Proposal to list aminolevulinic acid hydrochloride (Gliolan) in the Hospital medicines list

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal to list aminolevulinic acid hydrochloride (Gliolan) through a provisional agreement with Specialised Therapeutics Limited.

Aminolevulinic acid hydrochloride (Gliolan) is used for visualisation of malignant tissue during neurosurgery.

Details of the proposal are set out below, in summary, if progressed, it would result in aminolevulinic acid hydrochloride being funded by DHB hospitals, subject to restrictions, for the adjuvant treatment of patients with newly diagnosed, untreated, glioblastoma multiforme undergoing fluorescence-guided resection.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by Friday, 14 April 2017 to:

Danae Staples-Moon
Therapeutic Group Manager
PHARMAC
PO Box 10 254
Wellington 6143

Email: danae.staples-moon@pharmac.govt.nz

Fax:     04 460 4995

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

Details of the proposal

  • aminolevulinic acid hydrochloride (Gliolan) would be listed in Part II of Section H (the Hospital Medicines List, HML) of the Pharmaceutical Schedule from 1 June 2017 as follows (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Price

Aminolevulinic acid hydrochloride

Powder for oral soln, 1.5 g

Gliolan

1

$4,400.00

  • Gliolan would be listed subject to the following hospital restrictions:

Restricted

Initiation—high grade malignant glioma

Both:

  1. Patient has newly diagnosed, untreated, glioblastoma multiforme; and
  2. Treatment to be used as adjuvant to fluorescence-guided resection.
  • A confidential rebate would apply to Gliolan that would reduce its net price.

Background

Aminolevulinic acid hydrochloride (Gliolan) is a natural biochemical precursor of the heme molecule that is metabolised in a series of enzymatic reactions to fluorescent porphyrins which accumulate within malignant glioma tissue and glows brightly under blue light (wavelength 400-410 nm). When visualised with a specific filter attachment on a standard neurosurgical microscope, normal brain tissue reflects the violet-blue light and appears blue, whereas solid tumour tissue reflects as red and infiltrating tumour cells appear pink. This allows surgeons to more easily visualise and remove the tumour during neurosurgery. Aminolevulinic acid hydrochloride is used as an add-on to surgery and has no anti-tumour properties on its own.

Aminolevulinic acid hydrochloride should only be used by neurosurgeons who have completed a training course in fluorescence-guided surgery provided by the supplier.  Gliolan is supplied in a vial as a powder for oral solution. Information regarding dosing and administration can be found on the Medsafe datasheet(external link).

PHARMAC estimates that aminolevulinic acid hydrochloride would be used in approximately 40% of all glioblastoma cases (around 90 patients per year) and may increase the duration of neurosurgical procedures and theatre times as surgeons attempt complete resection.

The funding application for aminolevulinic acid hydrochloride was reviewed by the Cancer Treatments Subcommittee in October 2014 and by the Pharmacology and Therapeutic Advisory Committee (PTAC) in November 2014. Both committees recommended funding aminolevulinic acid hydrochloride with a high priority.

PTAC considered that overall the evidence demonstrated that its use improved resection rates and extent of tumour resection. The Committee considered that this would likely be associated with improved progression free survival and overall survival.

More information including links to the PTAC and Subcommittee minutes, can be found in the Applications Tracker records for amnolevulinic acid hydrochloride at: https://connect.pharmac.govt.nz/apptracker/s/global-search/amnolevulinic%20acid%20hydrochloride(external link)