1431 Final Protocol

Clinical Management Algorithm - clinical place for the proposed intervention

Provide a clinical management algorithm (e.g.: flowchart) explaining the current approach (see (6) Comparator section) to management and any downstream services (aftercare) of the eligible population/s in the absence of public funding for the service proposed preferably with reference to existing clinical practice guidelines.

Provide a clinical management algorithm (e.g.: flowchart) explaining the expected management and any downstream services (aftercare) of the eligible population/s if public funding is recommended for the service proposed.

Practitioners would perform the proposed medical service under the same circumstances as they would order the existing HbA1c tests and hence the clinical management algorithm will remain the same as current practice.

Figure Figure presents the diagnostic algorithm using HbA1c testing for diabetes. Patients who are referred for an HbA1c test (either via laboratory or PoC device) may present to the GP with known issues related to diabetes, or may present to the GP for unrelated issues.

Figure Diagnostic algorithm using HbA1c testing (laboratory or point of care) for diabetes

Note: ^a Whilst the confirmatory HbA1c test is recommended in the NHMRC practice guidelines (Colagiuri et al, 2009), this is not routinely performed in practice and confirmatory testing is not MBS funded.
Figure presents the algorithm for the management and review (cycle of care) of patients with diabetes using HbA1c (either laboratory or PoC).

Figure Management algorithm using HbA1c testing (laboratory or point of care) for patients with diabetes

Note: This figure is adapted from the NHMRC practice guidelines (Colagiuri et al, 2009)

10. Regulatory Information

Please provide details of the regulatory status. Noting that regulatory listing must be finalised before MSAC consideration.

There are several HbA1c PoC tests available in Australia that meet the defined acceptable performance criteria comparable to laboratory based testing as described in Section 4.

In Australia, HbA1c tests are Class 2 in vitro diagnostics and must be included on the ARTG by the TGA before being supplied in Australia. All PoC instruments undergo mandatory technical review by the TGA which assesses the test’s analytical performance and suitability for use at the point of care.

Below are examples of ARTG listed PoC test devices that meet the proposed performance specifications:

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  Afinion Test System:
  

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  ARTG identifier 204479: Instrument/analyser IVD
  
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  ARTG identifier 204476: Clinical chemistry substrate IVDs
  

• 
  cobas b 101system
  

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  ARTG identifier 202785: Instrument/analyser IVD
  
• 
  ARTG identifier 201876: Clinical chemistry substrate IVDs
  

11. Decision analytic

Provide a summary of the PICO as well as the health care resource of the comparison/s that will be assessed, define the research questions and inform the analysis of evidence for consideration by MSAC (as outlined in Table Error: Reference source not found).

Table Error: Reference source not found and Table provide a summary of the PICO criteria for the proposed medical service. Patients are reflective of the criteria currently funded for HbA1c testing for the diagnosis and management of diabetes (MBS items 66551, 66554, 66841). Intervention options include usual practice laboratory testing or PoC HbA1c testing with a system of appropriate analytical performance. Patient outcomes reflect the pivotal trial evidence described in Section 7.

Table Summary of PICO to define research question for the diagnosis of diabetes

PICO
Is HbA1c POC testing for the diagnosis of diabetes in at risk patients safe and effective, and cost-effective compared to HbA1c analysed in a pathology laboratory?
Patients	Patients who are judged to be at risk, either through a score of ≥12 on the AUSDRISK assessment tool, or are in one of the following population groups with a known higher risk: people with impaired glucose tolerance or impaired fasting glucose; women with a history of gestational diabetes mellitus; women with a history of polycystic ovary syndrome; people presenting with a history of cardiovascular disease event (i.e. myocardial infarction, stroke); and people on antipsychotic medication.
Intervention	HbA1c point of care test analysed in clinical PoC setting
Comparator	HbA1c testing analysed in an accredited laboratory
Outcomes	Claim of non-inferiority based on PASC advice Safety (adverse events of test procedure). Diagnostic accuracy, sensitivity, specificity in proposed setting (GP). % coefficient of variation, trueness, imprecision. Clinical effectiveness: Test adherence Diagnosis of diabetes Health outcomes: patient-relevant health outcomes including retinopathy, limb amputation, ischaemic heart disease, stroke), patient satisfaction, acceptability and convenience, quality of life). Impact of false negative- side effects of taking medication unnecessarily, captured in health outcomes Impact of false positive- unnecessary treatment, side-affects from treatment, unnecessary visits to GP and specialists Health care resources: number of HbA1c tests, total tests per year, number of GP consultations, other healthcare resource use

