STATUS OF ACCESS TO GLIOLAN IN NEUROSURGERY FOR GBM PATIENTS IN AUSTRALIA

Background

A new drug, Gliolan® (aminolevulinic acid HCl) is now being used in patients with glioblastoma multiforme (GBM) by some Australian neurosurgeons to improve intraoperative identification and visualisation of the margins between tumour and normal brain tissue. This in turn assists the surgeon to more completely remove the malignant tissue.

Gliolan was granted ‘orphan’ drug designation in April 2012 for “photodynamic diagnosis of gliomas that are glioblastoma multiforme (GBM) (malignant) on preoperative imaging, and intended for gross macroscopic resection of all visible tumour”.

Gliolan is approved by the Therapeutic Good Administration (TGA) for “visualisation of malignant tissue during surgery for malignant gliomas that are glioblastoma multiforme (GBM) on preoperative imaging, and who are intended for resection of the tumour.”

Frequently Asked Questions

Question 1: How and why is Gliolan used?

Answer: Gliolan is administered to patients as a drink three hours prior to surgery. It is taken up by the cancerous tissue in the brain and converted into fluorescent chemicals. During surgery, a specially modified neurosurgical microscope fitted with a blue operating light is used. This blue light activates the drug and causes the chemicals contained within the cancerous tissue to glow fluorescent red whilst normal brain tissue appears blue. This allows the surgeon to clearly visualise the malignant tissue and distinguish it from healthy brain tissue.

The drug is well tolerated, but does cause photosensitivity for 24 hours after administration, so avoiding direct sunlight or strong light sources for this period after surgery is essential.

Question 2: Where is the drug obtained from?

Answer: From Specialised Therapeutics Australia, located in Melbourne. The drug itself is manufactured in Germany.

Question 3: Is Gliolan available for use by all neurosurgeons in Australia?

Answer: Availability is increasing, but as at August 2016 BTAA has been advised that the following Australian and New Zealand hospitals have the equipment necessary to perform the operation using fluorescence with Gliolan. Please note, the drug is not reimbursed and may be charged to the patient. Some public hospitals have the equipment required for fluorescence surgery, but do not offer it as a service due to lack of funding for the drug (Gliolan). At other public hospitals it may be offered at no charge. You will need to check with your neurosurgeon at the hospital you are attending.

QLD

Royal Brisbane & Women’s Hospital (QLD)

The Wesley Hospital (Brisbane, QLD)

Princess Alexandra Hospital (Brisbane, QLD)

Gold Coast University Hospital (Gold Coast, QLD)

Townsville Hospital (Townsville, QLD)

The Mater Private (Brisbane, QLD)

Pindara Hospital (Gold Coast, QLD)

NSW

The Prince of Wales Hospital (Sydney, NSW)

Northshore Private Hospital (Sydney, NSW)

Nepean Hospital (Sydney, NSW)

Westmead Hospital (Sydney, NSW)

John Hunter Hospital (Newcastle, NSW)

Newcastle Private Hospital (NSW)

Macquarie University private Hospital (Sydney, NSW)

St George Private (Sydney, NSW)

South West Private Hospital (Sydney, NSW)

Prince of Wales Private Hospital (Sydney, NSW)

Wollongong (NSW)

Wollongong Private Hospital (Wollongong, NSW)

VIC/TAS

Royal Melbourne Hospital (Melbourne, VIC)

Epworth Private Hospital (Melbourne, VIC)

St Vincent's Private Hospital (Melbourne, VIC)

Melbourne Private Hospital (Melbourne, VIC)

Monash Medical Centre (Melbourne, VIC)

The Alfred Hospital (Melbourne, VIC)

Calvary Private Hospital (Hobart, TAS)

SA

Memorial Private Hospital (Adelaide, SA)

Wakefield Private Hospital (Adelaide, SA)

Flinders Medical Centre (Adelaide, SA)

Royal Adelaide Hospital (Adelaide, SA)

WA

Sir Charles Gairdner Hospital (Perth, WA)

NEW ZEALAND

Dunedin Hospital (NZ)

Wellington Hospital (NZ)

Waikato Hospital (NZ)

Christchurch Hospital (NZ)

Gliolan is currently only available for use by neurosurgeons who have been specifically trained in using the drug and the fluorescence resection method.

