Decision to list aminolevulinic acid hydrochloride (Gliolan) on the Hospital medicines list

28 April 2017

Medicines Decision

PHARMAC is pleased to announce that the approval of an agreement with Specialised Therapeutics Limited for the listing of aminolevulinic acid hydrochloride.

This was the subject of a consultation letter dated 31 March 2017. In summary, the effect of the decision is that aminolevulinic acid hydrochloride will be funded by DHB hospitals, subject to restrictions, for the treatment of patients with newly diagnosed, untreated, glioblastoma multiforme (brain cancer) who are undergoing fluorescence-guided surgery.

The proposed hospital restrictions differ slightly from those consulted on. An additional criterion has been added following consideration of consultation feedback which requires that the patient’s tumours must be amenable to complete resection.

Details of the decision

aminolevulinic acid hydrochloride (Gliolan) will 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, 30 mg per ml, 1.5 g vial	Gliolan	1	$4,400.00
Aminolevulinic acid hydrochloride	Powder for oral soln, 30 mg per ml, 1.5 g vial	Gliolan	10	$44,000.00

Gliolan will be listed subject to the following hospital restrictions:

Restricted

Initiation—high grade malignant glioma

All of the following:

Patient has newly diagnosed, untreated, glioblastoma multiforme; and
Treatment to be used as adjuvant to fluorescence-guided resection, and
Patient’s tumour is amenable to complete resection.

A confidential rebate will apply to Gliolan that will reduce its net price to the Funder.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 14 April 2017 were considered in their entirety in making a decision on the proposed changes.

All responses were supportive, and the following issues were raised in relation to specific aspects of the proposal:

Theme	Comment
One responder considered that the access criteria should require surgeons to aim for complete macroscopic resection, based on enhancement area on MRI; without this kind of criterion Gliolan could be used in all new glioblastoma multiforme patients including those where complete resection was not possible, for example in multi focal tumours or tumours that have spread into eloquent areas of the brain.	The criteria consulted on were as recommended by CaTSoP at its meeting in March 2017 (the minute of this meeting will be made available on our website once finalised). However, we note that CaTSoP’s October 2014 recommendation was to fund Gliolan restricted to the same patient group that was included in the Stummer et al. 2006 trial (Lancet Oncol 2006; 7:392-401). Exclusion criteria in that trial included patients whose tumours did not enable complete resection, meaning that only patients whose tumours were amenable to complete resection were included. Given the potential financial risk from wider usage raised by the responder, an additional criterion has been added to the restrictions to make it clear that the intended patient group is those whose tumour is amenable to complete resection.
One responder considered another potential use of Gliolan would be in selected cases of recurrent glioblastoma multiforme where complete macroscopic resection is feasible.	We note that the proposal is to fund ‘newly diagnosed, untreated glioblastoma multiforme. We welcome a funding application with evidence or information to support widening funded access to patients with relapsed or recurrent disease.

Theme

Comment

One responder considered that the access criteria should require surgeons to aim for complete macroscopic resection, based on enhancement area on MRI; without this kind of criterion Gliolan could be used in all new glioblastoma multiforme patients including those where complete resection was not possible, for example in multi focal tumours or tumours that have spread into eloquent areas of the brain.

The criteria consulted on were as recommended by CaTSoP at its meeting in March 2017 (the minute of this meeting will be made available on our website once finalised).

However, we note that CaTSoP’s October 2014 recommendation was to fund Gliolan restricted to the same patient group that was included in the Stummer et al. 2006 trial (Lancet Oncol 2006; 7:392-401). Exclusion criteria in that trial included patients whose tumours did not enable complete resection, meaning that only patients whose tumours were amenable to complete resection were included.

Given the potential financial risk from wider usage raised by the responder, an additional criterion has been added to the restrictions to make it clear that the intended patient group is those whose tumour is amenable to complete resection.

One responder considered another potential use of Gliolan would be in selected cases of recurrent glioblastoma multiforme where complete macroscopic resection is feasible.

We note that the proposal is to fund ‘newly diagnosed, untreated glioblastoma multiforme. We welcome a funding application with evidence or information to support widening funded access to patients with relapsed or recurrent disease.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.