Decision to secure supply of gabapentin capsules

Medicines Decision

We have secured ongoing supply of 100 mg, 300 mg and 400 mg gabapentin capsules.

What we’re doing

We're pleased to announce that we have secured ongoing supply of 100 mg, 300 mg and 400 mg gabapentin capsules.

This decision means that:

  • the Nupentin brand of 100 mg, 300 mg and 400 mg gabapentin capsules supplied by Mylan will be funded from 1 September 2021.
  • the Apo-Gabapentin brand of 100 mg, 300 mg and 400 mg gabapentin capsules supplied by Apotex will be delisted from the Pharmaceutical Schedule on 1 February 2022. 

From 1 February 2022, Nupentin will be the only funded brand of 100 mg, 300 mg and 400 mg gabapentin capsules.

What does this decision mean?

People taking gabapentin will need to change to the Nupentin brand by 1 February 2022 to continue to access funded gabapentin capsules. After this date, the Apo-Gabapentin brand will no longer be funded in New Zealand.

The Nupentin brand of gabapentin has been funded before.

Any changes to the original proposal?

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

Further consultation was undertaken in June 2021.

No changes have been made to this proposal based on the feedback received.

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.

Details about this decision

This decision follows Apotex New Zealand Limited’s (Apotex) decision to consolidate its international presence and leave the New Zealand market. Apotex currently supplies the funded brand of 100 mg, 300 mg and 400 mg gabapentin capsules (Apo-Gabapentin). To continue accessing a funded brand of gabapentin, people will need to change to the Nupentin brand of gabapentin capsules.

From 1 September 2021 Mylan’s Nupentin brand of 100 mg, 300 mg and 400 mg gabapentin capsules 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

Gabapentin

Cap 100 mg

Nupentin

100

$6.45

Gabapentin

Cap 300 mg

Nupentin

100

$8.45

Gabapentin

Cap 400 mg

Nupentin

100

$10.26

From 1 February 2022 the Apo-Gabapentin brand will be delisted from the Pharmaceutical Schedule and the Nupentin brand will be the only funded brand of 100 mg, 300 mg and 400 mg gabapentin capsules until at least 30 June 2024.

A discretionary variance (DV) limit of 1% will apply to these medicines in DHB hospitals. This means, 99% of the total volume purchases of 100 mg, 300 mg and 400 mg gabapentin capsules are required to be the Nupentin brand.

Our response to what you told us

We’re grateful for the time people took to respond to the consultation.

The consultations released in February 2021 and June 2021 included primidone and gabapentin which can both be used for the treatment of epilepsy. Where the feedback received did not specify whether it was for either gabapentin or primidone, we have included it below.

The table provides a summary of the main themes raised in feedback and our responses to the feedback received.

Theme

PHARMAC Comment

Support of the proposal

Respondents supported the proposal noting that the proposed brand has been funded previously, and the proposal will ensure continued supply of gabapentin for New Zealanders.

We are pleased that we have been able to secure ongoing supply of gabapentin for New Zealanders.

Respondents supported Pharmac’s consideration of the Medicines and Healthcare products Regulatory Agency (MHRA) categorisation of Antiepileptic drugs.

We acknowledge that the MHRA categorisation of antiepileptic drugs informs our approach for this change.

Request for brand switch fee

Requests for a brand switch fee be applied to medicines used in the treatment of chronic conditions.

A Brand Switch Fee will not be applied to gabapentin as it does not meet the criteria for a brand switch fee due to recent brand changes for gabapentin, most recently in 2018.

Support for patients and clinicians

Requests that patients should have access to funded GP visits to discuss the change and assist with transition.  

Our expert clinical advisors (the Neurological Subcommittee) [PDF, 51 KB] consider gabapentin is categorised by the MHRA as a category 3 anti-epileptic drug.

The MHRA guidance for this category does not indicate that people should be maintained on the same brand of anti-epileptic.(external link)

The Nupentin brand of gabapentin capsules was the sole-funded brand between 2006 and 2018.  Previous brand changes have been implemented without significant patient or clinician concern. In light of the clinical advice we received from the Neurological Subcommittee we do not consider funded GP visits are required to support the proposed brand change.

Respondents raised that there may be concerns about brand changes for medicines used in the treatment of epilepsy as a result of the lamotrigine brand change and requested that Pharmac should establish a manned 0800 hotline for patients.

Given the recent brand change for gabapentin, which was successfully implemented, we do not consider that a specific 0800 hotline for patients is required to support this change.

Pharmac’s 0800 enquires line will be available for people who would like more information or have questions about this brand change.

Respondents queried Pharmac’s plans to ensure patients are aware of the proposed brand change.

We will do our best to ensure prescribers and health care professionals are aware of the proposed brand changes, including developing patient information that healthcare professionals can easily access and download to support conversations with patients.

Pharmacists and patients will be notified of this brand change via the Pharmaceutical Schedule update and Pharmac’s regular communication channels for decisions.

Fitness to drive following brand change

We sought advice from Waka Kotahi (NZ Transport Agency) regarding determining medical fitness to drive following the proposed brand changes for primidone and gabapentin.

 

 

 

Waka Kotahi provided the following advice:

Health Practitioners through their expertise and direct relationships know their patients and are best placed to manage them through this change.

Determining medical fitness to drive is the responsibility of the Health Practitioner, taking into account each patient’s individual medical history and need to be satisfied their medical condition is under control and there is no increased risk to road safety.

If the Health Practitioner believes there is an increased risk to road safety they would need to determine if a temporary stand down period from driving and what timeframe would be appropriate.

Waka Kotahi reminded Health Practitioners that under Section 18 of the Land Transport Act 1998 they must notify Waka Kotahi if they believe their patient continues to drive despite instructions not to do so, or if they consider the patient doesn’t understand their advice.

Transition Period

Requests for a five-month transition period where both the incoming brands and the currently funded brands of these medicines would be listed on the Pharmaceutical Schedule.

There will be a five-month period where both brands of gabapentin capsules will be listed on the Pharmaceutical Schedule. The actual transition period may be shorter than this, depending on how quickly Apotex’s remaining stock of gabapentin is used.


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 66 00 50.