21 November 2011
NICE Opens Consultations on Two Medical Devices Set to Benefit Patients and the NHS
NICE, the healthcare guidance body, today (21 November), provisionally supports two innovative medical technology devices, which can benefit both patients and the NHS. The Institute has opened separate consultations on each device: PleurX which can help reduce the severe abdominal fluid retention experienced by some cancer patients, and the Pipeline embolisation device for treating unruptured giant or complex intracranial aneurysms - a bulging blood vessel in the brain.
In draft guidance issued today, NICE provisionally supports the PleurX peritoneal catheter drainage system for vacuum-assisted drainage of treatment-resistant, recurrent malignant ascites. The build up of too much fluid between membranes lining the abdominal wall is called ascites, which can be a symptom of different types of cancers. The large volume of fluid causes severe pain, very swollen abdomen, nausea, difficulty in getting around and psychological distress.
Evidence demonstrates that using the PleurX system can improve patients' quality of life for those with treatment-resistant, recurrent malignant ascites, that it is clinically effective, and has a low complication rate. The device fits into the abdomen wall, and enables the fluid to drain out via a catheter into a vacuum flask. One important benefit of the Pleurx system is that the fluid can be drained at home as needed, and there is no need to wait for a large volume to build up so it can be removed in hospital as is currently the case. The system is also likely to save the NHS around £679 per patient compared with inpatient large-volume paracentesis (fluid drainage).
In separate draft guidance also issued today, NICE provisionally supports the Pipeline embolisation device. Evidence shows that there is a case for adopting the 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.
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 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 is a self-expanding blood flow diverter that is placed across the neck of an intracranial aneurysm. It's a stent-like device which is loaded into and delivered via a microcatheter. Once in place, the blood flow through the parent vessel continues through the device, but it cuts off blood flow to the aneurysm sac. The blood remaining in the blocked-off aneurysm forms a clot and it is eventually excluded from the circulation.
The information presented by the sponsor claims that using the Pipeline embolisation device can reduce the symptoms caused by pressure of the bulging blood vessel on the brain. In addition, the Pipeline embolisation device may be the only feasible treatment for some patients with giant or complex intracranial aneurysms which are unsuitable for treatment with standard methods or surgery. The system is also likely to save the NHS around £421 per procedure compared with standard treatment.
In line with the standard NICE process, both sets of draft medical technology guidance have been issued for consultation and comments on the draft recommendations are welcomed.
The consultation on “PleurX peritoneal catheter drainage system for vacuum assisted drainage of treatment-resistant recurrent malignant ascites” and the consultation on “Pipeline embolisation device for the treatment of complex intracranial aneurysms” will both close at 5pm on 18 December 2011.
Ends
Notes
About the draft guidance on PleurX peritoneal catheter drainage system for vacuum assisted drainage of treatment-resistant recurrent malignant ascites
1. The PleurX peritoneal catheter drainage system is distributed by UK Medical Ltd.
2. The costs for the PleurX peritoneal catheter and the PleurX drainage kit with a 1 litre vacuum bottle are £245 and £64 per unit respectively.
About the draft guidance on Pipeline embolisation device for the treatment of complex intracranial aneurysms
3. The Pipeline embolisation device is manufactured by Covidien
4. The cost of the Pipeline embolisation device stated in the sponsor's submission was £10,171.
5. The Pipeline embolisation device is estimated to be cost saving when compared against stent assisted coiling, in patients with giant or complex intracranial aneurysms when the number of Pipeline embolisation devices inserted does not exceed two and when treatment would otherwise require the use of 29 coils combined with one stent for stent-assisted coiling. If two Pipeline embolisation devices are used the total procedure cost is estimated as £30,354 compared with £30,775 for the use of 29 coils for stent assisted coiling (a saving of £422 using Pipeline).
6. The draft guidance includes a recommendation that clinicians should submit details of all patients being treated with the Pipeline embolisation device to the UK Neurointerventional Radiology Group audit database, to increase the evidence base and guide future use of this technology.
About the Medical Technologies Evaluation Programme
7. Established by NICE in 2009, the focus of this new area of work is specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions.
The independent Medical Technology Advisory Committee (MTAC) has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. In producing medical technology guidance, MTAC looks at whether a device offers benefits to the patient and NHS at a lower cost compared with similar products, or increased benefits for equal cost. The guidance applies to the NHS in England, and is not mandatory.
About NICE
8. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.
9. NICE produces guidance in three areas of health:
- public health -guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies -guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice -guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
10. NICE produces standards for patient care:
- quality standards- these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
- Quality and Outcomes Framework -NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
11. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.