Download Position statement on access to anti-VEGF therapy

Position statement on access to anti-VEGF
therapy
October 2016
Executive Summary
Vision 2020 Australia has identified two key barriers to access to anti-VEGF therapy
for Aboriginal and Torres Strait Islander people and those in rural and remote
Australia. Key recommendations to eliminate these barriers and improve access to
these sight-saving therapies are:
1.
Permit fundus photography as documentation (rather than fluorescein angiography)
for the purpose of Authority approval of anti-VEGF medications (currently
ranibizumab (Lucentis) and aflibercept (Eylea)), until Optical Coherence
Tomography (OCT) has MBS listing and is available in rural and remote areas;
2.
allow for another medical practitioner to obtain Authority approval for Lucentis or
Eylea on behalf of an ophthalmologist, with the caveat that the treatment must be
prescribed by an ophthalmologist or in consultation with an ophthalmologist;
3.
expedite the implementation of an Medical Benefits Schedule (MBS) item for Optical
Coherence Tomography (as recommended by Medicare Services Advisory Council
MSAC);and
4.
secure funding for Optical Coherence Tomography (OCT) equipment to ensure that
anti-VEGF therapy is delivered according to best practice standards.
Policy context
At present, there are more than 453,000 Australians who are blind or vision impaired.
The situation for Aboriginal and Torres Strait Islander people is markedly worse with
three times the rate of blindness vision impairment than non-Indigenous Australians.1
Additionally, approximately 1.7 million Australians are estimated to be living with
diabetes and with an additional 280 people developing diabetes every day this figure is
estimated to grow to 2.45 million by 2030.
A recent estimate of the total indirect cost of vision loss associated with Diabetic
Macular Oedema (DMO) is estimated to be $2.07 billion in 2015. Much of this cost is
related to decreased workforce participation and loss of capacity. When the direct costs
of DMO treatment and the costs of other causes of vision loss from diabetes are taken
into account the total burden of the disease on the economy is substantially greater.
Eye health outcomes are poor for those living in rural and remote locations (ASGS-RA4
and ASGS-RA5), where there exists a lack of easily available and coordinated access to
specialist services provided by ophthalmologists, such as anti-VEGF therapies. A 2010
study by Indigenous Eye Health at the University of Melbourne illustrates that the supply
of ophthalmologists varies greatly across the country, but was up to 19 times lower than
the national average in remote and very remote communities2.
1
Foreman, J., et al, 2016, The National Eye Health Survey Report 2016, The Centre for Eye
Research Australia and Vision 2020 Australia, Melbourne
2
Indigenous Eye Health, the University of Melbourne, Provision of Indigenous Eye Health
Services, 2010
National body working in partnership to prevent avoidable blindness and improve vision care
While this is partly addressed through the Rural Health Outreach Fund (RHOF) which
provides funding support for specialist outreach services to ensure people living in rural
and remote locations have access to a wide range of health care services, including
ophthalmology, evidence shows that health outcomes remain poor in comparison to
Australians living in urban and regional areas.
However, poor eye health outcomes for Aboriginal and Torres Strait Islander people are
not limited by geography and additional barriers to access exist; including social
determinants of health and equality of opportunity in relation to health3. Ultimately,
even in urban and regional locations where services are more easily available, these
barriers result in many Indigenous Australians not accessing eye health services4.
Vision 2020 Australia position
Approximately 1.7 million Australians are living with diabetes in 2016 and this figure
is expected to grow to 2.45 million by 2030. Diabetes-related eye disease, such as DMO,
accounts for a significant amount of vision loss for Aboriginal and Torres Strait Islander
people, and is the most common cause of blindness among working age Australians.
Furthermore, Aboriginal and Torres Strait Islander people are at least three times more
likely than non-Indigenous Australians to be diagnosed with diabetes and as a result are
at a higher risk of losing their sight to the disease. Already, the situation for Aboriginal
and Torres Strait Islander people is markedly worse with three times the rate of
blindness and vision impairment than non-Indigenous Australians. Given the persistent
eye health gap between Aboriginal and Torres Strait Islander people and the remainder
of the population and the scarcity of access to ophthalmology services in rural and
remote locations, Vision 2020 Australia wants to ensure that the availability of existing
anti-VEGF treatments for DMO is as effective as possible for these two population
groups.
Vision 2020 Australia has identified two systemic barriers in the availability of anti-VEGF
treatment for DMO:
1.
The diagnostic requirement of fluorescein angiography (FA) for PBS approval; and
2.
the administrative processes to obtain PBS authority.
These concerns have particular relevance to closing the gap in Aboriginal and Torres
Strait Islander eye health and access to eye health care for Australians living in rural
and remote locations. There are two principal PBS approved anti-VEGF therapies used
to treat or reduce the impact of DMO in Australia, namely Lucentis (ranibizumab, PBS
item 10374B and 10373Y) and Eylea (aflibicept, PBS item 10505X).
Currently, in order to receive Authority approval for a patient for either of these
therapies, PBS guidelines require the treating ophthalmologist to document DMO using a
fluorescein angiogram (FA), unless contraindicated as listed in the Therapeutic Goods
Administration (TGA) approved product information, and submit a copy of the FA to
Medicare Australia. However, ophthalmologists who are treating patients living in rural
or remote areas through outreach programs often do not have access to FA.
It is essential to note that FA is the required form of documentation for the purposes of
PBS approval, but this is not the method of diagnosis used in current clinical practice.
3
Aboriginal and Torres Strait Islander Social Justice Commissioner, Achieving Aboriginal and
Torres Strait Islander health equality within a generation - A human rights based approach,
2007
4
Indigenous Eye Health, the University of Melbourne, Provision of Indigenous Eye Health
Services, 2010
Vision 2020 Australia: Position statement on access to anti-VEGF
therapy
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The diagnosis of DMO is made either by clinical examination or Optical Coherence
Tomography (OCT), the latter being the more sensitive for detection of DMO. Clinical
examination findings are documented with fundus photography, and the facility for
fundus photography (which recently received MBS reimbursement for rural / remote
areas) is currently being implemented.
OCT is the accepted standard for documentation of DMO and is the only imaging
modality capable of providing retinal thickness measurements. OCT is the standard
modality in international use to determine response to treatment and to monitor
progress.
Vision 2020 Australia notes that the Medicare Services Advisory Council (MSAC) has
recommended listing on the MBS an item for OCT scanning in the initial diagnosis of
macular disease for the purpose of determining eligibility for approved intravitreal
therapies. It is essential that this listing is expedited to ensure that access to
intravitreal therapy, in particular for DMO in Aboriginal and Torres Strait Islander people
in rural and remote Australia, is available without the unnecessary invasive test of FA.
The authority restriction further dictates that the prescriber must be an
ophthalmologist, and must be present to receive the call from Medicare with the
approval for the treatment. This is inefficient and unsustainable in outreach service
delivery where the ophthalmologist may only be present in an area for one day, often
with 15 or more patients to treat. In PBS authority guidelines for other treatments, such
as Anakinra (PBS item 10263E and 10264F), there are examples where the call for
authority can be made by another clinician or registrar, in consultation with the
relevant specialist.
It is proposed that the purely clerical/administrative component of the approval process
for anti-VEGF medication be able to be performed by another clinician in consultation
with an ophthalmologist. Exactly the same standard of care would apply to the
diagnosis, which would be made by the treating specialist ophthalmologist. The
treatment itself would also be performed in the same way is it is currently.
Recommendations
To maximize the availability and access to DMO treatments for all Aboriginal and Torres
Strait Islander people and for non-Indigenous Australians living in rural and remote
locations (ASGS-RA4 and ASGS-RA5), Vision 2020 Australia recommends that in the short
term the Australian Government:

