Health Technology Review: Expression of
Interest for Manufacturer’s
Expression of Interest
July 2015
Health Technology Review: Expression of Interest for Manufacturer’s
Published by the State of Queensland (Queensland Health), July 2015
This document is licensed under a Creative Commons Attribution 3.0 Australia licence.
To view a copy of this licence, visit creativecommons.org/licenses/by/3.0/au
© State of Queensland (Queensland Health) 2015
You are free to copy, communicate and adapt the work, as long as you attribute the
State of Queensland (Queensland Health).
For more information contact:
Clinical Access and Redesign Unit, Health Services and Clinical Innovation Division,
Department of Health, GPO Box 48, Brisbane QLD 4001, email
CARU@health.qld.gov.au, phone 3328 9170.
An electronic version of this document is available at:
https://www.health.qld.gov.au/newtech/html/docs.asp
Disclaimer:
The content presented in this publication is distributed by the Queensland Government as an information source only.
The State of Queensland makes no statements, representations or warranties about the accuracy, completeness or
reliability of any information contained in this publication. The State of Queensland disclaims all responsibility and all
liability (including without limitation for liability in negligence) for all expenses, losses, damages and costs you might
incur as a result of the information being inaccurate or incomplete in any way, and for any reason reliance was placed
on such information.
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Contents
Purpose .............................................................................................................. 1
Background ........................................................................................................ 1
Technologies considered .................................................................................... 2
Inclusion Criteria .................................................................................................. 2
Exclusion Criteria ................................................................................................. 2
Application Process ............................................................................................ 3
Submitting Applications ....................................................................................... 3
Process and timeframes ...................................................................................... 3
Assessment Criteria............................................................................................. 3
Preparing the EOI ................................................................................................ 4
Evidence..................................................................................................... 4
Contact details .................................................................................................... 4
Confidentiality ..................................................................................................... 4
Expression of Interest Questions ........................................................................ 5
Applicant Information ........................................................................................... 5
New health technology information ...................................................................... 5
Safety .................................................................................................................. 5
Clinical Need ....................................................................................................... 6
Clinical Benefit ..................................................................................................... 7
Value for Money .................................................................................................. 8
Organisational and Economic feasibility............................................................... 8
Organisational Feasibility ............................................................................ 8
Economic Feasibility ................................................................................... 9
Societal and Ethical Issues ................................................................................ 10
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Purpose
This document forms part of the process for manufacturer’s to have new technologies considered
and assessed prior to further discussions with Queensland Health. If appropriate, discussions may
include face-to-face meetings with manufacturers and clinical sponsors.
Background
Technology has contributed to remarkable advances in health care and continues to play an
important role in improving services and delivering them more effectively. However; technology
contributes to increases in health care expenditure. Therefore, the need to establish priorities in the
selection and management of health technological innovation is important.
Health Technology Assessment (HTA) is the systematic evaluation that summarises information
about the medical, social, economic and ethical issues related to the use of a health technology in a
transparent, unbiased and robust manner. The key objective is to establish whether a technology is
safe, effective and cost-effective.
On a case-by-case basis, this EOI may be reviewed by the Queensland Policy and Advisory
Committee for new Technology (QPACT) in providing advice to the Queensland Department of
Health (DoH) on the adoption, diffusion, implementation and evaluation of new health technologies
and their role in clinical practice. QPACT is comprised of members with expertise in a variety of
clinical disciplines, health service management, health economics and biomedical technology. The
decision-making criterion utilised by QPACT to assess technology applications is outlined under
Assessment criteria.
Queensland has a unique population distribution which requires a variety of service delivery models
to serve metropolitan, regional, rural and remote communities in an efficient, equitable and effective
manner.
Technology that supports the following objectives are welcomed:

improve patient experience

provide better value for money

enhance the safety and effectiveness of treatments or diagnostic services

improve service delivery through clinical redesign

improve equitable access to healthcare services.
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Technologies considered
Inclusion Criteria
QPACT will consider health technologies that:

are registered by the Therapeutic Goods Administration (TGA) for the indication stated in the
application

can demonstrate improved clinical outcomes for a defined patient population, and/or
reductions in long-term health costs, and/or improved access to treatment
Health technologies that are within remit of QPACT include:

Prostheses and implantable devices

Diagnostic tests

Medical procedures or devices Surgical procedures or devices

Treatments
Exclusion Criteria
QPACT will not consider the following technologies:

