Proposal to list new registered form of methylene blue

Medicines

Consultation Closed

What we’re proposing

PHARMAC is seeking feedback on a proposal to list a new Medsafe-registered formulation and strength of methylthioninium chloride, also known as methylene blue, in Section H (hospital) of the Pharmaceutical Schedule.

This is the result of a provisional agreement with Clinect Pty Ltd to list its brand of methylene blue (Proveblue).

We also propose to delist all other formulations of methylene blue for which there are no Medsafe-registered products available.

Consultation closes at 5 pm on Friday, 2 February 2018 and feedback can be emailed to Alexander Rodgers at alexander.rodgers@pharmac.govt.nz.

About methylene blue

Methylthioninium chloride [methylene blue] is a diagnostic dye. It can also be used in treating methemoglobinemia.

Two formulations of methylene blue are currently listed in Section H of the Schedule: inj 10 mg per ml, 10 ml ampoule and inj 10 mg per ml, 5 ml ampoule. There are no Medsafe-registered products in these formulations/strengths.

Proveblue is a brand of methylene blue that comes in a 5 mg per ml, 10 ml ampoule for injection. It is the only Medsafe-registered formulation of methylene blue.

What would the effect of the proposal be?

From 1 March 2018, the following formulation of methylthioninium chloride [methylene blue] would be listed in Part II of Section H of the Pharmaceutical Schedule for use in DHB Hospitals:

METHYLTHIONINIUM CHLORIDE [METHYLENE BLUE]   
Inj 5 mg per ml, 10 ml ampoule $240.35 5 Proveblue

No restrictions would apply.

From 1 July 2018, the other two formulations of methylene blue (inj 10 mg per ml, 10 ml ampoule and inj 10 mg per ml, 5 ml ampoule) would be delisted from Part II of Section H of the Schedule.

Who we think will be interested

This proposal may be of interest to clinicians who use or work with methylene blue, such as surgeons, emergency and ICU physicians, radiologists, and hospital pharmacists.

To provide feedback

Send us an email: alexander.rodgers@pharmac.govt.nz by 5pm on Friday 2 February 2018.

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.