Decision to fund ticagrelor for people with minor stroke or high-risk TIA

General Support for Proposal

All responses received were supportive of the proposal.

Responses highlighted the benefit that having an additional treatment for minor stroke or high-risk TIA would have, in particular, for people who do not receive sufficient benefit from clopidogrel.

We are pleased to be progressing a proposal which is supported by clinicians and will offer benefits to the wider health system.

Respondents considered that the proposal would offer cost savings to the health sector through a reduction in recurrent stroke and TIA events among high-risk patients and the associated care and resources required to manage these.

Respondents considered that the proposal would meet an unmet health need following the discontinuation of dipyridamole.

Respondents shared that populations with high health needs such as Māori and Pacific People are more likely than other populations not to receive benefit from clopidogrel and having ticagrelor available would provide an appropriate treatment option for them.

Respondents also noted that ticagrelor is available for the treatment of stroke or high-risk TIA in other countries such as the United Kingdom and this proposal would improve New Zealanders access to effective medicines.

The funding of ticagrelor is being proposed to address the discontinuation of dipyridamole.

We are pleased that this decision will provide a treatment option for New Zealanders with high health needs and mean that the people who need it have appropriate treatments available to them. We are also pleased to be widening access to ticagrelor.

Eligibility criteria  

Respondents supported the proposed criteria noting that access to genetic testing for clopidogrel resistance is not consistently available across the country and is associated with significant cost to Health NZ.

The access criteria are intended to target ticagrelor to people who experience a minor stroke or high-risk TIA but are not expected to respond to clopidogrel due to genetic factors, or who are allergic to it. We have heard from our clinical advisors that genetic testing for clopidogrel resistance is not consistently available in New Zealand. To help manage this, the proposed criteria do not require a person have a confirmed genetic test result to access ticagrelor; however, the treating clinician will be required to have documented clinical rationale for why the person is not expected to respond to clopidogrel.

Access to funded ticagrelor for other indications is subject to a range of different criteria. These criteria have been informed by advice from our clinical advisors at various times. We understand that it would be beneficial for access to ticagrelor for all indications to be subject to similar criteria regarding  clopidogrel resistance. This would require further analysis by Pharmac and is not being proposed at this time. 

A respondent considered that there should be no eligibility criteria applying to this short-term use for ticagrelor.

Clopidogrel is funded for anyone who requires it and is not subject to any eligibility criteria. We have been told that clopidogrel is expected to be an effective treatment for the majority of people who have a high-risk TIA or minor stroke.

The access criteria for ticagrelor have been informed by specialist clinical advice and have been designed to target treatment to the people with the highest health need, while retaining clopidogrel where it is appropriate.

The proposed criteria do allow people to access ticagrelor without requiring genetic testing, which may be difficult to access in some areas, and time consuming for clinicians, resulting in potential treatment delay.

A stroke specialist requested that the proposed access criteria is broadened to include ‘crescendo TIA’ to better reflect the high-risk TIA group who may not have an ABCD2 score 4 or more but would still be considered high risk due to an increasing frequency of TIA’s over a period of hours or days. It was noted that crescendo TIA, is included in the TIA guidelines alongside an ABCD2 score 4 or more and including crescendo TIA would align Pharmac’s criteria with this guidance.

We have considered this request and agree that the addition of crescendo TIA to the criteria reflects the intent of the criteria to capture the population of people with TIA at high risk of progressing to stroke. We have included this in the access criteria.

Implementation considerations

Respondents were supportive of the Health NZ Stroke National Clinical Network providing guidance to support the funding of ticagrelor and considered this would be important for identifying eligible people.

We have worked closely with the Health NZ Stroke National Clinical Network in the development of this proposal and have shared this feedback with them.

Ongoing funding of ticagrelor for minor stroke and high-risk TIA

Respondents supported the funding of ticagrelor for long term use following minor stroke or high-risk TIA when evidence is available to support its use.

Pharmac has not considered the funding of ticagrelor for long term use following minor stroke or high-risk TIA.

We have heard from stroke specialists that currently available evidence is not sufficient to support the funding of ticagrelor for long term use following minor stroke or high-risk TIA.

We would welcome a funding application for ticagrelor in this indication. More information about how to submit a funding application is available on our website.

Other feedback

A respondent raised that ticagrelor and dipyridamole are described as ‘blood thinners’ in Pharmac’s consultation which is not correct as they are antiplatelet agents.

Pharmac’s consultation has been written to be read and understood by a wide audience that includes people who may not be familiar with the technical aspects of medications available for stroke and TIA. The use of the term blood thinners is used to describe that these medicines work by reducing the ability of the blood to form clots.