In final draft guidance published today NICE has not recommended abiraterone for prostate cancer in people who received hormone therapy (androgen deprivation) but whose disease has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 which 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Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: "NICE has already recommended abiraterone as a treatment after docetaxel containing chemotherapy.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 (ERG) 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.
Notes to Editors
Explanation of terms
The Evidence Review Group (ERG) assess the strength and quality of the research evidence submitted by manufacturers to NICE as part of the technology appraisals process.
About the draft guidance
The draft guidance on the use of abiraterone acetate for the treatment of metastatic hormone relapsed prostate cancer not previously treated with chemotherapy will be available at http://guidance.nice.org.uk/TAG/434 from Friday 15 August 2014. Embargoed copies of the draft guidance are available from the NICE press office on request.
The Committee heard from clinical specialists that, when cytotoxic chemotherapy is indicated, most people would have docetaxel. But, when people have no or mild symptoms, and to defer chemotherapy and its adverse effects, clinicians may instead offer best supportive care including corticosteroids such as prednisolone or dexamethasone.
All cost per Quality Adjusted Life Year (QALY) estimated both by the manufacturer and the Evidence Review Group fell substantially above the range normally considered cost effective, that is, £20,000 to £30,000 per QALY gained. The manufacturer's base case was £46,700 per QALY gained.
The cost of abiraterone is £2,930 for 120 tablets (excluding VAT; British National Formulary [BNF] 67). Abiraterone is administered as a single dose of 1 g per day, taken as four 250 mg tablets. The manufacturer of abiraterone (Janssen) has agreed a patient access scheme with the Department of Health. This involves a single confidential discount applied to the list price of abiraterone across all indications.
The Committee concluded that current mean life expectancy for people with metastatic hormone-relapsed prostate cancer for whom chemotherapy is not yet indicated was unlikely to be less than 24 months, and abiraterone at this stage in the treatment pathway did not meet the end-of-life criterion for short life expectancy. Because the first criterion had not been met, the Committee did not conclude formally whether abiraterone met the other criteria.
SMC published advice to NHS Scotland not recommending abiraterone for this indication as the manufacturer did not submit any evidence to be considered http://www.scottishmedicines.org.uk/SMC_Advice/Advice/873_13_abiraterone_Zytiga_Non_Submission/abiraterone_Zytiga.
Abiraterone is available through the cancer drugs fund.
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