Age Related Macular Degeneration
Tier 3 Assessments
Project Plan
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National Health Committee
Anne Kolbe, Chair
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General Manager, NHC Executive
Peter Guthrie
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Implementation Manager, NHC Executive
Faye Ryan
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Janine Pratt, Implementation Lead (Contractor)
Document Location
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Projects/Eyes/Age-related Macular Degeneration/Planning/Project
Management
Status
Draft
Version History
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Version
51T
Date
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Summary of Changes
1.0
5 June 2015
Initial Draft
1.1
17 June 2015
Updated to align with other NHC project plans
1.2
21 June 2015
Updated with feedback from Faye Ryan
1.3
1 July 2015
Updated with feedback from Marty de Boer and Miranda Devlin
1.4
2 July 2015
Updated with further feedback from Faye Ryan and Peter
Guthrie
1.5
16 July 2015
Updated with feedback from Anne Kolbe
Document Consultation
The following stakeholders (internal or external) have been consulted with regarding
the content of this document.
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Name
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Role
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Date
Faye Ryan
Implementation Manager
17 June 2015
Marty De Boer
Acting Operations Manager
17 June 2015
Miranda Devlin, Ben
Campbell-Macdonald
Senior Advisor, Senior Analyst
26 June 2015
Anne Kolbe, Peter Guthrie
Chair, General Manager
2 July 2015
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1) Purpose of this Document
The purpose of this document is to seek agreement to proceed with a suite of three Tier
3 assessments for Age-Related Macular Degeneration (AMD) as proposed below.
Agreement of this document forms a contract between the project sponsors and owners
and the project leads and project manager for how this project will be managed and
progressed at a high-level, and the critical success factors it must deliver to.
2) Project Overview
a) Background and Context
In 2013/14 the NHC received a reactive referral from Waitemata and Auckland District
Health Boards asking “how many (Avastin) treatments should the DHB be doing?” to
manage AMD. The NHC prepared a Tier 2 assessment that explored the model of care
for patients with AMD, the role of intravitreal anti-VEGF treatments in the model of care
and where the National Health Committee (NHC) could conduct further assessment to
support improvements in health outcomes and efficiency. There has been a three to fivefold increase in the volume of bevacizumab (Avastin) procedures in in New Zealand in
the last five years, and growth in demand for intravitreal anti-VEGF treatments can be
expected to continue. There is also significant variance between DHBs in the rate of
procedures being performed, and how the treatment is delivered.
AMD is the leading cause of blindness in New Zealand in those aged over 50,
accounting for half of all cases. It is estimated that 15,000‒30,000 people in New
Zealand are affected by late (advanced) AMD, with 10,000‒20,000 affected by the more
severe and rapidly progressive wet form. The prevalence is expected to increase by 20‒
40% in the next 10 years as a result of population ageing.
There are two pathologically distinct stages of AMD: dry (non-exudative) and wet
(exudative or neovascular) AMD. However, it can be more clinically useful to classify
AMD as early AMD and late AMD, the latter including advanced dry AMD (geographic
atrophy; GA AMD) and wet AMD. In general only late AMD is associated with significant
vision loss.
First-line treatment of wet AMD is with intravitreal injection of vascular endothelial growth
factor inhibitor (anti-VEGF) agents, which not only slow loss of vision but can improve
vision for a substantial proportion of patients. The agents bevacizumab (Avastin) and
ranibizumab (Lucentis) have similar effectiveness, but PHARMAC has restricted
ranibizumab use to cases where bevacizumab is not appropriate because of its higher
cost.
In New Zealand, current annual costs of AMD are estimated at between $19.5‒$31.4
million across the public and private systems, including inpatient and outpatient care,
primary care optometry and rehabilitation services. A large proportion of care provision
is paid for privately, but the proportion differs across DHBs. Of this cost, $4 million‒$8
million is incurred for wet AMD. True current costs of intravitreal anti-VEGF treatments
are estimated at between $3 million and over $6 million, but this cost is probably offset
by reductions in other costs of care (such as reduction in vision related falls and
consequent hip fracture and earlier admission to aged residential care facilities). The
number of people aged 45–85 years with AMD is estimated to increase by 13% by 2026,
T3 AMD Project Plan
3
and those with late AMD by more than 40%, with a resulting increase in costs of
treatment of AMD.
The Tier 2 assessment identified that more detailed assessment by the NHC of the use
of intravitreal anti-VEGF treatments in AMD could support appropriate planning to ensure
that there is equitable access across the country, and by defining the most efficient
means of delivery, ensure that patient outcomes are optimised while costs are controlled.
The Blind Foundation (previously known as the Royal New Zealand Foundation of the
Blind) referred low vision rehabilitation services to the NHC’s 2014/15 reactive referral
round. The NHC considered this referral at its 31 March 2015 meeting. At that time the
referral was not prioritised to be undertaken.
Consultation on the Tier 2 AMD assessment was undertaken for a four week period
between 16 March and 13 April 2015. A total of nine submissions were received, seven
on behalf of organisations and two from ophthalmologists. The submissions supported
further more detailed analysis of intravitreal anti-VEGF treatments and identified other
areas, including low vision rehabilitation, for further analysis.
The NHC considered the consultation feedback at its May 2015 meeting. It was agreed
that based on the Tier 2 assessment and feedback received, the following Figure 1
provided an acceptable framework for the NHC to work in with regards to AMD. It was
also agreed that four Tier 3 assessments needed to be undertaken (refer top third of
Figure 1 diagram) – population screening; low vision rehabilitation; intravitreal anti-VEGF
treatment; and AMD genomic diagnostic risk stratification. Combined, these
assessments would show whether there could be change to the end-to-end model of
care for AMD over a period of time (eg five years) that would deliver some material
improvements to patient outcomes within the existing resources.
The specific recommendations from the NHC’s 6 May Meeting relating to AMD are as
follows:
a) Agree that the executive progress with Tier 3 assessments focused on the model of
care for age-related macular degeneration (AMD) including population screening; low
vision rehabilitation; intravitreal anti-VEGF treatment; and AMD genomic diagnostic
risk stratification.
b) Approve the creation of an age-related macular degeneration page on the NHC
website, including the: referral from the sector; modified referral crafted by the NHC;
Tier 2 document including correction of errors of fact; consultation documents;
summary of feedback received; and Tier 3 project plans.
c) Note the Tier 3 work for AMD will be outsourced and the project plan, draft request
for proposal and draft contract will be provided to the committee for approval in June
2015.
The NHC is providing a leadership role in this process and providing the 'scaffolding' for
the whole model of care for age-related macular degeneration. Therefore, rather than do
all the pieces of work itself, the NHC's role is also to encourage relevant groups and
agencies responsible for parts of the model of care (refer bottom two-thirds of Figure 1)
to consider and act on them and then coordinate their work with any work the NHC may
need to do itself. For example the National Health Board is undertaking service
development planning for low vision rehabilitation/support services. The NHC can add
T3 AMD Project Plan
4
value to the National Health Board’s work through providing evidence on low vision
support services
Figure 1 – Age Related Macular Degeneration Model of Care
Measurable health, wellness and independence gains for patients and populations
National Health Committee
Low vision rehabilitation
Population
Screening
AMD genomic diagnostic
risk stratification
Prevention
Intravitreal Anti-VEGF Treatment
Primary and community care
Secondary care
Palliative care
Sector
Public Education
NZBF AMD
Ophthalmology
<-----------------------------------------------------------Activity--------------------------------------------------------->
& Awareness
prevalence Study
Prioritisation Tool
Ministry National Health Board Business Unit
Low Vision Services Service Development
HWNZ Optometry &
Trained Nursing staff delivering
Ophthalmology scope of
<--------------------------------------------------------Workforce--------------------------------------------------------->
intravitreal treatments
practice
<--------------------------------------------------------Information-------------------------------------------------------->
Equipment in the
<---------------------------------------------------Capital
Investment--------------------------------------------------->
community
PHARMAC
Aflibercept
<-----------------------------------------------Purchase and procurement-------------------------------------------->
Funding Streams incentives and
Assessment
<------------------------------------------------Costs
and funding bundles-------------------------------------------->
disincentives
Prevention
Primary and community care
Secondary care
Palliative care
During the NHC meeting where the AMD feedback and next steps were discussed there
was lack of clarity between early detection, prevention and population screening. The
Committee indicated the Executive should resolve this during the development of the
project plan.
During preparation of this project plan it became clear that focussing on population
screening and genomic diagnostic risk stratification separately and excluding prevention
did not adequately cover the model of care components expected by the Committee.
For example genomic diagnostic risk stratification is a sub-set of population screening
and would mean duplication if they were assessed separately. Also the exclusion of
prevention and early detection could minimise the opportunities for identifying
interventions which could slow or reduce vision loss and therefore the need for
intravitreal anti-VEGF treatments.
As a result this project plan includes a Tier 3 assessment for the prevention, early
detection and risk stratification components of the AMD model of care instead of two Tier
3 assessments population screening and AMD genomic diagnostic risk stratification.
T3 AMD Project Plan
5
b) Project objectives
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The key objectives of this project are to:

