The U.K. could be lagging behind in regenerative medicine and missing out on opportunities to translate basic science to commercially viable treatments, a new report by Parliament's House of Lords found.
Specifically, the report criticizes the U.K.'s National Institute for Health and Care Excellence (NICE), a nondepartmental body within the Department of Health that publishes guidances on new and existing health procedures and medications, for hindering progress in the area of stem cell research.
NICE is responsible for assessing and approving therapies for use in the U.K.'s National Health System, but the House of Lords investigation says the agency's process for evaluating innovative treatments is "inappropriate," leaving companies and researchers in the dark about how much the NHS would pay for potential new treatments and causing uncertainty over whether they would be paid enough to recover their costs.
"Investors must see a clear path from the bench to the bedside if they are to invest, and a key component of this is reimbursement--a product must be bought at a suitable price by healthcare systems to generate an income," the report says.
The report cites two therapies whose use has been delayed by NICE--a gene therapy called Glybera to treat the rare disease lipoprotein lipase deficiency, and ChondroCelect, a cell therapy that takes a patient's cartilage cells that are biopsied, grown and expanded in a lab to treat cartilage defects in knees. While Glybera was only recently approved for use, ChondroCelect is used in private healthcare settings in the U.K. but is still awaiting evaluation by NICE. Neither has been approved by NICE because no centrally agreed-upon level of reimbursement level can be offered.
This process, the report says, could hurt future research efforts to develop novel stem cell and other therapies. The inquiry says NICE does not consider the long-term financial benefits for stem cell-based treatments, which often have high upfront costs.
Editor's Corner: Stem cell research needs breakthroughs