Table Summary of PICO to define research question for the management of diabetes

PICO
Is HbA1c POC testing for the monitoring of diabetes control in established diabetes patients safe and effective, and cost-effective compared to HbA1c analysed in a pathology laboratory?
Patients	Patients with established diabetes.
Intervention	HbA1c point of care test analysed in clinical PoC setting
Comparator	HbA1c testing analysed in an accredited laboratory
Outcomes	Claim of non-inferiority based on PASC advice Safety (adverse events of test procedure). % coefficient of variation, trueness, imprecision. Clinical effectiveness: Test adherence. Intermediate outcomes (test adherence, change in patient management including changes in intensification of therapy if above range; frequency of intensification of therapy at baseline; amount of change in dosage of oral agents only, oral agents plus insulin, insulin only), time from testing to intervention or treatment change; medication adherence; HbA1c levels at follow-up (% within range, mean HbA1c), hospitalisations (any major complications)). Health outcomes: patient-relevant health outcomes including retinopathy, limb amputation, ischaemic heart disease, stroke), patient satisfaction, acceptability and convenience, quality of life). Impact of false negative- side effects of taking medication unnecessarily, captured in health outcomes Impact of false positive- unnecessary treatment, side-affects from treatment, unnecessary visits to GP and specialists Health care resources: number of HbA1c tests, total tests per year, number of GP consultations, other healthcare resource use

12. Healthcare resources

Using Table , provide a list of the health care resources whose utilisation is likely to be impacted should the proposed intervention be made available as requested whether the utilisation of the resource will be impacted due to differences in outcomes or due to availability of the proposed intervention itself.

Table List of resources to be considered in the economic analysis

	Provider of resource	Setting in which resource is provided	Proportion of patients receiving resource	Number of units of resource per relevant time horizon per patient receiving resource	Disaggregated unit cost
					MBS	Safety nets*	Other government budget	Private health insurer	Patient	Total cost
Resources provided to deliver proposed intervention (HbA1c PoC test)
Initial GP consultation. (Treatment initiated if POC test indicates diabetes)	GP	Outpatient		1	37.05					37.05
HbA1c test	GP	Outpatient		1	Approx. $27					Approx. $27
Resources provided to deliver comparator
Initial GP consultation^a	GP	Outpatient		1	37.05					37.05
Patient episode initiation fee^b	Pathology	Laboratory		1	6.00					6.00
HbA1c test	Pathology	Laboratory		1	16.80					16.80
GP consultation for results and initiation of treatment if appropriate.	GP	Outpatient		1	37.05					37.05

Notes: ^aFor diagnosis only. ^bPatient episode initiation item (from Group 10 of the pathology services table) Fees range from $2.40 to $17.60. For the purpose of this protocol a fee of $6.00 is used.

13. Questions for public funding

Please list questions relating to the safety, effectiveness and cost-effectiveness of the service / intervention relevant to this application, for example:

• 
  Which health / medical professionals provide the service
  
• 
  Are there training and qualification requirements
  
• 
  Are there accreditation requirements
  

• 
  Will this service meet an unmet clinical need?
  
• 
  What will be the primary health benefits to patients?
  
• 
  What will be the key benefits to the health sector?
  

PASC noted that consultation feedback was received from one GP practice manager, one specialist, one QAAMS program manager, one organisation from the IVD industry, three peak bodies and one medical student. Overall positive feedback was received regarding:

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  Greater accessibility (particularly in regional/rural areas);
  
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  Decreased GP visits;
  
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  Decreased loss of patients to follow-up;
  
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  Increased patient convenience;
  
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  Education and management;
  
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  Increased health outcomes; and
  
• 
  Improved quality of life.
  

