National Institute for Health and Clinical Excellence (NICE)
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NICE draft guidance recommends new treatment option for advanced soft tissue sarcoma

A new treatment which could extend the lives of a specific group of cancer patients will be available on the NHS.  In the final draft of guidance published today (21 December 2009) by the National Institute for Health and Clinical Excellence (NICE), the drug, trabectedin is recommended as a treatment for certain patients with advanced soft tissue sarcoma.

This draft recommendation has been made possible after the drug manufacturer, PharmaMar, agreed to meet the costs of the drug if it is needed beyond the fifth cycle of treatment. The independent appraisal committee also applied NICE’s criteria for evaluating life-extending, end of life treatments.

In line with the NICE technology appraisals process this final draft of the guidance is now with consultees who have the opportunity to appeal against the proposed recommendation.NICE has not yet issued final guidance to the NHS. Final guidance will be published next year.

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 UK1and it is thought that between 500 and 600 people live with advanced soft tissue sarcoma in England and Wales. Trabectedin works by damaging the DNA in cancer cells, making them unable to grow and spread. Research shows the drug can extend life by at least 3 months more than other treatments currently available on the NHS.

NICE issued draft guidance earlier this year not recommending trabectedin for use on the NHS due to its high cost. However, PharmaMar then offered to cover the costs of the drug for any patient who needs it beyond five treatment cycles. This reduces the overall cost of trabectedin to the NHS meaning NICE is now able to recommend the drug.

Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: “We are delighted the Independent Appraisal Committee has been able to recommend trabectedin in its draft guidance. It has certainly not been an easy decision to make; soft tissue sarcoma is a rare cancer and the evidence was limited.

“However, treatment options for this type of cancer are limited and in the last 20 years there have been no major developments to treat the advanced stages of this disease. Being able to recommend trabectedin for use on the NHS represents a step forward in the care of this group of patients who may have very few treatment options left.”

According to this latest draft 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


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


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

Roger Wilson, Director of Sarcoma UK, said: "I am delighted that trabectedin has been approved. This is the end of a challenging process for sarcoma patients and the doctors who treat them, as well as for NICE. This drug benefits a large proportion of the small number of patients who receive it. I have long believed that trabectedin has a significant part to play in the treatment of advanced soft tissue sarcoma. The manufacturer, PharmaMar, deserves praise for its determination to get this drug approved and it must be thanked too for its constructive approach to making the treatment accessible to patients in the UK."


1Cancer Research UK

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