Proposal for the supply of various cardiovascular medicines

Extended consultation period

We have become aware that some groups were not directly notified when our original consultation on this proposal was released in February 2021. To ensure you have a chance to respond we are sending this document directly to groups that may not have received it and allowing additional time for responses.

This consultation was emailed to subscribers on 26 May 2021.

What we’re proposing

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

The proposed brands of 10 mg propranolol tablets and 40 mg and 80 mg nadolol tablets are not currently Medsafe approved and would need to be supplied initially under Section 29 of the Medicines Act(external link).

This proposal would mean everyone using these cardiovascular medicines 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 this medicine.

Background

Apotex, a pharmaceutical supplier, has made the decision to leave the New Zealand market from late 2021. Apotex currently supplies a number of pharmaceuticals in New Zealand. We’ve been working to secure alternative brands of these medicines to ensure continuity of supply for people taking the medicines.

Apotex currently supplies the following cardiovascular medicines to New Zealand:

• diltiazem tablets (120 mg,180 mg, and 240 mg)
• furosemide tablets (40 mg)
• metoprolol tartrate tablets (50 mg and 100 mg)
• propranolol tablets (10 mg and 40 mg) and nadolol tablets (40 mg and 80 mg).

This proposal would mean that funded brands of diltiazem tablets (180 mg, and 240 mg), furosemide tablets (40 mg), metoprolol tartrate tablets (50 mg and 100 mg), propranolol tablets (10 mg and 40 mg) and nadolol tablets (40 mg and 80 mg) would continue to be available to New Zealanders who need them.

An alternative brand of 120 mg diltiazem tablets has not been secured and does not form part of this proposal.

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 including the cardiovascular medicines in this proposal.

Details about our proposal

The proposed brands of these medicines would be listed Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

If this proposal is progressed it would mean we would secure supply of these medicines, however; it would mean people currently using these medicines would need to transition to the proposed brand from the listing date.

The proposed brand of diltiazem capsules (Cardizem CD) was previously funded in New Zealand between April 2014 and June 2018. The Propranolol Teva brand of 10 mg propranolol tablets and the Nadolol tablets brand of 40 mg and 80 mg nadolol tablets are not currently Medsafe approved and would need to be supplied under Section 29 of the Medicines Act initially. We consider it is important that 10 mg propranolol tablets and 40 mg and 80 mg nadolol tablets continue to be funded and are proposing to fund unapproved brands of these medicines as we consider it is preferable to these medicines not being available to New Zealanders who need them. Teva and Boucher & Muir have committed to working towards Medsafe approval for their brands these medicines.

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 change in this proposal.

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 10 mg propranolol tablets being supplied to New Zealand as Unapproved Medicines for a period of time.
• The impact of 40 mg and 80 mg nadolol tablets being supplied to New Zealand as Unapproved Medicines for a period of time.
• If there is any information that we could provide to help assist these changes.

Send us an email: consult@pharmac.govt.nz by 4 pm Thursday 10 June 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.

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.