Build your submission on the proposed changes to diabetes medicine Special Authority criteria

These three position statements form the opening of your submission. Untick any you do not agree with.

• I support the reduction in the cardiovascular risk threshold from ≥15% to ≥10%.
• I do not support the removal of ethnicity-based criteria.
• The consultation process for this proposal has been inadequate and disingenuous.

• A 14-day consultation window is insufficient for meaningful consultation, and is wholly inadequate for a change of this clinical significance, equity impact, and likely community and stakeholder interest.
• The process does not appear consistent with Pharmac's own commitment to greater transparency and clarity in funding decisions.
• Pharmac has a specialist Diabetes Advisory Committee which, based on the published 26 June 2025 meeting record, was clear about the ongoing need for the ethnicity criterion. Pharmac is progressing with a change that is not consistent with the specialist clinical advice it received.
• The proposal to lower the CVD threshold from 15% to 10% was routed through the Obesity Treatments Advisory Group (December 2025) rather than the Diabetes Advisory Committee. The Obesity Group itself raised concerns including that the 10% threshold is high by international comparison, that PREDICT does not capture renal outcomes, and that removing ethnicity-based criteria would introduce new access barriers for Māori and Pacific peoples.

• Ethnicity in this context is not a proxy for race — it is a marker of accumulated, structural, and clinical risk. Māori and Pacific peoples with type 2 diabetes carry a documented higher burden of disease prevalence, complications, and mortality, even after controlling for age, sex, smoking, BMI, and deprivation.
• Pacific peoples have type 2 diabetes at 4.1 times the rate of Europeans; Māori at 2.5 times the rate (VDR 2024).
• Pacific peoples with T2D are 6–7 times more likely to reach kidney failure than Europeans with the same condition. Māori are 3–4 times more likely. Māori with T2D have nearly double the cardiovascular mortality rate of Europeans — a gap that has persisted for over 20 years without closing.
• The under-prescribing of cardioprotective and renoprotective diabetes medications to Māori and Pacific peoples is not hypothetical. It represents real, measurable under-prescribing despite identical or greater clinical need. This is a policy precedent for the health sector.
• To qualify under non-ethnicity criteria, a patient must have completed a CVD risk assessment, an annual diabetes review, blood tests, and urine ACR testing. Māori men are 27% less likely than European men to have had a CVD risk assessment completed (Wheeler, Rahiri, Harwood et al., 2025). Removing the ethnicity criterion removes the safety net that compensates for this systemic gap.

• Paul, Keenan, Chepulis et al. (NZ Medical Journal, 2023) demonstrated that the inclusion of ethnicity in Special Authority criteria improved access to these medicines for Māori and Pacific peoples with type 2 diabetes — including exceeding access observed for medicines without Special Authority restrictions.
• Chepulis, Gan, Simmons et al. (Diabetologia, April 2026; n=59,505) found empagliflozin reduces all-cause mortality by 52.5% in Māori (HR 0.475), 49.3% in Pacific peoples (HR 0.507), and 33.3% in Europeans (HR 0.667). The medicine works better in the communities at highest risk.
• Special Authority criteria are themselves a barrier to access. The application process introduces administrative friction that disproportionately affects patients with less continuity of primary care. Replacing the ethnicity criterion with a narrower, more restrictive CVD threshold compounds this barrier.

• A lower CVD threshold does not fix systemic primary care access inequity. Māori are significantly less likely to have their cardiovascular risk assessed at all. Address the underlying primary care access inequity first — then a population-wide threshold can safely replace the targeted safety net.
• Cost–benefit analysis has not been published. No comparative analysis of the downstream cost of complications prevented (dialysis at $115,712/person/year, amputations at ~$40,000 per operation, cardiovascular hospitalisations at $10,000–$20,000 per admission) nor the cost of universally funded alternatives required if access is reduced.
• Health need impact has not been quantified. The projected 10,000 and 23,000 figures have not been broken down by ethnicity, are not specified as net or gross of people losing access, and are not accompanied by projections of impact on dialysis demand, major adverse cardiac events, hospitalisations, or mortality.
• Equity impact has not been assessed. The Diabetes Advisory Committee's June 2025 finding that no alternative pathway exists to capture the Māori and Pacific subset of the target population has not been reconciled with the proposed change.
• Pharmac's role as the Crown. Under the Pae Ora (Healthy Futures) Act 2022, Pharmac must give effect to the principles of Te Tiriti o Waitangi — including active protection. Pharmac must demonstrate this proposal is not an active decision that will have meaningful and significant negative impact on Māori lives.

