Decision to secure supply of folic acid, clarithromycin and azithromycin tablets

15 June 2021

Medicines Decision

We're pleased to confirm ongoing supply of folic acid, clarithromycin and azithromycin tablets to the New Zealand market following Apotex New Zealand Limited's withdrawal.

What we’re doing

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

This decision means that:

Folic acid 5 mg tablet

The funded brand of 5 mg folic acid tablets will change from Apo-Folic Acid (supplied by Apotex) to Folic Acid Mylan (supplied by Mylan), following a transition period starting on 1 July 2021.
From 1 December 2021, the Folic Acid Mylan brand of 5 mg folic acid tablets will be the only funded brand of 5 mg folic acid tablets until 30 June 2024.

Azithromycin 500 mg tablet

The funded brand of 500 mg azithromycin tablets will change from Apo-Azithromycin (supplied by Apotex) to Zithromax (supplied by Pfizer), following a transition period starting on 1 July 2021.
From 1 December 2021, the Zithromax brand of 500 mg azithromycin tablets will be the only funded brand of 500 mg azithromycin tablets until 30 June 2024.
Supply of 250 mg azithromycin tablets has not been secured.

Clarithromycin 250 mg and 500 mg tablet

The funded brand of 250 mg and 500 mg clarithromycin tablets will change from Apo-Clarithromycin (supplied by Apotex) to Klacid (supplied by Mylan), following a transition period starting on 1 September 2021.
From 1 February 2022, the Klacid brand of 250 mg and 500 mg clarithromycin tablets will be the only funded brand of 250 mg and 500 mg clarithromycin tablets until 30 June 2024.

Any changes to the original proposals?

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

Further consultation was undertaken on 21 May 2021 for:

Following the consultation period and consideration of the feedback three changes have been made to the folic acid tablet proposal:

It was originally proposed that Folic Acid Mylan would be funded on the Pharmaceutical Schedule from 1 June 2021. This has been changed to 1 July 2021.
It was originally proposed that the Folic Acid Mylan brand of 5 mg folic acid tablets would be supplied under Section 29 of the Medicines Act 1981. Mylan has recently informed us that it anticipates the Folic Acid Mylan brand of folic acid tablets may be Medsafe approved prior to being listed on the Pharmaceutical Schedule.
It was originally proposed that Apo-Folic Acid would be delisted from the Pharmaceutical Schedule on 1 February 2022. It is now proposed that Apo Folic Acid would be delisted from the Pharmaceutical Schedule on 1 December 2021

No other changes have been made to the proposal.

These are the first decisions as a result of the consultation dated 19 February 2021 and subsequent consultations for these medicines. Decisions on the remaining medicines are expected to be released over the coming months.

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.

Detail about this decision

Folic acid 5 mg tablet

From 1 July 2021 Mylan’s Folic Acid Mylan brand of 5 mg folic acid tablets would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical	Presentation	Brand	Pack size	Price & Subsidy
Folic acid	Tab 5 mg	Folic Acid Mylan	100	$5.82

Mylan has confirmed that it expects Folic Acid Mylan to be approved by Medsafe prior to it being listed on the Pharmaceutical Schedule on 1 July 2021.

In the event that Folic Acid Mylan is not approved prior to 1 July 2021 it will be supplied to New Zealand under Section 29 of the Medicines Act(external link).

From 1 December 2021 Folic Acid Mylan will be the only funded brand of 5 mg folic acid tablets in both community and hospital settings 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 in DHB hospitals, meaning that 99% of the total volume purchases of 5 mg folic acid tablets is required to be the Folic Acid Mylan brand.

Azithromycin 500 mg tablet

From 1 July 2021, Pfizer’s Zithromax brand of 500 mg azithromycin 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
Azithromycin	Tab 500 mg	Zithromax	2	$2.57

From 1 December 2021, Zithromax will be the only funded brand of 500 mg azithromycin tablets in both community and hospital settings 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 in DHB hospitals, meaning that 99% of the total volume purchases of the 500 mg azithromycin tablets is required to be the Zithromax brand.

Supply of a 250 mg azithromycin tablet has not been secured as part of this decision.

Clarithromycin 250 mg and 500 mg tablet

From 1 September 2021, Mylan’s Klacid brand of 250 mg and 500 mg clarithromycin 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
Clarithromycin	Tab 250 mg	Klacid	14	$8.53
Clarithromycin	Tab 500 mg	Klacid	14	$14.58

From 1 February 2022, Klacid will be the only funded brand of 250 mg and 500 mg clarithromycin tablets in both community and hospital settings until 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 in DHB hospitals, meaning that 99% of the total volume purchases of the relevant presentation is required to be the Klacid brand.

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.

Folic acid 5 mg tablet

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 Midwives, Nurse Practitioners and other Registered Nurse Prescribers would be able to prescribe unapproved medicines and the impact this could have on patients.	In February and May 2021 we consulted on a proposal for the Folic Acid Mylan brand of 5 mg folic acid tablets to be supplied to New Zealand as an unapproved medicine under Section 29 of the Medicines Act 1981. Based on recent communication with the supplier we anticipate Folic Acid Mylan 5 mg folic acid tablets could be approved by Medsafe prior to being listed on the Pharmaceutical Schedule on 1 July 2021. We acknowledge that if required supply of an unapproved brand of folic acid 5 mg tablets would be an inconvenience to all prescribers and to people receiving folic acid; however, on balance we consider it is important that this medicine continues to be available to patients.
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	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).
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 switch fee and have decided that one will be applied to this medicine from 1 December 2021.
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.	It is our intention that there will be a five-month transition period where both brands of these medicines would 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.

Azithromycin 500 mg tablet and clarithromycin 250 mg and 500 mg tablets

Theme	PHARMAC Comment
Support of the proposal
Respondents supported the proposal noting that it will ensure continued supply of medicines for New Zealanders.	Noted.
Education and resources
Requests for support and education for patients and clinicians to support the brand changes.	Health professionals, pharmacists and the public will be notified of this brand change through the Pharmaceutical Schedule Update.
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.	We have allowed for a transition period of 5 months where both the incoming brands and the currently funded brands of these medicines would be listed on the Pharmaceutical Schedule. Depending on the rate at which Apotex’s remaining stock of these medicines is used, the actual transition period may be shorter than this.
Request for brand switch fee
Requests for a brand switch fee be applied to medicines used in the treatment of chronic conditions.	This proposal does not meet the criteria for a brand switch fee to be applied.

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 660 050.