New MBS listing to align heart failure diagnosis with local guidelines

MedTech News: In Australia 69 new cases per 10,000 adults aged 45 and over are diagnosed with heart failure each year. The number of patients with suspected heart failure who present to a GP is estimated to be 209,620 in 2023. Unfortunately, heart failure is difficult to definitively diagnose in non-acute primary care setting as symptoms are non-specific and differential diagnosis is complex.

Raised NT-proBNP cardiac biomarker levels in the blood are indicative of heart failure. Several NT-proBNP assays* are currently subsidised (MBS item 66830) for the diagnosis of heart failure in patients presenting with dyspnoea to a hospital emergency department.

However, the focus of Roche Diagnostics’ application to be considered by the MSAC PASC in April 2023 is the use of NT-proBNP assays** in the non-hospital setting. The assay is to be included within the current diagnostic work up conducted by a cardiologist (clinical assessment, chest X-ray, ECG), prior to referring the patient for an echocardiogram.

Long wait times and the location of centres providing echocardiography services means that access is limited, particularly for Aboriginal and Torres Strait Islander people and those living in rural, regional and remote areas. Consequently, there is a profound need for accurate and timely differential diagnosis to improve equity of patient access to effective treatments and reduce the pressures on the healthcare system.

The National Heart Foundation of Australia and CSANZ guidelines for the Prevention, Detection and Management of Heart Failure in Australia include NT-proBNP quantitation in the clinical management algorithm for diagnosing heart failure. However, as it is not listed on the MBS most patients are not offered an NT-proBNP test as they would need to pay out-of-pocket. The indication proposed in Roche Diagnostics’ application aims to bring the MBS into line with the Australian guidelines for diagnosing heart failure in the non-hospital setting.

The SHAPE study determined 45% of patients who present to a GP with probable or definite heart failure will be referred to a cardiologist. According to Roche Diagnostics, the number of people seeing a cardiologist who would be eligible to use the proposed services is 20,064 – 85,368.

Survival rates for chronic heart failure range from 81% to 91% at 1 year and 52% to 63% at 5 years. A systematic review of mortality and repeat hospitalisation rates for patients hospitalised with heart failure in Australia found 20% of patients are readmitted within 30 days of discharge, and 56% of patients within 1 year of discharge, with all-cause mortality rates of 8% and 25% respectively.

As diagnosis of heart failure at the time of hospitalisation is associated with less improvement in survival, early identification of heart failure in primary care is needed to improve prognosis.

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*Other commercially available tests include Siemens Healthineers (Stratus CS Acute Care), BioMerieux
(VIDAS NT-proBNP2), Abbott Alere NT-proBNP, Ortho VITROS NT-proBNP II, Radiometer AQT90 FLEX NTproBNP

**Roche Diagnostics’ Elecsys NT-proBNP II and Elecsys NT-proBNP II STAT assays are intended for use on the cobas e 402, e 601, e 602, or e 801 immunoassay analysers, respectively. The assay is conducted on patients’ blood, collected through a standard blood test.