FREQUENTLY ASKED QUESTIONS ABOUT THE USE OF GLIOLAN IN AUSTRALIA FOR NEUROSURGERY ON BRAIN TUMOUR PATIENTS.
 
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Question: How is Gliolan (5-ALA – 5-Aminolevulinic Acid) used in connection with operations on people who have a suspected brain tumour?
 
Answer: The drug is ingested orally as a drink, three to four hours prior to their neurosurgery.
 
Question: What is the purpose of taking the drug?
 
Answer: After Gliolan is ingested it accumulates in the tumour cells within the brain. When a blue light on the surgeon’s specially modified neurosurgical microscope is engaged, it causes the drug contained within the tumour cells to fluoresce and glow a pink and red colour.  This allows the surgeon to clearly visulalise the malignant tissue and distinguish it from healthy brain tissue, in order to remove it.
 
Question: What is the advantage of using this drug in connection with neurosurgery to remove a brain tumour?
 
Answer: Prior to the use of this drug a neurosurgeon could only estimate the margin between ordinary and tumorous brain cells by what they could observe under an operating microscope.  The use of Gliolan aids the surgeon to clearly identify the cancerous tissue during the operation, and more completely remove it.  Clinical trials have shown nearly a doubling in the number of patients achieving a complete resection when Gliolan is used, compared to standard surgical procedure.
 
Question: Why is it important to try and obtain the greatest possible resection in brain tumour surgery?
 
Answer: The most common form of primary malignant brain tumours are known as glioblastoma multiforme (GBMs). The standard therapy for these tumours consists of neurosurgery, followed by concomitant radiation therapy and temozolomide (an oral chemotherapy), and adjuvant temozolomide. The desired strategy is to remove as much of the tumour as is possible so that a smaller mass can be targeted by the chemotherapy and radiation therapy.  Trails have shown that adjuvant therapy is more effective when more of the tumour is initially removed.
 
Question: But I understand that GBMs are not always a clearly-defined mass but are infiltrative and have tentacles that can extend in the brain?
 
Answer: That is sometimes correct.  Overall it is anticipated that use of the drug will enable a neurosurgeon to better identify not only the solid tumour mass, but also the infiltrating tumour cells, and remove them.  This is particularly important if the infiltrating tumour cells are situated in “eloquent” (important) areas of the brain responsible for key functions. Use of Gliolan has the capacity to enhance the outcome of surgery, but its optimum benefit depends on the skills and experience of the neurosurgeon.
 
Question: Is the drug available for use with all primary malignant brain tumours?
 
Answer: No. In Europe the drug is indicated in adult patients for visualisation of malignant tissue during surgery for malignant glioma (WHO grades III and IV).  Its use in Australia will mirror this indication in Europe
 
Question: Is Gliolan freely available for use by all neurosurgeons in Australia?
 
Answer: Unfortunately no. Gliolan is not yet approved by the Therapeutic Goods Administration (TGA).  It will however be made available to Australian neurosurgeons who have been specifically trained in using the drug and the fluorescence resection method, through the Federal Government’s Special Access Scheme (SAS) until TGA approved.  The SAS allows doctors to access certain unapproved drugs on an individual patient basis if deemed appropriate.  No prior approval from the TGA is required.  Your neurosurgeon is the approving authority.  As the patient, you must provide consent.
 
Question: Who makes the application for special access?
 
Answer: Your neurosurgeon, following the informed consent of the patient.
 
Question: Will Gliolan be approved for more generalised access?
 
Answer: Yes. The company that has the licence to distribute Gliolan, Specialised Therapeutics Australia, is submitting the drug to the TGA for approval.

Question: Will Gliolan also be available for paediatric patients with malignant glial tumours?

Answer: No.
 
Question: Where is the drug obtained from?
 
Answer: From Specialised Therapeutics Australia, located in Melbourne.  The drug itself is manufactured in Germany.
 
Question: Can any neurosurgeon apply for access to the drug?
 
