NICE Develops a Medtech Innovation Briefing on L-Dex U400 for Lymphoedema After Breast Cancer Treatment

NICE announced in July 2017 that has developed a medtech innovation briefing (MIB) on L-Dex U400 for lymphoedema after breast cancer treatment. The L‑Dex U400 (Impedimed Ltd.) uses bioimpedance spectroscopy to detect unilateral lymphoedema in the limbs (particularly the arms) after treatment for breast cancer that has removed or damaged the lymph nodes. It may also be used to detect leg lymphoedema in men, but this is beyond the scope of this briefing.

In bioimpedance spectroscopy, a small electrical current is passed through the affected limb and the resistance to the current is compared with the unaffected limb. The resistance is used to calculate the total water content in the body, which can be used to detect lymphoedema.

The technology described in this briefing [MIB111] is the L‑Dex U400. It is used for early detection of unilateral lymphoedema in the limbs after treatment for breast cancer.

The innovative aspects are that it uses bioimpedance spectroscopy to measure fluid status, aiming to detect lymphoedema earlier.

The intended place in therapy would be in diagnosing or monitoring lymphoedema related to breast cancer treatment. It could be used as an alternative to current detection or measurement techniques, such as simple tape measurement of limb circumference.

The main points from the evidence summarised in this briefing are from 3 studies in the UK and the US using prospective observational data, as well as a budget impact analysis, in a total of 978 patients (female adults) in secondary care. They show that the L‑Dex U400 is less effective than comparators in diagnosing lymphoedema, but potentially helps detect subclinical lymphoedema, in people who have had treatment for breast cancer.

Key uncertainties around the evidence and technology are that the evidence base is still developing. So far, it shows that the L‑Dex U400 is not as effective as current tests for diagnosing lymphoedema. Further complications are that, in NHS practice, there is no current surveillance for subclinical lymphoedema, and no consensus on the diagnostic gold standard for lymphoedema. A further study is ongoing.

Once diagnosed, lymphoedema is a chronic condition and treatment involves physical methods to reduce swelling. Surgery is an option in a small number of cases.

The cost of the L‑Dex U400 is 7,500 GBP per unit (exclusive of VAT). The resource impact for the NHS is unclear because of a lack of evidence.