Proposal to list oral betaine for rare disorder

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal to list betaine (Cystadane) resulting from a provisional agreement between Emerge Health Pty Ltd and PHARMAC.

The provisional agreement is the seventh that PHARMAC has reached with a bidder in a Request for Proposals we ran in 2014, related to the supply of medicines for rare disorders.

In summary, this proposal would result in betaine (Cystadane) being funded in the community under Special Authority criteria, and in DHB hospitals subject to restrictions, for the treatment of homocystinuria.

Listing in the Pharmaceutical Schedule would occur after any Medsafe approval of the pharmaceutical.

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 5pm Wednesday, 30 November 2016 to:

Caroline De Luca
Senior Therapeutic Group Manager / Team Leader
PHARMAC
PO Box 10 254
Wellington 6143

Email: caroline.deluca@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

Following Medsafe approval, betaine (Cystadane) would be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List, HML) of the Pharmaceutical Schedule as follows:

Chemical Presentation Brand Pack size Price and subsidy
Betaine Powder for oral soln Cystadane 180 g OP $575.00
  • Cystadane would be listed as soon as practicable following Emerge Health’s notification to PHARMAC that Medsafe has granted registration.
  • Cystadane would be listed subject to the following Special Authority criteria in the community and equivalent restrictions in the HML: