NICE Plans to Recommend Device for Sickle Cell Patients

October 23, 2015

An advisory committee of the U.K.’s National Institute for Health and Care Excellence has issued a preliminary recommendation that the Spectra Optia, a blood component separator, could be cost effective for sickle cell anemia patients who require regular transfusions.

Manufactured by Terumo, the Spectra Optia apheresis system, which has a CE mark as a Class 2b medical device, offers advantages to patients and the National Health Service versus manual red blood cell exchange, a commonly used treatment, according to NICE.

“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,” says Carole Longson, director of the NICE Center for Health Technology Evaluation. 

One potential advantage is that Spectra Optia could help patients who are iron overloaded. Some blood transfusion treatments can raise the amount of iron in a person’s body, potentially leading to liver disease or heart failure. Those receiving treatment must undergo chelation therapy to strip out excess iron; however, that treatment can make some patients feel sick. The committee heard from experts that Speactra “is the only reliable iron-neutral transfusion therapy currently available,” thus reducing the need for chelation therapy.

Still, there are some unknowns. “Uncertainties in the cost model for adopting Spectra Optia lead to a wide range of estimated cost consequences,” NICE says in a consultation document. The cost consequences range from roughly $150,000 per patient per year in savings, to imposing an additional cost of about $9,400 per patient per year compared with manual exchange. The highest costs are seen in patients with severe iron overload.

In addition, the healthcare costs regulator wants to see more data on the outcomes of treatment with Spectra Optia. Specifically, it sees the need for long-term data on the impact of automated and manual exchange on iron overload status and the subsequent need for chelation therapy.

To guide discussions, the committee is seeking stakeholder feedback on the following questions:

  • Has all of the relevant evidence been taken into account?
  • Are the summaries of clinical effectiveness and resource savings reasonable interpretations of the evidence?
  • Are the provisional recommendations a suitable basis for guidance to the NHS?
  • Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?

Interested parties may submit comments through Nov. 16 ahead of a second advisory committee meeting scheduled for Dec. 17. The consultation document is available here: http://www.fdanews.com/10-26-15-spectra-optia.pdf. — Elizabeth Hollis