Proposal for the supply of clomipramine hydrochloride and mirtazapine tablets

Extended consultation period

We have become aware that some groups were not directly notified when our original consultation on this proposal was released in February 2021. To ensure you have a chance to respond we are sending this document directly to groups that may not have received it and allowing additional time for responses.

This consultation was emailed to subscribers on 25 May 2021.

What we’re proposing

We are seeking feedback on a proposal to change the funded brands of clomipramine hydrochloride and mirtazapine tablets currently supplied by Apotex New Zealand Limited (Apotex), following the announcement that it is leaving the New Zealand market.

This proposal would mean everyone using clomipramine hydrochloride tablets and mirtazapine tablets would need to change brands to continue using a funded medicine. No changes are proposed to any dispensing or access estrictions that currently apply to this medicine.

Background

Apotex, a pharmaceutical supplier, has made the decision to leave the New Zealand market from late 2021. Apotex currently supplies a number of pharmaceuticals in New Zealand. We’ve been working to secure alternative brands of these medicines to ensure continuity of supply for people taking the medicines.

Two of the medicines Apotex currently supplies to New Zealand are clomipramine hydrochloride tablets (10 mg and 25 mg) and mirtazapine tablets (30 mg and 45 mg). This proposal would mean that funded brands of 10 mg and 25 mg clomipramine hydrochloride tablets and 30 mg and 45 mg mirtazapine tablets would continue to be available to New Zealanders who need them.

Why we’re proposing this

Following Apotex New Zealand Limited’s announcement that it is leaving the New Zealand market, PHARMAC released a closed Request for Tenders on 1 October 2020. As a result of this procurement process and our analysis of the tender bids received, we have has entered into provisional agreements with a number of suppliers for the supply of various medicines including clomipramine hydrochloride and mirtazapine tablets. Details about our proposal Teva Pharma (New Zealand) Limited’s brand of 10 mg and 25 mg clomipramine hydrochloride tablets and Noumed Pharmaceuticals Limited’s brand of 30 mg and 45 mg mirtazapine tablets would be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

If this proposal is progressed it would mean we would secure supply of 10 mg and 25 mg clomipramine hydrochloride tablets and 30 mg and 45 mg mirtazapine tablets, however; it would mean people currently using these medicines would need to transition to the proposed brands from the proposed listing date.

The Clomipramine Teva brand of 10 mg and 25 mg clomipramine hydrochloride tablets and the Noumed brand of 30 mg and 45 mg mirtazapine tablets are not currently Medsafe approved and would need to be supplied under Section 29 of the Medicines Act(external link) initially. We consider it is important that clomipramine hydrochloride and mirtazapine tablets continue to be funded and are proposing to fund unapproved brands of these medicines as we consider it is preferable to these medicines not being available to New Zealanders who need them. Teva and Noumed have committed to working towards Medsafe approval for their brands these medicines.

Prescribers would need to support people to change brands of medicine as a result of this proposal. Prescribers would be supported with information to manage the proposed brand change in this proposal.

To provide feedback

Consultation is a very important step in our process. When providing consultation feedback, you might want to think about:

• The impact of clomipramine hydrochloride tablets being supplied to New Zealand as Unapproved Medicines for a period of time.
• The impact of mirtazapine tablets being supplied to New Zealand as Unapproved Medicines for a period of time.
• If there is any information that we could provide to help assist these changes.

If you would like to respond to this consultation send us an email consult@pharmac.govt.nz. by 4 pm Thursday 10 June 2021.

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.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request.

This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.