Proposal to list galsulfase (Naglazyme) for mucopolysaccharidosis (MPS) VI
PHARMAC is seeking feedback on a proposal to list galsulfase (Naglazyme) resulting from a provisional agreement between BioMarin Pharmaceutical Australia Pty Ltd and PHARMAC.
The provisional agreement is the third that PHARMAC has reached with a bidder from a Request for Proposals we ran in 2014, related to the supply of medicines for rare disorders.
In summary, this proposal would result in galsulfase (Naglazyme) being funded in the community under Special Authority criteria and in DHB hospitals subject to restrictions. Listing in the Pharmaceutical Schedule would occur subject to Medsafe approval of the pharmaceutical.
Galsulfase is an enzyme replacement therapy administered as an intravenous infusion for the treatment of the rare disorder Maroteaux-Lamy Syndrome (mucopolysaccharidosis (MPS) VI).
Detail of the proposal and some background information is set out below.
PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm on Thursday, 18 February 2016 to:
Caroline De Luca
Senior Therapeutic Group Manager/Team Leader
PO Box 10 254
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
Following Medsafe approval, galsulfase (Naglazyme) would be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:
Price and subsidy
Inj 1 mg per ml, 5 ml vial
- A confidential rebate would apply to Naglazyme, which would reduce the net price of the treatment to the Funder.
- Naglazyme would be listed as soon as practicable following BioMarin’s notification to PHARMAC that Medsafe has granted registration.
- Naglazyme would be listed subject to the following Special Authority criteria in the community and equivalent restrictions in the Hospital Medicines List: