Tender decision for dabigatran capsules

7 December 2023

Medicines Decision

We have awarded ongoing supply of dabigatran capsules (branded as Pradaxa).

Update 17 April 2024

Late in 2023, in response to feedback from the sector, we moved the price change date from 1 January 2024 to 1 February 2024.

We are now updating the principal supply dates, the Pradaxa brand will have Principal Supply Status from 1 July 2024 until 30 June 2026.

[Dates in the following decision reflect what was originally published.]

What we’re doing

As part of our Annual Tender process, we have awarded the ongoing supply of dabigatran capsules (branded as Pradaxa) to the current supplier, Boehringer Ingelheim. This means people taking dabigatran capsules, used as treatment to help prevent strokes or blood clots, will not need to change brand.

We’ve made this decision by assessing this tender against our decision-making framework (the Factors for Consideration).

We’ve also considered feedback from the consultation on what support would be required for a potential brand change for dabigatran capsules.

The support required to help people with transitioning between brands of dabigatran is greater than what could be provided through our annual tender process at this time. We are grateful for the feedback we received and will use this to inform our future thinking in this area.

Your feedback has informed our decision

When we consulted in August, we asked to hear from people taking dabigatran capsules, healthcare professionals and the sector on what the impact of a brand change might be.

You told us that there would need to be a range of activities to support people taking dabigatran through a brand change.

Pharmac’s ability to support a brand change is important as we want to ensure people taking dabigatran, remain safe and are confident in the treatment they are taking throughout the transition.

We will use the feedback received through the consultation and engage further with advocacy groups and healthcare professionals to shape future thinking about this market.

What this means for people and prescribers

Pradaxa will continue to be the main funded brand of dabigatran capsule in New Zealand so no one taking dabigatran capsules will need to change brand. Dabigatran is regularly used by more than 60,000 people in New Zealand.

Principal supply means that Pradaxa would be guaranteed at least 95% of the funded dabigatran capsule market. We aren’t funding an alternative brand at this time as there is no proposed brand change. We would consider funding an alternative brand in the future if there is a clinical need.

Who we think will be most interested

People using dabigatran capsules and their family, whānau and caregivers
Primary Care Prescribers and Pharmacists
Cardiologists, Haematologists, and Internal Medicine Specialists
Those involved in the care of people undergoing major orthopaedic surgery
Pharmaceutical suppliers and wholesalers

Details about this decision

Dabigatran capsules (branded as Pradaxa) will be subject to the following price and subsidy (ex-manufacturer, excluding GST) in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 January 2024.

Chemical	Presentation	Brand (Supplier)	Pack Size	Subsidy and price (ex-man., ex. GST)
Dabigatran	Cap 75 mg	Pradaxa (Boehringer)	60	$27.99
Dabigatran	Cap 110 mg	Pradaxa (Boehringer)	60	$27.99
Dabigatran	Cap 150 mg	Pradaxa (Boehringer)	60	$27.99

The Pradaxa brand will have Principal Supply Status from 1 June 2024 until 30 June 2026. This will result in a decrease in subsidy for all three strengths of dabigatran capsules from 1 January 2024. From 1 January 2024 there will no longer be a confidential rebate for dabigatran capsules.

Our response to what you told us

We’re grateful to those who took the time to respond to our consultation. This is an important part of our decision making process. It gives us the opportunity to listen to the voices of the community and acknowledge and respond to feedback.

A summary of the main themes raised in feedback and our responses are detailed below:

Theme	Pharmac comment
Whether a brand change is appropriate
Feedback suggested that there can be serious side effects associated with dabigatran, including life threatening bleeds. While these may not be directly caused by a change in brand, a brand change could cause anxiety for people and their whānau. Robust implementation support would be needed so that people are confident in any potential change. Feedback suggested people currently on Pradaxa should remain on currently funded treatment and highlighted groups who may be more vulnerable, including elderly individuals, people with cognitive impairment and those with low health literacy. Feedback from other stakeholders suggested it would be appropriate for everyone to change brand.	We understand that people need to be confident in the funded brand of their medicine. We have carefully considered all of the feedback we received. The feedback indicated that the support required for a brand change is greater than what could be provided through our annual tender process at this time. Our ability to support a transition for everyone receiving dabigatran is important when we are considering a brand change. In response to the feedback we have made the decision to award the supply of dabigatran capsules (branded as Pradaxa) to the current supplier, Boehringer Ingelheim. This means people taking dabigatran capsules, will not need to change brand. The feedback we received during consultation will shape our thinking about any potential future brand change for dabigatran. We would engage further to understand the impact of a change before planning any future competitive process for dabigatran.
Implementation support required for a potential brand change
Feedback considered the following additional support would be required to help support a brand change and mitigate against the risk of increased reporting of side effects, including: Additional counselling on signs and symptoms of blood clots and bleeding Additional support, for example through free GP consultations Patient information leaflets	How we implement a brand change is a key consideration in our decision making. At this time the support required to help people taking dabigatran to transition brands would exceed what could be delivered though the Annual Tender process. The feedback we received gives us useful information to consider as part of our planning for future processes.
Some feedback suggested the transition period should be longer than five months. It would give people more time to discuss what a brand change would mean for them with their healthcare practitioner and whānau. It would also allow for more time to monitor their transition. Other feedback suggested a five-month transition period would be sufficient provided individuals changing brands receive proper support.	The feedback about a transition period for changing brands was varied. We would explore this with our expert advisors and consumer groups before planning any potential changes to the funded brand of dabigatran capsules.
Important features / considerations for a new brand
Feedback highlighted stability data is important. Any funded product should have the same (or better) stability than the current product. Feedback highlighted a preference for a product with improved stability once opened (compared with the currently funded product).	The stability data for funded dabigatran capsules would not change as there is no proposed brand change. Feedback regarding stability preferences would inform our planning for any future competitive process for dabigatran.
Feedback highlighted the medicine that reverses the effect of dabigatran, idarucizumab, needs to work with the funded dabigatran capsule brand.	The medicine that reverses the effect of dabigatran, idarucizumab has been funded since July 2016 in New Zealand. Generic dabigatran products approved by Medsafe are bioequivalent. This means they have the same active ingredients and work in the same way as the original brand. Our expert advisors have told us that generic dabigatran products would work with the reversal medicine as they have the same active ingredient. We understand generic dabigatran products are used with the reversal medicine overseas.
Feedback indicated a preference for a product that comes in a 60-capsule pack with 10-capsule blister packs.	The currently funded brand is supplied in a 60-capsule pack with 10-capsule blister packs. This feedback about pack sizes helps our planning for any future competitive process.
Feedback highlighted that continuity of supply of dabigatran is important.	We work closely with all of our suppliers to ensure continued supply of medicines for New Zealanders. We understand supply issues have a negative impact on anyone who isn’t able to access the medicines they need, including dabigatran. We consider a supplier’s ability to supply medicines as part of our decision making process.

Theme

Pharmac comment

Whether a brand change is appropriate

Feedback suggested that there can be serious side effects associated with dabigatran, including life threatening bleeds. While these may not be directly caused by a change in brand, a brand change could cause anxiety for people and their whānau. Robust implementation support would be needed so that people are confident in any potential change.

Feedback suggested people currently on Pradaxa should remain on currently funded treatment and highlighted groups who may be more vulnerable, including elderly individuals, people with cognitive impairment and those with low health literacy.

Feedback from other stakeholders suggested it would be appropriate for everyone to change brand.

We understand that people need to be confident in the funded brand of their medicine. We have carefully considered all of the feedback we received.

The feedback indicated that the support required for a brand change is greater than what could be provided through our annual tender process at this time. Our ability to support a transition for everyone receiving dabigatran is important when we are considering a brand change.

In response to the feedback we have made the decision to award the supply of dabigatran capsules (branded as Pradaxa) to the current supplier, Boehringer Ingelheim. This means people taking dabigatran capsules, will not need to change brand.

The feedback we received during consultation will shape our thinking about any potential future brand change for dabigatran. We would engage further to understand the impact of a change before planning any future competitive process for dabigatran.

Implementation support required for a potential brand change

Feedback considered the following additional support would be required to help support a brand change and mitigate against the risk of increased reporting of side effects, including:

Additional counselling on signs and symptoms of blood clots and bleeding
Additional support, for example through free GP consultations
Patient information leaflets

How we implement a brand change is a key consideration in our decision making. At this time the support required to help people taking dabigatran to transition brands would exceed what could be delivered though the Annual Tender process.

The feedback we received gives us useful information to consider as part of our planning for future processes.

Some feedback suggested the transition period should be longer than five months. It would give people more time to discuss what a brand change would mean for them with their healthcare practitioner and whānau. It would also allow for more time to monitor their transition.

Other feedback suggested a five-month transition period would be sufficient provided individuals changing brands receive proper support.

The feedback about a transition period for changing brands was varied. We would explore this with our expert advisors and consumer groups before planning any potential changes to the funded brand of dabigatran capsules.

Important features / considerations for a new brand

Feedback highlighted stability data is important. Any funded product should have the same (or better) stability than the current product.

Feedback highlighted a preference for a product with improved stability once opened (compared with the currently funded product).

The stability data for funded dabigatran capsules would not change as there is no proposed brand change.

Feedback regarding stability preferences would inform our planning for any future competitive process for dabigatran.

Feedback highlighted the medicine that reverses the effect of dabigatran, idarucizumab, needs to work with the funded dabigatran capsule brand.

The medicine that reverses the effect of dabigatran, idarucizumab has been funded since July 2016 in New Zealand.

Generic dabigatran products approved by Medsafe are bioequivalent. This means they have the same active ingredients and work in the same way as the original brand.

Our expert advisors have told us that generic dabigatran products would work with the reversal medicine as they have the same active ingredient.

We understand generic dabigatran products are used with the reversal medicine overseas.

Feedback indicated a preference for a product that comes in a 60-capsule pack with 10-capsule blister packs.

The currently funded brand is supplied in a 60-capsule pack with 10-capsule blister packs.

This feedback about pack sizes helps our planning for any future competitive process.

Feedback highlighted that continuity of supply of dabigatran is important.

We work closely with all of our suppliers to ensure continued supply of medicines for New Zealanders.

We understand supply issues have a negative impact on anyone who isn’t able to access the medicines they need, including dabigatran. We consider a supplier’s ability to supply medicines as part of our decision making process.

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.