NICE Wants More Information on BioMarin’s Vimizim
The UK’s healthcare cost regulator is asking BioMarin to provide more information on Vimizim, its treatment for the rare inherited disease Morquio A Syndrome, saying current evidence doesn’t support coverage of the drug.
In preliminary draft guidance released last week, the National Institute for Health and Care Excellence says it needs a cost explanation of Vimizim (elosulfase alfa), additional economic analyses, information on the budget impact of the drug and details of the criteria for using the drug in clinical practice before it can make a final determination on the therapy’s cost-effectiveness.
Specifically, NICE says that BioMarin has not adequately explained the reason for Vimizim’s high cost, which is estimated at $600,000 a year. There are currently 88 people living with Morquio A syndrome in England, and about three new cases are diagnosed each year.
Vimizim was the first product approved by the FDA under its rare pediatric disease priority review voucher program.
BioMarin is actively working to respond to the points raised by the evaluation committee, says company spokeswoman Debra Charlesworth.
Comments are due June 23. Read the draft guidance here: www.fdanews.com/06-15-NICE-Vimizim.pdf. — Jonathon Shacat