Decision to widen access for type 2 diabetes medicines

Lived experiences of people living with Type 2 Diabetes, their whānau and the healthcare professionals who support them.

Many respondents described the significant impact of type 2 diabetes on their health, wellbeing, finances, and daily life. People living with diabetes and their whānau reported that these medicines improved diabetes control, quality of life, and protection against future complications, and emphasised the value of earlier access to effective treatment.

We appreciate the insights provided through these lived experiences, which have helped inform and shape the proposal.

General Support for the proposal

There was general support for a lowering of the current CVD-risk threshold. The feedback suggested that this would enable many more people with T2DM to access these medicines

We are pleased to be removing the CVD risk-threshold for  these medicines and making them available for more patients with diabetes. 

Support for access criteria for empagliflozin, liraglutide, and dulaglutide to be based on individually assessed/measured risk factors and removal of ethnicity from access criteria.

We acknowledge that many patients would benefit from access to empagliflozin, liraglutide, and dulaglutide.

Following consideration of consultation feedback, Pharmac has made changes to the access criteria to enable access for many more people with T2DM who are unable to manage with other funded diabetes medicines.

Requests for access widening to include additional clinical indications

Support was expressed for widening access to empagliflozin for people with non-diabetic kidney disease, given evidence of improved outcomes and potential savings from avoided dialysis and hospitalisations.

Pharmac currently has an application(external link) to widen access to empagliflozin for patients with non-diabetic CKD.  It is ranked on our Options for Investment list, meaning it is something Pharmac would like to fund if budget is available.

Support for widening access to GLP-1a medications for the management of weight reduction  

Pharmac has received applications(external link) to fund semaglutide (Wegovy) for weight management which have been ranked on our Options for Investment list. Meaning that these are medicines Pharmac would like to fund if budget is available. 

Opposition to proposed removal of Equity and Ethnicity based access criteria

Many respondents expressed a strong opposition to removal of ethnicity-based criteria, which are viewed as a critical equity mechanism that directly improves access for Māori and Pacific peoples who experience disproportionately higher rates of diabetes, earlier onset, and worse outcomes.  

The original proposed changes to the Special Authority criteria were intended to ensure continued access for those most likely to benefit from SGLT2i and GLP-1a medicines. In response to feedback received, Pharmac staff have revised the criteria and consider the changes address the concerns and ensure that all those with the potential to benefit from treatment under the original criteria would continue to do so.

Respondents noted that the inclusion of ethnicity in access criteria assists in reducing health inequities for Māori. An equity analysis and review of Te Tiriti o Waitangi obligations in relation to removal of ethnicity-based access criteria should be conducted and consulted on. 

Pharmac staff acknowledge the concerns raised regarding potential impacts on health equity and we have developed revised Special Authority criteria to address these concerns.   

Access criteria should be co-designed with Iwi Māori Partnerships Boards, Māori health providers and clinicians, and Iwi. 

We acknowledge the feedback and will consider greater stakeholder engagement in the development of access criteria in the future.

Respondents noted Māori and Pacific people face a disproportionately high burden of diabetes and related mortality and that cardiovascular risk assessment tools may underestimate risk in these populations, who are also less likely to obtain cardiovascular risk assessments.

Since the inclusion of ethnicity-based access criteria in 2021, Māori and Pacific peoples have initiated treatment with these medicines at proportionally higher rates than other groups, likely contributing to reducing a health equity gap. 

Following consultation, Pharmac has revised the access criteria to provide clinicians with greater flexibility to identify patients at risk. The revised criteria enable clinicians to consider the circumstances of individual patients when assessing elevated risk and Pharmac consider that all those with the potential to benefit from treatment under the original criteria would continue to do so. 

This approach is consistent with Pharmac’s Access Criteria Policy, which supports targeting access to funded medicines based on clinical criteria. 

Concern that patients who have accessed empagliflozin under ethnicity-based criteria will lose the ability to progress to GLP-1a medicines as initially proposed criteria could prevent this treatment escalation for some patients. 

In response to this feedback, we have made amendments to the criteria, to make it clear that existing users of empagliflozin can progress to access to funded GLP-1a medicines as clinically indicated. 

General consultation feedback – Support for targeted initiatives in relation to T2DM

Request for greater investment in Māori-led initiatives for screening, primary care, early intervention, and adherence support are necessary to reduce health inequities faced by Māori. 

While Pharmac staff support any health sector initiatives that seek to improve health outcomes through early intervention, the responsibility for initiatives such as primary care, early intervention and adherence support sits with other health agencies rather than Pharmac directly, as the medicines funder. We will pass this feedback to Health New Zealand and the Ministry of Health. 

Consultation Process and Engagement 

Respondents described the consultation process as rushed, lacking transparency, and not enabling meaningful engagement. Concerns include short consultation timeframe, release of critical information after the initial deadline, absence of plain-language summaries, and the complexity and volume of supporting materials limiting accessibility. 

We heard from a number of organisations and individuals that two weeks was not enough time to respond. As a result, we extended the consultation for an additional two weeks, so that it was open for 4 weeks in total.  

