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NICE to update ovarian cancer drug guidelines

Draft guidance backs paclitaxel and Janssen’s Caelyx but not gemcitabine, topetecan or trabectedin

National Institute for Health and Care Excellence NICE logo 

The UK's National Institute for Health and Care Excellence (NICE) is to update its guidelines for the use of medicines in advanced ovarian cancer, with its current plan being to back two drugs but dismiss three others.

In draft guidance the watchdog, which assesses the cost effectiveness of medicines for NHS use in England and Wales, determined that both Janssen's Caelyx (pegylated liposomal doxorubicin hydrochloride or PLDH) and the chemotherapy paclitaxel justified NHS funding as treatments for ovarian cancer that has returned after previous treatment with chemotherapy.

However, NICE declined to recommend PharmaMar's Yondelis (trabectedin), as well as the generics gemcitabine and topetecan, as treatments for ovarian cancer that has returned for the first time six months or more after platinum-based chemotherapy.

On top of this, topetecan was also not recommended for the treatment of cancer that has returned less than six months after therapy with a platinum-based regimen or which did not respond to platinum at all.

According to NICE, the three drugs turned down for use provided little benefit for patients compared to other drugs approved for these stages and failed to prove their cost-effectiveness.

“These difficult decisions help the NHS to allocate its limited resources fairly,” said NICE chief executive Sir Andrew Dillon.

The news will be welcomed by Janssen, which has endured a troubled time for Caelyx over the past couple of years in the US, where it is sold as Doxil.

The drug was one of a number manufactured by the troubled Ben Venue Laboratories, which faced a temporary suspension of manufacturing and distribution of drug products due to a series of violations in standards.

This led to a shortage in the product, with the US Food and Drug Administration fast-tracking approval of Sun Pharma's generic version for use in multiple myeloma.

The news is less positive for PharmaMar, which already has a NICE recommendation for the use of Yondelis for the treatment of advanced soft tissue sarcoma.

The draft guidance is now in consultation stage and open to comments until October 18, 2013.

Article by
Thomas Meek

30th September 2013

From: Sales, Healthcare



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