Technologies not approved for use in Australia by Therapeutic Goods Administration (TGA)

Technologies that are part of early stage clinical trials

Information technology unless it is integral to the implementation of the new health
technology

Pharmaceuticals
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Application Process
Interested parties are required to submit an Expression of Interest (EOI). A form outlining the
required information for this process can be found later in this document. Completed Expressions of
Interest are to be submitted to Health Technology Assessment and Evaluation (HTAE) team,
Queensland Department of Health (DoH).
Submitting Applications
To submit an application, please email your EOI as a MS Word document to:
secretariat_hta@health.qld.gov.au
Process and timeframes
The HTAE team will the review application and undertake due diligence. The EOI and Due Diligence
will be submitted for assessment by the Queensland Policy and Advisory Committee for New
Technology (QPACT) using assessment criteria outlined below. QPACT will provide a
recommendation to the DoH regarding the outcome of the application.
Key milestones and dates of the application process are listed in Table 1.
Table 1 Key milestones and dates
Process
Time frame
Submissions accepted
Review and Due Diligence undertaken by the
HTAE team
Sent to QPACT for review
Anytime throughout the year
QPACT recommendation
Next QPACT meeting (quarterly)
Applicants Notified
Within 2 weeks of QPACT meeting
approximately 4 weeks from receiving application
At least 2 weeks before next QPACT meeting
Assessment Criteria
EOI applications will be assessed against the QPACT decision-making criteria which consider the
following factors:

Clinical and population need

Safety, efficacy and effectiveness

Value for money

Feasibility of adoption into the healthcare system (financial and organisational)