Answer: No. Only those neurosurgeons trained in its use can access Gliolan. This is to ensure the safe and effective use of the drug.  At the present time (October 2011), 21 Australian neurosurgeons have undertaken and completed training. They come from NSW, Victoria, Queensland, South Australia and Tasmania, and represent about one quarter of all Australian neurosurgeons who operate on brain tumour patients.
 
Question: Is the drug subsidised by the Australian Government?
 
Answer: No. Drugs firstly need to be approved by the TGA before they can be considered for subsidisation by the Australian government.  Once approved by the TGA, an application can be made to have the drug assessed by the Pharmaceutical Benefits Advisory Committee (PBAC) in order to achieve subsidisation through the Pharmaceutical Benefits Scheme (PBS).  
 
Question: Do all these neurosurgeons have access to the special type of operating microscope necessary to identify the drug in the tumour cells?
 
Answer: No. Two of the principal firms that supply operating microscopes (Leica Microsystems and Carl Zeiss) in Australia have developed a special fluorescence module to enable use of Gliolan.  Currently only three hospitals in Australia possess these upgraded microscopes: The Wesley Hospital in Brisbane, the Alfred Hospital in Melbourne, and the Royal Melbourne Hospital.
 
Question: Is it anticipated that further training courses will be conducted and additional neurosurgeons will receive the relevant training in the use of Gliolan?
 
Answer: This is likely to depend on the demand for and interest in the use of Gliolan.
 
Question: In the absence of Federal Government subsidisation who then will pay for the product when special access has been granted?
 
Answer: The cost ($3,990) could be covered by: (a) the hospital where the operation is performed, or (b) the patient, or (c) the patient’s health insurance, if it chooses to cover it.
 
Question: Are there any side effects associated with the use of Gliolan?
 
Answer: Like all medications Gliolan may cause side effects.  Gliolan should not be used in patients with hypersensitivity to 5-ALA or porphyrins, in cases of acute or chronic porphyria, or in pregnancy. Gliolan also can make patients sensitive to light for 24 hours and as such patients need to avoid direct sunlight or bright lights.  Cardiac disorders, gastrointestinal disorders and skin and subcutaneous disorders are all reported as being uncommon.
 
Question: Is Gliolan being used elsewhere?
 
Answer: Yes, it is approved in 27 countries, across Europe (since 2007) and Korea.  Germany in particular has incorporated Gliolan into its national neurosurgical guidelines following a multi-centre trial led by Professor Walter Stummer (Germany). A multi-centre Phase II trial has recently commenced in North America, under Assistant Professor Costas Hadijpanayis (Emory University).
 
Question: What are the prospects of the necessary microscope upgrade being more widely available in additional Australian hospitals?
 
Answer: This will depend on hospital administrators or private donors funding such purchases. They are believed to cost between $60,000 to $90,000 each.
 
Question: Is there anything that can be done to speed up the more widespread use of Gliolan in brain tumour surgery in Australia?
 
Answer: Patients who have been scheduled for neurosurgery because of a suspected Grade III or Grade IV glial brain tumour should enquire if Gliolan will be used during their neurosurgery. If it will not be used they should consider the possibility of referral to a neurosurgeon or institution where it might be used.
 
If the obstacle to its use is the failure of a particular hospital’s drug subsidisation committee to approve it, representations should be made in appropriate quarters. If the obstacle is the absence of the necessary microscope upgrade, questions should be asked if the decision revolves around funding and what solutions might be possible.
 
Generally, the Federal Minister for Health and Ageing (Hon Nichola Roxon MP) should be written to and encouraged to consider the removal of all obstacles to the speedy uptake of this procedure, including expeditious consideration of approval requests, support for additional training opportunities, and special assistance for those hospitals seeking to fund the purchase of the microscope upgrade.
 
Points in support of the urgency and appropriateness for these actions include:
Enquiries about this FAQ should be directed to the Freecall number for Brain Tumour Alliance Australia – 1800 857 221 (free from landlines, seven days a week).

Disclaimer - information on the BTAA website does not purport to be medical advice but is provided for informational purposes only. Readers should always consult a Doctor regarding their treatment.