview of the status of the “Inquiry into Approval Processes for New Drugs and Novel Medical Technologies in Australia” is also presented.
2021 MARCH PBAC OUTCOMES
With so many changes to PBAC Processes, reviewing the March 2021 PBAC Outcomes, released at the end of April, made for interesting reading, providing first insights into the new resubmission categories recommended by the PBAC post rejection. More will be revealed when the full PSD’s are published in the coming months, using the relatively newtransparency criteria impacting the visibility of financial, cost and clinical information.
The following tables provide an overview of the outcomes, comparisons between New Listings and Changes to Listings as well as the published recommended resubmission categories.
| Outcome | Number of Submissions | Major | Minor |
|---|---|---|---|
| Recommended | 27 | 14 | 12 +1 (Other) |
| Not Recommended | 20 | 19 | 1 |
| Deferred | 3 | 2 | 1 |
| N/A | 2 | 2 |
The “other” submission was seeking the PBAC’s advice regarding a listing change.
| Recommended | New Listings | Changes to Listings |
|---|---|---|
| Major Submissions | 4 | 10 |
| Minor Submissions | 3 | 9 |
| Other | 1 |
| Not Recommended | New Listings | Changes to Listings |
|---|---|---|
| Major Submissions | 14 | 5 |
| Minor Submissions | 1 |
| Resubmissions Categories | New Listings | Changes to Listings |
|---|---|---|
| Early Re-Entry | 7 | 1 |
| Early Resolution | 1 | 1 |
There was just over a 50% (27/50) success rate for the March 2021 PBAC Meeting submissions. The two “N/A” outcomes were a withdrawn submission, and a submission to be considered at a future PBAC meeting, with the outcomes providing noreason for the delay. Looking at the differences in PBAC success for New Listings undertaking Major submissions, highlights that 77% (14/18) of all New Listings (Major subs) were unsuccessful. Conversely, the Change to Listing Majorsubmissions had a 67% (10/15) success rate.
This is the first meeting where the new Resubmission Categories have been implemented. Both the Early Re-Entry and Early Resolution categories allow for resubmissions to the July meeting, with the updated agenda showing 5 submissions (4 New Listings & 1 Change to Listing) have taken up the early resubmission option. Also for the first time at the July PBAC Meeting, we will see 7 previously recommended submissions reviewed, in line with the latest policy of reviewing all recommendations that have made no progress to listing after 2 years.
Zimmerman Inquiry Update
Inquiry into Approval Processes for New Drugs and Novel Medical Technologies in Australia
At the time of writing, there were currently over 185 submissions to the “Zimmerman” inquiry from government departments and agencies, sponsors, industry associations, patient advocacy groups and individuals, outlining their experiences and offering their thoughts and recommendations to improve the current processes. There have been 7 days of public hearings with a further 3 days scheduled for May 2021. At these hearings the committee members have heard from industry on their frustration with the current process, including delays in departmental responses and inconsistencies in the acceptance of clinical data between different departmental agencies. Patient groups have painted a picture of how delays have impacted patients and carers quality of life. No expected conclusion date has been published so we will continue to update you as this inquiry progresses.
DEPARTMENTAL UPDATES
Draft Cost Recovery Changes
Consultation on the Draft Cost Recovery Changes is now closed, with the proposed changes not posing a dramatic change, following all the changes we have seen in the last 12 months. Should the confirmed Cost Recovery fees align with those presented in the draft documentation, Sponsors will incur only minor fee increases from 1 July. An update on the confirmed Cost Recovery fees will be provided once available.
Health Product Portal (HPP) Updates
KMC Health Care have been active users of the HPP since its inception, having been a part of the pilot program. The most recent updates having included the List Management Processes, Lodging a New Brand and Brand Deletions. Cost Recovery information, including invoice payment is now also via the HPP. This now means that most of your Pre-PBAC, PBAC, Post-PBAC and Listing needs and departmental communications can be undertaken through the HPP. If you haven’t used the HPP as yet, or require assistance successfully navigating the HPP, please contact KMC Health Care.