What’s the impact of the upcoming insulin discontinuations?

Novo Nordisk has announced the discontinuation of earlier generation insulin products over a 2-year period, which will leave many patients struggling to adjust to new medicine strengths and devices.

The product discontinuations include:

• October 2024: Mixtard 30 Penfill (insulin human/isophane [NPH] insulin human 30/70)
• December 2024: Fiasp vials (fast acting insulin aspart)
• February 2025: Ryzodeg FlexTouch (insulin degludec + insulin aspart 70/30)
• February 2025: Protaphane InnoLet (isophane [NP]) insulin human)
• June 2025: Fiasp FlexTouch (fast acting insulin aspart)
• December 2026: Protaphane Penfill (isophane [NPH] insulin human)
• December 2026: Levemir FlexPen & Penfill (insulin detemir) 
• December 2026: Actrapid Penfill (human insulin)
• December 2026: NovoFine Autocover.

Adelaide-based credentialled diabetes educator and accredited clinical pharmacist Cindy Tolba MPS said many of her clinic’s patients still use Mixtard 30/70, which was discontinued yesterday (1 October).

‘No other product presentation for Mixtard 30/70 will be available,’ she said.

What is Novo Nordisk’s position?

The number of people living with chronic diseases has continued to grow. To manage growing patient demand, a Novo Nordisk spokesperson told Australian Pharmacist that some of the manufacturer’s earlier generation insulin products, including those with multiple presentations – will be phased out.

‘We recognise the impact these decisions will have on patients today. That is why the consolidation will occur over the next two years,’ said the spokesperson. 

‘We are working with health authorities and the medical community to help patients transition to alternative options for continuity of care.

‘Novo Nordisk will also continue to work towards bringing new innovations into the market as treatment options for patients living with diabetes.’

‘Now in the clinic, we are in the process of going through a recall to try and get those patients in to transfer them over to a different insulin,’ she said.

There is also a risk of supply shortages of remaining insulin products as patients transition to different strengths and devices.

‘[For example], the impending discontinuation of the flex pens will put stress on the supply of non-disposable pen devices known as NovoPen 6 (or older versions) and cartridges,’ added Ms Tolba.

Who will be affected?

With nine insulin products being discontinued, patients from several different demographics will be impacted.

‘Some prescribers still prescribe Mixtard 30/70, particularly to patients in older generations,’ said Ms Tolba.

‘Many of them also still use the InnoLet device due to dexterity issues, so if the insulin product  and device are [both] discontinued, prescribers will have to look at something else to assist people with dexterity issues.’ 

Women with gestational diabetes – in some clinics started on Protaphane Penfill or Actrapid Penfill – will also be affected by the discontinuations. They will likely be placed under more stress with using a 1 ml syringe to extract the insulin through a vial or swapped over to the newer generation insulin, explained Ms Tolba.

It can be particularly difficult to source different medicines for women in pregnancy due to a lack of clinical trial data.

‘What they usually try is either Metformin, long-acting insulin or a basal-bolus [regimen],’ she said. ‘[But] it’s not really advisable for anything else to be trialled at this stage.’ 

Another demographic who will be impacted is people who are on steroids.

‘If a person has been treated with steroids for a period of time, the insulin choice is normally Protaphane, which has the best profile to mimic the rise of blood sugar levels with a steroid,’ said Ms Tolba.

This patient subtype is typically those with chronic obstructive pulmonary disease, on cancer treatment or who have an autoimmune condition and require treatment using disease modifying drugs – who require long-term steroids and also have diabetes.

Meanwhile, the discontinuation of Levemir over a 2-year period could impact patients with type 1 diabetes.

What can pharmacists do?

To ensure patients with diabetes have continued access to treatment, it’s important to begin  working on contingency plans.

‘The recall we’re doing for Mixtard 30/70 [includes] swapping patients over to either NovoMix 30 FlexPen or Ryzodeg 70/30 [penfill] – depending on their current dosage of a Mixtard,’ said Ms Tolba. ‘Then the dose adjustment will need to be looked at for the new insulins.

Despite one of Ms Tolba’s elderly patients having significant supplies of Mixtard, she has liaised with their GP to develop a transition plan.

‘The patient’s Mixtard dosage was 65 units, so when we swap it over to Ryzodeg 70/30 [penfill] – we’re not going to do dose for dose, but rather reduce it by approximately 20% and adjust the time of dodge to improve his glycemic profile.’

The plan for the patient is to split the dose into two, 20 units in the morning with breakfast and 30 units in the evening with dinner – as opposed to one dose in the evening.

This approach was designed to mitigate the risk of hypoglycaemia – which can increase in patents on a high dosage of insulin when switching to a new strength.

It’s crucial to ensure patients understand how to use the pen by reinforcing the gold standard injection technique and making sure they are self-monitoring their blood glucose levels.

‘We wanted to ensure the patient didn’t have any dexterity issues, so I had some demo devices to establish the correct use and safeguard against issues pressing the plunger,’ said Ms Tolba.

For patients whose injection burden will increase, Ms Tolba suggests advising them to rotate injection sites to prevent lipohypertrophy.

Because Protaphane will be discontinued in February 2025, Ms Tolba recommends pharmacists flag the issue with patients when they present with a script for the medicine, and suggest they discuss alternatives with their GP.

‘That’s really important, because it does take time to adjust and to tweak their insulin and ensure they are not exhibiting severe excursions in their blood glucose levels,’ she said.

For patients on long-term steroids, the best option is a basal-bolus regimen or pre-mixed insulin – appropriately timing the dose.

‘If a steroid is taken in the morning, the [concentration] rises at around lunchtime and [remains] until mid afternoon,’ said Ms Tolba. ‘So if a premix was taken at around 12.00 pm, the rapid-acting component will help with that peak, and the long-acting component will help with the tail end.’

For credentialed pharmacists providing home medicine reviews to patients with type 1 or type 2 diabetes who are using an insulin product on the discontinuation list, Ms Tolba suggests:

• advising patients that the medicine will be discontinued
• providing them with a timeframe until discontinuation
• checking patients’ stock levels
• ensuring the patient books in with their GP to discuss alternatives.

‘While in the patient’s house, pharmacists should check their dexterity and if they have any issues holding holding non-disposable insulin pens (e.g. Novopen 4 or 6 ), , if they’re able to put any cartridges in the pen, as well as twist it – because some people with arthritis find this very difficult,’ she added.

When patients change to different insulin strengths or devices, it’s also important to discuss maintaining the integrity of the insulin, said Ms Tolba.

This includes checking the consistency has not changed and that it is stored in the fridge – which is particularly important as holiday season approaches.

What about pets?

While Ms Tolba – who has received insulin scripts for cats, dogs and even a horse – said most of her pet clients are on a basal bolus regimen, patients of the furry kind who are prescribed Actrapid will also be impacted by the insulin discontinuations.

If pet parents present with a script for Actrapid, she suggests flagging the pending discontinuation and notifying the veterinary prescriber.

Is there any advice for patients using insulin pumps?

Those who use insulin pumps with Fiasp 10 mL vials should transition to a 3 mL Fiasp penfilled device – removing the insulin with a 1 mL syringe.

‘If people are already using the vials and prefilled devices interchangeably, they should be comfortable [transitioning],’ Ms Tolba added.