Prostheses List reforms
...the differing benefit setting arrangements for prostheses
between the public and private hospitals sectors result in private health
insurers having to reimburse prostheses at much higher levels in the private
hospital sector where clinicians are not required or encouraged to consider
cost effectiveness. While some differences reflect the level of training and
product support between public and private hospitals, benchmarking indicates
variation that exceeds this justification.[1]
3.1
The previous chapters have outlined the Prostheses List (PL) framework,
and the history behind the current issues that this inquiry seeks to address.
3.2
This chapter will examine the review of the PL framework undertaken in
2016 and the reforms announced by the government.
3.3
Chapter 4 will canvas the issues raised in relation to the review and
reforms that have been undertaken and those that are proposed to be undertaken.
3.4
The key issues which arise again and again in relation to prostheses
pricing and the administration of the system are the lack of transparency in
how decisions are made, and limited integration between health technology
assessment (HTA) systems and processes. These issues persist despite a number
of reviews, over an extensive period which have recommended greater
transparency and better coordination and integration of HTA systems.
Industry Working Group on Private Health Insurance Prostheses Reform
3.5
The government established the Industry Working Group on Private Health
Insurance Prostheses Reform (IWG) to assess the current PL system, in the
context of a broader review of private health insurance regulation.[2]
3.6
The IWG, chaired by Emeritus Professor Lloyd Sansom AO,[3]
was established by the Department of Health (department) in February 2016 and
included representatives from the medical devices industry, private for-profit
and not-for-profit hospitals, consumers, private health insurers, the medical
profession and the Department of Health.[4]
3.7
The IWG review was tasked with assessing the current prostheses benefit
setting system, including the Prostheses List Advisory Committee (PLAC) and its
subcommittees, and advising the department on:
-
creating a more competitive basis for purchase and reimbursement
of prostheses and devices, including consideration of options for new pricing
mechanisms;
-
specific products or categories which present opportunities for
immediate benefit rationalisation;
-
refining the scope of products currently listed on the Prostheses
List without adversely impacting on consumer access; and
-
opportunities for deregulation.[5]
3.8
The report of the IWG was provided to the department in March 2016 and
to the Minister for Health in April 2016.[6]
In its report, the IWG indicated that it had reached agreement on a number of
points, including that:
-
a PL should be maintained;
-
the PLAC and its advisory committee arrangements be revised;
-
government should consider opportunities for enhanced
co-operation between the PLAC and the Therapeutic Goods Administration (TGA);
-
appropriate costs for inclusion should be considered when setting
benefit levels;
-
consideration should be given to legislating a price disclosure
system, including public and private prostheses pricing;
-
reference pricing be considered as an option for setting PL
benefit levels, with appropriate domestic and international price benchmarks;
-
consideration be given to amending the PL criteria;
-
development of new PL guidelines; and
-
if the government wished to make immediate benefit reductions,
then benefits on the PL for cardiac, intra-ocular lens systems, hips and knees
should be considered.[7]
Government response to the IWG
report
3.9
In the 2016–17 Budget the government committed to reconstitute the PLAC
to further develop and advise on implementing changes to PL arrangements recommended
by the IWG,[8]
and, upon the public release of the IWG's report in October 2016, the Minister
for Health announced that the government's prostheses reforms would include:
-
reducing the cost of medical devices as set by the Prostheses
List by 10 per cent for cardiac devices and intraocular lenses and 7.5 per cent
for hip and knee replacements from 20 February 2017;
-
reconstituting the new Prostheses List Advisory Committee (PLAC)
that will develop, consult and advise the Government on further changes to the prostheses
listing arrangements;
-
investigating a move towards applying a more robust and
transparent price disclosure model of ongoing, sustainable reductions to the
cost of medical devices through the new PLAC;
-
faster access to new innovative medical device technologies
through improved listing processes without compromising safety; and
-
considering a transparent way to reimburse hospitals for the
costs of maintaining inventory of medical devices so that they are on hand when
needed.[9]
3.10
On 4 May 2017, the Minister for Health announced that the PLAC will
commence targeted reviews of hip, knee, cardiac and spinal prostheses groups,
following release of a draft Approach for Targeted Prostheses Reviews.[10]
Reforms already implemented
3.11
Of the reforms announced by the Minister for Health in 2016, two have
been implemented to date – reductions in the benefit levels for certain types
of prostheses and changes to the PLAC.
