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NICE plans to support new device to improve red blood cell exchange in sickle cell disease management

NICE is asking for views on its plans to recommend a new device that automatically replaces sickle red blood cells with healthy red blood cells in people with sickle cell disease.

In the public consultation that opens today (Monday 19 October), the draft medical technology guidance provisionally supports the use of the Spectra Optia Apheresis System for automated red blood cell exchange in patients with sickle cell disease who need regular transfusion.  

The evidence examined indicates that this automated device is faster to use and patients need the process less often than manual red blood cell exchange. As well as these improvements for patients, using Spectra Optia is estimated to be cost saving in most patients compared with manual red blood cell exchange or top-up transfusion. Potential savings depend on the patient’s clinical circumstance and if devices already owned by the NHS can also be used to treat sickle cell disease.

Sickle cell disease is an inherited genetic disease affecting red blood cells. The cells are a crescent – or sickle – shape instead of the normal round disc shape, affecting the cell’s ability to carry oxygen and move around the body. Symptoms may include intense pain and severe anaemia, and the condition can cause damage to major organs and infections, and life-threatening complications.  There are between 12,500 – 15,000 people with sickle cell disease in the UK, with an estimated 240,000 genetic carriers. It is more prevalent among people of African and African-Caribbean descent, but it can affect any ethnic group.  There is no routine cure for sickle cell disease but patients can be supported to manage the condition.

Some blood transfusion therapies increase the amount of iron in a person’s body which can lead to serious problems such as liver disease or heart failure.  Iron chelation therapy is required to reduce the amount of iron in the body, but this treatment can make some patients feel unwell and is very expensive for the NHS. Treatment with the Spectra Optia is intended to be iron neutral, meaning that patients who are already iron overloaded can have their condition managed effectively.

Professor Carole Longson MBE, Director of the NICE Centre for Health Technology Evaluation, said: “Sickle cell disease can be a painful, debilitating condition, potentially leading to major organ damage. Treatments are very limited. This draft medical technologies guidance proposes supporting the use of the Spectra Optia system.  The evidence considered indicates that the device benefits patients by making the red blood cell exchange process faster and less frequent, and could save the NHS money, with the size of the saving depending on the patient’s condition and the equipment already owned by the NHS. The draft guidance recommendations also highlight a need for data collection on treatment outcome to supplement the limited clinical evidence on some outcomes. In particular, the independent Medical Technologies Advisory Committee would like to see long-term data on how manual and automated cell exchange affects the amount of iron in the body and the need to treat this complication. We welcome comments on the draft guidance as part of this consultation.”

More information on the medical technology draft guidance consultation for the Spectra Optia system is available at http://www.nice.org.uk/guidance/indevelopment/gid-mt271. The consultation closes on 16 November 2015.  

 

 

About the NICE guidance

1. The draft medical technologies guidance, “Spectra Optia for automated red blood cell exchange in patients with sickle cell disease”, is available at http://www.nice.org.uk/guidance/indevelopment/gid-mt271 from Monday 19 October.

2. The Spectra Optia system is manufactured by Terumo.

3. The list prices (excluding VAT) for the components of the Spectra Optia system are as follows:

a) Capital costs: Spectra Optia device: £45,351.60; Exchange/depletion software: £6700.85

b) Consumables: Spectra Optia exchange set: £1007.04 per 6 (£167.84 each); Astotube with injection port: £218.50 per 50 (£4.37 each); ACD-A anticoagulant (750 ml): £57.36 per 12 (£4.78 each); Service charge: £4572 per year.

Bulk order discounts are available on the consumable sets.

4. Cost modelling shows that using Spectra Optia is cost saving in most patients compared with manual red blood cell exchange or top-up transfusion. The savings depend on the iron overload status of the patient, and are more likely to be achieved if devices already owned by the NHS can also be used to treat sickle cell disease. Uncertainties in the cost model for adopting Spectra Optia lead to a wide range of estimated cost consequences, from a saving of £96,512 per patient per year to an additional cost of £6,046 per patient per year compared with manual exchange (see table 2a in section 5.14 of the draft guidance for more information).

5. The Spectra Optia system is made up of 3 components: the apheresis machine, embedded software and a single-use disposable blood tubing set. Apheresis is the process where a patient’s blood is passed through a system, then selected blood components are removed and the rest of the blood is returned to the patient.

6. Sickle cell affects the normal oxygen carrying capacity of red blood cells, which should be round and flexible, allowing them to move around the body easily. But in people with sickle cell disease, the shape and texture of the blood cells can change, and they become rigid and sticky, and, as the name of the condition implies, shaped like sickles, or crescents. The cells do not survive as long as usual blood cells so that people do not have enough red blood cells and become anaemic.

7. Existing NICE guidance on managing sickle cell disease addresses patients with an acute painful episode (published 2012) which is outside the scope of this evaluation.

About the Medical Technologies Evaluation Programme

8. The Medical Technologies Evaluation Programme focuses 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 has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

More information is available at http://www.nice.org.uk/MT.