Question 4: How much will it cost me? Is there a difference for public or private patients?

Answer: The cost of Gliolan is $3,990 per vial. Most patients will require only one vial. However, as Gliolan is a mg/kg dose, some patients may require a second vial. The patient’s neurosurgeon will decide this. The cost is usually “self-funded” if you are having surgery in a private hospital, as there is no government reimbursement available for the drug at this stage.

Some public hospitals have opted to find fluorescence guided surgery using Gliolan. You will need to check if this is the case at the institution you are attending

Question 5: Is the drug indicated 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 is restricted to suspected GBM.

Question 6: Is the drug currently subsidised by the Australian Government?

Answer: No. however a submission for reimbursement has been made by the pharmaceutical company that distributes the drug, Specialised Therapeutics Australia.

Question 7: In the absence of Federal Government subsidisation who then will pay for the drug?

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

Answer: No. There is no data for the use of Gliolan in children.

Question 9: 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 of tumour bulk when Gliolan is used, compared to standard surgical procedure.

Question 10: Why is it important to try and obtain maximal resection of malignant tissue during brain tumour surgery?

Answer: The most common form of primary malignant brain tumours is glioblastoma multiforme (GBM). The standard therapy for these tumours consists of surgery, followed by concomitant radiation therapy and temozolomide (an oral chemotherapy), followed by temozolomide therapy aloone. The desired strategy is to remove as much of the tumour as is possible so that the smallest possible amount of residual tumour remains which is then targeted by the chemotherapy and radiation therapy. Trials have shown that adjuvant therapy is more effective when more of the tumour is initially removed.

Question 11: 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 potentially remove them. This is particularly important if the infiltrating tumour cells are situated in “eloquent” (important) areas of the brain responsible for key functions. Gliolan helps discriminate tumor from healthy tissue and improve surgical outcomes, but the extent to which fluorescing tissue is removed is at the surgeon’s discretion.

Question 12: How long would it take an experienced neurosurgeon to become proficient with the technique?

Answer: Depends on the surgeons overall experience and number of cases done with Gliolan. There is no major change in the resection procedure/technique other than the fact that the operation is done under dimmed theatre lights. The change is in what they can visualise and thus make decisions on the extent of resection.

Question 13: If an institution already has an intra-operative MRI machine, how much greater advantage would fluorescence guided resection with Gliolan confer to patients?

Answer: Both can be used together to provide even greater clarity.

Question 14: 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 can be used during their neurosurgery. If it cannot be used they could consider the possibility of referral to a neurosurgeon or institution where it might be used. Please remember that in most private hospitals, the patient will need to pay for the drug.

If the obstacle to its use is the failure of a particular hospital’s drugs and therapeutics committee to approve and fund it, representations should be made in appropriate quarters. If the obstacle is the absence of the necessary fluorescence upgrade of the neurosurgical operating, questions should be asked if the decision revolves around funding and what solutions might be possible.

Generally, the Federal Minister for Health and Ageing (The Hon Sussan Ley MP) could be 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:

• Malignant primary brain tumours have an extremely poor prognosis

• This procedure may lead to extended survival and a better quality of life

• This procedure may lead to a more efficacious use of radiation and

chemotherapy, which are already subsidised by the Federal Government

• There are very few options for treatment of malignant primary brain tumours

• The cost involved is relatively small in comparison with the economic burden

of brain tumours.

Fact sheet updated by BTAA Inc in August 2016

Facts checked with Specialised Therapeutics Australia.


Fact sheet updated by BTAA Inc in October 2016.

Printable word doc here.
 
Susan Pitt
Assistant Secretary
BTAA
www.btaa.org.au
 
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.