1431 Final Protocol

Fee for the proposed medical service

Explain the type of funding proposed for this service.

Public funding via the MBS is proposed for this service. It is proposed that the medical service will be listed as an additional medical service similar to the existing MBS items 66551, 66554 and 66841 (the quantification of HbA1c in established diabetes, management of pre-existing diabetes where the patient is pregnant, and the diagnosis of diabetes in asymptomatic patients at high risk respectively) with specific reference to conducting the test at the point of patient care.

Please indicate the direct cost of any equipment or resources that are used with the service relevant to this application, as appropriate.

Direct costs associated with the proposed medical service consist of:

• 
  Instrument and reagent costs
  
• 
  Training, accreditation and quality requirements
  

These costs will depend on the instrument that is used and the quality framework that is adopted.

To enable PoC tests to be accessible to patients, costs associated with accreditation, quality assurance and training need to be at an appropriate level to remove barriers to access. Different cost models will be included in the economic evaluation.

An indication of the costs of the medical service (including the device, consumables (test cartridge) and operating costs are included in Table per PASC advice. The items described in this table are adapted from those presented in the Australian Government PoCT GP trial report (2009).

Table Costs of the medical service

Item	Cost per year	Cost per test (based on 260 tests per practice per year)^a	Source/ Comments
Establishment and annual costs
Device	$1,000	$3.85	Sponsor. Based on a range of upfront device costs between $2,000 to $8,000 over 5 years
Training	$280	$1.08	Sponsor. Based on $600 in the first year, $200 per year thereafter, over 5 years.
Accreditation	$350	$1.35	Sponsor estimate based on proposed accreditation framework
QA program	$420	$1.62	Cost of enrolment in POC QAP program.
Subtotal	$2,050	$7.88	Calculations
Monthly costs
QA/QC consumables	$430	$1.65	Sponsor market estimate of QC material. QA material is included in QA program.
QA/QC Device Operator time	$130	$0.50	Based on 20 tests per year at $6.53 / test (15)
Subtotal	$560	$2.15	Calculations
Per test costs
Consumables	$2,860	$11.00	Sponsor market estimate
Device Operator time	$1,698.80	$6.53	Based on PoCT GP Trial (15)
Subtotal	$4,557.80	$17.53	Calculations
Total	$7,167.80	$27.57	Calculations

Notes: ^a Cost per test is based on practices using the device 260 times per year (ie assuming practices operate 5 days per week and use the POC test device once per day).

Provide details of the proposed fee.

The proposed fee is to be determined based on the direct costs of performing delivering the service and the value provided by the service through improved diagnosis and management of diabetes.

In a pivotal clinical trial of the effectiveness and safety of HbA1c PoC testing, the estimated MBS item fee was AUD$91.42, which included an operating margin as well as the full cost of the analyser, all training, accreditation, and maintenance requirements (15). It should be noted that this fee is high as it was only based on the number of times the HbA1c PoC test was used over the 18 month trial period, ie 73 times (approximately $18 per test). This cost was based on the within trial analysis, and is a significant overestimate of the cost if the PoC test was made available on the MBS.

An indication of the proposed MBS item fee is included per PASC advice. This is approximately $27 per test, and is based on an approximate of the total cost of the testing over 12 months (ie $7,168) and on an assumption of 260 tests conducted per practice per year. The items included in this total cost are based on those described in the PoCT GP trial, as listed in Table .Table

The Sponsors remains open to further discussions with PASC and MSAC regarding a suitable fee.

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