NICE issues draft guidance refusing the use of Lamzede for alpha-mannosidosis.- Chiesi.
In draft guidance, the National Institute for Health and Care Excellence has announced that the size and nature of any clinical benefits to the use of Lamzede (velmanase alfa) from Chiesi, for the treatment of patients with non-neurological manifestations of mild to moderate alpha-mannosidosis, are highly uncertain both in short and long term, due to key limitations and uncertainties in the evidence from trials presented to NICE.
NICE's draft guidelines also highlight uncertainties in the economic model, especially the fact that the model is based on expert opinion rather than clinical evidence. As a result, NICE has calculated cost-effectiveness estimates for Lamzede and expects it to go beyond the range considered acceptable for specialised therapies.
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