Decision to fund two new medicines for type 2 diabetes - Amended with Q&A

29 January 2021

Medicines Decision

We have made the decision to fund two new medicines for New Zealanders who are at high risk of heart and kidney complications from type 2 diabetes.

Useful links

Media release: Pharmac to fund two new diabetes medicines with amended Special Authority criteria

The first of these medicines will be available, fully funded from 1 February 2021. We would like to thank everyone who has helped contribute to this decision.

What we’re doing

We're pleased to announce a decision to fund two new treatments for type 2 diabetes through agreements with two suppliers:

empagliflozin (Jardiance) and empagliflozin with metformin (Jardiamet) supplied by Boehringer Ingelheim will be funded from 1 February 2021

dulaglutide (Trulicity) supplied by Eli Lilly will be funded as soon as possible following Medsafe approval. [Update: dulaglutide has since been approved and was listed on 1 September 2021]

Both treatments will be funded subject to patients meeting funding criteria as described below.

This proposal arose from a request for proposals (RFP) for treatments in three different classes of medicines for type 2 diabetes.

We will notify a decision about the treatments in the third class of medicines, vildagliptin (Galvus) and vildagliptin with metformin (Galvumet), separately.

What does this mean for people?

This decision means that people who are at high risk of heart and kidney complications from type 2 diabetes will have access to other funded treatment options, empagliflozin and dulaglutide, subject to certain access criteria (called Special Authority criteria). Any relevant practitioner, including Nurse Practitioners and Pharmacist Prescribers, will be able to apply for a Special Authority.

Empagliflozin with and without metformin will be funded from 1 February 2021.

Dulaglutide does not currently have Medsafe approval. Funding will occur as soon as possible following Medsafe approval.

We have prepared a list of questions and answers regarding this decision.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 9 September 2020. The consultation closed on 9 October 2020. We received feedback from around 60 different individuals, professional societies, and advocacy groups, and we would like to take this opportunity to again express our appreciation for the time people took to provide us with their feedback.

After having reviewed the consultation feedback, we determined that we needed additional time to consider the matters raised before a decision could be made. We had originally proposed that empagliflozin and empagliflozin with metformin would be funded from 1 December 2020. These medicines will now be funded from 1 February 2021.

After carefully considering the consultation feedback we have also made some changes to the Special Authority criteria, including a change in order of the criteria. These changes were made to clarify the intent of the criteria, which aim to target the treatments to people with type 2 diabetes who are at high risk of heart and kidney complications.

The changes from the original criteria are shown below (additions in bold, deletions in strikethrough, re-ordering not marked up).

Special Authority for subsidy

Initial application from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following:

Patient has type 2 diabetes; and
Any of the following:
1. Patient is Māori or any Pacific ethnicity; or
2. Patient has pre-existing cardiovascular disease or risk equivalent*; or
3. Patient has an absolute 5-year cardiovascular disease risk of 15% or greater according to a validated cardiovascular risk assessment calculator; or
4. Patient has a high lifetime cardiovascular risk due to being diagnosed with type 2 diabetes during childhood or as a young adult; or
5. Patient has diabetic kidney disease**; and
Target HbA1c (of 53 mmol/mol or less) has not been achieved despite the regular use of oral antidiabetic agents and/or insulin at least one blood-glucose lowering agent (e.g., metformin, vildagliptin or insulin) for at least 63 months; and
Treatment is to be used in conjunction with other measures to reduce cardiovascular risk in line with current standard of care; and
Treatment will not be used in combination with a funded [GLP-1 agonist/SGLT-2 inhibitor] (deleted as appropriate).
Treatment must be used as an adjunct to oral antidiabetic therapy and/or insulin; and

Note:

Criteria 2.1 – 2.5 describe patients at high risk of cardiovascular or renal complications of diabetes.

* Defined as: prior cardiovascular disease event (i.e., angina, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, transient ischaemic attack, ischaemic stroke, peripheral vascular disease), congestive heart failure or familial hypercholesterolaemia.

** Defined as: persistent albuminuria (albumin:creatinine ratio greater than or equal to 3 mg/mmol, in at least two out of three samples over a 3-6 month period) and/or eGFR less than 60 mL/min/1.73m2 in the presence of diabetes, without alternative cause.)