Assess three components of the model of care for AMD against the NHC’s four
domains and the 11 decision making criteria (refer Appendix 1), ie complete three
Tier 3 assessments for prevention, early detection and risk stratification; low
vision rehabilitation; and intravitreal anti-VEGF treatment . Focus on what model
of care should be in place, the population served and where investment is
required
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
Assess the overarching model of care based on these combined assessments to
identify whether there could be change to the end-to-end model of care for AMD
(Figure 2) over a period of time (eg five years) that would deliver some material
improvements to patient outcomes within the existing resources.

Assess the feasibility of adoption and the economics of the proposed model of
care and ensure the funding models and strategic directions developed by key
stakeholders are informed by the NHC assessments.
Figure 2 – Revised Age Related Macular Degeneration Model of Care
Measurable health, wellness and independence gains for patients and populations
National Health Committee
Low vision rehabilitation
Prevention, early detection and
risk stratification
Intravitreal Anti-VEGF Treatment
Prevention
Primary and community care
Secondary care
Palliative care
Sector
Public Education
NZBF AMD
Ophthalmology
<-----------------------------------------------------------Activity--------------------------------------------------------->
& Awareness
prevalence Study
Prioritisation Tool
Ministry National Health Board Business Unit
Low Vision Services Service Development
HWNZ Optometry &
Trained Nursing staff delivering
Ophthalmology scope of
<--------------------------------------------------------Workforce--------------------------------------------------------->
intravitreal treatments
practice
<--------------------------------------------------------Information-------------------------------------------------------->
Equipment in the
<---------------------------------------------------Capital
Investment--------------------------------------------------->
community
PHARMAC
Aflibercept
<-----------------------------------------------Purchase and procurement-------------------------------------------->
Funding Streams incentives and
Assessment
<------------------------------------------------Costs
and funding bundles-------------------------------------------->
disincentives
Prevention
T3 AMD Project Plan
Primary and community care
Secondary care
Palliative care
6
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Tier 3 Assessment - Prevention, early detection and risk stratification
The purpose of this Tier 3 assessment is to understand if it is possible and cost effective
to reduce or delay the progression of AMD related vision loss and therefore reduce the
numbers of patients who require intravitreal anti-VEGF treatment. This requires an
understanding of 3 areas - does increased awareness in the general population of the
signs and symptoms of AMD and/or population screening prompt earlier intervention and
therefore slower disease progression, and is it possible to identify the population with a
genetic profile for faster AMD progression and earlier vision loss?
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Currently there is no national AMD public awareness or AMD screening programme in
place. Current identification of patients with AMD is generally by optometrists and
ophthalmologists, either opportunistically or sometimes after referral from general
practitioners. Non-Government Organisations, such as Macular Degeneration New
Zealand, have undertaken marketing campaigns to increase the awareness, signs and
symptoms of AMD however ongoing funding is a challenge.
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A Tier 3 assessment is required to understand the tools to prevent further vision loss due
to AMD, risk stratification of patients with early AMD and the opportunities provided
through genomic macular diagnostic tools, based on the NHC’s domains and decision
making criteria :
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



whether tools are available to prevent the development of AMD eg management
of hyper tension and cholesterol, smoking cessation, diet and supplementation
with vitamins etc
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whether population screening is available for AMD, what tools or mechanisms
are the most appropriate
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whether there is a role for genomic macular diagnostic tools and risk stratification
in the overall model of care
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whether there will be an impact on the numbers of patients who require
intravitreal anti-VEGF treatment if the tools identified above are implemented
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This assessment needs to link with the NHC’s overall work in genomics, particularly the
framework being developed. It will also need to identify, the target population and take
into account the workforce’s scope of practice and funding implications as many of these
services are currently funded by patient out of pocket expenses. Analysis of prevention,
early detection and risk stratification for AMD against the four domains will also need to
encompass the following:
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Clinical effectiveness and safety

Review international best practice, information and knowledge to confirm the
clinical effectiveness and safety of:
o
population screening for AMD and the most successful methods for
implementing screening, ie as standalone screening or as part of an
established screening programme
o
prevention tools for AMD to minimise vision loss and further degeneration
o
genomic macular diagnostic tools. This will also require horizon scanning
as some of these tools may still be in trials.
T3 AMD Project Plan
7
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
Identify the impact of the use of prevention tools, population screening and
genomic diagnostic tools on the model of care including the number of patients
identified with AMD requiring treatment and the number of patients that would be
identified earlier in the process through use of these tools.

What patient outcomes will be improved through effective population screening,
prevention, early detection and risk stratification through use of genomic macular
diagnostic tools for AMD?

Review the current model of care for prevention, early detection and risk
stratification for AMD, identify the target population, intervention rate, funding
model, and patient outcomes. Note the Blind Foundation is completing a
prevalence study which may be available to inform this analysis.
Economic



What are the costs of screening or identification of patients with AMD within the
current model of care?
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How is the current model of care funded? What proportion is through patient out
of pocket expenses?
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What is the cost-effectiveness of prevention, early detection and risk
stratification compared to other interventions in the current model of care?
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
What would be the projected costs and savings of any proposed changes to the
model of care? This includes budget impact assessment and capital
requirements, ie is this intervention affordable for the sector?
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Societal and ethical

A significant proportion of the costs for the current model of care for the
identification of AMD are borne by the patient. Therefore current access to
services is determined by the “ability to pay” which can potentially disadvantage
some groups. How will this be mitigated by the proposed model of care?

Are there any other societal and/or ethical issues surrounding the current model
of care, including groups potentially disadvantaged or advantaged by current
interventions?
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
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Would there be any societal and/or ethical issues associated with changing the
model or care and/or implementation of a revised target population for screening?
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Feasibility of Adoption

What are the factors that have led to the current provision of identification,
prevention and risk stratification within the current model of care for AMD?

What issues prevent the adoption of a best practice model of care?

There are likely to be a number of service delivery options for screening ranging
from national awareness campaigns prompting people to self-refer, targeted
screening programmes attached to existing ophthalmology interventions eg
diabetes get checked or annual cardiac review. What are the implementation
implications of each of the delivery options?

What would be the requirements for implementing a revised model of care and/or
revised target population for prevention? This includes capacity and capability of
T3 AMD Project Plan
8
the workforce, clinical and service delivery model, training, facility, information
and implementation requirements.
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
What would be the requirements for implementing a revised model of care and/or
revised target population for use of genomic macular diagnostic tools? This
includes capacity and capability of the workforce, clinical and service delivery
model, training, facility, information and implementation requirements.

