Decision to secure supply of metformin tablets

Medicines Decision

We have secured ongoing supply of 500 mg and 850 mg metformin hydrochloride immediate-release tablets.

What we’re doing

We're pleased to announce that we have secured ongoing supply of 500 mg and 850 mg metformin hydrochloride immediate-release tablets.

This decision means that:

  • the Metformin Mylan brand of 500 mg and 850 mg metformin hydrochloride immediate-release tablets supplied by Mylan will be funded from 1 October 2021.
  • the Apotex brand of 500 mg and 850 mg, metformin hydrochloride immediate-release tablets supplied by Apotex will be delisted from the Pharmaceutical Schedule on 1 March 2022.
  • the Metformin Mylan brand will be the only funded brand of 500 mg and 850 mg metformin hydrochloride immediate-release tablets from 1 March 2022.

What does this decision mean?

People taking 500 mg and 850 mg metformin hydrochloride immediate-release tablets will need to change to the Metformin Mylan brand by 1 March 2022 to continue to access funded metformin tablets. After this date, the Apotex brand will no longer be funded in New Zealand.

The 850 mg strength of Metformin Mylan immediate-release tablets has been funded before.

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, the date for Metformin Mylan to be awarded sole supply status has been changed to 1 March 2022, rather than the 1 February 2022 originally proposed.

No other changes have been made to this proposal based on the feedback received.

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 brand of 500 mg and 850 mg metformin hydrochloride immediate-release tablets (Apotex).

From 1 October 2021 Mylan’s Metformin Mylan brand of 500 mg and 850 mg metformin hydrochloride immediate-release 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

Metformin hydrochloride

Tab 500 mg

Metformin Mylan

1000

$14.74

Metformin hydrochloride

Tab 850 mg

Metformin Mylan

500

$11.28

From 1 March 2022 the Apotex brand will be delisted from the Pharmaceutical Schedule and the Metformin Mylan brand will be the only funded brand of 500 mg and 850 mg metformin hydrochloride immediate-release tablets until at least 30 June 2024.

A discretionary variance (DV) limit of 1% will apply to these medicines in DHB hospitals. This means, 99% of the total volume purchases of 500 mg and 850 mg metformin tablets in DHB hospitals are required to be the Metformin Mylan brand.

Our response to what you told us

We’re grateful for the time people took to respond to the consultation. The table provides a summary of the main themes raised in feedback and our responses to the feedback received.

Theme

Pharmac comment

Brand change concerns

A respondent provided feedback that not all metformin tablets are the same and sole supply arrangements do not work.

Metformin Mylan 500 mg and 850 mg immediate-release tablets have been approved by Medsafe to have the same active ingredient as the original brand of 500 mg and 850 mg metformin tablets. This means they are clinically equivalent and work in the body in the same way.

We know that changes to medicine can cause some people concern; however, in this case, we had no choice about this brand change as we wanted to make sure funded metformin tablets continue to be available for people who need them.

Transition Period

Requests for a five-month transition period where both the incoming brand and the currently funded brand of this medicine would be listed on the Pharmaceutical Schedule.

There will be a five-month period where both brands of metformin hydrochloride tablets will be listed on the Pharmaceutical Schedule. The actual transition period may be shorter than this, depending on how quickly Apotex’s remaining stock of metformin hydrochloride is used.

Request for brand switch fee

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

A Brand Switch Fee will not be applied to metformin hydrochloride tablets as it does not meet the criteria for a brand switch fee due to recent brand changes.

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.