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In its final draft guidance, the National Institute for Health and Care Excellence (NICE) has not recommended abiraterone for prostate cancer in people who received hormone therapy (androgen deprivation) but whose disease has spread, who have few symptoms and when chemotherapy would not yet have been given.
Prostate cancer that has spread is first treated hormonally – with androgen deprivation therapy. When this treatment does not work any longer, docetaxel containing chemotherapy can be given. Abiraterone (also known as Zytiga and manufactured by Janssen) is a hormone therapy, and unlike chemotherapy that kills the cancerous cells, it stops more testosterone from reaching the prostate gland and thereby stifles the tumour.
Abiraterone has previously been recommended by NICE for treatment after docetaxel containing chemotherapy. The current appraisal is considering the use of abiraterone before chemotherapy.
Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: “NICE has already recommended abiraterone as a treatment after docetaxel containing chemotherapy. In this appraisal, we have been considering it for an earlier stage in treatment. Abiraterone is not a new drug, but it is the first treatment of its type to become available prior to chemotherapy.
“We know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way. However, the manufacturer’s own economic model demonstrated that the drug does not offer enough benefit to justify its price.”
The clinical evidence submitted by the manufacturer came from one trial (COU-AA-302). Although the results indicated that, when compared with placebo, abiraterone could delay the progression of the disease, it was not clear how much abiraterone actually extended life.
The committee also had a number of concerns with the way the manufacturer calculated estimated cost-effectiveness. The health economic model was particularly complex and the committee felt that this has made it difficult for the Evidence Review Group to validate and critique the model. However, it was clear that the drug is not cost-effective at its current price.
Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
