Abbott input to the Inquiry into approval processes for new drugs and novel medical technologies in Australia

Abbott input to the Inquiry into
              approval processes for new drugs
              and novel medical technologies in
              Australia

Abbott is a global healthcare leader. At Abbott, we're committed to helping people live their best possible
life through the power of health. For more than 125 years, we've brought new products and technologies
to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that
create more possibilities for more people at all stages of life. Today, 103,000 of us are working to help
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Abbott input to the Inquiry into approval processes for new drugs and novel medical technology

Abbott Diabetes Care Submission: Inquiry into approval processes for new drugs and novel
medical technologies in Australia
Overview:
Diabetes is a National Health Priority, the fastest growing chronic condition and the 21st century epidemic.
Approximately 1.3 million Australians are diagnosed with diabetes, including 128,000 with Type 1 diabetes
(T1DM). People with T1DM are generally diagnosed in childhood or early adolescence then require regular insulin
doses to survive for the remainder of their lives.
People with diabetes sometimes have to prick their fingers up to 12 times per day to maintain glucose levels—it’s
painful, it’s invasive and it’s a hassle. There is a need for better outcomes and reducing complications that cost up
to $16,698/person annually1. The FreeStyle Libre flash glucose monitoring system is revolutionizing diabetes care.
However, the listing of FreeStyle Libre on Australia’s National Diabetes Services Scheme (NDSS) took 5 years due to
a lack of any reimbursement process to establish cost-effectiveness. Abbott partnered with the Department of
Health to conduct 2 Ad-hoc health technology assessments of FreeStyle Libre for the subsidy of all Australians living
with Type 1 diabetes. FreeStyle Libre was finally listed on the restricted NDSS CGM Initiative on 1 March 2020.
The current expanded CGM subsidy scheme covers up to 58,000 people with T1DM, with ~25,000 already accessing
the scheme. However, >70,000 Australians with T1DM are currently denied access. These are working Australians
and are denied because they are not eligible for a Commonwealth concession card.
Many comparable countries have expanded access to all people with T1DM without restrictions and have
demonstrated improved health outcomes (e.g. HbA1c and hypoglycaemia) resulting in reduced costly diabetes
complications. These countries specifically include the United Kingdom, France, Germany, Sweden and Canada to
name a few. FreeStyle Libre is the #1 sensor-based glucose monitoring system used worldwide, changing the lives
of more than 3 million people across more than 50 countries, with partial or full reimbursement in 38 countries.
We believe broader access to FreeStyle Libre would be extremely well received and is supported by a current
independent petition of >237,000 signatures to enable FreeStyle Libre access for all T1DM’s and several mentions
in Parliament to broaden access to this life-changing technology.

Recommendation 1: To expand FreeStyle Libre access on the NDSS to all people with Type 1 diabetes by 1
September 2021.
Abbott has partnered with the Department of Health to conduct 2 Ad-hoc health technology assessments of the
FreeStyle Libre portfolio for the subsidy of all Australians living with Type 1 diabetes. This process has taken over 5
years and the Government should streamline the reimbursement for all Australians with Type 1 diabetes, including:
    •    Government policy change to add a co-payment for working Australian’s with Type 1 yet to get access
    •    Government policy change to re-invest NDSS savings back into the NDSS
    •    Government to include broader savings including reduced hospitalisations and increased productivity when
         allocating budgets to fund broader access to FreeStyle Libre
One of the key reasons why a medicine or technology may take longer to be reimbursed is that the Government
needs to approve any additional Budget expenditure. When considering listing on the NDSS, the Government only
looks at the relevant appropriated Budget for these technologies and hospitalisation savings have not yet been
considered in Australia due to the complex hospital budget allocation arrangements. However, if considered more
broadly (as done by many Government’s across the world), the FreeStyle Libre portfolio is widely considered as a
cost-saving device to the Healthcare system. The FreeStyle Libre portfolio reduces Government resource utilisation
including expensive hospitalisations caused by hypoglycaemia, hyperglycaemia, diabetes ketoacidosis (DKA) and
other diabetes complications as noted from research post-reimbursement in the United Kingdom.i

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Abbott input to the Inquiry into approval processes for new drugs and novel medical technology