What are the implications for the scope of practice for those delivering the
service? Are there training and development requirements?

What would be the benefits and implications of any proposed changes to the
model of care?

How is the proposed model of care funded? Does this need to change with the
new model of care, particularly the impact for patients and out of pocket
expenses?
Tier 3 Assessment - Low vision rehabilitation
Low vision rehabilitation has been identified by key stakeholders as a cost effective
intervention in the treatment of AMD. The Blind Foundation also referred low vision
rehabilitation services to the NHC’s 2014/15 reactive referral round.
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“Low-vision rehabilitation can encompass many types of services, including but not
limited to an eye examination with assessment of visual function, prescription and
training in the use of optical aids and other devices, training in adaptive skills for
performing everyday activities, psychological services, and vocational counselling and
training.” 1
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The focus of the NHC assessment for low vision rehabilitation is the additional clinical
interventions which might be available to improve maintain or slow the deterioration of
vision loss.
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The Tier 3 assessment for low vision rehabilitation services has some overlap with the
National Health Board’s work in this area and should be completed in collaboration with
the National Health Board and the stakeholder reference group they are planning to
establish. The National Health Board is due to report progress to the Minister of Health
in December 2015. The National Health Board staff have indicated they would value the
NHC’s support to identify the evidence base across the four domains to support low
vision rehabilitation.
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The assessment will need to incorporate the following:
1
Cynthia Owsley, PhD, MSPH; Gerald McGwin Jr, MS, PhD; Paul P. Lee, MD, JD; Nicole Wasserman, MPH; Karen Searcey,
MSPH. Characteristics of Low-Vision Rehabilitation Services in the United States. Arch Ophthalmol. 2009;127(5):681-689.
doi:10.1001/archophthalmol.2009.55
Faye EE Clinical Low Vision. Boston, MA Little Brown & Co1984;
Silverstone BLang MARosenthal BPFaye EE The Lighthouse Handbook on Vision Impairment and Vision Rehabilitation. 1
New York, NY Oxford University Press2000;
T3 AMD Project Plan
9


Review international low vision rehabilitation best practice interventions which
might be available to improve, maintain or slow the deterioration of vision loss
and the target populations for these interventions.
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Identify which interventions identified above are most effective, what is the
optimal level of intensity of intervention, and which is the most appropriate model
of delivery 2 3
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

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2F
Identify the ideal place for low vision rehabilitation interventions in the overall
model of care for AMD, including their role for patients who are unsuitable for or
fail intravitreal treatment.
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Across the NHC’s four domains of assessment and 11 decision making criteria,
assess the impact of potential changes to low vision rehabilitation service
interventions which might be available to improve, maintain or slow the
deterioration of vision loss in New Zealand, including:
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o
What would the target population be?
o
What would the effectiveness, cost-effectiveness and sustainability within
current budgets be?
o
What would the implementation issues be?
Clinical safety and effectiveness




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Is there any relevant evidence on the safety and effectiveness of low vision
rehabilitation service interventions which might be available to improve, maintain
or slow the deterioration of vision loss? Which of the services are more clinically
effective than others?
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Within the New Zealand model of care for AMD, how are these low vision
rehabilitation services currently delivered? Are they effective?
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In the New Zealand publicly funded healthcare system, what should the target
patient population be for these low vision rehabilitation interventions? Note the
different types of low vision rehabilitation interventions are likely to be most
effective with different target groups.
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What patient outcomes will be improved through effective low vision rehabilitation
interventions?
Economic


What are the costs of low vision rehabilitation services within the current model of
care?
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How is the current model of care funded?
2 Hooper P, et al, Age-related macular degeneration and low-vision rehabilitation: a systematic review. Can J Ophthalmol,
2008. 43(2): p.180-7.
3
Kammer R, et al, Survey of optometric low vision rehabilitation training methods for the moderately visually impaired.
Optometry, 2009. 80(4): p.185-92.
T3 AMD Project Plan
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

What is the cost-effectiveness of low vision rehabilitation interventions which
might be available to improve, maintain or slow the deterioration of vision loss
compared to other interventions in the current model of care?
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What would be the projected costs and savings of any proposed changes to the
model of care? This includes budget impact assessment and capital
requirements, ie is this intervention affordable for the sector.
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Societal and Ethical

Are there any societal and/or ethical issues surrounding the current model of
care, including groups potentially disadvantaged or advantaged by current
interventions?
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
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Would there be any societal and/or ethical issues associated with changing the
model or care and/or implementation of a revised target population for low vision
rehabilitation services?
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Feasibility of Adoption

What are the factors that have led to the current provision of low vision
rehabilitation services within the current model of care for AMD?

What issues prevent the adoption of a best practice model of care?

Issues have been identified in Australia, about inappropriately low volumes of
referral to visual rehabilitation and barriers to uptake among those who are
referred 4 . Are these issues reflected in the current New Zealand experience?
P3F
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P

How do low vision rehabilitation services fit within existing primary and secondary
care eye services? Are there opportunities to utilise these services to incorporate
other more beneficial low vision rehabilitation interventions?

What would be the requirements for implementing a revised model of care and/or
revised target population for low vision rehabilitation services? This includes
capacity and capability of workforce, clinical and service delivery model, training,
facility, information and implementation requirements.

What would be the benefits and implications of any proposed changes to the
model of care?
Tier 3 Assessment - Intravitreal anti-VEGF treatment
The Tier 2 assessment for AMD focussed on analysis of the increased use of intravitreal
anti-VEGF treatments. This highlighted that a more detailed Tier 3 assessment is
required to identify the target population, consistent delivery and access across New
Zealand, the implementation considerations and whether the increase in growth in
treatment is cost-effective and affordable for the Sector. Analysis of intravitreal antiVEGF treatment against the four domains and 11 decision making criteria will also need
to encompass the following:
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4
O’Connor PM, Mu LC, Keeffe JE, Access and utilization of a new low-vision rehabilitation service. Clin Experiment
Ophthalmol, 2008. 36(6): p.547-52.
T3 AMD Project Plan
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Clinical safety and effectiveness
The clinical effectiveness and safety of intravitreal anti-VEGF treatment has been
established through clinical trials 5 6 . However there remain questions that need further
analysis due to inconsistency between centres and concerns about the safe use of
intravitreal treatments:
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
When should intravitreal anti-VEGF treatment be initiated? What does this mean
for the target population and the expected growth in treatment delivered?

How often should it be administered, and for how long should treatment
continue?

How should potential complications with intravitreal injections be mitigated? Risk
of complications may be more important than the reported minor, clinically
unimportant differences in safety between ranibizumab and bevacizumab 7 .
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P

How can the potential safety concerns that arise from the need to reformulate
bevacizumab be mitigated? Bevacizumab is only supplied in 25 mg/ml 4 ml vials,
and thus must be dispensed into vials of appropriate dosage for intravitreal
administration, with an associated risk of contamination. Are there other
implications for ‘off-label’ use?

Should the range of potential anti-VGEFs include aflibercept in addition to
bevacizumab (Avastin) and ranibizumab (Lucentis) if the PHARMAC process
outcome is favourable from a clinical safety and effectiveness perspective?

What patient outcomes will be improved through increased access to intravitreal
anti-VEGF treatment?
Societal and Ethical


Geographical inequities in access were identified in the Tier 2 AMD assessment.
How could this be mitigated by the proposed model of care?
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Are there any other societal and/or ethical issues surrounding the current model
of care?
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
Would there be any societal and/or ethical issues associated with changing the
model or care and/or implementation of a revised target population for intravitreal
anti-VEGF treatment?
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Feasibility of Adoption

What is the impact of the proposed growth in the number of patients requiring this
treatment?