Who we think will be most interested

People with type 2 diabetes and their whānau
Organisations with an interest in diabetes treatment
All healthcare professionals in primary and secondary care who are involved in supporting people with type 2 diabetes
Pharmaceutical suppliers

Detail about this decision

Empagliflozin (with and without metformin)

Empagliflozin (Jardiance)(external link) and empagliflozin with metformin hydrochloride (Jardiamet)(external link) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 February 2021 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Empagliflozin	Tab 10 mg	Jardiance	30	$58.56
Empagliflozin	Tab 25 mg	Jardiance	30	$58.56
Empagliflozin with metformin hydrochloride	Tab 5 mg with 500 mg metformin hydrochloride	Jardiamet	60	$58.56
Empagliflozin with metformin hydrochloride	Tab 5 mg with 1,000 mg metformin hydrochloride	Jardiamet	60	$58.56
Empagliflozin with metformin hydrochloride	Tab 12.5 mg with 500 mg metformin hydrochloride	Jardiamet	60	$58.56
Empagliflozin with metformin hydrochloride	Tab 12.5 mg with 1,000 mg metformin hydrochloride	Jardiamet	60	$58.56

A confidential rebate will apply to Jardiance and Jardiamet that will reduce the net price to DHBs.

Jardiance and Jardiamet will be the sole subsidised brands of an SGLT-2 inhibitor for the treatment of type 2 diabetes until at least 30 June 2024, which could be extended by mutual consent between PHARMAC and Boehringer Ingelheim until 30 June 2025 and/or 30 June 2026.

Empagliflozin (with and without metformin) will be listed in Section B of the Pharmaceutical Schedule subject to the following Special Authority criteria:

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following:

Patient has type 2 diabetes; and
Any of the following:
1. Patient is Māori or any Pacific ethnicity; or
2. Patient has pre-existing cardiovascular disease or risk equivalent*; or
3. Patient has an absolute 5-year cardiovascular disease risk of 15% or greater according to a validated cardiovascular risk assessment calculator; or
4. Patient has a high lifetime cardiovascular risk due to being diagnosed with type 2 diabetes during childhood or as a young adult; or
5. Patient has diabetic kidney disease**; and
Target HbA1c (of 53 mmol/mol or less) has not been achieved despite the regular use of at least one blood-glucose lowering agent (e.g. metformin, vildagliptin, or insulin) for at least 3 months; and
Treatment will not be used in combination with a funded GLP-1 agonist.

Note:

Criteria 2.1 – 2.5 describe patients at high risk of cardiovascular or renal complications of diabetes

* Defined as: prior cardiovascular disease event (i.e. angina, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, transient ischaemic attack, ischaemic stroke, peripheral vascular disease), congestive heart failure or familial hypercholesterolaemia.

The same restrictions will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List).

Dulaglutide

Dulaglutide (Trulicity) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as soon as practicable following Medsafe approval at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical	Formulation	Brand	Pack size	Price and subsidy
Dulaglutide	Inj 1.5 mg per 0.5 ml prefilled pen	Trulicity	4	$115.23

Trulicity will be the sole subsidised brand of a GLP-1 agonist for the treatment of type 2 diabetes until at least 30 June 2024, which could be extended by mutual consent between PHARMAC and Eli Lilly until 30 June 2025 and/or 30 June 2026.

Dulaglutide will be listed in Section B of the Pharmaceutical Schedule subject to the following proposed Special Authority criteria:

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid without further renewal unless notified for applications meeting the following criteria:

All of the following:

Patient has type 2 diabetes; and
Any of the following:
1. Patient is Māori or any Pacific ethnicity; or
2. Patient has pre-existing cardiovascular disease or risk equivalent*; or
3. Patient has an absolute 5-year cardiovascular disease risk of 15% or greater according to a validated cardiovascular risk assessment calculator; or
4. Patient has a high lifetime cardiovascular risk due to being diagnosed with type 2 diabetes during childhood or as a young adult; or
5. Patient has diabetic kidney disease**; and
Target HbA1c (of 53 mmol/mol or less) has not been achieved despite the regular use of at least one blood-glucose lowering agent (e.g. metformin, vildagliptin, or insulin) for at least 3 months; and
Treatment will not be used in combination with a funded SGLT-2 inhibitor.

Note:

Criteria 2.1 – 2.5 describe patients at high risk of cardiovascular or renal complications of diabetes

The same restrictions will apply in Part II of Section H of the Pharmaceutical Schedule (the Hospital Medicines List).

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. PHARMAC and the PHARMAC Board considered all feedback received during consultation when making this decision.

The feedback we received was numerous, extensive, extremely thoughtful and was invaluable in informing our decision-making process.

As a decision for this proposal has now been made, and commercial negotiations for this proposal have concluded, we have released a copy of the feedback received in response to our consultation issued 9 September 2020.

