NICE approves balloon catheter for coronary restenosis

The NICE report makes the case for widespread adoption by hospital teams of the drug-coated balloon catheter, as the evidence showed that it reduces restenosis of the coronary arteries more than drug-coated stent. It also reduces the need for further treatments and procedures to treat restenosis, resulting in substantial savings.

After the first year of use, NICE estimates that the balloon catheter could yield an annual estimated cost saving to the NHS of nearly £485,000, compared with standard therapy. The report considers that reductions in the number of cases of restenosis requiring medical treatment, readmission and repeat surgery would have future cost savings, if these effects were maintained in the long term.

The main recommendations for the SeQuent Please balloon catheter include that it should be considered for use in patients with in-stent restenosis in bare metal coronary artery stents, and in patients with other types of stent where there are clinical reasons to minimise how long clopidogrel treatment is used.

It should also be considered as an option for use in patients in whom it isn’t technically possible to insert further stents. The guidance also recommends further research in a UK setting comparing long-term outcomes of patients treated with SeQuent Please balloon catheter to those treated with other types of drug-eluting balloon catheter and stent.

In a statement, Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, says: “We are delighted to publish this first medical technology guidance – it’s an important milestone both for NICE and the organisations we’ve worked with closely in establishing the new program to evaluate medical technologies.

“The evidence considered indicates that SeQuent Please balloon catheter may benefit patients and the NHS in the long term by reducing the number of cases requiring further treatment for restenosis. We hope that the NHS will find that our new pieces of medical technology guidance will help provide clarity on innovative devices that provide good-value improvements to patient care.”

Notes

1. The cost models used indicated that SeQuent Please balloon catheter is associated with an estimated annual cost saving of £484,800 to the NHS after the first year of use, compared with paclitaxel eluting stent.
2. SeQuent Please balloon catheter is manufactured by B.Braun.
3. The cost of a SeQuent Please balloon catheter is approximately £650 to £950; costs may vary because of differences in purchasing contracts.

Read NICE guidance in full online: http://egap.evidence.nhs.uk/MTG1