Proposal to fund two new medicines for type 2 diabetes

What we’re proposing

In summary, this proposal would result in the funding of two new medicines for type 2 diabetes:

• empagliflozin (Jardiance) and empagliflozin with metformin (Jardiamet) supplied by Boehringer Ingelheim, with funding to start from 1 December 2020;
• dulaglutide (Trulicity) supplied by Eli Lilly, with funding to start as soon as practicable following Medsafe approval.

The funding of both treatments would be restricted to people with type 2 diabetes who are at high risk of heart and kidney complications.

This proposal also includes amendments to the price and contractual arrangements with Novartis for vildagliptin (Galvus) and vildagliptin with metformin (Galvumet) from 1 December 2020. These treatments are already, and would continue to be, funded without restrictions.

Further details on this proposal, including how to provide feedback, can be found below.

Consultation closes at 4pm Friday 2 October 2020 and feedback can be emailed to consult@pharmac.govt.nz

To provide feedback

Consultation is a very important step in our process. When providing your consultation feedback you might want to think about the following questions. These are just a guide, to prompt your thinking.

• Do you support this proposal?
• What will help people with diabetes and their whānau access these medicines?
• What tools or approaches could be useful to support prescribers and people with diabetes?
• How could we specifically support Māori and Pacific people to access these medicines?

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Send us an email:  consult@pharmac.govt.nz  by 4pm Friday 2 October 2020.

What would the effect be?

Empagliflozin with and without metformin (Jardiance and Jardiamet) and dulaglutide (Trulicity) would be funded for the treatment of people with type 2 diabetes at high risk of heart and kidney complications who meet the proposed eligibility criteria (called Special Authority criteria).  People taking empagliflozin with or without metformin would not be eligible to take dulaglutide at the same time and vice versa.

Empagliflozin with and without metformin would be funded from 1 December 2020.

Dulaglutide does not currently have Medsafe approval. Funding would occur as soon as practicable following Medsafe approval.

Vildagliptin with and without metformin (Galvus and Galvumet) would continue to be funded without restrictions. Both the list and net price for these medicines would be reduced.

This proposal would mean that people who are at high risk of heart and kidney complications from type 2 diabetes would have access to two additional funded treatment options, from the SGLT-2 inhibitor and GLP-1 agonist treatment classes (see below for more information on these treatments).

Our clinical advice is that these new treatments provide benefits for people with type 2 diabetes beyond glycaemic control. For empagliflozin, this includes reduced rates of heart failure hospitalisation, all-cause death, progression to macroalbuminuria and initiation of renal replacement therapy in comparison to standard care. For dulaglutide, benefits include a reduction in the rate of major cardiovascular events (including death), and progression to macroalbuminuria.

We estimate that around 50,000 people per year would be eligible for treatment under the proposed Special Authority criteria for these agents.

Our clinical advice has indicated that these medicines would be used in addition to the currently funded medicines for type 2 diabetes, rather than replacing them. Dulaglutide is self-administered by weekly injection (using a pre-filled pen device) so may be associated with an increase in health system requirements for patient education and training.

Who we think will be interested

• People with type 2 diabetes and their whānau
• Organisations with an interest in diabetes treatment
• General practitioners, endocrinologists, diabetes specialists, diabetes nurses, and other health professionals involved in the management of type 2 diabetes
• Community and hospital pharmacists
• Pharmaceutical suppliers

About type 2 diabetes

Type 2 diabetes is a disease where the body can’t control blood sugar levels properly, either because cells have become insulin resistant or the body doesn’t produce enough insulin. Type 2 diabetes usually develops in adults, but it is becoming more common in children.

Uncontrolled diabetes has several serious long-term consequences. These include microvascular complications (including kidney, nerve and eye problems) and macrovascular complications (including heart disease, stroke and peripheral vascular disease). The risk of developing diabetes complications generally increases with time since diabetes onset, but is reduced with good blood pressure, blood glucose and blood cholesterol control. There are certain factors that can predict a person’s risk of developing diabetes complications.

Diabetes and its complications have a significant impact on quality of life. The primary burden of diabetes is experienced in working-age adults (aged 20-60 years of age) which may influence their ability to work and engage in society in the same way as they would if they did not have diabetes.

In New Zealand, it is estimated that the number of people living with a diagnosis of diabetes exceeds 250,000 people (predominantly type 2 diabetes). Within the New Zealand population, the prevalence of diabetes in Māori and Pacific populations is estimated to be around three times higher than among other New Zealanders. Prevalence is also high among South Asian populations. The occurrence and rate of progression of diabetes complications are notably higher in these high-risk populations.

You can read more about diabetes, including type 2 diabetes, on the Ministry of Health website(external link).

About empagliflozin

Empagliflozin belongs to a class of medicines called sodium glucose co-transporter 2 (SGLT-2) inhibitors. These medicines limit the absorption of glucose in the kidneys, increasing the amount of glucose that is removed from the body in the urine and therefore reducing the amount of glucose present in the blood. Use of SGLT-2 inhibitors is most effective for people with an adequate degree of kidney function. The likelihood of genital and urinary tract infections is increased with the use of SGLT-2 inhibitors. Certain medicines in this class, including empagliflozin, have also been shown to improve heart and kidney outcomes in people with type 2 diabetes who are at high risk of these complications.

Empagliflozin with or without metformin is a tablet generally taken once or twice daily. For people who are already taking metformin this could mean a reduction in the number of tablets that need to be taken each day.

Further information about empagliflozin can be found in the Medsafe datasheets for Jardiance and Jardiamet.