A summary of the main themes raised in feedback, and our responses, are set out in the table below.

After carefully considering the consultation feedback, we made the decision to specifically name Māori and Pacific ethnicities within the funding criteria. This is the first time we have explicitly included ethnicity within our Special Authority criteria. We consider this to be an intentional, proactive move to address medicines access equity for population groups who are at high risk of complications of type 2 diabetes and for whom there is evidence of inequities in access to already funded medicines for type 2 diabetes. We have identified five key drivers where shifts are needed to achieve medicine access equity for these population groups, and some aspects of medicine availability ie how we decide on eligibility to a funded medicine is in our direct control.

We see inequitable access to medicines as an outcome which is a subset of inequitable access to health care generally. Those experiencing health inequities also tend to experience inequitable access to health care; both are often a result of broader inequities that exist in the social determinants of health, which in turn have arisen as a result of the structural inequities. We know that the causes of health inequities are complex, and solutions do not lie solely with the funding of medicines, or within the health system, but we also know that PHARMAC has a role to play.

We have a broader programme of policy work, considering how we can directly influence medicines access equity. You can read more about our medicines access equity work here, and we intend to engage further with the sector early in 2021 on some of our work in this space.

PHARMAC will support the implementation and monitor the uptake of these medicines to see whether they are being accessed by those people with highest need. We will work with external experts to evaluate the uptake and assess whether any further changes are needed to support the appropriate use of these medicines.

Download the full feedback we received [PDF, 11 MB]