Reducing the cost of cardiac,
intra-ocular, hip and knee prostheses
3.12
As mentioned above, in October 2016 the Minister for Health announced
that there would be a reduction in certain benefit levels for some groups of
devices on the PL. Specifically, there would be a 10 per cent reduction in the
benefit level for cardiac devices and intra-ocular lenses and a 7.5 per cent
reduction for hip and knee replacements. The reduced benefit levels would come
into effect from 20 February 2017, with an estimated saving of $500 million
over 6 years.[11]
3.13
The government intends that these savings will be passed on to consumers
through lower increases in annual private health insurance premiums. The department
confirmed that the savings had already been factored into the premium increases
effective from 1 April 2017:
As part of the process of submitting their application to the
minister via APRA they [private health insurers] had to declare that they had
applied the prostheses savings and what the differences were.[12]
3.14
The Private Health Insurance (Prostheses) Amendment Rules 2016 (No. 4)
were to come into effect on 20 February 2017 to revise the benefits of 2,439
cardiac, intra-ocular lens, hip and knee prostheses on Part A of the Private
Health Insurance (Prostheses) Rules 2016 (No. 4).[13]
3.15
Prior to the commencement date, the department identified that details
relating to some billing codes on the Prostheses List were incorrect and made
the Private Health Insurance (Prostheses) Amendment Rules 2017 (No. 1) to
address this issue.[14]
The explanatory statement for the new rules noted that this most recent
amendment was made to 'ensure that benefit reductions as listed in the 2016
Amendment Rules take effect and that these devices remain eligible for benefits
from insurers.'[15]
3.16
The reductions to PL benefit levels for cardiac, intraocular lens, hip
and knee devices were made following the IWG's report indicating that these
areas could be considered for immediate benefit reduction. This was based on
data obtained by the IWG and analysed by the Chair of the IWG and the department.
3.17
Data in relation to prostheses pricing in the Western Australian public
hospital system and internationally was provided to the Chair of the IWG, who
then wrote to medical device sponsors with items on the PL requesting
information in relation to the net revenue for items in the categories of
cardiac, hips, knees and intra-ocular lenses for the year to 31 December 2015.
Sponsors were asked to provide the total revenue and volume sold in both the
public and private hospital sectors, as well as information in relation to the
value of any incentives provided.[16]
3.18
In its report, the IWG noted that the Chair of the IWG wrote to 57
medical device sponsors, with only 20 responses received. Similarly, the Chair
wrote to State and Territory governments seeking similar information, and four
jurisdictions provided a response.[17]
3.19
In evidence to the committee, the department stated that in response to
requests for information, the Chair of the IWG 'very often received a reply
that the issues they were seeking were covered by confidentiality
arrangements.'[18]The
department also provided evidence that:
The data was provided at an aggregate level and does not
clarify the level, how or if incentives were provided – whether as discounts,
rebates or other direct or indirect purchasing incentives.[19]
3.20
Despite this, the IWG stated that:
the responses received clearly indicated that a price
differential exists between public and private sectors. The IWG noted that the
differential varies between and within categories.[20]
3.21
While the details about the size and scope of PL benefit reductions were
made public, the precise method, and the data used, for calculating the benefit
reductions was not. The committee notes the IWG's recommendation to the
department in its report:
The IWG noted that benefit reductions may have relatively
larger financial impacts on smaller companies, and recommended that these
impacts be taken into consideration before benefit reductions are finalised.[21]
3.22
In a supplementary submission to the inquiry, a group of four Australian
owned small and medium enterprises (SMEs) who develop, manufacture and
distribute medical devices, stated that:
The recent 7.5% price cut to hips and knees on the Prostheses
List has reduced Global Orthopaedic Technology’s top line revenue by $2.4
million which has dropped straight to the bottom line. As a result, it has
implemented a hiring freeze and placed a significant research and development
project on hold. The spectre of more price cuts will further undermine
confidence and lead to employee redundancies, not just threatening its ongoing commitment
to innovation but the viability of the business.[22]
3.23
Other device sponsors have also been critical of the approach taken in
this initial targeted review and reduction of prostheses benefits on the PL.
