Supporting the

Neuroendocrine Cancer Community

Neuroendocrine Cancer UK: PERT UPDATE 30th May 2024

May 31, 2024

As you may be aware, over the last few months, we at Neuroendocrine Cancer UK, have been working with charity partners to address the urgent need to resolve the persistent shortage of PERT (Pancreatic Enzyme Replacement Therapy) medications: Creon®, Nutrizym® 22 and Pancrex V®

You may have seen, read or heard, media reports in local or national media about drug shortages including PERT.

We have been in discussion with charity colleagues, the Department of Health & Social Care (DHSC), the National Medicines Supply Team and Creon’s UK Supplier, Viatris, about the problems people are facing in accessing this essential medication.

Together, with charity colleagues, we have been pushing for prioritisation to address these shortages: calling for a proactive, long-term, plan that can ensure a sustainable and equitable supply for those that rely on PERT.

We would like to thank those of you who have taken the time to complete our PERT survey – the responses, we have so far received, reflect the concerns we have raised about the impact these shortages are having on people with neuroendocrine cancer – and support the demand for a sustainable resolution to current issues

We know how important PERT is for controlling symptoms, maintaining people’s quality of life and safeguarding their ability to undergo anti-cancer therapies.

We are also very aware of the distress and anxiety this ongoing situation has caused – but hope the following information provides an explanation and also reassurance that the use of alternative suppliers for PERT has now been authorised.

If you or a loved one are having difficulties with PERT, please get in touch if you need support. Our helpline team are here to help: 0800 434 6476 – available Tues-Thurs 10am-4pm or use our Contact Us form and we can arrange to call you.

Neuroendocrine Cancer and PERT

Pancreatic enzyme insufficiency (PEI), with or without Type III diabetes, can affect all types of neuroendocrine cancer – not just those with a pancreatic primary (or secondary)

Neuroendocrine cancer and/or its treatment, e.g., somatostatin analogues, can affect the body’s ability to properly digest food and maintain stable blood sugars. Without proper digestion – including sufficient pancreatic function – essential nutrients cannot be absorbed.

Taking PERT supports food absorption and digestion: helping people to maintain a healthy weight, regulate and ‘normalise’ bowel motions, alleviate gut symptoms, regulate blood sugars and be well enough to tolerate anti-cancer interventions and treatments.

Therefore, PERT (for treating PEI), is a vital part of effective and holistic, patient-centred, neuroendocrine cancer care.

So, what is the issue with supply?

There are a number of contributing factors – that are now being addressed:

According to the DHSC: “The supply disruption of Creon® capsules is due to limited availability of active pharmaceutical ingredients and manufacturing constraints to produce the volumes required to meet demand.”

1“Active pharmaceutical ingredients” – in other words source materials:

Pancreatic enzyme replacement medications are made from enzymes extracted from pig pancreas glands and there is currently no alternative to using pork products.

It is important to note that, for those who may have a religious objection to the ingestion of pork products, special dispensation to allow these products has been granted by religious organisations as they are a medicine.

In Europe and the UK, we have been told, there is an increasing demand for leaner meat – this means leaner pigs – which in turn reduces the volume of enzymes that can be extracted from each pig pancreatic gland. In essence, we need more pigs to be able to maintain the amount of enzymes needed to produce current demand for PERT.

We have also been informed, that while there are currently enough pigs to fulfil this need, a bigger production plant is needed to manage enzyme extraction.

2manufacturing constraints”:

If more pigs are needed there is also a consequent need for a larger facility to be able to produce PERT. But expanding a production site takes time. Plans are underway to expand the current facility – due completion in 2026.

Viatris have assured us that until then they can provide at least 90-95% of current demand: which is ~150,000 packs of Creon® 25,000iu / month: re-increasing production once expansion work has been completed.

3 Suppliers:

As with other countries in Europe, the UK has only had one licensed supplier of Creon®. However, the DHSC issued a Patient Safety Notice (29th May) authorising the use of unlicensed imports of Creon® capsules and alternative brands of PERT (n.b. delivery times may vary – so prescription filling time may take longer than usual – advice is to hand in your prescription at least 2 weeks before you are likely to need more PERT)..

The license refers to importing arrangements – all named products through this access are deemed safe and have FDA approval.

4 Prescribers information and awareness of alternatives:

Information has been sent to all prescribers, healthcare providers and pharmacies – and has also been shared by Community Pharmacy England – this is open access information – available here

But what of the alternatives to Creon® e.g., Nutrizym® 22 and Pancrex V®?

In terms of the current alternatives to Creon®, (Nutrizym® 22 and Pancrex V®), they have only had a very small share of the market for PERT (less than 10%), and we have heard that they have no capacity to expand production.

  • Nutrizym® 22 capsules are out of stock until mid-August 2024. The supply disruption for Nutrizym® 22 capsules has been caused by a manufacturing issue alongside an increased demand – because of the Creon® shortages over the last 6 months. Arrangements are in place to prioritise supply to those who cannot take Creon®.
  • Pancrex V® capsules and powder remain currently available but are unable to support an increase in demand.

However, as stated above, alternative suppliers have now been authorised.

We will keep monitoring the situation – and provide updates as and when verifiable information is available.

But, in the meantime, if you or a loved one are having difficulties with PERT, please do get in touch, if you need support.

Our helpline team are here to help: 0800 434 6476 – available Tues-Thurs 10am-4pm or use our Contact Us form and we can arrange to call you or provide information by email reply – depending on your preference.