Decision to secure supply of clomipramine hydrochloride and mirtazapine tablets

Medicines Decision

We have secured ongoing supply of and 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:

Chemical

Presentation

Brand

Pack size

Price &
Subsidy

Mirtazapine

Tab 30 mg

Noumed

28

$2.60

Mirtazapine

Tab 45 mg

Noumed

28

$3.45

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:

Chemical

Presentation

Brand

Pack size

Price &
Subsidy

Clomipramine hydrochloride

Tab 10 mg

Clomipramine Teva

28

$9.49

Clomipramine hydrochloride

Tab 25 mg

Clomipramine Teva

28

$11.19

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.

Theme

PHARMAC Comment

Support of the proposal

Respondents supported the proposal noting that it will ensure continued supply of medicines for New Zealanders.

Noted.

Funding of unapproved medicines

Noted concerns and impacts resulting from the funding of unapproved medicines, including that not all current prescribers such as, Nurse Practitioners and other Registered Nurse Prescribers would be able to prescribe unapproved medicines.

Respondents also raised that when patients are acutely unwell, there is a limit to the new information that they can accommodate. Informing patients that the medicines are Section 29, in addition to the change of brand, adds complexity for patients and carers and may detract from more pertinent medicine management information.

 

 

In our view the Noumed brand of mirtazapine tablets and the Clomipramine Teva brand of clomipramine hydrochloride tablets are the best available option for ongoing supply of these medicines, which were considered important to retain by our clinical advisors.

We acknowledge there are some draw backs to funding unapproved medicines however, we consider progressing with these awards to be appropriate for the following reasons:

Mirtazapine:

  • Noumed has already commenced the regulatory approval process for its product.
  • None of the tender bids received for mirtazapine tablets included a Medsafe approved brand.
  • Our clinical advisors noted that suitable alternatives are not available.

Medsafe approval is not guaranteed; however, Noumed is confident in the safety, efficacy, identity and effectiveness of its product and is currently working with Medsafe to achieve regulatory approval.

Clomipramine hydrochloride:

  • Teva intends to commence the regulatory approval process for its product following notification of award;
  • Teva was the only supplier to submit a tender bid for clomipramine hydrochloride tablets;
  • Teva is an experienced supplier and is familiar with the New Zealand regulatory approval process and is confident its product would meet required standards; and
  • Medsafe approval is not guaranteed, however Teva is a reputable supplier with an acceptable history in the New Zealand market. Teva is confident in the safety, efficacy, identity and effectiveness of its product.

Healthcare professionals and people using the medicines included in this proposal will be supported with appropriate information to manage the brand changes. Including information to support the prescribing of unapproved medicines.

Information about the provision of section 29 medicines is currently available for healthcare professionals at bpac(external link) and for consumers at Health Navigator(external link).

Requests that Section 29 of the Medicines Act 1981 be updated to allow Nurse Prescribers to prescribe unapproved medicines

We are unable to make changes to provisions in the Medicines Act 1981 relating to the prescribing of unapproved medicines.

The Ministry of Health is responsible for the Medicines Act 1981. This feedback has been shared with Ministry of Health staff.

Education and resources

Requests for support and education for patients and clinicians to support the brand changes, including information for prescribers to ensure they are able meet their obligations to their patients under the Code of Health and Disability Services Consumer’s Rights (Code of Rights) in relation to the prescribing of unapproved medicines

We will make sure there is information to support the change in brand available on the Pharmac website and to be downloaded to share with patients as required.

Information about the provision of section 29 medicines is currently available for healthcare professionals at bpac(external link) and for consumers at Health Navigator(external link).

Request for brand switch fee

Requests for a brand switch fee be applied to medicines used in the treatment of chronic conditions.

We have considered the request for a Brand Swich Fee and have determined that one will be applied to clomipramine hydrochloride tablets from 1 February 2022.

A Brand Switch Fee will not be applied to mirtazapine tablets as it does not meet the criteria for a brand switch fee.

Transition Period

Requests for a five-month transition period where both the incoming bands and the currently funded brands of these medicines would be listed on the Pharmaceutical Schedule.

There will be a five-month period where both brands of mirtazapine tablets and clomipramine hydrochloride tablets will be listed on the Pharmaceutical Schedule. The actual transition period may be shorter or longer than this, depending on the rate Apotex’s remaining stock of these medicines is used.

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.