Application Detail
Description of Medical Service
The CGM Initiative commenced on 1 April 2017 and provides fully-subsidised access to CGM products (no patient co-payment required) to eligible people through the National Diabetes Services Scheme (NDSS). Approximately 58,000 patients are eligible to access CGM products through CGM initiative.Under the expanded eligibility criteria introduced from 1 March 2020, CGM products are provided to:
- children and young people, under 21 years of age, with type 1 diabetes;
- children and young people with conditions very similar to type 1 diabetes, such as cystic fibrosis related diabetes and neonatal-onset diabetes, who require insulin;
- women with type 1 diabetes who are planning for pregnancy, pregnant or immediately post-pregnancy; and
- people with type 1 diabetes aged 21 years or older who have concessional status.
Description of Medical Condition
Type 1 diabetes is an auto-immune disease where the body's immune system attacks the insulin-producing cells of the pancreas. People with type 1 diabetes cannot produce insulin and require lifelong insulin replacement to survive. The disease can occur at any age, although it mostly occurs in children and young adults.Reason for Application
On 6 November 2020, the Department of Health announced a Review of CGM Products provided through the CGM Initiative will be conducted and evaluated by the Medical Services Advisory Committee (MSAC) to ensure government-funding of CGM products used in Australia is based on strong evidence of clinical and cost effectiveness. The Review will include currently subsidised CGM products, and CGM products for which subsidisation under the initiative is being sought. The Review is consistent with the periodic reviews of publically funded pharmaceuticals and medical technologies that are undertaken by the Department.Associated Documentation
Public Summary Document
July 2021 MSAC OutcomeAfter considering the available evidence presented in the Review of CGM Products (the Review), MSAC deferred providing advice on the clinical and cost-effectiveness of CGM products subsidised under the CGM Initiative and considered further work was required to better establish the patient population, clinical and cost effectiveness of CGM devices in Type 1 diabetes.
MSAC noted the current CGM Initiative eligibility criteria are based on a combination of clinical and financial-need considerations. MSAC noted the difficulty this caused when attempting to reconcile the eligible groups covered under the CGM Initiative with the available comparative study data. Therefore, MSAC considered further work was required in defining the patient populations that benefit most from use of CGM devices, noting that available guidelines recommend CGM for all people with Type 1 diabetes treated with multiple daily injections and choice of device is strongly influenced by patient and clinician preference.
MSAC noted that overall, the Review concluded CGM is most likely no different than self-monitoring of blood glucose (SMBG) in terms of HbA1c change over time and safety for most patients. MSAC noted that clinically relevant outcomes and clinical needs vary between patients using CGM devices. MSAC considered the Review did not adequately capture the range of clinical and quality of life benefits CGM devices could potentially offer type 1 diabetes patients compared to self-monitoring of blood glucose and requested they be further explored.
MSAC noted the economic model was based on the Sheffield model (Thokala et al. 2014), which was developed to predict disease progression for Type 1 diabetes, with the primary outcome modelled being change in HbA1c levels. MSAC considered that the model presented in the Review did not provide a reliable basis for estimating the cost effectiveness of CGM compared to self-monitoring of blood glucose. MSAC considered an informative cost effectiveness model would incorporate outcomes where benefits were observed and expected. Therefore, MSAC considered the economic evaluation should be revised to use a model that is CGM specific and that the primary outcomes modelled should include avoidance of hypoglycaemic events, time in optimal glycaemic range and quality of life data. MSAC further noted the lack of evidence available to suggest a significant difference in clinical outcomes between CGM devices and considered the revised economic model should be device agnostic.