What will be the impact on patient demand if other proposed changes to the
model of care eg population screening and risk stratification are implemented?
5
Zhang XY, et al, Comparison of bevacizumab and ranibizumab in age-related macular degeneration: a systematic review and
meta-analysis. Int J Ophthalmol, 2014. 7(2): p.355-64.
6 Comparison of Age-related Macular Degeneration Treatments Trials Research, G, et al, Ranibizumab and bevacizumab for
treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology, 2012. 119(7): p.1388-98.
7 Bethke W, Best Practices: Treating wet AMD. Review of Ophthalmology, 2013. August 2013: p.30-34.
T3 AMD Project Plan
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
What is the balance between public and private sector provision of intravitreal
anti-VEGF treatment? How will equity of access be managed?

What is the pathway of care for this treatment? How will variation in referrals,
access to treatment and service delivery be mitigated?

Who should provide this treatment? Is there a change to scope of practice
required? Will training and development be required?

Initial analysis has suggested both secondary care hospital outpatient clinics and
primary care as options for the location of service provision. Where is the
appropriate location for this treatment to be offered?

How might better and earlier access impact on patient outcomes and the need for
rehabilitative and support services?

What is the impact of the proposed model of care on the achievement of DHB
health targets and performance measures?

How will the increased supply of intravitreal anti-VEGF treatments to meet
demand affect the mix of ophthalmological procedures?

What equipment is required to deliver the treatment?

There are considerations relating to the use of the pharmaceuticals including
potential changes to follow-up and use of co-dependent technologies, how are
these best mitigated?

How will the treatment be funded? What are the funding implications if the
treatment is provided in the community rather than within secondary care? Will
funding the increasing volume of intravitreal anti-VEGF procedures put other
necessary eye interventions at risk?

What issues prevent the adoption of a best practice model of care?

Are there any other requirements for implementing a revised model of care
and/or revised target population for intravitreal anti-VEGF treatment? This
includes capacity and capability of workforce, clinical and service delivery model,
training, facility, information and implementation requirements.

What would be the benefits and implications of any proposed changes to the
model of care?
Economic

What is the economic impact of visual impairment/blindness?

What are the costs of intravitreal anti-VEGF treatment based on the current
model of care?

What are the costs of intravitreal anti-VEGF treatment based on the model
proposed?

Will the costs increase if there are any additional scheduling requirements eg codependent technology requirements or follow up review etc relating to the
introduction of new anti-VEGF agents?
T3 AMD Project Plan
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Will the costs increase with the introduction of new anti-VEGFs (eg aflibercept)?
When are these new medications expected to become available?

What is the cost-effectiveness of intravitreal anti-VEGF treatment compared to
other interventions in the current model of care?

How is the current model of care funded? Note the change to the national pricing
in 2014/15, also the work planned by the National Health Board on the most
appropriate way to fund treatment.

What would be the projected costs and savings of any proposed changes to the
model of care? This includes budget impact assessment and capital
requirements, ie is this intervention affordable for the sector.
Overarching model of care
The three Tier 3 assessments will inform the assessment of the overall model of care for
AMD and the management of the loss of visual acuity due to AMD. The overall
assessment will need to be able to answer the following questions:
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
What stops people getting AMD?

How do we identify people with the potential for or early signs of AMD?

What reduces the advancement of AMD?

What assists people with AMD to live independent lives?

Why do we have the model of care for AMD that we currently have?

What is the outcome desired by changing the model of care?

What would be the benefits and implications of any proposed changes to the
model of care?

Where could the NHC add value to the system? What recommendations could
the NHC make to improve the outcomes for people with AMD?
It is only by considering the end to end model of care for AMD that we can actually
answer the original referral question of –“ how many of these (Avastin) treatments should
we (ADHB/WDHB) be doing?”
3) Reasons for this Project
a) Mandate
The mandate for this project arises from the NHC’s overall mandate to prioritise new and
existing health technologies and make recommendations to the Minister of Health. Also
through the referral for assessment of bevacizumab put forward by Waitemata and
Auckland District Health Boards (DHBs) as part of the NHC 2013/14 referral round.
T3 AMD Project Plan
14
b) Project Drivers and Rationale
The Tier 2 assessment for AMD identified that a more detailed Tier 3 assessment of the
use of intravitreal anti-VEGF treatments in AMD could support appropriate planning to
ensure that there is equitable access across the country, and by defining the most
efficient means of delivery, ensure that patient outcomes are optimised while costs are
controlled. This was also supported by the stakeholders who provided feedback through
the consultation process.
In addition the feedback from stakeholders and other work the NHC was involved in
identified the NHC could add value through assessment of two other components of the
model of care – prevention, early identification and risk stratification, and low vision
rehabilitation. Through undertaking these two Tier 3 assessments, and working with
stakeholders who are working on other elements of the model of care, the NHC can
provide leadership across the whole model of care. The NHC can also support other
players in achieving appropriate prioritisation to meet demand for intravitreal anti-VEGF
agents within other competing priorities for ophthalmological budgets as this project will
also enable the original question, ie what is the appropriate volume of Avastin treatments
to be provided, to be more accurately quantified.
c) Strategic Alignment
The National Health Committee’s strategic focus for the next four years is to “lead and
influence sector change by leading development of recommendations that are
implementable and achieve sustainable health outcomes.
This approach is supported by two other strategies of, “finding the balance” – that is
assisting the sector improve clinical outcomes and meet immediate fiscal challenges
while providing the medium to long view on improving patient and population outcomes
and sector sustainability; and “fully applying the NHC mandate” for prioritising the most
cost effective health technologies.
This project contributes to the NHC’s strategic direction through:

Development of recommendations for AMD, a disease with significant forecast
cost and volume growth, with opportunities for improving patient and population
health and social outcomes

More detailed assessments in areas which respond to Sector requests for
confirmation of clinical and cost effectiveness and appropriate targeting of
specific interventions, ie intravitreal anti-VEGF treatments and low vision
rehabilitation, to assist with short to medium term financial sustainability

Analysis of the implications of implementing these interventions from an overall
model of care perspective as well as for each intervention. For intravitreal antiVEGF treatments the focus on the overall model of care will inform how many
people are likely to require this intervention due to improved population screening

Analysis which can also be utilised for the Tier 1 strategic overview for Eyes.
d) Key Benefits
The project expects to be able to make clear recommendations on the introduction or
otherwise for prevention, early identification and risk stratification through genomic
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T3 AMD Project Plan
15
macular diagnostic tools, low vision rehabilitation and intravitreal anti-VEGF treatment in
New Zealand within the model of care for AMD.

