In separate new NICE guidance, people with prostate cancer that has spread to other parts of the body, and who have been treated with the cytotoxic drug docetaxel, will be given access to enzalutamide through the NHS (enzalutamide is also known as Xtandi and manufactured by Astellas Pharma).

Professor Carole Longson, centre for health technology evaluation director at NICE, said: “Both cancer treatments are recommended on the basis that the manufacturers provide them to the NHS with a patient access scheme, where there is a discount on the price of the drug. We are also very pleased that the manufacturers have worked with us to provide more evidence so that we are able to recommend both treatments.”

Commenting on the enzalutamide guidance, Professor Longson said: “We are pleased to confirm that enzalutamide will be made available through the NHS for patients whose prostate cancer has progressed after previous treatment with cytotoxic chemotherapy. Enzalutamide works in a different way to the other options currently available for treating prostate cancer (1). As there are few treatments available for patients at this stage of prostate cancer, this is really good news for patients.”

Commenting on the ipilimumab guidance, Professor Longson said: “Advanced melanoma can significantly affect patients’ quality of life and without effective new therapies, the prognosis for advanced disease is very poor. For many years the treatments available for advanced skin cancer have been very limited and in some cases restricted to palliative care. However, new drugs such as ipilimumab can make a real difference. We already recommend it as a second-line treatment and are pleased to be able to extend that recommendation to first line treatment too.”

Notes to editors

About the enzalutamide guidance

1. The guidance is now available.
2. During consultation on the draft recommendations for using enzalutamide, we received a number of responses, including data and comments from the manufacturer of the drug, professional organisations and patient groups.  Due to this additional information we now know that, at the moment, evidence on the effectiveness of enzalutamide when given after abiraterone is too unc ertain to make a definitive evidence-based recommendation, so we have not done so. We know that the manufacturer is currently collecting data on the use of enzalutamide after abiraterone and we look forward to seeing the results of the ongoing trials.
3. When enzalutamide is used for treating metastatic prostate cancer previously treated with docetaxel only, abiraterone is the appropriate comparator. The Committee accepted that the cost per Quality Adjusted Life Year (QALY) for enzalutamide compared with abiraterone is associated with some degree of uncertainty. However, on balance, it was satisfied that, based on the evidence it had considered, it would remain below £30,000 per QALY gained. When enzalutamide is used to treat metastatic prostate cancer previously treated with 2 or more previous courses of cytotoxic chemotherapy, best supportive care is the appropriate comparator. The Committee noted that the cost per  QALY estimated by the manufacturer for enzalutamide compared with best supportive care was £45,500 and that the Evidence Review Group’s ICER was £48,000 per QALY gained compared with best supportive care
4. Enzalutamide costs £2734.67 for 1 pack of 112 40 mg capsules. Based on a daily dosage of 160 mg and a mean length of treatment of 8.5 months, the manufacturer has estimated that the average cost of treatment with enzalutamide, based on the list price, is £25,269. The manufacturer of enzalutamide has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the price listed above, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence.
5. Enzalutamide (Xtandi®) has been accepted for use within NHS Scotland by the Scottish Medicines Consortium: http://www.scottishmedicines.org.uk/SMC_Advice/Advice/911_13_enzalutamide_Xtandi/enzalutamide_Xtandi
6. In previously published guidance, NICE recommends ipilimumab as a second-line treatment for people with advanced (unresectable or metastatic) malignant melanoma.
7. The Committee considered the manufacturer’s updated base-case results submitted in response to consultation. The Committee concluded that the most cost per Quality Adjusted Life Year (QALY) was £47,900 for ipilimumab compared with dacarbazine and £28,600 per QALY for ipilimumab compared with vemurafenib.
8. Ipilimumab costs £3,750 per 10-ml vial or £15,000 per 40-ml vial. The manufacturer of ipilimumab has also agreed a patient access scheme with the Department of Health, in which the drug will be sold to the NHS at a discounted price. The level of the discount is commercial in confidence.
9. Prior to consultation, when considering the evidence for ipilimumab as a first-line treatment, the committee noted that the pivotal clinical trial CA184‑024 assessed ipilimumab 10 mg/kg plus dacarbazine and not its licensed dose (4 doses of ipilimumab 3 mg/kg alone over 12 weeks). The Committee concluded that trial data submitted by the manufacturer had demonstrated an overall survival gain for patients treated with ipilimumab, and that this gain was at least 3 months. After the manufacturer made several adjustments the Committee concluded that the data were suitable for estimating the clinical effectiveness of ipilimumab 3 mg/kg.
10. In 2010, 10,656 people were diagnosed with malignant melanoma in England. There are currently no national figures relating to the stage of the disease at diagnosis. http://www.cancerresearchuk.org/cancer-info/cancerstats/types/skin/incidence/#country