Proposal to fund two new medicines for type 2 diabetes
What we’re proposing
PHARMAC is seeking feedback on a proposal to fund two new treatments for type 2 diabetes and amend the contractual terms for one currently funded diabetes treatment through provisional agreements with three suppliers.
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 firstname.lastname@example.org
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: email@example.com 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.
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.
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.
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.
A New Zealand datasheet would be available following any Medsafe approval.
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: