Decision to secure supply of clomipramine hydrochloride and mirtazapine tablets

What we’re doing

We're pleased to announce that we have secured ongoing supply of mirtazapine and clomipramine hydrochloride tablets following the announcement that Apotex New Zealand Limited (Apotex), the current supplier, is leaving the New Zealand market.

This decision means that:

Mirtazapine 30 mg and 45 mg tablets

• A new brand of 30 mg and 45 mg mirtazapine tablets will be funded from 1 August 2021.  This will be the Noumed brand, supplied by Noumed Pharmaceuticals Limited (Noumed).
• The Apo-Mirtazapine brand of mirtazapine (supplied by Apotex) will continue to be funded until 1 January 2022. 
• From 1 January 2022, the Noumed brand of 30 mg and 45 mg mirtazapine tablets will be the only funded brand of 30 mg and 45 mg mirtazapine tablets until 30 June 2024.

Clomipramine hydrochloride 10 mg and 25 mg tablets

• A new brand of 10 mg and 25 mg clomipramine hydrochloride tablets will be funded from 1 September 2021.  This will be the Clomipramine Teva brand supplied by Teva Pharma (New Zealand) Limited (Teva).
• The Apo-Clomipramine brand (supplied by Apotex) will continue to be funded until 1 February 2022.
• From 1 February 2022, the Clomipramine Teva brand of 10 mg and 25 mg clomipramine hydrochloride tablets will be the only funded brand of 10 mg and 25 mg clomipramine hydrochloride tablets until 30 June 2024.

What does this mean for people and prescribers?

People taking mirtazapine or clomipramine tablets will need to transition to a different brand by January 2022 and February 2022, respectively. After these dates, the Apo-Mirtazapine and Apo-Clomipramine brands will no longer be funded in New Zealand.

It is anticipated that the Noumed brand of mirtazapine tablets and Clomipramine Teva will not have Medsafe approval when they are listed on the Pharmaceutical Schedule. This means that they would initially be prescribed and supplied under section 29 of the Medicines Act. More information on what this means is below.

Any changes to the original proposal?

These decisions were subject to a consultation letter dated 19 February 2021.

Further consultation was undertaken in May 2021.

Following the consultation period and consideration of the feedback we have made the following changes:

• A Brand Switch Fee will be applied to clomipramine hydrochloride from 1 February 2022 until 1 May 2022.
• The Noumed brand of mirtazapine tablets will initially be supplied to New Zealand in packs of 28 tablets rather than 30 tablets as advised in the May 2021 consultation.
• No other changes have been made to this proposal.

Who we think will be most interested

• People using these medicines and their family, whānau or caregivers.
• Hospital and community pharmacists, DHBs and wholesalers.
• Clinicians and other prescribers of these medicines.
• Suppliers of medicines to the New Zealand market.

Details about this decision

This decision follows Apotex New Zealand Limited’s (Apotex) decision to consolidate its international presence and leave the New Zealand market. Apotex currently supplies the funded brands of mirtazapine tablets (Apo-Mirtazapine) and clomipramine hydrochloride tablets (Apo-Clomipramine). To continue accessing funded brands of these medicines people will need to change to the Noumed brand of mirtazapine tablets and the Clomipramine Teva brand of clomipramine hydrochloride tablets.

Mirtazapine 30 mg and 45 mg tablets

From 1 August 2021 Noumed’s brand of 30 mg and 45 mg mirtazapine tablets will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

From 1 January 2022 the Apo-Mirtazapine brand will be delisted from the Pharmaceutical Schedule and the Noumed brand will be the only funded brand of 30 mg and 45 mg mirtazapine tablets until at least 30 June 2024, with an optional extension period until 30 June 2027.  A notification will be released at the time if this extension period is progressed.

A discretionary variance (DV) limit of 1% will apply to these medicines in DHB hospitals. This means, 99% of the total volume purchases of 30 mg and 45 mg mirtazapine tablets is required to be the Noumed brand.

The Noumed brand of mirtazapine tablets may not have Medsafe approval when it is listed on the Pharmaceutical Schedule on 1 August 2021; however, Noumed is currently working towards Medsafe approval for it.

This means that Mirtazapine may need to be prescribed and supplied under Section 29 of the Medicines Act 1981.(external link)

You can monitor the approval status of Noumed’s brand of mirtazapine tablets (Noumed) on the Medsafe website.(external link)

Wastage may be claimable by pharmacies upon eligible dispensings.

Clomipramine hydrochloride 10 mg and 25 mg tablets

From 1 September 2021 Teva’s brand of 10 mg and 25 mg clomipramine hydrochloride tablets will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

From 1 February 2022 the Apo-Clomipramine brand will be delisted from the Pharmaceutical Schedule and Clomipramine Teva will be the only funded brand of 10 mg and 25 mg clomipramine hydrochloride tablets until at least 30 June 2024, with an optional extension period until 30 June 2027. A notification will be released at the time if this extension period is progressed.

A discretionary variance (DV) limit of 1% will apply to these medicines in DHB hospitals. This means, 99% of the total volume purchases of 10 mg and 25 mg clomipramine hydrochloride tablets is required to be the Clomipramine Teva brand.

The Clomipramine Teva brand of clomipramine hydrochloride tablets will not have Medsafe approval at the time it is proposed to be listed on the Pharmaceutical Schedule; however, Teva has committed to working toward Medsafe approval for it.

This means that Clomipramine Teva would need to be prescribed and supplied under Section 29 of the Medicines Act 1981.(external link)

You can monitor the approval status of Clomipramine Teva on the Medsafe website.(external link)

Wastage may be claimable by pharmacies upon eligible dispensings.

A Brand Switch Fee will be payable to pharmacies from 1 February 2022 until 30 April 2022.  Only one Brand Switch Fee will be payable per patient. 

Our response to what you told us

We’re really grateful for the time people took to respond to the consultation on this proposal.

The table provides a summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you.

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.