Theme	PHARMAC Response
General topics
Feedback from most responders was strongly supportive of the funding of an SGLT-2 inhibitor and/or a GLP-1 agonist	We are encouraged that the funding of empagliflozin and dulaglutide has, in general terms, been supported by the vast majority of respondents to this consultation.
A number of responders thought the proposal would help address health inequities in Aotearoa New Zealand, including for Māori and Pacific people	Supporting the reduction of health inequities in Aotearoa New Zealand is a priority for PHARMAC. Notwithstanding other important feedback received on the topic of health equity, we are pleased that the funding of empagliflozin and dulaglutide is viewed as a positive step towards improving this. Following careful consideration of consultation feedback, we made changes to the Special Authority criteria with the intentional view to further enhance the health equity focus of this proposal.
Some responders considered that Māori and Pacific people living with type 2 diabetes should have a direct pathway to access these medicines eg. via an equity criterion	We acknowledge that Māori and Pacific people are disproportionately impacted by type 2 diabetes(external link). Following careful consideration of consultation feedback, we have amended the proposed Special Authority criteria to clarify that Māori and Pacific people who also meet certain other criteria would have access to these medicines. This recognises the heightened risk of cardiovascular and renal outcomes in these ethnic groups.
Some responders considered the consultation process too short to allow PHARMAC to meaningfully consider the feedback received. By contrast, others expressed disappointment that the decision had been delayed.	We are grateful for the time that responders took in responding to our consultation, which was conducted under timeframes consistent with our usual processes. All feedback has been carefully considered and provided in full to the Board when making its decision. Given the complexity of the feedback received, we have taken more time than anticipated to consider it.
Some responders considered that PHARMAC should report on the regulatory approval progress of dulaglutide	Regulatory approval is the responsibility of Medsafe, and the status of applications are publicised on the Medsafe website(external link). We regularly engage with Medsafe and will continue to do so.
Special Authority criteria changes
A number of responders requested that the criterion related to maximum tolerated dose of anti-diabetic treatments be clarified to only require metformin as a prior treatment	The Special Authority criteria have been amended to clarify that at least one prior anti-diabetes medicine (including, for example, metformin, vildagliptin or insulin) should have been used prior to treatment with empagliflozin or dulaglutide. We have also reduced the time requirement for assessing whether the prior treatment has worked from 6 months to 3 months.
A number of responders considered the existence of Special Authority criteria would reduce the ability of Māori and other high-risk populations to access these treatments, and called for the removal of these criteria	Open listing was considered, but ranked lower than other medicines awaiting funding within the available budget. Furthermore, some people we engaged with held the view that pro-equity access criteria would be an active approach to addressing inequities, rather than a passive approach. We are aware of inequities in access to medicines that exist even when they are listed without any access criteria. Instead, we worked extensively with our clinical advisors and external clinician groups to develop Special Authority criteria that we consider to be pro-equity. The Special Authority criteria specifically name Māori and Pacific ethnicities. We are aware that people of South Asian ethnicities may be at a higher risk of diabetes and its complications compared to other groups. However, data suggests that access to medicines for South Asian groups is, in general, equitable. [1] The Special Authority includes other criteria to identify those with high-risk disease that would be met by other groups, including people of South Asian ethnicities. We plan to work to support the sector with implementation activities with the express purpose of supporting equitable access to these medicines.
Some responders considered the proposed Special Authority criteria would not permit access by children and young adults with type 2 diabetes – a group for whom lifetime (but not five year) cardiovascular and renal complication risk is high – and called for the addition of a criterion based on age	We have considered this feedback and sought additional clinical advice. We have amended the SA criteria to enable access to people diagnosed with type 2 diabetes in childhood or as young adults and who therefore have a high lifetime risk of cardiovascular complications from type 2 diabetes, but for whom a 5-year risk calculation may be inappropriate.
A number of responders considered that there is a need for dual funding of SGLT-2 inhibitors together with GLP-1 agonists, including to reduce inequities in access	Concomitant use of a SGLT-2 inhibitor and GLP-1 agonist was outside of the scope of the RFP. PHARMAC has not had a funding application for the combined use of these two medicines so we have not been able to fully assess the evidence for or take appropriately considered clinical advice on such use. We would welcome a funding application for the concomitant use of these medicines.
Two responders noted that the SA criteria rely on screening and testing (e.g., HbA1c, ACR, CV risk assessment) which they consider to be inequitably delivered and would increase and entrench inequity for Māori and Pacific people	PHARMAC acknowledges that significant health inequities exist in Aotearoa New Zealand, that these are unacceptable, and that PHARMAC is a part of a system that has perpetuated these inequities. We consider that the tests included in the proposed Special Authority criteria are in line with quality care that should be available to all people living in Aotearoa New Zealand, particularly those at high risk of complications from type 2 diabetes. PHARMAC does not have a direct role in the provision of screening and testing. We have amended the Special Authority criteria to clarify that Māori and Pacific people meeting certain other criteria would have access to these medicines given the heightened risk of cardiovascular and renal outcomes in these ethnic groups, and documented inequities in access to health care [PDF, 8.5 MB]. We note that the criteria would still require that all people accessing these medicines have an HbA1c test, and to have tried at least one other medication for type 2 diabetes for at least 3 months.
Health equity – PHARMAC processes
A number of responders considered that equity members should be added to PHARMAC’s clinical advisory groups, and that PHARMAC should review its process for equity in funding decisions	We are working to enhance PHARMAC’s equity capabilities, including our processes related to funding decisions and when seeking clinical advice. Some of the feedback received will be valuable not only in informing the decision on this proposal, but in informing our ongoing work in this area.
A number of responders noted the importance of monitoring uptake by ethnicity and region, using a clear and strong equity framework	PHARMAC staff intend to actively monitor and evaluate uptake of these medicines with a view to identifying opportunities to enhance medicines access equity. We plan to report on this monitoring as part of our medicines access equity work, and specifically to support the ongoing implementation of these new medicines. We intend to work with the sector, including Māori health experts, to design our approach to this work and analysis of the results. This work is likely to be complex, and may not be available in its final form at the first date of funding.
