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Mounjaro Kwikpen approved by MHRA for treating type 2 diabetes

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The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a multi-dose version of Mounjaro (tirzepatide) called Mounjaro Kwikpen to treat people with type 2 diabetes. 

The Mounjaro Kwikpen will deliver four doses of tirzepatide instead of the one-dose Mounjaro pen which is already approved, which the MHRA says will support supply of Mounjaro. 

The National Institute for Health and Care Excellence (NICE) approved Mounjaro in October 2023 for treating type 2 diabetes on the NHS in England and Wales, and we await more details on when supplies will become available.

What is Mounjaro? 

Tirzepatide, brand name Mounjaro, is a GLP-1 analogue that is combined with a GIP analogue (short for glucose-dependent insulinotropic polypeptide). It is manufactured by pharmaceutical company Eli Lilly.  

Tirzepatide is administered through once-weekly injections. It works by activating both GLP-1 and GIP receptors to increase the level of incretins in the body. These incretin hormones increase the production of insulin in the body and decrease the glucose produced by the liver, lowering blood glucose. 

Research into the use of tirzepatide to treat type 2 diabetes found it led to greater improvements in blood glucose management and weight loss when compared to other type 2 diabetes medications.  

What will Mounjaro (tirzepatide) be used for? 

NICE has recommended tirzepatide to be used as an alternative to other GLP-1s to treat adults living with type 2 diabetes, along with diet and exercise, if they have a BMI of 35kg/m2 or more and have additional psychological or medical complications. 

It could also be prescribed to people living with type 2 diabetes who have a BMI below 35kg/m2 where using insulin would affect their occupation due to the risk of hypoglycemia, or for those who would see improvements in other obesity-related health issues with weight loss.  

This means that tirzepatide will be available through your healthcare team who would assess whether this is the best treatment for you.

When will Mounjaro be available in the UK? 

Tirzepatide has been approved for use within England and Wales. Normally the NHS has three months to prepare for a medication to be prescribed in line with NICE recommendations, which were made in October 2023.  

In the case of tirzepatide there was a need to get MHRA approval for a novel delivery method – the Mounjaro Kwikpen - before it could be launched.  This has now been approved and so we hope that Eli Lilly will launch the drug in the coming weeks. 

We anticipate that it will be made available for use within Northern Ireland in line with NICE recommendations, subject to necessary approvals. The Scottish Medicines Consortium (SMC) is responsible for approving drugs for use on the NHS in Scotland.

The SMC is currently reviewing tirzepatide, but we are awaiting confirmation of a timeline for the SMC’s advice on tirzepatide for treatment of type 2 diabetes and for treatment of obesity.

What is the Mounjaro Kwikpen? 

The Mounjaro Kwikpen has been approved by the MHRA to treat people living with type 2 diabetes as a four-dose pre-filled injection pen to be injected as a starting dose of 2.5mg once a week for four weeks.  

The pen has also been approved by the MHRA for weight management in people living with obesity or overweight who have weight-related health problems, high blood pressure, high cholesterol or heart problems. 

Though Mounjaro is currently authorised by the MHRA for weight loss, and the Kwikpen is authorised for this application, Mounjaro is yet to receive complete appraisal by NICE for weight loss.   

A NICE appraisal for Mounjaro to be used for treating overweight and obesity in the NHS is scheduled to be concluded in March 2024, when we would expect recommendations to be published. 

Douglas Twenefour, Head of Care at Diabetes UK, said:

“We hope the MHRA’s approval of this device will help people living with type 2 diabetes, who are eligible, to access this effective treatment.     

“Supporting people with type 2 diabetes to lose weight and manage their blood sugar levels is key to reducing the risk of diabetes-related complications, and tirzepatide (Mounjaro) expands the range of treatment options available to help people achieve this.” 

How will this affect GLP-1 RA supply issues? 

We are seriously concerned about the ongoing shortages of GLP-1 medications which are having serious implications for many people with type 2 diabetes.   

It is currently unclear what implications the approval of tirzepatide and the Kwikpen will have on the shortages. We are continuing to speak with the Department of Health and Social Care about the need for this issue to resolved as a matter of urgency.    

We welcomed the government’s guidance to restrict off-label prescriptions of GLP-1 medications while there is an ongoing shortage impacting people with type 2 diabetes, and the new National Patient Safety Alert issued in January that permitted people to be initiated onto Rybelsus due to an uplift in supply of that medication.  

However, we anticipate new guidance would need to be issued to ensure that tirzepatide can be prescribed to people with type 2 diabetes who meet the criteria.    

Does tirzepatide have side effects? 

Like all medications, tirzepatide can have side effects. Common side effects of tirzepatide can include feeling sick, indigestion, constipation and diarrhoea, while less common side effects include pancreatitis and gallstones. 

Before starting treatment with tirzepatide, it is important to take individual advice from your healthcare team. You should report any side effects, if you experience any, while taking the medication.  

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