Proposal for the supply of various medicines

What we are proposing

We are seeking feedback on a proposal to make changes to the funded brands of various medicines currently supplied by Apotex New Zealand Limited (Apotex), following the announcement that it is leaving the New Zealand market.

This proposal results from a procurement process for the supply of various medicines. This proposal would help ensure continuity of supply for these medicines following Apotex’s exit from the New Zealand market, so New Zealanders can continue to access funded brands of the medicines they need.

Everyone using the medicines included in this proposal would need to change brands to continue using a funded medicine.

No changes are proposed to any dispensing or access restrictions that currently apply to these medicines.

None of the brands of medicines that we are proposing to fund are currently supplied in New Zealand (some have been supplied in the past).  We anticipate that some of the medicines included in this proposal would not have Medsafe approval at the time they are listed on the Pharmaceutical Schedule.  Suppliers of the proposed brands have committed to working toward Medsafe approval for these medicines.

You can monitor the registration situation of the medicines included in this proposal on the Medsafe website.(external link)

The scope of this proposal does not include all the medicines in Apotex’s portfolio.

Further detail and regular updates of our progress towards sourcing alternative brands or, suitable alternative treatments for the other medicines in Apotex’s portfolio is available here.

We welcome your feedback on this proposal. Consultation closes at 4 pm Wednesday 10 March 2021 and feedback can be emailed to consult@pharmac.govt.nz.

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 any of the medicines included in this proposal being supplied to New Zealand as Unapproved Medicines for a period of time.

Send us an email: consult@pharmac.govt.nz by 4 pm Wednesday 10 March 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.

What would the effect be?

For patients

Patients would be able to continue accessing the funded medicines that they currently do; however, they would need to transition to another brand as these become available throughout 2021. All the medicines included in this proposal would continue to be fully funded.  

No changes would be made to any access restrictions that currently apply to these medicines.

Prescribers, pharmacists, and people using the medicines included in this proposal would be supported with appropriate information to manage the proposed brand changes.

Further detail of the proposed brand changes and the timeframes for these to occur is provided in the table below.  

For pharmacies and DHBs

Prescribers would continue to be able to prescribe the medicines as they do now.

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 changes in this proposal.

Some of the medicines included in the proposal do not yet hold market approval from Medsafe. In some circumstances we anticipate that there would be a period where these medicines may be funded by us and provided in New Zealand by their suppliers as Unapproved Medicines. Additional support from prescribers may be required to assist people to transition to unapproved medicines.

From the date that the proposed brands of the medicines are listed in Section B and Part II Section H of the Pharmaceutical Schedule a transition period would begin.

During the transition period your assistance would be required to support people using the currently funded brands of the medicines to change to the proposed brands.

Following the transition period, the currently funded brand of each of the medicines would be delisted from Section B and Part II Section H of the Pharmaceutical Schedule and the proposed brand would be the only funded brand of the medicine available. Further detail of the proposed timeframes for transition and the delisting of the currently funded brand of the medicines from the Pharmaceutical Schedule is provided in the table below.

Prescribers would be supported with information to manage the proposed brand changes in this proposal.

These medicines would have a DV limit of 1%, meaning that in hospitals, up to 1% of total purchases of the relevant presentation of each medicine could be a brand other than the proposed brand.

This proposal would help ensure continuity of supply for the medicines included in this proposal.

Who we think will be 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.

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.

This proposal would ensure funded brands of the medicines would continue to be available for all New Zealanders who need them.

Feedback to this consultation will help us to decide whether to enter into these agreements.

Background to the closed RFT

In June 2020 we released a Registration of Interest for various medicines currently supplied by Apotex, following its January 2020 announcement that it is leaving the New Zealand market.

This registration of interest was open for all suppliers to participate in and express interest in supplying any, or all the medicines to New Zealand. As a result of this process suppliers were shortlisted to participate in a closed Request for Tenders process, which was released on 1 October 2020.

Details about our proposal

This table provides detail of the brands of the medicines that would be listed in the Pharmaceutical Schedule as a result of this proposal. This proposal would result in an increase compared to current expenditure for these medicines. The amount people using these medicines would pay for their prescriptions would not change.

The price and subsidy for the various medicines would be notified should PHARMAC decide to progress the proposal following consideration of consultation feedback.

Printable table (PDF) [PDF, 15 KB]

None of the brands of medicines that we are proposing to fund are currently supplied in New Zealand (some have been supplied in the past).  We anticipate that some of the medicines included in this proposal would not have Medsafe approval at the time they are listed on the Pharmaceutical Schedule.  Suppliers of the proposed brands have committed to working toward Medsafe approval for these medicines.

From the proposed listing dates, the medicines would be listed in Section B and Part II Section H of the Pharmaceutical Schedule. Following a transition period, the current brands of the medicines, supplied by Apotex would be delisted from the Pharmaceutical Schedule and the proposed brand would have Sole Subsidised Supply status and Hospital Supply Status.

Sole Subsidised Supply and Hospital Supply Status arrangements as a result of this proposal would remain in place until at least 30 June 2024 with an optional extension period of three years until 30 June 2027 to be exercised by mutual agreement between PHARMAC and the proposed supplier. Only medicines that receive Medsafe approval prior to, or during the initial term, ending 30 June 2024 would be eligible for the three-year extension period.

These medicines would have a DV limit of 1%, meaning that in hospitals, up to 1% of total purchases of the relevant presentation of each medicine could be a brand other than the proposed brand.

The scope of this proposal does not include all the medicines included in Apotex’s portfolio.

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.