Negative National Institute for Clinical Excellence (NICE) Draft Guidance On Janssen Biotech Inc.'s Zytiga For Prostate Cancer

Published: May 14, 2014

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NICE issues preliminary recommendations on earlier treatment with abiraterone for prostate cancer

In draft guidance published today NICE has not recommended abiraterone for prostate cancer which has spread in people whose first treatment has failed, have no or mild symptoms and for whom chemotherapy is not yet clinically indicated1.

NICE already recommends abiraterone (also known as Zytiga and manufactured by Janssen) as a ‘second-line' treatment after a docetaxel containing chemotherapy regimen. This current appraisal looks at how well the drug works when people with the disease have few symptoms and chemotherapy would not yet be given.

Commenting on the draft guidance, Sir Andrew Dillon, NICE chief executive, said: “Although abiraterone is not a new drug, it is the first treatment to become available at this point in the treatment pathway. 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 showed that the drug would not be cost-effective at this stage - because of this we cannot recommend the drug in this preliminary guidance. We hope that during this consultation, the manufacturer uses this opportunity to look again at its submission and provides the committee with additional information which may enable them to reconsider.”

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 extend time to progression, the Committee was concerned that as the trial was stopped early and that the results never reached the level needed to prove whether abiraterone improved survival.

The committee also felt there were a number of issues with the way the manufacturer calculated estimated cost-effectiveness. The health economic model was particularly complex and the committee felt that it was not transparent enough for the Evidence Review Group (ERG)2 to fully validate and critique. However, the manufacturer's current data showed that abiraterone cannot be considered value for money.

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.

For more information call the NICE press office on 0845 003 7782 or out of hours on 07775 583 813.

Explanation of terms

Abiraterone is provisionally not recommended within its marketing authorisation for treating metastatic hormone-relapsed prostate cancer in people who have no or mild symptoms after androgen deprivation therapy has failed and in whom chemotherapy is not yet clinically indicated.

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 will be available at 14 May 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.

The Committee concluded that abiraterone compared with placebo increased the time to progression, but that whether it extended life was uncertain.

All the cost per QALYs (Quality Adjusted Life Year) estimated by both the manufacturer and the ERG fell substantially above the range normally considered cost effective that is, £20,000 to £30,000 per QALY gained. The manufacturer's base-case cost per QALY was £46,700 gained and its sensitivity analysis resulted in ICERs from £45,000 to above £50,000 per QALY gained. The ERG presented an ‘exploratory base case' of £57,300 per QALY gained. Additional sensitivity analyses resulted in ICERs of £57,200 to £74,800 per QALY gained.

The cost of abiraterone is £2930 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 considered that the mean life expectancy for people with metastatic hormone-relapsed prostate cancer was unlikely to be less than 30 months; and abiraterone at this stage in the treatment pathway did not meet the first end-of-life criterion for short life expectancy. The Committee concluded that not all of the end-of-life criteria had been met and the end-of-life criteria did not apply to abiraterone taken before docetaxel in the treatment pathway.

SMC published advice to NHS Scotland not recommending abiraterone for this indication as the manufacturer did not submit any evidence to be considered

Abiraterone is available through the cancer drugs fund.

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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