For example, Biotronik Australia Pty Ltd commented that:
An adhoc cut of 7.5‐ 10%
to benefits on the PL based on only a shallow assessment of price structures by
the IWG & DoH undertaken in isolation is poor governance as it creates
market and more importantly patient care dislocation. This is especially so
when the industry is put on notice that further reform will lead to further
disruption.[23]
3.24
The medical device industry association suggested that the benefit
reductions were not based on evidence 'and arose due to pressure from private
insurers to make some savings.'[24]
In their evidence before the committee, the Medical Technology Association of
Australia (MTAA), which was represented on the IWG and is also represented on
the PLAC, indicated that these first cuts 'pre-dated the reformed and amended
terms of reference of the PLAC which allows it to consider reforms to the
Prostheses List (PL)'[25]
and that:
Essentially, while the department had requested companies
provide information around the pricing of products and services that were being
provided and discounting or whatever, the information the department got was
that they were not able to draw definitive conclusions about what was really
happening in the marketplace, and that really reflects the level of complexity
that needs to be understood around the supply chain issues... One of the things
around the price cuts was that there was absolutely no evidence, or no tangible
evidence, on which the department would have provided advice to the minister as
to the size of the PL benefit adjustments that should occur.[26]
3.25
It is important to note that not all stakeholders were critical of the
first round of targeted cuts that came into effect in February 2017. Private
health insurers have welcomed the changes to the PL:
We estimated the government's recent price reductions would
realise approximately $24 million in savings to our customers, and we have
fully passed on those savings. Our 2017 premium increase is 35 basis points
lower than it otherwise would have been because of the government's recent
reductions to some prostheses prices. Prostheses reforms are, in other words,
delivering material benefits to consumers by helping to keep downward pressure
on private health insurance premiums.[27]
3.26
The committee notes that, following the reductions in benefit levels for
some groups on the PL, the Minister for Health wrote to the Chair of the
Independent Hospital Pricing Authority (IHPA) requesting a report regarding:
-
average public sector prosthesis costs (by Diagnosis Related Group
(DRG));
-
average public sector private insurance payments for prosthesis
(by DRG);
-
average private sector prosthesis costs by DRG;
-
an assessment of the validity and reliability of the average
costs, including identifying data limitations; and
-
proposals to increase the robustness of the private collection if
it were to be used for price setting (compel private hospitals to participate,
independent review of submissions etc.).[28]
3.27
In his letter, the Minister stated that, 'We need a better balance
between price and access for private patients,'[29]
and that the information provided in the report:
will provide the Prostheses List Advisory Committee and the
Department of Health data to help inform areas for potential reductions in the
costs of medical devices and deliver more savings to private health insurers.[30]
Committee view
3.28
The committee has heard that the PL benefit reductions to cardiac,
intra-ocular lens, hip and knee prostheses, which came into effect on 20
February 2017, were based on a recommendation of the IWG which included
stakeholders from across all relevant sectors.
3.29
The committee notes, however, that the decision by the Minister for
Health to make the cuts and the size of the cuts, appears to have been made
with limited access to sufficient data. The committee notes that the Minister
has subsequently requested data and advice from the IHPA which will assist the
Minister in making further changes to the PL.
3.30
The committee notes that the reforms undertaken to date have received
both praise and criticism from stakeholders. Despite this, there is
considerable support for ongoing reforms, and a willingness on the part of
stakeholders to participate in the improvement of the PL framework.
Reconstituted Prostheses List Advisory Committee
3.31
The other key PL reform undertaken to date is the re-constitution of the
PLAC. The new PLAC was announced in October 2016, and is comprised of an
independent Chair, Professor Terry Campbell, and individuals with expertise in health
technology assessment, specialist surgery/interventional work, health economics
and consumer issues, and representatives of stakeholders, including medical
device sponsors, private hospitals and private health insurers. There are up to
21 members at any one time, including up to 12 expert members, and up to 8
advisory members. The list of current members of the PLAC is attached at
Appendix 3.[31]
3.32
During evidence presented during the inquiry, the committee was informed
by the department that the newly constituted PLAC has 'a much more non-aligned
membership than it may have done in the past.'[32]
PLAC Terms of Reference
3.33
The terms of reference for the PLAC state that, in addition to its role
in making recommendations to the Minister on applications to list medical
devices on the PL and related matters, it will also:
-
develop options for improving application and assessment
processes as recommended by the Industry Working Group on Private Health
Insurance Prostheses Reform (IWG) to drive improved cost effectiveness of new
and current medical devices;
-
revise its governance structure including its sub-committees to
ensure alignment with the purpose of the Committee and reform directions
outlined by Government;
-
make recommendations to the Minister on moving to a benefit
setting mechanism that reflects real market dynamics for medical devices, such
as price disclosure and/or reference to pricing in other markets; and
-
assist the department to advise the Minister on any other policy
matters pertaining to the medical device listing arrangements.[33]
3.34
The PLAC is assisted in its consideration of PL applications by 11
sub-committees:
-
nine Clinical Advisory Groups (CAGs);
-
the Panel of Clinical Experts; and
-
the Health Economics Sub Committee (HESC).