We acknowledge the absence of plain language summaries. While we try hard to ensure that all supporting materials are accessible, this is something we could do better at and will take this on board as a learning for future consultations.  

Respondents felt that Pharmac did not provide sufficient information at the outset of consultation on the model used to assess the proposed access criteria changes. Information on modelling assumptions, data sets used, and numbers of patients of each ethnicity that would access each medicine in future with or without the proposed changes.  

Pharmac acknowledges these concerns.

Following receipt of this feedback, Pharmac extended the consultation period alongside publishing additional materials on our modelling for the proposed changes.  

Pharmac seeks to balance transparency with its obligations to protect confidential and commercially sensitive information. While we endeavour to provide information that supports informed feedback, not all underlying modelling or data can be made publicly available. Where possible, Pharmac provides additional information to explain the evidence and analysis informing its proposals. 

Concerns about Data Quality, Assumptions, and Modelling Robustness 

Respondents suggested that the Pharmac modelling for effects of the proposal is based on inconsistent population estimates, unclear methodology, and reliance on outdated or non-applicable clinical data. An assumption was made that Pharmac modelling was based on projected clinical eligibility and did not sufficiently consider real-world uptake data. 

Pharmac appreciates the feedback on the modelling approach and has used additional real-world data and advice to further refine patient estimates and informed decision-making. Budget impact modelling has since been released as part of the consultation to provide additional context. We intend to release the Technology Assessment Report (TAR) that describes the cost-effectiveness modelling in the near future. 

Pharmac modelling for the impact of access criteria changes considered only 5-year cardiovascular risk (rather than lifetime risk), and did not account for longer-term societal offsets, including effects on productivity.  

Pharmac’s modelling focused on 5-year cardiovascular disease (CVD) risk, as this was the access criterion under assessment. The model also reflects how risk can change over time. It allows for progression from a lower level of CVD risk to a higher level, and in some cases to more serious conditions such as heart disease or kidney failure. These changes were modelled over a person’s lifetime. The analysis also incorporated health system costs from CV events and kidney failure.  

Societal offsets and productivity impacts were not included in the modelling, as these are not currently part of Pharmac’s standard economic evaluation approach, however Pharmac is actively considering how to incorporate societal impacts into our model, this work is in development. Cost-effectiveness analyses are undertaken from the pharmaceutical funder perspective, consistent with the Prescription for Pharmacoeconomic Analysis.

Alignment with Clinical Guidance and Best Practice 

Respondents considered that the Proposal in consultation was misaligned with contemporary clinical guidelines and national strategies, including Health NZ’s Diabetes Roadmap. Modern best practice supports earlier and combined treatment approaches targeting cardiovascular, renal, and metabolic risk, rather than restricted or sequential access pathways. 

The revised access criteria provide greater clinical flexibility in identifying patients at elevated risk. 

Pharmac also recognises the directions in Health NZ’s Diabetes Roadmap and feedback supporting concurrent use of GLP-1 receptor agonists and SGLT2 inhibitors. A funding application(external link) for concurrent use has recently been received and will be assessed through Pharmac’s usual clinical and economic evaluation processes.

Some respondents considered the HbA1c threshold of >53 mmol/mol too restrictive and noted it may exclude people with significant cardiovascular or renal risk.

Some noted that, with type 2 diabetes now diagnosed at HbA1c ≥48 mmol/mol, funding criteria should be updated to better align with current clinical practice.

Pharmac acknowledges this feedback. However, changes to the HbA1c eligibility threshold were outside the scope of this proposal. Any change to the current threshold of 53 mmol/mol, including reducing it to 48 mmol/mol or removing it altogether, would require further assessment of the clinical, equity, financial, and access implications. Pharmac has noted this feedback for future consideration at the next Diabetes Specialist Advisory Committee meeting.

Pharmac’s use and Interpretation of Expert Advice 

Concerns expressed that the proposal does not accurately reflect or incorporate recommendations from expert advisory groups, particularly the Diabetes Advisory Committee. Respondent notes differences between expert advice received and the policy proposed, raising questions about interpretation and application of clinical input. 

Pharmac considers a wide range of factors when making funding proposals and decisions, including expert advice, analysis using the factors for consideration, consultation feedback from consumers and other stakeholders, and alignment with our internal policies and government expectations (such as our Letter of Expectations). These inputs are carefully considered together, and each contributes to the development of funding proposals and access criteria. 

Transparency and Decision-Making Integrity 

Respondents felt there was a lack of transparency regarding how decisions were made, including an unclear rationale for removing ethnicity criteria and potential influence of government direction. Requests for release of underlying data, modelling assumptions, and decision-making documentation to support accountability. 

In response to feedback, Pharmac has revised the proposed access criteria to provide greater clinician discretion in assessing individual patient risk. The revised criteria broaden access while remaining consistent with Pharmac’s Access Criteria Policy and were informed by consideration of our decision-making framework, the factors for consideration

Pharmac has published information on our website on the analysis undertaken for our initial proposal(external link) and intend to proactively release further information on a final funding decision in due course.