Clear articulation of the current status of the clinical safety and effectiveness

Description of the benefits and outcomes for New Zealand patients who have
received these interventions

Identification of the New Zealand target population suitable to receive these
interventions

Quantification of the patient benefits most likely to be achieved. These outcomes
may include:
o
Measurable improvement in the rate of vision preservation
o
Measurable reduction in the rate of ‘legal’ blindness
o
Increased provision of patient services in the community setting, ie closer to
home

Clear direction on the utility and development of targeting/patient selection tools

Assessment of the ability of current services to provide the interventions

Establishing the balance over time between the costs of developing or extending
service capacity to meet an increase in utilisation with potential longer term
hospital cost savings
The engagement with key stakeholders will also provide benefit through the increased
ability to deliver a model of care for AMD which is clinically practical and sustainable and
acceptable to stakeholders.
e) Impact of not undertaking this project
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If the project is not undertaken there is an increased risk of:

reducing the potential individual health outcomes for patients who could benefit
from the AMD interventions

inequitable access to treatment resulting in inequitable patient outcomes as some
patients may potentially be disadvantaged by the current model of care

delaying the potential achievement of hospital costs savings or cost avoidance for
the sector by not providing clear advice on the utility and value of these
interventions

incremental expansion of existing services through DHB localised decision
making processes

compromising ophthalmology budgets as providers meet demand for intravitreal
anti-VEGF treatments as well as other competing priorities

damage to the reputation of the NHC in the timely completion of previously
signalled work

damage to collegial relationships with clinicians and other decision makers due to
not progressing assessment of an important topic.
T3 AMD Project Plan
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4) Project Deliverables and Approach
a) Project Scope
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The following table delineates the scope of this project.
In Scope
Out of Scope


Non-AMD disease which impacts visual
acuity

The projects within the AMD model of
care being undertaken by other agencies
and organisations eg Ophthalmology
Prioritisation Tool and Royal Foundation
of the Blind prevalence study
The place of prevention, early
identification and risk stratification
through genomic macular diagnostic
tools, low vision rehabilitation, and
intravitreal anti-VEGF treatment within
the overall model of care for AMD
b) High-Level Milestones and Deliverables
Within the above scope, the project will deliver the following (a detailed GANNT Chart is
included as Appendix 2).
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High-Level Milestone or Deliverable
Contract signed with Project Manager
Establishment of Project Working Group, working with key stakeholders
Delivery of draft version of three Tier 3 Assessment Reports and
Decision Making Paper to NHC
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Sector consultation on draft Tier 3 Assessments
Delivery of Final version of three Tier 3 Assessment Reports and
Decision Making Paper to NHC
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Delivery of Committee Report to Minister, including final
recommendations
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Target Date
September 2015
November 2015
May 2016
May/June 2016
August 2016
September 2016
c) Project Approach
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Components of the assessment include:
•
Establishment of a Project Working Group to provide input to and peer review the
Tier 3 Assessment Reports (refer Appendix 3 for the draft Terms of Reference).
It is expected the Project Working Group will meet three times during the project:
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1.
2.
3.
Review and discuss the project scope and inform the literature,
information and knowledge search strategy. Provide access to current
local service provision and service outcomes and provide the conduit
to the sector for communication.
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Review the output from the data collection and analysis work and
inform the preparation of the draft report. In particular providing fact
and accuracy checking of qualitative information and review and
advice on the completeness of research evidence. Provide advice on
the preferred model of care implementation
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Review the draft report (note this meeting may be via teleconference).
Note: The National Health Board Disability Support Services Unit (NHB DSS) is
establishing a Stakeholder Reference Group to support their work in low vision
rehabilitation. The proposed membership of the NHB DSS group aligns with the
NHC’s proposed membership for the Project Working Group. Therefore there is
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T3 AMD Project Plan
17
an opportunity to establish one group to meet the requirements of both projects,
ie the agenda for the group meetings could be structured to meet both projects
requirements.
•
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Data collection and analysis including:
o
Literature, information and knowledge search. This will use a broad search
strategy of:




•
•
•
•
•
clinical evidence (RCTs, health technology assessment reports, clinical
guidelines, and assessment of current lifespan of the technology),
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health economic assessments (cost effectiveness of AMD interventions
and budget implications of changes to the model of care)
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health jurisdiction regulatory decisions
business models including capital and operational funding and
commissioning advice and decisions and service delivery research
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o
Structured stakeholder interviews with key identified stakeholders
o
Relevant quantitative information (eg, volumes, costs, funding, budgets)
including information to determine cost effectiveness for each of the three
assessments.
o
Implementation requirements, including consideration of workforce, facility
and equipment needs, capital and procurement linkages and clinical and cost
data collection requirements for ongoing performance monitoring and
evaluation.
Tier 3 assessment write-up by Domain, and summary findings for each of the
three components
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Formal external peer review by clinical, operational, funding and regulatory
stakeholders
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Completion of assessment package including technical paper using NHC Models
of Care methodology across domains, NHC Committee decision paper,
consultation plan and Committee report to the Minister of Health.
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Consultation of the draft Tier 3 assessments with the Sector.
Final Committee paper including summary of consultation feedback, proposed
changes (if any) to assessment based on feedback, implementation plan,
decision paper (inclusive of monitoring and evaluation approach and criteria),
Communications plan and Committee report to the Minister of Health.
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5) Stakeholders, Organisational Implications and Handover
d) Stakeholder Engagement & Consultation Plan
The National Health Committee has an agreed Implementation Plan (December 2014),
which sets out the approach and tools it will use to engage and communicate with
stakeholders. The relevant approaches for this project are set out below:
“Tool”
Action
Collaborate


work with partners on shared
goals and benefit
T3 AMD Project Plan
Utilise formal relationships between NHC,
Colleges and NGOs to ensure information
flow and formal involvement in PWG and
peer review processes
Lead
Project
Manager
18
“Tool”
Action

Create evidence

evidence to influence change
Engage


involve expert subject matter
stakeholders in NHC
assessment processes







Inform


share information with wider
stakeholders to allow them to
contribute to NHC
recommendations




Lead/influence


using monitoring and
evaluation to reinforce sector
changes
T3 AMD Project Plan
Identify key experts
Formally invite members to participate
Establish PWG
Run PWG as per project plan
Provide PWG with updated information
and minutes of meetings
Formal review of final documents
PWG debrief and formal thank you for
participation
Utilise NHC stakeholder fora (Chairs and
CEs meeting, GMs P&F, DHB COOs
monthly meetings, MoH, HWNZ and
NHBIT liaison meetings, establish a
regular engagement session with MOH
NHB DSS Unit) to share information on
AMD project
Utilise NHC newsletter to share
information with broader stakeholder group
PWG membership will include
representatives from relevant NHB and
MoH business units.
Utilise weekly PBU management meetings
to share information on project
Apply NHC operating policy regarding “No
Surprises” communication with Deputy
Director General Policy, Office of the
Director General and Minister of Health’s
Office
Project
Manager
Project Team
Project Lead
Project
Manager
GM NHC,
Operations
Manager,
Implementation
Manager

Follow the standard four week NHC
consultation process following the
publication of assessment work on the
Committee’s draft recommendations. A
consultation plan will be developed as part
of the AMD Committee package brought to
the Committee.

Utilise Clinical Colleges Road show (July –
Dec 2015) to initiate discussion
Chair and GM
NHC

To be confirmed in the implementation
plan included in the AMD final assessment
and recommendation report suite for the
Committee in August 2016
Implementation
Manager
utilise the NHC mandate to
ask the right questions to
influence sector thinking
Embed
Provide formal notification to stakeholders
that project will commence, invite formal
participation in PWG, set out project
timelines including peer review processes
Utilise NHC Tech note, updated evidence
review and service utilisation data to
inform PWG advice
Lead
19
The following stakeholders (internal and external) have been identified as playing a key
role in the success of this project. To ensure that we work closely with professional
colleges, consumer representative organisations and DHBs on this assessment review,
along with other identified key stakeholders, the Executive proposes to establish a
Project Working group (PWG) to:

