Proposal to award Principal Supply for aripiprazole tablets and celecoxib capsules

What we’re proposing

We are seeking feedback on a proposal to secure continued supply of the funded brands of aripiprazole tablets and celecoxib capsules.

If this proposal is approved the following would occur:

• The currently supplied brand (Aripiprazole Sandoz) of aripiprazole tablets supplied by Novartis New Zealand Ltd (Novartis) would continue to be available.
  
  It would have principal supply status from 1 October 2022 until 30 June 2025.
  
  
• The currently supplied brand of celecoxib capsules (Celecoxib Pfizer) supplied by Aspen Pharmacare Australia Pty Ltd (Aspen) would continue to be available.
  
  It would have principal supply status from 1 November 2022 until 30 June 2025.

Consultation closes at 4 pm Wednesday 16 March 2022 and feedback can be emailed to consult@pharmac.govt.nz

Who we think will be interested

• People currently taking aripiprazole or celecoxib and their family, whānau, and caregivers.
• Healthcare professionals or clinicians who treat people with schizophrenia and bipolar I disorder or who treat people with pain and inflammatory conditions.
• Hospital and community pharmacists, DHBs and wholesalers.
• Suppliers of pharmaceuticals to the New Zealand market.

Aripiprazole

What would the effect be?

If this proposal is approved, people would continue to access their current brand of aripiprazole tablets as they do now. From 1 October 2022, Aripiprazole Sandoz would have Principal Supply Status.

Refer to details section below.

About aripiprazole tablets

Aripiprazole is a second-generation (atypical) antipsychotic medicine approved in New Zealand for use in treating schizophrenia and bipolar I disorder. Previous clinical advice has made us aware that it may also be used off label for other uses. Approximately 6,700 people currently use funded aripiprazole tablets each year.

Aripiprazole tablets were first listed on the Pharmaceutical Schedule in August 2008 for patients with schizophrenia and related psychoses. Since 2018 aripiprazole tablets have been funded without restriction in both the community and DHB Hospitals.

Details about our proposal

Aripiprazole tablets would continue to be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule.  There would be no change to the brand, strengths or pack size of funded aripiprazole tablets.

Novartis would have Principal Supply Status (PSS) until 30 June 2025. There would be an extension period by mutual agreement between Pharmac and Novartis of 2 years until 30 June 2027.

This means it would be the main funded brand available in New Zealand and would be guaranteed at least 95% of the market for aripiprazole tablets, with a 5% Alternative Brand Allowance. This would be a change from the current sole supply status Aripiprazole Sandoz currently has where they are guaranteed the whole market with a 1% Discretionary Variance limit in DHB hospitals.

An Alternative Brand Allowance (ABA) of 5% means that 5% of aripiprazole tablets purchased in hospitals and the community could be a brand that is not Aripiprazole Sandoz. An alternative brand of aripiprazole tablets would only be funded in the community if an alternative brand is listed.

The price and subsidy would be notified should Pharmac decide to progress the proposal following consideration of consultation feedback. There is no rebate proposed.

Celecoxib

What would the effect be?

If this proposal is approved, patients would continue to access their current brand of Celecoxib Pfizer capsules as they do now.

From 1 November 2022, Celecoxib Pfizer would have Principal Supply Status.

Refer to details section below.

About celecoxib capsules

Celecoxib is a selective COX-2 inhibitor, a type of non-steroidal anti-inflammatory drug (NSAID) that directly targets COX-2. COX-2 is an enzyme responsible for inflammation and pain. Approximately 260,000 people use funded celecoxib capsules each year.

Celecoxib 100 mg and 200 mg capsules have been fully funded on the Pharmaceutical Schedule since June 2017, without restriction.

Details about our proposal

Celecoxib capsules would continue to be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule. There would be no change to the Celecoxib Pfizer strengths or pack size.

The Celebrex brand of celecoxib capsules was listed in 2019 to support a supply issue with celecoxib capsules. The Celebrex brand would be delisted in the future as a result of this decision.

Aspen would have Principal Supply Status (PSS) until 30 June 2025. There would be an extension period by mutual agreement between Pharmac and Aspen of 2 years until 30 June 2027.

This means it would be the main funded brand available in New Zealand and would be guaranteed at least 95% of the funded market for celecoxib capsules, with a 5% Alternative Brand Allowance. This is a change from the current sole supply status this product currently has where they are guaranteed the whole market with a 1% Discretionary Variance limit in DHB hospitals.

An Alternative Brand Allowance (ABA) of 5% means that 5% of celecoxib purchased in DHB hospitals and the community could be a brand that is not Celecoxib Pfizer. An alternative brand of celecoxib would only be funded in the community if an alternative brand is listed.

The price and subsidy would be notified should Pharmac decide to progress the proposal following consideration of consultation feedback. There is no rebate proposed.

Aspen has advised that the packaging of its product (Celecoxib Pfizer) would change in the future. This would not result in a change in formulation or manufacturing. It would only change the artwork and name of its product. We are working closely with Aspen on this potential change. Any name and packaging change would be communicated with those we think would be interested and would be published on our website.

Why we’re proposing this

Pharmac released an open Request for Tenders on 19 October 2021, inviting tender bids for the supply of aripiprazole tablets, COX-2 Inhibitors (celecoxib and etoricoxib) and prednisolone tablets. As a result of this procurement process and evaluation of the bids received, we have identified Novartis and Aspen as the preferred bids for aripiprazole and celecoxib capsules respectively. If this proposal is approved Novartis and Aspen would supply under the terms of the October RFT.

This proposal would ensure that these medicines would continue to be fully funded for New Zealanders.

Feedback on this proposal will help us to decide whether to enter into the agreements with Novartis and Aspen.

Etoricoxib tablets and prednisolone tablets are still under evaluation. We will provide further information regarding these products in the future. 

To provide feedback

Please send us an email: consult@pharmac.govt.nz by 4 pm 16 March 2022.

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.