NICE instructs NHS on new drug for advanced soft tissue sarcoma

New guidance published today (24 February) by the National Institute for Health and Clinical Excellence (NICE) will give a specific group of cancer patients, with soft tissue sarcomas, access to a new drug on the NHS which could help extend their lives.

Soft tissue sarcomas are tumours that develop in the soft, supporting tissue in the body, such as fat, muscle and blood vessels and can occur anywhere in the body. It affects around 2,000 people a year in the UK[1] and it is thought that between 500 and 600 people live with the advanced form of the disease in England and Wales.

The guidance recommends trabectedin (Yondelis) for the treatment of certain patients with advanced soft tissue sarcoma. The NHS will now have three months to being implementing this new guidance.

This recommendation was made possible after the drug manufacturer, PharmaMar, agreed to meet the costs of the drug for any treatment needed beyond the fifth cycle of treatment. The independent appraisal committee also applied NICE's criteria for evaluating life-extending, end of life treatments.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: "It's thought between 500 and 600 people live with advanced soft tissue sarcoma in England and Wales. We are pleased to be able to recommend trabectedin for NHS use as it will provide a treatment option for some patients."

In the published guidance, NICE recommends the use of trabectedin as a treatment for people with advanced soft tissue sarcoma if:

· Treatment with anthracyclines and ifosfamide has failed

Or

· They are intolerant of or have contraindications for treatment with anthracyclines and ifosfamide

And

· The acquisition cost of trabectedin for treatment needed after the fifth cycle is met by the manufacturer

The guidance is available to view at: http://guidance.nice.org.uk/TA185

www.nice.org.uk

Further information:

· Trabectedin (Yondelis) is an intravenous drug that works by damaging the DNA in cancer cells, making them unable to grow and spread. It is administered over 24 hours with a three week interval between cycles. The recommended dose is 1.5mg/m2 of body surface area.

· At a dose of 1.5 mg/m2, a patient with a body surface area of 1.7 m2 would need approximately 2.5 mg of trabectedin per cycle. One such infusion (using two 1-mg vials and two 250-microgram vials of trabectedin) would cost £3,458.

· The full cost per patient to the NHS is estimated to be £19,941, assuming the average patient needs around seven cycles of treatment and the acquisition cost of trabectedin for treatment needed after the fifth cycle is met by the manufacturer. However, the total cost depends on the number of cycles used and costs may vary in different settings because of negotiated discounts.

· Research shows trabectedin can extend the life of a person with advanced soft tissue sarcoma by at least 3 more months than current NHS treatment.

· NICE originally issued draft guidance in 2009 not recommending trabectedin for use on the NHS due to its high cost. However, the drug manufacturer, PharmaMar, then offered to cover the costs of the drug for any treatment needed beyond the fifth cycle. This reduces the overall cost of trabectedin to the NHS meaning NICE was able to recommend the drug.

Footnotes:

[1] Cancer Research UK: www.cancerhelp.org.uk