Provide early and ongoing input into the assessment review

Provide and facilitate access to key information

Ensure iterative engagement over the course of the project

Provide peer-review of a draft assessment report before it is provided to the
NHC. Note external independent peer review of the draft assessment reports
may also be required.
Establishment of the PWG will be co-ordinated with the NHB DSS.
Invitations for nominated representatives will be extended to the various groups. Rather
than running a separate external peer review process of the draft assessment report
covering key stakeholder groups, it is proposed to use the nominated representatives on
the PWG for this purpose to reduce the burden on the organisations.
A draft Terms of Reference for the PWG is contained in Appendix 3.
Stakeholder
Relationship to Project
Engagement Approach
Royal Australian and New
Zealand College of
Ophthalmologists, New
Zealand Branch
Professional Ophthalmology
perspective
Invitation to join Project
Working Group (PWG)
NZ Association of
Optometrists Inc
Professional Optometrists
perspective
Invitation to join PWG
Nursing Council of New
Zealand
Professional Nursing perspective
Invitation to join PWG
PSAAP
Primary care perspective
Invitation to join PWG
District Health Boards
(DHBs)
Planning & funding and Service
delivery perspective
Invitation to join PWG
PHARMAC
Perspective on anti-VEGF agents
Invitation to join PWG
Blind Foundation
Consumer and provider
perspective
Invitation to join PWG
Low vision rehabilitation
centres (1 representative)
Provider perspective
Invitation to join PWG
Visual Impairment Charitable
Trust Aotearoa NZ (VICTA)
Consumer perspective
Invitation to join PWG
Macular Degeneration NZ
Retina NZ
Role in awareness, education,
support, research, representation
Invitation to join PWG
National Health Board
Business Unit (NHB BU) –
Disability Support Services
Collaboration with Low Vision
Rehabilitation work
Invitation to join PWG
Health Workforce New
Zealand (HWNZ)
Workforce implications
Invitation to join PWG
Health Promotion Agency
Community awareness and
health promotion perspective
Invitation to join PWG
T3 AMD Project Plan
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Note: The NHB DSS Stakeholder Reference Group proposed membership also includes
Disabled Persons Assembly (DPA) and allied health (occupational therapy)
representatives.
e) Potential Linkages With Other Sector Work
Potential linkages with the following sector work have been identified, and will be
managed through the project. Other linked work may be identified through the PWG.
Organisation
Contact
Implications
Management
Approach
Ministry of Health
National Health
Board Business Unit
Disability Support
Services
Phil Wysocki
Marianne Linton
Overlap with low
vision rehabilitation
work. DSS is
establishing a
stakeholder advisory
group which may also
be useful to support
this project.
Opportunity for
collaboration
Identify any potential
linkages and agree
management
approach, if required
Ministry of Health –
Electives Team
Simon Duff
Potential linkages
with health target for
electives as some
DHBs include intravitreal treatments in
their discharges
Identify any potential
linkages and agree
management
approach, if required
Opportunities to
improve consistency
of funding of intravitreal treatments
across the sector
Identify any potential
linkages and agree
management
approach, if required
The Blind Foundation
is about to release its
prevalence research
(due May 2015)
Identify any potential
linkages and agree
management
approach, if required
PHARMAC
Implications for
implementation of
model of care due to
PHARMAC review of
aflibercept and off
label use of Avastin
Identify any potential
linkages and agree
management
approach, if required
Health Workforce
New Zealand
Ophthalmology and
Optometry scope of
practice project may
impact model of care
implementation
Identify any potential
linkages and agree
management
approach, if required
Ministry of Health
National Health
Board Business Unit
Blind Foundation
T3 AMD Project Plan
Chris Shelton
21
f) Handover Approach
Upon completion, the deliverables from this project will be handed over as follows. Note
the shading indicates the documents to be considered by the Committee.
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Deliverable
Receiving
Group
Handove
r
Recipient
Consultation
Held
Handover
Approach
Handover
Requirements
Agreed
Draft
Assessment
Reports
PWG
All PWG
members
Peer review
Peer review
feedback
TBC (email
and/or
teleconference)
Final
Assessment
Reports
NHC
All NHC
members
For sector
consultation
post NHC
consideration
Committee
Paper including
three
assessment
documents
Committee
sign-off
NHC Decision
Making paper
NHC
All NHC
members
For sector
consultation
post NHC
consideration
Committee
paper
Committee
agreed draft
Rec’s
Consultation
Plan
NHC,
Minister of
Health
All NHC
members
NHC meeting
Email and
hardcopy
Committee
sign-off
Aide Memoire
(and package
of
assessment
documents)
Minister of
Health
Minister’s
Office
(DDG
Policy &
DG)
NHC meeting
Email and
hardcopy
Committee
sign-off (DDG
Policy and DG
noting)
Consultation
feedback and
final Rec’s
NHC
All NHC
members
4 week sector
consultation
on draft Rec’s
Committee
paper
Committee
sign-off
Committee
Report (and
documents to
be published)
Minister of
Health
(Ministry
of Health)
Minister’s
Office
(DDG
Policy &
DG)
NHC meeting
Email and
hardcopy
Committee
sign-off (DDG
Policy and DG
noting)
Published
advice and
documents
Sector
NHC
website
Electronic
copies
Minister notes
Committee
report first
6) Risks
a) Key Risks
The following risks have been identified as having the potential to delay progress of the
project and/or impact on the ability to achieve the deliverables.
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Risk Description
(If X happens, there is a risk of Y,
meaning Z impact)
Risk
Rating
How Risk Will Be Managed
Inability to appoint a suitably qualified
and experienced project manager
18
Active external recruitment including
realistic recruitment timeframes to find
a suitable candidate
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Risk Description
(If X happens, there is a risk of Y,
meaning Z impact)
Risk
Rating
How Risk Will Be Managed
NHC executive resource
o new staff leading this project
requiring management input
and support to ensure
appropriate project roll out
o constraints in availability of
specialist team member input
including data, economic
analysis and clinical advice
o competing projects and
timeframes across the NHC
work programme
o limited provision of project
management support time
including meeting organisation
and minute taking
18
Utilise a project team approach and
clear project management protocols to
map project progress
Inability to access relevant stakeholders
to understand current Model of Care
within timeframes
18
Ensure adequate membership to PWG
and support for representatives to
ensure required access to information
and attendance at meetings.
Inability to develop a funding model to
support the model of care.
18
Engagement with Sector is required to
inform the feasibility of the proposed
model of care from an economic
perspective.
Feedback from NHC and/or PWG
resulting in revised assessment scope
and timeframes
17
Reassess resources required and
deliverable dates if this eventuates
Inability to develop a model of care
which is clinically practical and
sustainable and acceptable to the key
stakeholders
14
Stakeholders to be actively engaged in
the model of care development.
Inability to identify and quantify the
benefits to patients
14
Stakeholders to be actively engaged in
accessing the appropriate data to
support the model of care.
Inability to reduce the inequities from
the current model of care
14
Engagement with the sector to inform
the model of care development
Inability to maintain alignment with the
national service development work
being undertaken by the National Health
Board Business Unit of the Ministry of
Health for low vision services.
9
NHB invited to meet with the NHC.
Mutually agree how the two projects
can work together. Regular
communication with NHB team to
ensure alignment between work
programmes.
The workforce implications of the
proposed model of care, including
changes to scope of practice for nursing
staff, optometrists and
ophthalmologists, are insurmountable
9
Engage with HWNZ’s work with
ophthalmologists and optometrists.
Engage with the Nursing Council
regarding the nursing scope of practice
Inability to implement the model of care
due to the negative impacts on existing
infrastructure and business processes
9
Engage the NHB and DHBs in the
development of the model of care
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Provide formal mentoring and project
review with new staff to ensure early
identification of issues
Scope workplan specialist constraints
and secure additional support in a
timely manner
Utilise annual workplan wash up
process to identify workflow
requirements
Ensure project timelines and resources
include project management support
time
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7) Funding and Resourcing
a) Project Costs
The following table provides a high-level overview of project funding and costs.
Description
Funding Source
Cost
NHC Executive resources
NHC Departmental
Expenditure
Staff time
PWG expenses
NHC Departmental
Expenditure
Travel (and potentially
time in some cases)
Note these costs may
be shared with the NHB
DSS team.
Project Manager
NHC Departmental
Expenditure
Time
b) Funding Arrangements
Funding for the project is from the NHC’s budgeted Departmental Expenditure, under the
delegated authority of the General Manager.
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T3 AMD Project Plan
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c) Resource Requirements
NHC resource requirements will be met from within baseline figures.
The following additional resources are required for the successful delivery of this project.
Role
Person
Hours/Person
/Week
Project Manager
External
contractor
Project Lead
Faye Ryan
Period
Agreed by
Project Duration
NHC General
Manager
Peter Guthrie
8) Project Structure
a) Project governance
Sponsor
Anne Kolbe, Chair, NHC
Business Owner or
Responsible Manager
Peter Guthrie, General Manager, NHC
b) Project Team
The Project Team consists of the following:
Role
Name
Title
Project Leads
Faye Ryan
Operations Manager
Implementation
Manager
Project Manager
To be appointed
Clinical Advice (Executive)
TBC
Economics
TBC
Data
TBC
Feasibility of Adoption
TBC
Project Support
TBC
Project Administration
TBC
Note a process of allocating portfolios and projects to specific NHC Executive members
and external contractors is underway across the overall NHC work programme. The
project team will be confirmed prior to the project commencement.
c) Project Working Group
Invitations to be represented on the Project Working Group will be extended to the
following:
Organisation
Name
Royal Australian and New
Zealand College of
Ophthalmologists, New Zealand
Branch
Jim Borthwick
T3 AMD Project Plan
Title
Chair
25
Organisation
Name
NZ Association of Optometrists
Inc.
Lesley Frederikson
Title
National Director
Nursing Council of New
Zealand
PSAAP
Primary Care Health
Organisation (PHO) Group
PHOs
District Health Boards (DHBs)
GMs Planning and Funding
Group
Chief Operating Officers Group
GMs Planning and
Funding
Chief Operating Officers
Sandra Budd
Chief Executive
Visual Impairment Charitable
Trust Aotearoa NZ (VICTA)
Gordon Sanderson or Lynley
Hood
Chair
Trustee
Macular Degeneration NZ
Dianne Sharp
Trustee
National Health Board Business
Unit (NHB BU) – Disability
