Proposal to fund pancreatic enzymes modified-release granules (Creon Micro)
2 April 2020
A decision has been made
What we’re proposing
We are seeking feedback on a proposal to fund a new modified-release granule formulation of pancreatic enzymes (Creon Micro), which is used for the treatment of pancreatic enzyme insufficiency, from 1 June 2020 through a provisional agreement with Mylan New Zealand Limited (Mylan).
Further details on this proposal, including how to provide feedback, can be found below.
Consultation closes at 5pm Thursday 30 April 2020 and feedback can be emailed to firstname.lastname@example.org.
What would the effect be?
From 1 June 2020, people who have pancreatic insufficiency would have funded access to a new modified-release granule formulation of pancreatic enzymes, Creon Micro. This would mean that people who require small doses would have access to a funded product.
Currently, PHARMAC funds capsule formulations of pancreatic enzymes. However, we are aware that some patients, in particular paediatric patients with cystic fibrosis, require smaller doses than contained in the funded capsules. We understand that carers currently empty capsules into a measure of food puree and then divide the puree into a half or quarter portion depending on the dose required. The remainder is then discarded.
Creon Micro is a granule formulation that can be measured with a scoop. This means that small amounts of enzymes, i.e. smaller than the amount contained in the capsules, can be measured prior to mixing with food or fluids. We estimate that approximately 60 people could benefit in the first year of Creon Micro being funded, increasing to 95 people per year over time.
Who we think will be interested
- Paediatric patients and their whānau
- Paediatricians, respiratory physicians, gastroenterologists, respiratory nurses, pharmacists and other clinicians and health professionals involved in the management of cystic fibrosis
- Pharmaceutical suppliers
About pancreatic enzyme insufficiency and pancreatic enzymes
People with pancreatic enzyme insufficiency do not have enough pancreatic enzymes, resulting in the inability to digest food properly (maldigestion). Common causes include cystic fibrosis and chronic pancreatitis. The major consequences of pancreatic insufficiency are due to fat malabsorption and can result in diarrhoea, bloating and weight loss/the inability to put on weight.
Pancreatic insufficiency is the most common gastrointestinal complication of cystic fibrosis, affecting approximately 85 percent of patients at some time in their lives. Cystic fibrosis is a genetic condition that affects the lungs, digestive system and other organs. It is usually diagnosed soon after birth. There are over 500 children and adults living with cystic fibrosis in New Zealand.
In cystic fibrosis, mucus blocks the passageways of the pancreas and prevents pancreatic digestive secretions from entering the intestines. Without these digestive secretions, the intestines can't absorb fats and proteins completely, so nutrients pass out of the body unused rather than helping the body grow.
Pancreatic enzyme supplements contain a mixture of enzymes that are used to digest food by helping to break down fats, proteins and carbohydrates for use within the body. As noted above, PHARMAC currently funds a capsule form of pancreatic enzymes.
Modified-release pancreatic enzyme granules (Creon Micro) is a granule formulation taken with every meal (or feed if the patient is being breast-fed) by mixing with fluids or food. The number of required scoops per meal is based on bodyweight. One scoop (= 100 mg) is equivalent to Pancreatic Extract (Pancreatin) 60.12 mg (5,000 Ph. Eur. units of lipase, 3,600 Ph. Eur. units of amylase and 200 Ph. Eur. units of protease). Once opened, Creon Micro can be stored for three months, at or below 25˚C.
Why we’re proposing this
A funding application for modified-release pancreatic enzyme granules (Creon Micro) was reviewed by the Gastrointestinal Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) in April 2017 and recommended for funding with a high priority. This recommendation was accepted by PTAC in November 2017.
More information, including links to the Subcommittee minutes, can be found in the Application Tracker record for pancreatic enzymes, paediatric formulation (Creon Micro) for paediatrics patients with cystic fibrosis. (external link)
PHARMAC has reached a provisional agreement with the supplier, Mylan, to fund Creon Micro.
Details about our proposal
Pancreatic enzymes modified-release granules (Creon Micro) would be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 June 2020 at the following price and subsidy (ex-manufacturer, excluding GST):
Proposed price and subsidy
Modified release granules pancreatin 60.12 mg (amylase 3,600 Ph Eur U, lipase 5,000 Ph Eur U, protease 200 Ph Eur U)
There would be no restrictions to access for Creon Micro.
To provide feedback
Send us an email: email@example.com by 5pm Thursday 30 April 2020.
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.
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.
Last updated: 28 May 2020