UK NICE Supports Use Of Pipeline® Device For Treating Patients With Complex Brain Aneurysms

In short

UK’s National Institute for Health and Clinical Excellence(NICE)  has provided guidance supporting the use of Covidien’s Pipeline® embolisation device in the NHS when it is used in patients with giant or complex intracranial aneurysms who would need large numbers of coils during stent-assisted coiling and who are unsuitable for neurosurgical treatment.

Background

An aneurysm is a bulge in a blood vessel that’s caused by a weakness in the blood vessel wall. If an aneurysm in the brain ruptures, the resulting haemorrhage can cause death or serious brain damage and symptoms including sudden severe headache, stiff neck and nausea. 1 in 12,500 people will have a ruptured intracranial aneurysm in any given year in England.

The Pipeline® embolisation device was developed by ev3 Inc., a company subsequently acquired in 2010 by Covidien. It is a self-expanding blood flow diverter, loaded into and delivered via a microcatheter and placed across the neck of an intracranial aneurysm. Once in place, the blood flow through the parent vessel continues through the device, but the blood flow within the aneurysm sac is disrupted, leading to stagnation until it eventually forms a clot and is excluded from the circulation.

Why is it supported?

The case for adopting the Pipeline embolisation device in the NHS is supported by the current evidence when it is used in patients with complex giant or large intracranial aneurysms which are unsuitable for surgery and being considered for stenting, and where large numbers of coils would be needed during stent-assisted coiling.

Even at the unit price of £10,171 (approx $17,000) as quoted in Covidien’s submission, the Pipeline embolisation device is estimated to be cost saving when compared with stent-assisted coiling, in patients with complex giant or large intracranial aneurysms when the number of Pipeline embolisation devices inserted does not exceed two, and when treatment would otherwise require the use of 32 or more coils combined with one stent for stent-assisted coiling. If two Pipeline embolisation devices are used the total procedure cost is estimated as £30,346 compared with £30,838 for the use of 32 coils for stent-assisted coiling (a saving of £492 using the Pipeline embolisation device).

NICE comments

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “We’re pleased to publish this guidance supporting the Pipeline embolisation device for specific patients with giant or complex intracranial aneurysms. The independent NICE Medical Technologies Advisory Committee reviewed the evidence for adopting the Pipeline embolisation device in the NHS, and concluded that it has benefits for patients including a reduction in the symptoms caused by pressure of the bulging blood vessel on the brain, reduced rates of retreatment and a decreased rate of brain haemorrhage. In some clinical scenarios, using Pipeline is expected to save the NHS around £492 per procedure compared with standard treatment.

“We are also very keen for clinicians to submit details of all patients being treated with the Pipeline embolisation device to the UK Neurointerventional Radiology Group audit database, as the guidance recommends. This will increase the evidence base and help guide the future use of this technology.”

Company comments

“We were delighted to hear that the National Institute for Health and Clinical Excellence (NICE) has developed medical technology guidance for the Pipeline Embolization Device, which can be used to treat complex giant or large intracranial aneurysms which can’t be treated with surgery,” said Chris Hutchison, International Vice President and General Manager, Vascular Therapies, Covidien. “The Pipeline Embolization Device is a breakthrough and life-saving treatment that offers hope for those patients who have had no other options for treating this often debilitating and even fatal medical condition.”

Regulatory status

Pipeline was CE marked in 2009 and received FDA PMA clearance in early 2011.

The guidance “Pipeline embolisation device for the treatment of complex intracranial aneurysms” is available here.

Source: NICE, Covidien