This section presents the timeline of decisions as a single block. Choose whether to include the timeline and whether to include the red-flag summary that follows it.

• Public officials have stated that most Māori and Pacific peoples previously eligible through the ethnicity criterion will remain eligible through other measures. No numerical evidence has been provided to support this claim — and it is inconsistent with the experience of health professionals treating younger Māori and Pacific patients who would not have a 5-year CVD risk of ≥10% without either established disease or inadequate management.
• The Diabetes Advisory Committee explicitly confirmed in June 2025 that Pharmac and its clinical advisors "had been unable to identify any other factor that could be used to identify this group that could be workably applied as a criterion in clinical practice." The Obesity Treatments Advisory Group reiterated in December 2025 that not all Māori and Pacific peoples currently eligible would be captured by lowering the CVD risk threshold.
• The Minister's "mum managing her diabetes while raising her kids" example contradicts the proposal. A 35-year-old mother with type 2 diabetes, no established cardiovascular disease, no diabetic kidney disease, and an in-progress glycaemic management plan will not have a calculated 5-year CVD risk of ≥10%. Under the proposed criteria, she does not qualify. Under the current ethnicity criterion, if she is Māori or Pacific, she does. The rhetoric and the criteria are in direct contradiction.

• When dulaglutide and empagliflozin were originally funded in 2021, their criteria were similar — both required failure on only one blood-glucose lowering agent for at least 3 months. The original criteria approved by the Pharmac board did not require failure on three medicines.
• The current GLP-1 stepwise failure criteria — requiring documented failure on metformin, vildagliptin, AND empagliflozin for at least 6 months — were introduced as an emergency measure during the worldwide GLP-1 shortage. That shortage no longer exists. The temporary restrictions have not been reverted.
• Pharmac has continued to apply these restrictions in the development and review of criteria for liraglutide, dulaglutide, semaglutide, and tirzepatide. A genuine review of diabetes Special Authority criteria would include reverting these temporary measures alongside any other changes.

• The removal of ethnicity criteria — without appropriate consultation and in direct opposition to Specialist Advisory Group recommendations — would set a dangerous precedent for other targeted policy and programmes designed to address inequitable outcomes.

These are the specific things you are asking Pharmac to do. Untick any you don't agree with.

• Proceed with the CVD threshold reduction and add a discretionary clinical pathway. Lower the cardiovascular risk threshold from ≥15% to ≥10%, and introduce a discretionary clinical pathway in line with the Diabetes Advisory Committee's recommendations.
• Withdraw the proposal or extend the consultation. Withdraw the proposal to remove the ethnicity criterion, or extend the consultation period to a minimum of 12 weeks with active engagement with iwi Māori Partnership Boards, Pasifika Medical Association, Pacific health providers, and clinical colleges.
• Provide transparent modelling. Distinguish between eligibility and expected real-world uptake, account for individuals losing access through ethnicity criterion removal, account for individuals in the 10–15% CVD band who already qualify through other criteria, and explicitly consider workforce and system constraints including access to CVD risk assessment.
• Publish a comprehensive equity and health economic impact analysis. Quantify the impact on Māori and Pacific populations, demonstrate that equity will not be worsened, demonstrate alignment with Pharmac's Te Tiriti o Waitangi and Access Criteria policies, and assess downstream impacts including dialysis demand, hospitalisations, premature mortality, and the comparative cost of universally funded alternatives.
• Remove the Special Authority criteria for empagliflozin entirely. Provide universal access in line with NICE NG28 2026 and ADA 2026 best practice guidelines.
• Revert the GLP-1 receptor agonist Special Authority criteria to the original criteria approved by the Pharmac board. Require failure on only one blood-glucose lowering agent for at least 3 months, not the current triple-failure 6-month requirement (metformin, vildagliptin, and empagliflozin) introduced during the worldwide shortage that no longer exists.
• Support dual treatment with both SGLT2i and GLP-1 RA. Enable concurrent use in people with type 2 diabetes and cardiorenal risk, consistent with ADA 2026 and NICE NG28 2026 guidelines.
• Implement an alternative equity pathway before any removal. If the ethnicity criterion is to be removed, implement an evidence-based alternative pathway before 1 August 2026 that ensures equitable early access for Māori and Pacific peoples and achieves comparable reductions in mortality and complications.
• Inform the public about the limitations of universally funded alternatives. Ensure the public is appropriately informed about the lack of additional benefits and the adverse effect profile of universally funded alternatives (insulin, sulfonylureas) including weight gain, hypoglycaemia risk, glucose monitoring requirements, and driving implications.