Uncertainties were noted regarding:

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  Increase in practice time;
  
• 
  Increase in patient costs;
  
• 
  Changed model of care;
  
• 
  Requirement for other pathology tests; and
  
• 
  Potential duplicate testing.
  

Reference List

(1) Diabetes Australia. Diabetes in Australia: Facts. 2015(29 September 2015)

(2) RACGP. General practice management of type 2 diabetes 2014-15.

(3) Australian Bureau of Statistics. Australian Health Survey: Biomedical Results for Chronic Diseases, 2011-12. 2013 Jan 1.

(4) Valentine N, Alhawassi T, Roberts G, Vora P, Stranks S, Doogue M. Detecting undiagnosed diabetes using glycated haemoglobin: an automated screening test in hospitalised patients. MJA 2011 Feb 21;194(4):160-4.

(5) Colagiuri, Davies D, Girgis S, Colagiuri R. National Evidence Based Guideline for Case Detection and Diagnosis of Type 2 Diabetes. Canberra; 2009.

(6) Shephard M. Point-of-care testing comes of age in Australia. Australian Prescriber 2010 Jan 2;33(1):6-9.

(7) Miller CD, Barnes CS, Phillips LS, Ziemer DC, Gallina DL, Cook CB, et al. Rapid A1c availability improves clinical decision-making in an urban primary care clinic. Diabetes Care 2003;26(4).

(8) Bubner T, O Laurence C, Gialamas A, Yelland L, Ryan P, Willson K, et al. Effectiveness of point-of-care testing for therapeutic control of chronic conditions: results from the PoCT in General Practice Trial. MJA 2009 Jan 6;190(11):624-6.

(9) Cagliero E, Levina E, Nathan DM. Immediate Feedback of HbA1c Levels Improves Glycaemic Control in Typr 1 and Insulin-Treated Type 2 Diabetic Patients. Diabetes Care 1999 Jan 11;22(11):1785-9.

(10) Gialamas A, Yelland L, Ryan P, Willson K, O Laurence C, Bubner T, et al. Does point-of-care testing lead to the same or better adherence to medication? A randomised controlled trial: the PoCT in General Practice Trial. MJA 2009 Feb 2;191(9):487-91.

(11) Kennedy L, Herman W, Tideman P, Harris A, for the GOAL A1c Team. Impact of Active Versus Usual Algorithmic Titration of Basal Insulin and Point-of-Care Versus Laboratory Measurement of HbA1c on Glycaemic Control in Patients With Type 2 Diabetes. Diabetes Care 2006 Jan 1;29(1):1-8.

(12) O Laurence C, Gialamas A, Bubner T, Yelland L, Willson K, Ryan P, et al. Patient satisfaction with point-of-care testing in general practice. British Journal of General Practice 2010 Jan 3;DOI: 10.3399/bjgp10X483508:e98-e104.

(13) Thaler L, Ziemer DC, Gallina DL, Cook CB, Dunbar V, Phillips L, et al. Diabetes in Urban African-Americans. XVII. Availability of Rapid HbA1c Measurements Enhances Clinical Decision-Making. Diabetes Care 1999 Jan 9;22(9):1415-21.

(14) Khunti K, Stone MA, Burden AC, Turner D, Raymond NT, Burden M, et al. Randomised controlled trial of near-patient testing for glycated haemoglobin in people with type 2 diabetes mellitus. The British journal of general practice : the journal of the Royal College of General Practitioners 2006;56(528).

(15) Australian Government. Point of care testing in general practice trial: Final Report. Canberra; 2009.

(16) Lenters-Westra E, Slingerland RJ. Three of 7 hemoglobin A1c point-of-care instruments do not meet generally accepted analytical performance criteria. Clinical chemistry 2014;60(8).

(17) Schwartz KL, Monsur JC, Bartoces MG, West PA, Neale AV. Correlation of same-visit HbA1c test with laboratory-based measurements: a MetroNet study. BMC family practice 2005;6.

Appendix

Australian Government Point of Care Trial in General Practice (2009)

Conclusion in relation to clinical effectiveness of point of care testing in general practice for diabetes (Section 9.6).