3.35
The committee has been informed that the department currently engages 12 FTE
(full time equivalent) staff to support the work of the PLAC and its
subcommittees.[34]
It is not clear from the evidence provided to the committee if additional
resources have been provided to the PLAC to undertake its reform work.
3.36
Funding of the administration of the PL is undertaken on a cost recovery
basis through fees paid for by medical device sponsors to apply for, list and
maintain listing on the PL.[35]
The 2016–17 Budget did not provide additional resources for the reconstituted
PLAC or the reform process, indicating that 'the costs of this component to be
met from within existing resources of the Department of Health.'[36]
PLAC and administration of the PL
3.37
Some stakeholders expressed concern about the resourcing of
administration of the PL, and the impact that this has had, and continues to
have, on the ability of the PLAC to function as effectively as it might,
particularly in relation to review and updating of the PL to remove devices
that should no longer be on the list.[37]
3.38
In its submission, Biotronik Australia Pty Ltd was critical of the existing
arrangements, in which it said the secretariat was insufficiently resourced and
lacked corporate knowledge which has led to delays and errors in processing
applications[38]
3.39
There have been concerns expressed that the administration of the
current Prostheses List does not allow for timely reviews of medical devices on
the list, to 'weed out' items that are outdated or do not perform:
the department has its heart in the right place but the
problem is it is under resourced to deal with a list of 10,000.[39]
3.40
The committee notes the concerns expressed by some stakeholders in
relation to the resourcing of the PLAC and other administration of the PL. The
committee also notes the length of time taken for earlier reforms, for example
those arising from the 2009 Health Technology Assessment (HTA) review, to be
implemented.[40]
3.41
In its Cost Recovery Implementation Statement for 1 July 2016 to 30 June
2017, the department states that the costs of administering the Prostheses List
are recovered from medical device sponsors through the payment of application
fees to list new prostheses, a fee to list each new prosthesis and a periodic
fee to maintain listing on the Prostheses List. These fees are set by the
Private Health Insurance (Prostheses Application and Listing Fee) Act 2007 and
associated rules.
3.42
The department notes that since January 2009, the fees have been:
-
$600 to apply to list a new prosthesis
-
$$200 to initially list a new prosthesis; and
-
$200 each six months to maintain a listing.[41]
3.43
It does not appear that a review of fees has been undertaken since 2009.
3.44
The committee also notes that the key performance indicator for PL
activity is the percentage of PL applications completed within 22 weeks of the
date of application.[42]
There appear to be no performance indicators for review of the PL, nor for other
activities, including the proposed activities in the PLAC Reform Work Plan
(work plan).
Committee view
3.45
The committee welcomes the government's intention to maintain continuity
of operations of the PLAC whilst driving reforms of the PL. The reforms that
have been made to date are a start to a process of reform that needs to
continue and an excellent opportunity to review the best way to achieve longer
term goals of the reform process.
3.46
The committee notes the concerns raised by some stakeholders about the
limited resources available to the PLAC to better support administration of the
ever increasing PL itself, in addition to undertaking significant and
fundamental reforms to the benefit setting regime.
3.47
It is also important to note that there are very complex
interrelationships involved in the provision of prostheses through private
health insurance, and a very real need to avoid cost-shifting to the public
sector or significant adverse impacts on the various sectors involved. Achieving
the balance between price and access for private patients that the Minister for
Health desires, without causing significant disruption and unintended
consequences in other areas, may require additional support to ensure
appropriate consideration of all issues and consultation.
