Mbs reviews vitamin b12 testing report february 2014 table of contents section Page

MBS Reviews

VITAMIN B12 TESTING

REPORT

February 2014

TABLE OF CONTENTS

Section Page

Vitamin B12 testing 4

Concerns about vitamin B12 testing 4

Review methodology 5

Stakeholder consultation 5

Summary of findings 5

Conclusions 8

1.1 Description of current services 9

1.2 The clinical flowcharts 15

2.1 Secondary data analysis 17

2.2 Guideline concordance 17

2.3 Systematic literature review for clinical evidence 18

2.4 Systematic literature review for economic evidence 21

3.1 MBS item number usage and expenditure 22

3.2 Age and gender profile of patients 24

3.3 Frequency of testing by patient 24

3.4 Profile of providers requesting vitamin B12/folate testing services 24

3.5 Frequency of requests for testing by provider 25

4.1 Clinical practice guidelines 27

4.2 Recommendations from other reports 32

4.3 Summary of clinical guidance 32

5.1 Evidence base 33

5.2 Appropriate clinical indications for vitamin B12 testing 33

5.3 Evidence that testing for vitamin B12 levels improves health outcomes 33

5.4 Risks/harms associated with vitamin B12 testing 34

5.5 Quality of testing according to testing platform 34

6.1 Studies relevant to the economic evaluation of vitamin B12 testing 39

7.1 Current usage of vitamin B12 and/or folate testing services in Australia 40

7.2 Clinical guidance on vitamin B12 testing 41

7.3 Relationship between testing for vitamin B12 levels and health outcomes 42

7.4 Harms associated with vitamin B12 testing 42

7.5 Diagnostic performance of vitamin B12 tests 42

7.6 Cost implications of vitamin B12 testing 43

7.7 Conclusions 43

LIST OF ABBREVIATIONS

ANZFSC	Australian and New Zealand Food Standards Code
AUC	Area under the curve
CI	Confidence interval
CMFM	Comprehensive Management Framework for the MBS
holoTC	holotranscobalamin
HPLC	High performance liquid chromatography
HTA	Health technology assessment
Hyc	homocysteine
MBS	Medicare Benefits Schedule
MMA	Methylmalonic acid
MSAC	Medical Services Advisory Committee
NHMRC	National Health and Medical Research Council
NLR	Negative likelihood ratio
PA	Pernicious anaemia
PASC	Protocol Advisory Sub-Committee (of MSAC)
PICO	Population, Intervention, Comparator, Outcomes
PLR	Positive likelihood ratio
QUOROM	Quality of Reporting of Meta-analyses
RCC	Review Consultation Committee
RCT	Randomised controlled trials

EXECUTIVE SUMMARY

In the 2011-12 Budget, the Australian Government announced a further commitment to the Comprehensive Management Framework for the Medicare Benefits Schedule [MBS] (CMFM), to continue the systematic review of MBS items to ensure that they reflect contemporary evidence, improve health outcomes for patients and represent value for money.
MBS Reviews aim to ensure the clinical and financial sustainability of the MBS. Reviews assess specific MBS services (i.e. MBS items) and associated policy issues in a focussed, fit-for-purpose, evidence-based process. Findings recognise that the MBS funding should align with contemporary evidence, reflecting appropriate patient groups and best clinical practice.
The Reviews have a primary focus on improving health outcomes and the financial sustainability of the MBS, through the following criteria:

• 
  assess patient safety risk;
  
• 
  identify services that have limited health benefit and/or are used inappropriately;
  
• 
  be evidence-based and fit-for-purpose;
  
• 
  be conducted in consultation with key stakeholders including, but not limited to, the medical profession and consumers;
  
• 
  include opportunities for public submission; and
  

• 
  use Government resources efficiently.