Consultation on supporting a potential brand change for dabigatran capsules

What we’re seeking feedback on

We want to hear from people about a potential brand change for dabigatran capsules. Dabigatran is a medicine used to prevent and treat blood clots.

We are seeking feedback on what we could do to support a change to the funded brand. If a change occurred, people receiving dabigatran would need to transition from the currently funded brand, Pradaxa, to an alternative generic dabigatran capsule brand.

If a brand change were to occur, we would continue to fund dabigatran without restrictions.

Feedback on this consultation will help us to understand what the impact of a brand change would be. It would also tell us what support would be needed if a change occurred.

Consultation closes at 4pm Tuesday 5 September 2023 and feedback can be emailed to consult@pharmac.govt.nz.

Who we think will be interested

• People using dabigatran capsules and their family, whānau and caregivers
• Primary Care Prescribers, Healthcare Professionals and Pharmacists
• Cardiologists, Haematologists and Internal Medicine Specialists
• Cardiac Society of Australia & New Zealand
• Heart Foundation of New Zealand
• Te Whatu Ora hospitals
• Pharmaceutical suppliers

What would the effect be?

If the brand of funded dabigatran capsules changed, the new brand would have Principal Supply Status until 30 June 2026. However, an alternative brand allowance of 5% would apply. This means that up to 5% of people would be able to use an alternative brand if clinically necessary. We want to understand:

• whether there are any particular groups of people who would not be able to transition because of their clinical circumstances
• if a 5% alternative brand allowance would be suitable
• if a different alternative brand allowance is needed, what an appropriate alternative brand allowance would be and why.

There would usually be a five-month transition period for a brand change. During the transition period, both the old and new brands are listed. This gives people time to discuss the change with their prescriber and healthcare professionals.

We want to understand:

• if a five-month transition period would be suitable for dabigatran capsules
• if a longer transition period is needed, what this would be and why.

Support for people receiving dabigatran capsules and healthcare professionals

We understand that some people may be uncertain about transitioning to an alternative generic brand of a medicine. We want to hear what activities would support a smooth transition for people.

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.

You can find more information about generic medicines on our website.

Pharmac would work alongside the supplier, advocacy and support groups for people using dabigatran, and healthcare professionals to provide information to support the proposed transition.

Support for people taking dabigatran

We want everyone to have the information they would need to understand the change and what it would mean for them. Pharmac would work with consumer groups and the supplier to provide specific information about the new funded brand. 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.

This information would be provided to consumer groups to share with people who would be impacted by a change. We would also have a dedicated page on the Pharmac website with information for individuals as well as healthcare professionals. People would be able to download PDFs in a range of languages from the website to ensure all population groups affected by this change are appropriately informed.

Support for healthcare professionals

We would expect prescribers to lead the transition, working with people receiving dabigatran, their whānau and other healthcare professionals including pharmacists. We understand healthcare professionals would need information so they can support people through a transition. This would include:

• Access to patient education resources mentioned above to provide/counsel patients
• Any differences between the current and new brand, such as differences in excipients, storage conditions etc.

We would have a dedicated webpage on the Pharmac website with information for individuals as well as healthcare professionals, and this will include downloadable PDFs of all educational resources created.

Emails would be sent to relevant healthcare professionals ahead of any key dates relating to the transition.

We want to hear what other information about this medicine would help healthcare professionals support this transition.

About dabigatran capsules

Dabigatran is part of a group of medicines called Direct Acting Oral Anticoagulants (DOAC).(external link)

These medicines are used to prevent and treat blood clots. They are used in a range of conditions. For example, to prevent stroke and deep vein thrombosis (DVT) for people at risk of these conditions.

There are no restrictions for funded access to dabigatran capsules. Dabigatran is regularly used by more than 60,000 people in New Zealand.

Why we’re proposing this

Dabigatran was included in the 2022/23 Invitation to Tender. If the brand of dabigatran is changed to a generic brand as a result of the Annual Tender funds would be released which we can reinvest into other medicines.

Information on the Annual Tender is on our website.

Clinical advice on a competitive process

In 2022, Pharmac sought advice from its Haematology Advisory Committee. We asked about including Direct Oral Anticoagulant medicines in the annual Invitation to Tender.

Our advisors told us it would be clinically appropriate to fund a generic version of dabigatran capsules.(external link)

Details about our proposal

As part of the 2022/23 Annual Invitation to Tender, we sought bids from suppliers for a range of medicines. Most of these were already listed on the Pharmaceutical Schedule. This list included dabigatran capsules.

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 2026. There would be an alternative brand allowance of 5%. This means that 5% of people could use an alternative brand, if clinically necessary.

If a brand change were to occur, we would continue to fund dabigatran without restrictions.

We would like to hear from people taking dabigatran and the health sector about the potential impacts of changing the funded brand. We are also keen to hear what implementation activities we could provide to help support this brand change, particularly for Māori, Pacific peoples and our other populations experiencing health disparities.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm 5 September 2023.

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.