Consultation on a potential brand change for acetazolamide
What we’re seeking feedback on
We are seeking feedback from people about a potential brand change for acetazolamide tablets.
Acetazolamide 250 mg tablets (branded as Diamox) are currently supplied by Arrotex Pharmaceuticals.
Acetazolamide is a medicine used to treat:
- glaucoma
- idiopathic intracranial hypertension (increased pressure around the brain)
- epilepsy (rarely, as an additional treatment for some forms of epilepsy)
Acetazolamide tablets were included in Pharmac’s 2023/24 Annual Invitation to Tender.
If a brand change were to occur:
- people receiving acetazolomide would need to transition from the currently funded brand, Diamox, to an alternative generic brand of acetazolomide.
- we would continue to fund acetazolamide without restrictions.
We are seeking feedback on what support may be required if people need to change from their current brand of acetazolamide to another brand.
Consultation closes at 4pm Friday 18 October 2024
Submit feedback through our online form or email tender@pharmac.govt.nz
What would the effect be?
If the funded brand of acetazolamide changed, people would need to transition from their current brand of acetazolamide to a generic brand.
A generic medicine has the same active ingredients and works in the same way as the original brand. Generic medicines can look different to the original brand. Any generic medicine considered for a brand change must be approved by Medsafe.
How Medsafe ensures the quality of generic medicines - Medsafe website(external link)
Pharmac would work alongside the new supplier, patient support groups and healthcare professionals to provide information to support any transition.
If there is a brand change for acetazolamide, there would be a transition period of five months. During the transition period, both the old and new brands would be listed. This gives people time to discuss the change with their doctor or other healthcare professionals before starting the new brand.
We understand that some people may be uncertain about changing to an alternative generic brand of a medicine. We want to hear what we could do to support a smooth transition for people.
We want to understand:
- whether there are any groups of people who would not be able to transition to a different brand of the same medicine due to their clinical circumstances
- whether a five-month transition period would be suitable for people needing to change brand of acetazolamide.
- if a longer transition period is needed, how long this would need to be and why.
Why we’re proposing this
Acetazolamide was included in the 2023/24 Annual Invitation to Tender.
If the funded brand of acetazolamide changed to a generic brand through the Tender, this may result in a price reduction, and we could use the savings to fund new medicines.
About the Annual Invitation to Tender
About acetazolamide and its use in glaucoma, idiopathic intracranial hypertension and epilepsy
Acetazolamide
Acetazolamide is part of a group of medicines called carbonic anhydrase inhibitors.
These medicines are used to treat a range of conditions including glaucoma, idiopathic intracranial hypertension, and rarely as an additional treatment for epilepsy.
About carbonic anhydrase inhibitors on Healthify NZ(external link)
About carbonic anhydrase inhibitors on the New Zealand Formulary(external link)
Acetazolamide is currently funded without restriction and is used by around 5,000 people in New Zealand every year. The Diamox brand of acetazolamide (tablet 250 mg) has been funded since 1997.
Any brand change would be the first in New Zealand since the Diamox brand was first funded.
Glaucoma and idiopathic intracranial hypertension
Glaucoma is an eye condition where pressure inside the eye becomes too high, which can damage the optic nerve. Idiopathic intracranial hypertension occurs when there is increased pressure around the brain due to a build-up of spinal fluid.
Our clinical advisors have told us that the most common uses of acetazolamide are for glaucoma and idiopathic intracranial hypertension. They told us that a change to a generic brand is unlikely to have an impact on people using acetazolamide for these conditions. They did not identify any group who may require an alternative brand of acetazolamide if a brand change were to occur.
Epilepsy
Our advisors also told us that acetazolamide is very rarely used for the treatment of epilepsy. They considered that it may be used in children who have difficult to treat types of epilepsy that have not responded to any other treatment.
Our clinical advisors considered it unlikely that there would be any issues with a brand change for acetazolamide for children with epilepsy, as they would typically be receiving other anti-seizure medicines as well as acetazolamide and would likely not be seizure free. Our clinical advisors told us that acetazolamide is generally not used to treat adults with epilepsy.
Who we think will be interested
- People using acetazolamide, their family, whānau, and caregivers
- Primary care prescribers, healthcare professionals, and pharmacists
- Healthcare professionals involved in the care of people with glaucoma, idiopathic intracranial hypertension, and epilepsy
- Patient support groups who support people with glaucoma, idiopathic intracranial hypertension, and epilepsy
- Health NZ hospitals
- Pharmaceutical suppliers
Details about our proposal
As part of the 2023/24 Annual Invitation to Tender, we sought bids from suppliers for a range of medicines. This list included acetazolamide 250 mg tablets.
The pricing and timeframes for listing would be notified as part of a Tender decision. Any products listed through the Tender would have Principal Supply Status until 30 June 2027. This means that the successful supplier would be guaranteed 95% of the funded market for its brand of acetazolamide until 30 June 2027.
If a brand change were to occur, we would continue to fund acetazolamide without restrictions.
Support for people taking acetazolamide
We want everyone to have the information they would need to understand the brand change. This would include:
- any differences between the current and new brand, such as packaging or capsule shape or colour
- pictures of the new brand
- key dates for any changes
- information on generic medicines
- where to find more information.
Pharmac would provide this information to consumer groups and interested stakeholders to share with people who need to change brands. This information would be available on the Pharmac website. We would provide PDFs of the information in multiple languages to help ensure that those affected are aware of the change.
Support for healthcare professionals
We would need prescribers to lead the transition, working with people receiving acetazolamide, their whānau, and other healthcare professionals – including pharmacists. We understand healthcare professionals would need information to support people through a transition. We would provide:
- patient education resources to inform patients about changes to their brand of medicine
- information on differences between the current and new brand, such as differences in tablet ingredients or storage conditions.
This information would be available on the Pharmac website and all educational resources would be able to be downloaded as PDFs.
Emails would be sent to relevant healthcare professionals ahead of any key dates relating to the transition.
We want to hear what other resources or information Pharmac could provide to help healthcare professionals support this transition should a brand change occur.
To provide feedback
Please submit feedback through our online form or email tender@pharmac.govt.nz.
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.