Permit fundus photography as documentation (rather than fluorescein angiography)
for the purpose of Authority approval of Lucentis and Eylea, until Optical Coherence
Tomography (OCT) has MBS listing and is available in rural / remote areas;

allow for another medical practitioner to obtain Authority approval for Lucentis or
Eylea, with the caveat that the treatment must be prescribed ‘by an
ophthalmologist’ or ‘in consultation with an ophthalmologist’; and

expedite the implementation of an MBS item for OCT (as recommended by MSAC),
thus facilitating the use of OCT to document DMO for the purposes of PBS Authority
approval.
In the medium term, Vision 2020 Australia recommends that funding be provided for
OCT machines to ensure that all Aboriginal and Torres Strait Islander people, and nonIndigenous Australians in rural and remote areas, have access to best practice care for
their macular conditions, in particular DMO.
Vision 2020 Australia: Position statement on access to anti-VEGF
therapy
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About Vision 2020 Australia
Established in October 2000, Vision 2020 Australia is part of VISION 2020: The Right to
Sight, a global initiative of the World Health Organisation and the International Agency
for the Prevention of Blindness. Vision 2020 Australia is the peak body for the eye
health and vision care sector, representing over 50 member organisations involved in:
local and global eye care; health promotion; low vision support; vision rehabilitation;
eye research; professional assistance and community support.
Vision 2020 Australia: Position statement on access to anti-VEGF
therapy
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