Support Services
Michael Hundleby
(Marianne Linton)
National Director
Health Workforce New Zealand
(HWNZ)
Graeme Benny
Director Workforce
PHARMAC
Blind Foundation
Low vision rehabilitation
centres (1 representative)
Health Promotion Agency
d) Monitoring and Reporting
Describe all monitoring and reporting arrangements for all levels of the governance structure.
Who reports
To whom
What is reported
When
Project Owner
(GM)
Project Sponsor
(NHC)
Variance to plan
Monthly
management
report
Project Leads
Project Owner
Progress and variance to plan
Fortnightly
Operational
Meetings
Project Manager
Project Leads
Progress and variance to plan,
issues and risks
Weekly
Team
Meetings
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Appendix 1 - Domain and decision criteria for the three Tier 3 assessments
Decision criteria 8
P7F
Tier 3 Assessment Domains
1
clinical
2. societal and ethical
3.
economic
4.
feasibility of adoption
Analysis of evidence that the proposed Will the introduction of the AMD
three AMD interventions are safe and interventions raise safety concerns for
clinically effective.
patients and communities?
How does the use of the technology
impact on differential; population need
and outcomes particularly; quality of life
issues.
Analysis of evidence that the proposed
AMD interventions can be provided
effectively and safely within the New
Zealand health and disability
environment.
B. Health and independence gain
The focal outcomes of interest. May be
indirect – for example an intervention
providing equivalent outcomes to
existing treatment may be considered
beneficial if it is cost-saving thereby
freeing resources.
Analysis of evidence that the proposed
three AMD interventions will result in an
overall significant net benefit in health
and independence outcomes to patients.
Analysis of evidence that the proposed Analysis of evidence that the proposed
three AMD interventions will result in an intervention(s) will result in an overall
overall significant net benefit in health significant net benefit in improved health
and independence outcomes to whanau, and independence outcomes to funders.
carers, providers, and population
groups.
(if applicable)
Analysis of evidence that the proposed
intervention(s) will result in an overall
significant net benefit in improved health
and independence outcomes from an
organisational and system perspective.
C. Materiality Stakeholders will have a
view on the materiality of proposals, in
terms of their relevance to the sector’s
work. During assessments it will inform
decisions on the required level of
analysis to support robust
recommendations.
Analysis of evidence that the proposed
three AMD interventions will make a
clinically significant difference in
outcomes.
Analysis of evidence that the proposed
three AMD interventions will make a
socially significant difference in
outcomes.
Analysis of evidence that the proposed
intervention(s) will make a financially
and economically significant difference
in outcomes.
Implications of implementation of
proposed intervention(s) in terms of
workforce skills and capacity and
systemic provision.
Analysis of evidence about whether the
proposed three AMD interventions are
clinically practical and sustainable, in
terms of both processes and outcomes;
and whether the available evidence can
support robust recommendations.
Analysis of whether processes and
outcomes from the proposed three AMD
interventions are practical and
sustainable within existing constraints
from a societal or ethical perspective.
Analysis of whether the available
evidence for the proposed
intervention(s) is sufficient to be sure it
is economically practical and
sustainable.
Analysis of whether the available
evidence for the proposed
intervention(s) is sufficient to be sure it
is realistically achievable to implement
and sustain within the NZ health and
disability sector.
A. Clinical safety and effectiveness
The fundamental issue. If not safe and
effective, an assessment of other
domains is unnecessary.
D. Feasibility
8
from NHC website
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Decision criteria 8
P7F
E. Policy congruence
(if necessary) Policy congruence will
generally be covered at Tier 2 level and
a referral back to the Tier 2 paper may
suffice.
Tier 3 Assessment Domains
1
clinical
2. societal and ethical
3.
economic
feasibility of adoption
How does the proposed AMD
interventions align with agreed national
priority areas, targets or expected
outcomes
How does the proposed AMD
interventions align with agreed national
social development priority areas,
targets or expected outcomes
What is the evidence of the impact of
AMD interventions on existing inequity
of clinical outcomes?
(eg, differential response to intervention
for patient subgroups)
Is the introduction of the proposed AMD How will the AMD interventions impact
interventions fair and equitable
on economic aspects of equity (eg
considering both existing and potential targeted funding)
disparities in health.
Both horizontal equity (equal treatment
for equals) and vertical equity
(preferential treatment for unequals)
issues.
How can the proposed AMD
interventions be targeted to address
known need for care for high need
patients
G. Acceptability
Any significant clinical issues or
determination of acceptability will require consumer /clinical stakeholder concerns
not raised at Tier 2.
iterative engagement with relevant
stakeholders
Any significant ethical, legal, social, or
political issues; or consumer
/stakeholder concerns not already
addressed
Any significant consumer /clinical
stakeholder economic concerns not
already addressed
Impact of any significant ethical, legal,
social, or political issues or consumer /
stakeholder concerns not already
addressed
H. Cost effectiveness
(value for money) Will be used to help
determine the relative priority NHC work
and of different proposed interventions
Would this investment in resources be
fair given the limited nature of health
resources? Would those who are not
likely to benefit from the treatment view
this as cost-effective?
Detailed NZ-focused evidence and
analysis of the overall costs of the
proposed AMD interventions and the
aggregate benefits that it would
generate related to comparable
interventions.
Detailed NZ-focused evidence and
analysis of the implementation costs and
aggregated net benefits of the proposed
AMD interventions.
F. Equity
I. Affordability
T3 AMD Project Plan
How does the proposed AMD
interventions align with agreed national
economic priority areas, targets or
expected outcomes
4.
How does the proposed AMD
interventions align with agreed national
implementation priority areas, targets or
expected outcomes
Detailed NZ-focused analysis of the
Detailed NZ-focused analysis of the
affordability of short, medium and longer affordability of the implementation and
term financial and other resourcing costs ongoing resourcing needs for the
of the proposed AMD interventions;
proposed AMD interventions within the
including both set-up and operating
existing resourcing systems and
costs, any flow-on costs or cost-savings priorities.
to and from other areas, and longer-term
sustainability.
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Decision criteria 8
P7F
J. Risks
Includes social, political and economic
risks plus future risks to achieving
outcomes
K. Other criteria as the NHC thinks fit
Any significant topic-specific
considerations not covered in the
specified criteria that would influence
the recommendation
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Tier 3 Assessment Domains
1
clinical
What are the risks to achieving clinical
outcomes from the use of the proposed
AMD interventions both immediately and
in the longer term; plus risk
management.
2. societal and ethical
What are the risks to achieving social
and political outcomes from the
introduction of the proposed AMD
interventions both immediately and in
the longer term; particularly with regard
to specific populations; plus risk
management.
3.
economic
What are the risks to achieving
economic outcomes for the AMD
interventions both immediately and in
the longer term; plus risk management.
4.
feasibility of adoption
What are the risks to health provision
systems and funders from
implementation of the proposed AMD
interventions both immediately and in
the longer term; plus risk management.
When any additional criteria are used, the recommendations will need to clearly state the reasons for those criteria and how they were applied.
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Appendix 2 – Project GANTT Chart
July
August
September
October
November December January 2016 February
March
April
May
June
July
August September
10 17 24 31 7 14 21 28 4 11 18 25 2 9 16 23 30 6 13 20 27 4 11 18 25 1 8 15 22 29 5 12 19 26 4 11 18 25 1 8 15 22 29 6 13 20 27 3 10 17 24 1 8 15 22 29 5 12 19 26 2 9 16
Task
Milestones
Responsibility Deliverable
Project Planning
Committee Approval
RFP process
Contract Assigned
Contract Monitoring
Potential members invited
Meeting preparation
Meeting
Meeting de-brief
Research strategy implemented
Stakeholder Interviews
Quantitative analysis
Implementation analysis
Data collection write-up
Project Working Group Review
Draft structure of Tier 3 assessments
Write-up document content
Draft summary of findings
First Drafts completed
Executive review
Project Working Group Review
Independent Peer Review??
Final Committee Drafts Completed
Final decision making document completed
Prepare consultation plan
Develop consultation documentation
GM, Committee Project Plan
OM
RFP Documentation
GM
Project Manager
IM
Contract Management Progess Reports
PM
Invitations sent
PM
Agenda & papers
PM
PM
Minutes & Actions
PM
Best practice information
PM, IM
Sector information
PM, OM
Summary of data analysis
PM, IM
Summary of implementation requirements
PM
Evidence for tier 3 assessments
PM
Feedback
PM
Draft structure
PM
PM
First draft summary of findings
PM
First draft four Tier 3 assessments
GM, OM, IM
Feedback
PM
Feedback
Feedback
PM, GM
Committee papers
PM, GM
Committee papers
PM, OM
Consultation plan incl communication plan
PM, OM
Website updates, publication documents etc
Project Advisory Group
Data Collection
Four Tier 3 Assessments
First Draft
Consultation
Committee Approval of Tier 3 documents and consultation
Consultation preparation
Inform the Minister
Consultation Period
Analyse Feedback
Four Tier 3 Assessments
Update Tier 3 assessment documents
Final Draft post consultation Update decision making document
& Recommendations
Draft Health Recommendations Report
Release of Recommendations Plan
Executive Review
Committee Approval
Health report & Tier 3 assessments finalised
Health report & Tier 3 assessments sent to DDG & ODG
Health report & Tier 3 assessments sent to Minister
Tier 3 assessments and recommendations published
Key stakeholders advised of release of recommendations
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55T
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55T
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GM, Committee Approval
PM
Website updates, publication documents, communications etc
GM
Aide Memoire
PM
Feedback from stakeholders
PM
Summary of feedback and actions
PM
Committee papers
PM
Committee papers
PM, OM
Committee papers
PM, OM
Publication versions, website, communications plan
GM. OM, IM
Committee papers
GM, Committee Approval
PM
Health report & Tier 3 assessments
GM
Health report & Tier 3 assessments
GM
Health report & Tier 3 assessments
PM
Website updated
GM
Email sent
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
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











