NICE, the healthcare guidance body, has issued new draft guidance recommending enzalutamide (Xtandi, Astellas Pharma) as an option for treating hormone relapsed metastatic prostate cancer in adults.

Commenting on the draft guidance, Professor Carole Longson, Director, Centre for Health Technology Evaluation, NICE: "There are few treatments available for patients at this stage in their cancer so we are very pleased that we are able to produce draft guidance recommending enzalutamide. It is an effective treatment and it also allows patients to be treated at home as it can be taken orally."

Enzalutamide works in a different way to other drugs currently available for treating prostate cancer and it is recommended as an option for treating hormone relapsed metastatic prostate cancer in adults, only if their disease has progressed during or after 1 docetaxel-containing chemotherapy regimen and the manufacturer provides enzalutamide with the discount agreed in the patient access scheme.

Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.

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.

Ends

Notes to Editors

About the guidance

1. The draft guidance will be available at http://guidance.nice.org.uk/TAG/354 from 17 October 2013. Embargoed copies of the draft guidance are available from the NICE press office on request.

2. The Committee accepted that the cost per 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.

3. 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.

4. The SMC has not published advice on this topic

5. The Committee heard that, although both enzalutamide and abiraterone are oral treatments, only enzalutamide can be taken on a full stomach, making it more convenient to take. It also heard that enzalutamide can help to control the cancer longer because there is no need to reduce the dose to prevent liver toxicity, as with abiraterone.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

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