Description of Medical ServiceHexaminolevulinate hydrochloride (Hexvix®) is an optical imaging agent used with adapted specialised equipment, as an adjunct to white light cystoscopy to improve the accuracy of diagnosis, treatment and management of patients with known or a high suspicion of bladder cancer. While there are two types of cystoscopy, flexible and rigid, the instillation of Hexvix® is proposed for use in Australia only with rigid cystoscopy in the operating theatre under general anaesthetic. Blue-light cystoscopy with hexaminolevulinate (Hexvix®) has been developed to be used as an investigational tool to better visualise tumours for diagnosis, biopsy, and also in conjunction with the surgical treatment of bladder cancer by visualisation of malignant tissue during the TUR after white light visualisation. This enables a more complete detection and resection of bladder lesions. The improved tumour detection and resection also allows better risk stratification and thus a more appropriate, effective and individualized assignment of post-operative treatment regimen, reduced recurrence and reduced progression to muscle invasive disease.
Description of Medical ConditionBladder cancer is categorised as either nonmuscle invasive or muscle invasive disease. Staging is based on the 2002 TNM Classification of Malignant Tumours, in which stages Ta, T1 and CIS are categorised as nonmuscle invasive bladder cancer (NMIBC). While staged collectively as NMIBC, or superficial bladder cancer, these tumours represents a highly heterogeneous group that have very different prognoses. Accordingly, patients are continuously stratified into low, intermediate and high risk groups that reflect grade and also other information such as risk of recurrence and identifiable risk factors. The technology in this application is intended for the diagnosis, treatment and management of patients with known or high suspicion of NMIBC.
Reason for ApplicationNew MBS item
Medical Service TypeTherapeutic
Previous Application NumberNot Applicable
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