Decision for ongoing supply of primidone

Medicines Decision

What we’re doing

People taking primidone will be able to continue using the same primidone tablets.

We have contracted with Clinect for continued supply of the currently funded primidone tablets to New Zealand. The tablets will be exactly the same, but the labelling on the pack will be different from early 2022.

We consulted in June 2021 on a proposal to change the funded brand of primidone. This was to ensure primidone continued to be available in New Zealand. At that time, we understood that it would not be possible to keep the same primidone tablets available in New Zealand. During this consultation, we received new information from the supplier. We have now contracted with Clinect to continue the supply of the currently funded primidone tablets to New Zealand, although they will have a different brand name from early 2022.

We acknowledge that the possibility of a potential primidone brand change may have caused some distress. We are pleased to be able to confirm that the currently funded primidone tablets will continue to be available for people on this medicine (with a new brand name and labelling).

What does this mean for people and prescribers

There will be no change to the manufacturer of primidone tablets. Primidone will be supplied as a Medsafe approved product and will continue to be fully funded with no restrictions.

From March or April 2022, the brand name of primidone will change from Apo-Primidone to ‘Primidone’. People will still be taking the exact same product, which is manufactured in the same place. The brand name and labelling will change because a different company is taking over supply of the current product, but the tablets will be unchanged.

Who we think will be most interested

  • People taking primidone and their family, whānau or caregivers.
  • Healthcare professionals involved in supporting people taking primidone.
  • Hospital and community pharmacists, DHBs and wholesalers.
  • Suppliers of pharmaceuticals to the New Zealand market.

Detail about this decision

There will not be a change in primidone tablets supplied for New Zealand.

Apo-Primidone will continue to be listed on the Pharmaceutical Schedule as it is now. The price and subsidy will increase in Section B of the Pharmaceutical Schedule from 1 November 2021 as follows:

Chemical

Presentation

Brand

Pack size

New price &
subsidy

Primidone

Tab 250 mg

Apo-Primidone

100

$37.35

Clinect will take over the sponsorship of Apo-Primidone. This means that primidone will continue to be supplied as a Medsafe approved product. 

Around March or April 2022, the brand name will be updated to ‘Primidone’. The tablets will be exactly the same to Apo-Primidone, however because Clinect will be supplying the product, the brand name and labelling will be different. 

Clinect will have subsidy and delisting protection for primidone tablets 250mg in Section B of the Pharmaceutical Schedule until 31 October 2026. After this date, Clinect and Pharmac will continue to have an agreement for the supply of primidone in New Zealand. 

Any changes to the original proposal?

This decision was subject to a consultation letter dated 22 June 2021. In this consultation, we proposed that Teva would supply the Primidone-SERB brand of primidone to New Zealand from 1 September 2021 as the Apo-Primidone product would no longer be available. 

As a result of new information received during the consultation process this change to Primidone-SERB will no longer occur. The currently funded primidone tablets will continue to be available in New Zealand long-term and will be supplied by Clinect under the name ‘Primidone’. 

Why is a brand change no longer happening? 

Apotex, a pharmaceutical supplier, has made the decision to leave the New Zealand market from late 2021. Apotex currently supplies Apo-Primidone. You can find more information about Apotex leaving New Zealand on our website. 

Since Apotex announced it was leaving the New Zealand market, we worked with Apotex to understand which of its medicines could continue to be supplied in New Zealand by other suppliers. We understood that Apo-Primidone could not continue to be supplied. 

Primidone was included in a Request for Tenders released on 1 October 2020, to ensure it would continue to be available to New Zealanders who need it. As part of this process, Teva was selected as the preferred bidder to supply its brand Primidone-SERB. 

After releasing the consultation in June 2021 on the proposal to list the Primidone-SERB brand, we were made aware that Clinect could supply Apotex’s currently funded primidone product to New Zealand. 

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 when taking primidone for epilepsy.We received feedback from our clinical advisers and through consultation on how best to support a change in brand for primidone.

We now have the option to secure supply of the current primidone tablets. Recognising this and that a change in brand is not recommended for people taking primidone for epilepsy, we have made the decision to contract with Clinect to continue to supply the currently funded primidone tablets. 

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. We consulted on a proposed change in brand for primidone and were particularly interested to hear from people about the types of support and implementation that would be required to manage a change in brand. We appreciate the comprehensive responses we received on how best to support a change in brand for primidone. These responses in general agreed with our acknowledgement that a change in brand for primidone was not an ideal situation. 

Primidone tablets are no longer going to change and Pharmac will not be engaging in significant implementation activities to support a change. 

We will ensure that there is appropriate information available when the brand name changes in 2022 to assure patients and health care professionals that the product is the same. 

Consultation is an important part of our process. While there is now no change to primidone tablets, we have summarised the major themes we received in consultation so people are aware of what we heard. 

Themes of the feedback received

  • General support for the implementation activities Pharmac proposed. Further suggested implementation activities included:
    • Contacting individual primidone patients
    • Monitoring phenobarbital levels of patients taking primidone for epilepsy during the change in brand
    • Provision of information to GPs to support them to comply with the Code of Health and Disability Services Consumers' Rights
    • Pharmac establish a manned 0800 hotline for patients
    • Print media to get messages to users
    • Provision of transport assistance, should people need to stand down from driving
    • Provide printable notices to GPs and pharmacies
    • Encourage all prescribers to proactively interrogate their PMS system to identify patients using primidone and contact them
    • Engage with the major patient management system vendors in New Zealand
    • Undertake a random audit with a selection of prescribers and dispensers of primidone to ensure they fully understand what is happening and what the risks are for people changing brands
    • Contact pharmacies to identify patients using primidone so that their prescribers can be notified regarding the need for prescribing under Section 29
  • Noted Pharmac was actively considering the MHRA (UK) guidance and showing appropriate concern over primidone being a category 1 medication.
  • Noted concerns about changes being made to anti-seizure medications and considered that there is likely to be some concern among patients.
  • Noted that it would be important to ensure that the benefit of the GP co-payment was not negated by administrative costs involved in applying for it and to ensure that low fee practices are reimbursed fairly.
  • Feedback about fitness to drive:
    • Noted that Health Practitioners are best placed to help manage patients through this change.
    • Noted that determining medical fitness to drive is the responsibility of the Health Practitioner. 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 would be required and what timeframe would be appropriate.
    • Health Practitioners have obligations under Section 18 of the Land Transport Act 1998 where they must notify Waka Kotahi if they believe their patient continues to drive despite their instructions to not do so, or if they consider the patient doesn’t understand their advice.
  • Supportive of the proposal to ensure continued funding of primidone.
  • Noted that hospital services are unable to identify people taking primidone through its IT systems.
  • Concerns regarding the supply of primidone as an unapproved medicine.
  • Noted section 29 products were not able to be stocked by pharmacies, which could delay treatment getting to patients.
  • Supported the proposal and requested a minimum 5 month transition period to enable a smooth changeover.

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 660 050.