Consistency with social values and ethics

Advantages of introducing the technology compared with current practice or comparators,
including substituting or obviating the need for existing technologies.
Substantiation and assessment of applications may be sought from external independent referees.
During the assessment process the secretariat may seek further information from applicants to
verify details in the application.
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If an application is of poor quality and is found to be misleading or overly subjective, assessment will
not continue, and the application will be disqualified.
Preparing the EOI
Evidence
A variety of clinical evidence should be consulted during the literature research of the proposed
technology. It is crucial that the evidence you utilise is appropriate, of high quality and robust.
Please refer to the NHMRC guide on the levels of evidence (a link is provided in section 8).
Consider research directly relevant to the proposed technology, clinical indication/condition and
chosen comparator(s). The scientific literature you reference should examine a broad range of
factors related to the technology and align with the decision-making criteria outlined above.
Contact details
The HTAE team is available to answer any queries you have and provide guidance on completing
the EOI form. The primary email address for correspondence regarding the application process is:
secretariat_hta@health.qld.gov.au.
Confidentiality
Applicants should note that broad details of successful proposals, agreed outcomes, progress and
the level of funding awarded may be published by the Queensland Government internal internet.
Some information may be used to promote funded projects in the future.
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Expression of Interest Questions
Applicant Information
Name
Position
Company
Phone number
Email
Application submission date
New health technology information
1
Name of the health technology (including any alternative names).
2
Description of the health technology
Provide a brief summary in plain language of each component of the technology and how it
works.
3
Is the technology registered with the Therapeutic Goods Administration?
Provide Australian Register of Therapeutic Goods (ARTG) number(s) and certificate(s)
4
Briefly describe the diffusion of the proposed technology?
Please describe where the technology is currently being used (in Australia and internationally).
Safety
5
What are the clinical limitations of the technology?
Side effects, risks, adverse events and long term adverse effects.
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6
Are there any known safety risks concerning the design and operation of the
technology?
What would happen in the event of the technology failing?
Are there any health and safety risks such as exposure to radiation or other hazards?
7
If introduced, what plausible negative consequences need to be monitored relevant to
the learning curve?
8
What is the evidence on the safety of this technology to support the introduction into
Queensland?
Please consider adverse events and the generalisabilty of these results.
Please include at least 5 references.
Study
NHMRC
Level of
Evidence
New Technology
Population
Outcome
n/Na (%)
95% CI
Comparator
n/Na (%)
95% CI
(Author,
Year)
a.
n=number of patients with the outcomes, N=total number of patients included in the study
Clinical Need
9
What is the burden of illness, prevalence and incidence of the condition in Queensland
or Australia?
Please describe the size of the affected population that the technology will be used for.
10 Who is the target population? What are the indication(s) and contraindication(s) for the
use of this technology? Include any other relevant patient characteristics.
Briefly specify the population being targeted with this new health technology?
What are your inclusion and exclusion criteria?
If there are multiple indications, please list these out under separate headings.
11 What is the clinical need for this technology compared with the availability of
alternatives to manage the target condition implicit in this application?
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12 What is the most appropriate comparator(s) for the technology in Australia?
What existing and approved health technology is routinely used for the disease/condition in
Queensland or Australia?
If multiple indications have been nominated, different comparators should be nominated, if
applicable.
Clinical Benefit
13 What are the health benefits of this technology for patients?
Provide clear end points for both short and long term health outcomes such as morbidity,
mortality, improved quality of life, symptom control, etc…
14 What are the advantages of this technology compared with existing practices?
Does the introduction of the technology present opportunities to improve efficiency through
clinical redesign, change in clinical setting (inpatient to outpatients), etc.?
Please include diagrams/flow charts to support text if necessary.
15 What is the evidence on the effectiveness of this technology to support the introduction
into Queensland?
Please include at least 5 references. Delete the table not required.
Use this table for Procedures or Treatments (DELETE IF NOT APPLICABLE)
Study
NHMRC
Level of
Evidence
Population
Outcome
New Technology
n with event/N (%)
[or mean ± SD]
Comparator
n with event/N (%) [or
mean ± SD]
Effect size
(95% CI / p
value)#
(Author,
Year)
# Please use absolute risk reduction or NNT. Refer to the Application Guide for further information.
Use this table for diagnostic tests (DELETE IF NOT APPLICABLE)
Study
NHMRC
Level of
Evidence
Population & Reference standard and/or
setting
comparator
Sensitivity
Outcome [95% CI]
Specificity
{PPV}
{NPV}
(Author,
Year)
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16 Should this technology be introduced, what will be the key measures of success (or
failure) of this technology.
Value for Money
17 What is the evidence on the cost effectiveness to support the introduction into
Queensland?
What evidence exists on the cost effectiveness of this technology for the indications stated in
this application?
Study
Type of economic
evaluation
Population
Comparator/s
Incremental costeffectiveness
ratio (ICER)
(Author, Year)
18 How do you consider this technology will be able to provide value for money?
Consider reduced length of stay, efficiency gains, released capacity, improved access to
services and return on investment.
19 Will this technology replace or obviate need for additional tests or procedures?
If this technology results in an opportunity to disinvest in obsolete technology or reduces over
serving of patients this will reflect favourably on your submission.
20 Is this technology a hybrid technology or a technology that will require additional
testing?
Organisational and Economic feasibility
Organisational Feasibility
21 Who is the local distributer of the technology and what is their ability to support the
implementation of the technology, provide ongoing maintenance and technical support?
Please include an overview their expertise and experience in working with this type of
technology and clinical specialty.
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22 What are the timeframes involved in the procurement, implementation and evaluation of
the technology?
Does equipment need to be ordered from overseas? How long will it take to be delivered?
Does the equipment need to go through a safety/verification/ calibration process, how long will
this take, and who is responsible?
23 What are some of the common infrastructure or systems requirements required to
introduce this technology?
Please consider any capital works required, IT, etc.
If there is an information technology component associated with the technology, please provide
a description?
24 What training is required? Who requires training?
Which staff usually require training? Who will provide the training and any resources required?
How many procedures/treatments are required to achieve competency and maintain
proficiency? Please include any costs in the table of Question 25.
Economic Feasibility
25 What is the approximate cost of the technology and required accessories, consumables,
training packages and any other costs associated with the introduction?
Please complete the table below – include for a ‘typical’ set up.
Component
Description
Unit or Package
cost
Total cost
Technology equipment,
accessories and
Consumables
Other associated costs
Training
Licenses
Maintenance
Other
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26 Please list any diagnostic related groups (DRGs), procedure codes or MBS items
numbers that are relevant to the use of this technology in Australia.
Societal and Ethical Issues
27 Briefly describe how will this improve the patient experience
Please consider benefits such as less interventions, shorter treatment times and less invasive
procedures.
28 How does the technology contribute to more equitable delivery of public healthcare
services?
END OF APPLICATION
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References
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Department of Health
Health Technology Review: Expression of Interest for Manufacturer’s
www.health.qld.gov.au
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