PLAC Reform Work Plan
3.48
The PLAC issued a work plan in late 2016, which sets out proposed
activities to be undertaken by the PLAC to address the following issues:
-
targeted PL benefit and category reviews;
-
longer term PL benefits setting framework;
-
review the criteria for listing on the PL; and
-
minimise duplication and improve the process for listing on the
PL.[43]
3.49
Key proposed activities in the work plan include:
-
development of a framework to guide targeted reviews of benefits
and categories;
-
research, consultation and development of a benefit setting
model;
-
review and amend definitions and criteria for listing on the PL;
and
-
review the health technology assessment processes across the
Therapeutic Goods Administration (TGA), the Medical Services Advisory Committee
(MSAC) and PLAC to identify duplication, opportunities for data sharing, best
use of clinical expertise and post market monitoring, and options for faster
listing of devices.[44]
3.50
The PLAC pages on the department website provide updates on the work of
the PLAC through communiques.[45]
Five communiques were published between October 2016 and February 2017. A brief
outline of progress on this work as set out in the communiques is outlined in
the table below. Some further discussion in relation to specific issues and
activities follows, where some progress has been made.
Table
3.1: PLAC Reform Work Plan – progress on activities to February 2017[46]
Work Plan Issue for
Consideration
|
Progress on proposed Work
Plan activities
(at 5 May 2017)
|
Targeted benefits and category
review |
Discussion on establishment of
a formal structured mechanism to enable regular reviews of PL listings and
benefits.
Draft document 'Draft Proposed
Approach for Targeted Prostheses Reviews' released for consultation. |
Longer term benefits setting
framework |
Professor Philip Clarke,
Centre for Health Policy, University of Melbourne, engaged to research
pricing models for medical devices and develop potential options for a future
benefit setting framework.
Presentation on price
disclosure in the government's subsidisation of pharmaceuticals. Prostheses Benefit Setting
Framework: Comparative analysis of benefit setting models published. |
Review the criteria for
listing |
Initial talks on potential options
relating to how the assessment of critical consumable components, novel
devices, appropriate suffixes and benefits could occur in the future. |
Minimising duplication and
improve the listing process |
New committee, the Regulation
and Reimbursement of Medical Devices group, established comprising the chairs
of MSAC, PBAC and PLAC and department staff (TG and the Medical and
Pharmaceutical Benefits Divisions).
Group to explore collaboration
between HTA bodies, information sharing, parallel processing, comparison of
application processes and clinical evidence requirements. |
Consultation on PL reforms
3.51
The PLAC communique of December 2016 indicates that the PLAC agreed to:
convene stakeholder forums to enhance communication and broad
engagement with stakeholders. These forums will provide opportunities for input
to the reform process and will be conducted in the second quarter of 2017, once
progress has been made on the reform options.[47]
3.52
All stakeholders supported greater transparency from the department and
the PLAC in decision making and operations of the PLAC.
Committee view
3.53
The committee notes that the work plan for the PLAC contains a list of
proposed activities with proposed commencement times but does not provide any
clear indication for those outside of the PLAC membership about what will
indeed be occurring and within what timeframes.
3.54
Given the concerns raised across all stakeholder groups about ensuring
both transparency and access to timely information in relation to proposed and
actual PL reforms, the committee considers it appropriate for the PLAC to place
greater emphasis on more clearly defining what activities will be undertaken,
and setting some timeframes within which these activities will be completed. The
committee considers it a necessary step that a work plan with defined
activities, timeframes and concrete outcomes be finalised and published as a
priority, in consultation with stakeholders.
3.55
In addition, the committee notes the need for appropriate and broad
consultation in relation to significant regulatory and administrative changes
that, as many have noted, have the potential for unforeseen and potentially
perverse consequences.
3.56
It would be appropriate for the PLAC and the department to ensure that
wide consultations are an integral part of the early and ongoing stages of the
development and implementation of changes to the PL framework. It will be
important to ensure that these consultations are properly organised and
administered to enable timely and meaningful input from those who may be
affected by any changes.
Targeted benefits and category
review
3.57
The PLAC has included as part of its work plan the targeted review of PL
benefits and groups. This work has commenced with the development of a formal
mechanism within which to undertake PL listings and benefit reviews, as
indicated in the PLAC work plan and communiques to date.
3.58
Professor Campbell, Chair of the PLAC, informed the committee that some
specific groups had already been identified for targeting:
The plan at the moment is not to review all existing prices
but to look at a number of groups. That is out there in the public domain, and
the one we are starting with is hips and knees. We are then potentially looking
at cardiac and maybe ophthalmic, the big ones.[48]
3.59
The committee notes with interest that the items mentioned by the PLAC
chair as part of the first targeted review are the same groups for which
benefit reductions have already been made.