Implementation
The majority of responders considered that it would be important to educate prescribers, including in primary care about the availability and appropriate use of the new medicines	PHARMAC staff acknowledge the need for education for healthcare professionals to support the use of these treatments. PHARMAC staff are aware that the type 2 diabetes guidelines are currently being updated by New Zealand Society for the Study of Diabetes (NZSSD) and the Ministry of Health and we consider that these will help provide clear guidance of the place of these medicines in treatments. PHARMAC’s responsible use service provider, He Ako Hiringa,(external link) is focused on developing tools and resources to support the use of these, and other, treatments for type 2 diabetes and has already begun delivering these. These resources will have a major focus on promoting equity of access to these, and other, treatments.
A number of responders considered that PHARMAC should partner with Māori experts and other expert groups to develop and implement a pro-active plan to support equitable prescribing	PHARMAC welcomes the opportunity to engage with experts to help support equitable prescribing of and access to these treatments. PHARMAC has committed to strong working relationships with Māori as part of its commitment to upholding Te Tiriti or Waitangi as set out in Te Rautaki o Te Whaioranga – Māori Responsiveness strategy. PHARMAC’s Implementation and Access Equity programmes will continue to look for opportunities to undertake work to support equitable access to funded treatments in key health areas.
A number of respondents suggested that proactive identification and recall of eligible patients using clinical practice tools and systems will enhance access	We intend to encourage healthcare professionals to proactively identify their patients who would benefit most from treatment, as part of our implementation support activities. We are aware of the development of a tool to support PHOs to identify their patients who would benefit from treatment with an SGLT-2 inhibitor. This is being developed by the supplier PHARMAC staff plan to actively monitor the uptake of these treatments and share outcomes by ethnicity and DHB region.
A number of groups suggested that patient-facing resources and support, specifically be designed for and co-developed by Pacific, South Asian and Māori (including in language) to help uptake and adherence	PHARMAC staff will work with the suppliers of these treatments to help ensure that meaningful patient information is co-created with the people who would be eligible for funded access to these treatments.
Sector costs
One responder noted that there would be a cost to the sector to educate people on self-administration of dulaglutide	PHARMAC has considered costs and savings to the sector as a result of this proposal, including the cost of initiating injectable treatments. We consider that the proposal overall represents a good investment of DHB funds.
Request for funding of other pharmaceuticals
Two responders made a request to also fund CGM/Freestyle Libre for T1DM	The scope of the RFP was for SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors. We are considering applications for the funding of blood glucose monitoring technologies, including for type 1 diabetes. Progress of these funding applications can be noted via our Application tracker: Freestyle Libre(external link) Continuous Glucose Monitors(external link)
Two responders made a request to fund extended release metformin	Extended-release metformin was not within scope of the RFP. PHARMAC has received advice that this would be a suitable option for people with type 2 diabetes, and we have included this medicine in our 2020/21 annual invitation to tender.
One responder called to reduce funding for, what they considered to be, less effective medicines (e.g., other type 2 diabetes medicines, including vildagliptin), and to restrict access to insulin in order to enable open access to SGLT-2 inhibitor and GLP-1 agonist	A change to the funding arrangements for other medicines on the Pharmaceutical Schedule is not in the scope of this proposal. We seek regular advice from our clinical advisors on ongoing maintenance of the listings in the Schedule.
One responder requested to include pre-diabetes in the scope of the Special Authority criteria	We have not received an application for the funding of a SGLT-2 inhibitor or a GLP-1 agonist for the treatment of pre-diabetes. We would welcome a funding application for the use of one or more of these medicines in the treatment of pre-diabetes.
Some responders requested to include heart failure without diabetes in the scope of the Special Authority criteria	We have not received an application for the funding of a SGLT-2 inhibitor or a GLP-1 agonist for the treatment of heart failure without diabetes. We would welcome a funding application for the use of one or more of these medicines in the treatment of heart failure without diabetes.
One responder requested that a second SGLT-2 inhibitor be funded	The RFP sought proposals for the sole supply of a SGLT-2 inhibitor. Therefore, the funding of a second SGLT-2 inhibitor will not be possible until after the end of the sole supply period.
One responder suggested funding of medicine adherence/persistence support technology (e.g., apps) alongside the medicines for type 2 diabetes	PHARMAC staff are supportive of implementation activities that will support medicines access equity, including medicine adherence and persistence. The funding of technologies to support medicine adherence and persistence is currently considered to be outside of the scope of CPB.
Sector change requests
A number of respondents called for overall sector-wide improvement in quality of care for Māori and Pacific and other people experiencing inequitable outcomes from type 2 diabetes	PHARMAC acknowledges that significant health inequities exist in Aotearoa New Zealand, that these are unacceptable, We have shared this feedback with the Ministry of Health and we will continue to work with our sector partners to enhance PHARMAC’s equity capabilities.
A number of responders recommended nurse prescribers be able to prescribe and apply for Special Authority	The Special Authority criteria allow any relevant practitioner, which includes nurse practitioners and pharmacist prescribers, to apply for a Special Authority for these medicines. The ability of additional health care professional types to apply for Special Authorities is managed by the Ministry of Health, and we have shared this feedback with them.
A number of responders called for subsidy of these medicines (interpreted as removing the patient co-payment), and/or for visits with prescribers and other relevant health care professionals	The policies for co-payment and patient charges for health care professional visits and dispensing of pharmaceuticals sit with the Ministry of Health, and we have shared this feedback with them.

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 660 050.

[1] Chan WC, Lee M (AW), Papaconstantinou D. Understanding the heterogeneity of the diabetes population in Metro Auckland in 2018(external link). Auckland: Counties Manukau Health, 2020. ff

Chan WC, Papaconstantinou D. The need for better focus on primary and secondary prevention of cardiovascular disease(external link). Auckland: Counties Manukau Health, 2020. pp 3, 15-17.