• Medsafe datasheet for Jardiance(external link)
• Medsafe datasheet for Jardiamet(external link)

About dulaglutide

Dulaglutide belongs to a class of medicines called glucagon-like peptide-1 receptor (GLP-1) agonists. These medicines work by increasing the release of insulin and reducing the release of glucagon from the pancreas. GLP-1 agonists can slow digestion and reduce appetite. GLP-1 agonists are associated with gastrointestinal side-effects including diarrhoea, nausea and vomiting. Certain medicines in this class, including dulaglutide, have been shown to improve cardiovascular and kidney outcomes in people with type 2 diabetes who are at high risk of these complications.

Dulaglutide is a prefilled-syringe device and is generally given as a once weekly injection. The injection is packaged in a pre-filled pen device that is designed to be self-administered, without the assistance of a health professional.

Dulaglutide does not currently have Medsafe approval. Funding is proposed as soon as practicable following Medsafe approval.

Indicative information about dulaglutide can be found in the Australian TGA approved product information for Trulicity(external link).

A New Zealand datasheet would be available following any Medsafe approval.

About vildagliptin

Vildagliptin belongs to a class of medicines called dipeptidyl peptidase-4 (DPP-4) inhibitors. These medicines work by increasing the release of insulin and reducing the release of glucagon from the pancreas. In addition, DPP-4 inhibitors prevent the production of glucose by the liver when it is not needed. Medicines in this class have been shown to be as good as other funded diabetes medicines with respect to cardiovascular outcomes.

Vildagliptin with and without metformin is currently funded in New Zealand without restrictions. It comes as a tablet and is generally taken once or twice daily.

Information about vildagliptin dosing and administration can be found in the Medsafe datasheets:

• Galvus(external link)
• Galvumet(external link)

Why we’re proposing this

Our clinical advisors have told us that recent evidence shows that agents from the SGLT-2 inhibitor and GLP-1 agonist classes can provide benefits for people with type 2 diabetes beyond glycaemic control.

Our main clinical advisory committee, the Pharmacology and Therapeutics Advisory Committee (PTAC), has considered medicines from the SGLT-2 inhibitor and GLP-1 agonist classes on a number of occasions and has recommended that at least one agent from each class be funded with a high priority.

The Diabetes and Cardiovascular Subcommittees of PTAC have recommended that both an SGLT-2 inhibitor and a GLP-1 agonist be funded for the improvement of cardiovascular outcomes in people with type 2 diabetes with established cardiovascular disease subject to Special Authority criteria.

The Diabetes Subcommittee has considered that the current data for improved cardiovascular outcomes from antidiabetic agents is strongest for established cardiovascular risk populations and those with renal disease. We asked the Diabetes, Cardiovascular and Nephrology Subcommittees of PTAC for advice on Special Authority criteria that would enable these medicines to be used by these people who have the highest need and greatest potential for benefit. The proposed Special Authority criteria are based on this advice.

You can read more about these medicines, including the clinical advice we’ve received, via the links on our application tracker:

• SGLT-2 inhibitors (eg empagliflozin)(external link)
• GLP-1 agonists (eg dulaglutide)(external link)

On 15 January 2020, PHARMAC released a Request for Proposals (RFP) for the supply of diabetes medicines (SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors).

The RFP allowed proposals for medicines that were not approved by Medsafe, on the condition that PHARMAC would require that Medsafe approval would be sought and the product would be approved by Medsafe before funding would start.

As a result of the proposals received in response to this RFP, PHARMAC is proposing to list two new medicines on the Pharmaceutical Schedule with Special Authority restrictions and Hospital Indication restrictions, and amend the contractual terms of an existing funded medicine. This proposal is in line with the recommendations from our clinical advisors.

Details about our proposal

Empagliflozin (with and without metformin)

Empagliflozin (Jardiance) and empagliflozin with metformin hydrochloride (Jardiamet) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2020 at the following price and subsidy (ex-manufacturer, excluding GST):

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

Jardiance and Jardiamet would be the sole subsidised brands of a 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) would be listed in Section B of the Pharmaceutical Schedule subject to the following proposed Special Authority criteria:

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

PHARMAC would support the implementation and monitor the uptake of empagliflozin (with and without metformin) to see whether the medicines are being accessed by those people with highest need (for example Māori and Pacific). We would seek clinical advice on whether the equity of access could be improved over time, and how PHARMAC could support this.

Dulaglutide

Dulaglutide (Trulicity) would 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):

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

PHARMAC would support the implementation and monitor the uptake of dulaglutide to see whether the medicines are being accessed by those people with highest need (for example Māori and Pacific). We would seek clinical advice on whether the equity of access could be improved over time, and how PHARMAC could support this.

Vildagliptin (with and without metformin)

The price and subsidy for vildagliptin (Galvus) and vildagliptin with metformin hydrochloride (Galvumet) would be reduced in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 December 2020 as follows (ex-manufacturer, excluding GST):

An amended confidential rebate would apply to Galvus and Galvumet that would reduce the net price to DHBs.

Galvus and Galvumet would be the sole subsidised brands of a DPP-4 inhibitor for new patients starting a DPP-4 inhibitor for the treatment of type 2 diabetes until at least 30 June 2024, which could be extended by mutual consent between PHARMAC and Novartis until 30 June 2025 and/or 30 June 2026. Note that the proposed pricing would apply to all patients taking vildagliptin (with or without metformin), not just new patients.

There are currently no restrictions on the funding of vildagliptin (with and without metformin) and no change to this is proposed.

Giving feedback

Consultation closes at 4pm Friday 2 October 2020.  

Email your submission to: consult@pharmac.govt.nz