Minimising duplication and improve
the listing process
3.60
A number of reviews over the past decade have recommended better
integration of HTA processes, including some inquiries undertaken by this
committee.[49]
Submissions to this inquiry have also argued for better coordination and
reductions in duplication across HTA systems.[50]
3.61
In canvassing issues impacting on the operation and effectiveness of the
PL framework, the IWG:
noted some stakeholders held long-standing concerns regarding
the lack of interaction and feedback between the TGA [Therapeutic Goods
Administration] and PLAC; however, it was agreed that these were issues for the
Review of Medicines and Medical Devices, and were not issues which could be
addressed by this group.[51]
3.62
The committee notes that despite its terms of reference excluding
consideration of '[w]ork by the Department of Health on the reimbursement
systems, including reimbursement and or subsidy of medicine and medical devices',[52]
the Review of Medicines and Medical Devices (MMDR) in its first report recognised
the 'significant synergies' between the work of the different bodies
undertaking health technology assessments in Australia, and recommended that
the government:
give consideration to organisational structures that will
facilitate improved integration of:
-
Pre-market regulation of medicines
and medical devices with health technology assessment of these products for
subsidy and other purposes; and
-
Post-market monitoring of
medicines and medical devices for safety, efficacy and cost effectiveness.[53]
3.63
The Government response to the MMDR was released on 15 September 2016.
In relation to the MMDR recommendation on improved integration of health
technology assessments, the government supported the intent of the
recommendation and noted 'recent organisational changes within the department
to address process alignment and implement collaborative measures.'[54]
3.64
As indicated earlier, the PLAC Reform Work Plan published in December
2016 lists 'Minimising duplication and improve the listing process' as one of
its four Issues for Consideration, and lists a number of proposed activities
with desired outcomes which were due to commence from October 2016. The
proposed activities include:
-
review of the existing health technology assessment process
across TGA, PLAC and MSAC to identify areas of duplication, opportunities for
data sharing, optimal use of clinical expertise and post market monitoring;
-
identification of opportunities for faster listing;
-
consultation on proposed changes to processes including
regulatory savings and transition requirements;
-
refinement of proposed listing changes, including for example
through a pilot; and
-
publication revised process, and communicate the timelines,
transition and implementation arrangements.[55]
3.65
In its second and third communiques, the PLAC noted that a new
committee, the Regulation and Reimbursement of Medical Devices group, comprising
the chairs of the PLAC, MSAC, Pharmaceutical Benefits Advisory Committee (PBAC)
and departmental staff from the TGA and the Medical and Pharmaceutical Benefits
divisions, had been convened to explore:
-
opportunities for timely collaboration between the HTA bodies,
especially in relation to new and emerging health technologies;
-
legislative provisions around information sharing between the HTA
bodies, and how information could be shared without compromising security for
stakeholders;
-
collaboration on development of information technology systems to
support parallel processing of applications;
-
comparison of application processes; and
-
comparison of clinical evidence requirements to identify
similarities and differences.[56]
3.66
The PLAC's Communique 4 of February 2017 notes that the
Prostheses List Guide to listing and benefits for prostheses has been amended
following feedback from stakeholders and discussions about parallel application
processing at its previous meeting. To date, this appears to be the only
concrete action in relation to improved coordination between HTA processes to
date.
3.67
It is of interest to note that, at its December 2016 meeting and despite
a legal requirement for products on the PL to be first listed on the Australian
Register or Therapeutic Goods (ARTG),[57]
the PLAC appears to have recommended listing a number of devices for which
there was not an associated application or approval to be registered on the
ARTG. The communique notes that the committee considered 114 applications to
list new devices on the PL, that 104 of these were recommended for granting and
10 not recommended for granting on the grounds of insufficient clinical
evidence provided. Yet, the communique also notes that in its discussions on
these applications:
the Committee noted that 22 of devices [sic] were not yet
registered on the Australian Register of Therapeutic Goods (ARTG) and the TGA
had not received an application to register on the ARTG.[58]
Committee view
3.68
The committee commends the PLAC, MSAC, PBAC and the department for
establishing a working group to address issues in relation to duplication of effort
and developing greater efficiencies across systems and processes, for example
in relation to timing of consideration of applications. The committee is
concerned that despite this being raised as an issue in numerous forums over a
number of years, little appears to have been achieved in better integrating and
sharing resources and processes where possible and appropriate, despite HTAs
all being administered and supported by the same department.
3.69
The committee notes that there appears to be significant room for
improvement in this area.
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