Recommendation 2: Government to acknowledge FreeStyle Libre as an economic driver that increases
productivity by prioritising broader access
Australia, through its current Health Technology Assessment and other review mechanisms, has not considered or
acknowledged the ability for FreeStyle Libre to improve productivity within the economy.
    •    Diabetes is costly to the broader economy. Australians living with diabetes aged 45-64 years without better
         interventions cost the Australian economy $2billion+ annually from a reduction of GDP due to lost
         productivity, $100million+ annually from loss of annual taxation revenue and $300million annually from
         extra welfare payments. ii
    •    FreeStyle Libre is a life changing device that can improve work productivity, this is particularly important at
         a time post-COVID when productivity is a vital component of Australia’s recovery plan.
    •    FreeStyle Libre improves productivity within the economy and has been proven to reduce work
         absenteeism in the Netherlands by 58% iii
Recommendation 3: Government to implement parallel processing for TGA/MSAC processes
The Department of Health suggests “that the proactive approach within Australia to move toward synchronising the
timing of HTA and regulatory recommendation is achieving its purpose”. Yet more needs to be done in this area. For
example, this parallel process is not yet available for MSAC/TGA.
It can take longer to navigate subsidy pathways than the product life cycles, particularly when these pathways are
not fit-for-purpose and/or require separate assessment pathways. The MSAC process can take between 2-4 years
and this can be the same duration as a product lifecycle.
Combining parallel TGA and MSAC processes will increase efficiencies and reduce the time to reimburse critical
technologies such as the FreeStyle Libre portfolio to broader populations.
Recommendation 4: Government to broadly adopt real world evidence in Regulatory and Reimbursement
assessments
The guidelines for regulatory and reimbursement consideration are focussed and heavily weighted on randomised
controlled trials (RCT) with double-blind groups (i.e. participants are blinded to the traditional drug treatment).
However, it’s impossible to run double-blind groups with devices like FreeStyle Libre 2. Also, the data generated from
devices is different given the product cycles and, therefore, may be more practical to run real-world evidence (RWE)
to assess healthcare efficiencies. Ethics issues in device trials, sample sizes, all militate against direct comparison
between pharmaceuticals and device therapies.
In practice Health Technology Assessment (HTA) Agencies such as MSAC can have a substantial focus on internal
validity with RCTs from Australian HTA bodies that include both Government and academia bodies. It is quite likely
that a perfect package of evidence cannot be generated to meet the needs of all decision makers, given the ethical,
time and budget constraints for pivotal studies. The power of RWE with large sample sizes after market entry can be
greater than the power of small RCTs but RWE is undervalued. Further, effectiveness of a technology in a more
generalisable population should be considered equally as high as any available RCT’s, particularly when there is
substantial RWE demonstrating the effectiveness on a broad population.
Public support for broader access:
There is a high degree of public support for prioritisation of digital data-rich technology such as the FreeStyle Libre
portfolio, as evidenced by over 237,000 people who have signed an independent petition to reimburse FreeStyle
Libre for all Australians with Type 1 diabetes mellitus.
https://www.change.org/p/prime-minister-of-australia-we-need-ndss-rebates-for-life-saving-diabetes-equipment

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Abbott input to the Inquiry into approval processes for new drugs and novel medical technology

FreeStyle Libre Portfolio background: FreeStyle Libre 2 and digital ecosystem
FreeStyle Libre is the #1 sensor-based glucose monitoring system used worldwide, changing the lives of more than
3 million people across more than 50 countries, with partial or full reimbursement for T1DM & T2DM in 38 countries.
FreeStyle Libre 2 (FSL2) is a novel glucose monitoring system, including a small, water-resistant sensor applied to the
back of the upper arm for up to 14 days that automatically measures and provides customizable, optional real-time
alarms 24/7 in people with diabetes who require insulin. The FreeStyle Libre system also includes a reader or
compatible smart phone that displays the alarms and data for the user and a full glucose profile for their healthcare
provider (Fig. 1). FSL2 is the only system that continuously transmits glucose data every minute with optional real-
time alarms to alert users when their glucose is high or low without scanning (Fig. 2) and excellent accuracy and
alarm performance at low glucose levels.
FreeStyle Libre 1 and 2 continuously measures glucose in the interstitial fluid levels 24/7 by scanning the sensor with
a reader or App and are both listed on the Australian Register of Therapeutic Goods as a suitable replacement for
SMBG for people (age four and older) with diabetes who use insulin.
The Ambulatory Glucose Profile (AGP) report provides a snapshot of a typical day revealing trends in hypoglycaemia
(low glucose levels) and hyperglycaemia (high glucose levels). The Australian Diabetes Society (ADS) released a
consensus position statement on utilising the AGP to support decision marking iv
The FreeStyle Libre digital ecosystem (Fig.3) includes the FreeStyle LibreLink app enabling users to hold their
smartphone near their FreeStyle Libre sensor to capture and view their real-time glucose levels, their eight-hour
glucose history, and how their glucose is currently changing; and easily add notes to track food, insulin use,
medication and exercise. FreeStyle LibreLink users also have the option to share their information with loved ones
and caregivers through FreeStyle LibreLinkUp. In addition, LibreView, enables a series of reports to healthcare
professionals, which reveal trends and patterns to make more informed treatment decisions. LibreView has been
instrumental during COVID-19 lockdowns by enabling convenient data-sharing during patient telehealth consults.

     Fig 1: FreeStyle Libre 2              Fig 2: FreeStyle Libre 2 with                Fig 3: FreeStyle Libre digital ecosystem
                                            Optional Real-Time Alarms

    Abbott looks forward to engaging with the Committee to take actions to improve the efficient registration and
    reimbursement of priority critical technologies such as the FreeStyle Libre portfolio to broader populations as
    soon as possible

References:

i
   Deshmukh et al, 2020
ii
    Schofield D. et al (2017). The costs of diabetes among Australians aged 45–64 years from 2015 to 2030: projections of lost
    productive life years (PLYs), lost personal income, lost taxation revenue, extra welfare payments and lost gross domestic
    product from Health&WealthMOD2030. BMJ Open; 7
iii
    Fokkert et al, 2019
iv
    ADC Consensus Position Statement on: Utilising the Ambulatory Glucose Profile (AGP) combined with the Glucose Pattern
Summary to Support Clinical Decision Making in Diabetes Care 2020

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