Decision to list the Midazolam-Claris brand of midazolam injections in the community

10 November 2016

Medicines Decision

PHARMAC has made the decision to list the Midazolam-Claris brand of midazolam injections in Section B (community) of the Pharmaceutical Schedule.

This was the subject of a consultation letter dated 6 September 2016. In summary, the effect of the decision is that:

Midazolam-Claris will be listed, fully funded, in Section B of the Pharmaceutical Schedule from 1 December 2016 at the following prices and subsidies (ex-manufacturer and excluding GST):

Chemical	Presentation	Brand	Pack size	Price and subsidy
Midazolam	Injection 1 mg per ml, 5 ml ampoule	Midazolam-Claris	10	$4.30
Midazolam	Injection 5 mg per ml, 3 ml ampoule	Midazolam-Claris	5	$2.50

Midazolam-Claris will have subsidy and delisting protection until 30 June 2018.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 20 September 2016 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issue was raised in relation to specific aspects of the proposal:

Theme	Comment
It was noted that to avoid issues with glass particles and the need for an additional filter needle, the plastic ampoules are used for buccal administration of midazolam injection (eg for the treatment of status epilepticus).Concern was raised that community pharmacies may dispense glass ampoules to patients using midazolam for status epilepticus, with a resulting risk of ingesting glass particles.	There are currently two brands of midazolam injections listed in the community: Hypnovel (supplied by Roche in glass ampoules) and the Pfizer brand (supplied in plastic ampoules). Therefore, the issue of pharmacy dispensing glass versus plastic ampoules already exists.This decision is for an additional listing of midazolam in glass ampoules (Midazolam-Claris, supplied by AFT) in the community and does not limit the availability of midazolam in plastic ampoules (supplied by Pfizer) in the community.We note that, as a result of a previous decision, Midazolam-Claris will have Hospital Supply Status in DHB hospitals from 1 December 2016, with a 5% DV limit which can be used for other brands of midazolam in plastic ampoules. More information about the hospital decision can be found in the May 2016 tender notification.

Theme

Comment

It was noted that to avoid issues with glass particles and the need for an additional filter needle, the plastic ampoules are used for buccal administration of midazolam injection (eg for the treatment of status epilepticus).Concern was raised that community pharmacies may dispense glass ampoules to patients using midazolam for status epilepticus, with a resulting risk of ingesting glass particles.

There are currently two brands of midazolam injections listed in the community: Hypnovel (supplied by Roche in glass ampoules) and the Pfizer brand (supplied in plastic ampoules). Therefore, the issue of pharmacy dispensing glass versus plastic ampoules already exists.This decision is for an additional listing of midazolam in glass ampoules (Midazolam-Claris, supplied by AFT) in the community and does not limit the availability of midazolam in plastic ampoules (supplied by Pfizer) in the community.We note that, as a result of a previous decision, Midazolam-Claris will have Hospital Supply Status in DHB hospitals from 1 December 2016, with a 5% DV limit which can be used for other brands of midazolam in plastic ampoules. More information about the hospital decision can be found in the May 2016 tender notification.

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.