Key
GM – General Manager
PM – Project Manager
OM – Operations Manager
IM – Implementation Manager
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Appendix 3 – Project Working Group Terms of Reference
Introduction
Terms of reference for groups and meetings are required. They determine the roles and
responsibilities of its membership. They promote an effective meeting or group.
This document refers to the terms of reference for the Project Working Group to support the
Age Related Macular Degeneration (AMD) Tier 3 Assessments Project.
Project Statement
In response to a 2013/14 reactive referral from Waitemata and Auckland District Health
Boards asking “how many (Avastin) treatments should the DHB be doing?” the NHC
prepared a Tier 2 assessment that explored the model of care for patients with age-related
macular degeneration (AMD).
The NHC agreed that based on the Tier 2 AMD assessment and feedback received, that
three Tier 3 assessments needed to be undertaken - population screening; low vision
rehabilitation; intravitreal anti-VEGF treatment; and AMD genomic diagnostic risk
stratification.
Purpose
It is the purpose of this Project Working Group (PWG) to provide the specific knowledge and
expertise to inform and guide the information and processes necessary to complete the
three Tier 3 AMD assessments.
Three meetings are planned, the focus of each meeting is as follows:
1. Review and discuss the project scope and inform the literature, information and
knowledge search strategy. Provide access to current local service provision and service
outcomes and provide the conduit to the sector for communication.
55T
2. Review the output from the data collection and analysis work and inform the preparation
of the draft report. In particular providing fact and accuracy checking of qualitative
information and review and advice on the completeness of research evidence. Provide
advice on the preferred model of care implementation
55T
3. Review the draft report (note this meeting may be a teleconference).
55T
Accountability
Each member is accountable to his/her own manager of their team or division or
organisation. They shall inform them of the PWG activities, and communicate both agenda
and minutes.
A delegated representative may attend in the absence of a member.
Composition of the PWG
Member
Relationship to Project
National Health Committee
Project Management and Leadership
Royal Australian and New Zealand College of
Ophthalmologists, New Zealand Branch
Professional Ophthalmology perspective
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Member
Relationship to Project
NZ Association of Optometrists Inc
Professional Optometrists perspective
Nursing Council of New Zealand
Professional Nursing perspective
PSAAP
Primary care perspective
District Health Boards (DHBs)
Planning & funding and Service delivery
perspective
PHARMAC
Perspective on anti-VEGF agents
Blind Foundation
Consumer and provider perspective
Low vision rehabilitation centres (1
representative)
Provider perspective
Visual Impairment Charitable Trust Aotearoa
NZ (VICTA)
Consumer perspective
Macular Degeneration NZ
Retina NZ
Role in awareness, education, support,
research, representation
National Health Board Business Unit (NHB
BU) – Disability Support Services
Collaboration with Low Vision Rehabilitation
work
Health Workforce New Zealand (HWNZ)
Workforce implications
Health Promotion Agency
Community awareness and health promotion
perspective
Additional expertise may be co-opted at any time as needed
Quorum
A quorum will be more than half the total membership
Chair
The chair person will be the Project Lead (National Health Committee) or delegated member
The agenda will be issued by the chair 5 working days prior to the meeting
Minutes
Minute taking will be managed by the Project Lead (National Health Committee).
The minutes will be issued by the minute taker five working days after the meeting
Meeting Frequency/Duration/ Venue
It is expected that three meetings will be held each of four hours duration. These will be held
in Wellington at the Ministry of Health utilising video/teleconferencing facilities if required.
Conflict of Interest
It is the responsibility of the individual to declare any potential conflict of interest.
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