CREON (pancréatine)

Enzyme therapy

Opinions on drugs - Posted on Mar 18 2020

Reason for request

First assessment

Key points

Favourable opinion for reimbursement in pancreatic enzyme replacement therapy in exocrine pancreatic insufficiency associated with cystic fibrosis and other diseases (for example, chronic pancreatitis, pancreatectomy or pancreatic cancer).

What therapeutic improvement?

No clinical added value compared to other CREON (pancreatin) proprietary medicinal products in pancreatic enzyme replacement therapy in exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and other diseases (for example, chronic pancreatitis, pancreatectomy) and in the treatment of EPI associated with unresectable pancreatic cancer.

Role in the care pathway?

Overall strategy:

Following a diagnosis of exocrine pancreatic insufficiency (EPI) confirmed by assay of faecal elastase and as long as meals and snacks contain fats, it is recommended that enteric-coated pancreatic enzymes, represented by the proprietary medicinal products CREON (pancreatin) and EUROBIOL (porcine pancreas powder) be prescribed as first-line treatment. It should be noted that the efficacy of CREON (pancreatin) is related to its intrinsic pharmacological properties, irrespective of dosage.

Role of CREON 35,000 U (pancreatin) in the care pathway:

CREON 35,000 U (pancreatin) is a first-line treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis and other diseases (for example, chronic pancreatitis, pancreatectomy or pancreatic cancer).

Special recommendations

The use of pancreatic extracts outside the indication “exocrine pancreatic insufficiency”, for example in the treatment of dyspepsia, is not justified and constitutes misuse.

Clinical Benefit

Substantial

The clinical benefit of CREON 35,000 U (pancreatin) is substantial in the MA indication.

Clinical Added Value

no clinical added value

In pancreatic enzyme replacement therapy in exocrine pancreatic insufficiency associated with cystic fibrosis and other diseases (for example, chronic pancreatitis, pancreatectomy), the Committee considers that CREON 35,000 U (pancreatin) is a line extension that provides no clinical added value (CAV V) compared to the proprietary medicinal products already listed.

In pancreatic enzyme replacement therapy in exocrine pancreatic insufficiency associated with unresectable pancreatic cancer, considering:

the low level of evidence of the data available, not enabling evaluation of the new dosage of CREON 35,000 U (pancreatin) in the treatment of EPI associated with unresectable pancreatic cancer;
the already defined recommendations specifying the central role of supportive care, including the treatment of EPI by enzyme replacement therapy, in unresectable pancreatic cancer;
its safety profile that appears to be favourable;

the Committee considers that CREON 35,000 U (pancreatin) provides no clinical added value
(CAV V) in the treatment of EPI associated with unresectable pancreatic cancer.

the Committee considers that CREON 35,000 U (pancreatin) provides no clinical added value (CAV V) in the treatment of EPI associated with unresectable pancreatic cancer.