A parliamentary inquiry has been urged to overhaul medical device approval processes to allow more timely and affordable access to devices such as flash glucose monitoring systems.
The makers of the FreeStyle Libre device, Abbott, said it took five years to gain approval for the device on the National Diabetes Services Scheme (NDSS) and currently about 25,000 patients with type 1 Diabetes are accessing devices through the scheme.
In a submission to the House of Representatives inquiry into approval processes for new drugs and novel medical technologies in Australia, the company has called on government to expand FreeStyle Libre access on the NDSS to a further 70,000 people with Type 1 diabetes who are currently denied access because they do not have a concession card.
Without subsidy the device currently costs the user about $50 per week, or $2600 per year.
The company said health regulators such as MSAC should look beyond the immediate costs of the device and take into account savings in other areas of healthcare from the use of such devices. They noted that many other countries such as the UK and Canada have expanded access to all people with T1DM without restriction, and had seen substantial savings in other healthcare and society costs.
“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,” the company wrote.
In its submission, Abbott also called on government to to implement parallel processing for TGA/MSAC processes, and to 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. 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.”
The company said there was wide public support for expanding access to flash glucose monitoring devices, noting a change.org petition has gained almost 240,000 signatures backing calls to made the devices available to all Australians with T1D.