Decision to list new registered form of methylene blue

12 February 2018

Medicines Decision

We’re pleased to announce a decision 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, from 1 March 2018.

What we’re doing

Formulations of methylene blue for which there is no Medsafe-registered product will be delisted from 1 July 2018.

Any changes to the original proposal

This decision was subject to a consultation letter dated 19 January 2018. The decision was unchanged from the proposal in the consultation.

Who we think will be interested

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

Detail about this decision

The following changes will occur in Part II of Section H of the Pharmaceutical Schedule.

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 Price is ex-manufacturer, excl. GST)	5	Proveblue

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) will be delisted from Part II of Section H of the Schedule.
Please note that the delisting of the other forms does not affect DHB hospitals right to use stock they have already purchased.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback and our responses to the feedback received is in the table below.

Theme	Our response
Supports the funding of registered medicines.	Noted.
The proposal would be a cost, as the unregistered form is available at a lower price.	PHARMAC considers it is appropriate to pay a higher price for a registered, contracted product. It provides certainty of quality, it supports the Medsafe system, and it provides a guarantee of supply to DHBs which was previously lacking.
No major issues in transitioning from 50 mg in 5 ml to 50 mg in 10 ml, though staff education would be required.	Noted.
The currently used product, Methylene Blue Sterop, is internationally registered. Medsafe-registration is less important in a product mostly used as a diagnostic dye.	While methylene blue has multiple uses, it is a product for which Medsafe deems registration necessary.
Having other formulations listed allows DHBs to access a different formulation if there is a stock availability issue. Otherwise, the unregistered formulation would need to be added in an emergency listing.	In the event of an out of stock issue, PHARMAC would retain the ability to list alternative formulations, including those without Medsafe registration if deemed necessary.
DHBs have stock of the unregistered forms and would not use them all up before 1 July.	Even if a product is delisted from the HML, DHBs are entitled to use the stock of product they have purchased. Delisting only prevents buying more of that product.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number on 0800 66 00 50.