Proposal for the supply of primidone and gabapentin

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. We are sending this document directly to groups that may not have received it and allowing additional time for responses.

Consultation closes at 4pm on Friday 9 July 2021 and feedback can be emailed to consult@pharmac.govt.nz.

What we’re proposing

We are seeking additional feedback on a proposal to change the funded brands of primidone tablets and gabapentin capsules. This change is proposed to start from 1 September 2021. No changes are proposed to any dispensing or access restrictions that currently apply to these medicines.

This proposal would mean everyone using primidone tablets and gabapentin capsules would need to change brands to continue using a funded medicine. Primidone would initially be supplied as an unapproved medicine, under Section 29 of the Medicines Act.

These are currently supplied by Apotex New Zealand Limited (Apotex). Apotex announced that it is leaving the New Zealand market and we are securing continued supply of medicines it currently supplies.

We acknowledge that a change of brand, particularly of primidone, may be difficult for people. Given the withdrawal of the current supplier we are faced with limited options. We are proposing to change the brands as the advice we have received is these are important medicines to continue to fund. We consider this proposal is our best available option to secure ongoing supply of primidone and gabapentin to New Zealand and want to ensure people are supported through the change.

About the Apotex withdrawal

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.

Two medicines Apotex currently supplies to New Zealand are included in this proposal: primidone tablets (250 mg) and gabapentin capsules (100 mg, 300 mg and 400 mg). This proposal would mean that 250 mg primidone tablets and 100 mg, 300 mg and 400 mg gabapentin capsules would continue to be funded and available to New Zealanders who need them.

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 primidone tables and gabapentin capsules.

Details about our proposal

Teva Pharma (New Zealand) Limited’s brand of 250 mg primidone tablets and Mylan New Zealand Limited’s brand of 100 mg, 300 mg and 400 mg gabapentin capsules would be be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

Primidone

If this proposal is progressed it would secure supply of 250 mg primidone tablets and mean people currently using primidone would need to transition to the primidone-SERB brand from 1 September 2021. The other option is that primidone is no longer funded. Based on the clinical advice we have received we do not see this as an appropriate approach.

The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom classifies primidone as a category 1 epilepsy medicine(external link). This means the MHRA recommends that patients be maintained on a specific brand. We acknowledge that a change of brand, particularly of primidone may be difficult for people and given the withdrawal of the current supplier we are faced with limited options. We consider this proposal is our best available option to secure ongoing supply of primidone to New Zealand.

Prescribers would need to support people to change the brand of primidone as a result of this proposal. Prescribers would be supported with information to manage this.

The Primidone-SERB brand of 250 mg primidone tablets is not currently Medsafe approved and would initially be supplied underSection 29 of the Medicines Act(external link). Clinical advice from the Neurological Subcommittee of PTAC noted that continued supply of primidone was clinically essential. The advice we received was that supply under Section 29 of the Medicines Act would be preferable to it not being available at all. We are proposing to fund this brand of primidone to ensure it continues to be available for New Zealanders who need it. If this proposal is approved Teva has committed to seek Medsafe approval for the Primidone-SERB brand of 250 mg primidone tablets.

The Primidone-SERB brand of primidone would be awarded Sole Subsidised Supply and Hospital Supply Status. These arrangements 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.

Gabapentin

If this proposal is progressed it would secure supply of 100 mg, 300 mg and 400 mg gabapentin capsules and mean people currently using gabapentin would need to transition to the Nupentin brand from 1 September 2021. The proposed brand of gabapentin (Nupentin) was the funded brand of gabapentin from 2006 to 2018.

The Nupentin brand of gabapentin would be awarded Sole Subsidised Supply and Hospital Supply Status. These arrangements 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.

Implementation

We appreciate that people taking either of these medicines may want to consult with their healthcare professional prior to any change in brand. PHARMAC plans to engage in implementation activities to assist health care professionals to transition their patients as needed.

Primidone

In particular, we note that there would need to be prescriber oversight of a change in brand for primidone. Therefore, if the proposal to change the brand and secure supply of primidone is progressed, we would do the following:

• Reimburse a person’s GP for the cost of a visit to discuss this change.
• A brand switch fee would be put in place early (for example before sole supply of the new brand) to ensure pharmacists are reimbursed for providing any additional patient counselling including ensuring patients go back to their prescriber to be supported with the change.
• Provision of patient information leaflets about the change to support conversations by healthcare professionals with their patients.

Gabapentin

Gabapentin has previously undergone a change in brand. The proposed brand, Nupentin has previously been funded in New Zealand. We propose to provide patient information leaflets about the change to support conversations between healthcare professionals and their patients. We are interested in your feedback about other support you would consider helpful.

To provide feedback

Consultation is a very important step in our process. When providing consultation feedback, you might want to think about:

• If there is any information or implementation activities that we could provide or support to help assist these changes
• Ways in which we could manage the impact of primidone being supplied to New Zealanders as an Unapproved Medicine for a period of time.

If you would like to respond to this consultation send us an email: consult@pharmac.govt.nz by 4 pm Friday 9 July 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.