NICE asks for views on plans to recommend the Spectra Optia Apheresis System which automatically replaces sickle red blood cells with healthy red blood cells
The National Institute for Health and Care Excellence (NICE) is asking for feedback on its plans, announced this week, to recommend use of an innovative new device for people with sickle cell disease.
Sickle cell disease can be a painful, debilitating condition, potentially leading to major organ damage and treatments are very limited
As part of a public consultation, draft medical technology guidance provisionally supports the use of the Spectra Optia Apheresis System, manufactured by Terumo, 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 their 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.
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
The Spectra Optia system is made up of three 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.
“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.”
To read the full guidance, click here.