The NICE medical technology guidance 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 device automatically replaces sickle red blood cells with healthy red blood cells in people with the disease. The Spectra Optia is faster to use and patients need the process less often than manual red blood cell exchange.

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.

Professor Carole Longson MBE, Director of the NICE Centre for Health Technology Evaluation, said: “Sickle cell can be a painful, debilitating condition, potentially leading to major organ damage. Treatments are very limited, so this new guidance recommends a novel option which is very good news for patients as it makes the red blood cell exchange process faster and less frequent.  The device could save the NHS in England an estimated £13 million each year – around £18,000 per patient – with the size of the saving depending on the patient’s condition and the equipment already owned by the NHS.

“We also recommend that specialists collaborate to collect and publish data on some outcomes of treatment with Spectra Optia to provide further clinical evidence. It would be particularly helpful to have long-term data on how automated and manual exchange affects the amount of iron in the body and the need to treat this complication.”

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. 

Kelly Samuel, who has sickle cell disease and is being treated with the Spectra Optia system, and who also contributed to the development of the NICE guidance said: “Without Spectra Optia treatment my health and quality of life would be radically diminished. My Sickle Cell Disease would dominate my existence with pain, weakness, and ultimately death. This treatment has been a real lifeline - nowadays my life isn’t constantly overshadowed by the grim prospect of spending weeks, and sometimes months in a hospital bed. Thankfully, I have regular access to the treatment, which I only need to have 5 or 6 times a year instead of every month with the old treatment.  I now have the strength to enjoy my work, my children, family and friends and study for a postgraduate degree. This NICE guideline can encourage best practice in managing sickle cell throughout the NHS – its value to patients is absolutely immeasurable.”

John James, Chief Executive of the Sickle Cell Society, said: “The Sickle Cell Society welcomes the NICE guidance on Spectra Optia. The Society has worked hard to improve access to this technology, and participated in the process every step of the way with NICE to help produce the guidance.  Many people living with sickle cell would benefit from automated red cell exchange and guidance will enable more and more patients to access this treatment. We anticipate that this guidance will help more hospitals adopt the technology, saving patients from costly and often exhausting travel.”

The NICE medical technology guidance on the Spectra Optia system is available at http://www.nice.org.uk/guidance/mtg28 . 

ENDS

For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142, or out of hours on 07775 583 813.

Notes to Editors

About the NICE guidance

1. The 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/mtg28 from Wednesday 2 March. Embargoed copies are available on request from the NICE press office.

2. The Spectra Optia Apheresis System is manufactured by Terumo BCT.

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

a) Capital costs: Spectra Optia device: £45,350; Red blood cell exchange software: £6700

b) Consumables: Spectra Optia exchange set: £1007 per 6; Astotube with injection port: £218 per 50; ACD-A anticoagulant (750 ml): £57 per 12; Service charge: £4572 per year.
Bulk order discounts are available on the consumable sets.

4. Based on current evidence and expert advice on the anticipated benefits of the technology when used in patients with iron overload, cost modelling shows that in most cases using Spectra Optia is cost saving 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 be used to treat sickle cell disease. The estimated cost saving for adopting Spectra Optia is £18,100 per patient per year, which has the potential to save the NHS in England £12.9 million each year.

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.